Wednesday, October 22, 2014

M.D. Fla. Double Trouble on Fraudulent Joinder

What the deuce is it about today?  The date is made up of two 2’s.  Today is the 76th birthday of two of our favorite, though couldn’t-be-more-different, actors:  Derek Jacobi (I, Claudius/Last Tango in Halifax) and ChristopherLloyd (Back to the Future/Taxi).  This day in 1978 saw the papal inauguration of John Paul II.  And, after much hand-wringing and soul-searching, today we have decided to drop two tv shows from our viewing rotation:  Homeland and Masters of Sex.  Sorry, Showtime, but those programs jumped a shark swimming in a pool of implausibility. (Boozy, sexy, sometimes thrilling implausibility, to be sure, but implausibility nonetheless.)

It’s only fitting that today we address a pair of stinkpot cases. Fronczak v. DePuy Orthopaedics, Inc., 2014 U.S. Dist. LEXIS 146347 (M.D. Fla. October 14, 2014) and Wier v. DePuy Orthopaedics, Inc., 2014 U.S. Dist. LEXIS 146353 (M.D. Fla. October 14, 2014) were decided on the same day by the same judge, involve the same issues, and offer the same lame fraudulent joinder analysis. 

The plaintiffs in both cases (represented by the same attorneys) alleged injuries from the implantation of artificial hip prostheses manufactured by DePuy and distributed by Bayside Orthopaedics.  The plaintiffs asserted claims for negligence, negligent failure to warn, strict liability failure to warn, strict liability, and breach of warranty.  The cases were filed in state court in Sarasota, Florida.  The inclusion of Bayside as a local defendant wrecked diversity. Nevertheless, DePuy removed the cases to federal court and argued that Bayside had been fraudulently joined.     

DePuy argued that the claims against Bayside were preempted.  Its reasoning was clever, compelling, and correct.  It was also futile.  The federal court followed the argument, up to a point:  “In Mensing, the Supreme Court held that all state-law tort claims based on an alleged failure to warn of the risks of generic medications are preempted by federal law because it is impossible to comply with both a jury’s charge to strengthen a generic drug warning under state law, and the federal mandate that a generic drug’s labeling be the same as that of the brand-name drug.  Bartlett extended this reasoning in design defect claims, holding that redesigning a generic drug was also impossible because federal drug regulations require a generic drug to have the same active ingredients, route of administration, dosage form, and strength as the brand-name drug on which it is based.”  Wier, 2014 U.S. Dist. LEXIS 146353 at *5-6 (citations omitted).   So far so good.  DePuy then took the logic a little further and argued that the Mensing-Bartlett impossibility line should apply to other failure to warn cases, such as these two, and should preclude an action against a distributor that clearly had no ability to change any device warning.    

Rather than embrace DePuy’s admirable syllogism, the federal court lunged for the 11th Circuit “no possibility of recovery” standard for testing fraudulent joinder arguments, and held on fast.  We’ve bemoaned this standard before.  If the TwIqbal standard for testing fraudulent joinder is the state-of-the-art, Peyton Manning-level standard, and the TwIqbal-light standard favored by some courts is Nick Foles (pretty good, but makes us nervous), then the no-possibility-of-recovery standard is Joe Pisarcik (look up “Miracle in the Meadowlands” on your browser).  (By the way, when a federal court decides whether there was fraudulent joinder by applying some dreadfully permissive state law pleading standard, that is like slapping an old leather helmet on your friendly neighborhood barista and sending him in against JJ Watt.)  The no-possibility standard inspires more indolence than insight.  

We’re used to all sorts of lax standards that give plaintiffs the benefit of the doubt on what the facts might be.  But what is so pernicious about the no-possibility-of-recovery standard is that it tells the court to “resolve uncertainties about the applicable law in favor of the plaintiff.”  Wier at *4.  If that isn’t an invitation to lazy-thinking, then we’ll turn in our bar cards and spend the rest of our days watching Claire Danes cry-a-thons and Lizzy Caplan-Michael Sheen, um, hug-a-thons.

