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A (relatively) long time ago in a state not so far away, the Michigan Legislature enacted the Michigan Product Liability Act.  It contained a provision providing the manufacturers of FDA-approved drugs with immunity from product liability absent the application of two narrow exceptions.  A challenge to the constitutionality of the provision soon followed and the Michigan Supreme Court, in Taylor v. Smithkline Beecham Corp., 658 N.W.2d 127 (Mich. 2003), basically said the legislature can enact a law like that and the immunity on drug manufacturers was as broad as it seemed.  (This guest post provides a nice history.)  Other decisions followed, like Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir. 2004), and Desiano v. Warner-Lambert & Co., 467 F.3d 85, 98 (2d Cir. 2006), aff’d by equally divided court, 552 U.S. 440 (2008), coming down on opposite sides of the issue of whether the first exception—the defendant “before the event that allegedly caused the injury . . . intentionally withholds from or misrepresents to [FDA] information concerning the drug that is required to be submitted” under the FDCA that would have prevented original or continued approval—runs into Buckman preemption.  What also followed was that Michiganders who wanted to sue over alleged drug started to go elsewhere.  (Not to galaxies several parsecs—a unit of distance, not time—away, but just to other states.)  They did so because they hoped that the immunity in § 600.2946(5) would not follow them.

We have called this phenomenon the Michigan diaspora, and, while the dispersal of the Michigan litigation tourists is merely temporary, their cases do keep popping up in some likely spots.  Just last month, we discussed how West Virginia state courts have applied Michigan law to the claims of Michiganders hoping to find more plaintiff-friendly law.  We have also discussed how the claims of Michiganians claiming gynecomastia from Risperdal have fared in the Philadelphia Court of Common Pleas, a jurisdiction that has seen plenty of action in that particular litigation.  We praised the court’s application of the Michigan statute to bar the claims.  The plaintiffs in that case appealed to the Superior Court of Pennsylvania, which has reversed more than a few defense rulings we have liked.  Instead In re Risperdal Litig., __ A.3d __, 2017 WL 5712521 (Pa. Super. Nov. 28, 2017), respected the force of the Michigan Legislature’s clear enactment and affirmed.

On appeal, the plaintiffs agreed that Michigan law applied, but argued that the statute provided no protection where the use was off-label.  When the plaintiffs (actually all but one of them) were prescribed the drug it had been approved but did not yet have an indication for use in juveniles, which they were at the time.  The statute, however, hinged on whether “the drug was approved for safety and efficacy,” not whether the particular indication had been approved.  Federal courts had followed “the plain language of the statute” and found off-label use was irrelevant to the application of immunity as long as the drug was approved.  2017 WL 5712521, **5-6.  “Thus, we conclude that as long s a drug has received approval, and its label is compliant with FDA regulations, the MPLA applies to bar any product liability claim, despite the drug’s indicated uses.” Id. at *6.

Next, plaintiffs argued that they had enough evidence to raise a genuine issue as to the statutory exception based on a fraud on the FDA.  Defendants claimed that any attempt to meet the exception would be preempted because the FDA had never found such a fraud.  The Superior Court did not take the opportunity to add to either side of the preemption ledger because plaintiffs did not have the evidence they needed anyway. Id. at *7.  The statute did not just require any fraud on FDA, but a withholding of information such that its proper submission would have meant “the drug would not have been approved” or FDA “would have withdrawn approval for the drug.”  Plaintiffs argued that their evidence of purported fraud was relevant to the approval of the additional indication for juvenile use, but they never contended that the drug would not have been approved or would have been withdrawn.  “[T]he proof of fraud a plaintiff is required to present in order to receive the benefit of the fraud exception must relate to the initial FDA approval.” Id. at *8.  Given that FDA had denied a citizen’s petition in 2014 that requested the drug be withdrawn, it was clear that any purported fraud related to the application to add the juvenile use indication almost a decade earlier was insufficient to trigger the exception. Id. We all know Yoda famously said “Do or do not.  There is no try.”  Here, plaintiffs tried and tried again, but they did not get around the statutory immunity despite their sojourn to Pennsylvania.

 

We can be inundated with news.  Old news.  New news.  Fake news.  Breaking news.  News that makes you want to break something.  News that makes you want to go back to bed.  In trying to be discerning consumers of the news, it is useful to do not just a reality check but a date check.  Stories on a social media stream come with a presumption of newness, but the date of the release of the story—once you find it—may make you stop reading because it is not news any more.  You may even have read the old news when it was new and just got suckered back by the misimpression of novelty.  A story about a new species of dinosaur, or even beetle, being discovered?  We are clicking.  Einstein’s prediction of gravitational waves verified?  Click—wait, we saw that way back in early 2016, and a Nobel Prize was awarded for that last month.

