Design Defect

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Back in the antediluvian era of the Bone Screw Litigation some 25 years ago, Bexis was responsible for crafting (and sometimes outright inventing, see fraud on the FDA) defenses for that then-unusual medical device-related mass tort.  One of the first post-MDL-remand Bone Screw cases involved a Louisiana statute, La. Stat. Rev. §9:2800.56, requiring that, for a product to be “unreasonably dangerous in design,” the plaintiff must establish that “[t]here existed an alternative design for the product that was capable of preventing the claimant’s damage” based on the statute’s risk/utility test.…

Continue Reading A Primer on Alternative Design

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As much as we liked those parts of In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, 888 F.3d 753 (5th Cir. 2018) (applying Texas law), that overturned a half-billion dollar verdict caused by a combination of attorney misconduct and judicial lassitude, we also recognized the problematic effects of certain other Fifth Circuit rulings in that decision.  While the good parts of Pinnacle Hip were good enough to win that decision a spot in our 2018 top ten cases, that decision’s adverse aspects were bad enough that it also landed on our list of 2018’s worst ten decisions.  Specifically we observed:

The most serious error the court made was refusing to apply established Texas law that comment k precludes strict liability across the board.  Pinnacle Hip ignored – really ignored − a half dozen prior decisions (including one of its own) on this issue.  Even if there wasn’t any precedent (which there was), expanding state-law liability where the state courts have not is not the job of a federal court sitting in diversity.

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Continue Reading Comment K, Presumptions, and Medical Device Design Defects Under Texas Law

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For many years, the “one-two punch” was our affectionate label for post-Mensing cases that prevent innovator liability and preempt generic liability.  But it’s been several years since we’ve used the expression this way because it was so effective in knocking out those cases, we just aren’t seeing them like we used to. …

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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 (8th 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.      …

Continue Reading Eighth Circuit Upholds Jury Verdict for Plaintiff in Hip Implant Case

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Some of us on the Blog are veterans of the original vaccine wars – those that preceded the enactment of the Vaccine Act, 42 U.S.C. §§300aa-10, et seq.  That litigation, involving DTP and certain other childhood vaccines, nearly destroyed this country’s ability to vaccinate its children against often deadly diseases – much to the delight of antivaxxers everywhere.  After Congress acted in 1986, much to the delight of everyone else, the Act’s alternative compensation system, combined with its strong preemption provisions restricting post-compensation system litigation have largely restored the nation’s childhood vaccine supply to a sound footing.  The Supreme Court did its part in Bruesewitz v. Wyeth LLC, 562 U.S. 223, 231-33 (2011), holding that the Vaccine Act preempted all design defect claims asserted by claimants who rejected Vaccine Act awards and sought to litigate their claims instead.…

Continue Reading Terrible Decision Contravenes the Vaccine Act’s Purpose and Would Gut Its Protections

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Two weeks ago, we decried the pattern that some courts follow in allowing shifting slates of boilerplate allegations to cases to discovery.  The decision in Corrigan v. Covidien LP, No. 22-cv-10220, 2022 U.S. Dist. LEXIS 210296 (D. Mass. Nov. 21, 2022), reminded us of another of our post-TwIqbal pet peeves:  when courts treat sweeping legal conclusions as if they were plausible factual assertions.  The basic allegations in Corrigan were that the plaintiff’s surgeon used defendant’s surgical stapler to perform an anastomosis—reattachment of two parts of the digestive tract—in connection with removing part of his sigmoid colon (for unspecified reasons, but often diverticulitis or cancer) and the anastomosis later leaked, leading to further surgical intervention.  As we said two weeks ago, medical device manufacturers are not insurers.  That makes sense because surgery on humans, even done by the best surgeons, in the best hospitals, and with the best devices and equipment, has less than a 100% success rate.  Anastomoses leak, infections develop, hernias recur, patients report post-operative pain, and all manner of complications and less than optimal outcomes occur.  A common refrain when scientists are presented with a surgical study reporting no complications or failures is that the study was too small, too short, and/or insufficiently rigorous.  Thus, a common procedure with a very high success rate will still generate large numbers of reported failures, like anastomoses that leak.  This is part of why rates, and particularly comparative rates, provide more useful information about devices and surgeries than do gross numbers.

