We just returned from our annual “girl trip” to a lovely spa in the mountains of Pennsylvania. And we stared our decrepitude full in the face. For the first time, we set off enthusiastically on a bike ride (cool “fat tire” bikes we’d never seen before) and found ourselves falling behind on hills and struggling to catch up with the 25-year-olds who composed the rest of the group. Don’t get us wrong – we rowed the hell out of the rowing machines and acquitted ourselves nicely in boxing class. But we were forced to admit that the legs and knees, challenged by tough terrain and compared to those belonging to others with much fresher faces, just didn’t work the way they were supposed to anymore.

So we are heartened to present a case in which implied conflict preemption—“warnings preemption” under Wyeth v. Levine—worked just the way it was supposed to. In Maze v. Bayer Health Care Pharm., Inc., 2019 WL 1062387 (E.D. Tenn. Mar. 6, 2019), the plaintiff alleged that the defendant’s contraceptive pill caused her to suffer a stroke. She asserted the usual warnings claims, alleging that the defendant’s warnings of the risk of thromboembolism were inadequate, though admitting in the same breath that the defendant “devoted substantial space to warning of the risk of venous thromboembolism.”   Maze, 2019 WL 1062387 at *1. The defendant moved to dismiss, arguing that all of the plaintiff’s claims were preempted.

The court explained that, under Levine, state law can still hold a manufacturer liable for failing to update a prescription drug label with “newly acquired [risk] information or even a new analysis of previously submitted data.” Id. (citation to Levine omitted). But changes “not based on new information—and thus necessarily based on the same information already considered by the FDA—require prior FDA approval.” Id. (citation omitted). That is what initial FDA approval is all about. So federal law preempts any claim that the manufacturer should unilaterally have changed a label based on information the FDA had at the time it approved the label. As the court explained, this “lets the FDA be the exclusive judge of safety and efficacy based on information available at the commencement of marketing, while allowing states to reach contrary conclusions when new information not considered by the FDA develops.” Id., quoting In re Celexa & Lexapro Mktg. & Sales Practices Litig., 779 F.2d 34, 41 (1st Cir. 2015).

Under that reasoning, the court continued, “[i]t follows . . . that any claim asserted by [the plaintiff] and based on information known to the FDA as of April 2012—when the label at issue here was approved—is plainly preempted by federal law.” In her complaint, the plaintiff alleged that the defendant was aware, at the time the label at issue was created, that the medication increased users’ stroke risk by 500% (the defendant disputed this fact), and did not set forth “any newly acquired information or even new analyses of previously submitted data,” id. at *3 (internal punctuation and citation omitted). She argued, in her motion, that such information existed, but, the court held, her “blanket statements [were] merely conclusory allegations and [did] not count as a sufficient showing that the plaintiff is entitled to relief.” Id. (internal punctuation and citation omitted).

The court continued,

Finally, and what seals the deal here, is that the label in effect during the entire relevant time repeatedly warned about the risk of stroke. Thus, even assuming the science marshaled by [the plaintiff] is newly acquired and says anything at all about the risk of stroke (as stated above, it is not and does not), nothing indicates that the risk is any higher than what is reflected in the . . . label that the FDA approved in 2012.

Id. In Levine, in contrast, the “main question [was] whether a nonexistent warning should be included in the label at all,” not whether “an FDA-approved, repeated stroke warning that the . . . label has included all along” is adequate. Id. “The former,” the court stated, “is heads-or-tails, the latter involves matter-of-degree questioning with respect to something that was clearly known and considered by the FDA in 2012.” The court concluded, “Without some indication that the science available now is somehow different, the Court will not second guess the adequacy of [the] warning label with state tort law.” Id.   And because the manufacturer could not unilaterally change the label’s stroke warnings, any claim the plaintiff might have had under state law was preempted by federal law.   Case dismissed.

This is how preemption is supposed to work, in the hands of the still-too-rare judge who is not afraid to dismiss a tort suit on preemption grounds. We like this decision, and we will continue to keep you posted on the good, the bad, and the very bad in the world of preemption jurisprudence.

Child:  “Can I have ice cream before dinner?”

Parent:  “No”

Child:  “What if it’s strawberry ice cream?”

Parent:  “Still, no”

Child:  “What if my teacher told me I had to eat ice cream for homework?”

Parent: “Still, no”

Child:  “What if a monster ran in here right now and said I had to eat ice cream or he’d take me away to his evil lair forever?”

Parent:  “…..”

Child:  “Well”

Parent:  “Give me a minute, I’m thinking.”

            That’s the “What if” game.  If you’ve been a parent, you’ve played it in some form.  It’s a close cousin of the “Why” game or the “But” game.  It’s also possible that you played What If” during a late-night college cram session that led to a serious conversation about a zombie apocalypse.  Come to think of it, late-night camping, late-night tequila, or late-night horror movies are all stimuli for the zombie apocalypse “What If” game.

In the recent case of McDonald v. Schriner, 2019 U.S. Dist. LEXIS 34514 (W.D. Tenn. Mar. 5, 2019), the court allowed plaintiff to play the “What If” game on a motion to dismiss.  In this context, it’s probably more appropriately titled the “Assuming Arguendo” game.  This is how it went.

Plaintiff:  “Can I keep my claim?”

