2022

Fallacious FDA Reporting Claim Finally Falls

By Eric Alexander on December 30, 2022

Product liability litigation over Class III medical devices is an interesting creature. Absent something unusual, cases and litigations should not get past motions to dismiss. That is pretty clearly what Congress intended when an express preemption provision was added to the Medical Device Amendments of 1976. We understand that each plaintiff may think her case is exceptional in that it should meet the exception to the rule of preemption. (We do not really think the plaintiff lawyers think that, although they sure argue it enough.) But the usual is more common than the unusual by definition. When you hear hoof beats, you should look for a horse not a zebra, unless you happen to be in a part of the world where zebras are endemic or end up in a zebra enclosure in a zoo. When you hear Class III medical device product liability case, you should look for all claims to be dismissed unless there is something as unusual as a basis to claiming the plaintiff’s particular device deviated from its FDA-approved specifications.

In 2001, the Supreme Court made getting past motions to dismiss harder when it held in Buckman that plaintiffs could not recover claims predicated on violations of FDA regulations. An unfortunate fiction developed post-Buckman—particularly after Riegel v. Medtronic, Inc. 552 U.S. 312 (2008)—that plaintiffs could assert “parallel claims” that were neither expressly preempted by the provisions of the MDA nor impliedly preempted under Buckman. We, and others, have described the purported path of a parallel claim as being like navigating between Scylla and Charybdis, a monster and whirlpool on opposite sides of a narrow strait per ancient Greek mythology. Without claiming that mythology is the same as fiction—we are not touching that with a twenty foot sarissa—we can say that a true parallel claim is as rare as a striped unicorn or perhaps a flying horse. The unfortunate fiction of which we spoke above has taken shape with particularly egregious appellate decisions like Bausch such that some trial courts are advised, when they hear the hoof beat of a Class III medical device product liability case, to expect Pegasus or his stripy, horned pal to gallop around the corner.

Viewed over the course of more than five years and many decisions, three of which have featured in prior posts (here, here, and here, which drew honorable mention honors in 2018), we think Bausch delayed the inevitable in Gravitt v. Mentor Worldwide, LLC, __ F.Supp.3d __, 2022 WL 17668486 (N.D. Ill. Dec. 14, 2022), by insisting that parallel claims for failure to report adverse events to FDA exist. After an unnecessary odyssey, the manufacturer of a Class III breast implant won summary judgment on the last of plaintiffs’ claims, alleged failure to report adverse events to FDA. (We say “plaintiffs,” but the decision referred to the plaintiff with the implant—who we will call the “plaintiff”—by her first name and the consortium plaintiff by his first name. In terms of whether the last claim was supported, the court referred the female plaintiff only and somehow omitted any reference to “burden.” These are usually signs that at least one claim will survive summary judgment.) A shout out to Dustin Rawlin and his colleagues for sticking it out on this case and sending us this decision.

The Thrill of Victory – The Ten Best Prescription Drug/Medical Device Decisions of 2022

By Bexis on December 29, 2022

So, another year has passed. 2022 is in the books and the republic still stands, even if Roe v. Wade (and, soon, Twitter) do not. The COVID-19 pandemic – if not COVID-19 itself, which has instead become endemic – is largely over, except for some probably PREP Act preempted shouting.

For the Blog, the end of the year means that it’s time for our annual celebration of the Drug & Device Law Blog’s top ten decisions of the year. Some of these cases establish important legal principles, such as preemption, Rule 702 expert exclusion (don’t say Daubert), or the learned intermediary rule. Others are important because they affect large numbers of cases gathered in the increasingly dysfunctional federal multi-district litigation system. Some do both. In either event, these decisions make the legal world at least somewhat less dangerous for our clients and (not incidentally) more favorable for us defense lawyers.

So Long to All that Junk

By Stephen McConnell on December 28, 2022

As we prepare to greet 2023, we find ourselves assuming the Janus-ian posture of simultaneously looking backward and forward. Forward is more fun, as we scan a schedule full of motions, MDL decision-trees, and trials in, er, challenging jurisdictions. But it really is folly to plan the future without learning from the past. It is hard to beat Bexis’s lists of the best and worst DDL cases, the latter of which graced us last week, and the former of which will adorn this blog tomorrow, for inventorying what happened and what mattered in our area of the law in 2022. We’ve also been asked in various fora and by various inquisitors to hold forth on trends we espy. Clients and colleagues demand analyses and prognostications. We’ve also worked up presentations for ACI, DRI, and in-house CLEs. As we draw a curtain on a very interesting year (African safari, new house, introduction to pond management, Phillies World Series, and clients who gave us the gifts of trust and humor), so we’ll share some top-line observations and suspicions with you, our loyal readers:

Since Covid-19 paid our society an unwelcome, prolonged visit, we’ve heard a lot about supply-chains. Enterprising plaintiff lawyers are exploiting the many residents of drug and device supply chains to gin up personal jurisdiction by finding local players (raw material suppliers, clinical trials, etc.) or bolstering liability theories by taking out of context Materials Safety Data Sheets that list risks relevant for OSHA but not FDA issues.

