For several years now, the Valsartan MDL has been something of a poster child for the problems with modern serial product liability litigation. It started with questionable data coming out of a questionable lab, leading to publicity and regulatory actions that outpaced reliable evidence of increased risk from an alleged carcinogenic contamination. It snowballed
There is a reason the one-two punch – a jab followed by a cross – is one of the most common sequences in boxing. It’s effective. The boxer uses his lead hand to throw a jab which has two objectives – to assess the distance between the fighters and if done correctly to lift his
A month or so ago, we castigated some extremely poorly reasoned expert exclusion decisions in the Bulox v. Coopersurgical litigation. The end results weren’t horrible (p-side motions were denied), but th0se Rule 702 opinions completely ignored the changes wrought by the 2023 amendments to that Rule. It was so striking that we went on PACER to see whether defense counsel was to blame for any of that – they weren’t.
Well, today we’re cheering the latest decision(s) in the same litigation. Bulox v. Coopersurgical, Inc., 2025 U.S. Dist. Lexis 56370 (Mag. S.D. Tex. March 6, 2005) (“Bulox I”), adopted, 2025 U.S. Dist. Lexis 54755 (S.D. Tex. March 25, 2025) (“Bulox II”), is as good a PMA medical device preemption decision as a defendant has a right to expect. This Bulox decision should go a long way towards defeating the other side’s latest campaign to deprive women of contraceptive choice.Continue Reading Clip, Clip Hooray
Today’s case has shocking facts but not a shocking result. It should come as no surprise that a complaint attacking the safety of an FDA-approved Class III medical device is squarely preempted by the express preemption provision of the Medical Device Amendments, 21 U.S.C. § 360k(a). But somehow, 17 years post-Riegel, that still does not seem to deter plaintiffs from filing plainly preempted claims.Continue Reading No Shock Here: D. Mass. Holds Complaint Regarding Class III Medical Device Preempted
Taking pot shots at “Big Pharma” is easy. Crack a joke about Big Pharma and you are sure to get a laugh. Amirite?
That is not to say there is never a fair point or two to be made about pharmaceutical development or marketing, or health care and the delivery of same in this country.
Last summer, we gleaned the bitter fields of Davidson v. Sprout Foods, Inc., an opinion in which the Ninth Circuit allowed direct private enforcement of Food, Drug, and Cosmetic Act (FDCA) food labeling requirements because the class plaintiff used the fig leaf of California’s Sherman Act to do so. Our post about the Ninth
And patience is a virtue…all great achievements require time…trust the process. All easier said than done. Waiting can be a breeding ground for discouragement or frustration—like in litigation where, unfortunately for defendants that waiting usually comes at the significant cost of having to defend against and conduct discovery. Especially when the result after all
Rieger v. Medtronic Minimed, Inc., 2025 Cal. Super. Lexis 14 (Cal. Super. L.A. Cnty. Jan. 28, 2025), is an excellent PMA preemption decision from, of all places, Los Angeles County Superior Court, in California – home of the notorious “the Bank” courthouse. We have no idea whether Rieger was adjudicated in LA’s Central Civil West Courthouse, but that is the first thing we defense hacks think of when we see a “Cal. Super. L.A. Cnty.” citation.
But a few more like Rieger, and maybe we won’t any longer.Continue Reading Taking Preemption to the Bank
Prescription drug warnings require FDA approval which dictates what the manufacturer can say in the product’s labeling. An exception to the FDA-approval rule is the Changes Being Effected (CBE) regulation which allows a manufacturer to unilaterally change a drug’s warnings “to reflect newly acquired information” and where the revision would “add or strengthen a contraindication
Yes, we are the Drug and Device Law Blog. Yes, we at times stray into other areas when we think a decision has application to our DDL world. Yes, today’s case is about a “drug” product. No, today’s case is not about a drug for humans. In fact, it really isn’t about a drug at