Friday, July 25, 2014

Guest Post - Another Third Party Payor Case Is Shown The Door

Today we have this guest post from Reed Smith's Andrew Stillufsen about a recent defense win in a third party payer (or is it"payor"?) case here in the Eastern District of Pennsyvania.  We hope you find it as interesting as we did.  As usual all credit and/or blame belong to the guest poster.


Travelers Indemnity Co. v. Cephalon, Inc., is a third party payor case where plaintiffs – workers compensation insurers – claimed that they were injured by paying for prescriptions for defendant drug company’s  pain medications which were written as a result of its alleged off-label marketing of the drug.  2014 U.S. Dist. Lexis 95075 (E.D. Pa. July 14, 2014).  SPOILER ALERT:  as with similar cases, even after extensive discovery and an amended complaint, plaintiffs still failed to allege facts sufficient to establish standing or to support any of their fraud claims.  Motion to dismiss granted.

Before the court could address plaintiffs’ substantive claims, it first had to determine whether the allegations were sufficient to establish standing.    To establish standing, the plaintiff must show that they suffered a cognizable injury. Id. at *16-18.   “The contours of the injury-in-fact requirement, while not precisely defined, are very generous, requiring only that the claimant allege some specific, identifiable trifle of injury.”  Id. at *17.  (citations and internal quotations omitted).  Under the now-familiar TwIqbal analysis, plaintiffs failed to allege sufficient facts to show even a mere “trifle.” 

In this case, plaintiffs essentially alleged two theories of injury.  First, they claimed they were injured because “they did not get what they paid for,” as plaintiffs paid for drugs that were not safe or effective due to defendant’s alleged fraudulent off-label marketing.  Second, but for the alleged off-label marketing, plaintiffs  claimed they were injured when they paid for more expensive drugs when less-expensive drugs were available.  Id. at *18-19.

To support their first theory, plaintiffs pointed to the labeling and FDA-mandated “dear-doctor” letters stating the drugs were contraindicated for certain users.  In addition, plaintiffs claimed that the medications had never been proven safe and effective for any use other than the approved indication.  However, the court warned that “the liberal use of conclusory adjectives such as ‘ineffective’ will not establish standing without factual allegations to show that the plaintiffs themselves were injured by paying for the drugs.”  Id. at *19.  Major point one:  Furthermore, “[t]he absence of data or evidence affirmatively proving that a drug is safe and effective in treating a particular condition, without more, does not support the conclusion that the drug is actually ineffective or unsafe for the use.”  Id. at *21.  (citation omitted).  In addition, the court noted that “[t]he fact that a drug poses even a significant possibility of harm does not, by itself, establish injury-in-fact to the party paying for the drug.”  Id. at 24 (emphasis added).  As Carl Sagan would say, “absence of evidence is not evidence of absence.”

Looking at these allegations through the TwIqbal lens,  the court held that plaintiffs did not plead sufficient facts “to show that they paid for an ineffective drug, or that the drug’s safety risks resulted in some expenditure by the plaintiffs themselves.”  Id. at *24-25.  Therefore  plaintiffs’ first theory – that they did not get what they paid for – failed.

Plaintiffs’ second theory - that they paid for more expensive drugs when less expensive ones were available - suffered the same result.  Major point two:  The court lucidly noted that “[a] plaintiff is not injured simply because it paid for a more expensive drug. If this were so, then any successful marketing campaign  - no matter how truthful – that induced a consumer to purchase the more expensive of competing products would cause economic injury.”  Id. at *25 (quotations omitted).  Plaintiffs “must also plead facts to show that the drug was prescribed or purchased in reliance on untrue statements or misrepresentations about the drug’s attributes.”  Id. at *28. 

Once again, plaintiffs could not meet their burden.  Somewhat nonsensically, plaintiffs pointed to defendant’s price reductions, made to compete with generic competitor and to maintain market share, as evidence.  The court was not impressed.  It held that plaintiffs not only failed to “name any equally effective, safer, less expensive drug that doctors might have prescribed,” but they also did not “identif[y] any demonstrably false statement or material omission by the defendants about the safety or efficacy” of the medications.  Id at *28-29.  Therefore, no cognizable injury, no standing, motion granted, complaint dismissed. 

In some helpful dicta, the court also booted plaintiffs’ substantive claims.  Since the amended complaint contained numerous allegations that the alleged off-label marketing campaign was intentionally deceptive, plaintiffs’ intentional and negligent misrepresentation claims “sounded in fraud.”  Therefore, these claims were subject to Rule 9(b)’s “heightened pleading requirements.”  Id. at 32. 

On this count, plaintiffs again failed to meet their burden, as they “fail[ed] to identify a single false statement, misrepresentation or deliberate material omission” by defendants.  Id. at 34.  Major point three:  Plaintiffs’ argument that off-label promotion “is ipso facto fraudulent” was simply incorrect, as “[c]ourts have consistently held that off-label promotion is not inherently deceptive, and does not support a private action for fraud or negligent misrepresentation unless the promotion includes an untruthful or misleading statement about the safety or efficacy of the drug itself.”  Id. (emphasis added). 

A similar fate befell plaintiffs’ state unfair competition laws.  “State consumer protection statutes do require that a plaintiff have suffered an ascertainable loss or injury as a result of a defendant’s alleged wrongdoing.”  Id. at *44.  Since the court had already found that plaintiffs failed to allege sufficient facts to show a cognizable injury, they couldn’t satisfy this requirement either.  Plaintiffs’ unjust enrichment claim was also dismissed, as plaintiffs failed to show a cognizable loss or that defendant engaged in  fraudulent behavior.  Id. at 48. 

In sum, this decision falls squarely in line with previous third party payor decisions.  While making splashy allegations about off-label promotion may look good on paper, courts will show  the door to these claims without particularized allegations about what the defendant did and how it hurt plaintiff. 

Thursday, July 24, 2014

Testing the Limits of Prescription Drug Preemption

Just how far can a state go in regulating prescription drugs?  The simple answer is that states can go nowhere and that FDA is king in this field under the FDCA and the Supremacy Clause.  But we all know that it is not that simple.  We are reminded every day when we come to work that states regulate prescription drugs by allowing state-law tort lawsuits, although federal preemption is a mighty shield where it applies.  We are also aware that states regulate the practice of medicine, as well as regulating the pharmacies that dispense prescription drugs on doctors’ orders. 
So before we blithely tell our various state regulators to stand down and keep their hands off, let’s take a more nuanced view, including revisiting what is going on in Massachusetts over the narcotic pain medication Zohydro.  As we have previously said, Zohydro ER is an extended release version of hydrocodone, but it is the only hydrocodone analgesic on the market whose sole active ingredient is hydrocodone.  Others contain acetaminophen, and removing that component mitigates the risk of liver damage for which acetaminophen is well known. 
After the FDA approved Zohydro in December 2013, the state of Massachusetts and others tried to prohibit its use because of concerns over abuse.  In Massachusetts, the state issued an emergency order banning the prescription, ordering, dispensing, and administration of Zohydro—essentially a state-law order taking an FDA-approved drug off the market.  On April 15, 2014, the District of Massachusetts enjoined the law as an obstacle to the purposes and objectives of Congress.  In other words, it was a textbook example of implied conflict preemption, and the only solution was for the state requirement to give way, which is what the district court held in granting a preliminary injunction.  Zogenix, Inc. v. Patrick, No. 14-11689-RWZ, 2014 WL 1454696 (D. Mass. Apr. 15, 2014).  Our post on that decision is here. 
To be honest, since a federal “yes” trumps a state “no,” we thought that would be the end of this particular controversy, if not the larger battle over prescription opioids generally.  But we were wrong.  One week after the district court’s order, Massachusetts replaced its blanket prohibition with a set of regulations that purport to limit, but not entirely prohibit the prescription and use of Zohydro.  See Zogenix, Inc. v. Patrick, 2014 U.S. Dist. LEXIS 92382, at **3-4 (D. Mass. July 8, 2014).  For prescribers, the regulations required individual assessment of each patient, including discussing risks and benefits and entering into “agreements” regarding the use, storage, and disposal of the drug.  Most significantly, the regulations required that each prescribing physician supply a “Letter of Medical Necessity” indicating compliance with the regulations and verifying “that other pain management treatments have failed.”  Id. at *4 (emphasis in original). 
For pharmacists, the regulations limited who could handle Zohydro and set a number of prerequisites for dispensing the drug, including storing it in a locked cabinet, dispensing it in child-proof containers, reviewing the “Letter of Medical Necessity,” providing warnings and counseling, and checking the patient’s history.  Id. at *5.  Considered all together, the state’s message was that, if it could not outright prohibit the prescription and use of Zohydro, it would instead make doctors and pharmacists jump through so many hoops before the product reached the hands of patients that it would be too much trouble to try. 
So now what do we do?  For the record, we still think that state regulations such as these are preempted by federal law, but we acknowledge that burdens like those imposed here – as opposed to all-out prohibitions – present a more difficult issue.  It’s at least the same sort of problem raised by recent state attempts to regulate into oblivion the off-label use of certain drugs used to terminate pregnancies.
The manufacturer moved again for a preliminary injunction, arguing with substantial justification that the regulations were a de facto ban on Zohydro.  And even if they were not, federal law still preempted the regulations because the FDA approved Zohydro for a specific use and purpose:  “management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.”  Id. at *10.  The state regulations set a different standard:  Instead of other options being merely “inadequate,” the state law requires that “other pain management treatments have failed.”  According to the manufacturer, the state’s new requirement was preempted because it undermined the FDA’s power to approve drugs for specific uses.  Id.
We think the manufacturer has a point, and so did the district court in holding that there is no “health” exception to federal preemption:

Sure enough, the Commonwealth’s police powers permit it to regulate the administration of drugs by health professionals . . . But it may not exercise those powers in a way that is inconsistent with federal law.  Preemption principles have no less heft because health is a matter of “special concern” to the states. . . .  To say as [the Commonwealth does], that they are exercising their constitutional authority does not answer the question.  I must do as Savage [v. Jones] instructs and assess whether the regulations prevent the accomplishment of the FDCA’s objective that safe and effective drugs be available to the public. 

Id. at *11.  As we said the last time we discussed this case, helpful preemption authority sometimes comes in unexpected places, and this quote is a good one that we will store away. 
On the merits of the dispute, the drug manufacturer got only half of what it wanted.  Federal law preempted the prescriber regulation because its mandate that physicians verify that “other pain treatments have failed” was too vague.  Exactly what “other pain treatments” must have failed?  Other opioids?  And how long ago must “other pain treatments” have failed?  Zohydro is a scheduled drug, subject to a thirty-day maximum prescription.  Does a doctor have to try “other pain treatments” every time he or she refills the prescription, or every second or third time? 
At bottom, the Massachusetts regulations could be interpreted (including by the state’s own expert) as making Zohydro a last-resort opioid, thus making it less available, or even “severely frustrat[ing] Zohydro’s availability.”  Id. at **13-14.  According to the district court, “That presents a constitutional problem.”  Id. at *13.  Physician regulations enjoined. 
The district court, however, denied the injunction of the pharmacy regulations because the manufacturer had not proved that the regulation would affect pharmacies’ willingness to carry the drug.  Perhaps most telling, the district court noted both that the Commonwealth could move to lift the injunction and that the manufacturer could renew its motion on the pharmacy regulations “upon a more detailed submission.”  Id. at *16.  So unlike last time, we are under no illusions that the final word has been said.  Will Massachusetts amend its regulations?  Will the manufacturer hire pharmacy experts make another run?  The answers are probably yes on both counts, and the resulting order will again help us understand just how far states can go in regulating prescription drugs.  We at the Drug and Device Law Blog hope that the district court treads lightly and pays all due deference to federal law. 

Wednesday, July 23, 2014

Court Dismisses Balderdash Solodyn Complaint


The genius who devised the theory of evolution.  The statesman who defended Western Civilization against the Nazis.  The man who freed a subcontinent via the majesty of nonviolent resistance.  The greatest basketball player of all time.  The composer of Shaft.  The Pope's favorite saint.  Our national emblem. 


What do these heroes have in common?


Today’s case is Dimieri v. Medicis Pharm. Corp., 2014 U.S. Dist. LEXIS 95409 (M.D. Fla. July 14, 2014).  Dimieri ingested Solodyn for the treatment of acne.  He discontinued use of Solodyn  after experiencing “numbing pain in the crown of his head” and noticing alleged hair loss.  He alleged that Solodyn was making him bald.  That, apparently, ranks as an injury.  He brought a complaint against the defendant for failure to warn, strict liability, breach of warranties, misrepresentation, negligence, and fraud. 


The defendant filed a motion to dismiss all the claims, arguing that they ran afoul of the learned intermediary doctrine, TwIqbal pleading standards, and the requirement that fraud claims be articulated with specificity.  The court agreed with the defendant, and dismissed the complaint, while affording the plaintiff with leave to try again and amend. 


The court rejected the failure to warn claim because, on the face of the complaint, there was no hint that the doctor – the learned intermediary – had been inadequately warned or that any additional warning would have made a difference.  The plaintiff did not allege the extent of his physician’s knowledge regarding the risk of consuming Solodyn.  The plaintiff did not assert whether his physician’s knowledge of Solodyn was inadequate, which is the relevant question.  The complaint contained the usual sloppy formulation about how the defendant failed to warn “Plaintiff and other people”, but the court rightly deemed that allegation to be too vague to imply that the physician had inadequate knowledge of the risks of Solodyn.  In any event, the complaint offered the court no reason to infer that any inadequacy of warnings to the plaintiff’s physician proximately caused the plaintiff’s injury. 


Maybe the plaintiff was trying to allege a design or manufacturing defect, but the plaintiff did not identify the source or nature of any such alleged defect.  The “Complaint fails to make a sufficient causal connection; Plaintiff does not state what possible defect in Solodyn might have caused the hair loss or deny the existence of other factors which might have caused his hair loss.”  Id. at *13.    


