We love the unexpected. We loved standing up after what we thought was the finale of the fireworks show last night only to be left breathless by a stunning and unexpected encore.  We loved walking in to a “quiet family dinner” for our recent advanced birthday to find the room filled with dear relatives and friends shouting “surprise.”  But sometimes it is nice when things happen just as they are supposed to (which, in the jurisprudential world, may actually be unexpected!), like they did in today’s case, a terrific summary judgment decision out of the Eastern District of New York.  (A shout out to Tom Kurland of Patterson, Belknap for the victory and for sending us the decision before it was available online.)

In Chandler v. Janssen Pharms. Inc., et al., — F.Supp. 3d —,  2018 WL 3212422 (E.D.N.Y June 29,  2018), the plaintiff, placed in foster care in 1996 when he was six years old,  began taking Risperdal the next year after displaying aggression at school.  He continued to have serious psychiatric and behavioral problems and to take Risperdal in gradually increasing doses, until 2009.  That year, during a visit with his psychiatrist, the plaintiff complained that his breasts were enlarged.  The psychiatrist recommended that the plaintiff stop taking Risperdal, which he observed was “probably responsible for the breast enlargement,” and noted that he had been aware of the correlation between the drug and breast enlargement for several years. The plaintiff continued to see psychiatrists, and to take antipsychotic medications, until late 2012.   In April 2014, he underwent bilateral mastectomies to remove his enlarged breast tissue.  In March 2015, he filed suit alleging that the defendants failed adequately to wan about rate of incidence of gynecomastia (breast enlargement) in pediatric users of Risperdal.  Specifically, although the label at all relevant times, had always included a Precaution about gynecomastia, the plaintiff alleged that gynecomastia should have been listed in the “Warnings” or “Adverse Reaction” section, and that gynecomastia rates were two to five times higher than the 2.3% rate listed in the label after October 2006, when Risperdal was approved for pediatric use.  He alleged that his doctor would not have prescribed Risperdal if he had known about the higher incidence rate.

The defendants moved for summary judgment, arguing that the plaintiff had not produced admissible evidence that the Risperdal gynecomastia warning was inadequate.   The defendants argued that the only “evidence” supporting the plaintiff’s warnings claim was the two cherry-picked clinical studies that ostensibly demonstrated the higher incidence rate, a “contention that [was] inadmissible without expert testimony.” Chandler, 2018 WL 3212422 at *6.

The court explained that, under the learned intermediary doctrine, a drug warning is “adequate as a matter of law if it clearly and unambiguously notifies the prescribing physician of the particular adverse reaction that forms the basis of the plaintiff’s complaint.” Id. (citations omitted).  Because the Risperdal label always warned that the product could cause gynecomastia, the plaintiff could not prove that the label was inadequate.   The court also rejected the argument that the label should have included an incidence rate for gynecomastia before the drug was approved for use in children, noting that the defendants “were clearly keeping abreast of knowledge” of the drug through available methods and were “taking steps to bring that knowledge to the attention of the medical profession.”   Id. (internal punctuation and citation omitted).  Finally, the court held that the plaintiff had not produced admissible evidence that the gynecomastia incidence rate in the 2006 and 2007 labels was inadequate.  The plaintiff relied on two studies (of eighteen conducted around the same time)  that allegedly showed higher incidence rates, but the plaintiff “introduce[d] no  expert testimony on the validity of [those]  studies, either standing alone or  compared to the other sixteen studies, or [on]  the regulatory requirements of labeling.” Id, at *8.  Without an expert, the court held, the plaintiff could not opine on the “statistical or methodological differences between the studies or why the two studies he cited were correctly decided in comparison to the other sixteen.” Id.  Concluding, “To be clear, while the two studies could be evidence of higher incidence rates, the absence of an expert to interpret and validate them precludes their admission,” id, the court held that Risperdal’s gynecomastia warnings were adequate as a matter of law at all relevant times.

Warnings Causation

Though the defendants were entitled to summary judgment based on the adequacy of the warning, the court went on to consider the issue of warnings causation; in other words, whether a different warning would have changed the plaintiff’s doctors’ decisions to prescribe the drug. The court added, “if the treating physician is aware of the risks of a drug, independent of any warning by the manufacturer, such knowledge constitutes an intervening event relieving the manufacturer of any liability to a patient under a failure to warn theory.” Id. at *10 (internal punctuation and citations omitted).   In this case, both of the plaintiff’s prescribing physicians knew of the possible correlation between Risperdal and gynecomastia “both before and during the time that they prescribed the drug” for the plaintiff. Id.  One of the doctors testified that he wasn’t sure he would have changed his prescribing decisions even if he knew the risk was higher.  The other  testified that, although he knew of the gynecomastia risk from other  sources, he didn’t read the label or advise the plaintiff of the risk, both of which constituted intervening causes, “severing the causal connection between Defendants’ alleged failure  to warn and Plaintiffs’ injury.” Id. (citation omitted).  Finally, the court disregarded the plaintiff’s guardian’s affirmation to the effect that she would not have consented to the Risperdal prescription if the plaintiff’s doctor had advised her of the gynecomastia risk.  The court explained, “A failure to obtain informed consent might be a viable theory of liability against [a] physician or … hospital,” but neither was a party to the lawsuit.  Because the plaintiff could not establish specific (warnings) causation, the court held that the defendants were entitled to summary judgment on that basis as well.

We love a good warnings decision, and we are delighted that we had the chance to bring this one to you.   We hope you all had a great holiday.

Until very recently, the only state high court decisions (from VA and DE) on our ediscovery for defendants cheat sheet involved sanctions against plaintiffs for destroying social media evidence.

No longer.

In Forman v. Henkin, ___ N.E.3d ___, 2018 WL 828101 (N.Y. Feb. 13, 2018), the New York Court of Appeals reaffirmed that discovery of plaintiff social media is available to defendants on the same basis as any other discovery, and put the kibosh on plaintiff-friendly discovery restrictions that had lower New York courts had developed to hamstring defendants seeking access to plaintiffs’ social media.

Forman was about as far from prescription medical product liability as one can get and still involve personal injury.  The plaintiff fell off a horse, was badly injured, and sued the owner of the horse. Forman, 2018 WL 828101, at *1.  Plaintiff, who claimed to have become “reclusive” following the accident, was a heavy social media user:

At her deposition, plaintiff stated that she previously had a Facebook account on which she posted “a lot” of photographs showing her pre-accident active lifestyle but that she deactivated the account about six months after the accident and could not recall whether any post-accident photographs were posted.

Id.  She also claimed to “ha[ve] difficulty using a computer and composing coherent messages” after her accident.  Id.  Thus, the relevance of plaintiff’s social media activities was as plain as the nose on that horse’s face.  After plaintiff testified to these facts, social media information confirming or refuting them, at minimum, bears on credibility, and goes to damages, as well – right?