In both Weir and Fronczak, the court previews its conclusion thusly:  “Because uncertainties exist as to the applicability of Mensing’s preemption with regard to distributors of medical devices, the Court concludes that remand is appropriate.”  Weir at *2; Fronczak at *2.   Then we get this:  “Mensing and Bartlett are arguably distinguishable because they both addressed federal preemption in the specific context of generic drug manufacturers, rather than medical device distributors.”  Wier at *5; Fronczak at *5.  Why would that factual distinction matter in terms of applying the Supreme Court’s impossibility analysis?  Either way, the defendant at issue cannot change the label/IFU. 

Now in defense of the Wier and Fronczak courts (really “court” singular, since it is the same judge), there was a precedent out there that jabbered at this issue:  “The Court has previously acknowledged this distinction in the context of Mensing, explaining [we cannot resist inserting a sic here] ‘[t]here is a marked difference between a duty requiring a drug manufacturer to physically change its federal approved label and a duty requiring a distributor to warn a third party of what the federal approved label or warning on a file with the FDA says.  Accordingly, whether Florida law imposes a duty to warn upon device distributors such as the [d]istributor [d]efendants is a determination best left to State court.’  See Zaremba v. Orthopedics, Inc. 8:14-CV-1016-T-33TGW, 2014 U.S. Dist. LEXIS 91762, 2014 WL 3057400, at *4 n. 2 (M.D. Fla. July 7, 2014).”   If you can explain what that quote means, or why it calls off a Mensing-Bartlett impossibility analysis, then maybe you can also explain how the main character in Homeland was not tried for treason at the end of  season 2.     

What exactly did the distributor do in this duet of sad cases besides, you know, distribute?  The plaintiff in Wier alleged that Bayside “disseminated literature to the orthopedic community in Florida” and provided the plaintiff’s orthopedic surgeon information “including, but not limited to, the advantages of the ASR System compared to its competitors, information regarding the design rationale for the ASR System, surgical techniques on how to implant the ASR System, and demonstrations on how to implant the ASR System and the components that could best be mated with the ASR System” with the “intended purpose of convincing and inducing Plaintiff’s orthopedic surgeon to use the ASR System.”  Wier at *8-9.  We can discern nothing actionable in any of that.  Then:  “Plaintiff also alleged that in preparation for his surgery, ‘Defendants (or their employees or agents) selected and provided the specific components to be used during the surgery and delivered them to the operating room where Plaintiff’s implant surgery took place.”  Id. at *9.  Aha!  Well, actually, nope, we still do not see anything actionable.  

Maybe the plaintiff in Fronczak came up with something juicier.  Let’s see:  “Plaintiff alleged that Bayside ‘disseminated literature to the orthopedic community in Florida stating that the ASR components were ‘large diameter, high performance metal-on-metal bearings designed and manufactured within fine tolerances to facilitate a state of fluid film lubrication’ and ‘designed to reduce wear and provide high function for all patients.’  Plaintiff also alleged that in preparation for his surgery, ‘Defendants (or their employees or agents) selected and provided the specific components to be used during the surgery and delivered them to the operating room where Plaintiff’s implant surgery took place.  Thus, Plaintiff has stated a colorable claim against Bayside for strict liability.”  Fronczak at *8-9 (citations omitted).  Somewhere between that last sentence, where the court concluded there was a colorable claim, and everything that led up to it, there must be some sort of legal cogitation.  Or is it a leap of faith, inspired by the “no possibility” standard’s requirement that if any interpretation or mutilation of the law might keep the non-diverse defendant in, then the federal court can push the remand button with a clean conscience and a slightly lighter docket?

Is it possible that reading a pair of cases can make you dumber?  (Some uncharitable wag will inevitably point out that we cannot get any dumber.)  These opinions on fraudulent joinder leave us thirsty for something better.  Perhaps we will reach for a beverage.  Perhaps we will reach for two. 

Tuesday, October 21, 2014

Georgia Court Takes a Holistic Approach to Pleading

            Holism is a concept modernly used most commonly in medicine –treating both the body and the mind.  We don’t see it too often in legal parlance as it’s come to be associated with a somewhat touchy-feely approach.  Not something litigators are often accused of being.  At its core, holism is a philosophy based on treating something as more than the sum of its parts.  So when we read in Schmidt v. C.R. Bard, 2014 U.S. Dist. LEXIS 146459 (S.D. Ga. Oct. 14, 2014) that on a motion to dismiss, the judge was “[r]eading Plaintiff’s Complaint holistically,” we were fairly sure we weren’t going to be happy with the results.  And we were right. 

