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Generic Preemption Redux: Can Juries Deem A Drug Too Dangerous?

Executive Summary

Supreme Court will decide in Mutual Pharmaceutical v. Bartlett whether generic drug manufacturers can be sued for alleged design defects; at issue is whether a jury can determine that a drug’s risks outweigh its benefits.

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Preemption Preference: Supreme Court Seems Wary Of Having Jurors Override FDA Safety Decisions

During oral arguments in Mutual Pharmaceutical v. Bartlett, some justices seemed reluctant to close off a pathway for plaintiffs to seek compensation for generic drug injuries, but others indicated that it should be up to FDA rather than juries to make the call on whether a drug’s benefits outweigh its risks.

FDA May Drop Generic Liability Shield, Allow ANDA Manufacturers To Change Labels

Solicitor General notes that FDA is considering changing its regulations in an amicus brief in Mutual Pharmaceutical v. Bartlett; government says design defect claims against generic manufacturers are preempted by federal law in the case at hand but may be brought in other situations.

Post-Mensing Blues: Generic Mfrs. Still Face Product Liability Claims

While the Supreme Court’s ruling last year found that failure-to-warn claims against generic manufacturers are preempted by federal law, some courts have refused to dismiss all claims.

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