Today Time Magazine announces its Person of the Year.  The publisher called us a week or so ago to say we were PROBABLY going to be named Man (Person) (Blog) of the Year, but we would have to agree to an interview and a major photo shoot.  We said “probably” is no good and took a pass. Thanks anyway!

[None of that actually happened.  You might even call it fake news.]

Still, we can see why this blog would receive a major award for its literary achievements.  We admit that we are not quite on the same level as, say, James Joyce’s Ulysses, which 84 years ago on this date was found by an SDNY judge not to be obscene.  We also must ruefully acknowledge that our case analyses are not as funny and transgressive as Lolita, which Vladimir Nabokov completed 64 years ago on this date.  But we have occasionally encountered preemption issues as mystifying as Ulysses and plaintiff pseudo-experts who made the unhinged Humbert Humbert character in Lolita seem rational.

If there is a product liability issue that lends itself to literary invention, it is the issue of warnings.  All that even a minimally creative plaintiff lawyer needs to do is parse an existing warning, then dream up some specification or adjective that would frighten doctors or patients just a tiny bit more.  Stephen King is a fine writer, and odds are that he could do a splendid job of boosting terror in both warning labels and failure to warn claims. Of course, let’s remember that we are talking about fiction.

It is not fictional that there are many assorted asinine warning labels out there based on fear of lawsuits.  A hairdryer bears a warning against use by folks “while sleeping.” A tag on an iron helpfully advises against ironing clothes while worn on the body.  A bag of peanuts cautions us that the product … contains nuts.  The instructions for a chainsaw counsel against trying to stop the chain with one’s hands. An over-the-counter bottle of sleeping pills lists possible side effects, including … drowsiness.

There is more than a little fiction at work in the failure to warn claim in Cerveny v. Aventis, Inc., 2017 U.S. Dist. LEXIS 197194 (D. Utah Nov. 29, 2017).  You may remember the name Cerveny.  This litigation has already produced one of the best decisions of 2017.  The crux of this latest Cerveny decision was the fiction that the plaintiffs’ proposed warning would pertain to the plaintiffs. The court ultimately arrives at a sensible ruling on inapplicability of a warning about a risk to a population group that did not contain the plaintiffs.  The court also makes clear that in fraud/negligent misrepresentation claims, a contraindication is not intended to induce reliance.

The plaintiffs in Cerveny were the parents and their child, who was born with certain physical defects.  The mother had taken a prescription fertility drug before pregnancy, but not during the pregnancy.  That rather obvious and fundamental temporal fact is central to the case. The FDA at one point proposed a warning of possible fetal harm when the drug is taken during pregnancy.  That warning was not on the medicine when taken by the mother in this case, and one of the claims was that it should have been.  The failure to warn claim was essentially that the future mother would not have taken the medicine before pregnancy if she knew that taking it during pregnancy could cause birth defects.

Courts all too often are all too tolerant of plaintiff failure to warn theories.  Those claims all contain a dose of speculation, but some are speculative to the point of implausibility. It might be tempting for the court to pass the question, no matter how absurd, to the jury.  Not the Cerveny court: “When a proposed warning does not apply to the plaintiff, she cannot prove defect or inadequacy.”  The Cerveny court quotes from Rivera v. Wyeth-Ayerst Labs, 283 F.3d 315, 321 (5th Cir. 2002), which rejected as “absurd,” and “too speculative to establish Article III standing” a claim based on an allegation that an “extra warning, though inapplicable to [the plaintiff] might have scared her and her doctor” from using the drug.  Cerveny and Rivera recognize that there must be a limitation to how speculative a  failure to warn theory can be, and that Article III standing must actually mean something.  Accordingly, the Cerveny plaintiffs cannot prevail on a cause of action based on a failure to warn about the risk of a medicine used during pregnancy when the use in the case was only prior to pregnancy.  That is a notable result.  We already have a post collecting opinions that likewise reject warning claims based on inapplicable risks.

There was another ground for rejecting the failure to warn claim.  The label for the drug might not have contained an express warning, but it did contain a contraindication vs. use during pregnancy.  So if that is what the plaintiffs claim needed to be said, it was said in the contraindication section, and that is enough.

What about the plaintiffs’ misrepresentation claims?  The contraindication discussed above also said that “no causative evidence of a deleterious effect” of the medicine on the human fetus had been seen. The plaintiffs contended that the “no causative evidence” language was false.  But even if that is so, the contraindication was not directed to the plaintiff, and it was not intended to induce her to take the medication.  The purpose of the contraindication was to inform doctors that their pregnant patients should not take the medicine.  The plaintiff was simply not in that category. The failure to warn theory conjured up by the plaintiff lawyers was clever and creative, but it was also wrong.

And it’s the start of another season of too much eating, drinking, shopping, and socializing. Sometimes it feels like a year’s worth cramped into a little over a month. And, for some of us (OK, me), we’re entering this week still a little groggy and foggy. So, we’ll admit to looking for something fairly straightforward and on the shorter side to post about as we clear our heads and shake off the haze. That’s not to say Mitchell v. Boehringer Ingelheim Pharma, Inc., 2017 U.S. Dist. LEXIS 192498 (W.D. Tenn. Nov. 21, 2017) isn’t noteworthy, it’s just not overly complicated. Sometimes that’s what you need to get the ball rolling again.

Plaintiff in Mitchell alleged that she suffered diabetic ketoacidosis (“DKA”) as a result of using the prescription drug Jardiance to treat her type-2 diabetes. Id. at *3. The drug, one of a class of drugs known as SGLT-2 inhibitors, was approved by the FDA in August 2014 and plaintiff began using it in February 2015. In May 2015, the FDA issued a safety alert warning about the risk of DKA with this class of drugs. The alert was based on a review of adverse event reports collected from March 2013 to June 2014 – before Jardiance was approved. Id. at *3-4.