            A holistic approach to pleadings is precisely what TwIqbal aims to prevent.  Either the complaint contains sufficient and specific factual allegations that go beyond speculation and legal conclusions or it doesn’t.  Using the TwIqbal standard, a complaint is only as good as its parts; its allegations.  You can’t fix bad pleadings by reading into them more than what is there.  But we think that is exactly what the court did in this case.

            The suit involves the implantation of a mesh device to repair a hernia.  Plaintiff ultimately had to have the device removed and alleges permanent injury as a result.  Id. at *1-2.  Assessing whether plaintiff sufficiently pleaded a design defect claim, the court starts off with a general statement we support:  “a bald assertion that the [device] was defective in design . . ., was unreasonably dangerous, and the foreseeable risks outweighed the [] benefits would be insufficient to survive a motion to dismiss.”  Id. at *8.  But then the court goes on to conclude, and repeatedly state, that plaintiff listed 9 possible design defects and therefore survives a motion to dismiss.  The court never identified what those 9 “defects” were, so we looked at the complaint ourselves. 

            The first 6 “defects” plaintiff alleges are that the mesh degrades; harbors infections; migrates; erodes; shrinks; and causes inflammation.  Schmidt v. C.R. Bard, Complaint at ¶ 11a-e, i, No. 6:14-cv-62.  Nowhere in the complaint, however, will you find a single factual allegation to support those general conclusory statements.  Moreover, nowhere is there any allegation that the plaintiff actually suffered from any of these alleged “defects.”  Did plaintiff suffer from an infection or inflammation; did his mesh shrink or migrate?            

            We can only surmise that the remaining 3 “defects” the court identified in the complaint were:  (1) the mesh regularly fails to perform its intended purpose; (2) due to its defects, the mesh causes injury; (3) if the mesh needs to be removed due to its defects it is often difficult and poses additional risks.  Id. t ¶ 11f-h.  These aren’t defects.  The first two are simply legal conclusions and the third is an alleged potential injury.  An injury that is again not tied to plaintiff’s particular condition in this case.  Simply listing numerous speculations doesn’t make them any less speculative.  This is something holism can’t cure.

            From here the court moved on to find that the plaintiff also alleged a safer alternative design – the element at “the heart” of design defect under Georgia law.  Schmidt, 2014 U.S. Dist. LEXIS 146459 at *9-10.  What plaintiff actually alleged wasn’t an alternative design of the device, but an alternative method of surgically repairing hernias that doesn’t involve the use of the mesh device.  Id. at *9.   This argument, of course, is a disguised form of absolute liability, that is, it’s another way of saying that the product should simply not have been used at all, that “nonuse” is the alternative design.  Fortunately, there is an extensive body of law recognizing that altogether different products or different procedures are not alternative designs.  You can read about it here  

            Not only should plaintiff’s design defect claim have been dismissed under TwIqbal, so should have his failure to warn claim.  The complaint simply alleges that the warnings provided were inadequate.  What isn’t alleged is what warnings were given to the plaintiff’s surgeon and how they were in any way inadequate.  The court accepts as true plaintiff’s completely unsupported assertion that plaintiff’s surgeon wasn’t warned of any of the “defects” identified in the complaint.  Incorporating everything we said above about those “defect” allegations, plaintiff was already well-behind the starting line if they are the basis for his failure to warn claim too.  Not to mention there is no allegation that plaintiff suffered from any of the allegedly unwarned about risks and no allegation about what information was in fact conveyed to the surgeon or what knowledge the surgeon had at the time of the surgery.  All are information within plaintiff’s ability to ascertain before filing his complaint.   

            Finally, defendant also moved to strike plaintiff’s request for punitive damages.  Here the court engages in a nonsensical analysis that seems to result in the inability to ever have punitive damages dismissed at the pleadings stage.  First the court says that a motion to strike is “proper only where the relief requested is not available as a matter of law.”  Id. at *16.  That is neither true nor the crux of defendant’s argument in this case.  Rather, defendant challenged the factual basis for plaintiff’s request for punitive damages.  That, the court agreed, sounds more like a Rule 12(b)(6) motion to dismiss.  However, a motion to dismiss is also improper.  Rule 12(b)(6) can only be used to dismiss a “claim” in its entirety and a request for punitive damages isn’t a “claim” but rather is part of the relief requested.  Id. at *18-19.  The court, therefore, concludes that plaintiff’s request for punitive damages is “subject neither to dismissal nor striking.”  Id. at *19. 