Well…. Not as the Appellate Division saw the issue (note: only plaintiff appealed, so the issues being considered are somewhat narrow).  It limited disclosure only “to photographs posted on Facebook that plaintiff intended to introduce at trial” and “eliminate[ed] the authorization permitting defendant to obtain data relating to post-accident messages.”  Forman, 2018 WL 828101, at *2.  Why?   The Appellate Division held that unless the defendant could find something in plaintiff’s public social media suggesting a specific basis for additional discovery, the defendant had no right to any discovery from the plaintiff’s private social media:

[T]he Appellate Division . . . employ[ed] a heightened threshold for production of social media records that depends on what the account holder has chosen to share on the public portion of the account. . . .  Several courts applying this rule appear to have conditioned discovery of material on the “private” portion of a [social media] account on whether the party seeking disclosure demonstrated there was material in the “public” portion that tended to contradict the injured party’s allegations in some respect.

Id. at *4 (citations omitted).

The defendant argued that its right to discover relevant evidence under the control of an opposing party is not predicated on the legal equivalent of a snipe hunt.  Id.  Thankfully, the Court of Appeals “agree[d],” id., and threw out the Appellate Division’s made up impediment to ediscovery for defendants.  First, discovery is discovery, no matter who seeks it:

Disclosure in civil actions is generally governed by CPLR 3101(a), which directs: “[t]here shall be full disclosure of all matter material and necessary to the prosecution or defense of an action, regardless of the burden of proof.”  We have emphasized that the words material and necessary are to be interpreted liberally to require disclosure, upon request, of any facts bearing on the controversy.

Id. at *2 (citation and quotation marks omitted).  New York recognizes only “three categories of protected materials” – “privileged matter,” “attorney[] work product,” and “trial preparation materials.”  Id.  A plaintiff’s (or defendant’s, for that matter) social media doesn’t fit in any of these categories.

Beyond the three categories, discovery may be limited if unduly “onerous.”  Id. at *3.  Discovery of photos actually posted by the plaintiff (with an exception for “nudity or romantic encounters” specified by the trial court) wasn’t “onerous” either, and plaintiff did not argue otherwise.  Id.

The Court of Appeals in Forman flatly rejected the plaintiff’s supposed precondition to social media discovery, recognizing that it would let plaintiffs hide the ball:

[A] threshold rule requiring that party [seeking discovery] to “identify relevant information in [the social media] account” effectively permits disclosure only in limited circumstances, allowing the account holder to unilaterally obstruct disclosure merely by manipulating “privacy” settings or curating the materials on the public portion of the account.  Under such an approach, disclosure turns on the extent to which some of the information sought is already accessible − and not, as it should, on whether it is “material and necessary to the prosecution or defense of an action.”

Forman, 2018 WL 828101, at *4 (citation, quotation marks and footnote omitted) (emphasis added).  Hear, hear.

Rather, the principle circumscribing social media discovery is the same as for all discovery – relevance to the theories and defenses of the particular case.  While blanket discovery of everything in every case, whether social media or otherwise, would be “onerous,” id., discovery tailored to the plaintiff’s claims and the defendant’s defenses is normal and proper:

[T]here is no need for a specialized or heightened factual predicate to avoid improper “fishing expeditions.”  In the event that judicial intervention becomes necessary, courts should first consider the nature of the event giving rise to the litigation and the injuries claimed, as well as any other information specific to the case, to assess whether relevant material is likely to be found on the [social media] account.

Id. at *5.  Plaintiffs would have a chance to assert “any specific ‘privacy’ or other concerns” about the social media discovery being sought.  Id.  In “a personal injury case . . . it is appropriate to consider the nature of the underlying incident and the injuries claimed.”  “Temporal limitations may also be appropriate” so that social media “posted years before an accident” may not “be germane.”  Id.

The Court of Appeals also rejected the plaintiff’s argument that social media discovery “necessarily constitutes an unjustified invasion of privacy.”  No it doesn’t.  A plaintiff who brings a lawsuit necessarily waives privacy with respect to evidence relevant to that action.

We assume . . . that some materials on a [social media] account may fairly be characterized as private.  But even private materials may be subject to discovery if they are relevant.  For example, medical records enjoy protection in many contexts under the physician-patient privilege.  But when a party commences an action, affirmatively placing a mental or physical condition in issue, certain privacy interests relating to relevant medical records − including the physician-patient privilege − are waived.  For purposes of disclosure, the threshold inquiry is not whether the materials sought are private but whether they are reasonably calculated to contain relevant information.

Forman, 2018 WL 828101, at *5 (citation omitted) (emphasis added).  We note that one of the omitted citations is to Arons v. Jutkowitz, 880 N.E.2d 831 (N.Y. 2007), the decision confirming defendants’ right to informal interviews with treating physicians in New York, which we blogged about, here).

In short, plaintiffs who don’t want to produce their social media shouldn’t be plaintiffs.  If you can’t stand the heat, get out of the courtroom.

Thus, it was “err[or]” to condition discovery of “private” social media on what a plaintiff might, or might not, have done on public social media.  The Appellate Division had “effectively denied disclosure of any evidence potentially relevant to the defense.”  Id. at *5 n.6.  Rather, plaintiff’s testimony about her social media activities “more than met [any] threshold burden of showing that plaintiff’s Facebook account was reasonably likely to yield relevant evidence.”  Id. at *5.  Any photos of plaintiff’s activities “might be reflective of her post-accident activities and/or limitations.”  Id.  Further, “data revealing the timing and number of characters in posted messages would be relevant to plaintiffs’ claim that she suffered cognitive injuries that caused her to have difficulty writing and using the computer.”  Id. at *6.

Forman thus confirms what we have always thought – anything a plaintiff puts on social media is fair game for discovery, to the same extent as any other information under the plaintiff’s custody and control.  Decisions that seek to impose additional limitations on social media discovery, because social media is somehow different or more private, are wrongly decided.

Happy birthday, Christopher Plummer.   The great Canadian actor turns 88 today, and seems as vibrant as ever.  What a marvelous career Plummer has had.  He is a preeminent Shakespearean actor.  We saw him play Iago to James Earl Jones’s Othello on Broadway 35 years ago.  Of course, most people remember Plummer as Captain Von Trapp in The Sound of Music (1965), a film for which Plummer reserves enormous contempt, referring to it (if at all) as “The Sound of Mucus.” Much more recently, we enjoyed Plummer’s flinty interpretation of Ebenezer Scrooge in The Man Who Invented Christmas.  And there has been abundant publicity over Plummer’s replacement of Kevin Spacey in House of Cards.  It seems a thankless task to succeed someone in such scandalous circumstances.  But we’ll thank Plummer, if only because he supplied a (strained) segue into today’s post, which is about successor liability.

 

More specifically, we have a pro-defense decision on successor liability with respect to a bankrupt medical device manufacturer. The court holds that there is no liability for design and manufacturing claims under either NY or PA law – including PA’s peculiar product line liability theory. The court concludes as a matter of law that product line liability applies only to manufacturers, not to distributors. But there is a fly in the ointment: the court’s conclusion on the failure to warn claim is rather muddled – to the point where that cause of action is not concluded at all.