Generic drug preemption may not be as clickworthy as a “new” ankylosaur, but these decisions do still catch our attention.  After Mensing, Bartlett and scores of published decisions preempting the vast majority of conceivable claims—or holding that state law does not recognize the claim the plaintiff would need to sidestep preemption—you might think that plaintiffs would stop pursuing these claims.  Well, the nonsense that is innovator liability has not provided a viable alternative—although the plaintiffs keep trying (like here and here)—and courts have not yet resorted to Rule 11 for pursuing obviously preempted claims, so the plaintiffs keep trying.  When Kious v. Teva Pharmaceuticals USA, Inc., No. 16-990-R, 2016 WL 9559038 (W.D. Okla. Dec. 8, 2016), popped up in our searches, we thought it might be new and newsworthy.  It really was old news made to seem new because it had taken eleven months to get on Westlaw.  The generic manufacturer defendant secured dismissal of the claims against it on preemption, but was there anything new, different or interesting about it?  We think it is pretty much old hat, but that may be the point.

Kious involves a plaintiff who claims to have developed Stevens-Johnson Syndrome as the result of the use of a generic antibiotic, the label for which apparently matched that of the reference drug.  The plaintiff sued the generic manufacturer, asserting standard state law claims, and a motion to dismiss the amended complaint followed.  (He also sued the branded manufacturer, but that is not discussed in the opinion.)  The court walked through each asserted claim, starting with design defect.  Preemption of such claims is not really a question post-Bartlett, but the Tenth Circuit’s decision in Schrock, discussed here, left no doubt that strict liability and negligence design claims fail.  Id. at *2.  Next up was the claim for manufacturing defect, which was really just a re-packaged claim for design defect.  Plaintiff claimed “that every dose of azithromycin was defective because of its design and/or lack of adequate warnings,” so he did not plead a manufacturing defect claim under Oklahoma law (and the design claim under a different label was still preempted). Id.

Next up were the warnings claims.  Plaintiff did not allege a failure to update the generic label to mirror the reference drug’s label, so Mensing’s application should have been straightforward.  Not so, claimed the plaintiff, because Mensing involved prescriptions written before the Food and Drug Administration Amendments Act of 2007, which established a procedure under which FDA could ask for a new label from a generic manufacturer if the reference drug was no marketed and there is new safety information.  Even this argument, however, was not new, as courts like the Seventh Circuit had already rejected it.  The Wagner decision (a lofty fifth place on last’s year’s best list) made clear that the FDAAA did not remove the prohibition against a generic drug manufacturer changing its label unilaterally.  2016 WL 9559038, *4. Kious went a step further—and we think this was actually novel—and noted that the FDA’s proposed rule from 2013 to allow generic manufacturers to change their labels unilaterally in some situations supports preemption.  “The proposed rule would be unnecessary if, as Plaintiff urges, the 2007 Amendments permitted unilateral labeling changes by generic manufacturer.” Id. No news is good news, at least here, so warnings claims are still preempted.

The remaining claims were also dismissed.  Express warranty claims are really preempted warnings claims and implied warranty claims were really preempted design claims or preempted warnings claims, depending on how construed.  Again, the Schrock decision, also under Oklahoma law, determined the result. Id. at *5.  For the claims of fraud, negligent misrepresentation, and negligent concealment, the court looked to the Eleventh Circuit’s decision in Guarino for clear authority that these were simply another version of preempted warnings claims. Id. at **5-6.  That was it for every claim plaintiff offered and, plaintiff did not get to amend again.  Judgment for the defendant after only two strikes.  Could it be that sanctions for asserting frivolous claims are next in such suits?  That would be news, no matter when it happens.

 

 

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.

 

Implied Preemption.  Off-label promotion. TwIqbal.  They make up a core of our posts, yet we never seem to tire of them.  Maybe our readers, especially interlopers from the other side of the v., tire of reading about them, but we can often find a wrinkle in a case that merits our huzzahs or inspires a rant.  Today’s case falls into the praiseworthy category, as the court dismissed a complaint predicated on violations of the FDCA in spite of sympathetic allegations that might have carried the day with some other courts. Markland v. Insys Therapeutics, Inc., — F. Supp. 3d –, 2017 WL 4102300 (M.D. Fla. Sept. 15, 2017), involved the alleged death of a patient as a result of respiratory distress from the defendant’s sublingual spray prescription painkiller drug, which she had started the day before.  Rather than offer the typical product liability claims under Florida law, perhaps because the labeling had extensive warnings on respiratory distress, plaintiff asserted only a claim for negligent marketing.  Calling it “negligent marketing” does not really identify what duty was allegedly breached, whether state law recognizes a claim for such a breach, and such a claim would be preempted.  The allegedly actionable conduct in Markland was promoting the drug for off-label use, like the chronic back pain of plaintiff’s decedent, as opposed to the approved indication for breakthrough pain with cancer.  While we do not know the merits, there were many allegations about off-label promotion, which seem to tie to the conduct at issue in well-publicized federal and state investigations.