Court:  “No, you don’t have subject matter jurisdiction.”  Plaintiff’s complaint failed to allege the place of incorporation or principal place of business for any defendant, but rather only provided the address of their registered agents.  Id. at *7.  Because that doesn’t establish the residence of any defendant, the court could not determine if the parties were diverse and could not just assume they were.  Id.  Case dismissed.

Plaintiff:  “Assuming, arguendo, I fixed that and showed you there was diversity, can I keep my claim?”

Court:  “Still dismissed because you also don’t have personal jurisdiction.”  The court shot down general jurisdiction, but we don’t need to cover that since post  Daimler AG v. Bauman, 571 U.S. 117 (2014) we know “merely doing business” isn’t sufficient for general jurisdiction.  McDonald, 2019 U.S. Dist. LEXIS 34514, *10-12.  As to specific jurisdiction – jurisdiction only over claims that arise out of or relate to the defendant’s contacts with the forum – plaintiff couldn’t satisfy the first prong of the test, showing that defendant purposefully availed itself of acting in the forum.  Id. at *12.  In the Sixth Circuit, courts use a “stream of commerce plus” approach to determine purposeful availment.  Id. at *13.  The “plus” concerns things like the amount of control a defendant had over the flow of the product into the state or the quantity sold in the state.  But all plaintiff’s complaint alleged was the drug was sold in Tennessee.  Not enough.  Case dismissed.

Plaintiff:  “Assuming, arguendo, I added more allegations that satisfied the purposeful availment test, can I keep my claim?”

Court:  “Still dismissed because you’ve also failed to state a claim.”  In addition to the manufacturers of the drug at issue, plaintiff sued the pharmacy where he filled his prescriptions.  But claims against pharmacies in Tennessee are governed by the Tennessee Health Care Liability Act (“THCLA”) which requires both that plaintiff provide pre-suit notice and a certificate of good faith – neither of which plaintiff did.  Id. at *16-17.  Pharmacy case dismissed.

Plaintiff’s claims against the manufacturer are governed by the Tennessee Products Liability Act (“TLPA”).  First and foremost, the TLPA provides that FDA-approved products are “presumptively not defective or unreasonably dangerous.”  Id. at *17.  But plaintiff’s only allegation of defect was a conclusory statement that the drug used to treat his restless leg syndrome induced his gambling.  That wasn’t enough to rebut the presumption or to show that the alleged defect existed at the time the drug left the manufacturer’s control.  Id. at *18.  Plaintiff also failed to state a claim for failure to warn.  He didn’t allege any facts about the warnings.  In fact the complaint only included a conclusory allegation that his losses were caused by a failure to warn.”  Id. at *19.  Manufacturer case dismissed.

But, there was one last “What if.”  Plaintiff never bothered to respond to defendants’ motions to dismiss.  Instead, only after the magistrate issued his report and recommendations and after the time allowed for objections to the magistrate’s findings did plaintiff file an objection.  Id. at *20.  So,

Plaintiff:  “Assuming, arguendo, I had timely raised any of my responses or objections, would I get to keep my case?”

Court:  “Still dismissed.”  In fact, the only new facts plaintiff’s objections added was that he couldn’t remember any effective warnings.  What he still didn’t allege was that he read or attempted to read the warnings when they were provided to him.  Id. at *22.  So, plaintiff’s claims failed for lack of proximate cause.

Having running out of “assuming, arguendo” propositions, the Court had the last words:  “Dismissed with prejudice.”

If we were to recap briefly our reactions to the Levine decision and ten years of decisions attempting to apply it, then we might say something like this. The Court’s creation of a clear evidence standard for conflict preemption in the context of warnings claims for branded drugs was both novel and misguided. The Court gave more credence to the CBE mechanism as a way to change the label, at least temporarily, without FDA approval than FDA ever had. Over time, courts took baby steps to recognizing that some warnings claims—even the fundamental claims underlying a litigation—should not proceed where the label plaintiffs wanted would not have passed muster with FDA at the time. Facts like FDA’s rejection of the same proposed label, FDA’s statements about the lack of an association with the risk at issue, the lack of new evidence to justify submitting a CBE, and FDA’s pronouncements that a CBE could not be used for a certain type of labeling change allowed courts to find that the high standard had been met. The endorsement of complimentary conflict preemption principles in some Supreme Court cases and rejection of the presumption against preemption in others helped emboldened courts to find warnings claims preempted. This trend might have peaked in a series of Fosamax decisions out of the District of New Jersey, which we touted not too subtly. Then the Third Circuit reversed, essentially holding that summary judgment cannot be granted for defendants under a Levine analysis because juries have to decide whether the clear evidence bar was met. We sharpened our proverbial pens to decry the reasoning of that decision, its impact on litigation, and its invitation for juries to second-guess FDA.