 

In Deluca v. Portland Orthopaedics Ltd., et al., 2017 U.S. Dist. LEXIS 198962 (E.D.N.Y. Dec. 2, 2017), a husband and wife sued for injuries relating to a failed hip implant. The husband and wife lived in New York. That is where the 2009 implant operation took place. That is also where the injury – the 2012 failure of the implant – took place. The implant was manufactured by Portland, an Australian company that had entered into receivership shortly before the plaintiff’s implant operation and that had sold off its assets before the implant failed three years later. The plaintiffs sued Portland, as well as the Singapore successor company and its manufacturing and distributing affiliates, which were incorporated in Pennsylvania (not something we’d ever recommend doing). The complaint included claims for strict liability (failure to warn, manufacturing defect, and design defect), negligence, and breach of warranty – the usual. Portland never appeared on the case and was dismissed. One presumes it would be judgment-proof. The remaining defendants moved for summary judgment, and their arguments centered around successor liability – or, to be precise, absence of successor liability. The court sensibly held that New York law governs because that is where the injury occurred, but the court also treats us to an analysis under Pennsylvania law, where it arrives at the same destination, albeit via a slightly more complicated route.

 

The successor corporation purchased certain assets of Portland. There was no purchase of stock or any formal merger. Under those circumstances, the successor typically does not acquire prior tort liabilities. That is the law in both New York and Pennsylvania. There are some exceptions to this general rule, but none applies here.

 

New York recognizes four possible exceptions, none of which saved the plaintiffs’ design or manufacturing defect claims:

 

First, the successor did not expressly or impliedly assume prior liabilities. In fact, those liabilities were expressly excluded.

Second, the de facto merger exception does not apply. There was no continuity of ownership, management, or physical locations. In addition, the seller continued to exist, even if only in gossamer form.

Third, the “mere continuation” exception does not apply. Again, the seller lingered, and there was no hint of overlapping owners or managers.

Fourth, there is no evidence that the asset sale was a fraudulent effort to evade liability.

 

Pennsylvania adds another factor – whether the transfer was made without adequate consideration and without provisions for creditors of the selling corporation. That factor also does not apply here. More significantly, or problematically, some Pennsylvania courts have announced a “product line” exception, an extreme pro-plaintiff doctrine left over from the 1980s. The Deluca court is not persuaded that this exception has been endorsed by the Pennsylvania Supreme Court. And remember that the Deluca court has chosen New York law to govern this case. Nevertheless, just in case some appellate court might get dodgy, the Deluca court goes through the motions of measuring the evidence in the case against the product line exception and concludes that it does not help the plaintiffs here. The factors animating the product line exception are pretty fuzzy: (1) whether the purchase of the product line caused the “virtual destruction of the plaintiff’s remedies against the original manufacturer,” (2) does the successor have the ability to assume the original manufacturer’s “risk-spreading role,” and (3) the fairness of requiring the successor to assume responsibility insofar as the successor was enjoying the original manufacturer’s good will.

 

The Deluca court easily dispensed with these factors by pointing to some important facts:

 

  1. Portland’s insolvency preceded the asset sale, and was certainly not caused by it.
  2. The asset sale was not prompted by any scheme to evade product liability claims. At the time of the sale, the problem of implant failures was not on the radar screen.
  3. The purchase agreement explicitly excluded goodwill as well as related liabilities.

 

Further, the Deluca court held that the product line exception could not be used against the defendants who were never involved in manufacturing. Thus, even if someone wanted to shape the gooey product line factors so as to preserve claims against a successor, the distributor defendants would still be off the hook.

 

The plaintiffs requested additional discovery on the successor liability question. The Deluca court refused that request on both procedural and substantive grounds. The procedural problem for the plaintiffs was that they failed to submit a Rule 56(d) affidavit documenting what discovery would be sought and why it wasn’t obtained earlier. The substantive ground was futility. Even from the face of the plaintiff’s’ arguments, it was clear to the court that the request was a mere fishing expedition, with no justification for the delay and no expectation that anything reeled in would make a difference.

 

So far so good for the defense. But the court also kept the failure to warn claim alive, at least for now. New York law recognizes that successor corporations sometimes have an independent duty to warn. That duty arises not from succession of the prior manufacturer’s duties, but from the successors’ relationship with customers. Here, the plaintiffs alleged that a sales representative working for one of the defendants was in a position to provide additional warnings to the treating doctor. We do not know what those warnings would be, and are not sure how they would fit into the chronology of the case. The defendants pointed to the Instructions for Use as containing ample warnings. The Deluca court responded that it is unclear whether the physician received the IFU or whether the warnings were in fact adequate.

 

To our eyes, those questions should not be enough to stave off summary judgment. How could the doctor not have access to the IFU? Is there any suggestion that the defendants did something to make the IFU unavailable? Seems unlikely. How is the adequacy of the warning not an issue of law? And is there any open issue of warning causation? That is, did the plaintiffs proffer any evidence that a different warning – whatever that might be – would have changed the doctor’s mind in such a way as to avoid the alleged injury? On these points, the court’s reasoning is full of holes.  We suspect that the plaintiffs will ultimately be unable to fill those holes with evidence.  Then the defendants will be in a position to borrow a title from the Bard: all’s well that ends well.

 

We harbor a suspicion that half the drug/device tort cases we encounter are really medical malpractice cases in search of a deeper pocket (thank you medmal damage cap statutes).  We’ve said before (e.g., https://www.druganddevicelawblog.com/2008/10/everything-you-need-to-know-about-wyeth.html) that both Levine and Riegel were really med-mal cases.   That search for a deeper pocket is undertaken by the lawyer, not the client.  We say this because we can use up all the fingers on one hand counting cases over the last year or so where it became clear that the product liability plaintiffs were certain that it was actually their doctors who erred.  The plaintiffs said so themselves.  They said so in their testimony.  They said so in contemporaneous diaries.  This evidence was hard to align with the lawyers’ strategy of making the case all about the manufacturer and its documents.  But why let reality get in the way of a game plan?  The plaintiffs’ discovery, motions, and rhetoric pretty much ignored whether the doctor met the standard of care.  Indeed, the doctors often got dropped just before trial.  Sometimes, we are sorry to say, our cynical eyes espied a shady quid pro quo, as the same doctors show up as witnesses for the plaintiffs

 

 

Why does a med-mal case turn into a product liability case?  Perhaps we should add a qualifier here.  It is product liability lawyers, not all lawyers, who contrive to turn med-mal cases into product liability cases.  There are plenty of superb med-mal plaintiff lawyers out there who are perfectly happy to practice their craft, and would sooner set their hair on fire before steering a case into comment K, the learned intermediary doctrine, or an MDL.  But product liability lawyers are at home with these lovely little bits of business.  It’s like that old saw about how a hammer sees nails everywhere.  We had lunch earlier this week with a friend who formerly worked with us at a defense firm, but who has now become a plaintiff med-mal lawyer and is doing terrifically well.  He wracks up big verdicts all the time.  His name on a complaint must up the settlement value of a case by 20%.  But he acknowledges that suing doctors isn’t easy.  He estimated that 90-95% of med-mal trials in Pennsylvania end with a defense verdict.  Of course he files his cases in Philadelphia whenever possible, but even in that benighted jurisdiction the defense win rate hovers in the 80s.  We were astonished to hear this.  We were less astonished after our friend explained that the slam-dunk med-mal cases invariably settle.  The ones that go to trial tend to be a bit on the flimsy side, or at least there is a yawning weakness somewhere in the case.  And then there is the fact that most people are willing to give the benefit of the doubt to doctors.  Unless you get the kind of stunning insider testimony that dealt Paul Newman a winning hand in The Verdict, doctors win most med-mal cases.  In addition, there are often procedural hurdles or damages caps unique to med-mal cases.  It is a different playing field from a mass torts case.  Doctors get treated like the home team.  Drug or device companies get treated like a criminal syndicate – even when the trial really is on their home turf.   