The warranty claims flunk Florida law, which requires that the parties be in privity. The plaintiff did not allege the existence of privity between himself and the defendant.  Nor did the plaintiff allege any sort of substantial contact with the defendant’s representative.  At most, the complaint said that “Defendant impliedly warranted that “SOLODYN’ was a safe and suitable medication to be used to help acne,” but such a boilerplate statement does not come close to showing the existence of a warranty or the presence of privity. 


The misrepresentation claims were also woefully vague and general.  They were bereft of any specific misrepresentation given to the plaintiff’s physician regarding Solodyn, or of any personal contact the plaintiff may have had with the alleged fraudulent advertising.  Consequently, such claim was barred by TwIqbal, lack of specificity, and the learned intermediary doctrine.  The plaintiff did allege that the bottle of Solodyn lacked a proper label and that “improper information” was provided to him, preparing the reader for something actual, and meaty and specific.  Maybe even something hair-raising.  But, alas, such expectations are dashed because there is no there there. The complaint furnishes no specificity as to the content of this information (or misinformation).  Again, the learned intermediary doctrine applies and the pleading falls far short of the specificity standard under Fed.R.Civ.P. 9(b) for fraud and misrepresentation. 


As is often the case, the negligence claim is a bit of a puzzler.  We often get the sense that it is designed by plaintiffs to be a forlorn catchall.  Dimieri based his claim for negligence on these two sentences:  “Plaintiff relied on the superior knowledge of the Defendants and their instructions for ‘SOLODYN’ and thus sustained damages as a result from the improper instructions furnished by Defendant,” and “[a]s a direct and proximate result of the negligent acts of the Defendant, Plaintiff has been awarded damages in the amount in excess of $20,000.00.”  The court declined to play catchall.  The claim was devoid of that first element of a negligence claim that we all learned in law school:  existence of a duty between the defendant and the plaintiff.  But even if the plaintiff had made the old school try at stating a duty, it would not have been recognized at law because of the learned intermediary doctrine. 


The court’s disposition of the Dimieri complaint was clean and efficient.  Perhaps there was no need to reach the most interesting question:  is baldness really an injury?  As alluded to above, some very successful, happy men achieved great things despite being follicularly challenged.  And we’ve barely begun the list of clean-headed heroes.  Our baldest presidents were also our greatest.  John Adams had a great wife, his son had the best post-presidential career (think Amistad), Eisenhower oversaw Operation Overlord, and Garfield had the most colorful assassin.  Lionel Messi won the award for most outstanding player in the recent World Cup, but to any impartial eyes the player who most consistently made positive differences for his team was Arjen Robben, who runs around the field like Robert Duvall doing a St. Vitus Dance.  Rock and roll artists define cool, and two of the coolest are Billy Corgan (lead dirge-singer of Smashing Pumpkins) and Ed Cassidy, drummer in the late, lamented LA band Spirit.  Cassidy was called Mr. Skin.  The skin he displayed was his scalp.  The only reason anyone ever watched the ABC courtroom drama Murder One was because the bald star (like everyone else, we forget his name) who oozed gravitas and menace.  When Senator Alan Cranston ran for president, there were some who predicted that his baldness would doom his candidacy.   Cranston turned the issue around, asserting that baldness proved his virility – he wasn’t wasting valuable hormones growing hair.  And we all know how well he did. Adlai Stephenson at least got nominated.  He lost to Eisenhower (see above), but his bald head was so full of wit and wisdom that he made the term "egghead" respectable. 


It’s not just men who made the most out of a glowing pate.  Sinead O’Connor rocked a dome, masterfully covered a Prince tune, and produced one of the two or three all-time weirdest moments on SNL.  The only reason to watch the first Star Trek movie was Persis Khambatta, an arresting presence in what was otherwise a turgid mess.    Demi Moore has shown off all sorts of crazy looks, including a head as bald as Bruce Willis’s. 


Where were we?


If nothing else, the Dimieri case shows a court that insists on factual pleading.  A plaintiff is not going to satisfy TwIqbal with bald assertions.


Tuesday, July 22, 2014

No Duty for Sales Representatives in the Operating Room

            If anyone is still shocked that medical device manufacturers’ sales representatives are present during surgery – don’t be.  It’s a common practice.  If you don’t believe us, see our posts here and here.  Surgeons believe manufacturers’ representatives have an important role to play in making sure the surgical instruments and the surgical team are fully prepared.  That means that reps are in the OR to stay. 

            With that comes the very real possibility of sales representatives being sued by plaintiffs who believe something went wrong during surgery or the possibility of manufacturers being sued for the alleged acts/omissions of their representatives during surgery.  Our earlier posts cover both situations and today we’ve stumbled upon another example of the latter -- McCartney v. U.S., No. 2:13-CV-1118 TS, slip op. (D. Utah Jul. 16, 2014).   Plaintiff underwent multiple surgeries involving implantation of defendant’s spinal cord stimulator.  One or more of defendant’s representatives was present during plaintiff’s surgeries.  McCartney, slip op. at 1-2.  During one of the procedures, one of these reps called the plaintiff’s wife to ask about the location of the plaintiff’s pain.  Plaintiff’s wife didn’t know which leg was afflicted.  Id. at 2.

            Plaintiff brought two negligence claims against the manufacturer based on its representatives being present during his surgery.  The first claim is premised on an alleged general duty of care owed by manufacturers to ensure that their devices are properly implanted.  Id. at 4.  In support, plaintiff alleged that the manufacturer’s representatives “instructed” his surgeon as to how to implant the stimulator (an act) and failed to ensure that the device was properly implanted (an omission).  Id. at 6.  The difference between an act and an omission was critical to the court’s decision on whether there was a duty.  “Acts of misfeasance typically carry a duty of care while nonfeasance generally implicates a duty only in cases of special legal relationships.”  Id.  

            In this case, however, neither portion of plaintiff’s claim survived.  While the complaint alleged that the defendant’s reps instructed the surgeon – it contained no facts to back that up.  So, on misfeasance, plaintiff’s claim didn’t meet the TwIgbal standards.  Id. at 7.  As to nonfeasance, the court concluded “that there is no special relationship between medical device manufacturers and patients such that medical device manufacturers owe a duty of care for their nonfeasance during a physician’s surgery.”  In other words, the mere presence of a sales rep in an operating or treatment room does not create a duty. 

            But what about something beyond simply being present?  That was plaintiff’s second cause of action – that defendant voluntarily undertook a duty to make sure the device was properly implanted when its sales rep called plaintiff’s wife during the surgery.   Plaintiff argued that by placing this call, the defendant (via its rep) “involved itself in medical-decision making in some affirmative way.”  Id. at 8.  Given that plaintiff’s wife’s response was “I don’t know” – we think common sense alone negates plaintiff’s argument.  Fortunately, the court also had a strong legal basis for rejecting the argument.  Relying on Restatement (Second) of Torts § 324A regarding a voluntary undertaking, the court found that plaintiff didn’t allege any facts that defendant acted unreasonably in its undertaking or that anyone relied on defendant’s undertaking.  What was there to rely on?  Without supported allegations that defendant’s representative supplied misinformation or that plaintiff’s surgeon relied on said misinformation, plaintiff hasn’t stated a claim for liability for a voluntary undertaking.  But the court did give plaintiff a little wiggle room here and dismissed the claim without prejudice in case evidence about reliance or misinformation is revealed during discovery. 

            While this case worked out okay for defendants, the role of manufacturer’s representatives in the operating room is anything but plain and simple.  Like we’ve seen with other cases, this is a very fact sensitive issue.  And the lines between duty and no duty; reasonable and unreasonable; breach and no breach are very blurry.  We know the answer is not removing the reps from all treatment situations, they provide a valuable service.  The only partial answer we do have is training, restraint and caution.  That doesn’t solve all of the problems, but it’s a start.    

The Next Best Thing to Removal

Okay, so you’d really like to remove that case that the other side filed in one of the notorious litigation tourist traps, but. . . .  The insignificant in-state – that is to say, nondiverse – defendant was held not to be fraudulently joined, so your case was remanded to state court.  What next?

Defense lawyers shouldn’t give up.  We’ve written before about Bauman and the new personal jurisdiction arguments it may provide.

But other, less novel approaches also exist.  How about forum non conveniens?

That’s the lesson of the recent California trial court decision in In re Accutane Drug Cases, 2014 WL 3579826, slip op. (Cal. Super. L.A. Co. July 21, 2014), obtained courtesy of Brian Ziska at Shook Hardy.

The defendant in Accutane was the same boat as a lot of defendants in California litigation.  Plaintiffs from all over the country, literally from New York to Washington state, joined a factually insignificant  in-state drug distributor (McKesson Corp.) for the purpose of defeating diversity jurisdiction, and for that reason alone.  We’ve blogged about this fact pattern before, and it’s undoubtedly duplicated in dozens of fraudulent joinder/remand cases from California.

Once back in state court, the defendant moved to have the case sliced up (severing the 7 non-resident plaintiffs that had been misjoined in one complaint) and shipped off to the states where these litigation tourists lived on grounds of forum non conveniens.  The court (Judge Freeman of the L.A. County complex litigation docket) agreed and sent the tourists home.

Suitable Alternative Forum – Basically, any state in the U.S. is a suitable alternative forum.  Slip op. at 3-5.  Beyond that, consenting to jurisdiction in the proper forum and making suitable statute of limitations arrangements take care of this factor.  Id. at 4-5.

Private Interest Factors – These litigation tourists don’t belong here.  Slip op. at 6.  They don’t live here; weren’t treated or prescribed the drug in question here.  Id.  The target defendant isn’t from here, either.  Id. at 6.  The only party with any connection to California is McKesson, and it has next to nothing to do with any issues in the case.  The drug wasn’t made or tested here.  Id.

That means that there are no California fact witnesses.  It also means there’s no easy way for a California state court to subpoena the fact witnesses.  Id. at 6-7.  Litigating these cases in the plaintiffs’ home states is cheaper and more efficient.  Id.

Public Interest Factors – California has more litigation tourists than probably any other state (although Illinois might beg to disagree).  Our courts and jurors are being overburdened by litigation of no concern to the community.  Slip op. at 7.  “[C]ompared to the Plaintiffs’ domiciles, California’s interest in hearing these particular Plaintiffs’ claims is small.”  Id.

Other Considerations – Plaintiffs go home!  Go east - or north - young lawyers.

Where all parties live outside California, and the action arises elsewhere, forum non conveniens may compel dismissal.  California has no interest in providing a forum for disputes between nonresidents involving claims about which California has no interest:  Under these circumstances, even if general jurisdiction is assumed, it would be an abuse of discretion for a trial court to do anything but dismiss the actions.

California’s interest in the case is minimal.  The two major Defendants, . . . are located outside of California, and manufactured [the drug] outside of California.  It was distributed in California by the one California party to the case, McKesson Corporation.  However, all of the listed Plaintiffs are out-of-state residents, and were prescribed Accutane outside of California by non-California physicians. Thus, notwithstanding the listed Plaintiffs’ choice of California as a forum, these competing facts (demonstrating California's miniscule interest in these particular claims) demonstrate that granting the motion is appropriate.

Slip op. at 8 (citations and quotation marks omitted) (emphasis original).

These are strong words that we like to hear.  We’ve cheered on similar forum non conveniens progress in Illinois.  We hope to see more rulings like this – that’s why we’re letting you know about the decision.

As for these plaintiffs, they can:  (1) never re-file, (2) re-file in their home state's court, where they may well find themselves in federal court on diversity jurisdiction, (3) re-file in some other federal court (and perhaps be transferred), or (4) re-file in the defendant’s home state (not as attractive as before) where the forum defendant rule may prevent removal.

Monday, July 21, 2014

Preemption Made Easy

The reason that the court’s decision in Wagner v. Pfizer, 2014 U.S. Dist. LEXIS 94281 (W. D. Wisc. July 11, 2014), is useful is not because it dismisses state-law claims against generic manufacturers on the basis of preemption and other defenses we like.  It certainly does those things, and that’s good.  But we see decisions like that almost every week.  What Wagner does, however, is add to the quality of those decisions, not just their quantify.  Its opinion is clear and unhesitating.  It takes on Mensing and Bartlett preemption and the non-existence of failure-to-update claims in barely more than three crisp pages.  And, along the way, it provides uncomplicated and convincing passages that all of us can use in our future briefing.  

Wagner is a hormone therapy (synthetic progestin) case in which the plaintiff sued both generic and brand manufacturers using the usual claims, and some not so usual claims.  The generic manufacturers moved for judgment on the pleadings.  From there, the court went to work.  It described Mensing and Bartlett in the simplest of terms:  

In Mensing, the Supreme Court held that the FDCA preempts any state law that would require companies to improve generic drug labels.  Mensing, 131 S. Ct. at 2577-78.  The Court reasoned that it would be impossible for those companies to both change the generic drug label and maintain sameness with the corresponding brand-name drug label.  Id.  In Bartlett, the Court extended the principles in Mensing to cover state defective-design laws.  Bartlett, 133 S. Ct. at 2470.  To comply with the defective-design tort law, the Court determined that generic drug companies would have to either change the drug's formula or change its label.  Id. at 2474.  Alternatively, generic drug companies could choose to stop selling the generic drug.  Id. at 2477.  The Court held that the first two options were impossible because of the FDCA and the last option, withdrawal of the product from the market, was unreasonable. Id. at 2470.  Thus, under Mensing and Bartlett, where a generic company faces only these three options to satisfy a state law duty and avoid liability, that state law is preempted by the FDCA.

Id. at *7-8.  