We have, of course, tracked the appeal of Fosamax to the Supreme Court, including the amicus brief of the Solicitor General and the oral argument. The Solicitor’s brief advocated that judges should decide preemption under Levine when interpreting the scope of an agency decision is required for the decision. Drawing on the Administrative Procedures Act, the brief argued that “[n]o sound reason exists for treating the meaning and effect of an FDA administrative determination differently” than other federal agency decisions, which are questions of law. Drawing on Supreme Court authority in the patent context, the brief reasoned that “[t]o the extent extrinsic evidence may sometimes be relevant in litigation between private parties to determine the meaning and effect of FDA’s agency action, the court’s evaluation of such subsidiary facts does not alter the ultimate legal character of the inquiry or the court’s exclusive authority to resolve it.” Cases are not exactly on hold while the Supreme Court mulls over what to do with the Fosamax appeal, so we were intrigued by the question certified on appeal in Rinder v. Merck Sharpe & Dohme Corp., — N.E. 3d –, 2019 IL App. (1st) 171969 (Ill. App. Jan. 23, 2019):

Under [Levine] federal law preempts state-law failure to warn claims related to the use of a prescription drug if there is “clear evidence” that the FDA would not permit the manufacturer to include the plaintiff’s requested warning in the drug’s labeling. Is the question whether the defendant has presented the necessary “clear evidence” one for resolution by the court or jury?

We will skip over the underlying facts of the case, but we can say there are multiple FDA decisions to be interpreted, it was pretty to clear to us that FDA would have rejected the label plaintiff wanted when they wanted it, and the plaintiff’s arguments seemed to hinge on after-the-fact evidence of causation. But here is where we come back to Fosamax. Although most published decisions involved the court deciding whether there was the clear evidence in the record required by Levine, the court identified Fosamax as the only relevant federal circuit decision and proceeded to follow it in rejected each of defendant’s arguments for why the court should decide the issue and find it was impossible to the defendant to have the label that plaintiff wanted. In essence, the Rinder court ruled that “the issue presented by the [Levine] inquiry is simply a particular application of the task juries regularly perform in tort cases, determining what the evidence shows probably would have happened if the allegedly wrongful conduct had not occurred.” Therefore, substantive Illinois law would require a jury to consider the defense of conflict preemption and summary judgment would be impossible in cases where plaintiff could come up with some arguments against defendant’s urged interpretation of the FDA’s decisions. Until Fosamax is reversed or at least rejected by other circuit courts, this is the sort of facile decision we will keep seeing.

 

You’ll find plenty of decisions from the amiodarone litigation discussed on the blog.  Not surprisingly, because it is a generic drug, they almost exclusively focus on Mensing preemption – or we should say on plaintiffs’ attempts to bypass Mensing.  But there are cases involving exposure to the branded product as well.  And earlier this month, the brand name manufacturer got about the best ruling it could hope to get – defendant’s warnings were adequate as a matter of law.  Generic defendant also got dismissed after plaintiff tried to argue around Mensing by claiming the generic manufacturer was also a distributor.

Plaintiff in Marroquin v. Pfizer, Inc., 2019 WL 636845, *1 (E.D. Cal. Feb. 14, 2019), brought claims for strict liability, negligence, breach of warranty, and various fraud/misrepresentation claims.  Plaintiff’s wife suffered from fatal pulmonary disease caused by the administration of amiodarone.  Id. at *2.  While the complaint does not state why plaintiff’s wife was prescribed the drug, the decision walks through the Indications and Usage and Warnings section of the drug’s label, of which it took judicial notice.  The labeling states that the drug is to be used only to treat two very serious heart conditions and only when other treatments have failed “because of the life-threatening side effects and the substantial difficulties associated with its use.”  Id. at *5.  The label further states that the drug has “several potentially fatal toxicities, the most important of which is pulmonary toxicity,” which is fatal about 10% of the time.  Id.  The court noted that label discussed pulmonary toxicity at least 15 times.  Id. at *2.

While plaintiff argued that the adequacy of a warning is “generally” a jury question, generally doesn’t mean alwaysId. at *6.  In this case, the warnings were clear, conspicuous, and warned of the exact risk plaintiff’s wife suffered – they were adequate.  Id.  Moreover, plaintiff’s complaint contained no allegations that explain why the warning provided was inadequate.  Certainly a difficult task given the breadth and depth of the warning provided, but an essential element that can’t be overlooked.  Nor could the court overlook plaintiff’s lack of allegations that the alleged inadequate warning was a substantial factor in plaintiff’s wife’s death.  Id. at *5.  Plaintiff also tried to argue that the risks as set forth in the label would not have been understood by the “ordinary consumer.”  But that’s not the standard.  The manufacturer’s duty to warn runs to the physician, not the patient.  Id.  Whether the warning was sufficient to inform plaintiff’s wife’s physician is the appropriate question.  One the court answered in the affirmative.

Finally, on failure to warn, plaintiff tried to argue that the physician may not have read the label defendant relied on.  But failure to read does not equal failure to warn.  “The Court is unaware of any authority that holds a warning is inadequate simply because a person or physician failed to read the warning.”  Id. at *6.  Aside from the implication that physicians aren’t people, we agree with this statement completely.

On his breach of warranty claim, the court again had to remind plaintiff that the learned intermediary doctrine applied.  A core element of breach of warranty of fitness for a particular purpose is the buyer’s reliance on the skill or judgment of the seller.

[I]n a context of prescription drugs, a patient’s expectations regarding the effects of a prescription drug are those related to him by his physician, to whom the manufacturer directs the warnings regarding the drug’s properties.  For breach of warranty claims, ordinarily it is the prescribing doctor who in reality stands in the shoes of the ordinary consumer.  [B]reach of express or implied warranty claims … may not be maintained against a manufacturer of prescription drugs who has properly prepared the product and marketed it with warnings of known or knowable dangers.

