Thursday, July 30, 2015

Plaintiffs Allowed To Make a Case Out of Thin Air



            This post is from the non-Reed Smith side of the blog.

            Is anyone else watching the CW’s “Penn & Teller: Fool Us”?  It is perfect summer TV – easy, funny and interesting.  Each week aspiring, talented magicians perform to try to fool Penn & Teller.  If at the end of the trick, the comedy-magic duo can’t figure out how the trick was performed, the magician gets to appear on Penn & Teller’s enormously popular Las Vegas show.  Recorded on your dvr so you can skip commercials, it’s 45 minutes of stage performances, most of which are quite good and entertaining.  And that’s where we like to see magic – on the stage.  Who isn’t intrigued when a torn up playing card turns up tucked into a magician’s wallet whole again?  Or when a dove appears where only an egg was before?  Slight of hand, hidden compartments, mirrors, trap doors – all things designed to make an audience think they are seeing something more than they really are. 

            When magic is at work in legal opinions, we aren’t as enthusiastic.  Especially, where the result is the conjuring of a case out of thin air.  That is precisely what happened in Fields v. Eli Lilly and Co., slip op., Case No. 2:13-CV-35-WKW (M.D. Ala. Jul. 20, 2015).  Plaintiff alleged that because she ingested Prozac in 1996 during the first 8 months of pregnancy, her son was born with a congenital heart defect.  But she has NO proof of two of the most fundamental aspects of any prescription drug case – that she ingested the drug and that an alleged inadequate warning caused the injury.  We would have thought that a complete lack of evidence on two key elements is enough for summary judgment, but plaintiffs managed to pull a rabbit out of a hat. 

            Let’s sum up all of the missing evidence.  Plaintiff has no pharmacy records showing that a Prozac prescription was ever filled.  She alleges her pharmacy no longer has those records.  She has no financial records (bank statements, receipts, credit card statements) showing a purchase of Prozac.  Id. at 9.  Presumably she also doesn’t have insurance records reflecting a Prozac prescription. She has no medical records that Prozac was ever prescribed.  Id. at 8.  There isn’t a single reference in any of her medical records that confirms that Prozac was ever prescribed to plaintiff. 

            The only mention of Prozac at all is in a note by one doctor that stated that he wanted lab work done and then he would decide whether or not to start Prozac.  That note was made for an appointment on May 23, 1996.  Just eleven days later, Plaintiff returned to her doctor to report a positive pregnancy test.  There is no mention that Prozac was discussed at that second appointment.  Nor was Prozac ever discussed with plaintiff’s treating obstetrician/gynecologist.  Id. at 5-6.  Allow me to break our blogging rule about first person for a minute.  As a woman who has been pregnant twice – I cannot conceive of an ob/gyn who upon assuming the care for a pregnant woman does not ask her, even 19 years ago, what medications she was currently taking.  The fact that no place in those records is Prozac mentioned is a huge red flag for me.

            Back to blogging.  So the only “evidence” of Prozac usage is plaintiff’s self-serving statement that at that May 23 appointment where he had not yet decided to prescribe Prozac, her doctor gave her a sample packet and a prescription with three refills.  Plaintiff claims she got the blood work done, heard nothing from the doctor’s office, assumed no news was good news and started taking Prozac.  Id.  She also stated that she stopped taking Prozac around her 8th month of pregnancy on her own decision.  Id. at 7.  Conveniently, not only did she never discuss with any doctor whether she should be taking Prozac while pregnant, neither did she discuss with any doctor the impact of stopping the drug either.  Plaintiff’s husband also alleged that he remembers seeing Prozac prescription bottles in their home.  Id. at 7.    

            At this point you may be asking yourself, why not just ask the alleged prescriber?  Because he died in 2009, four years before this lawsuit was commenced.  Id. at 10.  So, this is truly a case where absolutely the only evidence that Plaintiff took a prescription drug is her say so.  That cannot be enough.  The court looked at the question as one of credibility not admissibility. Id. at 15.  The court was also unwilling to find that plaintiff’s self-serving testimony was directly contradicted by the pharmacy and medical records such that her testimony should not be accepted for purposes of a summary judgment motion.  The court found that the “absence of physical evidence” (no pharmacy records) is not the same as “the presence of physical evidence that directly contradicts a fact.”  Id. at 16.  Finally, defendant argued that the rule regarding viewing the facts in a light most favorable to the non-moving party should be different “in pharmaceutical cases where the plaintiff cannot produce medical or prescription drug records to substantiate a self-serving affidavit or declaration that he or she actually used the drug at issue.”  Id. at 17.  The court didn’t agree, but we do. 

            Prescription drugs are heavily regulated and as such there are numerous records kept regarding how they are dispensed – doctors, pharmacies, insurers.  If a plaintiff can’t offer up even one record from one source that indicates he/she was prescribed a drug – the case should not proceed.  One of the problems in this case is the time between the alleged ingestion/injury and the filing of the suit.  We understand the long statute of limitations to protect the interests of minors who may wish to file suit after they become adults.  But we again find it slightly disingenuous that plaintiff waited 16 years to file suit and in all that time did nothing to preserve any of the evidence either she or her son would need to pursue this case.  That burden should fall to plaintiff and plaintiff should not reap a benefit when all of the supporting documents and witnesses are no longer available. 