Simple enough, and the court didn’t back away from any of it in the face of plaintiff’s claims.  Plaintiff’s state law claims were numerous: “varieties of negligence; strict products liability; misrepresentation; breach of warranty; consumer fraud; assault and battery; and infliction of emotional distress.”  But they all attacked labeling or design, and the court saw that: 

The factual allegations underlying each of Wagner's claims are that the Generic Defendants should have either improved the safety of MPA by changing the formula or strengthened the warnings on the label.  But the Generic Defendants could not comply with the FDCA and avoid liability under Wagner's state-law theories.  These claims are thus preempted by the FDCA because the Generic Defendants cannot change the formula or the label of MPA without violating federal law. 

Id. at *8-9.  The court held all these claims preempted.

The court was equally succinct in taking down plaintiff’s claim that the generic defendants failed to update their products’ labels to match changes made to the labels of the brand-name drugs.  Id. at *10.  Generic manufacturers’ obligations to update labels come from the FDCA, not from state law.  But the FDCA does not authorize private plaintiffs to enforce its provisions:

[T]the FDCA does not provide a private cause of action for its enforcement.  21 U.S.C. § 337(a); Morris v. PLIVA, Inc., 713 F.3d 774, 777 (5th Cir. 2013) (citing Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 349 n.4, 121 S. Ct. 1012, 148 L. Ed. 2d 854 (2001)).  The FDA exclusively, not private citizens, has the authority to enforce the FDCA labeling requirement on generic drugs.  As mentioned above, the question of whether Wagner could use state tort law to effect the same enforcement result to her private benefit is not entirely settled, but most courts that have addressed the issue have decided against allowing it.  See, e.g. Morris, 713 F.3d at 777. 

Id. at *11-12.  In other words, plaintiff’s failure-to-update claim had no basis in law.

The court believed that it had no basis in logic either.  In her claims against the brand-name manufacturers, plaintiff alleged that labels for those drugs were deficient.  Yet her failure-to-update claim alleged that the generic manufacturers should have adopted those (supposedly deficient) labels.  That logic leaves a hole big enough for causation to fall through:

[E]ven if her private claim were not barred, [alleging that the generic manufacturers should have matched the brand-name drug labels] is inconsistent with Wagner's theory of the case.  Wagner alleges that the brand-name labels are themselves inadequate.  Thus, even if the Generic Defendants had timely updated their labels, Wagner would not have been adequately warned of the dangers of the drugs she was taking.  Under Wagner's own theory of the case, the Generic Defendants' failure to timely update their labels to a different but still deficient form could not be a cause of Wagner's injuries. 

Id. at *12.  The court dismissed plaintiff’s failure-to-update claims.

More opinions should be written this clearly and succinctly. 

Friday, July 18, 2014

Innovator Liability at 100

This post is only from the Reed Smith (more properly, the non-Dechert) side of the blog.

One hundred what, you say?

Certainly not years; the awful Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299, (Cal. App. 2008), decision just turned six – this blog is older than that.

According to our innovator liability scorecard, there are now more than 100 decisions rejecting innovator liability/Conte theories – quite a few more, if you count all the different opinions in litigation where the invalidity of innovator liability has been affirmed on appeal.

Our last post on the subject was just last Friday, to break the news of Huck v. Wyeth, Inc., ___ N.W.2d ___, 2014 WL 3377071 (Iowa July 11, 2014), but Huck isn’t even the last  case on our scorecard any longer – that honor currently belongs to Johnson v. Teva Pharmaceuticals USA, Inc., ___ F.3d ___, 2014 WL 3397786 (5th Cir. July 11, 2014) (applying Louisiana law), which we later found out was decided the same day.

In one of our earlier posts, less than a week after Conte was decided, we made up an example to illustrate the potentially wide-ranging impact of allowing non-manufacturer liability for products based solely on “foreseeability”:

Plaintiff New Dad gives plaintiff New Mom his old SUV, manufactured by Gasguzzlers ‘R Us, so she has something big and safe to drive New Baby around.  To replace it, he buys a hybrid made by Minigas, Inc. to drive to work.  Wife puts New Baby’s carseat in the front seat, and plows into a telephone pole (or something else, it really doesn't matter).  The airbag kills New Baby.  Gasguzzlers ‘R Us didn’t get its federal bailout and goes bankrupt.  But since both of the family cars had identical government-mandated (allegedly) inadequate warnings about not putting an infant car seat next to an airbag, who gets sued, Minigas – even though it’s car had nothing to do with the accident.

Farfetched?  We wish.  Isn’t it foreseeable that New Mom and Dad would have relied on the warnings in the brand new owner’s manual they just saw when buying their brand new hybrid, instead of the older manual in the SUV, which they haven’t looked at in years (assuming they still have the old manual at all)?  Under Conte’s omniforeseeability analysis, why not?

More Thoughts On Conte v. Wyeth (Nov.13, 2008).  Now we didn’t think much more about that – analogies are a dime a dozen – until we were reading another recent case rejecting Conte.  Guess what we found in Huck?

We are unwilling to make brand manufacturers the de facto insurers for competing generic manufacturers.  It may well be foreseeable that competitors will mimic a product design or label.  But, we decline [plaintiff’s] invitation to step onto the slippery slope of imposing a form of innovator liability on manufacturers for harm caused by a competitor's product.  Where would such liability stop?  If a car seat manufacturer recognized as the industry leader designed a popular car seat, could it be sued for injuries sustained by a consumer using a competitor's seat that copied the design?  Why not, under Huck's theory, if it is foreseeable others will copy the design?

2014 WL 3377071, at *23 (citation omitted).  It’s not exact, but this eerily close for a coincidence.  So maybe we are having some sort of influence after all.

If we are, we certainly want to keep that up.  Thus, we think it’s time to take a closer look at the status of innovator liability.  A lot of states now have some sort of decision on this specific subject, but depending on the strength of that precedent, we may add some thoughts on product identification generally, since the issue comes up in other contexts, most notably market share liability and asbestos.  For example, Huck relied primarily on the Iowa Supreme Court’s prior decision rejecting market share liability – another novel claim that tries to decouple liability from actually making the allegedly injurious product.

So on the occasion of 100 decisions rejecting Conte innovator liability theories, here is a 50-state survey on the status of this benighted form of liability.
If any of our readers know of any innovator liability decisions that we have missed, by all means send them along.


It’s not a bad thing to get the worst out of the way at the beginning.  Back in January of 2013 we were shocked when the Alabama Supreme Court issued a long, and awful, opinion in Wyeth, Inc. v. Weeks, 2013 WL 135753, at *11-19 (Ala. Jan. 11, 2013), reconsideration granted, No. 1101397 (Ala. June. 13, 2013), holding essentially that, since those meanies on the United States Supreme Court aren’t letting plaintiffs sue generic manufacturers, we’ll change Alabama common law and let them sue someone else.  Id. at *15.  We discussed that Weeks reasoning extensively at the time, so we won’t inflict that on you again.

It turned out that the Alabama court had issued Weeks without even the courtesy of oral argument.  Thus we were relieved when the Court granted reargument.  We await the reargued decision with bated breath – actually that’s not true; we’d be bluer than a Blue Dog Democrat if that were so.  Anyway, we’ll have to see what happens.  To change the result in Weeks would require more than one justice to change their minds. 

Prior to Weeks, everything else in Alabama seemed pointed towards rejection of innovator liability.  Several lower court decisions had done so explicitly:  Overton v. Wyeth, Inc., 2011 WL 1343392, at *6-7 (Mag. S.D. Ala. March 15, 2011), adopted, 2011 WL 1343391 (S.D. Ala. April 7, 2011); Simpson v. Wyeth, Inc., 2010 WL 5485812, at *3-5 (N.D. Ala. Dec. 9, 2010); Mosley v. Wyeth, Inc., 719 F. Supp.2d 1340, 1345-51 (S.D. Ala. 2010); Barnhill v. Teva Pharmaceuticals USA, Inc., 2007 WL 5787186, at *2-3 (S.D. Ala. April 24, 2007); Buchanan v. Wyeth Pharmaceuticals, Inc., 2008 WL 7136137 (Ala. Cir. Oct. 20, 2008); Green v. Wyeth Pharmaceuticals, Inc., 2007 WL 6428717, at *1 (Ala. Cir. May 14, 2007).

Not only that, courts applying Alabama law have rejected market share liability, Franklin County School Board v. Lake Asbestos of Quebec, Ltd., 1986 WL 69060, at *5-6 (N.D. Ala. Feb. 13, 1986), and generally required product identification as an essential element in other product-related litigation involving prescription medical products.  Bloodsworth v. Smith & Nephew, 2005 WL 3470337, at *5 (M.D. Ala. Dec. 19, 2005).


Alaska hasn’t been cursed with much prescription medical product liability litigation, and we haven’t run across anything on Conte, market share liability, or product identification.  The general statement of strict liability in Alaska is that “a manufacturer is strictly liable . . . when an article he places on the market” is defective.  Clay v. Fifth Avenue Chrysler Center, Inc,, 454 P.2d 244, 247 (Alaska 1969).


No Arizona court has directly passed on innovator liability, but the federal district court in the Darvocet litigation twice held that the theory was incompatible with Arizona law.  In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 3842045, at *7-8 (E.D. Ky. Sept. 5, 2012), aff’d on other grounds, ___ F.3d ___, 2014 WL 2959271 (6th Cir. June 27, 2014); In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 4831632, at *2-3 (E.D. Ky. Oct. 10, 2012), aff’d on other grounds, ___ F.3d ___, 2014 WL 2959271 (6th Cir. June 27, 2014).  No Arizona plaintiffs appealed in Darvocet, so the Sixth Circuit’s opinion, In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation,___ F.3d ___, 2014 WL 2959271 (6th Cir. June 27, 2014), doesn’t discuss Arizona law.

Otherwise, courts applying Arizona law have rejected market share liability, both as to prescription medical products, In re Minnesota Breast Implant Litigation, 36 F. Supp.2d 863, 876 (D. Minn. 1998) (applying Arizona law), and products generally.  White v. Celotex Corp., 907 F.2d 104, 105 (9th Cir. 1990) (asbestos) (applying Arizona law).  Product identification has been required in pain pump cases under Arizona law.  Placencia v. I-Flow Corp., 2011 WL 1361562, at *2, 3-4 (D. Ariz. April 11, 2011); Peterson v. Breg, Inc., 2010 WL 2044248, at *2 (D. Ariz. April 29, 2010).


The Eighth Circuit has twice held that Arkansas law rejects innovator liability.  Fullington v. PLIVA, Inc., 720 F.3d 739, 744 (8th Cir. 2013); Bell v. Pfizer, Inc., 716 F.3d 1087, 1092-93 (8th Cir. 2013).  So did the Sixth Circuit in Darvocet:

Guided by our sister circuit, we likewise predict that the Arkansas Supreme Court would construe Plaintiffs' misrepresentation claims as product liability claims that fail for lack of product identification under Arkansas law.

In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, ___ F.3d ___, 2014 WL 2959271, at *20 (6th Cir. June 27, 2014).  See also Fields v. Wyeth, Inc., 613 F. Supp.2d 1056, 1060-61 (W.D. Ark. May 11, 2009); Neal v. Teva Pharmaceuticals USA, Inc., 2010 WL 2640170, at *2 (W.D. Ark. July 1, 2010).  ‘Nuff said for now.


California, of course, is where Conte was decided.  However, Conte was decided by but one of several California appellate courts, and we understand that they don’t have to follow each other’s decisions.  In a hopeful development, after Conte was decided, the California Supreme Court, in an asbestos case, rejected the sort of foreseeability uber alles rationale on which Conte was based:

An interpretation of [the law] that would require a manufacturer to warn about all potentially hazardous conditions surrounding the use of a product, even when those hazards arise entirely from the product of another manufacturer, reaches too far.  There is no precedent in California law for such a broad expansion of a product manufacturer’s duty.

O’Neil v. Crane Co., 266 P.3d 987, 1003 (Cal. 2012)

[F]oreseeability alone is not sufficient to create an independent tort duty. Instead, the recognition of a legal duty of care depends upon the foreseeability of the risk and a weighing of policy considerations for and against imposition of liability.

Id. at 1005 (citations and quotation marks omitted).  We pointed out this evident impairment of Conte immediately.

So far, however, arguments based on O’Neil have not deterred courts from following Conte under California law – even in the Darvocet MDL.  In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 3842271, at *5-7 (E.D. Ky. Sept. 5, 2012).  Defendants in California thus probably need to take the lead on making direct challenges to Conte based on O’Neil.


Colorado has a product liability statute that pretty explicitly defines “product liability action” as litigation brought against a “manufacturer” and the definition of manufacturer is not broad enough to include the manufacturer of a competing product that the plaintiff did not take.  Colo. Rev. Stat §13-21-401.  Thus, a “plaintiff must establish that a particular defendant's product was a substantial contributing cause of his injury.”  Merkley v. Pittsburgh Corning Corp., 910 P.2d 58, 59 (Colo. App. 1995).  In Sheeks v. American Home Products Corp., 2004 WL 4056060, at *1-2 (Colo. Dist. Oct. 15, 2004), the court rejected innovator liability.


Connecticut was one of the states that the Sixth Circuit in In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation,___ F.3d ___, 2014 WL 2959271 (6th Cir. June 27, 2014), held would reject innovator liability:

Because Plaintiffs bring a personal injury claim allegedly caused by a defective product, their claims are within the scope of the CPLA [Connecticut Product Liability Act] and require product identification. . . .  We predict that if the Connecticut Supreme Court were directly faced with this question under Connecticut Law, it would find that Plaintiffs’ claims are product liability claims within the scope of the CPLA that do not survive under CUTPA [Connecticut Unfair Trade Practices Act]. Accordingly, the district court did not err in dismissing Plaintiffs’ claims against the Brand Manufacturers arising under Connecticut law because Plaintiffs did not allege that they ingested a product manufactured by the Brand Manufacturers.

Id. at *21.

