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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.” 2003), aff’d , 810 N.Y.S.2d For physicians to prescribe such a safer drug, it must reach the market. 2d 506 (N.Y.

FDA 59
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Unimpressed Learned Intermediaries Defeat Warning Causation

Drug & Device Law

The prescriber’s] testimony, however, does not establish that he would have altered his prescribing conduct. Given this testimony, the plaintiffs could not “show that stronger manufacturer warnings would have altered the physician’s prescribing conduct.” Plaintiff] has not identified any testimony from [the prescriber] that. . .

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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.