Defendants moved to dismiss on various grounds, the most relevant of which (for our purposes) were that there was no claim under Florida law for this conduct and it would be impliedly preempted under Buckman anyway.  These had been hot topics recently in some Florida state and federal cases we have discussed, like Mink (here and here) and Wolicki-Gables, but those dealt with PMA devices and the additional issue of express preemption.  Here, with a prescription drug marketed under an NDA approval, there is no express preemption to navigate, but the plaintiff still had to walk a narrow path to state a claim that would not be impliedly preempted.  As we have said before, we think the appropriate order of analysis here would be the determine if there was a cognizable state law claim asserted and then determine if it was preempted, but the Markland court did not separate out its analysis.  It also did not weigh in on whether the allegations here were of truthful off-label promotion that might implicate First Amendment protection.  Instead, it assumed that the off-label promotion alleged violated the FDCA’s prohibition on misbranding.  2017 WL 4102300, *6 & n.4.

The court could take this approach because the plaintiff’s claim was so squarely focused on alleged violations of the FDCA.  Since Buckman, plaintiffs tend to be a bit cagier in making it look like their claims were not predicated on violations of the FDCA or fraud on the FDA.  The Markland plaintiff, however, labeled the defendant’s alleged conduct as violating the FDCA, “federal law,” and “requirements imposed by the FDA regarding the condition that this drug should be utilized to treat cancer patients with breakthrough cancer pain.” Id. at *9.  “Hence, [the claim], while framed in the language of negligence, appears to derive from [defendant’s] alleged off-label promotion of [the drug]” and “the very concepts of off-label use and off-label marketing are born out of the FDCA.” Id.   This was well phrased, as was the later statement that “it is only because of the existence of the FDCA’s restrictions on off-label marketing that Mr. Markland claims [defendant’s] actions were improper or otherwise violated a duty.” Id.

This is the recipe for implied preemption under Buckman.  It also means there is no negligence claim under Florida law, “which bars plaintiffs from using state negligence actions to seek recovery for FDCA violations.” Id. at 10 (citing negligence per se cases).  Of course, Buckman recognized that the FDCA does not provide for a private right of action, and preempts claims with FDCA violations as “critical element[s],” which should prevent such piggybacking.  So, plaintiff’s case was done and could not be revived by amending the complaint.  In other words, there was no need for a second and third strike before judgment could be entered.  This was so despite the Court’s expression of compassion:

The Court does not question for a moment the grievous nature of Carolyn Markland’s death, nor the deep sadness Mr. Markland must face on a daily basis as a result of his wife’s untimely passing. Nonetheless, the Court must act within the bounds of the law.

Id. at *11.  This a good lesson, especially for courts sitting in diversity, that the law should not be expanded to allow for recovery by sympathetic who cannot make their case under accepted tort theories.

 

Normally, when we think of decisions relating to medical monitoring, the issue is whether a state will recognize medical monitoring for uninjured people as a separate claim or relief that can be sought under an existing theory of recovery.  Just last month, we noted that it looked like the issue had been largely resolved against allowing such claims or relief.  Sometimes, the issue is whether the plaintiff sufficiently pleads the elements of a medical monitoring claim in a jurisdiction that recognizes it.   Today’s case involves a different consideration of medical monitoring, looking at whether the requirements of Fed. R. Civ. 23 are met and a medical monitoring class can be certified.  There is quite a bit to Barraza v. C.R. Bard Inc., No. CV16-01374-PHX-DGC, 2017 WL 3976720 (D. Ariz. Sept. 11, 2017), and we are only going to focus we find most interesting.

Barraza comes from an IVC Filter MDL, which has been the source of some other decisions that drew our interest, and ultimately focused on the question of whether class certification was appropriate for eleven separate classes, each for the residents of a state that has recognized medical monitoring and had a resident proposed class representative.  Each class sought medical monitoring for people with one of seven of the defendant’s IVC filter devices in-place (after being implanted at any time) who had not brought a case alleging personal injury.  In other words, these were to be classes of uninjured plaintiffs with on-going use of the allegedly defective devices.  (Note that the proposed class definition does not expressly exclude all patients claiming current complications, but the court addresses the case as though it presents a “no injury” class, so we will too.)  Keep in mind that a common reason for rejecting medical monitoring has been that the tort system is predicating on an actual injury, giving rise to accrual of claims, damages that can be determined by somewhat predictable rules, a duty to mitigate, etc., and people who have not have an actual injury do not fit well within the existing tort system.  Someone with an actual injury, however, may be entitled to compensation for on-going medical care to minimize the progression or sequelae of the injury.  With that in mind, we turn to the evaluation of whether individual considerations or common issues predominate in trying to decide the elements of medical monitoring—as identified by the plaintiffs based on an amalgam of the law of the eleven states.

We will focus on the elements that mattered to the outcome.  While plaintiffs argued that negligent design and failure to warn could be decided on common evidence, the court disagreed.  The seven devices were designed and launched over a more than ten year period and exhibited different design features, manufacturing specifications, and testing.  Similarly, the labeling for the devices differed depending on the date and product, but seemed to address the risks that plaintiffs claim required monitoring.  “Trial of a single class representative’s claim would not suffice because the representative would have received a different filter with different warnings than many members of the class.”  Similarly, the application of affirmative defenses like assumption of the risk and contributory negligence would also turn on individual evidence about what the plaintiff and her doctor knew and did.  The court noted how some of the named plaintiffs—putative class representatives—had ignored recommendations for medical follow up and removal of the device they claim subjects them to an increased risk of harm requiring monitoring.  Thus, individual considerations in evaluating liability predominated and “the classes cannot be certified simply because Plaintiffs allegedly face a common risk and need medical monitoring.”