 

How does a med-mal case morph into a product liability case?  Failure to warn and failure to train are usually the operative theories.  Mind you, we don’t think failure to train is a legitimate theory at all. We have a whole topic thread devoted to that issue.  https://www.druganddevicelawblog.com/tag/duty-to-train/  If there isn’t some specific law that requires such training, or that such training be carried out in a particular way, and if the company is going above and beyond what is legally required, it seems stupid and unfair to pin additional liability on a company for a voluntary undertaking or through some other specious legal theory.  In any event, at the doctor’s deposition the plaintiff’s lawyer will play the game of “wouldn’t you have liked to know x,” and whatever the x is, such as adverse event data, a footnote in a study, or the surprise ending of the new Harry Potter play, the doctor will likely say yes, because … well, because nobody with an advanced degree wants to come across as stubbornly ignorant.  Moreover, a plaintiff’s product liability case acquires enhanced sex appeal if it turns out that a company sales representative was in the operating room.  The plaintiff attorney will argue that the sales rep’s action or inaction was somehow a huge factor as to why the patient sustained the alleged injury.  Once or twice we have met sales reps who bragged about how they would use a laser pointer during an operation to ‘help’ the doctor, but most acknowledge that they would never render such ‘advice.’ Sales reps cannot and do not practice medicine.  More importantly, we have never met a doctor who said that a sales rep superseded seven-plus years of medical education.  Turning a med-mal case into a product liability case presupposes a willing suspension of disbelief, but upon that suspension of disbelief rests a huge chunk of the American tort industry. 

 

But here is a nifty New York County (that’s Manhattan) decision upholding the proposition that medical device manufacturers, even if they have representatives in attendance during the use of their products, are not liable for how the physician chooses to use them.  Gregory v. Tehrani, et al., 2017 N.Y. Misc. LEXIS 3491, 2017 N.Y. Slip. Op. 31963(U) (Supreme Ct. N.Y. County Sept. 15, 2017).  The Gregory case sheds light on the med-mal vs. product liability distinctions in an odd and unexpected way:  the plaintiff tried to make the manufacturer a defendant in a med-mal case.  The case wasn’t restyled as a product liability case – it was still travelling under a med-mal theory.  And therein lies the problem for the plaintiff. 

 

The plaintiff had undergone plastic surgery on his face.  The doctor used a facial filler during the procedure.  Representatives of the facial filler manufacturer were allegedly present during some of the treatments rendered by the doctor to the plaintiff.  Something apparently went wrong and the plaintiff sued the doctor, the facility, and the manufacturer of the facial filler for medical malpractice and lack of informed consent.  The manufacturer filed a motion to dismiss the claims against it.  The manufacturer won.

 

The medical malpractice claims simply did not fit against the manufacturer.  The court considered the second theory (lack of informed consent) first.  The plaintiff’s claim that the facial filler manufacturer failed to inform the patient was foreclosed by the learned intermediary rule.  The manufacturer had a duty to warn the doctor, not the manufacturer.  Put simply, informed consent is not a theory that lies against a manufacturer.  The medical malpractice claim made even less sense.  Rather than allege the classic product defect claim against the manufacturer, the plaintiff alleged that the manufacturer failed to ensure that the doctor used the device in “a safe, indicated manner … and according to their own product guidelines and the guidelines of administrative agencies and bodies including but not limited to the Food and Drug Administration.”   Gregory, 2017 N.Y. Misc. LEXIS 3491 at *5.  It sounds almost as if the plaintiff was complaining that the manufacturer had failed to practice medicine.  That is a weird theory.  It is also rare.  (Though it was alleged all the time in Bone Screw litigation.)  We have blogged about something like this before:  see https://www.druganddevicelawblog.com/2013/12/drugdevice-labels-are-not-required-to.html.  There’s a reason why the theory is rarely seen: it is fundamentally wrong.  It conflates product liability and med-mal law.  The Gregory court proceeds to un-conflate them:  “[W]hile the manufacturer of a medical device has a duty to warn a patient’s physician of the risks associated with the device, the manufacturer is not responsible for how the physician uses the device and renders the medical care.”  Id.  Further, the plaintiff didn’t allege anything wrong with the warnings themselves.  Further further, the plaintiff’s allegations did not connect any of the manufacturer’s actions or omissions to the alleged injuries.  In short, there was no reason for the manufacturer to be a defendant in this med-mal case, and after the court granted the motion to dismiss, it wasn’t.   

 

 

 

We’ve made no secret of our dislike of the so called “heeding presumption.” We have a tag on this subject with multiple posts decrying this presumption — that juries may presume that if an alternative adequate warning had been given, it would have been heeded by the plaintiff (or, in prescription medical product cases, the prescriber). That is essentially a shift of the burden of proof on warning causation from plaintiffs to defendants without any justification. Warnings are ignored all the time.

Our posts note that it is a fairly even split between jurisdictions rejecting and those adopting the heeding presumption. But we’ve taken special note of New York law on the issue because it is a bit muddled. In a post a couple of years ago we explained how a bad Second Circuit decision on the issue (Liriano v. Hobart Corp., 170 F.3d 264 (2d Cir. 1999)) overreached and ignored New York state court precedent spawning a line of cases which purport to recognize a general heeding presumption. At that time we predicted it would require a decision from the New York Court of Appeals to clean up the mess the federal and lower courts had made. We came close to such a decision last year in In re New York City Asbestos Litigation, 59 N.E.3d 458 (N.Y. 2016) (“NYC Asbestos”). Unfortunately, the court determined that the defendant had waived the issue of whether the heeding presumption existed in New York. But, in dicta, went on to say:

[Defendant’s] current complaint about the court’s instructions on the presumption is unpreserved. Of course, our rejection of [defendant’s] claim on preservation grounds should not be taken as an acceptance or rejection of the trial court’s heeding instructions on the merits, and regardless of the propriety of those instructions, trial courts must continue to ensure that their jury instructions honor the principle that the burden of proving proximate causation, which in a case like this one includes the burden of demonstrating that the injured party would have heeded warnings, falls squarely on plaintiffs.

Id. at 482 (emphasis added).

We are happy to report today that that dicta has not gone unnoticed in the drug and device context. Last week, a New York federal court ignored the line of cases from Liriano and instead cited NYC Asbestos and basic New York causation law to hold that New York doesn’t recognize a heeding presumption. The case is Adeghe v. Janssen Pharmaceuticals, 2017 WL 3741310 (S.D.N.Y. Aug. 30, 2017) and involves allegations that plaintiff developed gynecomastia as a result of his use of Risperdal. Id. at *1.  In addition to NYC Asbestos, the court relied on other cases for the general proposition that plaintiff bears the burden of proof that the alleged failure to warn was a proximate cause of his injury and that plaintiff’s burden “includes adducing proof that the user of a product would have read and heeded a warning had one been given.” Id. at *6.