            Finding plaintiff’s statement was enough to survive summary judgment on the issue of ingestion, the court next looked at defendant’s argument that plaintiff could not prove causation on her failure to warn claim.  Because Alabama recognizes the learned intermediary doctrine, “the success of [plaintiff’s] failure-to-warn claims is contingent upon whether she can show that an adequate warning would have altered [her doctor’s] prescribing practices.”  Id. at 21.  Defendants logically argued that therefore, the prescriber’s testimony was necessary for plaintiff to carry her burden on causation.  Again, the court disagreed, but at least acknowledged that the plaintiff’s path forward was a “rocky one.”  Id. at 24. 

            The court appears to agree with defendant that plaintiff could not satisfy her burden with objective evidence of how a reasonable physician would have acted upon receiving a different warning.  Id. at 23-24.  But then goes on to find that plaintiff, absent the prescriber’s testimony, could still meet her burden.  First the court examined the parties’ competing views of what needs to be proven under the learned intermediary doctrine.  Both sides agreed that the issue is the impact of the warning on the prescriber, not the plaintiff.  But they differed on what that really means.  Defendant argued that plaintiff had to demonstrate that if the prescriber had received a different warning he would not have prescribed the medication – a fact to which only the prescriber could testify.  Id. at 28.  Plaintiff, on the other hand, took a broader view and argued that the question is whether the doctor would have behaved differently if he had received a different warning.  Id. at 26.  And “behaved differently” is not limited to not prescribing – it included whether the doctor would have warned the plaintiff differently. 

[Plaintiff] can demonstrate factual causation by proving that had [defendant] given [the prescriber] a strong warning about the association between the ingestion of Prozac during pregnancy and an increased risk of birth defects, [the prescriber] would have informed [plaintiff] of the risk and his warning would have resulted in a different outcome for [plaintiff] in that she would not have taken Prozac.  This theory is not predicated upon the effect an adequate warning would have had on [plaintiff] but rather upon the effect an adequate warning would have had on [the prescriber]’s prescribing practices.

Id. at 29. 

            This still leaves open the question of how plaintiff demonstrates, without the prescriber’s testimony, whether her prescriber would have changed his risk discussion with plaintiff.  According to plaintiff and the court – through his long time nurse.  The nurse testified that it was the doctor’s “standard practice to discuss with all of his patients the risk and benefits disclosed on a drug’s package insert.”  Id. at 31.  The court found that a reasonable inference could be drawn from that testimony that if the Prozac label disclosed the increased risks of birth defects, the doctor would have discussed it with plaintiff.  Id.  This seems like a stretch in a more typical case – testimony that the doctor was diligent in discussing risks means he would have discussed a particular risk with a particular patient.  Feels more like that objective reasonableness standard that the court was disinclined to allow.  But now put it in the context of this case.  Based on the doctor’s standard practice, we are supposed to infer that he would have discussed a risk of use during pregnancy with a woman who was not pregnant at the time and for whom he was only considering starting the medication?  You can’t look at each piece of the case in a vacuum.  You have to look at the whole.  And here the whole adds up to a whole lot less than the sum of its parts.  Inference, upon inference, upon speculation, upon self-serving testimony should not get a case to the jury.

            Plaintiff here really pulled off a quite a magic trick.  She had nothing up her sleeves; nothing in her pockets; nothing tucked in her socks.  And poof, she made a case appear.  If this was “DDL Blog:  Fool Us” – the answer is, she didn’t.            

Wednesday, July 29, 2015

Guest Post - Just the Fax, Ma’am

While Bexis is on vacation, here is a guest post to take up some of the slack.  Our guest blogger today is Henry Pietrkowski, a partner in Reed Smith's Chicago office.  This one's a little different.  It's about the impace of a 1991 federal statute prohibiting unrequested faxes, and how it could impact on pharmaceutical promotional activities that send faxed information to healthcare providers.  As always, our guest bloggers deserve all the credit, as well as any blame, for their posts.  Here goes.

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Scottish inventor Alexander Bain is credited with inventing the first fax machine in 1843 – an “Electric Printing Telegraph.”  By 1846, Bain was able to reproduce graphic signs in laboratory experiments by synchronizing the movement of two pendulums to transmit a message across a wire.  But it was not until over a century later, in 1964, that the Xerox Corporation introduced the first commercialized version of the modern fax machine. From there, faxes became ubiquitous.  They provided a standardized method of communication used worldwide, and their validity as a method of transmission was adopted by the business world.  By the 1980s, faxes had become widely used as a form of marketing.  Why pay the cost of postage to send an advertisement when the advertiser could use the recipient’s own paper and toner to print it?

It was at this point that Congress stepped in by passing the Telephone Consumer Protection Act of 1991 (the “TCPA”).  Among other alleged telemarketing abuses, the TCPA specifically prohibits the use of a “telephone facsimile machine, computer, or other device to send, to a telephone facsimile machine, an unsolicited advertisement.”  47 U.S.C. § 227(b)(1)(C).  To ensure that businesses took the Act seriously, Congress imposed a minimum statutory damage award of $500 per fax regardless of the sender’s intent, and up to $1,500 for a knowing or willful violation of the statute.  Id. at § 227(b)(3).  Senator Ernest Hollings, who sponsored the bill, expressed his hope that violations of this law could be enforced by aggrieved individuals in small claims court where counsel would not be needed. 

As it turns out, however, it was the clients who would not be needed.  Instead, plaintiffs’ class action attorneys have filed hundreds of class action lawsuits alleging violations of the TCPA’s fax provisions, calling them “junk fax” or “blast fax” cases.  These lawsuits have resulted in hundreds of millions of dollars being paid to the plaintiffs’ class action bar, with actual fax recipients receiving relatively little compensation.  One the primary targets in recent years has been pharmaceutical and medical device companies.