            So, how do you dismiss a punitive damages claim?  Do you have to wait until summary judgment to challenge it?  The mere presence of the claim could be used as the basis for significant discovery of defendant that is completely unwarranted, including the disclosure of sensitive financial data.  Here, the court was willing to at least say that the allegations that defendant was aware of the “defects” and represented that the device was safe sufficiently supported a potential punitive damages award if proven.  Since that conclusion is still based on plaintiff’s insufficient and unsupported conclusory allegations, it suffers from the same problems as all of the other conclusions reached in this decision. 

            The bottom line is this -- you can read this complaint backwards, sideways, up-side down or holistically and it just isn’t good enough to survive TwIqbal.       

ACI’s Drug & Medical Device Litigation Conference – Shameless Plug

In a first for the DDLaw Blog, we’re an official "Media Partner" for the American Conference Institute’s 19th Annual Drug & Medical Device Litigation Conference, to be held December 8-10, in New York City.

That means we’re going to be there – and you can be too. More cheaply than usual, it turns out. Anybody who signs up with ACI can get $200 off of the conference price when registering if they mention the Drug and Device Law Blog. ACI gave us a discount/promo code for that – it’s "DD200."

Still, why would you want to do that?

Here’s why:

1. The agenda’s been revamped, relying on customer research and on recommendations from the insights of an Advisory Board with 10 in-house members, from litigation-savvy companies like Johnson & Johnson, W.L. Gore, and others.

2. This year’s conference co-chairs from Bayer, Eli Lilly, and Medtronic who have created a cutting-edge program.

3. Dynamite in-house faculty speakers – more than 20 of them − including Actavis, Biomet, Bard, GSK, du Pont, Endo, McKesson, Merck, Novo Nordisk, Olympus, Roche, and Teva. They’re litigating what we write about here on DDLaw.

4. The kind of up-to-the-minute things you need to know: e-discovery post-Actos, social media in litigation; the latest creative theories on removal (including CAFA), third-party payors, and third party litigation funding.

5. A bunch of judges – we count seven – from California (Kramer), Illinois (Herndon), Indiana (Nuechterlain), Louisiana (Methvin), Minnesota (Tunheim), New Jersey (Pisano), and New York (Keenan). In other words, judges you’ve heard of.

6. FDA-related topics, including the keynote speaker, along with topics near and dear to our hearts, such as off-label use/promotion, and lots of preemption (generic and medical device).

7. "Meet-Ups" facilitated by in-house counsel, included in the conference registration, an opportunity to swap litigation war stories, and product-specific updates on mesh, anti-psychotics, and blood thinners. More stuff you can use.

8. In-house insights − What do General Counsel really want from their defense teams − in the pre-conference session, "View from the General Counsel’s Office: Limiting Liability and Managing and Reducing Costs in Drug and Med Litigation."

9. Ethics CLE – This year’s topics being, Inclusion, Diversity, and the Products Credits Liability Bar (don’t come to places like Philly without ‘em); and Dealing with the Increasingly Aggressive Plaintiffs’ Bar Without Sinking to Their Level.

10. Networking, networking, and more networking – ACI has sponsored cocktail receptions, luncheons, and other organized activities designed to encourage mingling with hundreds of peers throughout the country.

See you there.

Friday, October 17, 2014

Louisiana Liability For A Sales Representative's Sizing Error

            Those of us whose childhood had low tech play options and at least a touch of OCD recall playing with dominoes.  Not whatever the game is where the number of dots on a tile matters, which we understand exists from witnessing it in screen classics like “Boyz n the Hood.”  No, we mean the activity where you line up a series of dominoes in a sequence where tipping over the first one will cause a chain reaction where many or all fall over.  If you were really motivated or bored, then the arrangement of dominoes might have included the construction of elaborate stairs, towers, or catapults or tiles falling off of tables to start new chains.  There is probably some app for this now.