The court provided a strong rationale for why the heeding presumption is not justified in drug/device cases:

Particularly in a case involving failure to warn of the risks of a pharmaceutical product, depending on the plaintiff’s condition and treatment alternatives, one may not reasonably assume that a patient or his treating physician will forego a drug because of disclosed risks.

 Id.

This is an important reminder about just what it means to apply a heeding presumption in a pharmaceutical case. The warnings at issue for drugs and devices are warnings about potential risks. Risks that the prescriber, the learned intermediary, needs to weigh against his knowledge of his patient, his patient’s medical condition, other available alternative treatments (and their risks), and his general medical knowledge. All of that cannot be swept under the rug with a presumption that an alternative warning would have tipped the scales toward non-prescription. Doctors prescribe drugs/devices everyday despite any number of risks inherent in their use.   At best a heeding presumption in a pharmaceutical case, if applied at all, should only go so far as to assume that the alternative warning would have been read by the prescriber. But, it is simply too huge a leap to presume the effect that new warning would have had on the prescribing decision given all the other variables.

In Adeghe, the court found no evidence (no prescriber testimony) that plaintiff wouldn’t have been prescribed Risperdal if a different warning had been given. Id. at *7. Moreover, plaintiff did not adduce any evidence that when the risks of the drug were balanced against its benefits, it would not have been prescribed. Id. “Plaintiff cannot rely on mere speculation as to this medical determination to defeat summary judgment.” Id. Kudos to the court for distinguishing prescription drugs and devices from household consumer goods.

Summary judgment was granted on plaintiff’s failure to warn claim (and on express warranty for lack of any affirmation, id. at *5), but several other causes of action remain because summary judgment was denied on medical causation. The court found plaintiff’s expert had done enough, reviewed studies and considered and addressed alternative causes, to survive a Daubert challenge. Certainly not the worst expert we’ve seen and hardly as important as the heeding presumption decision both for its help in further clarifying New York law and in its acknowledgement of why the presumption has no place in prescription drug and device cases.

We’ve posted a lot about Plavix recently but all in the context of the Supreme Court’s decision in BMS v. Superior Court on personal jurisdiction. So, we don’t blame you if you forgot that the product at issue in that case was Plavix. The product wasn’t really at the heart of the analysis. Neither the plaintiff nor the defendant having any contacts with or relation to the jurisdiction was where all the action was. But that’s state court. There is also a federal MDL concerning Plavix where the claims of plaintiffs who weren’t trying to be “litigation tourists” are moving forward on the substance. But it doesn’t look like they are moving very far if the recent decision in Armantrout v. Bristol-Myers Squibb, 2017 U.S. Dist. LEXIS 131334 (D.N.J. Aug. 17, 2017) is any indication.

Plavix is an anticoagulant which is approved for prescription alone or in conjunction with aspirin. Because the purpose of an anticoagulant is to prevent the formation of blood clots, it is well known that Plavix carries an increased risk of bleeding. Information about the risk of bleeding has been in the Plavix label since it entered the market. Id. at *4-5. While most of that is probably common knowledge, we thought it warranted repeating given that the crux of the claims in this litigation are for failure to warn. Failure to warn of a risk known by practitioners and most lay persons and that was disclosed in the product’s labeling. If this isn’t an uphill battle for plaintiffs, we don’t know what is.

Plaintiff alleged that he was prescribed and used Plavix in combo-therapy with aspirin following implantation of a stent to treat his acute coronary syndrome. Plaintiff used Plavix and aspirin for 8 years before he was hospitalized with gastrointestinal bleeding. Id. at *7-8. His prescriber testified at his deposition that:

  • He was aware of the risk of bleeding the entire time he prescribed Plavix, id. at *9;
  • He was aware of the increased risk of bleeding when prescribed in combination therapy with aspirin, another anticoagulant, id.;
  • He believed that combo-therapy was medically necessary for the type of stent implanted in plaintiff, id. at *10;
  • In his medical assessment, the benefits of combination therapy outweighed the risks for this plaintiff, id.;
  • “having reviewed all the relevant studies regarding Plavix, he believes – even now – that prescribing Plavix to [plaintiff] was the most appropriate medical therapy.” Id. at *21.

We’ve seen testimony like this before and it simply makes us giddy. It means that there is no causal nexus between any alleged inadequate warning and plaintiff’s injuries. If the prescriber was aware of the risk and prescribed anyway – no causation. If the prescriber, knowing the current state of the scientific information, would still prescribe – no causation. No causation, no causation, no causation. We just love the way that sounds.

But plaintiff wasn’t going down without at least some fight. He proffered an expert opinion on the adequacy of the warning. His expert opined that defendant failed to warn about the lack of studies evaluating the use of Plavix for greater than one year. Id. at *19. But the court found that was sort of like bringing a knife to a gunfight. Defendant wasn’t arguing the sufficiency of the warning but rather whether the prescriber would have prescribed even when provided with the most current research and labeling. Id. at *19-20. So, at oral argument, plaintiff tried to change weapons by arguing that his expert’s report called into question the prescriber’s credibility.

To make this argument, plaintiff relied on an old New York case that held that prescriber testimony similar to the testimony here was insufficient for resolving the issue of proximate cause because the doctor had a been a defendant in the case and since the testimony was not “self-disserving” the doctor’s credibility was in doubt and therefore was an issue for the jury. Id. at *24. But as the court pointed out – the prescriber here wasn’t a defendant. “[W]hen the treating physician is not a defendant, but rather a disinterested witness, the same concern regarding credibility is not present.” Id. at *25. Unfortunately, there are two decisions from the Southern District of New York and the Second Circuit that without explanation extend the concept of “self-disserving” to testimony of treaters who were not defendants. See id. at *22-25. Fortunately, this judge was more thoughtful in her analysis and, like a federal-judge sitting in diversity should be – was unwilling to enlarge state law. The court found no New York cases endorsing the Second Circuit’s decision but found decisions by New York’s highest court granting summary judgment relying on unrebutted doctor testimony. Id. at *27. The court also offered an important observation about the cases relied on by plaintiff:

Importantly, if I were to follow [the Second Circuit], summary judgment would never be granted in these types of cases, because a third-party prescriber’s testimony would always be subject to doubt, unless the prescriber testified he or she would not have prescribed the drug. Such a one-sided result for a disinterested physician’s testimony cannot be correct.

Id. at *25. We agree wholeheartedly.

So, the doctor’s credibility isn’t in question simply because his testimony isn’t “self-disserving.” That left plaintiff to argue that the prescriber wasn’t credible because he didn’t agree with plaintiff’s expert. Plaintiff’s expert opined that defendant should have warned about the lack of long-term safety and efficacy studies and because the prescriber didn’t have such studies while he was prescribing, his testimony wasn’t credible. The court found the argument “wholly without merit.” Id. at *28-29. Most importantly, plaintiff never questioned the prescriber at this deposition on this issue. Id. at *29. Probably because he didn’t think he’d like the answer. The doctor did testify about various studies he read and relied on and each of those studies reported on the duration. So he was both aware of the length of those studies and the lack of any longer studies and that did not change his prescribing decision. Id. at *30.