But wait a minute (you say), no one uses faxes anymore.  We have email and websites and a million other ways of using computerized technology to engage in marketing communications.  Not true – at least not in the pharmaceutical/medical device industry.  The reason is simple:  doctors love faxes, and pharmacies love them too.  Yes, for some strange reason, doctors and pharmacies still prefer this antiquated communication method from the Industrial Revolution over email, web portals and computers.  Some surmise that doctors believe fax transmissions are more secure and ensure greater privacy for patients.  Maybe they just like the palpable feel of paper crackling in their hands.  Regardless of the reason, however, the fax is alive and well among doctors and pharmacies.  And as a result, pharmaceutical and medical device companies are still using faxes to communicate with them.

And if you’re wondering whether your company uses faxes, here’s some food for thought.  As a TCPA class action defense lawyer, many of the cases I’ve encountered arise from a variant of the following scenario:  Pharma/medical device company has a new drug or device that it wants to bring to market.  An individual (or team) in the marketing department is assigned to this task.  He or she retains an outside marketing consultant to find out the “best practices” for marketing that product to doctors or pharmacies in particular geographic areas or specialties.  The marketing company proposes a variety of marketing methods, one of which is faxes.  The vendor promises to obtain a list of physicians and take care of all the details.  Usually, there is no discussion about compliance with the TCPA; when there is, the vendor gives it short shrift, saying that it has sent faxes many times in the past and never encountered a problem.  A few months (or up to four years)  later, the company is hit with a TCPA class action lawsuit. 

Perhaps you are one of the lucky few companies with a centralized marketing team who runs every detail of every promotion by the legal team for a full TCPA compliance review.  Most companies don’t fall into this category, however.  They conduct compliance reviews, but those reviews are aimed at FDA regulations.  They leave it to the marketing companies and vendors to deal with TCPA compliance.  That could be a big mistake.

Despite being a strict liability statute, however, there are a number of defenses that pharma/medical device companies can raise to a TCPA fax claim.  I will briefly discuss three of them here:  (1) the faxes are not “advertisements”; (2) the faxes are not “unsolicited”; and (3) the company is not vicariously liable for the vendors’ actions.

Is the fax an “advertisement?”

The TCPA prohibition on faxes applies only to “unsolicited advertisements,” which the TCPA defines in relevant part as “any material advertising the commercial availability or quality of any property, goods, or services . . . .”  47 U.S.C. § 227(a)(5).  A spate of litigation has ensued over the scope of this definition as well as what evidence can be considered in deciding whether a fax contains an “advertisement” under the TCPA. 

The Sixth Circuit recently weighed in on this issue, holding that a pharmacy benefit manager’s faxes encouraging providers to “consider prescribing plan-preferred drugs” on its formulary was not an “advertisement” under the TCPA.  Sandusky Wellness Ctr., LLC v. Medco Health Solutions, Inc., ___ F.3d ___, 2015 WL 3485900, at *1-2, 4-5 (6th Cir. June 3, 2015).  The Sixth Circuit found it essential to the term “advertisement” that the faxes involve buying or selling property, goods or services for a profit.  Id. at *3, 5.  Because the pharmacy benefit manager was not out to make a profit, but merely to inform the provider what drugs its clients might prefer in order to save them money, the faxes were not “advertisements.” Id. at 4-5.  The Sixth Circuit further held that its analysis was limited to the face of the fax itself rather than extrinsic evidence that the sender of the faxes might gain some “hypothetical benefit later on.”  Id. at 6.

In another recent case, a federal district court dismissed the plaintiff’s TCPA claim where it found that faxes about reclassifying a drug for insurance purposes were informational with only “an incidental amount of commercial material.”  Physicians Healthsource, Inc. v. Jannsen Pharma., Inc., No. 12-2132 (FLW), 2013 WL 486207, at *1 (D.N.J. Feb. 6, 2013).  The court found that the “potential to gain some benefit from sending information, without the presence of additional commercial statement in the message, is insufficient to transform an informational message to an advertisement.”  Id. at *4.  However, after granting the plaintiff leave to amend its complaint to state additional facts regarding the timing and nature of the faxes at issue, the court subsequently denied the defendant’s summary judgment motion on the “advertisement” issue, leaving it for the trier of fact to decide.  Physicians Healthsource, Inc. v. Jannsen Pharma., Inc., No. 12-2132 (FLW-TJB), 2015 BL 196108 (D.N.J. June 19, 2015).

Other recent federal court decisions involve faxes inviting physicians to “free” seminars regarding a new drug or medical device.  Courts have studied these faxes on a case-by-case basis to determine whether or not they are “advertisements” under the TPCA.  See, e.g., Physicians Healthsource, Inc. v. Stryker Sales Corp., ___ F. Supp. 3d ___, 2014 WL 7109630, at *5-10 (W.D. Mich. Dec. 12, 2014, as amended Jan. 12, 2015) (finding issues of material fact precluding summary judgment as to whether a fax that featured a picture of an implantable device and offered a free steak dinner to attendees was an “advertisement” under the TCPA).

Is the fax “unsolicited?”

The TCPA prohibition on faxes applies only to “unsolicited advertisements,” which means that it must be “transmitted to any person without that person’s prior express invitation or permission, in writing or otherwise.”  47 U.S.C. § 227(a)(5).  Determining whether the named plaintiff consented to the fax at issue is often the first order of business for a class action defendant.  But even if the named plaintiff did not consent, individual issues of consent among the putative class members can be a potent defense to a class certification motion.  See, e.g., Gene & Gene LLC v. Biopay LLC, 541 F.3d 318, 326-29 (5th Cir. 2008) (reversing district court’s class certification order where “evidence show[ed] that some of the fax advertisements it sent were solicited by the recipients, but which ones can only be decided on a case-by-case basis”).