Id. at *7 (citations omitted).  In this case, plaintiff did not allege what information his wife’s physician considered when deciding to prescribe the drug.  What the evidence does show is that risk of pulmonary toxicity was adequately warned about.  Id.  And, the only inference that the court could draw was that plaintiff’s wife was relying on the skill and judgment of her physician, not defendant.  Id. at *8.

That left only plaintiff’s fraud and misrepresentation claims which were all based on representations that the drug was “safe, fit, and effective for human use.”  Id. at *9.  Plaintiff conceded that he failed to plead his intentional misrepresentation claim with sufficient particularity to satisfy Rule 9(b).  Id.  Which the court informed him applied equally to negligent misrepresentation and concealment.  The defendants were lumped together and the complaint lacked any allegations of who, where, when, and how the alleged misrepresentations were made.  Id.  As to the “what” was misrepresented – safety and effectiveness – the court expressed “serious concerns over the plausibility of this allegation,” given the FDA approval of the drug as a drug of last resort for two serious heart conditions and the fact that it has been used to treat these conditions for over 30 years.  Id.  And, plaintiff’s lack of reliance on defendant, as opposed to her physician, is another obstacle to the fraud/misrepresentation claims.  Id. at *10.

The generic defendant had all of the brand warning and reliance arguments but of course also had a Mensing preemption argument.  Because plaintiff had no allegation that the generic defendant’s label differed from the brand label, plaintiff instead tried to argue that Mensing preemption does not extend to distributors which the generic defendant also was.  However, the cases plaintiff relied on to draw the distinction between distributors and manufacturers were in the context of motions to remand based on fraudulent joinder.  In those cases, where all doubts are to be resolved in favor of remand and no binding authority had extended Mensing to distributors, the courts were required to find proper joinder and remand the cases to state court.  Id. at *11.  “However, context is key.”  Id.  Outside the removal/remand situation, courts have applied Mensing to distributors.  “[A] mere distributor sits in the same shoes as a generic manufacturer, neither has the ability to alter or change an approved FDA warning label.”  Id. at *12.  The Supreme Court’s concern about misleading or confusion caused by competing, different labels applies equally, and perhaps even more so, to distributors.  Id.  Mensing requires dismissal of all of plaintiff’s claims against the generic manufacturer that are based on some duty to convey information about the drug – failure to warn, breach of warranty, fraud/misrepresentation.  It would not apply to a manufacturing defect claim if plaintiff was bringing one.  Id.

Despite the court’s “serious concerns” with the plausibility of plaintiff’s claims, it did grant leave to amend based on the allegations being so conclusory that it could not definitively decide that amendment would be futile.  But the court certainly has made it clear that plaintiff has substantial work to do if the amendment is going to overcome the vast shortcomings of plaintiff’s case.

We may not know much about skin care, but we know a thing or two about labeling claims.  Whether for a drug, a device, a food, a cosmetic, or some other product, it is necessary to apply some common sense in determining what is or is not in a product’s labeling should give rise to liability.  The court in Browning v. Unilever U.S., Inc., No. SACV 16-02210, 2018 WL 6615064 (C.D. Cal. Dec. 17, 2018), applied a healthy dose of common sense in granting summary judgment for the defendant against consumer fraud and warranty claims by a purported of deceived purchasers.  The product at issue was St. Ives Apricot Scrub and allegations centered on the presence in the product of a powder from the crushed shells of walnut to lend exfoliating power to the scrub.  We will try to keep the nuttiness to a minimum as we discuss the decision.

The court’s introduction gets to the kernel of the dispute:

This “Scrub” is an exfoliant and like all such products is necessarily abrasive. Plaintiffs claim that the Scrub causes “micro-tears” and speeds up the aging process. Plaintiffs allege Unilever failed to disclose the scrub’s negative side effects before selling it to the public and misled consumers into believing it was dermatologist recommended.

Id. at *1.  Before we crack into the analysis, we have a little detour into some things not really spelled out in the decision.  This is probably obvious, but the scrub is used by gently rubbing it into the skin on your wet face and then washing it off.  Under the directions section on the tube of scrub are the ingredients section, which lists “Juglans Regia (Walnut) Shell Powder” right after water.  For those who are curious, these shells come from one of twenty-one species of walnuts.  If a reader or potential consumer were curious enough to look at the website for the product, then it would not be hard to see that Walnut Shell Powder is identified as the second “key ingredient” of the product (after apricot extract) and that the “exfoliation factor” of the product is characterized as “deep.”  With that extra-judicial context, we get back to the meat of the decision. (OK, we will stop with the gratuitous nut references.)

We will start with the second of plaintiffs’ basic claims, that the label was misleading in saying it was “Dermatologist Tested.”  Plaintiffs claimed that statement somehow suggested the product was “recommended” or “approved” by dermatologists, but they acknowledged that the product was tested by dermatologists and the court could read.  Id. at *4.  So, plaintiffs went to a back-up argument that references to testing were misleading without disclosing an alleged risk of the product.  That brings us to the first argument.