The bottom line is that plaintiff didn’t refute any of the prescriber’s testimony. In other words, plaintiff did not meet his burden of proving that a different warning would have altered the doctor’s decision to prescribe. In fact, the only evidence in the case is that the doctor was fully aware of the risk when he prescribed and prescribed anyway. Under New York law, the prescriber’s independent knowledge of the risk is an intervening event that precludes manufacturer liability regardless of the adequacy of the warning. Id. at *30-31.

Plaintiff also brought a design defect claim, but the court found it was no different than his failure to warn claim and in addition to failing for all the same reasons, also ruled that under New York law a design defect claim can’t be based on failure to warn alone. Id. at *36.

Summary judgment wins in Plavix cases are hardly anything new. Take a look at our prior posts here and here. But, it’s been a few years since the last wave and maybe Armantrout is the start of another round of dismissals. Given the well-known risk at issue, we wouldn’t be surprised to see more Plavix cases fail under the learned intermediary doctrine based on very similar testimony.

May 10 is an important day in the history of the law.  On this date, way back in 1893, the Supreme Court ruled that the tomato is a vegetable, not a fruit.  The case was called Nix v. Hedden, 149 U.S. 304 (1893).  The issue concerned application of the Tariff Act of 1883, which imposed a tax on vegetables, but not fruits.  The appellant was one of New York City’s biggest produce sellers.  He imported lots of tomatoes, and was looking to dodge the tax.  He cited dictionaries defining tomatoes, in a technical/botanical sense, as the “’fruit’ as the seed of plants, or that part of plants which contains the seed, and especially the juicy, pulpy products of certain plants, covering and containing the seed.”  But, alas, the High Court ruled that “[t]hese definitions have no tendency to show that tomatoes are ‘fruit,’ as distinguished from ‘vegetables,’ in common speech, or within the meaning of the tariff act.”  Science be damned, people eat tomatoes in their salads, not desserts, so they are vegetables, not fruits.  Because common parlance prevailed, the taxpayer did not.

 

*                    *                    *                    *                    *

 

We’ll exploit this historical legal oddity and its exaltation of common understanding as a semi-ironic preface to a case where a pro se plaintiff went down in flames in a product liability case.  In Coleson v. Janssen Pharmaceutical, Inc., et al., , 2017 U.S. Dist. LEXIS 68072 (S.D.N.Y. May 3, 2017), the plaintiff filed a pro se complaint against the defendants in New York state court (the Bronx, to be specific) , which alleged that he developed gynecomastia as a result of taking Risperdal and generic risperidone. The defendants removed the suit to federal court.  Things were already heading in the right direction for the defense.  After discovery, during which the plaintiff apparently never found an expert on causation, the defendants moved for summary judgment.  The defendants won.  The plaintiff lost.  Common sense also won: the court rejected innovator liability for an alleged failure to warn by a generic competitor.  Finally, we are reminded of that most common of courts, The People’s Court, where Judge Wapner routinely blasted plaintiffs for not having the requisite paperwork to back up their claims. 

 

After the plaintiff in Coleson had been diagnosed with bipolar schizophrenia around 2009 or 2010, physicians prescribed Risperdal and risperidone. Risperdal is the brand name product and was manufactured/sold by the defendants.  Since at least 1996, Risperdal’s FDA-approved disclosures stated that Risperdal is associated with endocrine-related side-effects, including gynecomastia.   Risperidone is the generic version.  It had been available since 2008.  Medicaid paid for all of the plaintiff’s prescriptions. New York’s Medicaid program excludes coverage of brand-name drugs when there is an FDA-approved generic equivalent on the market unless one’s healthcare provider specifically requests an exemption for the patient.  So it looks as if the plaintiff was probably taking risperidone.  That is, he took risperidone until sometime in 2013-14, when he switched to an entirely different atypical antipsychotic, which was also associated with gynecomastia.  The plaintiff was diagnosed with gynecomastia in 2015. 

 

Despite his usage of generic risperidone and a different antipsychotic, the plaintiff sued only the Risperdal brand manufacturer.  As with most pro se complaints, the theories of the case were less than pellucid.  The defendants and the court construed the causes of action as failure to warn and design defect against the brand manufacturers.  The plaintiff alleged that the side-effect information in the generic risperidone was different from the FDA-approved Risperdal label.  The defendants’ summary judgment motion argued that the plaintiff’s claims failed for lack of any evidence that the plaintiff ingested name-brand Risperdal, as opposed to generic risperdone. The defendants argued that they could not be held liable for either failure to warn or design defect for an injury resulting from a product that they did not manufacture, distribute, or sell. The defendants also argued that the plaintiff could not show medical causation between Risperdal and his gynecomastia.

 

Yes, we are confronted yet again with the issue of innovator liability.  Under Erie, the federal court needed to determine the substantive law of the forum, New York.  The New York Court of Appeals has not yet addressed whether a manufacturer of a name-brand prescription drug can be held liable for injuries resulting from another company’s generic equivalent. But there is at least one federal case, Goldych v. Eli Lilly & Co., No. 04 Civ. 1477 (GLS)(GJD), 2006 WL 2038436 (N.D.N.Y. July 19, 2006), and one New York state case, Weese v. Pfizer, Inc., 2013 N.Y. Misc. LEXIS 4761, 2013 N.Y. Slip Op. 32563 (Sup. Ct., N.Y. Cty. Oct. 8, 2013), rejecting innovator liability.  Those two New York decisions are in accord with the majority of courts to consider the topic: fifty-five other state courts across twenty-one states, in addition to all six circuit courts of appeal, have ruled that innovator liability makes no sense.  See our general innovator liability posts here and here. The Conte decision in California, which applied such innovator liability, stands as an egregious, eccentric exception.   The Coleson court acknowledged that there are a couple of cases clumsily following Conte, but the Coleson court declined to join the heresy.

 

Supporting its decision, the Coleson court discussed a recent asbestos case that, at first blush (but only first blush) seemed to offer some hope for the plaintiff.   Last year, in In re N.Y. City Asbestos Litig., 27 N.Y.3d 765, 59 N.E.3d 458 (2016), the New York Court of Appeals held that manufacturers had a duty to warn of potential dangers resulting from their products’ use in conjunction with third party products. To support this interpretation, the asbestos court observed that the manufacturers had “knowledge and ability to warn of the dangers” when consumers used the product with a third party’s product. As we discussed at the time, here, that is quite a bit different from being required to warn about use of a competitor’s product, when the defendant’s own product was not being used at all.  The Coleson court reasoned that the asbestos ruling was unlikely to make “the cost of liability and litigation . . . unreasonable”  and, moreover, the manufacturers “derive[d] a benefit from the sale of the [other party’s] product.” This rationale weighed in the opposite direction in Coleson. The brand defendants “had no oversight in the manufacturing of the generic drugs. They earned no profit from the sale of the generic drugs. Given the length of time generic drugs can sell following a patent’s expiration, to find a new duty would unforeseeably expand the cost of liability on brand-name drug manufacturers.”  Coleson, 2017 U.S. Dist. LEXIS 68072 at *10.  

