Search We the Jury

Over the past few months, Bexis, with the substantial help of several Reed Smith associates, has prepared a law review article – “Federal Preemption and the Post- Dobbs Reproductive Freedom Frontier” – which will soon be published in the Food & Drug Law Journal.  A draft of this article is now available on SSRN.

The core premise of Bexis’ article is very simple:  Once the FDA has said “yes” and approved a particular drug for a particular indication (“intended use”) for sale in the United States, federal preemption precludes any state from saying “no” and trying to ban that same FDA-approved drug.  It doesn’t matter whether that drug is morphine, methadone, minoxidil – or mifepristone.Continue Reading Mifepristone Manufacturer Wins First Round in West Virginia

One of the most fundamental limitations on tort liability – all tort liability – is that a plaintiff must suffer an injury before s/he can bring a lawsuit.  As Judge (later Justice) Benjamin Cardozo, held “[p]roof of negligence in the air, so to speak, will not do.”  Palsgraf v. Long Island Railroad Co., 162 N.E. 99, 99 (1928) (citation omitted).  Or, as Professors William Prosser and Page Keeton, put it in their treatise:Continue Reading Live Free, or at Least Have a Present Injury

Second chances, sure.  Two bites at the apple, we see it all the time.  Three strikes before you are out, fairly common.  But a fourth amended complaint to cure basic pleading deficiencies?  That seems overly generous by any standards.  Well, almost any standards because that is what plaintiff got in Greenwood v. Arthrex, Inc.…

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

We write on the heels of a long weekend layered with dogs and fun.  The National Dog Show, which you may have watched on TV yesterday, is held about ten minutes from our house, and a fabulous corded Standard Poodle named Joel, who just happens to be “family” (he is the sire of our gorgeous puppy, Luca) won Best of Opposite Sex two days running (and stayed overnight with us).  And two out-of-town handlers we know unexpectedly needed a place to exercise their charges, so we twice got to stand in our back yard while no fewer than seven show dogs, from ten pounds to 150 pounds, swirled around us.  We can’t imagine being much happier.

Layers of good mark today’s case, as well.  Arevalo v. Mentor Worldwide LLC, et al., 2022 WL 16753646 (11th Cir. Nov. 8, 2022), is a decision on the appeal of a Northern District of Florida decision we liked very much.  Arevalo is a pelvic mesh case.  The plaintiff alleged that mesh devices implanted to treat her stress urinary incontinence and pelvic organ prolapse caused her to undergo mesh removal surgery and to suffer a familiar litany of injuries.  The plaintiff’s general and specific causation expert was the ubiquitous Dr. Bruce Rosenzweig.  Among numerous other motions, the defendant moved to exclude Dr. Rosenzweig’s specific causation opinion as unreliable because Dr. Rosenzweig did not perform an adequate differential diagnosis.  The court granted the motion and excluded the specific causation opinions, holding that Dr. Rosenzweig “did not explain how he systematically and scientifically ruled out the other potential causes for the plaintiff’s symptoms.  Arevalo, 2022 WL 1673646 at *4.  The court then granted summary judgment for the defendant because the plaintiff could not reach the jury without expert specific causation testimony.  The plaintiff appealed to the Eleventh Circuit, and today’s decision is the result. Continue Reading Eleventh Circuit Affirms Exclusion of Flawed “Differential Diagnosis” in Pelvic Mesh Case

As we head past Halloween, your Reed Smith bloggers wanted to offer our loyal readers a treat: Reed Smith is once again offering its virtual “Life Sciences CLE Week” starting Monday, November 7. (See the end of this post for information on jurisdictions in which credit is offered. You can register for the webinars here.)

And we will now mix our holiday references to note that yes, Virginia, there is an Ethics Credit session.

Bexis will be kicking things off on Monday, November 7, at 2 p.m. ET with a presentation on “The Ebb and Flow of the Law – A Year of Drug, Medical Device, and Vaccine-Related Preemption Developments,” which will discuss significant preemption-related developments over the last twelve months, both favorable and unfavorable, in product liability litigation involving prescription drugs (including generics), medical devices, vaccines, and OTC drugs.

Next up, on Tuesday, November 8 at 12 p.m. ET, our colleagues Dave Cohen and Selina Coleman will discuss “Ethics and E-Discovery: Lessons Learned from the Alex Jones Cases and Others.” Dave and Selina will use the Alex Jones cases as a starting point for discussing Model Rules 1.1, 1.6, 3.1, 3.3, and 3.4 and other recent matters where sanctions or major fines were issued relating to discovery or information governance.

Continue Reading Shameless Plug: Reed Smith’s Virtual Life Sciences CLE Week

Recently, in describing a decision granting summary judgment in an IVC filter case, we identified some additional analyses we would have liked to have seen:

[W]hile interrelated, we think the concepts of a “compensable injury” and causation are separate.  For instance, an exposure might cause a risk of future injury, but state law may hold that such a risk without present injury is not compensable.  Or a subclinical injury like pleural thickening may not be compensable, in part because of the inconsistency with the principles of accrual of claims for statute of limitations purposes.  Is a medical procedure not required by specific symptoms—regardless of what caused them—itself a compensable injury?  We think not.  A surgery may be part of the damages allegedly related to an injury allegedly caused by the drug/device/exposure, but is not an injury in and of itself.  Gomez did not delve into this either.

That same day—but well after we had set our prescient post to publish—the court in Fuss v. Boston Sci. Corp., No. 2019-02348, 2022 Mass. Super. LEXIS 251 (Mass. Super. Ct. Oct. 20, 2022), did those same analyses in another IVC filter case.  Rather than fall prey to the post hoc ergo propter hoc fallacy that plagues plaintiffs’ causation theories in so many drug and device product liability cases, we will admit this is mere coincidence.  After all, compensable injury seems like an obvious threshold issue in an IVC filter case where perforation of the inferior vena cava (IVC) is the only claimed injury.

Given the facts of Fuss, we will go a step further and say that it would be better if there were a way to get rid of cases without compensable injuries without the time and expense of going through fact and expert discovery and briefing an all-issues summary judgment motion with accompanying Daubert motion.  After a pulmonary embolism, plaintiff had his IVC filter implanted by an experienced vascular surgeon in 2007.  It has remained in place, without embolism or any symptoms tied a complication, for the fifteen years since.  Then plaintiff saw a lawyer advertisement, was sent by lawyers to get a CT scan ordered by a doctor he did not know and never met, and brought a lawsuit over an alleged perforation.  After suing, plaintiff conferred with his implanting surgeon, who, with the benefit of an x-ray, concluded the filter was doing its job and required no treatment or intervention.  In deposition, plaintiff admitted that he had been asymptomatic.  After the parties completed discovery and teed up motions for both summary judgment and exclusion Massachusetts’s version of a Daubert motion on plaintiff’s catchall expert, plaintiff still had never received any treatment or intervention.Continue Reading No Muss, No Fuss In Disposing Of Litigation-Driven “Injury”

The defendants in Mixson v. C.R. Bard, Inc., ___ F. Supp.3d ___, (N.D. Fla. Sept. 16, 2022) (“Mixson I”), and Mixson v. C.R. Bard, Inc., 2022 WL 7581737 (N.D. Fla. Sept. 23, 2022) (“Mixson II”), by no means won everything, but what they won was more important than what they didn’t, so we’re OK with the results.Continue Reading Mixson Somewhat Mixed, But We’ll Take It

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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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