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

In third party payor litigation over prescription medical products, we have often marveled at the causation arguments that plaintiffs have offered and the willingness of some courts to accept collective proof over what really should involve individualized proof. Like here, here and here. (This same dynamic plays out when governmental entities seek reimbursement for such products too.) Usually, though, the plaintiffs allege that the manufacturer’s fraud—under whatever particular statutes or headings it is pursued—was unknown to them during the time for which they seek damages for amounts paid for the product and that the damages stopped once they found out. In Teamsters Local 237 Welfare Fund v. Astra-Zeneca Pharms. LP, No. 415, 2015, 2016 Del. LEXIS 236 (Del. Apr. 12, 2016), the plaintiff payors were undone by their concession that they knew about the alleged fraud and kept paying for the drug at issue anyway. Based on its self-described common sense analysis, the Delaware Supreme Court affirmed the dismissal for lack of causation without weighing in on the Superior Court’s rejection of causation where individual physicians made individual decisions about what to prescribe. This is a good result, but we are concerned about the implications for the practices of payors who seem increasingly interested in signing up with contingency fee lawyers to sue medical product manufacturers. (In case you were wondering, that was a teaser, designed to get you to read all the way to the end of the post.)

The basic facts are that the plaintiff filed a purported nationwide class action on behalf of third-party payors in Delaware state court in 2004, alleging that the defendant violated state consumer fraud laws by falsely marketing Nexium as being more effective than Prilosec, an older product with allegedly one-half of the same active ingredient per dose. Adding some facts omitted in the opinion, the initial NDA for Prilosec had been approved in 1989 (under the name Losec) and lost exclusivity in 2001, around which time FDA approved the NDA for Nexium, which had an enantiomer (here, the left hand chiral image) of the Prilosec’s active ingredient as its active ingredient. The indications for both drugs were expanded through the years, with Prilosec going over-the-counter in 2015. These drugs together accounted for a large chunk of the prescriptions written for heartburn, gastroesophageal reflux disease, and related complaints. Plaintiffs claimed that the development of Nexium and the marketing campaign after its introduction were designed to get the defendant paid a high price for its newer branded product instead of money going to pay for cheaper generic versions of the older product. They claimed they had been harmed by paying for the Nexium prescribed by physicians for the patients participating in their plans. The same group of lawyers apparently filed other “essentially identical class actions” with different sets of named plaintiffs, including one in Delaware federal court that resulted in the dismissal of a New York consumer fraud claim. Ignoring some history and details much like the plaintiffs ignored the marketing for Prilosec over the last fifteen years and the difference between a racemic mixture and an enantiomer, the Delaware state court action woke up from a long slumber in 2014 with its second amended complaint asserting the same claims the federal court had disposed of a few years before.

The Superior Court first determined that the law of New York, where the named plaintiffs were based, applied instead of the law of Delaware, where the defendant was based, or the laws of thirteen other states. Id. at *9. The court found that plaintiffs had not alleged the causation required for a consumer fraud claim: the “purported chain of causation that runs from the allegedly deceptive advertisements that may have influenced the decisions of individual doctors to prescribe a drug to their patients to causally affect the payer unions in this case is simply too attenuated,” as the doctors would be “presumed to go beyond advertising medium and use their independent knowledge in making medical decisions.” Id. at **9-10. We certainly like this reasoning, which would apply to a bunch of these cases. We also like that the court did not give plaintiffs a fourth chance to frame a complaint that stated a claim.

Continue Reading TPPs Fail to Put Their Money Where Their (Litigation) Mouth Is and Lose

Every now and then even Bexis comes across a decision involving legal propositions he’d never heard of before. Such was the human tissue case Kennedy-McInnis v. Biomedical Tissue Services, Ltd., No. 13-CV-6545, slip op. (W.D.N.Y. April 12, 2016). Kennedy-McInnis introduced us to the common-law “right of sepulcher” – and more importantly to the defenses, including broad “good faith “ immunity, that limit this little known “right.”

First, why should anybody interested in drug/device product liability care? The answer is that a lot of products, particularly implantable medical devices, are used in conjunction with so-called “allograft bone.” As everyone knows, many other types of tissue are transplanted as well. Other medical devices, and some drugs, are typically used in conjunction with – or to support transplants of – various types of human tissue that doctors and hospitals typically obtain from tissue banks. Human tissue used in this manner can be extremely medically beneficial – and anything so beneficial is potentially worth a great deal.

Anything that’s worth a great deal creates a market for itself, and in our market-based society, there is always temptation for somebody in the chain of distribution to cut corners. When that happens, we’ve seen product manufacturers end up getting sued. Thus, we have blogged several times about litigation involving human tissue incorporated into certain medical devices, and allegations that fly-by-night (and convicted) intermediaries hadn’t bothered testing the tissue in question for communicable diseases. Ultimately, the litigation fizzled because, as bad as the intermediaries’ conduct had been, plaintiffs couldn’t prove that it actually caused anybody to get sick.

Continue Reading Learning Something New – Limits To Human Tissue Liability

Not so long ago in a Circuit not so far away, the issue of whether design defect claims against branded prescription drug manufacturers are preempted was joined.  Much like the origins of the Jedi or the major end-of-year holidays as we know them, one would expect a clearer published record of how this came to be.  There can be a tendency to read back from recent experience and imbue our past selves with more knowledge or foresight that we actually had.  For preemption of design defect claims against branded prescription drug manufacturers, we know we have been arguing for it for years and we are not quite sure why it took so long for a Circuit Court to adopt it.  As we noted a few weeks ago, Yates v. Ortho-McNeil-Janssen Pharms., Inc., No. 15-3104, 2015 U.S. App. LEXIS 21428 (6th Cir. Dec. 11, 2015), did find preemption, and did it pretty definitively.  So definitively that it took our spot as top decision of 2015.  Along the way, the court declined to follow a prior decision of the same court, Wimbush v. Wyeth, 619 F.3d 632 (6th Cir. 2010), which itself reversed decisions of the trial court in Longs v. Wyeth, 536 F. Supp. 2d 843 (N.D. Ohio 2008) (granting summary judgment), and Longs v. Wyeth, 621 F. Supp. 2d 504 (N.D. Ohio 2009) (denying motion to alter judgment), each of which included the holding that pre-approval design defect and negligence claims were preempted.  It is with the Longs/Wimbush decisions where our story starts, subject to some back story and with a healthy dose of links to past posts.

We first note, however, that it has long been our view, expressed in many posts and elsewhere, that design defect does not make much sense as a theory of liability for a prescription drug.  In most cases, what the plaintiff alleges made the drug excessively risky and thus defectively designed cannot possibly be changed without making it a different drug.  One of the principles of pharmacology is that changes to the chemical compound will typically affect both the desired and undesired effects in the body–or as the Supreme Court observed in Bartlett, “because of [a drug’s] simple composition, [it] is chemically incapable of being redesigned.”  133 S. Ct. 2466, 2475.  Rarely, a true change to the “design” of the active compound can be identified—maybe chop off this ethyl group or change it from a racemic mixture to a stereoisomer—that will plausibly reduce the pertinent risk, while maintaining benefits and avoiding new risks.  Even where that kind of proposed design change exists, the change would make the drug a different product, not a better version of the same product, which is what design defect is supposed to be about.  There may be some cases where a plaintiff claims that a different balance of a combined drug’s ingredients, or an
inactive ingredient, or the delivery system should be changed to reduce the risk without making it a different drug. Even those cases, though, seem better suited to warnings-based claims.

Continue Reading The Saga of Preempting Prescription Drug Design Defect Claims