 

Goodbye failure to warn claim.  The plaintiff’s failure to warn claim was dismissed because he alleged a warning defect as to only risperdone, over which the defendants had no duty of care.

 

The Coleson plaintiff’s design defect claim also failed.  He could not show by a preponderance of the evidence that he ever ingested name-brand Risperdal. The plaintiff’s declaration and deposition stated that he was prescribed, amongst other drugs, “Risperdal (risperidone)” and that a hospital in 2009 or 2010 dispensed “Risperdal and/or risperidone.” The plaintiff also claimed that hospital records proving he actually received Risperdal in the hospital were likely destroyed by a fire in January 2015. [We know some especially nettlesome plaintiff lawyers who would turn this misfortune into a spoliation claim, but the pro se plaintiff lacked either the expertise or chutzpah to pursue that vexatious path.] It was true that the plaintiff’s medical records at times recorded his prescription as only for Risperdal.  But generic risperidone is regularly written as “Risperdal (risperidone),” a nomenclature even the plaintiff repeatedly adopted in his papers.  That a drug is prescribed under its brand-name does not mean that a patient receives that name-brand drug, and it is hardly justifiable to infer that it does. In the absence of real evidence, the Coleson court was unimpressed by the plaintiff’s “mere speculation or conjecture” as to Risperdal usage.  Coleson, 2017 U.S. LEXIS 68072 at *11.

 

But let’s for the moment speculate that a “fair-minded jury” could speculate that the plaintiff was prescribed brand name Risperdal somewhere in the relevant time-frame. And yet it was undisputed that by 2009, when the plaintiff was first prescribed the medicine, risperidone was a widely available generic to Risperdal. It was also undisputed that all of the plaintiff’s prescriptions were paid by Medicaid.  Aside from exceptional circumstances the plaintiff never showed, the plaintiff’s prescriptions under Medicaid needed to be filled with generic drug equivalents. Thus, from the evidence presented, no jury could draw the “justifiable inference” that the plaintiff received name-brand Risperdal for his prescriptions. There might well have been an inference of injury from ingestion of risperdone, but the Coleson plaintiff had not sued the generic manufacturer.  Id. at *12.

 

Even assuming that the plaintiff had ingested Risperdal, his design defect claim against the defendants would still fail because he could not establish that Risperdal caused his gynecomastia. The Coleson court embraced the requirement in products liability cases that, to establish causation, plaintiffs must offer admissible expert testimony regarding both general and specific causation. The requirement is particularly pertinent where a causal link is beyond the knowledge or expertise of a lay jury.  In the Coleson case, there was no such expert in sight. Id. at *13.   

 

The plaintiff suggested he did not need an expert on causation when he had something even better:  the Risperdal label.  That label contains a warning regarding gynecomastia.  The plaintiff also pointed to a  July 2015 medical report, which concluded that the plaintiff’s gynecomastia “is related to phychiatric [sic] medical ingestion.”  The court did not buy either of these arguments.  First, Risperdal’s warning label cannot establish general causation: “Product warning labels can have over-inclusive information on them, often out of ‘an abundance of causation or the avoidance of lawsuits.’  Coleson, 2017 U.S. Dist. LEXIS 68072 at *14 (quoting In re Mirena IUD Prods. Liab. Litig., , 202 F. Supp. 3d  304, 323 (S.D.N.Y. 2016)).  Unless a warning label specifically says that an alleged injury can be caused by a drug, courts have held that a drug’s product warning label alone cannot “raise a genuine issue of material fact with respect to general causation.”  Id. Risperdal’s label states merely that it “elevates prolactin levels” and that “gynecomastia . . . ha[s] been reported in patients receiving prolactin elevating compounds.” This information is not the same as an admission of “a genuine phenomenon” creating a “material fact with respect to general causation.”

 

Nor did the Coleson plaintiff’s July 2015 medical report establish proximate cause. The plaintiff claimed to have taken Risperdal around only 2009-10. Throughout 2010 to 2014, the plaintiff took risperidone. In early 2014, the plaintiff switched to a different antipsychotic, which is also associated with cases of gynecomastia. The plaintiff was diagnosed with gynecomastia only in early 2015, and the medical report to which the plaintiff points indicates the plaintiff had taken both risperidone and the other antipsychotic. This report does not state which, if any, of these drugs was responsible for the plaintiff’s injury. Without competent medical expert testimony on the issue of causation, a jury would be left only to “theorize” as to how the plaintiff came to suffer from gynecomastia. Id. Accordingly, the defendants’ motion for summary judgment was granted.

 

So what we have here is a good result from a smart court.  That decision was made a bit easier because a pro se plaintiff sued the wrong party, hired no expert who would render some frail opinion on ‘substantial causative factor,’’ and failed to assemble decent evidence of usage.  What’s that saying about someone who acts as his own lawyer?

 

 

 

However a drug/device product liability is styled, it will almost always be focused on a claim of failure to warn.  Why do plaintiffs insist on inserting a cause of action for manufacturing liability when there is not a whiff of evidence that anything went wrong on the production line?  Seldom do we see the pharma equivalent of a mouse in the Coke bottle or, thinking of a more recent case, a bat in the salad.  Similarly, a design defect claim is often a make-weight claim.  How should the design have been improved?  Not selling the product at all is hardly a design improvement.  An entirely different product is not a safer alternative under the law of any enlightened state.  Changing the molecule or the device design cannot be done without FDA approval, so preemption should apply (even if courts often miss this point).  No, failure to warn is where the action is.  In the wake of Wyeth v. Levine, it seemed that preemption would be a tough row to hoe in such cases, but keep hoeing that row because the preemption defense might still be available – as a motion to dismiss, summary judgment motion, directed verdict, or argument to the jury.

 

The recent case of Amos v. Biogen Idec, Inc. et al., 2017 WL 1316968 (W.D.N.Y. April 10, 2017), makes every one of these points for us.  The court granted summary judgment to the defendants in that case, holding that all of the claims were fundamentally about failure to warn, the warning was adequate as a matter of law, and the FDA’s earlier rejection of proposed warnings meant that the plaintiff’s claims were preempted.  The facts of Amos present the sort of situation defendants encounter all too often, but which make for a hard sell to a jury: something very sad happened to an innocent patient, but it was nobody’s fault.  The patient had Multiple Sclerosis too severe to respond well to the usual treatments.  Her doctor recommended Tysabri.  That medicine came with a black box warning that it might increase the risk of Progressive Multifocal Leukoencephalopathy (“PML”), a viral infection of the brain that is as incurable as MS is.  The patient eventually contracted PML and died.  Her estate filed a lawsuit that included claims for negligence, negligent misrepresentation, strict liability, and breach of implied warranty. 

 

From the recital of facts in the Amos case, it appears that the manufacturer of Tysabri was quite diligent and proactive.  It also appears that the defense attorneys did an excellent job of mining the administrative record.  The manufacturer continued to perform clinical trials after initial approval, and promptly alerted the FDA of whatever risks it observed.  Among other things, the company asked the FDA to add information in the label about screening for certain virus antibodies that might increase the risk of PML.  The FDA rejected this proposal a couple of times, finding insufficient evidence at those times to support the label change.  The FDA ultimately relented and approved a label change in 2012 – after the plaintiff’s decedent died.