Connecticut law also rejects market share liability, even in the DES context.  Gullotta v. Eli Lilly & Co., 1985 WL 502793, at *9 (D. Conn. May 9, 1985).  Product identification has also been required in prescription medical product cases, Barbour v. Dow Corning Corp., 2002 WL 983346, at *3 (Conn. Super. April 19, 2002) (no liability for products made after sale of manufacturing subsidiary); and in product liability generally.  Bobryk v. Lincoln Amusements, Inc., 1996 WL 24566, at *3 (Conn. Super. Jan. 5, 1996) (“the plaintiff must plead and prove that the item which caused him harm was in fact the defendant’s product’ within the meaning of the Act”).


In Delaware plaintiffs must prove “that there was a causal relationship between the defendant’s product and the plaintiff’s physical injury.”  Money v. Manville Corp. Asbestos Disease Compensation Trust Fund, 596 A.2d 1372, 1377 (Del. 1991).  There is no Delaware law directly rejecting innovator liability.  However, Delaware rejects market share liability.  Nutt v. A.C. & S. Co., 517 A.2d 690, 694 (Del. Super. 1986) (asbestos); In re Asbestos Litigation, 509 A.2d 1116, 1118 (Del. Super. 1986), aff’d, 525 A.2d 146 (Del. 1987).

District of Columbia

In the District, “[i]t is, of course, incumbent on the plaintiff in any product liability action to show that the defendant’s product was the cause of his or her injuries.”  Claytor v. Owens-Corning Fiberglas Corp., 662 A.2d 1374, 1381 (D.C. 1995).  D.C. courts haven’t passed on innovator liability.  However D.C. law has rejected market share liability, even in the DES context.  Tidler v. Eli Lilly & Co., 851 F.2d 418, 424 (D.C. Cir. 1988).  Market share liability has also been rejected with respect to other products.  Bly v. Tri-Continental Industries, Inc., 663 A.2d 1232, 1244 (D.C. 1995) (gasoline); Claytor v. Owens-Corning Fiberglas Corp., 662 A.2d 1374, 1383 & n.10 (D.C. 1995) (asbestos); District of Columbia v. Beretta U.S.A. Corp., 2002 WL 31811717, at *55-56 (D.C. Super. Dec. 16, 2002), aff’d in part and rev’d in part on other grounds, 872 A.2d 633 (D.C. 2005) (firearms).


In Florida, tort claims “fail as a matter of law [when] the record is undisputed that [defendant] did not design, manufacture, or distribute the [product].”  Hall v. Sunjoy Indus. Grp., Inc., 764 F. Supp. 2d 1297, 1301 (M.D. Fla. 2011) (collecting cases).  Florida is one of the states where innovator liability has been rejected over and over again.  Florida state courts have done so.  Dietrich v. Wyeth, Inc., 2009 WL 4924722 (Fla. Cir. Dec. 21, 2009); Sharp v. Leichus, 2006 WL 515532, at *2-6 (Fla. Cir. Feb. 17, 2006), aff’d per curiam, 952 So.2d 555 (Fla. App. 2007).

The Eleventh Circuit threw out all such claims in Guarino v. Wyeth, 719 F.3d 1245 (11th Cir. 2013), in reliance upon a “mountain of authority.”  Id. at 1251-53.  So have the following federal district courts:  Metz v. Wyeth, Inc., 830 F. Supp.2d 1291, 1293-95 (M.D. Fla. 2011), aff’d, 525 F. Appx. 893 (9th Cir. 2013); Levine v. Wyeth, Inc., 684 F. Supp.2d 1338, 1344-46 (M.D. Fla. 2010); Howe v. Wyeth Inc., 2010 WL 1708857, at *3-4 (M.D. Fla. Apr. 26, 2010).

Florida was also one of the states’ laws addressed in the Darvocet litigation.  In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, ___ F.3d ___, 2014 WL 2959271, at *22 (6th Cir. June 27, 2014) (“We predict that the Florida Supreme Court would construe Plaintiffs’ misrepresentation claim as a product liability claim that fails for lack of product identification under Florida law”); In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 3842045, at *7 (E.D. Ky. Sept. 5, 2012), aff’d on other grounds, ___ F.3d ___, 2014 WL 2959271 (6th Cir. June 27, 2014).


The Georgia product liability statute limits liability to manufacturers.  OCGA §51-1-11(b)(1). Thus, [r]egardless of whether the plaintiff proceeds under a theory of negligence or strict liability, a plaintiff must prove as part of his case that the defendant’s product was the proximate cause of the injuries alleged.”  Fouch v. Bicknell Supply Co., 756 S.E.2d 682, 687 (Ga. App. 2014).

  We know of one Georgia trial court rejecting innovator liability.  Reynolds v. Anton, 2004 WL 5000272 (Ga. Super. Oct. 28, 2004):

As to Plaintiffs second argument, holding one manufacturer liable for the packaging/warnings of another is not based upon traditional Georgia tort law principles.  Accordingly, reliance upon federal regulations to achieve that result is not permitted.  Further, the regulations in question impose duties upon the generic manufacturer and not upon the brand-name manufacturer.  Thus, a brand name manufacturer cannot be held liable for the accuracy of the labels placed on such products by generic manufacturers.

Id. at ??? (no page numbering; last issue in opinion) (citations and quotation marks omitted).

A couple of Georgia federal district courts have likewise rejected innovator liability.  Moore v. Mylan, Inc., 840 F. Supp.2d 1337, 1344 (N.D. Ga. Jan. 5, 2012); Swicegood v. Pliva, Inc., 543 F. Supp.2d 1351, 1354-59 (N.D. Ga. 2, 2008).

The Sixth Circuit in Darvocet predicted that Georgia law would reject innovator liability.  In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, ___ F.3d ___, 2014 WL 2959271, at *22 (6th Cir. June 27, 2014) (“we predict that the Georgia Supreme Court would either construe Plaintiffs' misrepresentation claims as product liability claims that fail for lack of product identification or that Brand Manufacturers did not owe Plaintiffs a duty that could give rise to liability under Georgia law”); accord In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2013 WL 5184129, at *2 (E.D. Ky. July 29, 2013).

Georgia law rejects market share liability.  Blackston v. Shook & Fletcher Insulation Co., 764 F.2d 1480, 1483 (11th Cir. 1985) (applying Georgia law); Starling v. Seaboard Coast Line Railroad Co., 533 F. Supp. 183, 186 (S.D. Ga. 1982).  Product identification has also been required in other situations:

To survive summary judgment, Hoffman clearly needed to present evidence that she was exposed to defendants' products. . . .  [U]nless the manufacturer’s defective product can be shown to be the proximate cause of the injuries there can be no recovery.  A manufacturer has the absolute right to have his strict liability for injuries adjudged on the basis of the design of his own marketed product and not that of someone else

Hoffman v. AC&S, Inc., 548 S.E.2d 379, 382 (Ga .App. 2001) (citations and quotation marks omitted) (asbestos case).  See Murphy v. Aventis Pasteur, Inc., 270 F. Supp.2d 1368, 1377 (N.D. Ga. 2003) (holder of expired patent for medical device owed no “duty to warn the purchasers and recipients of . . . copied products manufactured by other companies”).


There isn’t any law in Hawaii on innovator liability.  Hawaii did adopt market share liability in a blood products case over 20 years ago, but as far as we know hasn’t addressed product identification since then.  See Smith v. Cutter Biological, Inc., a Div. of Miles Inc., 823 P.2d 717, 719 (Haw. 1991) (“Traditional proof in a negligence case includes the factor of causation.”) (syllabus at 6).


There’s nothing under Idaho law about innovator liability.  In Doe v. Cutter Biological, 852 F. Supp. 909, 912-914 (D. Idaho 1994), the court rejected market share liability in the context of a blood product.  “Idaho would not allow recovery when it is not possible for plaintiff to prove which defendant caused his injury.”  Id. at 924.


Illinois has long required product identification for all product liability matters, as evinced by the Illinois Supreme Court’s rejection of industry-wide liability under both market share liability and public nuisance rubrics.  See Young v. Bryco Arms, 821 N.E.2d 1078, 1087-91 (2004) (public nuisance); Smith v. Eli Lilly & Co., 560 N.E.2d 324, 337-39, 344-45 (Ill. 1990) (market share liability); City of Chicago v. American Cyanamid Co., 823 N.E.2d 126, 134-35 (Ill. App. 2005) (market share liability in public nuisance) Lewis v. Lead Industries Ass'n. Inc., 793 N.E.2d 869, 874-76 (2003) (same) (all four cases finding no causation as a matter of law without product identification).  See also Leng v. Celotex Corp., 554 N.E.2d 468, 470-471 (Ill. App. 1990) (rejecting market share liability pre-Smith in asbestos case); York v. Lunkes, 545 N.E.2d 478, 480 (Ill. App. 1989) (rejecting market share liability pre-Smith in battery case); Poole v. Alpha Therapeutic Corp., 696 F. Supp. 351, 353 (N.D. Ill. 1988) (rejecting market share liability pre-Smith in blood products case); Coerper v. Dayton-Walther, 1986 WL 4111, at *1 (N.D. Ill. March 27, 1986) (rejecting market share liability pre-Smith in tire rim case).

Moreover, in Illinois there is no duty to warn about the risks of a competing product:

[Defendant] is under no duty to provide information on other products in the marketplace.  Such a duty would require drug manufacturers to rely upon the representations made by competitor drug companies.  This arrangement would only lead to greater liability on behalf of drug manufacturers that were required to vouch for the efficacy of a competitor's product.

Pluto v. Searle Laboratoriess, 690 N.E.2d 619, 621 (Ill. App. 1997).

Nonetheless, in the teeth of all this precedent, a federal court sitting in diversity improperly predicted an expansion of Illinois law to encompass innovator liability in Dolin v. SmithKlineBeecham Corp., 2014 WL 804458, at *8 (N.D. Ill. Feb. 28 2014) (“Taken out of context, language in product identification cases like Smith and Lewis may well appear to support [defendant’s] argument.  In truth, the principles for which that line of cases stands are inapposite here”).  In one paragraph, after agreeing that strict liability is precluded, Dolin decided that negligence was different:

This reasoning does not hold where a name-brand manufacturer is found, not strictly liable, but liable for negligence.  An injury (or at least liability for an injury) that occurs due to negligence can be avoided simply by satisfying one’s duty of care.  Significantly, this is so without regard to whether the name-brand or generic version of the drug was consumed.  Where a company’s negligence in connection with a product causes injury, it may naturally be held liable for having caused that injury.  Where there is no fault, however, the public policy rationale that justifies burdening the seller with the cost of injury rather than the consumer does not merit placing liability on an entity whose benefit from the sale is so remote, and whose ability to account for the cost is so limited.

Id. at *13 (no citations omitted; Dolin did not cite anything).  As we’ve said many times before, federal courts sitting in diversity should not do this – they have no authority to invent new forms of state-law liability.

However, In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, ___ F.3d ___, 2014 WL 2959271 (6th Cir. June 27, 2014), the Sixth Circuit was also called upon to construe Illinois law.  The appellate court trashed Dolin thoroughly:

We disagree with the Dolin court’s holding.  While Illinois does not have a product liability statute, its case law indicates that Plaintiffs’ misrepresentation claims would be construed as product liability claims and fail for lack of product identification.  Under Illinois law, a plaintiff must identify the supplier of the product and establish a causal connection between the injury and the product.  [citing Smith and York].  But, even if Plaintiffs’ misrepresentation claims were not construed as product liability claims, applying the same factors, we predict that the Illinois Supreme Court would not recognize brand manufacturers owed generic consumers a duty that can give rise to liability.

First, the generic consumers’ injuries are not the foreseeable result of the brand manufacturers’ conduct, but of the laws over which the brand manufacturers have no control.  Congress made the public policy decisions to lower barriers of entry for generic drugs, as has the Illinois state legislature in enacting laws to require certain prescriptions be filled with available generics.  Using these laws as the basis of supplying the duty element for tort liability stretches foreseeability too far.  Additionally, the Dolin court failed to properly account for the magnitude of brand manufacturers’ burden of guarding against the injury; and the consequences of placing that burden on the brand manufacturers.  Courts in the majority note the traditional reticence against imposing liability on a manufacturer for injuries caused by their competitor's products.  Further, there are grave health policy consequences associated with recognizing brand manufacturer liability in these situations including higher priced brand name drugs and fewer innovative drugs.

As a federal court predicting state law . . ., given a choice between an interpretation of state law which reasonably restricts liability, and one which greatly expands liability, we should choose the narrower and more reasonable path.  The potential for wide-ranging ramifications on Illinoisans’ health and welfare should we recognize a duty in this case renders the narrower path the proper choice.

We predict that the Illinois Supreme Court would either construe Plaintiffs’ misrepresentation claims as product liability claims that fail for lack of product identification or that Brand Manufacturers did not owe Plaintiffs a duty that could give rise to liability under Illinois law.

Darvocet, 2014 WL 2959271, at *22-24 (citations and quotation marks omitted).


Indiana law requires a plaintiff to “produce evidence to support a reasonable inference that the defendants’ products caused” the claimed injury.  Peerman v. Georgia-Pac. Corp., 35 F.3d 284, 287 (7th Cir. 1994) (applying Indiana law).  An Indiana trial court rejected Conte and innovator liability in Short v. Eli Lilly & Co., 2009 WL 9867531, at *4-9, slip op. (Ind. Super. Marion Co. March 25, 2009).  Indiana has a product liability statute, Ind. Code §34-20-1-1, et seq., that applies to all theories and limits liability to manufacturers.  Failure to identify the defendant’s product as being ingested by the plaintiff was fatal.  Id. at  *5-6.  Negligent misrepresentation was no away around the statute because the plaintiff never relied upon the defendant.  Id. at *6 (citing one of Bexis’ Bone Screw cases).  Conte was “inconsistent with Indiana law.”  Id. at *7-9.

