We generally keep our distance from medical cannabis/marijuana. We’re not one of those blogs. But if legal holdings of interest to us happens to involve cannabis, we will comment. Thus, we bring you Schmidt v. Schmidt, Kirifides & Rassias, PC, ___ A.3d ___, 2023 WL 7502499 (Pa. Commw. Nov. 14, 2023), holding that
Sometimes there are decisions that we begin to read with an expectation—perhaps based on a thumbnail from Bexis—that we will have a strong impression. Not surprisingly, the expected impression is usually negative. This was the case with Apter v. HHS, No. 22-40802, 2023 U.S. App. LEXIS 23401 (5th Cir. Sept. 1, 2023), which concerned
When we last commented on the Alliance for Hippocratic Medicine v. FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.”
Attempting to stay up on every filing in every medication abortion case could be a full-time job these days. We have one of those already, so we tend to stick to court rulings. The filings in the Fifth Circuit on the AHM appeal are something of an exception. In addition to party briefs, the
The federal government cannot compel pharmaceutical manufacturers to sell prescription drugs at a discount to unlimited numbers of pharmacies. That is the takeaway from the Third Circuit’s recent opinion in Sanofi Aventis U.S. LLC v. United States Department of Health and Human Services, No. 21-3167, 2023 WL 1098017 (3d. Cir. Jan. 30, 2023) (to
Today’s guest post is by Jim Fraser of Greenberg Traurig. Jim is a long-time product liability defense lawyer, but who also worked as a litigation attorney in FDA’s Office of the Chief Counsel (“OCC”). Utilizing his FDA perspective, he offers some useful suggestions on the regulatory aspects of defending drug or medical device product liability cases. As always, our guest-posters are 100% responsible for what they wrote, deserving all of the credit and (any) of the blame.
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Lawyers defending drug and medical device companies in product liability litigation routinely deal with FDA-related issues. For example, they present expert witnesses to testify that their clients complied with the applicable regulatory requirements, they move to exclude purportedly “bad” FDA documents (e.g., FDA Form 483s and Warning Letters), and they file summary judgment motions arguing that the FDCA or FDA regulations preempt plaintiffs’ claims.Continue Reading Guest Post – What a Product Liability Defense Lawyer Learned While Working for FDA.
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
An interesting issue recently arose (but was not resolved) in In re: Proton-Pump Inhibitor Products Liability Litigation, 2022 WL 2188038 (D.N.J. June 17, 2022) (“PPI”). The ability of an FDA expert witness to testify was challenged under 18 U.S.C. §207, a federal conflict of interest statute. We have never seen that statute invoked in connection with an ex-FDA witness before, and apparently neither has anyone else, since the opinion observes that “the fact pattern presented here is something of an unprecedented issue.” Id. at *4 (citation and quotation marks omitted). So we thought we’d alert our readers.Continue Reading Regulatory Witnesses – Something Else To Watch
Although it is not a drug/device case (if it were, we would have discussed it before now), the recent Supreme Court decision in Gallardo v. Marstiller, 142 S. Ct. 1751 (2022), raises some interesting issues that attorneys defending personal injury action of any sort should consider. Settlement of any personal injury case involving a
The Orthopedic Bone Screw litigation would never have occurred – and Bexis might never have found his way to prescription medical product liability litigation – if not for the Kessler-era FDA’s ill-considered salami slicing of the “intended use” of that product. In that instance, the FDA had limited its cleared “intended use” to disc spaces