Products liability claims in Tennessee are governed by the Tennessee Products Liability Act. Under the TPLA, drug manufacturers have a duty to minimize the risk or dangers from their products and they can discharge that duty by providing adequate warnings and instructions. Id. at *7. Plaintiff in Mitchell alleged defendant failed to satisfy that duty because it did not warn about DKA at the time the drug was approved and did not amend the warning via the FDA’s Changes Being Effected (“CBE”) process at any time before plaintiff was injured. Id. at *4.

We see CBE and we immediately start looking for a preemption discussion. Sure enough, there is one. As discussed here many times before, the CBE process allows a manufacturer to add or strengthen a warning based on “newly acquired information” without first obtaining FDA approval. Id. at *9-10. Where a CBE label change is an option for a manufacturer, the Supreme Court has held that failure to warn claims are not preempted. See Wyeth v. Levine, 555 U.S. 555 (2009).

But what about when a CBE is not an option? In Mitchell, the court broke the plaintiff’s failure to warn claim into two pieces – a challenge to the original labeling and a challenge to warning as it was at the time plaintiff used the drug. The court found the former preempted because defendant could not have changed the original FDA approved labeling. The data plaintiff relied on to support her allegation on this claim was pre-launch data. In other words, data that was known to the FDA at the time they approved the drug’s warnings – not newly acquired. “[T]he FDA is the exclusive judge of safety and efficacy based on information available at the commencement of marketing.” Id. at *11 (citing  In re Celexa & Lexapro Mktg. & Sales Practices Litig., 779 F.3d 34, 41 (1st Cir. 2015).

Similarly, plaintiff cannot base her failure to warn claim challenging defendant’s failure to amend the warning after the drug was introduced on the market on information that existed pre-FDA approval. Id. at *13. So plaintiff cannot rely on the adverse events collected before June 2014. Plaintiff’s allegations must be based on information that was not known by the FDA at the time of approval. In her complaint, plaintiff alleged that additional DKA adverse events were reported in 2015. Defendant, citing federal regulations, argued that while later in time, the additional reports did not provide any “new” information that would support a CBE. The court determined that was an issue better suited to a motion for summary judgment and that plaintiff had done enough to withstand a motion to dismiss. Id. at *15. Not a win yet, but the door is certainly still open.

The court made a few other rulings as well. Based on the learned intermediary doctrine, plaintiff cannot bring a failure to warn claim premised on failing to warn plaintiff directly. She is limited to a claim for failure to warn her prescriber. Id. at *17-18. And plaintiff must plead warning inadequacies with specificity. The court determined her allegations as to DKA were sufficient. But, plaintiff failed to state a claim to the extent she was looking to recover for “other related health complications.” Id. at *22. Plaintiff’s complaint neither specified the alleged complications nor how the drug’s warnings were inadequate as to those complications. So, as to unspecified complications, the failure to warn claim was dismissed.

In the end, plaintiff is left with a narrow failure to warn claim and the hurdle of proving proximate cause.

We remember how, shortly after the atrocious decision in Johnson & Johnson v. Karl, 647 S.E.2d 899 (W. Va. 2007), rejecting altogether the learned intermediary rule, litigation tourists visiting West Virginia argued that Karl represented that state’s “public policy” and therefore the learned intermediary rule could not apply even to their out-of-state cases under the “public policy” exception to the ordinary rules for sorting out choice of law issues.  This was also back in the halcyon days (for the other side) of essentially unlimited plaintiff forum shopping pre-Bauman, so the specter existed that, if this argument succeeded, plaintiffs from all over the country, or even the world, would flock to West Virginia, and by the mere fact of their litigation tourism, thereby rid themselves of one of our side’s most significant arguments.

A couple of West Virginia federal courts were sufficiently pro-plaintiff to buy that “public policy” choice-of-law analysis.  Woodcock v. Mylan, Inc., 661 F. Supp.2d 602, 609 (S.D.W. Va. 2009) (“[b]ecause West Virginia has rejected the learned-intermediary doctrine on public-policy grounds and applying Alabama law to the marketing defect claim would violate that public policy, West Virginia law applies to that claim”); Vitatoe v. Mylan Pharmaceuticals, Inc., 696 F. Supp.2d 599, 610 (N.D.W. Va. 2010) (“it is impossible to apply the substantive law of Louisiana to [plaintiff’s] inadequate warning claim without violating West Virginia public policy”; following “Woodcock’s helpful public policy analysis”).  For doing this, we trolled Woodcock with eighth place on our 2009 bottom ten decisions list:

This decision invoked “forum public policy” to apply West Virginia’s rejection of the learned intermediary rule to a forum shopping plaintiff from Alabama – a staunch learned intermediary state.  That can’t be right.  Practically all major tort law doctrines are grounded in a court’s sense of “public policy.”  Thus the “forum public policy” exception (previously limited to legislatively set policy) becomes another constitutionally suspect means of applying forum law to cases with no significant ties to the state in question.  Any other forum shopper can presumably make the same argument. We’re sure we haven’t seen the last of this.  We blogged about Woodcock here.

Fortunately, the West Virginia legislature stepped in and did the right thing, making its own declaration of West Virginia public policy in 2011:

Choice of Law in Pharmaceutical Product Liability Actions.

It is public policy of this state that, in determining the law applicable to a product liability claim brought by a nonresident of this state against the manufacturer or distributor of a prescription drug for failure to warn, the duty to warn shall be governed solely by the product liability law of the place of injury (“lex loci delicti”).