Two federal courts applying Indiana law have relied on Short rejected innovator liability.  In In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, ___ F.3d ___, 2014 WL 2959271 (6th Cir. June 27, 2014), the court recognized its role in diversity to tread softly on state law.  Id. at *24.  The court found no basis under Indiana law principles to hold a manufacturer liable for defects in a competing product:

[W]e take up the three factors in [used by the Indiana Supreme Court to evaluate duty claims].  First, the party’s relationship, we note that the generic consumers were injured by a product that the Brand Manufacturers did not manufacture, and, as already noted, courts are reluctant to impose “competitor liability.”  Second, the generic consumers’ injuries are not the foreseeable result of the Brand Manufacturers’ conduct, but of the laws over which the Brand Manufacturers have no control.  Using federal and Indiana state laws designed to increase the availability of generic drugs as the basis of supplying the duty element for tort liability stretches foreseeability too far.  Further there are grave health policy consequences associated with recognizing brand manufacturer liability in these situations including higher priced brand name drugs and fewer innovative drugs.  Taken together, we predict that the Indiana Supreme Court would decline to recognize that brand manufacturers owe generic consumers a duty of care that could give rise to liability.

Id. (citations and quotation marks omitted).  In Stewart v. Sanofi Aventis U.S., LLC, ___ F. Supp.2d ___, 2014 WL 1400235 (N.D. Ala. April 10, 2014), the court made a similar prediction of Indiana law:

While the Indiana Supreme Court apparently has not yet addressed this specific issue, a plain reading of the IPLA [Indiana Product Liability Act] as well as several IPLA-related opinions from other Indiana courts persuade this court that a plaintiff . . . who allegedly was injured by a prescription drug cannot state a claim for failure to warn under the IPLA against the manufacturer of a brand name prescription drug . . . when the allegations show that the plaintiff ingested solely a generic form of the drug.

Id. at *2.

Indiana has also rejected market share liability.  City of Gary v. Smith & Wesson, Corp., 801 N.E.2d 1222, 1245 (Ind. 2003).  It requires product identification in asbestos cases.  Asbestos Corp. Ltd. v. Akaiwa, 872 N.E.2d 1095, 1098 (Ind. App. 2007).


In Iowa we have Huck v. Wyeth, Inc., 2014 WL 3377071 (Iowa July 11, 2014).  In Huck the Iowa Supreme Court does a number on innovator liability.  Id. at *12-23.  Although it appears to be a plurality opinion (3-1-3), it’s firmly based in Iowa precedent, which mandates product identification.  See  Mulcahy v. Eli Lilly & Co., 386 N.W.2d 67, 75-76 (Iowa 1986) (rejecting market share liability in DES cases); Doe v. Baxter Healthcare Corp., 380 F.3d 399, 410-11 (8th Cir. 2004) (evidence insufficient to exclude other products as possible causes) (applying Iowa law) You can read more about Huck here.


In Kansas, “[the plaintiff] still has the burden of establishing that the particular defendant has sold a product . . . and that it caused his injury.”  Mays v. Ciba–Geigy Corp., 661 P.2d 348, 357 (Kans. 1983).  There’s no Kansas law on innovator liability or market share liability.  But Kansas has as product liability statute, K.S.A. §60-3301, et seq., which we expect will lead to results similar to those obtained under similar statutes in other states.


The Sixth Circuit has twice held that Kentucky’s product liability statute precludes innovator liability.  In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, ___ F.3d ___, 2014 WL 2959271, at *25 (6th Cir. June 27, 2014); Smith v. Wyeth, Inc., 657 F.3d. 420, 423-24 (6th Cir. Sept. 22, 2011) (applying Kentucky law).  Accord Neeley v. Wolters Kluwer Health, Inc., 2013 WL 3929059, at *20-24 (E.D. Mo. July 29, 2013).
That’s probably enough, but every Kentucky case to consider market share liability has also rejected that dodge of product identification.  Collins v. Ansell Inc., 2003 WL 22769266, at *2 (W.D. Ky. Nov. 19, 2003) (rejecting market share liability in latex gloves case); Dawson v. Bristol Laboratories, 658 F. Supp. 1036, 1040-41 (W.D. Ky. 1987) (rejecting market share liability in antibiotic case).


Louisiana, with its statutory product liability regime (La. Rev. Stat.. §9:2800.52), is another of these states with lots of precedent rejecting innovator liability, every which way but loose.  The Fifth Circuit has rejected the theory twice.  Johnson, ___ F.3d ___, 2014 WL 3397786, at *5-7; Demahy v. Schwarz Pharma, Inc., 702 F.3d 177, 183-84 (5th Cir. 2012).  The Sixth Circuit followed Demahy in reaching an identical holding in In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, ___ F.3d ___, 2014 WL 2959271, at *25 (6th Cir. June 27, 2014).

A Louisiana appellate court agreed.  Stanley v. Wyeth, Inc., 991 So.2d 31, 34-35 (La. App. May 2, 2008) (“a name brand drug manufacturer owes no legal duty to the consumer of a generic equivalent of its drug”).

Given all this appellate authority, Louisiana federal district courts have for years been playing wac-a-mole with plaintiffs asserting innovator liability.  Tillman v. Woldenberg Village, Inc., 2013 WL 6198864, at *5 (E.D. La. Nov. 27, 2013); Morris v. Wyeth, Inc., 2011 WL 4975317, at *3-4 (W.D. La. Oct. 19, 2011); Cooper v. Wyeth, Inc., 2010 WL 4318816, at *2-3, (M.D. La. Oct. 26, 2010); Craig v. Pfizer, Inc., 2010 WL 2649545, at *2-4 (Mag. E.D. La. May 26, 2010), adopted, 2010 WL 2649544 (W.D. La. June 29, 2010); Morris v. Wyeth, Inc., 2009 WL 4064103, at *4-6 (W.D. La. Nov. 23, 2009); LeBlanc v. Wyeth, Inc., 2006 WL 2883030, at *5-6 (W.D. La. Oct. 5, 2006); Possa v. Eli Lilly & Co., 2006 WL 6393160, at *1 (M.D. La. May 10, 2006); Tarver v. Wyeth, Inc., 2005 WL 4052382, at *2 (Mag. W.D. La. June 7, 2005), adopted, 2006 WL 1517546, at *2-3 (W.D. La. Jan. 26, 2006).


No court applying Maine law has addressed innovator liability, but in Maine there is “no authority for . . . a duty to warn against another supplier’s dangerous product.”  Bouchard v. American Orthodontics, 661 A.2d 1143, 1145 (Me. 1995).  Such claims “failed to establish any causal link between defendant's product and plaintiffs’ harm.”  Id.
In Kinnett v. Mass Gas & Electric Supply Co., 716 F. Supp. 695, 697 n.7 (D.N.H. 1989) (applying Maine law), the court suggested that Maine would reject market share liability.  Defendant-specific product identification has also been required in Maine asbestos cases.  E.g., Elderkin-Graham v. New England Insulation Co., Inc., 2011 WL 6424838, at 1 n.1 (E.D. Pa. Nov. 28, 2011) (applying Maine law); Rumery v. Garlock Sealing Technologies, Inc., 2009 WL 1747854 (Me. Super. April 24, 2009).


Maryland law produced the first decision rejecting innovator liability in a generic drug case.  Foster v. American Home Products Corp., 29 F.3d 165 (4th Cir. July 14, 1994) (applying Maryland law).

Although actions for negligent misrepresentation arise in many contexts other than products liability, in this case the allegations of negligent misrepresentation are an effort to recover for injuries caused by a product without meeting the requirements the law imposes in products liability actions. Maryland law requires a plaintiff seeking to recover for an injury by a product to demonstrate that the defendant manufactured the product at issue.

Id. at 168; accord id. at 171 (plaintiffs “offer no authority for their assertion that one manufacturer can be held liable for injuries stemming from another manufacturer’s product”).  In In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, ___ F.3d ___, 2014 WL 2959271, at *25-26 (6th Cir. June 27, 2014), the Sixth Circuit was “guided” by Foster and reiterated that Maryland would reject innovator liability.  Accord Gross v. Pfizer, Inc., 2010 WL 4485774, at *2-3 (D. Md. Nov. 9, 2010) (following Foster; rejecting Conte), reconsideration denied, 2011 WL 4005266 (D. Md. Sept. 7, 2011).

As discussed in Foster, Maryland has rejected market share liability, even in the DES context.  Tidler v. Eli Lilly & Co., 851 F.2d 418, 424 (D.C. Cir. 1988) (applying Maryland law).  A fortiori Maryland has also retained its product identification requirement and refused to apply market share liability outside of DES.  Reiter v. AC&S, Inc., 947 A.2d 570, 573 (Md. App. 2008) (asbestos), aff’d, 8 A.3d 725 (Md. 2010); Lee v. Baxter Healthcare Corp., 721 F. Supp. 89, 93-94 (D. Md. 1989) (breast implant), aff’d without op., 898 F.2d 146 (4th Cir. 1990); Herlihy v. Ply-Gem Industries, Inc., 752 F. Supp. 1282, 1291 (D. Md. 1990) (fire retardants).

See Miller v. Bristol-Myers Squibb Co., 121 F. Supp.2d 831, 836-837 (D. Md. 2000) (granting summary judgment where “Plaintiff will not have testimonial, documentary, or real evidence available at trial to confirm the identity of the manufacturer”).


In Massachusetts “[w]e have never held a manufacturer liable . . . for failure to warn of risks created solely in the use or misuse of the product of another manufacturer.”  Mitchell v. Sky Climber, Inc., 487 N.E.2d 1374, 1376 (Mass. 1986).

A trial court in Massachusetts rejected innovator liability in Kelly v. Wyeth-Ayerst Laboratories Co., 2005 WL 4056740, at *2-5 (Mass. Super. May 6, 2005).

[T]his Court finds no merit to the plaintiffs’ argument that [defendant] . . ., by promoting their own product, undertook a duty to all users of [a drug], including those users who ingested generic [versions]. . . .  [A] manufacturer of one product owes no duty of care to one who did not use their product. . . .  [Defendant] owed no legal duty to the consumer of a generic equivalent of one of its products.  [T]here are strong social policy reasons for declining to find that a brand name drug manufacturer owes a duty to consumers of generic equivalents. . . .

Id. at *4.  In In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 4831632, at *3 (E.D. Ky. Oct. 10, 2012), aff’d on other grounds, ___ F.3d ___, 2014 WL 2959271 (6th Cir. June 27, 2014), the court also dismissed innovator liability claims under Massachusetts law.

Further strong support for product identification in Massachusetts is the Commonwealth’s repeated rejection of market share liability even in the DES context.  Payton v. Abbott Labs, 437 N.E.2d 171, 189-90 (Mass. 1982); Kelley v. Eli Lilly & Co., 2007 WL 1238789, at *4 (D.D.C. April 27, 2007) (applying Massachusetts law); Armata v. Abbott Laboratories, 747 N.Y.S.2d 863, 865 (N.Y.A.D. 2002) (applying Massachusetts law).  A fortiori market share liability does not eliminate product identification as to other products.  Santiago v. Sherwin Williams Co., 3 F.3d 546, 549-51 (1st Cir. 1993) (lead paint) (applying Massachusetts law); Spencer v. Baxter International, Inc., 163 F. Supp.2d 74, 77 n.3 (D. Mass. 2001) (blood product); Mills v. Allegiance Healthcare Corp., 178 F Supp.2d 1, 8-9 (D. Mass. 2001) (latex gloves); Gurski v. Wyeth-Ayerst Division of American Home Products Corp., 953 F. Supp. 412, 418-19 (D. Mass. 1997) (oral contraceptive).


In In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, ___ F.3d ___, 2014 WL 2959271 (6th Cir. June 27, 2014), the Sixth Circuit concluded that Michigan law was incompatible with innovator liability:

[W]e take up the three [duty] factors in [Michigan law].  First, regarding the party’s relationship, the generic consumers were injured by a product that the Brand Manufacturers did not manufacture, and as already noted, courts are reluctant to impose competitor liability.  Second, the generic consumers’ injuries are not the foreseeable result of the brand manufacturers’ conduct, but of the laws over which the brand manufacturers have no control.  Using federal and Michigan state laws designed to increase the availability of generic drugs as the basis of supplying the duty element for tort liability stretches foreseeability too far.  Finally, there are grave health policy consequences associated with recognizing brand manufacturer liability in these situations, including higher priced brand name drugs and fewer innovative drugs.  Taken together, we predict that the Michigan Supreme Court would decline to recognize that brand manufacturers owe generic consumers a duty of care that could give rise to liability.

Id. at *26 (citations and quotation marks omitted).

There hasn’t been much prescription drug litigation in Michigan since the state enacted its FDA compliance presumption.  Market share liability under the state’s peculiar Abel v. Eli Lilly & Co., 343 N.W.2d 164 (Mich 1984), DES theory has not extended beyond that drug, with product identification being maintained in both breast implants, In re Dow Corning Corp., 2010 WL 750200, at *2-3 (E.D. Mich. March 3, 2010) (“threshold requirement of any products liability action is identification of the injury-causing product and its manufacturer”); In re Dow Corning Corp., 250 B.R. 298, 362-63 (Bankr. E.D. Mich. 2000), and in asbestos.  Marshall v. Celotex Corp., 651 F. Supp. 389, 392-94 (E.D. Mich. 1987).

In Michigan there is no “duty to warn of the hazards of using products manufactured by someone else.”  Brown v. Drake-Willock International, Ltd., 530 N.W.2d 510, 515 (Mich. App. 1995).


An appellate court in Minnesota rejected innovator liability in Flynn v. American Home Products Corp., 627 N.W.2d 342 (Minn. App. May 15, 2001).

Appellant argues that respondents intended all consumers rely on their representations to the FDA and owed all consumers a duty to disclose material facts, but that contention conflicts with Minnesota common law, which requires a stronger relationship and a direct communication.  Appellant did not purchase or use respondents’ product, and therefore, there was no direct relationship between them, let alone a fiduciary relationship that gave rise to a duty.

Id. at 350.