Where the evidence demonstrates, however, that the faxes at issue were sent en masse without any attempt to obtain prior express consent from any fax recipients, courts generally have certified such classes.  See, e.g., Chapman v. Wagener Equities, Inc., No. 09 C 07299, 2014 WL 540250, at *15 (N.D. Ill. Feb. 11, 2014) (“defendants have identified no basis to believe that this case will be different than the ‘normal’ § 227 class action in which the common issues arising from the near-simultaneous transmission, by the same defendant, of the same unsolicited fax predominate”). 

A statutory exception does exist for faxes sent to those with whom the defendant has an “established business relationship.”  47 U.S.C. § 227(b)(1)(C).  However, that exception is much more limited than companies often believe.  It is not enough to simply have an “established business relationship” with the recipient.  The fax number must also have been received in a particular way and, more importantly, the fax must contain specific opt-out language required by the statute and its regulations.  Courts have held that the failure to include this opt-out language is itself a violation of the TCPA that creates a common issue for class certification.  See, e.g., A Aventura Chiropractic Ctr., Inc. v. Med Waste Mgmt. LLC, No. 12-21695, 2013 WL 3463489, at *4 (S.D. Fla. July 3, 2013).  In the pharma/medical device context, issues arise regarding whether doctors have consented to receive faxes, or created established business relationships, by agreeing to be part of certain professional associations, such as the AMA.  See, e.g., Stryker Sales, 2014 WL 7109630, at *11-13 (refusing to find that plaintiff’s participation in AMA’s physician database was sufficient to establish consent to receive advertising faxes from third parties).  Again, this is an evolving area of the law that suggests that caution be used in determining whether consent has been obtained before any faxes are sent.

 Is the company liable for the acts of its vendors?

Another litigation battleground in blast fax class action lawsuits involves the extent to which companies may be liable for the acts of third-party vendors who sent the faxes at issue.  While the FCC has opined that the telemarketing portions of the TCPA are subject to the federal common law of agency, the FCC has refused to apply the same standard to faxes.  See Bridgeview Health Care Center v. Clark, No. 09 C 5601, 2015 WL 1598115, at *4-5 (N.D. Ill. Apr. 8, 2015), appeal filed 7th Cir. Apr. 13, 2015.  In a letter to the Eleventh Circuit, the FCC stated that the relevant standard for faxes is embodied in the FCC’s definition of the term “sender”: “the entity or entities on whose behalf facsimiles are transmitted are ultimately liable for compliance with the rule banning unsolicited facsimile advertisements.”  Id. at *5.

Courts have struggled with how to apply this definition.  Does it literally mean that a company whose products are advertised by fax is strictly liable for those faxes even if the company did not know they were being sent?  At least one federal district court found this interpretation to be “absurd,” reasoning: “[t]o conclude that a defendant is always liable for faxes advertising her goods or services would allow an overzealous third party to expose a defendant to substantial liability without notice or without receiving any direction to do so.  This sort of universal liability does not appear to have been contemplated by Congress.”  Id. at *7.

We hope this helps you to spot potential problems that can arise from sending faxes to physicians, pharmacies or other health professionals without obtaining prior consent or ensuring that the technical requirements of the “established business relationship” exception have been met.  A thorough compliance review is highly recommended.  And if you have been sued, please contact an attorney who is experienced with the ever-changing legal landscape of the TCPA.

Tuesday, July 28, 2015

Almost, but Not Quite: No Summary Judgement for Mentor on Two of Plaintiff’s ObTape Claims

We flew to Pittsburgh this week for depositions.   From Philadelphia, it takes only about 40 minutes in the air to get to Pittsburgh.  But there are only a few nonstops each day.  With no other options, we booked a nonstop flight scheduled for a 7:55 a.m. departure, coordinated plans with colleagues, clients and witnesses, and went to sleep with our overnight bag packed and waiting at the door.  All in order, right?  Until our phone rang at 3:30 a.m. bearing the robotic message, “Your flight has been canceled.”  No explanation.  We called back to find that we had been “protected” – re-booked – on the next available flight, a couple of hours later.  So far, so good.   (Well, not really, but as good as it gets at that point.)  But then we discovered that our colleague, scheduled to fly with us, was not “protected” on our flight, but had been bumped to a much later flight so he could continue to take advantage of the first class upgrade he had not requested in the first place.  Good times. The next day, our flight for home departed right on schedule.  We landed in Philadelphia, taxied to the gate, stood up, and remained standing in the aisle for the next 30 minutes, informed that the jetway would not move to the door of the plane and “a mechanic has been called.”  Twice in one trip, the airline stopped just short of getting it right. 