Even more authoritative sources than this Blog agree with us.  FDA, for instance, makes clear that data from its Manufacturer and User Facility Device Experience (“MAUDE”) database “is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices.”  The reasons for this are not a secret:  “The incidence, prevalence, or cause of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use.”  Directly stated, “[t]he submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event.”  FDA’s description of the MAUDE database also makes clear in a number of places that the data may be outdated or incomplete for various benign reasons.…

Continue Reading Criticizing FDA Reporting Systems Should Not Be Enough To Plead A Warnings Claim

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Bexis has already plugged the Reed Smith Life Sciences CLE programs this week, so we won’t replug  — except to remind you that Rachel Weil and the drudge/author of this post will tomorrow discuss the taxonomy and tactics of warning causation.  We talk in terms of taxonomy because there are so many interesting variations of the contents of the warning, the relevant audience, doctors who read, who didn’t read, who already know, and who would like to have known, as well as the rules and burdens of proof in jurisdictions around this great, over-warned country. 

It turns out that Kentucky offers some good pro-defense law on warning causation but, then again, there is some weird, unnerving stuff courtesy of the Sixth Circuit.  Tune in tomorrow for details.  In the meantime, we (obviously) have a preference for clear rules, even though the muddy areas are (obviously) where good lawyers can make a difference and earn their money.

There’s nothing wrong with being obvious.  In today’s case, Adamson v. Lupin Pharmaceuticals, Inc., 2022 WL 3448044 (W.D. Ky. Aug. 17, 2022), we get a blissfully clear and obvious ruling from a Kentucky court, and it is in our favorite legal area, preemption, to boot.  The plaintiff in Adamson alleged that he suffered from Stevens-Johnson Syndrome (SJS) — a serious disease that causes the top layer of the skin to die and shed — as a result of taking generic amlodipine besylate.  If you are one of those folks wrestling with hypertension, you might have some familiarity with amlodipine. 

The Adamson complaint included a messy mixture of claims for failure to warn, negligence, negligent misrepresentation, defective design, and breach of warranties.  The defendant moved to dismiss the complaint on the ground that all the claims were preempted by federal law.  The court agreed with the defendant, dismissed the complaint, and did not waste any time in doing so.…

Continue Reading W.D. Kentucky Dismisses Amlodipine Claims on Preemption Grounds

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This post is from the non-Reed Smith side of the blog.

Defendants in Pizzitola v. Ethicon, Inc., filed motions to exclude two of plaintiff’s experts and both decisions (two orders issued) heavily favored the defense, rejecting recurrent design defect arguments by plaintiffs.

The product at issue is synthetic pelvic mesh.  Plaintiff’s first challenged expert was a gynecologic surgeon.  While is area of practice may overlap with issues in the case, his report went well beyond both relevant issues and his area of expertise.  Namely, plaintiff’s expert wanted to opine that lots of things were alternative designs that in fact were not.  Starting with a different medical procedure altogether.  “It is not an alternative design of any product.  In fact, it is not a product at all.”  Pizzitola I, 2022 U.S. Dist. LEXIS 184352, *6 (S.D. Tex. Oct. 7, 2022).  Plaintiff argued the testimony was relevant to a risk/utility analysis but showing that a different medical procedure may be safer, “does not affect whether a product has utility and/or risks.”  Id. at *7.  The decision to perform a different medical procedure lies within the medical judgment of the treating surgeon and has no bearing on the design of the device at issue.  Id. …

Continue Reading Two Strikes Against Plaintiff’s Experts in Texas Pelvic Mesh Case

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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