            The decision in Grabowski v. Smith & Nephew, Inc., No. 14-433, 2014 La. App. LEXIS 2367 (La. Ct. App. Oct. 1, 2014), reminds us of dominoes.  (We do try to have our non-legal introductions have something to do with our purported point.)  The case was really a detour from what looked like a medical malpractice action against a surgeon who performed a knee replacement with an insert that was too small for the tray he used.  The details of the two part implant system are not terribly important here, but the sizing of the insert and tray should match up.  The surgeon blamed the sizing error on the sales rep present at the implant after learning about it from another rep at a revision surgery three months later.  Skipping over some procedural parts and a whole section of the decision about a motion to recuse the judge—arrangements of dominoes sometimes have dead ends on purpose—plaintiff sued the original rep, the distributor with whom he had a contract at the time of the implant surgery, and the manufacturer of the implant with whom he used to have a contract.  The defendants eventually moved for and were granted summary judgment.  The basic idea was the rep was not liable for negligence because the duty of providing medical care to the patient—including using the right size of any medical device—rested solely with the surgeon.  In addition, the distributor was not liable for acts or omissions of someone who was its independent contractor and the manufacturer was not liable for someone with whom it had no direct contractual relationship.  On appeal, all the tiles fell to bring the deep pockets back into the case.  (We cannot tell what happened in terms of litigation between the plaintiff and the surgeon.)

            To impose any liability on the defendants in the absence of any allegation of failure to warn, mislabeling or product defect, first there had to be a duty owed by the rep to the plaintiff to “insure the proper implant was used in Mrs. Grabowki’s surgery.”  Id. at *18.  That sounds like part of practicing medicine to us and the evidence was that the surgeon “determined that Mrs. Grabowski required a size 5 implant . . . inserted the poly insert into the tray and tested it to verify that the dovetail mechanism of the implant held the tray and insert together in place [and] then completed the surgery.”  Id. at *3.  Regardless of what size insert the rep handed over to the nurse, it was the surgeon who did or did not perform the surgery correctly, including using the right devices.  Drawing largely on a distinguishable case where a physician’s answering service owed a duty to patients to promptly and accurately relay information from the patients to the physician, the appellate court found that the rep owed a duty “to provide the appropriate size poly insert for the size 5 implant that Dr. Collins determined Mrs. Grabowski required.”  Id. at *26.  That the duty was owed to the patient—with whom the rep never interacted—as opposed to the doctor or hospital staff—with whom the rep did have interaction—was glossed over.  The novel duty was rationalized largely on economic terms:

We do not see that imposition of this duty will result in an unmanageable flow of litigation . . . . [T]he nature of [the rep’s] activities, his experience, and his expected conduct in the OR made it clearly foreseeable that his failure to provide the proper size implant and corresponding poly insert would result in harm to the patient in whom it was being implanted.  Mrs. Grabowski was not at fault.  The economic impact is that all parties that contributed to Mrs. Grabowski’s harm share in the responsibility for her damages.  Surgeries, especially ones like Mrs. Grabowski’s, are becoming more and more technologically advance, requiring technological assistance from sales representatives who are specially educated and trained with respect to the medical devices they sell.  Accordingly, it is reasonable for these sales representatives to be responsible for their negligent acts.
Id. at **26-27.  Among other things, this rationale seems to ignore that the consequence of imposing potential liability for reps and entities that may be responsible for their acts or omissions is that it would deter the provision of this necessary technical assistance unless liability can be reallocated to the doctors and hospitals.  If we start with the assumption that “more technologically advance[d]” surgeries appeal to surgeons because they might improve the care provided to patients, then expansion of liability like this does not seem like a good idea, as we have said before. 

