On August 2, Sarah Scott authored "Plaintiffs' New Tactics for Saving Their Brand-Name Pharmaceutical State Law Design Defect Claims from Preemption and Defendants' Best, Albeit Surprising, Response" in DRI Raising the Bar, a publication for defense lawyers. The following is an excerpt:
"With their post-FDA design defect claims facing more and more challenges, plaintiffs have turned to a seemingly fantastical variation to these design defect claims. They now increasingly claim that the manufacturer should have changed the composition or dosage of a brand-name pharmaceutical before they asked for FDA approval. In other words, plaintiffs are claiming that manufacturers should have developed a different drug than they did. Following this logic, the manufacturers either should have submitted a different Investigational New Drug Application (IND) so that they could fulfill the required clinical trials to obtain FDA approval, or they should have stopped their clinical trials before requesting FDA approval and scrapped the drug they did manufacture to pursue a different IND for a drug with a different composition or dosage—all of which happened years before FDA approval."
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