A little over a year ago, we discussed one of the best decisions we had ever read on why comparative risk claims – premised on a manufacturer’s alleged failure to warn that a competing product was supposedly “safer” – are both statistically invalid and practically impossible.  That decision, Nelson v. C.R. Bard, Inc., 553 F. Supp.3d 343 (S.D. Miss. 2021), explained at length both how product “comparisons,” if based on the FDA’s voluntary “MAUDE” adverse event reporting system are inherently suspect due to “informational bias,” id. at 355, and, if based on non-public information, would require access to unavailable information about competitors’ products.  Id. at 354-55.

Continue Reading More on Comparative Warnings

Maybe we have been doing this too long.  Or maybe, like the prequels, spinoffs, and reboots that are so prevalent among streaming entertainment options, there is just a lot of repetition.  In serial product liability cases, we hope that repetition leads to consistency of results or at least predictable rules of the game.  Consider the

This post is from the non-Reed Smith side of the blog only.

Mismatch your socks – you’re bold.  Mismatch your shoes – you’re frazzled.  Mismatch plates on a dining table – your creating ambience.  Mismatch your pizza with pineapple – well don’t knock it until you’ve tried it.  Treat the law like it’s your socks

We’ve seen a couple of decisions recently in which defendants raised the “commonly known” hazards exception for medical device labeling, so we thought we’d give it a look.

The FDA’s regulations for medical device labeling generally require that such labeling include “any relevant hazards, contraindications, side effects, and precautions.”  21 C.F.R. §801.109(c).  That requirement comes

Confident prescribing physicians and implanting surgeons are the best “learned” intermediaries.  They’re experienced at what they do and aren’t intimidated by plaintiffs’ counsel and their threats of malpractice claims if they don’t testify the way plaintiffs want them to.  Confident learned intermediaries stand by their medical decisions.  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.  Because we encountered many stand up learned intermediary surgeons in the Bone Screw litigation, several of the relatively early decisions from the 1999-2001 timeframe are Bone Screw cases.

Continue Reading Confident Learned Intermediaries Defeat Warning Causation

Under Fed. R. Evid. 9(b), “[i]n alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.”  In our sphere, federal courts are quite variable in how they apply this standard when deciding 12(b)(6) motions.  In particular, MDLs seem to have an unfortunate habit of allowing general allegations to support

We do not care much about car racing.  Sure, we have seen some parts of some races on television, had toy racecars in our remote youth, and have craned our necks to see a few fancy “street legal” versions zooming past.  However, we have never attended a race in person and do not follow any

A relatively short post about Greisberg v. Boston Scientific Corp., 2022 WL 1261318 (3d Cir. 2022), a short decision that came out the right way, but did so based on a problematic statute that creates a rebuttal presumption that warning labels approved by the FDA are adequate as a matter of state law.

The