W. Va. Code §55-8-16(a).  We cheered that development here.

Of course, the entire Karl learned intermediary brouhaha became moot (or so we thought) several years later when the legislature did themselves one better and directly overruled Karl on the merits.  See W. Va. Code 55-7-30 (restoring the learned intermediary rule).  Even more vigorously, we cheered on that development – after the fact, of course, since we made sure not to breathe a word about this before it was a done deal (we know the other side reads our blog, so there are some things we do keep quiet about).

Given this background, it is with no small degree of schadenfreude that we bring to you M.M. v. Pfizer, Inc., ___ S.E.2d ___, 2017 WL 5077106 (W. Va. Nov. 1, 2017).  M.M. involved the West Virginia sojourn of other litigation tourists, this time from Michigan.  Id. at *2.  Michigan, as anyone involved in the defense of prescription medical product liability litigation knows, has a statute that provides the strongest FDA compliance defense in the country (although Texas is close):

In a product liability action against a manufacturer or seller, a product that is a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable, if the drug was approved . . . by the [FDA], and the drug and its labeling were in compliance with the [FDA’s] approval at the time the drug left the control of the manufacturer or seller. . . .

Mich. Comp. Laws Ann. §600.2946(5).  As we’ve mentioned before, that statute has produced a “diaspora” of Michigan plaintiffs all running away from the policy judgment made by the legislature of their chosen state of residence.  Those prior plaintiffs didn’t have much luck, and as it turns out, neither did this one.

This time, even if West Virginia courts might have been inclined to cut the Michigan plaintiffs a break, they ran headlong into the West Virginia choice-of-law statute mentioned above.  Even though it was passed to overturn half-baked Karl-based “public policy” determinations, the statute’s literal terms establish West Virginia choice of law “public policy” as to all prescription drug warning cases.  Thus, the M.M. plaintiff – despite having nothing to do with Karl – was entirely out of luck.  “Here, there is no dispute that the injuries alleged by [plaintiffs] all occurred in the State of Michigan.  Thus, [the] failure to warn claim is governed by Michigan law, which forecloses such a claim if the drug was approved by the FDA and the manufacturer complied with the FDA’s labeling requirements.”  2017 WL 5077106, at *3 (also discussing why fraud-on-the-FDA exception to statute doesn’t apply).  Thus, “Michigan law forecloses [plaintiffs’] failure to warn claim.” Id. Interestingly, the court added:

To recognize such a claim under West Virginia law where the same already is foreclosed in the same case by the law of another jurisdiction, however, would contradict the full faith and credit due our sister jurisdictions.

Id. (citations omitted).  “Full faith and credit”?   We confess we haven’t seen that much, indeed ever, before in prescription medical product liability litigation, but anything that keeps a plaintiff from relitigating something they’ve already lost finds favor here.

Unfortunately for these plaintiffs, they were also entirely unable to come up with any defect claim that wasn’t really a statutorily covered warning claim.  “[B]oth the strict liability and negligence claims allege that [defendant] improperly failed to include . . . warnings on its labeling, which, again, constitute allegations that [defendant] failed to warn.”  Id. at *4.  Even if West Virginia law could apply, the choice-of-law statute meant that West Virginia law kicked things back to Michigan, and was “foreclosed thereby.”  Id.  Both their strict liability and negligence claims, although making boilerplate allegations, were “merely a restatement of [plaintiffs’] failure to warn claim,” id. (strict liability), or “merely a reiteration of [plaintiffs’] failure to warn claim.”  Id. at *5 (negligence).  Any way one looked at the case, plaintiffs alleged only a failure to warn, and failure to warn claims had to be determined by Michigan law, where plaintiffs lost.

[B]ecause [plaintiffs’] failure to warn claim is governed by Michigan law, and the governing Michigan statutes provide that a manufacturer cannot be held liable where it has complied with the FDA reporting, disclosure, and labeling requirements, there exists no duty that could have been breached so as to establish a claim for negligence.

Id. at *5.

Now that BMS has pulled the welcome mat away from litigation tourists, we don’t expect much more of a Michigan diaspora, but even if there were, the West Virginia choice-of-law statute, enacted for an entirely different purpose, will preclude any of them from relying on more favorable West Virginia law.  See Id. at *3 n.2 (noting that §55-8-16(a) has since been expanded so that it applies to “all liability claims at issue,” not just warnings).

In the mass torts world in which we find ourselves, glimmers of jurisprudential light can seem few and far between. Two things we love are good warnings causation decisions and sneaky plaintiffs getting caught at their own games.  Today’s case has both.  In Thompson v. Janssen Pharm., Inc., 2017 WL 5135548 (C.D. Cal. Oct. 23, 2017), the court considered simultaneous motions:  the plaintiffs’ motion for voluntary dismissal without prejudice and the defendants’ motion for summary judgment.

The plaintiff began taking Risperdal in 2001 after he was diagnosed with tics and other disorders, and he alleged that the drug caused him to develop gynecomastia (breast enlargement). Nevertheless, he continued – and continues – to take Risperdal (sixteen years, five doctors, and counting) because it effectively controls his tics, notwithstanding his alleged gynecomastia, his lawsuit, and his doctor’s recommendation that he stop taking the drug.

The Plaintiffs’ Motion for Voluntary Dismissal without Prejudice

The plaintiffs sued in the Central District of California, asserting the usual litany of claims. One day before the defendant moved for summary judgment, the plaintiffs moved for voluntary dismissal without prejudice so they could re-file their case in state court and park it in the already-existing JCCP, California’s version of an MDL.  They claimed that, though they had “been diligently seeking discovery” to prove their case, they were “unable to do so effectively” in federal court. Thompson, 2017 WL 5135548 at *4.