The first argument was that the walnut shell powder made the product too abrasive and caused indiscernible micro-tears in the skin that increase the incidence of acne, infection, and wrinkles, which in turn make the skin of users look older faster.  Because this was in the posture of summary judgment, plaintiffs actually offered up evidence like expert declarations, deposition testimony, and even published articles and a study done for litigation by their retained expert.  Viewed in a light favorable to plaintiffs, this evidence “at best show[s] that St. Ives Scrub could, in theory, alter the skin’s surface.”  Id. at *3 (emphasis in original).  However, under California law, “the alleged unreasonable safety hazard must describe more than merely conjectural and hypothetical injuries.”  Id. (internal citation and quotation omitted).  Plaintiffs did not show “that the alleged microtears are a safety hazard” and their experts did not contend the product was “dangerous.”  Id.  So, no injury.

They also did not prove causation:  “Evidence is lacking that St. Ives, and not other products or lifestyle or sun damage or any other factor, produced acne, wrinkles, inflammation, or loss of moisture (even if these were actionable safety hazards).”  Id.  The court considered the consumer complaints offered by plaintiffs to say nothing about causation, especially because they occurred at a low frequency.  Id.  The court also was not impressed by the plaintiffs’ for-litigation study:  “Plaintiff’s short-term clinical study does little to advance Plaintiff’s causation theory or prove their allegations of longer-term skin conditions.”  Id.  Bringing the evidence back to the context of alleged omissions of unreasonable safety hazards of the product from labeling, the court stated:

Again, Plaintiffs haven’t shown that micro-tears themselves (as distinct from potential resulting symptoms, such as wrinkles or acne) are counter to the product’s central function. Indeed, the Scrub was marketed as an exfoliant (Mot. at 25), which implies some intended resurfacing or abrasion. Plaintiffs do not address this issue or offer a description of the central function of a facial exfoliant. There is far too little for a reasonable jury to conclude that the presence of walnut shells neuters that undefined function.

Id.  Contraction notwithstanding, we think this is fine analysis.  As noted above, a little broader look would indicate that this product was not just marketed as an exfoliant, but one for deep exfoliation with the ground up walnut shells as a key ingredient.  People who might want to use a scrub—any scrub, pre-packaged or homemade—might consider in advance whether scrubbing the skin on their face with something with sufficient grittiness to accomplish a scrubbing is what they want.  That is not really a labeling issue.

To cap it off, the purported class reps did not have any injuries.  They just “assume[d] they suffered from micro-tears which they could neither see nor feel.”  Id. at *4.  We have seen uninjured class reps before and the need for a cognizable present injury clearly applies in a range of contexts, including medical monitoring and consumer fraud.  There is nothing nutty about that requirement.

 

A little over a year ago, we reported on a decision by Judge Rufe (E.D. Pa.) dismissing an Avandia heart attack case on the grounds of the learned intermediary rule (Utah law). All of the plaintiff’s claims boiled down to an alleged failure to warn, and that was a problem for the plaintiff, as the plaintiff’s proposed enhanced warning ended up being discredited by the science after the case was filed. Thus, even though the prescriber had stopped prescribing the product for a period of time after some adverse data came out, by the time of the prescriber’s deposition he testified that he felt comfortable with his decision to prescribe the medicine to the plaintiff. That evidence prompted the district court to bid adieu to the claims. Our defense hack hearts were gladdened by this result.

Those defense hack hearts are even more gladdened by the Third Circuit’s recent affirmance of the district court’s decision. In re: Avandia Marketing, Sales Practices and Products Liability Litigation (Siddoway), 2018 WL 6828423 (3d Cir. Dec. 28, 2018). The Third Circuit did not see fit to publish the affirmance in the West Reporter, but we see fit to publicize it.

As the Third Circuit reminds us, the plaintiff’s claims in Siddoway drew a causal link between prescriptions for Avandia prescribed in 2001 and 2002 and the plaintiff’s two heart attacks in 2003. The case hinges on what the prescribing doctor would have done, with regard to prescribing Avandia, if he had seen the warning the plaintiff preferred. The prescriber testified that he stopped prescribing the drug after learning of a 2007 meta-analysis of 42 clinical trials by Dr. Steven Nissen – a familiar name to many of us — that associated Avandia with an increased risk of heart attack. The prescriber testified that he would have “thought twice” and would have been “much more thoughtful” about prescribing Avandia and would not have prescribed the drug to the plaintiff “in the middle of all these heart attacks” if he knew this information in early 2003.

That testimony is mildly interesting, but does not really mean much because (a) the undisputed record shows that the actual prescription occurred one year before the plaintiff’s heart attacks, not “in the middle” of them, and (b) for the prescriber to say he would have been “much more thoughtful” and would have “thought twice” about prescribing Avandia if he knew in early 2003 the risk information that arose in 2007 does not cut it. The Third Circuit concluded that “the vague and highly speculative nature” of the prescriber’s testimony “suggests no concrete action and it is tied to hypothetical knowledge in 2003.” That is an important ruling, because it is exactly that sort of general, speculative, might’ve-thought-more stuff that plaintiff attorneys usually elicit from prescribers. The plaintiff lawyers then pack up their papers and smugly climb aboard their private jets, sure that they have staved off summary judgment. But they have not (or should not have) staved off summary judgment. Rather, they have walked right into it.