Recently, defendant Mentor Corp, moving for partial summary judgment in the Mentor ObTape Transobturator Sling Products MDL, similarly found itself at the mercy of a Court that laid the groundwork for a correct decision then stopped just short of getting it right.  Twice.
Plaintiff had been implanted with an ObTape transobturator sling in 2004 to address her stress urinary incontinence.  It was apparently undisputed that plaintiff “did not speak with anyone from Mentor or see any brochures, videos, product inserts, or other materials from Mentor before the procedure.”  In re Mentor Corp. Obtape Transobturator Sling Prods. Liab. Litig., 2015 U.S. Dist. LEXIS 93001 at *5 (M.D. Ga. July 17, 2015).  Plaintiff was happy with her implant until 2010, when she “began experiencing pain in her thighs.”  Id.  Initially, plaintiff was diagnosed with a groin strain; however, after several months of worsening symptoms, she was diagnosed with an abscess caused by erosion of the ObTape. She underwent excision surgery during which as much of the ObTape as possible was removed.  Id. at *6-7.
Plaintiff filed suit against Mentor asserting the usual litany of claims: negligence, design defect, manufacturing defect, failure to warn, breach of warranty, negligent and fraudulent misrepresentation, and fraudulent concealment.  Mentor filed for partial summary judgment on plaintiff’s manufacturing defect, express and implied warranty,  negligent and fraudulent misrepresentation, and fraudulent concealment claims.  It also sought “summary judgment as to [plaintiff’s] negligence claim to the extent it alleges a duty to recall and as to [her] failure-to-warn claim to the extent she alleges that Mentor breached a continuing duty to warn” after the ObTape device was implanted in the plaintiff.  Id. at *4.  [Apparently, Mentor did not move for summary judgment on plaintiff’s warnings claims to the extent that the claims related to any time period before plaintiff’s ObTape device was implanted.]  Plaintiff’s warranty and “failure to recall” claims were dismissed by agreement, leaving her “continuing duty to warn,” concealment/misrepresentation, and manufacturing defect claims to be resolved by the court.
 
Continuing Duty to Warn
Plaintiff alleged that Mentor breached a “continuing duty to warn [plaintiff’s] physicians of problems with ObTape” after plaintiff’s implant surgery.  Mentor argued that plaintiff “did not point to sufficient evidence of causation on her continuing duty to warn claim because she did not point to evidence that either of her implanting physicians would have done anything differently had Mentor provided them with additional warnings regarding ObTape.”  Id. at *13.   The court agreed, noting the record “establish[ed] that [plaintiff’s surgeon] did not contact any of his patients after their implant surgeries even though he learned of increased risks of ObTape.  And if [plaintiff] presented to [her surgeon] today with the complications she had in 2011, [he] would treat her exactly the same as he did then.”  Id.   Summary judgment for Mentor on “continuing duty to warn” claim.  But then came the turbulence.
 
Misrepresentation and Concealment Claims
Plaintiff alleged that her surgeon “received certain materials from Mentor that led him to recommend ObTape for [her], and that those materials contained material misrepresentations and concealed material facts about ObTape,” including facts about the frequency and severity of ObTape complications.”  Id. at *10.  Mentor argued that plaintiff could not prove the required reliance element of her misrepresentation and concealment claims, as it was “undisputed that Mentor did not make any representations directly to [plaintiff].” Id.  at *11.  The court conceded that, ‘[i]n general, a fraudulent or negligent misrepresentation claim must be based upon a misrepresentation made to the defrauded party, and relied upon by the defrauded party.” Id. at *11-12 (internal punctuation and citations omitted).  However, it held that “"the requirement of reliance is satisfied where . . . A, having as his objective to defraud C, and knowing that C will rely upon B, fraudulently induces B to act in some manner on which C relies, and whereby A's purpose of defrauding C is accomplished."  Id. at *12 (internal punctuation and citation omitted).  Thus, plaintiff created a material issue of fact by alleging that Mentor made misrepresentations to her surgeon, on whom she relied, intending to induce her to undergo the ObTape procedure.   Id.  Hmmmm.  There were:  A) no statements to the plaintiff, and B) no reliance by the plaintiff, so how do we get to C) no summary judgment?  We think that twisting the learned intermediary doctrine this way turns the entire concept of reliance on its head, allowing plaintiffs who were never defrauded to prevail on fraud claims.  It is a little bit like permitting a claim for a manufacturing defect where there is no evidence that the product in question was defectively manufactured.  Which is just what the court did.
 
Manufacturing Defect
Plaintiff’s manufacturing defect claim was based on evidence presented by plaintiffs in an earlier phase of the ObTape MDL, that the pore size of those plaintiffs' ObTape samples varied from Mentor’s specifications.  Id. at *9.  Mentor pointed out that plaintiff “did not point to any evidence that any expert examined the specific ObTape that was explanted from [plaintiff’s] body and opined that a manufacturing defect existed.”  Id.   No matter, the court held.  Because other plaintiffs’ experts had tested “a number of [other plaintiffs’] ObTape samples” and had found deviations in a “substantial portion” of them, plaintiff, relying on that evidence, created a genuine issue of fact.  Id.   Seriously?  Need we even comment on the absurdity of permitting a plaintiff to use other plaintiffs’ evidence to prove that her device – never examined – was defectively manufactured?   Is this some sort of non-mutual collateral estoppel jiggery-pokery? We shudder at the slippery slope this approach could create.

And so, despite a promising holding on plaintiff’s “continuing duty to warn” claim, the court twice stopped short of getting it right.  Like our travel adventures.  Next time, we’re taking the train.