The court explained that factors relevant to its decision included: 1) the opposing party’s effort and expense in preparing for trial; 2) excessive delay and lack of diligence by the moving party in prosecuting the action; 3) insufficient explanation of the need for dismissal; and 4) the fact that the opposing party has moved for summary judgment. Id. at *5 (citations omitted).  Naturally, the plaintiff argued that all of these factors weighed in favor of granting the motion, but the court disagreed.

The court pointed out that, though the plaintiffs argued that they had been diligent in prosecuting his case, they had “failed to serve expert disclosure or expert reports.” Id. at *6.  Moreover, through the plaintiffs’ motion was “purportedly premised on their intention to join the pending state court [Risperdal litigation],” they gave “no explanation as to why they waited until . . . mere days before the summary judgment deadline” when they had notice of the state court litigation for more than a year. Id. The court concluded that this was “an insufficient explanation of the need for dismissal,” one of the factors to be considered. Id. (internal punctuation omitted).

In addition, though the defendants’ motion for summary judgment was not pending when the plaintiffs filed their motion (it was filed the next day), the defendants had notified the plaintiffs that they would be filing for summary judgment before the plaintiffs moved for dismissal. The court held that “the proximity of the two motions raise[d] the inference that that Plaintiffs’ motion might have been motivated by a desire to . . . avoid an imminent adverse ruling by way of Defendants’ summary judgment motion and also avoid the consequence of their failure to serve expert disclosures.” Id. (internal punctuation and citation omitted).

Simply put, as the court correctly perceived, the plaintiffs’ tactic was a transparent attempt to hide their meritless case in another mass proceeding on the chance that an inventory settlement would line their pockets at some point down the road.  The court concluded, “. . . Plaintiffs have not provided sufficient justification for voluntary dismissal given the untimeliness of the request and the proximity to Defendants’ motion for summary judgment.” Id.  Motion denied.

The Defendants’ Motion for Summary Judgment

It was undisputed that all of the plaintiffs’ claims were premised on the defendants’ alleged failure to warn about the rate of gynecomastia. As such, the defendants argued that all of the plaintiff’s claims failed because, inter alia: 1) the plaintiff assumed the risk by continuing to take the drug once he was aware of the alleged risk; and 2) the plaintiff could not prove “warnings causation;” in other words, he could not satisfy his burden of proving that that a different warning would have changed his doctors’ decisions to prescribe the drug for him. Id.

As to assumption of the risk, the defendants argued that the plaintiff was aware of the risk of gynecomastia but “continues to use Risperdal because he believes the benefits of the medicine in treating his condition outweigh the very risks that he has sued upon.” Id. at *7 (citation omitted).  The court disagreed, holding that the record did not clearly indicate that the plaintiff’s treating physicians discussed the risk of gynecomastia with the plaintiff.

But it was clear, on the record, that all of the plaintiff’s prescribing physicians were themselves aware of the risk of gynecomastia. And the plaintiff “provided no evidence that a different warning would have altered the physicians’ decisions to prescribe Risperdal.”  Therefore, the plaintiff could not “demonstrate the [warnings] causation required to survive summary judgment under California’s learned intermediary doctrine.” Id. at *8.

Nor were the plaintiffs’ claims saved by California’s “overpromotion exception.” As the court explained, “California courts have in the past recognized that the learned intermediary doctrine may not apply where a medication has been overpromoted to the extent that any warnings would have been nullified.” Id. at *9 (citation omitted).  But the overpromotion exception applies only in “unusual cases” (our California colleagues tell us that it is very rarely applied), and not “where a plaintiff’s prescribing physician did not rely on promotional statements when choosing treatment options.” Id. (citation omitted).  In this case, there was no evidence that any of the plaintiff’s prescribers relied on the defendant’s promotional activities, and the exception did not apply.

And so, in the absence of evidence of warnings causation, the court granted summary judgment for the defendants. The correct result, and a nice cautionary tale for plaintiffs thinking they can game the system, ignore both rules and law, and await the filling of their outstretched hands.  Does our defense heart good.

 

 

Defense hacks. Homers. Biased. These are just a few of the labels we have applied to the authors of this Blog. While we recognize our leanings and strive to offer something more than just cheering a decision for the defense and jeering a decision for the plaintiff, we do see some cases as having an obvious right result, no matter how long it takes to get there. However, just because a case is from a “bad” jurisdiction does not mean that all the decisions will be bad. In Johnson & Johnson v. Fortenberry, No. 2015-CA-01369-SCT, 2017 Miss. LEXIS 421 (Miss. Oct. 19, 2017), the geriatric plaintiff was prescribed defendant’s antipsychotic medication for about two years before developing a mild oral tardive dyskinesia (something that had appeared with the second medication plaintiff had been on). This was the third medication that plaintiff took for her severe psychosis and it apparently worked well for her. Her prescribing physician was well aware of the risk of tardive dyskinesia with every antipsychotic at the time, considering that the medication had a lower risk of tardive dyskinesia and other extrapyramidal symptoms according to both the medical literature and defendant’s marketing materials. After pending for twelve years, the case went to trial in a notorious plaintiff-friendly jurisdiction before a similarly known judge. Plaintiff proceeded at trial on failure to warn and negligent misrepresentation theories and won a sizable compensatory verdict, although punitive damages did not go to the jury. An appeal and cross-appeal followed.