And then there is the inconvenient (for the plaintiff) fact that the prescriber in Siddoway also testified that if he had also known in 2001 and 2002 about the exculpatory information available in 2015, the time of his deposition, when the Food and Drug Administration removed the link between Avandia and an elevated risk of heart attack, he would have made the same choice to prescribe the drug to Siddoway. As we wrote a little more than a year ago, the result in Siddoway seemed “inevitable.” The Third Circuit saw it the same way.

It took us more than a week, but we finally put away the last serving pieces from last week’s family Hanukkah celebration.  We love Hanukkah, a festive holiday that celebrates victory over a tyrant king, a reclaimed temple, and a small quantity of oil that should have lasted only one night but that miraculously burned for eight nights.  In commemoration, we light candles for eight nights. And we use oil.  Lots and lots of oil.  Like, eight dozen potato latkes-worth of oil.   Though the holiday has far less religious significance than does Christmas, it is a time for family and gifts and food and song and celebrating the “miracle” of the bit of oil that improbably shed eight nights of light.

In a similar vein (pun intended), today we celebrate a very short, but surprisingly bountiful, decision out of the inferior vena cava (“IVC”) filter MDL pending in the Southern District of Indiana.  We love warnings causation, a potent doctrine too often rendered toothless by passive judges.  Not so in In re Cook, Inc. IVC Filters Marketing, Sales Practices, and Prods. Liab. Litig. (Tonya Brand), 2018 WL 6415585 (S.D. Ind. Dec. 5, 2018).   In the IVC filter MDL, the plaintiffs allege that the filters are prone to tilting, migrating, fracturing, and perforating the inferior vena cava.  In Brand, the defendants’ IVC filter was inserted in the plaintiff’s inferior vena cava to prevent pulmonary embolism during an upcoming spine surgery.  Two years later, the plaintiff began to experience pain on the inside of her right thigh.  Shortly thereafter, the plaintiff noticed something protruding from her thigh and pulled out a portion of her IVC filter.  The plaintiff was required to undergo open surgery to remove the rest of the filter.  The plaintiff sued, alleging that the instructions for use (“IFU”) that accompanied her filter did not adequately warn her physician of the risks associated with the filter.

The court explained that, under Georgia’s learned intermediary doctrine, the plaintiff could prevail on her warnings claims only by proving both that the warnings in the IFU were inadequate and that the inadequate warnings proximately caused her injuries.  The court emphasized, “Where the learned intermediary has actual knowledge of the substance of the alleged warning and would have taken the same course of action the plaintiff contends should have been provided, . . .  the causal link is broken and the plaintiff cannot recover.”  2018 WL 6415585 at *3.  The plaintiff’s physician testified that he was aware of all of the relevant risks when he implanted the Plaintiff’s IVC filter.  His knowledge of the risks was not based on the IFU; rather, it was based on his “education, training, and experience.”  Id.    Moreover, the doctor testified that he continued to use the defendant’s filter even after the plaintiff’s filter fractured, and that nothing about the plaintiff’s experience changed his mind about IVC filters in general or about the specific filter he used in the plaintiff.  The court held, “In the face of this devastating testimony, Plaintiff fails to raise a genuine issue of material fact on the proximate causation element” of her failure-to-warn claims.  Id.  at *4.

The plaintiff also argued that the defendants breached Georgia’s continuing post-sale duty to warn because they did not warn her physician, after he implanted her filter, of the filter’s propensity to  perforate and fracture.  She alleged that, if the defendants had provided such a warning, her doctor “potentially could have removed the filter before it fractured and pieces migrated throughout [her] body.” Id.   The court rejected this argument as well, holding that it was based on speculation and that the evidence, including the fact that the plaintiff’s physician continued to use the same filter in patients even after the plaintiff’s filter fractured, suggested that no post-placement warning would have prompted the doctor to retrieve the plaintiff’s filter any earlier.  As such, the plaintiff “fail[ed] to raise a genuine issue of material fact that any post-implant failure to warn caused her injuries.”   Id.   Because the plaintiff failed to sustain her burden of proving the causation element of her warnings claims, the court granted summary judgment for the defendants on those claims and on the claims that were based on them.

We make these same arguments over and over and over again in our medical device cases.  We often don’t prevail, even on clear records.  We wish that more courts had the clear-eyed approach to warnings causation that this MDL judge employed.  We will keep you posted on similar decisions.  And we still have a couple dozen potato latkes in the freezer, in case you are in our neighborhood.

 

Not terribly long ago, we had a series of posts—too many to link—that recounted court decisions rejecting efforts to impose liability on a generic manufacturer for the standard design and labeling claims and/or on an NDA holder for injuries allegedly caused by the use of the generic version of its drug. When the conjunctive held, we called it a one-two punch. We cannot say that we coined the term as used here, but we repeated it more than a few times. It has since become fairly standard for most claims against generic manufacturers to be held preempted by the frightful duo of Mensing and Bartlett. Save abominations like the T.H. case, the concept of innovator liability has largely been put to bed like a kid crashing after a sugar high. Still, plaintiffs sometimes try to impose liability on both the generic manufacturer whose drug they took and the branded manufacturer whose drug they did not.