The assault on non-prescription products continues. Plaintiff lawyers seem to be paying more attention to over the counter and consumer products, alleging dangers from contaminants. These products have lots and lots of users (call them prospective clients), and there’s hardly a pesky learned intermediary in sight to get in the way of a failure to warn claim.

That assault is aided by “independent” laboratories that masquerade as public-spirited do-gooders, when they are actually in league with plaintiff lawyers and treat science as a game. These labs follow good lab practices erratically if at all, and certainly not good practices that would produce bad results for plaintiffs. The bottom line is that these not-so-independent labs would find contaminants, degradation artifacts, and/or asbestos in unicorn tears.

You got that reference to asbestos, right? The plaintiff playbook du jour comes from the talc asbestos litigation, and that litigation, in turn, is only the latest wave in the asbestos wars. If the first victim in war is the truth, then the asbestos wars have murdered truth, science, and anything approaching due process. Too many judges presiding over asbestos dockets have given up any gatekeeping, wave frail causation opinions along to juries, and grudgingly consider dispositive motions only on the eve of trial — all of which seems designed to force panic settlements.

As the asbestos model gets applied to other mass torts, we are starting to see an unfortunate feature of asbestos litigation crop up in those mass torts: the use of bankruptcy proceedings as a necessary refuge from a mass tort run amok. The availability of bankruptcy as such a refuge is replete with controversy, of course. Results have been mixed. The consequences of such bankruptcy filings are obviously profound for the debtor and claimants, but also pose complex implications for codefendants. Some have called such bankruptcy filings a scourge, threat, and mess, but they are really rational responses to a litigation system that has become a scourge, threat, and mess.

At the same time, some judges are willing to climb on top of the mountain of junk science and call a halt to the nonsense. Yesterday, Bexis summarized the Zantac MDL rulings on Rule 702 and summary judgment. The judge in that case did a heroic job of mastering the evidence and seeing the many ways in which the plaintiff experts practiced “situational science.” Even in advance of the new and improved Rule 702 expected to go into effect next year, the Zantac judge set the standard for testing whether plaintiffs met their burden of offering scientific opinion backed by rigor and reliability. That result should gladden the hearts of those who care about the civil justice system, but it should also remind defense lawyers of their responsibility to do the work necessary to reveal the shortcomings of the other side’s experts and provide the judge with the basis for closing the gate.

The Zantac decision was, without a doubt, a remarkable achievement. When a judicial opinion contains over 300 pages of erudition, one tends to sit up and take notice.

Zantac Chronicles – Concluding Chapters in the MDL

By Bexis on December 27, 2022

What follows is from the non-Dechert side of the Blog.

In the Zantac MDL, the plaintiffs’ causation problems were plainly visible on the horizon, as we mentioned in our post last year about the Zantac ruling on medical monitoring, In re Zantac (Ranitidine) Products Liability Litigation, 546 F. Supp.3d 1152 (S.D. Fla. 2021). The Zantac MDL plaintiffs’ claims regarding risk of injury and exposure levels to purported ranitidine-derived nitrosamines (“NDMA” for short) seemed not only trivial, but in many ways bizarre (use of extreme temperatures and other parameters). They even relied on a retracted study. That’s why we referred to the “wheels coming off” the plaintiffs’ scientific case in that post.

Now the plaintiffs’ wheels are fully off in Zantac MDL – as we mentioned before, all of their causation experts for the five types of cancer that plaintiffs themselves considered the most plausible have been excluded under F.R. Evid. 702, and summary judgment entered. In re Zantac (Ranitidine) Products Liability Litigation, ___ F. Supp.3d ___, 2022 WL 17480906 (S.D. Fla. Dec. 6, 2022). This is a lengthy opinion, 341 pages in slip form. To keep this post as short as possible, we’ll be summarizing (at best) large parts of it.

Change of Venue Granted in D. Minn. Mesh Case

By Rachel B. Weil on December 23, 2022

We start this, our last post of 2022, by indulging in a few words about hope. Jumping way back, the story begins when we were around 20 and moved to Nashville (from Philadelphia) for a couple of years, on a whim. That’s the only way to describe it – there was no good reason, except that we thought it would be fun. While we were in Nashville, we made some friends who were then big names in the country music industry. They are still our friends, more than 40 years later. And, though many have forgotten them, they still perform, but at coffeehouses and “small dates,” not in huge auditoriums. Last week, one of our friends, who still lives in Nashville, did a “swing” of four such small dates in Pennsylvania and its environs. She (and her guitarist) stayed with us all week. On the last night, we held a house concert in our home. As we sat in our living room, surrounded by friends and fellowship and oh-so-beautiful music, we felt magic, and we felt hope, both of which have eluded us amid the multi-faceted darkness that marked much of 2022. Bottom line is that we don’t always have choice in the events that shape our lives. But we can choose music, and we can find hope. We hope your 2023 is filled with both.

