Remove 2001 Remove Marketing Remove Testimonials Remove Trials
article thumbnail

Another RICOdiculous Decision

Drug & Device Law

341 (2001). The drug is still on the market, and it has other risks that the FDA has found significantly more serious – requiring a boxed warning – than a three-one hundredths-of one-percent (0.0003) increase in absolute incidence of bladder cancer. Plaintiffs Legal Committee , 531 U.S. You can see where this is going.

article thumbnail

Ruling On Motion To Dismiss In A Pennsylvania (Prescription) Device Case Takes Us Back

Drug & Device Law

After more than a month away at trial, we probably should not have picked a case that hit so close to home, so to speak. Instead, it looked to Pennsylvania’s ultimate requirement of proof of expert testimony to prove a prescription drug (!!!) Atrium Medical Corp. , — F. 3d –, 2022 WL 3357485 (E.D. Wyeth , 85 A.3d 3d 434 (Pa.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Confident Learned Intermediaries Defeat Warning Causation

Drug & Device Law

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. Confident learned intermediaries stand by their medical decisions. caused anything. 3d 87, 95 (Tex.

article thumbnail

The FDA and Feasible Alternative Designs

Drug & Device Law

In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.” For physicians to prescribe such a safer drug, it must reach the market. Wyeth Laboratories, Inc. , 2d 839, 851 (N.Y.

FDA 59
article thumbnail

No Expert Do-Overs

Drug & Device Law

In the middle was In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices. & Plaintiffs will not be heard to argue that they “could have shored up their cases by other means had they known their expert testimony would be found inadmissible.” Weisgram v. Marley Co. , 440, 455-56 (2000). Fru-Con Inc. , 3d 734 (7th Cir.