As we often do, we will focus on the parts of the decision that seem more relevant to us. First, the warnings claim. You may have already guessed that we think this should have been a slam dunk for the defense. You would be right. In addition to what we noted above about the prescriber’s knowledge and plaintiff’s medical course, the prescriber testified that specifically warned plaintiff and her daughter-caregiver (who later pursued the suit for plaintiff’s estate) of the risk of tardive dyskinesia and other extrapyramidal symptoms. Id. at *8. His awareness of the risk was consistent with the thorough warnings for tardive dyskinesia in the FDA-mandate class labeling for all antipsychotics, which he considered to be consistent with his understanding of the risk from other sources. Id. at **9-11. For plaintiff, the prescriber stood by his decision to prescribe the drug, noting “the psychotic symptoms which are terrible and unremitting and lead to very bad outcomes. And those are much more certain than the risks of possible side effects.” Id. at *19. Plaintiff attacked the class labeling as “cookie cutter” and the prescriber’s self-professed understanding of the risk as influenced by the marketing for the drug. Id. at **20-21.

The first question on appeal was whether the label itself was sufficient to warn of the risk of tardive dyskinesia. This was not a close call, as the “label unequivocally communicated the risk of tardive dyskinesia associated with the use of all antipsychotic drugs, including Risperdal.” Id. at *18. In addition, the prescriber “specifically testified that he considered the language of the Risperdal label adequate to warn him of the risk of tardive dyskinesia in Risperdal users at the time he prescribed it to Taylor.” Id. at **18-19. It does not appear that the plaintiff, despite an array of willing expert, had much to say about the adequacy of the label itself. This may have never featured in the trial court, but there would have been an obvious problem with saying that the defendant needed to change the class labeling to avoid liability—implied preemption. In this situation, the drug’s manufacturer could not have taken an independent action to change the already robust class labeling. That did not come up on appeal because the plaintiff argued that marketing undercut the actual content of the label. However, the Mississippi Products Liability Act limits the inquiry to the label itself and the Mississippi Supreme Court was unwilling to allow marketing evidence to be considered. Id. at **21-23. Thus, after fifteen years, an obviously flawed warnings claim—we have not even mentioned the obvious lack of proximate cause—went away.

The negligent misrepresentation claim was another matter, as marketing evidence counted. As an initial matter, the parties agreed that the focus on such a claim for a prescription drug was on the representations to the prescribing physician. From the summary of the evidence at trial, it does not appear that there was a specific representation ever made to the plaintiff’s prescriber that was proven to be false and relied upon in connection with plaintiff’s care. Instead, generic evidence purportedly showing that the manufacturer marketed the drug as having less of risk of tardive dyskinesia and other extrapyramidal symptoms than other drugs was not tied to the prescriber’s decisions with plaintiff. Id. at **26-32. There was no evidence that he saw any of the marketing pieces that plaintiff contended were misleading or acknowledged a specific representation that misled him.

Instead, plaintiff offered a less direct chain of purported proximate cause: 1) prescriber testimony that “I just remember the information about it, and I assume marketing as well as reading about it – I can’t always differentiate because I read journals and things, too – but all the information identified it as atypical and having fewer EPS side effects”; 2) his view from all sources was that the risk of tardive dyskinesia was lower with Risperdal than lower than with older antipsychotics; 3) that he probably would have prescribed another, unspecified medication if he believed the risk of tardive dyskinesia with Risperdal was actually equal to an older antipsychotic; and 4) expert testimony that plaintiff would not have developed tardive dyskinesia if she had been prescribed one of two other antipsychotic medications instead of switching to Risperdal. Id. at **26 & 33-37. For the court, this was enough to raise a jury question as to whether the marketing materials provided to the prescriber misrepresented “that the tardive dyskinesia risk was low and materially lower than the tardive dyskinesia risk from Haldol”—the drug plaintiff was initially prescribed, but not one of the drugs plaintiff’s expert said would have avoided her injury—whether the prescriber relied on such a misrepresentation, and whether it proximately caused plaintiff’s injury. Id. at **38-39.

Here are some problems with that analysis. For the same reason that an adequate pleading of a misrepresentation claim needs to include the who, what, where, and when of the representation, it is hard to see how a plaintiff can establish a misrepresentation without something more specific than what plaintiff offered here. Moreover, where the general representations to the prescriber were perceived as being consistent with what he understood from the medical literature and other sources, there does not seem to have been reliance on any misrepresentation. Any reliance also did not seem to result in the prescription to plaintiff, as the prescriber’s impression from medical literature also would have needed to have been different to affect the prescribing decision. Plaintiff’s evidence on proximate cause also did not seem to match up because the prescriber did not say he would have prescribed one of the two medications that plaintiff’s expert testified would have avoided her injury. That all does not sound like plaintiff established enough to get to a jury on a negligent misrepresentation claim, but, like we said, we might be a bit biased.

Part of why plaintiffs like misrepresentation claims is that they tend to be a better vehicle for punitive damages than failure to warn claims. Here, despite the broad evidence admitted on marketing, which plaintiff contended showed intent to justify punitive damages, the trial court did not let punitives go to the jury. Along the way, the court excluded the defendant’s guilty plea to allegations of improper marketing after plaintiff’s last prescription. Id. at *64. That is a correct decision, but still deserves some recognition. In Mississippi, the trial is supposed to evaluate all the evidence to see if a punitive damages claim should go to the jury. Id. at **65-66. Because the trial judge did that, the Mississippi Supreme Court affirmed. That deserves a little credit too.

 

Can you recall what you were doing back in March of this year? To be more precise the day before St. Patty’s Day and the day after the Ides. No? Well, apparently the defendants in the Risperdal and Invega Products Liability Cases pending in California state court were celebrating but they forgot to invite us to the party. We just learned about the very nice preemption decision entered by the trial court in that litigation. Since it’s never too late to celebrate a preemption victory, here are the highlights.