When they do and a court rules, we pull the one-two punch from the back of our metaphor closet and see how it lands. In Preston v. Janssen Pharms., Inc., No. 158570/17, 2018 WL 5017045 (N.Y. Sup. Ct. Oct. 12, 2018), the plaintiff claimed vision loss from her off-label use of the generic version of Topiramate, a well-established anti-convulsive. For more than a decade before she began her three year course, the label for the branded version contained warnings and precautions about ocular conditions that could result in permanent vision loss if untreated. After waiting more than two years to sue, she sued both the branded and generic manufacturers, claiming the records were unclear as to which drug she took for three years.

The branded manufacturer moved to dismiss, contending the complaint only asserted claims based on the generic drug that it did not make. It is not clear that the plaintiff tried to assert innovator liability in addition to claiming that the branded dug might have been used, but the court looked at the evidence and ruled on the merits. Because the evidence was clear that only the generic drug had been used, the next step to first punch was whether New York recognizes innovator liability. Citing the same cases we have before, the Preston court held that “named-brand drug manufacturers . . . cannot be held liable to the user of the generic form of that drug, since the manufacturer of the brand named drug owes no duty to the user of the drug’s generic form.” Id. at *3.

That takes us to the motion to dismiss of the generic manufacturer, the potential second punch. Plaintiff conceded, and the court accepted, that design claims are preempted because the generic manufacturer cannot change the drug’s design. Id. at *6. The plaintiff disputed that the warnings claim was preempted based on an alleged failure to update the generic label to match the branded drug’s label. For about eight months after the plaintiff started the generic drug, its label allegedly did not match. When the plaintiff alleged suffered her injuries, it did. A few years later, it allegedly did not match again. Plaintiff claimed that the later mismatch knocked out preemption for any warnings claim, but the court parried that argument. Following Mensing, the court held preempted claims based on any period when the warning of the generic drug matched, but allowed at the pleadings stage any claim based on the pre-injury period when there was an alleged failure to update. Id. at *5. So, the second punch did not quite land flush. It may be difficult for the plaintiff to sustain a claim about the warning when the plaintiff was first prescribed the drug when she kept receiving it when the warning was updated and her injuries allegedly developed during this later period. We suppose the warning claim might get kicked at the summary judgment stage. Preston also addressed the adequacy of pleading of various other claims that tend to be thrown into a product liability complaint, but she will have a chance to try to correct what was inadequately pled. Nothing too decisive or interesting about that, at least to us and at this stage.

Happy Halloween. We are very old school when it comes to this spooky holiday. Our pumpkins are orange, our candy bowl is full of Kit Kats, and our favorite horror movies are black and white Universal monster movies from the 1930’s and 40’s. To our ears, nothing screams Halloween quite like the great Una O’Connor screaming. See and listen here for examples of her wonderful performances in The Invisible Man and Bride of Frankenstein as a proper lady properly terrorized by creepy creatures. (O’Connor’s last film role was in Witness for the Prosecution as an ear-witness who resisted impeachment.) The Invisible Man, Bride of Frankenstein, and the original Frankenstein movie were all directed by James Whale, a man of enormous talents and humor, as well as enormous tortures. The Gods and Monsters film portrays Whale in his uneasy later days.

At this point, we cannot resist a Halloween joke, this one by Dana Gould. It goes like this: In this country we celebrate a holiday where frightening strangers come to our homes and take goodies from us. We call it Halloween. A month later, the next big holiday arrives – Thanksgiving. But Native Americans have another name for that holiday; they call it … Halloween.

Recently, we found ourselves screaming like Una O’Connor after a plaintiff filed a summary judgment motion against us. That plaintiff had the temerity to argue that her failure to warn claim was a foregone conclusion. Our screams arose from surprise, indignation, and, finally, laughter. With one brain tied behind our back, we could scare up a genuine factual dispute. Take a look at the report by our expert, who is very smart and says our warning was adequate and no reasonable doctor would have been misled. While you’re at it, read our Daubert motion, wherein we demonstrate that the plaintiff experts are about as scientific as Colin Clive in Frankenstein, dancing under the lightning and proclaiming, “It’s alive, alive!” Not quite. Our expert marshals the data and literature and says this about the lawsuit: “It’s dead, dead!”

Plaintiff motions for summary judgment are menacing, but miss the mark more often than not. That was certainly true in Nielsen v. Smith & Nephew Inc. et al., 2018 WL 5282901 (E.D. Wisc. Oct. 24, 2018). If anyone is screaming in this case, it is the judge, obviously pained by bad briefing. The plaintiff alleged that a hip replacement device fractured ten years after it had been implanted. The complaint’s main target was the distributor of the implants, because the manufacturer had gone under. There were 11 causes of action, but a defense summary judgment motion prompted the plaintiff to concede that almost all were pure hooey. Not a great start for the plaintiff. The only real motion fight was on the negligence claim against the distributor. Meanwhile, the plaintiff moved for summary judgment against the distributor on two grounds: (1) that the distributor of the hip devices could be liable under Wisconsin law because the manufacturer had gone bankrupt and lacked insurance coverage, and (2) the device lacked adequate warnings.