Monday, July 27, 2015

Cymbalta Class Certification Denied Again


 
Is there a tougher federal district judge than Stephen Wilson in Los Angeles?  By “tougher,” we do not mean in the usual sense when applied to judges: handing out long criminal sentences – though that certainly does apply to Judge Wilson.   No, we mean in the sense of not suffering fools gladly.  (To borrow a phrase from the movie Rounders, if you are in court for a case for more than a few minutes and you cannot spot the fool, odds are that it is you.)  Judge Wilson, like Judge Rakoff in SDNY or Judge Posner on the 7th Circuit or Judge Kozinski on the 9th Circuit, has a sharp mind and sharp pen (or keyboard).  If he thinks your theory is wrong, he will say so.  If he thinks you are dumb, he will say so.  Sometimes Judge Wilson can come across as a wee bit impatient.  When we were a prosecutor in C.D. Cal. (as Judge Wilson had been several years before us), Judge Wilson was the first judge we encountered who imposed strict time limits during trial.  If he decided that a witness examination had gone on long enough, he would halt the examination on the spot.  We remember a guilty plea in front of Judge Wilson that took place the day before trial was scheduled.  Guilty pleas can be messy affairs.  Some people, no matter how overwhelming the evidence, have a hard time admitting that they did the crime.  And yet, such admission is an essential part of the guilty plea.  Often, the defendant stumbles over the admission.  It can take some goading, some reassuring whispers from defense counsel, and simply some time before the defendant can bring him or herself to utter the magic words.  In our case, the defendant hemmed and hawed a little too much.  Judge Wilson said that there was not enough there for a valid guilty plea, he rejected it, ordered the parties to show up the next day for jury selection, and then called the next case.  It seemed to happen in an instant.  There was panic.  We had already told our witnesses that the case would plead out and that they did not need to come to the federal courthouse the next day.  For all we knew, our case agent was already well outside the jurisdiction, on a protection detail or going undercover.  On the other side of the ledger, the defendant knew what the result at trial would be, and wanted at least to get a couple of points off the sentencing guidelines for acceptance of responsibility.  Somehow the defendant and his lawyer got their act together and returned to court near the end of the day and performed the requisite guilty plea allocution, and all was right with the world.   Judge Wilson’s demonstration of impatience had worked.

 

That being said, Judge Wilson seems to have displayed quite a lot of patience in dealing with the putative Cymbalta class action.  The plaintiffs alleged that the withdrawal effects of Cymbalta had been understated.  They initially moved to certify a class of consumers in California, Missouri, New York, and Massachusetts who had “received a product that had less value than the value of the product as class members expected to receive it.”  They said they would prove this harm via a “conjoint analysis.”   A conjoint analysis is a statistical technique used in market research to determine how people value different attributes (feature, function, benefits) that make up a product or service.  If you have ever answered a survey where you were asked to assign point values to different attributes of a product or service, you were probably part of a conjoint analysis.  We have dealt with conjoint analyses in cases just enough to be dangerous.  We know this much:  conjoint analysis is complex.  It can be done with rigor.  It can also be outcome-driven hocus pocus.  In any event, Judge Wilson in December 2014 rejected the proposed damages model because it looked only to the demand side of the equation, whereas the prescription drug market is such a hodge-podge on the supply and insurance sides that the relationship between price and consumer value is tenuous at best.  In fact, in Judge Wilson's view, it is "severed."  Different consumers pay different prices with different copays, etc.  Causation and injury cannot possibly be common issues.  Class certification, consequently, would make no sense. 

 

The plaintiffs decided to try again.  They did not succeed, and Judge Wilson’s order denying class certification in Saavedra v.Eli Lilly & Co., No. 2:12-cv-9366-SVW (C.D. Cal. July 21, 2015), is exactly what we would expect:  succinct and tough-minded.  The plaintiffs moved to certify New York and Missouri subclasses that would seek only the statutory minimum damages ($25 per transaction for Massachusetts, and $50 for New York).  By this technique, the plaintiffs hoped to dodge the need for individualized damages calculations.  But the plaintiffs would still need to establish injury of some sort.  Again, the theory was that the alleged misrepresentations caused the plaintiffs to pay a price premium.   This time, instead of relying on a conjoint analysis, the plaintiffs claimed they could make their point via the defendant’s own internal documents.  But Judge Wilson did not buy what the plaintiffs were selling.  He assigned exactly the right value to the plaintiffs’ argument:  zero.  The plaintiffs admitted that the alleged “premium pricing affected class members to varying degrees because of the existence of health insurance and the varying terms of pharmaceutical benefits that can accompany it.”  Even if the plaintiffs disclaimed the need to quantify the damages, since they were content with statutory damages (at least their lawyers were), they could not use common proof to show the fact of injury.  Whatever the internal documents might show, they could not show (1) that a price premium was actually charged, (2) that the price premium was a premium over the medicine’s true value rather than a premium over competing antidepressants, or (3) that any alleged price premium was passed along to the consumers (who probably handed over a copay).  Judge Wilson denied class certification again.  Tough, but fair.

 

This excellent result is the newest addition to our Class Action Denial Federal Cheat Sheet. 

 

         

Friday, July 24, 2015

Inside the Implied Conflict Preemption Box

Federal preemption in the drug and medical device world is a game of categories.  Express preemption versus implied.  Conflict preemption versus field preemption.  Drugs versus devices, generic versus branded, premarket approved versus not.  These categories make a difference, and if you can place your controversy into the correct boxes, you can usually determine how to analyze whether federal law preempts state-law claims.  Sometimes you can even predict the result, or at least predict what the correct result should be.  We say “should” because there is discretion involved, and also some ambiguity in the applicable law.  Moreover, preemption is like hockey:  Many Americans can discuss it with some familiarity, but a much smaller number have studied all the nuances of the game. 