Applying Minnesota law, the Eighth Circuit rejected innovator liability in Mensing v. Wyeth, Inc., 588 F.3d 603, 612-14 (8th Cir. 2009) (relying on Flynn and Foster), rev’d in part on other grounds, 131 S.Ct. 2567 (2011), reaffirmed in pertinent part and vacated in part on other grounds, 658 F.3d 867 (8th Cir. 2011).

In Zandi v. Wyeth, 2009 WL 2151141, at *3-4 (Minn. App. July 21, 2009) (unpublished), the court affirmed summary judgment for an innovator drug manufacturer and one generic company where the plaintiff failed to introduce evidence that she ever ingested those defendant’s drugs, as opposed to a different generic brand.

Minnesota has rejected market share liability as a way around product identification.  Bixler v. Avondale Mills, 405 N.W.2d 428, 430 (Minn. App. 1987) (cotton cloth); Mason v. Spiegel, Inc., 610 F. Supp. 401, 406 & n.7 (D. Minn. 1985) (same).


Mississippi is another state with an abundance of law concerning innovator liability.  In Lashley v. Pfizer, Inc., 750 F.3d 470 (5th Cir. 2014), the Fifth Circuit affirmed that Mississippi rejects this theory:

The Mississippi Products Liability Act (“MPLA”) applies “in any action for damages caused by a product” and requires a plaintiff to prove that it was the defendant’s product that caused the injury.  [Plaintiff] argues that the . . . brand defendants are not “manufacturers or sellers” of the product, relying on a Mississippi case holding that “the MPLA does not preclude claims against defendants who are neither manufacturers nor sellers” of a defective product.  Lawson v. Honeywell International, Inc., 75 So.3d 1024, 1030 (Miss. 2011).  This argument fails because brand defendants are, indeed, manufacturers − and were they not, there would be no relationship on which to presume liability (since they did not design the drug).  In any event, because [plaintiff] did not ingest the . . . brand defendants’ products, he has not established a duty.

Id. at 476-77 (other citations omitted).  The district court opinion that was affirmed, Lashley v. Pfizer, Inc., 877 F. Supp.2d 466, 471-76, 480 (S.D. Miss. 2012), contained a lengthy discussion of why innovator liability was incompatible with Mississippi law.  Other Mississippi trial courts agree.  Gardley-Starks v. Pfizer, Inc., 917 F. Supp.2d 597, 601-04 (N.D. Miss. 2013); Washington v. Medicis Pharmaceuticals Corp., 2013 WL 496063, at *3-4 (S.D. Miss. Feb. 7, 2013).  In In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, ___ F.3d ___, 2014 WL 2959271, at *27 (6th Cir. June 27, 2014), the Sixth Circuit followed Lashley in holding that Mississippi rejects innovator lability.

Chatman v. Pfizer, Inc., 960 F. Supp.2d 641 (S.D. Miss. 2013), allowed innovator liability based on a misrepresentation theory (recognizing that product liability theories were invalid).  However, Chatman relied (id. at 652-55) on the same Lawson v. Honeywell rationale specifically rejected by the Fifth Circuit in Lashley. Therefore Chatman can no longer be considered good law.

In Gorman–Rupp Co. v. Hall, 908 So.2d 749, 757 (Miss. 2005), the court enforced the product identification requirement in an asbestos case.


In Missouri, a plaintiff must “establish that the particular defendant actually caused the problem.  Absent product identification evidence, [plaintiff] simply cannot prove actual causation.”  City of St. Louis v. Benjamin Moore & Co., 226 S.W.3d 110, 116 (Mo. 2007).  The only Missouri precedent specifically on innovator liability is, In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 3610237, at *2 & n.7 (E.D. Ky. Aug. 21, 2012) (“There is no theory of product liability under which a defendant can be held liable for an injury caused by a product it did not sell, manufacture, or otherwise supply to the plaintiff.”), aff’d on other grounds, ___ F.3d ___, 2014 WL 2959271 (6th Cir. June 27, 2014) (no Missouri plaintiff appealed).  This Darvocet opinion cited, inter alia, St. Louis v. Benjamin Moore, 226 S.W.3d at 112–15, in which the Missouri Supreme Court rejected market share liability.  Indeed, Missouri rejected market share liability as a way around product identification, even in the DES context.  Zafft v. Eli Lilly & Co., 676 S.W.2d 241, 246-47 (Mo. 1984) (discourages safety innovations since defendants liable for competitors’ conduct).  In all “product liability claims,” a Missouri statute requires that the defendant have “transferred” the product that injured the plaintiff.  VAMS §537.760(1).


There is no law in Montana on either innovator liability.  The general causation rule for product liability actions in Montana requires that a “defect existed when the product left the hands of the particular defendant.’  Duncan v. Rockwell Manufacturing Co., 567 P.2d 936, 939 (1977) (quoting Prosser).


 “[U]nder Nebraska law, a plaintiff must show, inter alia, the defendant’s product caused injury to a plaintiff.”  Barrett v. Rhodia, Inc., 2009 WL 2477560, at *8 (D. Neb. Aug. 11, 2009), aff'd, 606 F.3d 975 (8th Cir. 2010).  In In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, ___ F.3d ___, 2014 WL 2959271 (6th Cir. June 27, 2014), the Sixth Circuit predicted that Nebraska would reject innovator liability:

We predict that the Nebraska Supreme Court would either construe Plaintiffs' misrepresentation claims as product liability claims under the Nebraska statute defining product liability actions that fail for lack of product identification, or that the Brand Manufacturers did not owe the Plaintiffs a duty that could give rise to liability under Nebraska law.

Id. at *28 (noting that Nebraska, like a number of other states, has a comprehensive product liability statute).  The Tenth Circuit has also indicated that Nebraska would adhere to product identification and reject market share liability.  Menne v. Celotex Corp., 861 F.2d 1453, 1468 n.22 (10th Cir. 1988) (applying Nebraska law).


In Nevada, “the injured party must prove that exposure to the products made or sold by that particular defendant was a substantial factor in causing the injury.”  Holcomb v. Georgia Pac., LLC, 289 P.3d 188, 197 (Nev. 2012) (citations omitted).  In Moretti v. Wyeth, Inc., ___ F. Appx. ___, 2014 WL 2726886 (9th Cir. June 17, 2009) (affirming Moretti v. Wyeth, Inc., 2009 WL 749532, at *3-4 (D. Nev. March 20, 2009)):

The district court properly concluded that Nevada law does not recognize [plaintiff’s] claims.  Under Nevada law, a misrepresentation by omission is actionable only if the defendant was under a duty to disclose the relevant information.  The duty to disclose requires, at a minimum, some form of relationship between the parties.  [The Nevada Supreme Court] explicitly rejected concealment claims against [a defendant], stating that: “[it] had no duty to disclose to the [plaintiffs] any superior knowledge it may have had regarding the safety of [its] products, however, because it was not directly involved in the transaction from which this lawsuit arose, or any other transaction with the [plaintiffs].

Id. at *1 (following Dow Chemical Co. v. Mahlum, 970 P.2d 98 (Nev. 1998)).  Accord Baymiller v. Ranbaxy Pharmaceuticals Inc., 894 F. Supp.2d 1302, 1307-11 (D. Nev. 2012) (also rejecting innovator liability and Conte).

New Hampshire

In Bartlett v. Mutual Pharmaceutical Co., 659 F. Supp.2d 279 (D.N.H. Sept. 30, 2009), the court, in the course of rejecting a (pre-Mensing) preemption argument, noted:.

The vast majority of courts have rejected the notion that the manufacturer of the brand-name drug may be liable for defects in its generic equivalent on a theory of “innovator liability.”

Id. at 309 n.40.  Bartlett did not decide the issue under New Hampshire law.

In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 3842045, at *7 (E.D. Ky. Sept. 5, 2012), aff’d on other grounds, ___ F.3d ___, 2014 WL 2959271 (6th Cir. June 27, 2014), the court held that New Hampshire would reject innovator liability.  Darvocet cited University System of New Hampshire v. U.S. Gypsum Co., 756 F. Supp. 640, 653-56 (D.N.H. 1991), rejecting market share liability in an asbestos case, and MacCleery v. T.S.S. Retail Corp., 882 F. Supp. 13, 15-16 (D.N.H. 1994), a corporate succession dispute holding that “imposition of liability depends upon the plaintiff proving that the defendant manufacturer made the product that caused the plaintiff's injury.”

New Jersey

New Jersey has a product liability statute that subsumes all other claims and requires product identification.  N.J.S.A. §§2A:58C-l, et seq.  Four New Jersey trial court opinions have rejected innovator liability in generic drug cases, most recently Condouris v. Wyeth, 2012 WL 2401776 (N.J. Super. Law Div. June 26, 2012):

Having concluded that the Plaintiffs’ claims are governed by the [Product Liability Act], the Court finds that Plaintiffs’ action must fail because they did not ingest a product made or sold by the Brand Defendants.  In New Jersey, it is well-settled that in products-liability litigation, [a plaintiff] must demonstrate that his or her injuries were caused by defendant’s product.

Id. (citation and quotation marks omitted).  Condouris followed the prior three cases, Rossi v. Hoffmann-LaRoche, 2007 WL 7632318 (N.J. Super. L.D. Jan. 3, 2007); Westerlund v. Wyeth, Inc., 2008 WL 5592753, at *3 (N.J. Super. Law Div. Oct. 20, 2008); Sloan v. Wyeth, 2004 WL 5767103 (N.J. Super Law. Div. Oct. 13, 2004).

Federal courts agree.  Three different Darvocet opinions have rejected innovator liability under New Jersey law.  In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 856 F. Supp.2d 904, 911 (E.D. Ky. 2012), aff’d on other grounds, ___ F.3d ___, 2014 WL 2959271 (6th Cir. June 27, 2014); In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 767595, at *2 n.5 (E.D. Ky. March 7, 2012), aff’d on other grounds, ___ F.3d ___, 2014 WL 2959271 (6th Cir. June 27, 2014); In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 4831632, at *1-3 (E.D. Ky. Oct. 10, 2012), aff’d and rev’d on other grounds, ___ F.3d ___, 2014 WL 2959271 (6th Cir. June 27, 2014).  None of the New Jersey plaintiffs appealed, so the Sixth Circuit did not address New Jersey law.  Also, in Adamson v. Ortho-McNeil Pharmaceutical, Inc., 463 F. Supp.2d 496, 505 (D.N.J. Nov. 16, 2006), reconsideration denied, 2007 WL 604790 (D.N.J. Feb. 20, 2007), the court rejected innovator liability under New Jersey law when advanced as a claim for unjust enrichment.

Product identification has repeatedly been required in cases rejecting market share liability, both with respect to DES and other products, including prescription medical products.  Shackil v. Lederle Laboratories, 561 A.2d 511, 517, 526 (N.J. 1989); (no market share liability in vaccine cases); Namm v. Charles E. Frosst & Co., 427 A.2d 1121, 1125 (N.J. Super. App. Div. 1981) (same, DES); Lyons v. Premo Pharmaceutical Labs, Inc., 406 A.2d 185, 190 (N.J. Super. App. Div. 1979) (same, DES); Johnston v. Aventis, 2007 WL 954017 (N.J. Super. Law Div. March 9, 2007) (same, vaccine); Pipon v. Burroughs-Wellcome Co., 532 F. Supp. 637, 639 (D.N.J. 1982) (same, asbestos), aff’d without op., 696 F.2d 984 (3d Cir. 1982) (applying New Jersey law); Gianvito v. Premo Pharmaceutical Laboratories Inc., 940 N.Y.S.2d 272, 273-74 (N.Y. App. Div. March 20, 2012) (same, DES) (applying New Jersey law).

New Mexico

There is no New Mexico precedent either on innovator liability or market share liability.  The general New Mexico causation standard is that “[a] defendant can only be liable for damages that the particular defendant caused.”  Westbrook v. Lea General Hospital, 510 P.2d 515, 518 (N.M. App. 1973).  In asbestos cases, New Mexico law requires “product identification” so “that defendants’ products actually caused the [injuries].”  Huber v. Armstrong World Industries, Inc., 930 F. Supp. 1463, 1465 (D.N.M. 1996).

New York

In In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, ___ F.3d ___, 2014 WL 2959271 (6th Cir. June 27, 2014), the Sixth Circuit held that innovator liability did not exist under New York law:

[A]ny duty a brand defendant has in connection with its own products and labels does not extend to products and labeling over which it has no control, even if those products and labels mirror its own, because it has done nothing toward putting them in the hands of consumers.  We predict that the New York Court of Appeals would construe Plaintiffs’ misrepresentation claims as a product liability claim that fails for lack of product identification, or alternatively that the Brand Manufacturers did not owe Plaintiffs a duty that could give rise to liability.

Id. at  *28-29 (citations and quotation marks omitted).  Darvocet relied upon prior New York precedent rejecting innovator liability.  Id. (citing Goldych v. Eli Lilly & Co., 2006 WL 2038436, at *3-8 (N.D.N.Y. July 19, 2006); Weese v. Pfizer, Inc., 2013 WL 5691993, at *2 (N.Y. Sup. Oct. 8, 2013).

New York has allowed market share liability for DES, and only DES, distinguishing both the characteristics of the product and the circumstances of DES-specific legislative action.  With respect to all other products, medical or otherwise, the product identification requirement remains.  See Hamilton v. Beretta U.S.A. Corp., 750 N.E.2d 1055, 1067-68 (N.Y. 2001) (no market share liability for handguns); Brenner v. American Cyanamid Co., 699 N.Y.S.2d 848, 851-52 (N.Y. App. Div. 1999) (same, lead paint); In re New York State Silicone Breast Implant Litigation, 631 N.Y.S.2d 491, 494 (N.Y. Sup. 1995) (same, breast implants), aff’d mem., 650 N.Y.S.2d 558 (N.Y. App. Div. 1996); Catherwood v. American Sterilizer Co., 532 N.Y.S.2d 216, 220 (N.Y. Sup. 1988) (same, toxic chemical); 210 E. 86th St. Corp. v. Combustion Engineering, 821 F. Supp. 125, 145-46 (S.D.N.Y. 1993) (same, asbestos).