            From here, the analysis of whether there was a genuine issue of material fact as to whether the alleged breach of the new duty caused plaintiff’s injuries was brief.  The defendants went as far as introducing expert evidence that the implanting surgeon and hospital acted below the standard of care in connection with the implant.  Id. at *28.  Based on no evidence from plaintiff we see beyond that the rep did provide the implant after the surgeon specified the size, the court found a genuine issue of material fact.  We understand that joint tortfeasor law varies and not everywhere has the concept of last clear chance, but there should be some evidence that what the rep did caused the injury when the surgeon is the one who determined that the implant he received was the size he wanted to use in the surgery he performed.
            With potential liability for the rep established, the court turned to imposing liability on the distributor and manufacturer for the rep’s alleged breach of a novel duty.  To its credit, it rejected the argument that the basic reciprocal indemnity provisions in the contract between the rep and the distributor made plaintiff a third party beneficiary of the contract.  Id. at **29-32.  The handling of the argument that the rep acted with apparent authority for the manufacturer, with whom he had no direct relationship at the time of the implant surgery, is more problematic.  The court set out several “facts” that collectively established a genuine issue as to the existence of apparent authority.  While having a business card saying he was the representative of the manufacturer and the manufacturer’s name on a badge the hospital gave him to allow him to enter the operating room may be relevant facts, others were not “facts.”  The implanting surgeon offered that he “believed” the rep represented the manufacturer and “opined” that the manufacturer should be liable for failing to train the rep who no longer had any direct relationship with it.  That all sounds more like a justification for why the manufacturer should be liable than facts supporting apparent authority, but it was enough for the appellate court.  Id. at **35-37.

            Similarly, the last piece to fall was that the distributor’s contract with the rep created a “master-servant” relationship even though it purported to create an independent contractor relationship.  The basic question is whether the contract gave the distributor the right to supervise and control how the rep performed his contractual responsibilities.  The contractual provisions that were sufficient to deem the rep an employee of the distributor included “the payment of commissions for his sales, the number of causes for termination [of the rep], the lack of consequences in the event [the distributor] breaches the contract, and the ownership of the rep’s] product ideas without evidence of what training [the distributor] provided [the rep] that equipped him with special knowledge needed to formulate product ideas.”  Id. at *43.  We are not so sure how these all go to supervision or control, but what troubles us more is that provisions requiring the rep to be accurate and complete in communicating on the products, to use only written materials he was provided, and to comply with applicable laws were also seen as evidence of employment.  Id. at **40-41.  These provisions, of course, are necessary given various FDA requirements on the marketing of medical devices.  We suspect that absence of such requirements as to reps who market a medical device, regardless of whether the manufacturer, distributor, or nobody employs the rep, could be seen as a lack of appropriate marketing practices by the manufacturer.  In effect, manufacturers would need to have reps bound by such provisions, even when the reps are set up as independent contractors of distributors.  The presence of such provisions, in turn, makes reps employees of the distributors (or, of the manufacturer in instances where there is a similar independent contractor agreement with the manufacturer).  Combined with the potential liability of the rep for breach of a novel duty running to the patient, this, in turn, greatly decreases the chance of complete diversity in an ensuing injury lawsuit.  This, in turn, greatly increases the chance for bad rulings and new ways to impose liability.  Like a Mรถbius strip of perpetually falling dominoes. 

Thursday, October 16, 2014

A Colorado Federal Court Adopts Restatement (Third) of Torts Section 6(c)

A federal court recently placed Colorado amongst the states that apply Restatement (Third) of Torts §6(c) in design defect cases.  That’s a good place to be when you’re defending a medical device company.  Section 6(c) creates a tougher burden for design defect plaintiffs than does Restatement (Second) of Torts.  Showing a safer alternative design isn’t enough.  And that’s important, because there are often alternative designs for medical devices.  Section §6(c) instead focuses on prescribing doctors and their risk-benefit analysis:

A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients.
Restatement (Third) of Torts § 6(c).  In short, if a reasonable doctor would choose to use the device for any class of patients, knowing the risks, it is not defectively designed – regardless of whether there might be an alternative design.  

The facts of the Colorado case, Haffner v. Stryker Corp., No 2014 U.S. Dist. LEXIS 137214 (D. Col. Sep. 29, 2014), show how this can work.  The plaintiff had knee replacement surgery, but later needed revision surgery.  He was allergic to the cobalt and nickel contained in the knee replacement system.  So he sued, claiming, amongst other things, that the system was defectively designed.  Id. at *1, 2, 7.  

But the question under § 6(c) is not whether the device could have been designed without cobalt and nickel so that it is better suited for a particular patient or class of patients.  It’s whether the device, as designed, would be used by a reasonable doctor with “any” class of patients.  In other words, would it be prescribed for a class of patients without such allergies?  That question will often answer itself.  The Haffner court answered it for us:

Prescription medical devices are not the same as ordinary consumer products. A variety of similar devices made with different materials can be developed and manufactured to address the needs of different classes of patients. Simply because a product would not be compatible with a certain class of individuals--in this case, those with cobalt and nickel allergies--does not mean the medical device is defectively designed. The Restatement (Second) considered the possibility that certain drugs could be unavoidably unsafe while still remaining beneficial. The Restatement (Third) took this conclusion one step further, reasoning that medical devices can be safe for certain patient populations and not others without their risk outweighing their utility. It is for this reason that these devices can only be sold to doctors and administered by prescription. The plaintiff has failed to state a plausible claim that the Knee System is defectively designed. Therefore, this claim is dismissed.