The related issues of whether the proposed monitoring was necessary and different from the treatment the plaintiffs would otherwise receive also turned on individual considerations.

Here, the amount of monitoring a class member would require in a normal course of her treatment and illness, without the monitoring sought in this case, is an individualized inquiry into the medical needs and ongoing course of treatment for each class member.

For instance, some named plaintiffs were already undergoing monitoring of their own doctor’s devising with different levels of compliance.

Even what law would apply to classes defined by the state of residency involved individual considerations as the state where each plaintiff’s implant surgery occurred, the state where the injury occurred, and the state where the defendant designed the products and drafted labeling could affect the law that would apply.

Put it all together and plaintiff did not come particularly close to satisfying the predominance requirement and class certification under Fed. R. Civ. P. 23(a).  (The plaintiffs also tried for certification of a 23(b)(2) class, but that was pretty much a non-starter as the relief sought—paying for monitoring—is not injunctive.)  Some of the result here is likely due to the plaintiffs’ insistence on broad classes and the selection of putative class representatives with warts, but Barraza also illustrates how class treatment of medical monitoring claims should be a long shot even when state law allows monitoring for uninjured people.

The cases we typically write about focus on events after medical products have made their way through the applicable regulatory process and been marketed in the United States.  The marketed product is used, people claim to have been injured by it, and they sue the manufacturer under various product liability theories.  Often, in the course of seeking lots of discovery about the product and manufacturer, the plaintiffs in such cases will seek documents relating to foreign regulatory submissions and interaction.  While there might be some relevance of such documents in some cases, getting and producing them tends a pretty big pain for reasons like privacy laws and translation.  Plus, there is plenty of room for confusion given different regulatory standards in the United States and elsewhere around the world.  Under the old version of Fed. R. Civ. P. 26, however, some degree of burdensome foreign discovery was pretty standard in large drug or device litigation.  We have seen some signs (like here and here) that the new version of Rule 26 will be less friendly to plaintiffs seeking foreign fishing expeditions.

Schueneman v. Arena Pharms., Inc., No. 10cv1959-CAB (BLM), 2017 WL 3118738 (S.D. Cal. July 21, 2017) (Magistrate order), aff’d 2017 WL 3587961 (S.D. Cal. Aug. 21, 2017), is a securities case based on the allegation that the defendant pharmaceutical company defrauded investors by its representations about the likelihood that its new weight loss drug would get approved by FDA.  The focus of the allegation is about tumors in a rat study that ultimately led to FDA issuing a non-approvable letter in October 2010.  (As an aside, the drug was developed with a serotonin receptor subtype mechanism of action that was supposed to avoid heart valve issues seen with other weight loss drugs, litigation over which included allegations about a signal from tumors in a rat study—although the main plaintiff expert supporting that allegation did not get past Daubert.)  The non-approval was made public at that time, although the plaintiff investors claim that they continue to have been misled for another three months.  (The decisions do not mention either, but there was a fair amount of press on the rat study in September 2010 and the drug was ultimately approved, after more research, in June 2012.)  In March 2012, the company submitted an application to the European Medicines Agency to try to market the drug in Europe.  After some back and forth, the company withdrew that application in May 2013.  (We are feeling parenthetical, so we will note that the withdrawal of the European application was also the subject of U.S. press attention, spurred on by Public Citizen, whose actions often seem coordinated with litigation efforts.)  The plaintiffs sought every document conceivably related to the European application and its withdrawal, even though the allegations in the case were about earlier representations about FDA approval.  Defendants balked and the fight was joined.

The requirement that discovery be “relevant to any party’s claim or defense and proportional to the needs of the case” allowed for a more rational analysis that we have seen in the past on such disputes.  Noting the “different standards utilized by the EMA and the FDA and the different time frames of the statements,” the court required plaintiffs to “explain how documents presented to the EMA, especially those unrelated to the Rat Study, are relevant to the issue in this case of whether Defendants ‘intentionally withheld information material to the market’s assessment of whether and when the FDA would likely approve [L]ocaserin.’”  2017 WL 3118738, *4.  Plaintiffs could not do that.  They also could not establish proportionality, a burden now assigned to the proponent of the discovery (although the posture here was a motion to compel rather than a motion for protective order).  Defendants had already produced or were producing lots of documents and estimated that a production of the documents at issue would take weeks and cost $80,000.  In the past, such a cost estimate for even marginal documents sought from a drug company would probably not be seen as an undue expense sufficient to cut off the discovery.  Now, in the age of proportionality, it is part of the puzzle:

Given the extremely broad discovery requests, including the fact that the requests are not limited to the Rat Study, the minimal relevance of the statements made after the class period in an application in the European Union involving drug standards that are different from those in the United States, and the large number of potentially responsive documents, the Court finds that requests 34-37 are not proportional to the needs of the case.

