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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

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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”

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Today’s guest post is from Reed Smith‘s Micah Brown. He discusses a recent appellate decision that we think is counterproductive, in that it interprets the federal Anti-Kickback statute to preclude drug manufacturers from alleviating the high expense of breakthrough drugs that treat relatively rare medical conditions. As always our guest bloggers deserve 100% of the credit (and any blame) for what they have to say.

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Illustrating the principle that hard cases make bad law, a panel of the Second Circuit in July unanimously upheld a Department of Health and Human Services Office of Inspector General (“OIG”) advisory opinion that a drug manufacturer’s plan to offer significant cost-sharing support for Medicare beneficiaries who use a life-saving, but expensive, drug was unlawful.  The Second Circuit agreed with the OIG that the manufacturer’s proposal could constitute prohibited remuneration under the Federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b (“AKS”).  Pfizer, Inc. v. United States HHS, 42 F.4th 67 (2d Cir. 2022).  The manufacturer sought to cover Medicare patients’ Part D cost-sharing obligations for the drug – which were estimated at approximately $13,000 per year – but the OIG said “no thanks,” and the Second Circuit has affirmed that outcome.…

Continue Reading Guest Post – Second Circuit Rejects Manufacturer’s Plan to Share Cost of Expensive Drug with Medicare Part D Beneficiaries

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This is a guest post by Luther Munford, Butler Snow LLP, who comes to us fresh from the pelvic mesh wars.  He is grateful to Jin Yoshikawa of that firm for his help with this post. As always, our guest posters do their own work and thus deserve 100% of the credit (and any blame) for what they write.

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As previously stated, Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), has nothing useful to say about the FDA’s current system for clearing medical devices.  The 1982 world it describes disappeared decades ago.  This author’s article in the Food and Drug Law Journal, L. Munford, “Courts v. FDA: A Lesson from Pelvic Mesh Litigation on Relative Competence to Decide a Legal Question,” 76 Food & Drug L.J. 6 (2021), provides the details, and it is hardly alone in its conclusions.…

Continue Reading Guest Post − No One Should Ever Rely on What Lohr Says about FDA Device Clearance

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In our civil society, many non-governmental entities certify various things.  We’ve all heard of the Good Housekeeping Seal of Approval, which has been around for over a century.  Then there is Consumers Union/Consumer Reports – a magazine that does nothing but rate products, and recommends those it rates particularly highly rated or as providing a particularly good value.  There are a host of private standards testing organizations like the ASTM International, the American National Standards Institute, and the International Standards Organization, which in their respective fields create and maintain voluntary industrial standards for any number of commercially related operations.  These entities determine things such as what the “N95” in an N95 facemask means.  A myriad of other industry, medical, and online organizations certify and rate an almost endless variety of goods and services.  Heck, even lawyers get rated.…

Continue Reading Suing the Certifiers – A Dangerous Undertaking

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Particularly in economic loss class actions, we occasionally have to deal with claims involving the Magnuson Moss Warranty Act (“MMWA”).  Thus, we have covered MMWA issues before.  Here’s another one.  In In Re Hill’s Pet Nutrition, Inc., Dog Food Products Liability Litigation, 2022 WL 1641291 (D. Kan. May 24, 2022), the court held…

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We’ve seen a couple of decisions recently in which defendants raised the “commonly known” hazards exception for medical device labeling, so we thought we’d give it a look.

The FDA’s regulations for medical device labeling generally require that such labeling include “any relevant hazards, contraindications, side effects, and precautions.”  21 C.F.R. §801.109(c).  That requirement comes…

Drug & Device Resources

Bexis’ Book

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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