Id. at *7-8.  That’s the crux of it.  Under § 6(c), the device need only be of a type that a reasonable doctor would prescribe to some patients.  That is almost always the case with a device approved or cleared by the FDA.  And therein lies the power of § 6(c).  

Now, § 6(c) is not all protective.  It does not necessarily protect against failure to warn claims, and so the Haffner court allowed plaintiff’s strict liability and negligent failure to warn claims to go forward.  

But the defendants are in a better place.  They no longer have to deal with, arguably, the most difficult claim to defend – design defect – particularly if they had to conduct that defense under law that allows consideration of alternative designs.  With that in mind, this was a very good result. 

Wednesday, October 15, 2014

A Juicy Little Decision

            This is actually a post from Reed Smith’s Rachel Weil.  While this is not her first post, she is still a mere "guest poster" at this point and takes sole responsibility for the content of her posts.  We have allowed her to use first person plural pronouns, though.

* * *
            On this unseasonably warm day where we are, as we lament the passage of another summer and the demise of its bounty of strawberries, blackberries and peaches, we rejoice that a recent trip to our local grocery uber-chain revealed a silver lining in the return of perfect clementines.  Clementines, those Lilliputian cousins of the tangerine, represent nature’s engineering at its best.  Easily accessible, their perfect sections are joined in a seamless whole, uniformly sweet and unmarred by “bad spots” or detritus. 

            Such are the attributes of a tidy little decision out of the Ortho Evra® MDL.  (We have blogged about other Ortho Evra® decisions, like here and here, for example, but this is the first that was postured in a fashion that facilitated total victory for the defendants in one shot.  Today’s breaking news post, also comes from the Ortho Evra® MDL.)   In Giffen v. Ortho McNeil Pharmaceutical, Inc., No. 3:12 oe 40001, 2014 U.S. Dist. LEXIS 136587 (N.D. Ohio. Sept. 26, 2014), Plaintiff was given samples of the Ortho Evra® birth control patch and used them for one month.  Alleging that the patch caused her to suffer a stroke, Plaintiff asserted the standard failure to warn, negligence, design defect, and warranty claims, along with a litany of fraud-based claims.  Defendants moved in the alternative (wisely, as you will see) for judgment on the pleadings or for summary judgment on all of the Plaintiff’s claims.  Id. at *1-2.  

            Failure to Warn

            Defendants argued that the Ortho Evra® package insert was adequate as a matter of Missouri law.   The Court explained that, under Missouri’s learned intermediary doctrine, a warning is adequate if it “properly warns the doctor of the dangers involved in using the medication,” id. at *9-10, and that “Missouri courts have dismissed failure to warn claims where the manufacturer warns of the specific injury alleged.”  Id. at *10 (internal quotation marks and citations omitted).    The Court found that the Ortho Evra® package insert warned of the risk of stroke, and that the “detailed patient labeling document explicitly warned that the product could cause strokes;” Id. at *11, thus, the warning was “sufficient to meet the Defendants’ duty to provide adequate warning to physicians regarding the risks associated with the product.”  Id.  The Court also noted that “the record also establishes that [Plaintiff’s prescribing nurse-practitioner] “was aware that the Ortho Evra® birth control patch could cause a stroke [and] . . . was familiar with the language of Ortho Evra®’s FDA approved package insert and detailed patient labeling which warned about the risk of stroke.”  Id.   In addition, Plaintiff “acknowledged receiving a box sample of the Ortho Evra® birth control patch which included the package insert and detailed patient labeling.”  Id.

