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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…

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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

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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