We are delighted to report that we are in love. The object of our affection, named Luca, is eight weeks old and weighs 9.6 pounds. Yes, our new standard poodle puppy, trumpeted repeatedly to patient readers of these pages, is home. The couple-hundred-mile trip to pick him up was packed with excitement and anticipation
A few months ago, we reported on what we believed—and still believe—was an abusive application of offensive non-mutual collateral estoppel, Freeman v. Ethicon, Inc., 2022 WL 3147194 (C.D. Cal. 2022), which precluded those defendants in one of their numerous pelvic mesh cases from disputing at a jury trial certain factual findings entered by a
Few medical treatments suffer from an image problem as bad as electroconvulsive therapy (ECT). We remember when it was called electro shock therapy. We also remember its gruesome depiction in One Flew Over the Cuckoo’s Nest. But modern medicine has redeemed ECT. It can be a genuinely effective treatment for maladies such as depression
Only 37 days until this blogger heads back to her home away from home—Key West. My last trip to the island having ended exactly 105 days ago. So, as we were divvying up this week’s cases, it was a no brainer that I chose the case regarding whether the Lower Keys Medical Center
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
We are not the only ones who have pointed out that every new contraceptive for the last fifty years or so has been the subject of litigation and that it is not hard to see how the burden associated with such litigation, even if the manufacturer does well, discourages the development of new options. This
Okay, retail shelves don’t have eyes. We coined that phrase to mimic the title of the Wes Craven films featuring desert mutants and the horror they impose on unsuspecting travelers. We watched the original 1977 film The Hills Have Eyes while traveling a few years back and thought it was not that great. Imagine then
Fraud via omission of facts is a popular plaintiff lawsuit theory, but many of those lawsuits themselves suffer from the omission of plausibility and specificity. In Womack v. Evol Nutrition Assocs., 2022 U.S. Dist. LEXIS 145754 (N.D.N.Y. Aug. 16, 2022), the plaintiff filed a purported class action alleging that a manufacturer of energy drinks failed
Some of us DDL bloggers have admitted to occasionally choosing our subject case based on its length. In theory a shorter case is less complicated, has less to analyze, and takes less time to write up. In theory. In reality, if there is not enough “there” there, drafting a compelling post can require more creative
For a decision that affirmed not just a verdict, but an award of punitive damages, against a device manufacturer, Nicholson v. Biomet, Inc., 46 F.4th 757 (8th Cir. 2022), is not as bad as it could have been. That’s because most of the decision was about evidentiary rulings that the court found to be “harmless” error, and one might even have some benefit for our clients in the long run.
Still, Nicholson was pretty darn depressing.Continue Reading Nicholson – Not So Harmless