Before we get into the case specifics, the court’s general preemption analysis merits a minute of our time. ‘[I]f the tort plaintiff’s failure to warn theory was already tested by FDA action or inaction or would have required the use of a label on a prescription drug which the FDA would have prohibited,” the claim is preempted. Risperdal and Invega Product Liability Cases, 2017 WL 4100102 at *5 (Cal. Super. Mar. 16, 2017). What remains for private plaintiffs to challenge in a tort setting, therefore, is the adequacy of the label or the reasonableness of the manufacturer in updating the label based on new or additional information not already considered by the FDA. Id.

 In discussing whether information was presented to the FDA for consideration, of course, fraud-on-the-FDA and Buckman enter the discussion. The court nicely summarized the public policy reasons supporting Buckman preemption:

The understandable concern is that allowing a private right of action for “fraud on the FDA” would embroil the agency’s staff, particularly its scientific staff, in court litigation to the derogation of their performance of their primary duties. This would result both from the consumption of time in litigation activity and from a concern that their routine duties, decision-making processes and public communications would all have to be vetted with litigation avoidance in mind.

Id. at *6.

Next the court establishes that the Wyeth v. Levine “clear evidence” standard does not require indisputable evidence, but rather defendants must establish impossibility preemption by “clear and convincing evidence.” Id. And finally, the court found that preemption is a question of law, not fact and therefore an issue for the court, not the jury. To the extent deciding preemption requires the court to rule on a factual dispute regarding what the FDA would do, “the dispute is one regarding a legislative fact, not an adjudicative fact. Thus it presents a legal question for judicial resolution.” Id. at *7.

With that as background, we turn to the specific facts of the case. Risperdal is an anti-psychotic medication. Id. at *1. The Risperdal label that plaintiffs claim is inadequate was modified in 2006 to include language about prolactin elevation and the reported rate of gynecomastia (enlargement of male breasts) among Risperdal users. Id. at *3. Plaintiffs allege that defendants failed to adequately warn of this risk because the labeling did not include the “true” rate of gynecomastia and should have included an instruction to physicians to monitor blood prolactin levels. Id. at *1. Defendants moved for summary judgment on preemption grounds in 5 cases involving plaintiffs from 4 different states. Id.

With respect to the rate of gynecomastia set forth in the label, the FDA specifically approved the pooling of data from 18 studies to arrive at the rate that was used in the labeling. Id. The FDA re-examined the label in 2007-2008 and concluded that it required no labeling changes regarding gynecomastia or prolactin elevations. Id. Plaintiffs argue that the pooled average was lower and that defendants should have disclosed the higher incident rates observed in 2 of the 18 studies. Id. at *8. Because those 2 studies were among those considered by the FDA during the approval process, “the FDA’s position is clear [as to] how information regarding the 18 studies should be described in the label.” Id. This portion of plaintiffs’ claim is therefore preempted.

As to plaintiffs’ allegation that defendants failed to adequately warn about monitoring prolactin levels, plaintiffs rely on “Table 21.” This is a table containing an analysis of 5 studies purportedly showing a statistically significant association between elevated prolactin levels and gynecomastia. Id. The table was in a draft of a journal article but not in the final publication and therefore not submitted to the FDA during the approval process. The studies reviewed in the table, however, were among those considered by the FDA. Id.

 Plaintiffs argued that based on the information in the table, defendants should have independently changed their label under the Changes Being Effected (“CBE”) regulations. However, to implement a CBE label change without prior FDA approval, the change must be based on “newly acquired information” which is defined as

data, analyses, or other information not previously submitted to the agency, which may include (but are not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.

Id. at *9. Table 21 doesn’t fit that definition. It may be a different analysis of the data, but it did not show a different type or greater severity or frequency of the risk of gynecomastia which is the focus of the CBE regulation. To the extent plaintiffs also tried to rely on their litigation experts’ analysis of the data, the court point out that that was a tactic tried and rejected in several other litigations as a means of avoiding preemption. Id. So, plaintiffs’ claims are also preempted because the data they rely on to suggest defendants could have changed the label is not newly acquired and could not serve as the basis for an independent label change.

Not only could defendants not have changed the label on their own, the court found clear evidence that the FDA also wouldn’t have approved it.  In 2012, one plaintiffs’ counsel submitted a Citizen’s Petition to the FDA alleging that the Risperdal label did not adequately address elevated prolactin levels, the need to monitor for elevated prolactin levels, or the rates of gynecomastia. Id. at *4. Essentially the same allegations raised in the litigation. In its response denying the petition, the FDA stated that it was commonly known that Risperdal increases prolactin and that gynecomastia is one of the manifestations of increased prolactin. Id. at *5. Based on that the court concluded:

This Court is persuaded that these reasons articulated by the FDA in response to the very claims alleged here provide the kind of “clear evidence” of “legislative fact” which the U.S. Supreme Court requires before a court can hold that impossibility preemption applies. By any standard, there is “clear evidence” that Plaintiffs’ entire theory of label inadequacy focused on prolactin levels was not only considered and rejected by the FDA but also rests on information (and allegations) known to the FDA and the medical community. The FDA’s review of the 18 clinical studies—which form the underlying data of any theory that Plaintiffs posit—both pre-approval and in subsequent reviews, and its subsequent inaction, seem to be the definite upshot of a conscious FDA choice on information before the agency. It is not this Court’s job to revisit a decision made by the FDA.

Id. at *11.

It may not be the court’s job to revisit FDA decisions, but it is certainly this blog’s job to visit strong preemption decisions like this one. So, just a reminder that if you get a good decision – forward it along. Don’t make us wait 6 months to join the party.