Id. Similar reasoning could be applied to disallow quite a few requests in drug and device product liability cases, particularly those on foreign regulatory discovery.

The defendant also forced plaintiffs to reveal the identity and contact information for six confidential informants relied upon for allegations in the complaint.  Plaintiffs claimed attorney work product protection, which the magistrate rejected and the district court found to be so frivolous as to merit the award of expenses under Fed. R. Civ. P. 37(a)(5). Id. at **6-7; 2017 WL 3587961, *2.  We cannot recall seeing a product liability plaintiff resist discovery on the basis for allegations in a complaint on a claim of work product protection, so we will not dwell on this holding—but the same reasoning would apply.  Rather than just sound like homers and cheer when a drug company wins discovery motions, we will say that we like it when discovery is ordered on the actual allegations in the complaint and limited on issues outside of the allegations in the complaint.

 

We have offered our view that cases seeking to impose liability based on well-known risks found with an entire class of prescription medications tend to be weak.  We think design defect claims usually are clearly preempted in this context and warnings claims will often be preempted too, even with Levine’s high “clear evidence” hurdle.  Cases about thrombotic risks with hormonal contraceptives have featured prominently in such posts, like this opus, precisely because design is not the issue and FDA has long been intimately involved with labeling of these products.

Another obvious fertile ground for preemption has been with gastrointestinal bleeding with anticoagulants, something of the therapeutic flip side to the risk of thrombosis.  First, it is a well-known issue.  Our quick PubMed searches easily got us to articles about this from the 1950s.  Second, this risk has been described in drug labels for a long time.  We easily found this as the first warning in prescription labels as early as 1998, although we suspect they had been around for a few decades by that point.  Third, this risk has been seen with every anticoagulant since there have been anticoagulants.  We have no doubt that any anticoagulant drug coming to market gets a thorough review of its bleeding risk and its labeling about that risk by FDA.  This surely includes attention to any differences in the labeling of the different anticoagulants and whether any post-approval studies or adverse events merit changes.  These facts should make it hard to articulate, let alone prove, a design defect claim that gets by Bartlett or a warning claim that gets by Levine, unless Buckman gets ignored.

We say “should,” but, in all fairness, it certainly depends on where the case is and who is deciding it.  Even in the nascent era of drug and device product liability litigation where cases should pretty much be in federal court unless they are in state court in the defendant’s true home state, the court can be all but determinative of the decisions on litigation-altering issues.  The selection of court can, in turn, depend on the selection of the MDL’s home in litigations where the lawyer advertising drums up enough cases to get the JPML’s attention.  We were going to contrast cases decided by different MDL courts overseeing product liability litigation over the bleeding risk of relatively new prescription anticoagulants.  Instead, we will be discussing one decision addressing allegations we think are pretty typical of what is getting offered up elsewhere and our dear readers can draw their own conclusions.

Fortner v. Bristol-Myers Squibb Co., No. 17cv1562 (DLC), MDL No. 2754, 2017 U.S. Dist. LEXIS 117030 (S.D.N.Y. July 26, 2017), comes out of the Eliquis MDL.  Based on the JPML’s statistics, when decided, there were 23 pending cases out of a total of 69 ever-filed cases in this relatively young MDL.  The drug was approved in 2012 with extensive warnings about the risk of bleeding.  Plaintiffs in the MDL offered various allegations about how the drug was defectively designed because it had a clotting risk, was not accompanied by a drug-specific clotting test, was not accompanied by an “antidote,” and was to be taken twice a day.  These same criticisms were offered as warnings claims, but there were no allegations that the manufacturer had received post-approval safety information triggering some alleged duty to try to change any aspect of the label through the CBE process.  The manufacturers challenged whether these allegations stated any state law claim that was not preempted and, before there was even an MDL established, dismissed a number of cases without prejudice in Utts I, which we discussed here.  After the MDL was established, the plaintiffs got another shot with amended complaints and still came up short in Utts II, this time with prejudice.  The court, in an exercise of magnanimity, invited the remaining plaintiffs to see if they could come up with complaints that stated a non-preempted claim.  That is how we get to Fortner, who alleged a variety of claims under Tennessee law based on the same allegations about the drug, manufacturers, and FDA that most of the remaining plaintiffs apparently offered.

As is often the case with pleading around statutes of limitation—complaints with dates for everything but when plaintiff’s alleged injury occurred—it looks like the fourth attempt at a complaint was modified to be vague, repeating allegations “in less detail and without identifying or appending the specific studies from which these allegations are drawn.” Id. at *7.  The Fortner court saw through this “pleading tactic” of “masking the basis for her claim”:  The complaint’s “claims do not become more plausible simply because the plaintiff has omitted from the FAC the sources upon which her conclusory factual allegations are based.” Id. at **7-8.  Well stated and clearly correct, but many courts let uncertainty work to the plaintiff’s advantage in this posture, despite TwIqbal’s requirement of factual allegations that plausibly state a claim.