Nor does New York impose a duty to warn about other manufacturer’s similar products;

[W]e decline to hold that one manufacturer has a duty to warn about another manufacturer’s product when the first manufacturer . . . had no control over the production of the subject [product], had no role in placing that [product] in the stream of commerce, and derived no benefit from its sale.

Rastelli v. Goodyear Tire & Rubber Co., 591 N.E.2d 222, 225-26 (N.Y. 1992).

North Carolina

North Carolina federal district courts, applying the state’s product liability statute, N.C. Gen. Stat. §§99B–1, et seq., have rejected innovator liability twice.  Couick v. Wyeth, Inc., 691 F. Supp.2d 643, 645 (W.D.N.C. 2010) (“no North Carolina authority allow[s] a name-brand drug manufacturer to be held liable for injuries caused by a generic competitor’s drug”); Stoddard v. Wyeth, Inc., 630 F. Supp.2d 631, 633-34 (E.D.N.C. 2009) (“under North Carolina law a manufacturer of a brand name pharmaceutical may not be held liable for injuries stemming from the use of another manufacturer's generic bioequivalent”).

This authority convinced the Sixth Circuit in In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, ___ F.3d ___, 2014 WL 2959271 (6th Cir. June 27, 2014), that North Carolina would not embrace the theory:

Guided by these decisions, we predict that the North Carolina Supreme Court would construe Plaintiffs’ misrepresentation claims as product liability claims that fail for lack of product identification, or alternatively that the Brand Manufacturers did not owe Plaintiffs a duty that could give rise to liability.

Id. at *29.  See also Bennett v. Hoffmann-LaRoche Inc., 2013 WL 1191899, at *3-6 (E.D.N.C. March 22, 2013) (rejecting innovator liability; finding sufficient product identification evidence to survive summary judgment); John & Jane Doe 2 v. Ortho-Clinical Diagnostics, Inc., 335 F. Supp.2d 614, 628-29 (M.D.N.C. 2004) (defendant’s “duty to Plaintiffs would not extend to warning Plaintiffs or other manufacturers who copied [defendant’s contrast agent]”).

North Carolina also rejects market share liability.  Griffin v. Tenneco Resins, Inc., 648 F. Supp. 964, 966 (W.D.N.C. 1986) (applying North Carolina law) (“the defendant manufacturer must be identified with the specific instrumentality allegedly causing the injury”).

North Dakota

North Dakota law has not addressed innovator liability.  However, the state has not allowed market share liability.  Black v. Abex Corp., 603 N.W.2d 182, 189 (N.D. 1999) (asbestos).  Other asbestos cases under North Dakota law also impose a product identification requirement.  E.g., Various Plaintiffs v. Various Defendants, 847 F. Supp. 2d 722, 732 (E.D. Pa. 2012) (applying North Dakota law).


Product identification is incorporated into the Ohio Product Liability Act (“OPLA”).  A plaintiff must prove that the defendant “designed, formulated, produced, constructed, created, assembled, or rebuilt the actual product that was the cause of harm for which the claimant seeks to recover.”  Ohio Rev. Code §2307.73(A)(3).  The statute expressly bans innovator (“the type of product”), as well as market share liability:

Proof that a manufacturer designed, formulated, produced, constructed, created, assembled, or rebuilt the type of product in question is not proof that the manufacturer designed, formulated, produced, constructed, created, assembled, or rebuilt the actual defective product. . . .  A manufacturer may not be held liable in a product liability action based on market share, enterprise, or industrywide liability.

Ohio Rev. Code Ann. §2307.73(C).  Cf. Sutowski v. Eli Lilly & Co., 696 N.E.2d 187, 192-93 (Ohio 1998) (rejecting market share liability in DES cases); Kurczi v. Eli Lilly & Co., 113 F.3d 1426, 1431-32 (6th Cir. 1997) (same) (applying Ohio law).

Ohio courts have twice rejected innovator liability under OPLA.  Hendricks v. Pharmacia Corp., 2014 WL 2515478, at *5-6 (Mag. S.D. Ohio June 4, 2014) (§2307.73(C) “readily dispose[s]” of innovator liability); Hogue v. Pfizer, Inc., 893 F. Supp.2d 914, 918-19 (S.D. Ohio 2012) (“OPLA precludes [plaintiff's] argument that the Brand Manufacturers are subject to liability as inventors or primary manufacturers of [the drug] as neither theory is an exception to the rule that a plaintiff must prove [his or] her injuries were caused by the actual product the defendant manufactured”).  This precedent “guided” the Sixth Circuit’s conclusion that Ohio would not permit innovator liability.  In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, ___ F.3d ___, 2014 WL 2959271, at *29-30 (6th Cir. June 27, 2014) (“we predict that the Ohio Supreme Court would construe Plaintiffs’ misrepresentation claims as product liability claims that fail for lack of product identification”).


The Tenth Circuit held that innovator liability was incompatible with Oklahoma law in Schrock v. Wyeth, Inc., 727 F.3d 1273 (10th Cir. 2013), rejecting:  strict liability, negligence, fraud/misrepresentation, a “duty to speak,” and warranty.  Id. at 1281-84.  Plaintiffs “fail[ed] to cite Oklahoma case law suggesting that these general tort principles impose liability with respect to a defendant that did not sell, distribute, manufacture, or otherwise have contact with the allegedly harmful product.”  Id. at 1284 (affirming 601 F. Supp.2d 1262, 1266 (W.D. Okla. 2009)).  In reliance on these precedents, the Sixth Circuit agreed that Oklahoma law did not recognize innovator liability.  In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, ___ F.3d ___, 2014 WL 2959271 (6th Cir. June 27, 2014) (“Guided by our sister circuit's analysis of Oklahoma tort law, we predict that the Oklahoma Supreme Court would find that Brand Manufacturers did not owe Plaintiffs a duty that could give rise to liability under Oklahoma law”),

If that were not enough, Oklahoma has also rejected market share liability, both in the DES context and elsewhere.  Case v. Fibreboard Corp., 743 P.2d 1062, 1067 (Okla. 1987) (asbestos); Wood v. Eli Lilly & Co., 38 F.3d 510, 513-514 (10th Cir. 1994) (applying Oklahoma law) (DES); outside DES


The Oregon Supreme Court determined in Senn v. Merrell-Dow Pharmaceuticals, Inc., 751 P.2d 215, 233 (Or. 1988), that any tort theory that eliminated a plaintiff’s obligation to prove product identification “requires a profound change in fundamental tort principles of causation,” and “cannot [be] . . . consistent with common law principles of tort liability.”  Id. at 223 (rejecting alternative liability).

Three Oregon trial courts have rejected innovator liability.  In Phelps v. Wyeth, Inc., 857 F. Supp.2d 1114 (D. Or. 2012), the court, following the Mensing generic preemption decision, reaffirmed this position:

Under Oregon’s product liability law, the name-brand defendants cannot be found liable for plaintiffs’ injuries because plaintiffs cannot show that their injuries resulted from the use of the name-brand manufacturers’ product . . . .  I decline to stretch the duty of care for name-brand defendants to cover injuries caused by generic manufacturers’ products, given that their argument directly contradicts Oregon law.  [discussion rejecting Conte and Kellog omitted]  Oregon product liability law is controlling here, and it does not allow for name-brand manufacturer liability unless [plaintiff] can demonstrate that the name-brand manufacturers' products caused her injury.

Id. at 1120-21.  See Phelps v. Wyeth, Inc., 2010 WL 2553619, at *2 (Mag. D. Or. May 28, 2010) (“I cannot find that a decision to hold a manufacturer liable for injury caused by its competitor's product is rooted in common sense”), adopted, 2010 WL 2553614 (D. Or. June 21, 2010).  Accord DaCosta v. Novartis AG, 2002 WL 31957424, at *8-9 (D. Or. March 1, 2002) (no liability where plaintiff never took defendant’s “chemically identical drugs”; “the allegedly defective product or form of [the drug], that [defendant] sold was not consumed by [plaintiff] and could not have caused [her] injuries”); Lukas-Werner v. Novo Nordisk, A/S, No. 1009-13177, transcript at 26 (Or. Cir. May 11, 2012) (“I do not think the Oregon Supreme Court would conclude that the innovator, the original manufacturer of a drug responsible for its labeling, has a duty arising out of the FDA regulations to the consumers or prescribers of all generic versions of its drug”).


“Pennsylvania . . . follows the general rule that a plaintiff, in order to recover, must establish that a particular defendant’s negligence was the proximate cause of her injuries.”  Skipworth v. Lead Industries Ass’n, 690 A.2d 169, 172 (Pa. 1997) (rejecting market share liability) (lead paint case).  Thus, (“[a] plaintiff must also establish that the injuries were caused by a product of a particular manufacturer.”  DeWeese v. Anchor Hocking Consumer & Industrial Products Group, 628 A.2d 421, 423 (Pa. Super. 1993).

[A] defendant must be identified as the manufacturer, distributor, or seller of the offending product before the injuries suffered by the plaintiff may be found to be proximately caused by some negligent act or omission of the defendant.  Absent such identification, there can be no allegations of duty, breach of duty, or legal causation, and hence there can be no liability.

Mellon v. Barre-National Drug Co., 636 A.2d 187, 191-91 (Pa. Super. 1993) (citations and quotation marks omitted) (rejecting market share liability for OTC drug).

The first Pennsylvania court to consider innovator liability was Colacicco v. Apotex, Inc., 432 F. Supp.2d 514 (E.D. Pa. May 25, 2006), aff’d on other grounds, 521 F.3d 253 (3d Cir. 2008), vacated on other grounds, 556 U.S. 1101 (2009).  Finding Foster “persuasive,” the court held:

[W]e agree that to impose a duty in this case would be to stretch the concept of foreseeability too far, as [an innovator manufacturer] cannot reasonably expect that consumers will rely on information they provide when actually ingesting another company's drug.  Also, we agree that unfair consequences would result if we were to impose a duty upon [an innovator], when it obtained no benefit from the sale of [the] generic equivalent and had no control over the manufacturing or labeling of [the generic drug], yet it bore the expense of developing [the innovator drug] from which [the generic manufacturer] materially benefits.

*          *          *          *

Plaintiff in this case invites this Court to drastically expand the boundaries of Pennsylvania tort law without precedent or policy to support his position.  We believe the Supreme Court of Pennsylvania would not accept this invitation, and accordingly, we decline to do so as well.  Thus, this Court holds that under Pennsylvania law, there is no duty of care owed by a brand-name prescription drug manufacturer to a plaintiff allegedly injured by a generic equivalent drug manufactured by another company.

432 F. Supp.2d at 541 (footnote, citations and quotation marks omitted).

Based largely on Colacicco, the Sixth Circuit in In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, ___ F.3d ___, 2014 WL 2959271, at *31 (6th Cir. June 27, 2014) (“Guided by the Eastern District’s analysis of Pennsylvania tort law, we predict that the Pennsylvania Supreme Court would find that Brand Manufacturers did not owe Plaintiffs a duty that could give rise to liability under Pennsylvania law”).

Taking a contrary view in an economic loss case, the court in Clark v. Pfizer, Inc., 2008 WL 7668730 (Pa. C.P. Phila. Co. March 17, 2008), held that an innovator manufacturer that allegedly promoted its product off-label could be liable for the “foreseeable” effect that its promotion would also increase off-label prescriptions of generic equivalents.  Id. (applying Restatement (Second) of Torts §§ 552 & 531 (1965)).

In addition to Skipworth and Mellon, numerous appellate courts have reaffirmed the product identification requirement under Pennsylvania law by rejecting market share liability or similar theories in litigation involving a wide variety of products.  Pennfield Corp. v. Meadow Valley Electric, Inc., 604 A.2d 1082, 1088 (Pa. Super. 1992) (electrical cable); Cummins v. Firestone Tire & Rubber Co., 495 A.2d 963, 972 (Pa. Super. 1985) (tires); City of Philadelphia v. Lead Industries Ass’n, 994 F.2d 112, 127 (3d Cir. 1993) (lead paint) (applying Pennsylvania law); Robertson v. Allied Signal, Inc., 914 F.2d 360, 379-81 (3d Cir. 1990) (asbestos; rejecting “fiber drift” theory) (applying Pennsylvania law); see also Bortell v. Eli Lilly & Co., 406 F. Supp.2d 1, 6-7 (D.D.C. 2005) (DES) (applying Pennsylvania law).

Rhode Island

In Rhode Island, “[i]t is axiomatic that a plaintiff must prove that the proximate cause of his or her injuries was the defendant’s product.”  Clift v. Vose Hardware, Inc., 848 A.2d 1130, 1132 (R.I. 2004).  While there isn’t any Rhode Island law on innovator liability, product identification is strongly supported by the Rhode Island Supreme Court’s firm rejection of market share liability non-manufacturer liability in Gorman v. Abbott Laboratories, 599 A.2d 1364, 1364 (R.I. 1991), refusing to allow market share liability even in DES cases.

South Carolina

“It is a fundamental principle of the law of products liability that a product manufacturer is not an insurer of its product, and a plaintiff may recover against a manufacturer only upon a showing that the product was in a defective condition unreasonably dangerous at the time it left the manufacturer’s control.”  Baughman v. General Motors Corp., 627 F. Supp. 871, 874 (D.S.C. 1985).

In Fisher v. Pelstring, 2010 WL 2998474 (D.S.C. July 28, 2010), after a lengthy discussion of the Fourth Circuit’s Foster decision and its progeny, the court “conclude[d] that South Carolina law does not support an action against the name-brand drug manufacturers . . .  for injuries allegedly caused by a generic drug manufactured by another company.  Id. at *8.  The same cases cited in Fisher led the Sixth Circuit to agree that South Carolina would not adopt innovator liability:

[P]laintiffs could not establish that the brand manufacturers owed them a duty because they did not manufacture or sell the products allegedly responsible for their injuries.  Guided by the Fisher court’s analysis of South Carolina law, we predict that the South Carolina Supreme Court would find that Brand Manufacturers did not owe Plaintiffs a duty that could give rise to liability under South Carolina law.