The plaintiff in today’s case also was denied choice, this time her choice of the venue for her case. In Yumei Li-Bachar v. Johnson & Johnson, et al., 2022 WL 17094600 (D. Minn. Nov. 21, 2022), the plaintiff, a Michigan resident at all times relevant to the lawsuit, was implanted with the defendant’s pelvic mesh device in Michigan. Fourteen years later, she underwent revision surgery in Rochester, Minnesota. She filed suit in the District of Minnesota, asserting the usual litany of product liability claims, and the defendant moved to transfer venue to the Western District of Michigan.

The court explained that, under the “transfer statute,” 28 U.S.C. § 1404(a), it had broad discretion when considering a motion to transfer venue. The court continued:

The decision to transfer under Section 1404(a) involves a two-step inquiry. First, the district court must determine whether the action might have been brought in the proposed transferee district. Second, the district court must weigh three factors, which are whether transfer would be (1) convenient for the parties, (2) convenient for the witnesses, and (3) in the interests of justice.

The Agony of Defeat -The Ten Worst Prescription Drug/Medical Device Decisions of 2022

By Bexis on December 22, 2022

It’s that time of year again – time to review drug and medical device product liability litigation during 2022 and select the year’s ten worst decisions. Frankly, it’s not that hard to do – they reek to high heaven, so they are pretty easy to find. What’s harder is finding the motivation to write about decisions that we find profoundly distasteful for one reason or another. It’s fun to write about wins, but not about losses, so watch for decisions we might not have addressed previously.

S.D. Texas Says Nay to Doctors’ Ivermectin Claim; Refuses to Rein in FDA Criticisms of Ivermectin Off-Label Use

By Stephen McConnell on December 21, 2022

Apter v. United States, HHS, 2022 U.S. Dist. LEXIS 225612 (S.D. Texas Dec. 6, 2022), is yet another ivermectin case, but with a twist. Most of the ivermectin cases we have seen involve Covid-19 patients or their representatives complaining that they were denied ivermectin treatment by hospitals or doctors who insisted on following standard medical practice, which deems ivermectin to be ineffective against Covid. But in Apter, the plaintiffs were three doctors who sued the FDA and some of its officials, claiming the doctors’ ability to practice medicine was impaired by the FDA’s statements criticizing off-label use of ivermectin for Covid-19. The plaintiffs pointed to several statements issued by the FDA counseling against the use of ivermectin to treat or prevent Covid. They also pointed to republications of such FDA anti-ivermectin statements. For example, they cited a tweet/LinkedIn post/Facebook post that reads, “You are not a horse. You are not a cow. Seriously, y’all. Stop it,” which links to an FDA article. It is nice to see that the FDA enjoys equine jokes as much as we do.

While the plaintiffs acknowledged the FDA’s authority to regulate drugs (they get no credit for that; it’s like Margaret Fuller’s announcement that she “accept[ed] the universe,” and Thomas Carlyle’s retort that “By Gad, she’d better!”), they argued that the FDA lacked authority to “prohibit, direct, or advise against off-label uses of drugs approved for human use.” The plaintiffs relied on 21 U.S.C. section 396, which provides that nothing in the federal Food, Drug and Cosmetic Act “shall be construed to limit or interfere with the full authority of a health practitioner to prescribe or administer any legally marketed device for any condition or disease within a legitimate health care practitioner-patient relationship.” Did you catch the word “device” in that quote? The plaintiffs did, but nevertheless contended that section 396 also applies to the prescription and administration of drugs. We have some sympathy with the overarching notion that the FDA does not regulate the practice of medicine, and we certainly have expressed some skepticism about some of the FDA’s efforts to limit off-label prescriptions (inasmuch as some of those off-label prescriptions are necessary and are within the standard of care), but we have little sympathy for the ivermectin pro-conspiracy and anti-vax crowd, and even less sympathy for the plaintiffs’ statutory construction in Apter.