The critical aspect of Fortner’s approach is that the court required the plaintiff to plead a warning claim based on “sufficient factual content to support a plausible inference that there exists newly acquired information such that the defendants could unilaterally have changed the Eliquis label to include additional warnings.” Id. at *8.  This, in turn, flowed from the court’s prior decisions holding that “post-approval failure to warn claims are preempted unless the plaintiff can plausibly allege that there existed ‘newly acquired information’ such that, pursuant to the Changes Being Effected (‘CBE’) regulation, the defendants could independently have updated the Eliquis label to include such warnings.” Id. at *5.  There is no such thing as a pre-approval warning claim—absent an allegation that the launch label resulted from fraud-on-the-FDA that side-stepped Buckman—so this is a pretty good statement of what a non-preempted prescription drug warnings claim should allege.

By contrast, under the court’s prior analysis, there is no such thing as a non-preempted post-approval design defect claim because “FDA regulations prohibit a change of the type implicated by the claim.” Id. Here, the first urged defect was twice daily dosing—which is a design issue if the plaintiff alleges the product should have been designed to deliver the effective dose by taking it once a day, for instance, and something that clearly cannot be changed without a new NDA.  The other urged defects are things we see as more labeling than design issues—lack of a drug-specific clotting test or an “antidote” to the drug that could be recommended or sold with the drug.  Even if such a test or antidote existed, it could not be sold with the drug based on anything the manufacturer could have done independent of FDA action.  In reaffirming its prior decision on the preemption of pre-approval design defect claims, the Fortner court noted that Yates was the only appellate court to address the issue and no binding authority disagrees with its analysis.

Based on a trio of preemption rulings at the pleading stage, it looks like the Eliquis MDL will be short lived.  That is not always the case with MDL proceedings based on dubious claims, where the burden of one-sided discovery and the weight of the docket tend to dictate the result more than anything approaching the merits.  In terms of issues that seem as obvious to us as preemption of pre-market prescription drug design defect—we note that “duh” and “no duh” mean the same thing, like “regardless” and “irregardless” or “flammable” and “inflammable”—it will help to have more appellate courts follow Yates.

 

Our day job has been keeping us busy, so busy with depositions, motions, delayed flights, and assorted drama that we have not posted in more than a month.  After such a long layoff, we had hoped to return with a vengeance, a “the North remembers” sort of vengeance.  Instead, we get fair market value, Current Procedural Terminology codes, and a Daubert challenge to a defense expert accountant.  Eh.  The decision is in a False Claims Act case about Medicare fraud and kickbacks, about which we care and have even spent some billable time.  But the reason we are writing about U.S. ex rel Lutz v. Berkeley Heartlab, Inc., No. 9:14-cv-00230-RMG, 2017 U.S. Dist. LEXIS 107481 (D.S.C. July 12, 2017), is because the rejection of opinions offered by the expert in this case undercuts the damages claims we see in other cases.

Lutz involves allegations that the defendants overbilled Medicare in connection with blood tests.  One part of the alleged scheme was that the defendant labs charged high processing and handling fees.  (We will ignore the issues of FCA materiality and causation that seem to flow from the absence of evidence of Medicare payment on processing and handling charges.) From what we can tell, the defendant’s expert opined that these fees were consistent with the fair market value—a defined term under the, aptly named, Stark Act—and did not represent kickbacks to referring physicians.  He offered a “charge-based methodology” to conclude that the fees were consistent with fair market value because physicians allegedly expected to recover for time spent on processing handling, not just for the actual blood draw.

“[I]t is no secret that the sticker price of services listed in physician bills and hospital chargemasters are totally unmoored from the reality of arm’s-length transactions actually taking place in the marketplace.” Id. at *12.  We think you can see where we are going with this.  In product liability cases, economic damages related to medical care, past and future, are typically based on amounts incurred.  The collateral source rule is often used offensively to create a windfall of the difference between the amount on the bills and the portion of that amount anybody ever paid or will pay.  We have called this “phantom damages.”  In FCA, RICO, and consumer protection cases, for instance, the plaintiff’s theory of price gouging or other impropriety sometimes relies on the list price of a drug or the amounts appearing on bills, regardless of what typically gets paid.  Although in the context of granting a challenge to an expert for healthcare providers that wanted the charges to matter, the Lutz decision supports the more typical defense position.

Actual transactions, not just bills, are a better indicator of fair market value because “physicians deliberately set their fees higher than the amount they either expect to receive or do in fact receive to ensure that no money is left on the table.” Id. at *16.  The court identified a number of decisions, from various types of cases, recognizing that “physicians’ billed charges do not necessarily reflect the market value of physician services.” Id. at **17-18 (citing cases).  So, the next time you have a case where the plaintiff says her damages include the total of all her medical bills and the only support she needs is her expert mouthing that “the charges were all reasonable and necessary,” think about whether Lutz and the cases it cites help you push back.  That was our return:  brief, a little bloody, and with the promise of more to come.