In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, ___ F.3d ___, 2014 WL 2959271, at *31 (6th Cir. June 27, 2014).

Among the cases relied upon in Fisher were those holding that South Carolina would rejected market share liability, even in DES cases.  Mizell v. Eli Lilly & Co., 526 F. Supp. 589, 596 (D.S.C. 1981) (applying South Carolina law); Ryan v. Eli Lilly & Co., 514 F. Supp. 1004, 1007 (D.S.C. 1981) (applying South Carolina law).

South Dakota

“It is a fundamental principle that a plaintiff must prove, as an essential element of his case, that the defendant manufacturer actually made the particular product in question.”  Bradley v. Firestone Tire and Rubber Co., 590 F. Supp. 1177, 1179 (D.S.D. 1984) (refusing to expand market share liability beyond DES).  There are no innovator liability decisions from South Dakota.  No innovator liabilty case has yet been decided under South Dakota law.


The Sixth Circuit has twice determined that innovator liability is contrary to the law of Tennessee.  In Strayhorn v. Wyeth Pharmaceuticals, 737 F.3d 378 (6th Cir. 2013), the court held:

The Tennessee Product Liability Act] . . . applies to all of the plaintiffs’ claims against the Brand-Name Manufacturers.  Unfortunately for the plaintiffs, however, these defendants were not the manufacturers or sellers of the generic drugs that injured the plaintiffs.  Yet “in order to recover under the TPLA, a plaintiff must show that the product manufactured and sold by the defendant caused the injuries he alleges to have sustained. . . .  [S]imply because a particular harm is foreseeable “is not dispositive in determining the existence of a legal duty. . . .  [W]e have no basis to conclude in this diversity case that the Tennessee Supreme Court would overrule its prior decisions holding that a manufacturer owes no duty of care to consumers of products made by others.  Tennessee law instead requires manufacturers to warn of hidden and unknown dangers in their products.

Id. at 403-05 (citations and quotation marks omitted) (affirming 882 F. Supp.2d 1020, 1028-31 (W.D. Tenn. Aug. 8, 2012)).  See In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, ___ F.3d ___, 2014 WL 2959271, at *31 (6th Cir. June 27, 2014) (“[t]his Court has already determined that claims by consumers of generic drugs against brand manufacturers cannot stand under Tennessee law”).

Tennessee law also rejects market share liability.  Barnes v. Kerr Corp., 418 F.3d 583, 589 (6th Cir. 2005) (applying Tennessee law) (dental amalgam).  Nor is there any duty to warn about other manufacturer’s products.  Id. at 591 (“a product manufacturer generally has a duty to warn of the dangers of its own products, it does not have a duty to warn of the dangers of another manufacturer’s products”); McConkey v. McGhan Medical Corp., 144 F. Supp. 2d 958, 964 (E.D. Tenn. 2000) (“Plaintiffs cannot establish that [defendant] owed a duty . . . to warn about dangers of breast implants it did not produce”); Kellar v. Inductotherm Corp., 498 F. Supp. 172, 175 (E.D. Tenn. 1978) (“[i]f a manufacturer could be held liable for injury merely because it foresaw a danger created by another party, there would literally be no end of potential liability,” and manufacturers would become “insurers of products manufactured by others”).


Texas is another state with abundant precedent rejecting innovator liability.  In Eckhardt v. Qualitest Pharmaceuticals, Inc., 751 F.3d 674 (5th Cir. 2004), the court relied on extensive contrary precedent, in Texas and elsewhere:

Although [plaintiff] concedes that he has never used a product manufactured by the Brand Defendants, he argues that given the structure of the pharmaceutical industry as a result of federal law, the Brand Defendants owe a duty to eventual consumers of the drugs they design, even if those consumers use a generic version of the drug.  Several courts have faced this question.  Every circuit court has held (under the laws of several different states) that a brand-name manufacturer does not owe a duty to consumers who use a generic version of the drug.

Id. at 681 (citations omitted) (affirming 889 F. Supp.2d 901, 905-10 (S.D. Tex. 2012)).  The court in Lashley v. Pfizer, Inc., 750 F.3d 470 (5th Cir. 2014), the court reached the same conclusion.

Under Texas law, meanwhile, a products liability action is broadly defined as “any action against a manufacturer or seller for recovery of damages arising out of personal injury . . . allegedly caused by a defective product whether the action is based in strict tort liability, strict products liability, negligence, misrepresentation, breach of express or implied warranty, or any other theory or combination of theories.”  Tex. Civ. Prac. & Rem. Code Ann. §82.001(2).  The Texas Supreme Court has determined that under this statute, entities are “‘manufacturers’ . . . only with respect to their own products.”  It has also found that “[a] fundamental principle of traditional products liability law is that the plaintiff must prove that the defendants supplied the product which caused the injury.”

Id. at (quoting Owens & Minor, Inc. v. Ansell Healthcare Products, Inc., 251 S.W.3d 481, 485 (Tex. 2008) (no duty to indemnify for competing products); Gaulding v. Celotex Corp., 772 S.W.2d 66, 68 (Tex. 1989) (rejecting market share liability in asbestos cases)).  The Sixth Circuit concurred in this conclusion.  In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, ___ F.3d ___, 2014 WL 2959271, at *31-32 (6th Cir. June 27, 2014).

A raft of Texas trial courts also reject innovator liability.  Negron v. Teva Pharmaceuticals USA, Inc., 2010 WL 8357563, at *1 (Tex. Dist. May 7, 2010); Phares v. Actavis-Elizabeth LLC, 892 F. Supp.2d 835 (S.D. Tex. 2012); Finnicum v. Wyeth, Inc., 708 F. Supp.2d 616, 620-22 (E.D. Tex. 2010); Hardy v. Wyeth, Inc., 2010 WL 1049588, at *2-5 (Mag. E.D. Tex. March 8, 2010), adopted, 2010 WL 1222183 (E.D. Tex. March 29, 2010); Burke v. Wyeth, Inc., 2009 WL 3698480, at *2-3 (S.D. Tex. Oct. 29, 2009); Cousins v. Wyeth Pharmaceutical, Inc., 2009 WL 648703, at *2 (N.D. Tex. March 10, 2009); Pustejovsky v. Wyeth, Inc., 2008 WL 1314902, at *2 (N.D. Tex. April 3, 2008), aff’d on other grounds, 623 F.3d 271 (5th Cir. 2010); Block v. Wyeth, Inc., 2003 WL 203067, at *2 (N.D. Tex. Jan. 28, 2003).


In Utah, there must be “causation between [a plaintiff’s injuries] and the breach of any particular defendant.”  Highland Construction Co. v. Union Pacific Railroad Co., 683 P.2d 1042, 1047 (Utah 1984).

Innovator liability was rejected in Beutella v. A.H. Robins Co., 2001 WL 35669202, at *2-3 (Utah Dist. Dec. 10, 2001).


In Vermont, “in a products liability action, a plaintiff must show that the defendant's product . . . caused injury to the consumer.”  Farnham v. Bombardier, Inc., 640 A.2d 47, 48 (1994); see Haskins v. Zimmer Holdings Inc., 2010 WL 342552, at *2 (D. Vt. Jan. 29, 2010) (“Plaintiffs must at least allege in their complaint that [defendant’s] product was administered”).  Nonetheless, a federal district court, in the absence of any Vermont precedent, chose to recognize innovator liability in Kellogg v. Wyeth, 762 F. Supp.2d 694 (D. Vt. 2010), because it was “fair” and “[t]here is no reason, under Vermont law, to limit [defendant’s] duty of care to physicians by the pharmacist's choice of a generic bioequivalent.”  Id. at 706, 709.  Cf. Lyman v. Pfizer, Inc., 2012 WL 2970627, at *17-18 (D. Vt. July 20, 2012) (dismissing innovator liability case where warnings have changed because any reliance on older warnings would not have been justifiable as a matter of law).


In Virginia, a duty to warn “has no application in this case because [defendant] was not the manufacturer of the [product] or any of its component parts.”  Baker v. Poolservice Co., 636 S.E.2d 360 (Va. 2006).

In Colas v. Abbvie, Inc., 2014 WL 2699756 (N.D. Ill. June 13, 2014), the court, predicting Virginia law, held that Virginia would not recognize innovator liability.

Plaintiff admits that defendants were not the “suppliers” of the [drug] he took.  Thus, plaintiff cannot, as a matter of Virginia law, state a failure to warn claim against defendants. . . .  Apparently, no Virginia court has decided whether a company that makes a brand name drug owes a duty to consumers of a generic drug made by another company.  However, the Virginia failure to warn decisions, and the weight of authority from other jurisdictions, suggest that the Virginia Supreme Court would not recognize such a duty.

Id. at *2 (citations omitted).


In Washington, “[i]n order to have a cause of action, the plaintiff must identify the particular manufacturer of the product that caused the injury.”  Lockwood v. AC & S, Inc., 744 P.2d 605, 612 (Wash. 1987).  Further, a “manufacturer’s duty to warn is restricted to warnings based on the characteristics of the manufacturer’s own products, the law generally does not require a manufacturer to study and analyze the products of others and warn users of the risks of those products.”  Braaten v. Saberhagen Holdings, 198 P.3d 493, 498 (Wash. 2008) (citations and quotation marks omitted).

In Madden v. Teva Pharmaceuticals, USA, Inc., 2012 WL 4757253. (Pa. C.P. Phila. Co. Oct. 1, 2012), the court applied Washington law (where the plaintiff was domiciled and the prescription written) and concluded that innovator liability was not proper:

[T]he Court properly dismissed Plaintiff's claims . . .  because [defendant] was not the manufacturer or seller of the product ingested by the Plaintiff.  Here, it is undisputed that the Plaintiff purchased and ingested the generic drug . . ., not the brand-name drug . . . manufactured by [defendant].  Moreover, courts across the country have overwhelmingly refused to allow claims against the manufacturer of a name-brand medication for damages allegedly caused by the use of another manufacturer’s generic-equivalent medication on both legal and policy grounds.

Id. at ?? (near end of opinion) (footnote omitted).  In reliance on Madden, the Sixth Circuit also concluded that Washington would not recognize innovator liability.  In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, ___ F.3d ___, 2014 WL 2959271 (6th Cir. June 27, 2014).

West Virginia

In In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, ___ F.3d ___, 2014 WL 2959271, at *19 (6th Cir. June 27, 2014), the Sixth Circuit affirmed dismissal of West Virginia plaintiffs alleging innovator liability because they had “to specifically allege that the defendant's product caused their harm.”  Id. at 19.  However, unlike the 21 other states’ laws it adjudicated, the court did not discuss West Virginia law separately.  Darvocet relied upon Meade v. Parsley, 2009 WL 3806716, at *2-3 (slip op.) (S.D.W. Va. Nov. 13, 2009).

[Innovator defendants] are not responsible for the damage resulting from a product that they did not manufacture, distribute or sell. . . .  Product liability law in West Virginia allows for recovery when the plaintiff can prove that “a product was defective when it left the manufacturer and the defective product was the proximate cause of the plaintiff's injuries.”  Because neither [innovator defendant] manufactured the product that injured plaintiffs, there is no proximate cause.

Id. at *2-3 (quoting Dunn v. Kanawha County Board of Education, 459 S.E.2d 151, 157 (W. Va. 1995)).

 See In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 4831632, at *2-3 (E.D. Ky. Oct. 10, 2012), aff’d in pertinent part, rev’d in part on other grounds, 2014 WL 2959271 (6th Cir. June 27, 2014); In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 3842045, at *7 (E.D. Ky. Sept. 5, 2012), aff’d, 2014 WL 2959271 (6th Cir. June 27, 2014); In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 3610237, at *2 & n.7 (E.D. Ky. Aug. 21, 2012), aff’d, 2014 WL 2959271 (6th Cir. June 27, 2014) (all dismissing innovator liability claims brought by West Virginia plaintiffs).

West Virginia law has not embraced market share liability.  State v. AAER Sprayed Insulations, 1987 WL 1428107 (W. Va. Cir. Sept. 4, 1987).  Nor does West Virginia require warnings about other persons’ products.  Smith v. Wyeth Laboratories, Inc., 1986 WL 720792, at *10 (S.D.W. Va. Aug. 21, 1986) (“plaintiffs offer no authority for their argument that a drug manufacturer may be required to represent that other drugs with similar effects are safe”).


There are no innovator liability decisions in Wisconsin.  Wisconsin’s new product liability statute, however, subsumes all common-law claims (W.S.A. §895.046(2)) and mandates product identification.

[T]he manufacturer, distributor, seller, or promoter of a product may be held liable in an action under sub. (2) only if the claimant proves, in addition to any other elements required to prove his or her claim, that the manufacturer, distributor, seller, or promoter of a product manufactured, distributed, sold, or promoted the specific product alleged to have caused the claimant’s injury or harm.

W.S.A. §895.046(3).  A very limited exception is provided to the statutory product identification requirement, but it cannot be applicable to prescription drugs.  An essential element of that exception requires that the product “[w]as distributed or sold without labeling or any distinctive characteristic that identified the manufacturer, distributor, seller, or promoter.”  W.S.A. §895.046(4)(a)(3)(c).


There are no Wyoming decisions on innovator liability or market share liability.  The general Wyoming causation standard “require[s] the plaintiff to show the defendant's product or negligence was a ‘substantial factor’ in bringing about the plaintiff's harm.”  Johnson v. Allis-Chalmers Corp. Products Liability Trust, ___ F. Supp.2d ___,  2014 WL 1383314, at *3 (D. Wyo. April 7, 2014).