From time to time a preemption order thinks outside the box, and that is what happened in Williams v. Zimmer US, Inc., No. 5:14-cv-468, 2015 U.S. Dist. LEXIS 91238 (E.D.N.C. July 14, 2015).  The case involved a bizarre situation where a surgeon took a medical device home, and “in his own garage, [he] used nonmedical tools purchased from a home improvement store to bend a 5.5 mm chrome rod into a ‘U’ shape.”  Id. at *4.  Facts like these make us scratch our heads, but putting the weird facts aside, the device was cleared through the 510k premarket notification process.  As our readers know, under Lohr and Riegel, there generally is no express preemption under the Medical Device Amendments for 510k-cleared devices, so our knee-jerk reaction when a 510k device is involved is to put that case into a “no preemption” box. 
But don’t forget about implied preemption, which is where this district judge went with this case.  Our do-it-yourself doctor used his Home Depot version of the device to treat a patient, who later sued alleging injuries.  But she couched her complaint entirely in terms of violations of the FDCA. 
That had two dramatic consequences.  First, the defendants removed the case to federal court, and the district court ruled that it had subject matter jurisdiction because the case arose under federal law, i.e., the court had federal question jurisdiction.  Id. at **6-7.  This is exceptional because the vast majority of drug and medical device cases in federal court are there under diversity jurisdiction, even though the industry is subject to intense federal regulation.  An opinion finding federal question jurisdiction in a medical device case is a welcome development, and this plaintiff seems to have pleaded straight into it.
Second, because the plaintiffs placed the FDCA and alleged violations thereof at the center of their complaint, the district court ruled that federal law preempted the state-law claims under Buckman and dismissed the case.  Id. at **11-17.  This is not an application of implied conflict preemption that we often see.  Nor is it routine to apply Buckman outside the context of fraud-on-the-FDA claims, although there are multiple cases where courts have done that.  This district court did so too, and its reasoning was absolutely correct.  Again, the court applied implied conflict preemption, under which “state law may conflict with federal law either because ‘compliance with both state and federal law is impossible’ or because the state law impedes a federal purpose.  Id. at *11.  In Buckman, the Supreme Court invoked implied conflict preemption to hold that fraud-on-the-FDA claims were preempted.  As this district court saw it,

Buckman did leave room for a small range of state law claims based on the FDCA, namely those state-law claims that would rely on traditional state tort law independent of the FDCA.  Put in other terms, “a state law claim only endures if it manages to incorporate, but not depend entirely upon, and FDCA violation and is premised on conduct that would give rise to liability under traditional common law principles.”  If, however, the defendant would not be liable “but for the FDCA, ‘then the plaintiff is effectively suing for a violation of the FDCA (no matter how the plaintiff labels the claim), and the plaintiff’s claim is thus impliedly preempted under Buckman.’” 

Id. at **12-13 (citations omitted).  This is a very good gloss on Buckman, although we would read the Supreme Court’s preemption ruling even more broadly.  But we will not dwell on that here because the district court’s application of Buckman to dismiss this case was bang on.  First, the court ruled that it is now settled that Buckman’s holding is not limited to fraud on the FDA.  Citing multiple examples, the court reiterated that federal law impliedly preempts any claim where the plaintiff is effectively suing for violations of the FDCA, including claims pleaded as breach of warranty, negligence per se, design defect, and failure to warn.  Id. at **14-15. 
Here, the plaintiffs alleged a number of purportedly state-law claims, but all were premised on either (1) off-label use of the device or (2) failure to advise that the FDA had not yet approved or cleared other devices used in the surgery:  These claims were all preempted because “Buckman is not limited to fraud-on-the-FDA claims” and because “the present claims depend entirely upon alleged violations of the FDCA.”  Id. at *16.  As we know from Buckman and many other cases, there is no private right of action for violations of the FDCA. 
We also like how this district court understood that express preemption and implied preemption are two different things.  The plaintiffs argued that federal law did not preempt their claims because the MDA’s express preemption provision did not apply.  Id. at *13.  Fair enough, but that does not foreclose implied preemption.  As the district court stated, “Buckman dispensed with the notion that an express preemption provision prevents the application of [implied] conflict preemption.”  Id. at *17.  We will acknowledge that the plaintiffs’ argument was not outlandish.  The Supreme Court in Wyeth v. Levine did give some credence to the idea that the lack of an express preemption clause could suggest a Congressional intent that there should be no preemption of any kind.  We think that is wrong.  The Supreme Court has ruled on multiple occasions—both before and after Levine—that implied preemption operates independently from and without reference to express preemption.  That is the law and that is the way it ought to be.
Finally, the district court dismissed the case with prejudice because any amendment to the complaint would be futile.  We routinely express our dissatisfaction with orders granting leave to amend when circumstances do not warrant it, so this part of the ruling is welcome news too, mainly because the plaintiffs will not get to fish around in expensive discovery.  The main story though is Buckman-style preemption and this district court’s exceptionally clear minded application of implied preemption to the plaintiffs’ allegations.
 
 

Thursday, July 23, 2015

ABA Hijinks No More (For Now)

We are pleased to report that the proposed ABA Resolution 105 - first blogged about here - has been withdrawn and will not be an issue at the House of Delegates session at the upcoming ABA meeting.  The originators chose to withdraw it in the face of opposition from "several ABA entities and individual leaders within the ABA."  We know that this opposition included the Litigation Section's Product Liability Committee, the TIPS Section, and the Section of Science & Technology Law.  We heard that other ABA committees were also preparing oppositions.

A lot of defense groups were also heard from.  We at the DDL Blog thank everyone who participated in the effort to head off this destructive and extremely biased proposal.