Earlier this week, we posted on the Ninth Circuit’s conversion of the Daubert’s gate (that the trial court should keep) into more of a swinging saloon door.  A week before the Ninth Circuit ruled that a trial court had erred in excluding unreliable causation testimony (and granting summary judgment as a result), the Third Circuit had affirmed a trial court’s exclusion of unreliable causation testimony (and grant of summary judgment as a result).  Even though we are discussing In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., __ F.3d __, 2017 WL 2385279 (3d Cir. 2017), second, it really is a bigger deal because it reaffirmed the end of an entire MDL.

We followed the district court’s Daubert rulings on the epidemiology and mechanism experts offered for all the plaintiffs.  We watched in amazement as the plaintiffs got to try again and still could not offer reliable expert testimony on general causation.   With our typical restraint, we applauded the court’s subsequent decision that no plaintiff could make out a case for general causation between maternal use of the drug and the cardiac birth defects claimed without the excluded experts and that was fatal to their claims.  We found that the plaintiffs, maybe because of the sympathy associated with their claimed injuries, got plenty of leeway before the court determined that there was simply no there (i.e., good science) there.  (Along the way, we saw that Pennsylvania and West Virginia state courts came to similar conclusions.)

The appeal to the Third Circuit focused on whether the biostatistician offered as a back-up expert on epidemiology was properly excluded, with plaintiffs conceding that they should have lost if he was.  Plaintiffs’ central contention was that the district court created a standard that requires general causation opinions to be “supported by replicated observational studies reporting a statistically significant association between the drug and the adverse effect.”  We think that standard, similar to Havner and Daubert II, is a fine standard, but the district court did not create or apply such a standard in knocking out the biostatistician.  Likewise, the Third Circuit declined to “state a bright-line rule” that “statistical significance is necessary to prove causality.”  (We think it is, because the Bradford Hill Criteria, which the biostatistician purported to apply, starts with an association demonstrated through epidemiologic studies.  We will try to resist arguing for the tighter standard given the result.)  The district court considered the lack of multiple statistically significant studies supporting an association to be contrary to what teratologists generally require and thus relevant to whether an opinion without such support was unreliable.  A flexible approach to evaluating the reliability of a general causation opinion was fine with the Third Circuit and its reading of the Bradford Hill Criteria.  (There is flexibility, but only when there is an association from epidemiologic studies as a predicate.  OK, we will have to try harder.)

The Third Circuit “accept[ed] that the Bradford Hill and weight of the evidence analyses are generally reliable.  We also assume that the ‘techniques’ used to implement the analysis (here, meta-analysis, trend analysis, and reanalysis) are themselves reliable.”  That assumption is dicta—which is a good thing—because the court concluded that the biostatistician did not reliably apply the methodology or techniques that he claimed to be applying.  First, he gave lip service to analyzing “multiple positive, insignificant results,” but he really just eyeballed trends.  Second, his trend analysis was based on cherry picking and inconsistent application of basic statistics principles.  Third, his meta-analysis was also result-driven, as he could not justify why he included some studies and excluded others.  Fourth, his reanalysis was done for no reason but to conclude that a published study reporting no association should have found one.  Altogether, “the fact that Dr. Jewell applied these techniques inconsistently, without explanation, to different subsets of the body of evidence raises real issues of reliability.  Conclusions drawn from such unreliable application are themselves questionable.”

The court probably could have stopped there.  It went on to detail how the biostatistician’s purported application of Bradford Hill was riddled with errors that he could not explain.  This was more than enough to conclude that the district court had not abused its discretion in excluding the expert.

Along the way, however, it noted that it may be possible to have a reliable reanalysis that draws a different conclusion than the original published study and that an expert can make unsupported assumptions in connection with doing an “informational” reanalysis.  It offered that “[t]hese inquiries are more appropriately left to the jury.”  We disagree and think the broader context has to be considered.  A plaintiff’s expert offered on the epidemiologic evidence who cannot offer a reliable opinion that there is an association between the exposure and the type of injury the plaintiff claims, let alone that there is a causal relationship, should not be talking to the jury about anything.  A plaintiff’s expert offered on the epidemiologic evidence who can offer a reliable opinion that there is a causal relationship between the exposure and the type of injury the plaintiff claims can be allowed to discuss the various analyses she did to form that opinion.  And the defense can cross-examine her on whether some of her analysis was result-driven for-litigation drivel or based on unsupported assumptions.  A jury can hear that sort of back and forth and decide what weight to give to the expert’s testimony on general causation.  However, no trial court should abrogate its gatekeeping role and let juries hear about reanalysis of published studies unless plaintiffs have reliable evidence of general causation in the first place.  I guess we prefer the opinions of the district court, which took its gatekeeping seriously, even if it let plaintiffs take a few shots at entry.

 

Parties often file motions in limine on fairly case-specific issues, building on the history of discovery and motions practice in the case.  Applying a ruling on in limines from one case to another can be a dicey proposition as potentially significant differences in the facts, law, claims and defenses asserted, and other rulings can usually be identified.  Plus, many pre-trial decisions on evidence do not last once doors get opening and evidence can be cumulative, among other reasons why judges’ minds change.  Still, we do posts on rulings on motions in limine that we guess might have some relevance to other cases our readers have.  When we do, we can be hamstrung by the limited information in these opinions on the facts, allegations, and other rulings, such as rulings on motions for summary judgment that would typically be rendered before the in limines are decided.