To put it mildly, the Nielsen judge was not impressed by the plaintiff’s motion. The plaintiff supported his motion by attaching letters and emails from the manufacturer’s counsel and insurer. That’s all inadmissible hearsay. Consequently, the solvency of the manufacturer — and, therefore, whether the distributor could be a proper defendant — would need to be decided at trial, not on summary judgment. The plaintiff’s summary judgment on product warnings fared no better. The plaintiff’s expert did, predictably, say the warnings should have been more explicit and petrifying. But just as predictably, the defense expert pronounced the warnings to be just peachy. We in the business call this sort of thing a factual dispute. That’s also what the court called it. It was not a close call, as far the court was concerned. The plaintiff “inexplicably declined to dispute any of [the distributor defendant’s] statements of additional facts.” Moreover, the plaintiff offered no relevant case law under Wisconsin’s product liability act. Rather, the plaintiff “seems content to leave it to the Court to find the law that supports his arguments. It will not do so.” Ouch.

The distributor defendant’s motion for summary judgment was more successful than the plaintiff’s motion. (Frankly, it is unimaginable how it could be less successful.) The plaintiff’s motion was premised on his expert’s opinion about what the warnings should have included. But the issue was the warning obligation of a “reasonable distributor.” Amazingly, the plaintiff’s expert addressed only manufacturer duties. Those duties were plainly inapplicable to the distributor defendant, which was “simply a middle man.” The complete failure of the plaintiff to join issue mightily annoyed the judge, who wrote as follows: “Such minimal effort, devoid of any citation to law or meaningful discussion of evidence, is an insult to the Court.” Double ouch. The plaintiff basically brought motions and then made no attempt to prove what he had to prove.

The distributor defendant did not cross-move on every claim. There is still a strict liability claim against it, and that claim will go to trial in November. But based on what happened with the cross motions for summary judgment, if we were the Nielsen plaintiff we would not be sanguine. Nope. We’d be scared.

It would seem to go without saying that for a defendant to be liable for the purported “common-law” claim of failure to report adverse events to the FDA, there must actually be some adverse events that needed to be reported.  One would think so, but certain California breast implant plaintiffs (yes, some still exist) would beg to differ – at least they did before the recent decision in Mize v. Mentor Worldwide LLC, No. BC649083, slip op. (Cal. Super. Oct. 1, 2018).

One problem that that current breast implant litigants face that their more numerous predecessors did not is preemption.  All that earlier litigation caused the FDA to upclassify breast implants to Class III, pre-market approved devices, and PMA means preemption.

In California, that also means the filing of half-baked, failure-to-report claims that no self-respecting plaintiff would otherwise bring, as a way to allege something that gets around preemption.  Trouble is, these breast implant plaintiffs can’t even allege that the defendant didn’t report any adverse incidents.  Even what plaintiff did allege was notably speculative:

Plaintiff now has alleged, however, that if [defendant] had reported additional adverse incidents subsequent to 2000, and if the FDA had made such incidents public, and if Plaintiff’s doctors had been aware of such reports, Plaintiff’s doctors might have provided an earlier diagnosis leading to earlier surgery to remove the implants and Plaintiff’s damages . . . might have been lessened.

Slip op. at 5. That’s a lot of “what ifs” piled on top of “what ifs,” but this plaintiff couldn’t even get to that.

There weren’t any unreported adverse events.

So the plaintiff tried to make them up.

The entire questionable “causal chain” wasn’t based on any known, but unreported, events at all, but rather on allegations about how studies were conducted:

[I]t is premised on [defendant’s] failure to report adverse incidents that were not detected because of how [defendant] conducted the studies rather than on a failure to report adverse incidents that actually occurred.

Id.  Even for a liberal jurisdiction, that was just too much.  There must be something that actually wasn’t reported.

Because Plaintiff has failed to allege facts showing that [defendant] failed to report actual adverse events that in fact occurred, the failure to warn (failure to report adverse events) claim is preempted because plaintiff has failed to allege how [defendant’s] actions in conducting these studies violated federal law.

Id.

While the Mize court “adopted the reasoning” of Ebrahimi v. Mentor Worldwide LLC, 2017 WL 4128976 (C.D. Cal. Sept. 15, 2017) – a case we discussed hereMize was really a step into fantasy beyond even Ebrahimi.  As pleaded, Ebrahimi at least involved allegations that (vaguely) alleged that events weren’t reported.  Mize didn’t.  She seems to have been alleging that the defendant was obligated to conduct studies in a way that maximized the number of reportable adverse events.  That “duty” is, of course, contrary to tort policy and medical ethics, both of which seek to reduce, not increase, product injuries.

The plaintiff in Mize also tried to allege a “manufacturing defect,” but that didn’t fare any better.  Lacking any direct evidence, plaintiff tried to rely on “allegations that supported . . . [a] 1998 Consent Decree.” Slip op. at 3.  But plaintiff’s implant wasn’t manufactured until at least two years after that decree, and the decree itself was “evidence of a promised change in practices,” so the decree could not be evidence of any defect in the device implanted in the plaintiff.  Id.  Again, simple logic seems beyond the plaintiff in Mize.

Finally, the Blog wishes to express its appreciation to Dustin Rawlin, of Tucker Ellis, and his team of, Peter Choate, Monee Hanna and Allison Burke, who not only won the case, but were thoughtful enough to send it along to us.  Keep up the good work.