Be that as it may, the plaintiffs in Apter asserted five claims for relief: (1) ultra vires acts by the FDA; (2) violation of the Administrative Procedure Act (the good old APA – taking us back to a third-year law school class we thought had been safely packed away in our life experience attic forever) by virtue of the FDA acting in an “arbitrary and capricious” fashion; (3) violation of the APA by virtue of the FDA acting “not in accordance with law,” which seems like a clumsy catch-all; (4) violation of the APA by virtue of the FDA acting in “excess of statutory authority” (and now we sigh at the monotony and redundancy); and (5) declaratory judgment in accordance with all the other claims. The defendant filed a motion to dismiss the complaint. Purely on aesthetic grounds, Judge DDL (woe betide the plaintiffs’ bar if Judge DDL should ever actually ascend to the bench – the first dispositive motion wins!) would grant the motion. Purely on legal grounds, the non-fictitious judge in Apter did grant the motion.

The complaint in Apter was structured the way it was (ultra vires and APA) because the chief barrier facing the plaintiffs was sovereign immunity. The plaintiffs were suing the United States which, like the rest of us, does not enjoy being sued but, unlike the rest of us, cannot be sued absent the existence of consent. A waiver of sovereign immunity cannot be implied. It must be expressed unequivocally. One way for plaintiffs to overcome sovereign immunity is to claim that the governmental body acted ultra vires. If a governmental officer acted beyond statutory limitations, such action is considered that of an individual, not the sovereign. In Apter, the court held that the FDA did not act in an ultra vires manner, because section 396 prevents the FDA from interfering with the practice of medicine only with respect to medical devices. Remarkably, the Apter court’s analysis of this issue turned on another case’s employment of a “See” citation rather than a simple, straight-up citation to authority. That “See” meant that the other case (Fifth Circuit) had not quite cozied up the extension of section 396 to drugs. Don’t let anyone tell you that the Bluebook does not matter. Moreover, the Apter court simply did not believe that the FDA, which is charged with protecting public health, lacks any authority to make public statements in furtherance of that mission. At the same time, the Apter court allowed that the FDA “ should have been more prudent in their communications.” That, friends of the DDL blog, is dicta.

Eighth Circuit Upholds Jury Verdict for Plaintiff in Hip Implant Case

By Michelle Yeary on December 20, 2022

We think that a product can either be in a “defective condition unreasonably dangerous” or not in a “defective condition unreasonably dangerous.” But it can’t be both. Unfortunately, the Eighth Circuit did not see things our way in deciding defendant’s appeal in Bayes v. Biomet, Inc., — F4th –, 2022 WL 17661149 (8^th Cir. Dec. 14, 2022). This metal-on-metal hip implant case went to trial in October 2020 and the jury awarded plaintiff $20 million on a split verdict. The jury found in favor of defendant on strict liability design defect but for plaintiff on negligent design defect. The problem is under Missouri law, both causes of action require a finding that the product was in a defective condition unreasonably dangerous. Despite that, the Eighth Circuit was unwilling to find the verdict inconsistent or excessive.

While both causes of action require a defective condition unreasonably dangerous – in fact the exact same language was used in both jury instructions — there are differences between the claims. Which is where the court focused. In strict liability the product must be unreasonably dangerous “when put to a reasonably anticipated use.” Id. at *2. Negligence does not carry the same use requirement but rather requires a finding that the manufacturer failed to use ordinary care to design a reasonably safe product. Id. The Eighth Circuit found it was possible for the jury to have concluded there was proof the product was not used in a reasonably anticipated manner and therefore find for defendant on strict liability and against defendant on negligence which does not require the same element. Id.

Defendant argued that whether the product was put to a “reasonably anticipated use” was undisputed and should have been considered functionally stipulated. Defendant did not challenge reasonable use in its closing argument, but that was not enough for the appellate court. “The absence of contrary argument by [defendant] did not create a constructive stipulation obviating the necessity of a jury finding on an element of [plaintiff’s] claim.” Id. at *3. The court was also disinclined to defendant’s argument because at trial defendant offered evidence that the device was implanted not in the “optimal position.” So, evidence of medical misuse of the device ironically came back to disadvantage the defendant. Having introduced the evidence, the defendant could not complain on appeal that the jury might have agreed.

Blackburn – That’s Just Plain Wrong

By Bexis on December 19, 2022

We disagree with plenty of courts on plenty of things, but most of the time it’s at least arguably just a conflict with one of our pro-defense views. But occasionally, very occasionally, we run into a decision that’s just plain wrong on some factual or legal aspect. Blackburn v. Shire U.S., Inc., 2022 WL 16729466 (11th Cir. Nov. 7, 2022) (thankfully unpublished), is such a decision.

Shameless Plug – Anybody Need End of the Year CLE?

By Bexis on December 17, 2022

To anyone who needs a few more CLE hours before the end of the 2022, we wanted to let you know that sessions from Reed Smith’s recent Life Sciences CLE Week are now available on demand. Here are descriptions of the topics, and registration links.

The Ebb and Flow of the Law – A Year…

Drug & Device Law