In In re Depakote, No. 15-CV-702-NJR-SCW, 2017 WL 2126837, *2 (S.D. Ill. May 16, 2017), we have rulings on a grab bag of motions in limine after the court issued partial summary judgment for the drug manufacturing defendant based on “preemption of label changes related to development delay” after fetal exposure of the medication.  If this summary judgment ruling sounds familiar, then you might need a hobby.  You also might have read any number of our posts on the Rheinfrank case and the ultimate affirmance of its preemption decision and defense verdict by the Sixth Circuit.  Like here, here and here.  As we said of the appellate decision, “The court held, ‘[g]iven, then, that as of 2008 the FDA did not believe the state of the data supported a developmental delay warning, it stands to reason that as of 2003, with even less data to go on, the FDA would similarly have rejected a developmental delay warning.’ Thus, Rheinfrank joins those courts that have drawn a preemptive line barring all plaintiffs who used a drug prior to an FDA insufficient evidence decision concerning the risk at issue.”  We also wondered how the case got to a jury given trial court’s preemption decision and the requirements of Ohio law.  We have similar wonderment at the instant case, which involved 2006 fetal exposure.  The decision is sparse on facts, but it is hard to imagine a viable product liability claim for the plaintiff’s injury when plaintiff cannot prove that the label in place when the drug was prescribed to the mother should have said something different about the risk of the injury in question.  Some sort of warnings claim seems to be pending, along with a claim for punitive damages.

With that background, we turn to the subset of the 28 total motions in limine that we think matter most.  First, consistent with the preemption ruling and the applicable regulation, plaintiff could not preclude the manufacturer from explaining that a proposed change to the label through the CBE regulation is still subject to FDA’s decision to accept, reject, or modify the proposed change.  2017 WL 2126837, *2.  What the CBE regulation has to do with plaintiff’s surviving warnings claim or whether it could have used (e.g., based on new evidence of safety) is unclear. Second, plaintiff’s red herring argument about whether FDA is required to do its own post-marketing studies did not preclude the defendant from presenting evidence that it followed labeling regulations.  Third, while the court allowed some speculative evidence from the plaintiff’s mother in connection with the inquiry on proximate cause for failure to warn—which should not happen unless a different developmental delay warning has been articulated—this opened the door to some amount of evidence on what she knew and how she behaved. Id. at **2-3.

As to the defendant’s motions, the post-conception labeling and regulatory communications were excluded and defendant agreed not to raise pre-conception discussions with FDA about labeling changes that were not yet approved. Id. at *3.  (With the limited information presented in the opinion, we cannot say if there was evidence that FDA rejected or discouraged whatever labeling change plaintiff was allowed to urge in the case.)  The court also excluded a 2009 FDA alert about the risk of birth defects with the drug, although plaintiff was allowed to discuss any pre-conception studies that went into the alert. Id. at *4.  Limiting warnings evidence to what existed before the prescription at issue makes sense, but it also makes sense that there needs to be a claim based on what the warnings should have said instead at that point.  Along those lines, plaintiff was not allowed to argue that the drug should have been contraindicated for use in pregnancy because plaintiff offered no expert who disclosed such an opinion. Id. (And such an opinion would have had some preemption problems, we think.)  Plaintiff was allowed, however, to offer evidence about foreign labels for the drug in place before plaintiff’s conception, holding that the manufacturer’s knowledge of these labels was relevant to its duty to warn. Id. at **7-8.  Breaking somewhat from its previously firm line on the irrelevance of the post-conception evidence to the warnings claim, the court did not foreclose the possibility that some post-conception marketing materials could be relevant if “they contain pre-2006 facts.” Id. at *6.  Again, we would think the pre-2006 facts would need to relate to whatever about the 2006 warnings for developmental delay that plaintiff was allowed to claim should have been different.

There was one last ruling that bears some discussion.  The defendant had pleaded guilty to a misdemeanor and paid a very, very large fine related to allegations of off-label promotion for use of the drug for schizophrenia and elderly dementia, which were not labeled indications. Id. at *9.  The plaintiff’s mother did not use the drug for these conditions and there was no evidence to “connect these activities with the 2006 Depakote teratogenicity warning.” Id. So, there was far too much prejudice compared to the probative value to let the jury hear about the plea or fines.  However, plaintiff was allowed to “introduce evidence regarding the off-label marketing and sales efforts . . . regarding bipolar disorder,” which was an indication added during 2006 (based on our quick look). Id.  The court saw this evidence as supporting plaintiff’s claim for punitive damages.  It seems to us that a plaintiff’s punitive damages evidence is not relevant unless it tends to show that the underlying conduct giving rise to liability was done with the requisite intent.  It does not sound like there is any connection between an alleged, non-preempted issue with the 2006 warnings for developmental delay and any off-label promotion issue, but maybe that link was just not spelled out in the opinion.