Wednesday, July 22, 2015

Little Reprieve for Prisoner Zyprexa Suit


 
Happy birthday, Louise Fletcher, who won an Academy Award for her portrayal of the sadistic Nurse Ratched in One Flew Over the Cuckoo’s Nest (1975).  Happy birthday also to Albert Brooks, writer/director/star of Modern Romance (1981), Lost in America (1985), Defending Your Life (1991), and a gaggle of other comedies.  Brooks also did fine work as an actor in several non-comedies, such as Taxi Driver (1976), Broadcast News (1987), and Drive (2011).  But for our money, his best performance is in Out of Sight (1998), where Brooks played a Michael Milken-esque financier-turned-prison-inmate.  By the way, Brooks’s birth name was Albert Einstein.  Brooks changed his name for obvious reasons.  He cracked that the great physicist had changed his name to Albert Einstein simply to sound smart.  Finally, happy birthday to Don Henley of The Eagles.  Henley sang and co-wrote “Hotel California” (1977), an allegory about SoCal showbiz excess.  The best line in the song is “We are all just prisoners here of our own device.”

 

Does that trio of birthdays suggest a theme?  Indeed, it does:  drugs and prisoners.  Today’s case is Flowers v. Eli Lilly & Co., 2015 U.S. Dist. LEXIS (D. Nevada July 10, 2015), in which a pro se plaintiff prisoner claimed that Zyprexa gave him diabetes.  The plaintiff had been prescribed Zyprexa at the beginning of his incarceration in 1997, went off it in 2003, and then back on it in 2009, continuing up through the filing of the lawsuit in 2014.  The plaintiff was diagnosed with diabetes in November 2012.  After learning of the diagnosis, the plaintiff requested that he be taken off Zyprexa.  The request was denied.  Remember, the plaintiff was a prisoner.  Patient choice seldom matters from a legal point of view in these cases (because of the learned intermediary doctrine, discussed below), but in this case it really, really does not matter.  Zyprexa is an antipsychotic drug that can be used to treat very serious conditions such as schizophrenia and bipolar disorder.  The court’s opinion does not tell us why the prison wanted the plaintiff to be on an antipsychotic, but odds are there was a very good reason. 

 

There has been a lot of litigation involving claims that antipsychotics cause diabetes.  It is unclear what the scientific theory is -- whether the drugs are alleged directly to raise glucose levels, or whether they prompted the patient eat more, leading to obesity, leading to diabetes.  People who take antipsychotics grapple with profound, life-disrupting issues.  They can be a danger to themselves or others.  They might face an inability to do basic, daily things that the rest of us take for granted, such as working, sleeping, or eating.  Against those desperate medical issues, the risk of obesity and diabetes might seem like an easy trade-off.  Plus, people on antipsychotics often already possess a large number of comorbidities.  All of which is to say that a plaintiff in these cases faces an uphill battle when it comes to specific medical causation. 

 

But in Flowers the court did not need to reach medical causation.  Instead, the learned intermediary doctrine and warning causation proved to be almost insurmountable barriers.  We say “almost” because the court left open the possibility that the case might proceed based on only the early usage by the plaintiff.  For that case, if it exists at all, we foresee a specific medical causation problem that will likely doom the case.  But let’s not get ahead of ourselves.       

 

The plaintiff’s case was premised on an alleged failure to warn of the risks of diabetes.  But in 2003, the FDA required certain antipsychotic drugs, including Zyprexa, to include warnings about the risks of diabetes.  That warning language was added to the Zyprexa label in September 2003, and, in March 2004, the defendant sent a letter to doctors informing them of the label change.  There is no decent argument that the diabetes warning was in any way inadequate.  Moreover, the record in the case showed that all the prescribing doctors were aware of the drug’s potential side-effects.  Those doctors decided that those risks were outweighed by the risk of discontinuing the plaintiff’s Zyprexa prescription, which had been more effective than other drugs in treating his psychotic symptoms.  There was no evidence that any doctor “would have altered his prescription had the warning that accompanied Zyprexa been different”. 

 

That takes care of any claim premised on usage after the diabetes warnings went into effect.  But the plaintiff had used Zyprexa before 2003, as well.  What to do about that?  At this point the Flowers court considered a Second Circuit case that had confronted a similar chronological issue, Shepherd v. Eli Lilly & Co., 497 Fed Appx. 143 (2d Cir. 2012).  In Shepherd, the Second Circuit held that the “Dear Doctor” letter insulated the defendant from liability for failure to warn after 2004.  But in Shepherd, as in Flowers, there was also some usage antedating the warning.  The Shepherd court concluded that the plaintiff’s claim that his injuries “were caused by residual effects of his Zyprexa usage before 2004” failed because the plaintiff’s own causation expert “concluded that his diabetes was caused by the Zyprexa he took from 2006 to 2009.”  Now that’s a helpful expert.  By contrast, in the Flowers case, the parties had not yet conducted expert discovery regarding causation from pre-warning usage.  Thus, while the Flowers court granted summary judgment as to post-warning usage, it allowed the case to proceed as to pre-warning usage. 

 

But – and this thought seems peculiarly pertinent given that the plaintiff is a prisoner – it’s only a matter of time.  Even if the plaintiff is not so cordial as to furnish an expert who disavows the causative effect of the pre-warning usage, it seems incredibly unlikely that the plaintiff will be able to find an expert who can opine with medical certainty that it was the pre-warning usage that caused the diabetes.  Why do we think no such plaintiff expert will emerge?  First, an opinion connecting usage from a particular period of time to a diagnosis 8+ years later seems simply implausible.  Second, the plaintiff is a prisoner.  Even if there are experts out there who would sell their scientific integrity, they will not sell it cheap.