Hope springs eternal. At least that is what the optimists say, and while we would like to see the bright side of the Missouri Supreme Court’s split opinion on venue in Barron v. Abbott Laboratories, Inc., No. SC 96151, 2017 WL 4001487 (Mo. Sept. 12, 2017), we are having trouble this morning finding our rose-colored glasses.  The court’s ruling that a black box warning on the exact condition at issue is “irrelevant” does not help either.

Faithful readers will recognize Barron v. Abbott Laboratories from our list of worst opinions of 2016.  The Missouri Court of Appeals’ opinion in Barron affirming a $38 million verdict came in at #3 on that list.  What did that opinion do to warrant such distinction?  You might call it a twofer:  The court upheld an unfair application of Missouri’s unique and unexplainable venue rules, plus held that a black box warning that warned of the exact risk at issue was sufficiently inadequate to sustain a failure-to-warn verdict and punitive damages.  We discussed that opinion here.

The Missouri Supreme Court has now affirmed this result, and it is still unfair on multiple levels. Let’s start with venue.  The only claims at issue in this trial were those brought by a Minnesota plaintiff against an Illinois defendant under Minnesota law.  Of course, the Minnesota plaintiff found her way to the City of St. Louis by filing a complaint there with 24 plaintiffs from 13 different states, including four from Missouri. Barron, 2017 WL 4001487, at *1.  This is a tactic we often see and to which we object.  But the angle that seems to be unique under Missouri procedure is that venue is proper in the county where any plaintiff “was first injured.” Id. at *5 (concurring opinion).  That means that any plaintiff—including the Minnesotan who got her claims to trial—can piggyback his or her way into any Missouri county where any co-plaintiff “was first injured,” even though neither her claims nor the defendant have any identifiable relationship to that forum.

Even the Missouri Supreme Court in Barron could not defend this rule, but instead affirmed the plaintiff’s verdict on the basis that the trial court’s refusal to transfer venue caused the defendant no prejudice. Id. at *2.  Query how a verdict this size on these facts would not demonstrate prejudice.  Regardless, we find it interesting that a four-judge majority of the Missouri Supreme Court dodged the merits.

Which leads to a ray of hope. Three judges filed a concurring opinion stating that once the trial court determined that each Plaintiff’s claims should be tried separately, it was error for the court not to sever and transfer claims for which venue was no longer proper. Id. at *7.  In other words, venue is not a static inquiry.  When the trial court determined that the claims should be tried separately, it “necessarily decided there are no further gains in efficiency of expeditiousness to be had from the joinder.” Id. at *6.  At that point, “the trial court has discretion to deny a subsequent or renewed motion to sever only in the rarest of circumstances” and “an abuse of discretion in denying such a motion will be patently prejudicial.” Id. The concurring opinion further faulted the majority for applying a “no prejudice” standard because a defendant

will never obtain relief without showing the elusive, undefined, and likely unprovable prejudice that the principal opinion demands. I am unwilling to countenance such an immediate, improper, and easily avoided outcome.

Id. at *7. Sure, it’s a concurring opinion, but it calls out the unworkable situation that Barron has reinforced.  We will take this four-to-three decision as endorsing efforts for reform.

Missouri-based defendants should take particular interest. The United States Supreme Court’s BMS opinion clamping down on personal jurisdiction should reduce the number of out-of-state plaintiffs suing non-Missouri defendants in Missouri.  But the joinder problem remains where personal jurisdiction is not an issue.  As the concurring opinion noted, “Even though the use of a Rule 52.05(a) joinder to combine multiple in-state and out-of-state plaintiffs in a single action largely will be prevented in the future by Bristol-Myers Squibb Co. v. Superior Court, [137 S. Ct. 1773 (2017)], . . . the use of Rule 52.05(a) to join the claims of multiple Missouri plaintiffs in a single petition will (and should) still occur.” Barron, at *4.  Missouri’s joinder rules therefore discriminate against Missouri defendants, who will remain subject to Missouri’s joinder rules while out-of-state defendants will less often be around.  This is another reason why reform should finally occur.

Now, how about the warnings? When a boxed warning—the strongest warning permitted under the FDCA—warns of the complication about which the plaintiff is complaining, it should be adequate as a matter of law.  Period.  You can read more on this here.  In Bannon, the Supreme Court did not set forth what the black box warning said, so we will:  “[THE DRUG] CAN PRODUCE TERTOGENIC EFFECTS SUCH AS NEURAL TUBE DEFECTS (E.G., SPINA BIFIDA).  ACCORDINGLY, THE USE OF [THE DRUG] IN WOMEN OF CHILDBEARING POTENTIAL REQUIRES THAT THE BENEFITS OF ITS USE BE WEIGHED AGAINST THE RISK OF INJURY TO THE FETUS.”  The plaintiff in Barron alleges she was born with spina bifida, which is right there in the warning—in all caps, and boldface, and surrounded by box.  To make matters worse, the Missouri Supreme Court held that the black box warning was “not relevant” to punitive damage. Id. at *4.  Quibble if you will over whether a black box warning is adequate as a matter of law.  But where the basis for liability is an alleged failure to warn, there is no way to explain how a clear and prominent warning on the exact complication at issue can be “not relevant.”  We will leave it at that.

So is there room for hope? As we observed in connection with another Missouri case a few weeks ago, time will tell.  Whatever the future holds, we are betting that Barron v. Abbott Laboratories will be in the running for the worst opinions of 2017.  Time (and Bexis) will tell.

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.

