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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.

Continue Reading Fallacious FDA Reporting Claim Finally Falls

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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.

Continue Reading Zantac Chronicles – Concluding Chapters in the MDL

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Earlier this year we blogged about the Lone Pine order entered in the Zostavax MDL that required those plaintiffs alleging that the anti-shingles vaccine caused them to get shingles (1,189 of them) to produce evidence of specific causation by means of a PCR test.  The goal of the Lone Pine order was to winnow out non-meritorious claims.  That was Part 1.  Defendant’s motion to dismiss all 1,189 plaintiffs because not a single one produced the required test result or even asked for an extension – that was Part 2.  Without evidence of specific causation, the court dismissed about half the cases in the MDL. 

Shingles are caused by the same virus that also causes chicken pox, although the adult disease shingles is much more dangerous.  The virus remains in the body for life and can either lie dormant or reactivate and cause shingles.  Almost everyone over the age of 30 in the United States has had chicken pox and therefore carries the “wild-type virus” in their systems.  In re Zostavax Products Liability Litigation, 2022 WL 17477553, *2 (E.D. Pa. Dec. 6, 2022).  The vaccine consists of the Oka strain of the virus, a live-attenuated virus that is a weakened form of the wild-type.  Defendant presented “uncontradicted medical authority” that the only way to know whether a person’s shingles was caused by the wild-type virus or the Oka strain is through a PCR test.  In fact, plaintiffs’ own expert testified that specific causation could only be determined with a PCR test.  Id.  That is the same expert who failed to perform a differential diagnosis ruling out the wild-type virus in 5 bellwether cases that were therefore dismissed on summary judgment.  That is what led to the entry of the Lone Pine order.  If none of the bellwether plaintiffs had sufficient causation evidence, the court wanted to know which plaintiffs did.

Continue Reading Lone Pine Stands Tall in Zostavax MDL — Part 2

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In a 341-page opinion, In re Zantac (Ranitidine) Products Liability Litigation, 9:20-md-02924-RLR, slip op. (S.D. Fla. Dec. 6, 2022), the MDL court held that all of the Zantac plaintiffs’ general causation experts (concerning five cancer types) failed to meet the admissibility standards of Fed. R. Evid. 702. Consequently the court granted the defendants’ motions

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In preparation for our OTC panel next week at ACI-NY, we have kept our eyes open for any OTC cases that raise interesting issues.  Today’s case, Rooney v. Procter & Gamble Co., 2022 U.S. Dist. LEXIS 210218 (E.D. La. Nov. 21, 2022), involves a claim by the plaintiffs that a woman developed triple negative breast cancer as a result of using an antiperspirant that she asserts contained benzene.  

The assertion that benzene was in the antiperspirant rested on testing by Valisure, an analytical pharmacy.   Some of you have heard of a Valisure before, as its testing, and results allegedly showing contamination, have been relied upon by plaintiffs in other mass torts.  Valisure calls itself “the pharmacy that checks.”  Perhaps we are cynical, but we think of a different sort of checks when we see a purported independent outfit that seems to cooperate closely with plaintiff lawyers. Here, Valisure ran tests on batches of the antiperspirant and came up with concentrations of benzene significantly higher than levels recommended by OSHA.  Valisure filed a Citizen’s Petition with the FDA seeking a recall of antiperspirant batches containing too much benzene.  (Sound familiar?) The FDA had not responded to the Citizen’s Petition.  The defendant voluntarily implemented a recall of certain batches of the antiperspirant.  

Before the court was the defendant’s motion to dismiss the plaintiffs’ second amended complaint.  The plaintiffs alleged that the defendant violated the Louisiana Products Liability Act by selling antiperspirants without issuing adequate warnings.  The plaintiffs also alleged that the defendant was liable under theories of negligence, gross negligence, strict liability, and “fault,” and that the defendant violated the FDCA.  Some of those claims seem weird (some of what’s missing also seems weird, but it’s not our job to help plaintiffs author complaints – our criticisms are strictly destructive), but remember, we’re in Louisiana.  Not that we’re complaining.  The people are fun, the food is great, and did we mention that the Judge in this case dismissed the second amended complaint?  

Continue Reading E.D. Louisiana Dismisses Antiperspirant/Benzene Claims

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In today’s case, Chapman v. AstraZeneca, a Delaware state court granted summary judgment to the defendant pharmaceutical manufacturer after excluding the plaintiff’s causation expert under Delaware Rule of Evidence 702 because the expert’s opinion was not “stated in terms of medical probability.”

The plaintiff claimed that the defendant’s proton pump inhibitor, a class of

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Confident prescribing physicians and implanting surgeons are the best “learned” intermediaries.  They’re experienced at what they do and aren’t intimidated by plaintiffs’ counsel and their threats of malpractice claims if they don’t testify the way plaintiffs want them to.  Confident learned intermediaries stand by their medical decisions.  Thus a confident learned intermediary’s testimony will defeat causation as a matter of law by stating that, notwithstanding a poor result, the treatment provided was standard of care, and even in hindsight they would not do anything different.  Because we encountered many stand up learned intermediary surgeons in the Bone Screw litigation, several of the relatively early decisions from the 1999-2001 timeframe are Bone Screw cases.

Continue Reading Confident Learned Intermediaries Defeat Warning Causation

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Under Fed. R. Evid. 9(b), “[i]n alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.”  In our sphere, federal courts are quite variable in how they apply this standard when deciding 12(b)(6) motions.  In particular, MDLs seem to have an unfortunate habit of allowing general allegations to support