There are two main issues that make the eyes of your dutiful Drug and Device Law bloggers well up in frustration over In re Taxotere (Docetaxel) Eye Inj. Prods. Liab. Litig., No. 3023, 2025 U.S. Dist. LEXIS 233514, 2025 WL 3442731 (E.D. La. Dec. 1, 2025).
The first is a gut-level, “this is an
As we’ve discussed before, Florida’s offer of judgment statute has real teeth. Under the Florida statute (Fla. Stat. § 768.79), a defendant can recover its costs and attorney’s fees if the other side rejects the offer and ultimately recovers 25% less than the amount of the offer. The risk of paying the defendant’s attorney’s fees ought to be a meaningful deterrent to meritless claims.
In today’s decision, Jacob v. Mentor Worldwide LLP, 2025 WL 3134227 (M.D. Fla. Nov. 7, 2025) (rep. & rec.), the defendant made an offer of judgment under the Florida statute. But that didn’t deter the pro se plaintiff from pursuing her claim that a ruptured breast implant caused her to develop lupus-like symptoms. As we blogged about here, following a lengthy and tumultuous procedural history, the defendant ultimately prevailed on summary judgment. Prior to moving for summary judgment, the defendant made an offer of judgment of $3,500, which was the amount of its limited warranty for implant ruptures. After obtaining summary judgment, the defendant moved for its costs and attorney’s fees. Continue Reading Chomp Chomp – Taking a Bite with Florida’s Offer of Judgment Statute
We’ve blogged a lot recently about preemption and the dismissal of complaints alleging that certain over the counter products, including acne medications, sunscreens, antiperspirants, expectorants, and shampoos contain benzene. Almost a year ago we blogged about the dismissal of an OTC case involving medicated shampoo that allowed plaintiff leave to amend. Today’s decision, Pineda v. Lake Consumer Products, Inc., 2025 WL 2698991 (E.D. Pa. Sept. 22, 2025), is a mixed bag that addresses plaintiff’s amended complaint. It’s about coal-tar shampoos, which are known to include benzene and are subject to an FDA monograph that recognizes the naturally occurring presence of benzene in coal tar. Yet, shockingly, plaintiff filed a class action claiming she would not have purchased the shampoos had she known they contained benzene.Continue Reading OTC Preemption Letdown in the Eastern District of Pennsylvania
The preemption case du jour is Gregory v. Boston Sci. Corp., 2025 U.S. Dist. LEXIS 164801, 2025 WL 2452382 (E.D.N.Y. Aug. 25, 2025), in which the Eastern District of New York granted summary judgment on federal preemption grounds.
Every time we see a case that does that—upholds preemption on summary judgment—we wonder
We’ve blogged recently about good preemption decisions in the Filshie Clips litigation from the Southern District of Texas (per Bexis, “as good a PMA medical device preemption decision as a defendant has a right to expect”) and the Northern District of Georgia. Today we add another preemption win in the same litigation from the
Note: There is a table in this post that may be easier to view on a phone than on a computer.
Medical device preemption provides powerful protection from litigation involving Class III devices with premarket approval (or “PMA”).
These devices are a very small subset of FDA-regulated medical devices – around 1% — and they
We are medical device and pharmaceutical lawyers, so preemption is our thing. It may not make for scintillating cocktail conversation, but we find the intersection between Constitutional law (the Supremacy Clause and the federal/state balance of power) and public policy issues (health and safety, and regulation versus litigation as the best way to promote
It is looking very much as if the U.S. Supreme Court will hear a case this upcoming October term that will permit it, at long last, to inter the Chevron doctrine. Under that doctrine, if there is ambiguity about the scope of rule making powers provided to an agency by Congress, courts will defer to
This week my health care colleagues authored an industry trends report highlighting many of the major regulatory issues facing life sciences and health care companies in the coming year. The “Outlook: U.S. Health Care 2021” report includes sections on post-COVID trends and lessons learned, the future of value-based care, the intersection of health care and
This week we are pleased to report on yet another breast implant case in which a plaintiff’s effort to circumvent preemption failed. In Diodato v. Mentor Worldwide LLC, 2020 WL 3402296 (D. Md. June 19, 2020), the plaintiff brought manufacturing defect, breach of warranty, and failure to warn claims that were typically skimpy in