We write this in the first minutes of the eclipse, about 75 minutes from whatever “totality” will be visible here in southeastern Pennsylvania. We have our certified safety glasses at the ready, we have instructed the midday dog-walker to keep the Drug and Device Law Little Shaggy Rescues indoors (lest they unwittingly look skyward), and we have a continuous loop of the Fifth Dimension’s “Age of Aquarius” going around in our head. (Parenthetically, we accidentally typed “Fifth Amendment” just then for the name of the band.) The song has nothing to do with the eclipse, but it talks about the moon. And about Jupiter aligning with Mars. Appropriately thematic, we thought.

And, while “love steering the stars” may be a little strong to describe recent activity in Risperdal litigation, we have been pleased by a recent spate of positive developments. Last week, Bexis reported on two favorable decisions out of federal courts, one a post-BMS personal jurisdiction denial and the second a refusal to consolidate dissimilar cases for trial. Today we round out the triumvirate with a nice summary judgment decision from Pennsylvania’s state court system.

In In re: Risperdal Litigation: P.D. v. Janssen Pharmaceuticals, Inc., 2017 Phila. Ct. Com. Pl. LEXIS 231 (July 26, 2017), the (male) plaintiff allegedly developed gynecomastia – excessive breast tissue – when he was prescribed Risperdal (beginning when he was eight years old). He sued, including claims for design defect, failure to warn, and fraud. The defendant won summary judgment. The published decision occurs in a peculiar posture that is a creature of the Pennsylvania Rules of Appellate Procedure. Under Pa. R.A.P. 1025, when a grant of summary judgment is appealed, the trial judge prepares a written opinion in support of affirmance, arguing that there were adequate grounds for the summary judgment decision.

Design Defect

First, the court addressed the plaintiff’s design defect claims sounding in both strict liability and negligence. Because there were unresolved choice-of-law issues, the court considered these claims under the laws of both North Carolina, where the plaintiff was prescribed Risperdal and developed gynecomastia, and Pennsylvania, the forum state. Both states prohibit strict liability design defect claims against pharmaceutical manufacturers. While Pennsylvania, since Lance v. Wyeth, permits claims for negligent design defect, “a drug manufacturer can shield itself from liability for the design of drugs by including appropriate warnings; however, when it becomes known that a drug should not be used in light of the relative risks, the manufacturer can only avoid liability by removing it from the market.” P.D., 2017 Phila. Ct. Com. Pl. LEXIS 231 at *8-9. Here, the plaintiff did not offer “any evidence that Risperdal was so dangerous no warning could mitigate the relative risk of gynecomastia.” To prevail on a negligent design defect claim under North Carolina law, the plaintiff was required to submit evidence of a safer alternative design, and he had not “even address[ed] this requirement . . . , let alone submit evidence of a safer alternative design for Risperdal.” Id., at *9. As such, the court held, the plaintiff’s negligent design defect claims also failed under either body of applicable law.

Failure to Warn

The court’s dismissal of the plaintiff’s warnings claims rested on a finding that the plaintiff had not met his burden, under either North Carolina law or Pennsylvania law, of proving “warnings causation;” in other words, he had not proven that any alleged inadequacy of the product’s warnings was causally related to the his injury. We love this doctrine, because a successful argument can turn on the opportunistic exploitation of a plaintiff’s lawyer’s failure to ask a single question when deposing the plaintiff’s prescribing physicians.

The plaintiff’s warnings expert opined that the 2006 Risperdal label, in effect when the drug was prescribed for the plaintiff, should have included: 1) a recommendation for physicians to monitor prolactin levels; and 2) an indication that there was a statistically significant association between Risperdal use and gynecomastia. Id. at *12. But, as the court explained, “[a]lthough the parties deposed Plaintiff’s prescribing physicians, neither party elicited any testimony from [the doctors] concerning whether [the expert’s] proposed warnings . . . would have affected their prescribing decision.” Id. And so, the court concluded, “In light of the dearth of testimony from his prescribing physicians that [the expert’s] proposed warnings would have changed their prescribing decision, Plaintiff failed to establish proximate causation.” Id. (citation omitted).

The plaintiff attempted to save his warnings claim by arguing that the defendant engaged in illegal off-label promotion. The court held that, because the plaintiff was in an indicated population and was prescribed the drug for an indicated use, any discussion of off-label promotion was irrelevant to the case.

Fraud

Finally, the plaintiff argued that the court erred in dismissing his fraud claim. Again the court considered this claim under both North Carolina law and Pennsylvania law. Federal courts have interpreted Pennsylvania law as ‘barring [fraud claims]against pharmaceutical manufacturers.” Id. at *18 (citations omitted). Pennsylvania appellate courts have not addressed this issue. North Carolina law permits such claims, but not “where the purported misrepresentation was made solely to a third party.” Id. (citations omitted). “Because . . . neither Plaintiff nor Plaintiff’s mother relied on any representation” from the defendant in deciding whether to use the drug, “Plaintiff’s fraud claim must fail under North Carolina law.” Id.

The parties agreed that, where a true conflict of law existed, North Carolina law would apply, as that state, where the Plaintiff ingested the drug and developed gynecomastia, had a greater interest in the application of its law than did Pennsylvania, the forum state. “Ultimately,” the court held,

[I]t is immaterial whether Pennsylvania law permits a fraud claim in pharmaceutical cases. Assuming, arguendo, that Pennsylvania permits [such a claim], then Pennsylvania law conflicts with North Carolina law and North Carolina law would apply. Conversely, if Pennsylvania law prohibits such a claim, then Pennsylvania law applies. In either scenario, Plaintiff’s fraud claims would be dismissed.

Id. at *19.

We love a good summary judgment decision.  P.D. is sound and well-supported, and we trust that it will be affirmed on appeal. We will keep you posted. In the meantime, the [very cool] eclipse has come and gone. In the words of the Fifth Dimension, “let the sun shine!”