 

In considering the defense motion for summary judgment, the court concluded that all of the plaintiff’s claims turned on the sufficiency of the warnings.  New York law applied, and there was ample precedent under New York law that adequate warnings precluded claims for negligence, strict liability, breach of warranties, or fraud.  What’s more, the learned intermediary applied to claims regarding prescription drug warnings, and the record was replete with evidence that the prescribing doctor was well aware of the increased risk of  PMI.  It certainly helped the defense that the defendant, in collaboration with the FDA, had created a program called Tysabri Outreach: Unified Commitment to Health (“TOUCH”), which required that, prior to prescribing Tysabri, a physician had to acknowledge in writing that he/she understood the risks of PML and obtained a written acknowledgment from the patient that the patient understands the PML risk. The existence of the TOUCH program was one of several facts that made Amos a hard case for the plaintiff to win.

 

Even so, we all know that no matter how comprehensive and informative a warning label is, a good plaintiff lawyer can flyspeck it and find, or make up, some gaps.  The plaintiff lawyers in the Amos case are well known to us, and are very, very good.  They argued that the Tysabri warnings were inadequate because they failed to include information regarding the correlation between the virus antibodies and PML, and failed to inform doctors of the risks associated with duration of treatment and prior treatment with an immunosuppressant.  To our eyes, the plaintiff lawyers made the best arguments they could.  In too many courts, such an argument would furnish enough of a crutch for a plaintiff-leaning (or lazy-leaning) judge to mutter ‘factual dispute’ and deny the motion in a post-card ruling.  But not this court.  The judge analyzed New York law and held that even without the details regarding specific risk factors, “when read as a whole, the warnings unmistakably conveyed the seriousness of PML and its association with Tysabri treatment.”  That “read as a whole” point is important.  Do not let a court tell you that it is the jury’s duty to read the warnings as a whole.  It is the court’s job to assess whether the warning is adequate as a matter of law, and plaintiff post hoc fly-specking should not be enough to plant a case in front of twelve citizens good and true (and half-asleep and inflamed with sympathy and anti-corporate hatred).    

 

Even aside from the conclusion that the Tysabri warnings were adequate as a matter of law, the court offered an alternative basis for dismissing the case:  the claims were preempted as a matter of law.  Wyeth v. Levine ruled against preemption on the (at least partially specious) ground that drug companies can unilaterally ramp up warnings through the Changes Being Effected (“CBE”) process.  But the Amos court accurately observed that CBE is not available in all situations, and definitely is not available to add or change a black box warning, which is what was at issue in this Tysabri case.  Moreover, “the evidence of record leads inescapably to the conclusion that the FDA would not have approved a change to Tysabri’s label prior to 2012.”  With respect to Tysabri, there were two “smoking gun” rejections from the FDA. 

 

Also notable in Amos:  a second defendant in the case, a distributor of Tysabri, received summary judgment on preemption grounds.  The distributor did not own the drug’s New Drug Application, and thus had no power under the FDA scheme to alter warnings in any way.  The distributor’s inability to act independently to change warnings meant that, under the Mensing and Bartlett decisions, all claims against it were preempted.

 

There have been other cases around the country where courts arrived at similar rulings that Tysabri warnings were adequate as a matter of law and that failure to warn claims were preempted.  Perhaps plaintiff lawyers will do their best to distinguish these cases on their facts.  We will, doubtless, hear that “smoking gun” has become the standard for the Wyeth v. Levine “clear evidence” standard. We heard something nearly as silly from our home appellate court recently.  But reading the Amos case in the same way that the Amos court read the Tysabri label – as a whole – there is an awful lot of comfort in that case for drug and device defendants.

   

 

The recent decision of the New York Court of Appeals in In re New York City Asbestos Litigation, ___ N.E.3d ___, 2016 WL 3495191 (N.Y. June 28, 2016) (“NYCAL”), was not too good for asbestos defendants – as it permitted, under certain circumstances, non-manufacturers to be sued for failure to warn of a risk that the product they manufactured didn’t have (exposure to asbestos), where they “encourage[ed]” the use of products containing that risk with their products and thereby benefitted economically:

[A] manufacturer’s duty to warn of combined use of its product with another product depends in part on whether the manufacturer’s product can function without the other product, as it would be unfair to allow a manufacturer to avoid the minimal cost of including a warning about the perils of the joint use of the products when the manufacturer knows that the combined use is both necessary and dangerous. And, the justification for a duty to warn becomes particularly strong if the manufacturer intends that customers engage in the hazardous combined use of the products at issue.

*          *          *          *

[W]here a manufacturer creates a product that cannot be used without another product as a result of the design of the product, the mechanics of the product or the absence of economically feasible alternative means of enabling the product to function as intended, the manufacturer has a substantial, albeit indirect, role in placing the third-party product in the stream of commerce. . . .  Specifically, when the manufacturer produces a product that requires another product to function, the manufacturer naturally opens up a profitable market for that essential component, thereby encouraging the other company to make that related product and place it in the stream of commerce.

NYCAL, 2016 WL 3495191, at *__ (for some reason there is no Westlaw star paging at the moment).  This opinion is very bad news for the affected companies, who are now sucked into the maw of interminable asbestos litigation on the basis of products they didn’t even make, but it should not open the door to innovator liability type claims against our medical product manufacturer clients, and it’s good on causation, too.

Here’s why.

Continue Reading New York Decision Not Good For Asbestos, But Not Bad For Drug/Device

This post comes from the Cozen O’Connor side of the blog.

Last week, the New York Appellate Division upheld a preemption decision in a medical device case involving alleged off-label promotion. Pitkow v. Lautin, 2016 WL 2746469 (N.Y. App. Div. May 12, 2016). While the Appellate Division’s opinion was only three-paragraphs long, it affirmed the trial court’s ruling in every respect, making the trial court’s lengthier opinion that much more important. We obtained a copy, and here it is.

The plaintiff’s claims were based on complications that arose after her use of an injectable product, Sculptra, for cosmetic purposes, which was an off-label use. Plaintiff sued the doctors who injected her and the manufacturers of Sculptra. Among other things, she alleged that the manufacturers had improperly promoted off-label use of Sculptra.

After discovery, the manufacturers moved for summary judgment, arguing that all of plaintiff’s claims were preempted. The trial court agreed and, quite effectively, walked through the manner in which both Riegel and Buckman preempted plaintiff’s claims as well as the deficiencies of plaintiff’s attempts at parallel violation claims.

First up was Riegel preemption, since Sculptra was approved under the FDA’s PMA process:

Sculptra is a Class III medical device that was undeniably approved through the PMA process. What is more, all of the plaintiff’s claims against the [manufacturers] regard the safety and effectiveness of the device or require a finding that Sculptra’s design, labeling, and/or manufacturing process should have differed from that approved by the FDA via the PMA process . . . . Thus, the claims are preempted by the federal law.

Slip. Op. at 8-9.

Continue Reading New York Appellate Division Rejects Parallel Violation Claims Based on Off-Label Promotion