            The Court rejected Plaintiffs’ arguments that the Ortho Evra® package insert was “63 pages long;” thus, her prescriber “could not possibly go over every risk with every patient.” In a clear-eyed (and too rare) distillation of the essence of the learned intermediary doctrine, the Court emphasized that “Missouri law does not require a prescriber to go over every risk with every patient.  Rather, Missouri law requires manufacturers to provide adequate warnings to physicians regarding the risks associated with the product. . . . Thus, whether [the prescriber] directly warned Plaintiff is irrelevant.  Defendants have met their burden to [the prescriber], which is all Missouri law requires.”  Id. at *13.

            Remaining Claims

            The Court denied Defendants’ Motion for Judgment on the Pleadings as to Plaintiff’s remaining claims, holding that Rule 8(a) and Twiqbal were satisfied.  “Nevertheless,” it noted, “these claims fail pursuant to Defendants’ alternative request for summary judgment, which Plaintiff does not oppose.”  Id.  The Court held:

·                     Plaintiff could not prevail on a negligent failure to warn claim because, as explained, her failure to warn claim was without merit under Missouri’s learned intermediary doctrine.  Id. *14-15.

 ·                     While Plaintiff alleged a design defect, “she has put forth no facts to support her claim that the design was defective.  Plaintiff must set forth specific facts showing that there is a genuine issue for trial. . . . Because Plaintiff has not demonstrated a defect in Ortho Evra®’s FDA-approved design, she has not met this burden.”  Id. at *16.

·                     With respect to Plaintiff’s manufacturing defect claim, she “[a]gain . . . recites factual allegations but fails to put forth any facts creating a genuine issue that shows Defendants’ deviated from manufacturing specifications or otherwise identical units.  Without more, Plaintiff’s allegations fail as a matter of law.”  Id.

·                     To prevail on her negligent representation, fraudulent representation, fraudulent concealment, fraud and deceit, and breach of warranty claims, Plaintiff was required to prove “reliance on a false statement or that the goods were not of a certain kind or quality” fit for a particular purpose.  Id. at *16-17 (citations omitted)   Defendants argued that Plaintiff had failed to show that she relied on any statement.   The Court commented, “[T]he root of the issue is much simpler; namely, Plaintiff has failed to show Defendants’ alleged representation was false or that the goods were not fit for a particular purpose.” Id. at *17-18 (emphasis in original).  The Court concluded, “Because Plaintiff has failed to establish she relied on Defendant’s representations, or that such representations were false or unsuitable, these claims fail as a matter of law.”  Id. at *18.

            Thus, cutting to the heart of the burdens the Plaintiff was required to sustain and holding that she could not sustain them, the Court closed the door on her claims.   Compact, accessible, and uniformly sweet – a worthy model for courts facing these ubiquitous issues.

Breaking News – Branded Design Defect Preemption

     From the time that the Supreme Court handed down its decision in Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013), we have been declaring that design defect claims against branded dugs should also be preempted.  See,, here, here, and here.  We now have a decision that has done just that.  Booker v. Johnson & Johnson, No. 3:12 oe 40000, slip op. (N.D. Ohio. Oct. 10, 2014).  Booker is from the Ortho Evra MDL, which has produced many good partial summary judgment decisions.  In some, we have noted that design defect claims were left standing after motions for judgment on the pleadings while other claims fell to summary judgment.  Booker got a second bite at the apple with a motion for summary judgment on design defect and some other lingering claims and raised directly the issue of whether a state law (Georgia, in this case) claim for design defect for a branded drug was preempted under Bartlett.  In the first such decision we know about, it was:  “The Court, having carefully read Mutual Pharmaceutical Co., concludes that it was impossible for Defendants to comply with both its state-law obligation to alter the drug’s composition, and its federal-law duty not to do so.”  This is so good that we will ignore the grammar glitches.  There is nothing about the basic fact pattern here that should limit the logic of this ruling to a minority of drugs or states.  It also should not be terribly surprising that the decision came from this judge, who issued the first published decision excluding evidence under Buckman, Bouchard v. American Home Prods. Corp., 213 F. Supp. 2d 802, 811 (N.D. Ohio 2002), and whose former Chief Judge held design defect claims for a branded drug preempted four years before Bartlett in Longs v. Wyeth, 621 F. Supp. 2d 504, 508-09 (N.D. Ohio 2009), reversed in part sub nom. Wimbush v. Wyeth, 619 F.3d 632 (6th Cir. 2010).  We are happy to spread the word on Booker, hope it gets published, and hope that other courts follow its path.