When Should False Claim Act Complaints Be Dismissed? US Supreme Court Wants Government's Views
Solicitor General to weigh in on Gilead's petition asking court to clarify application of its Escobar decision; PhRMA and BIO say FDA, not jury, should decide whether company has complied with FDCA.
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US Solicitor General says facts lacking on what government knew about alleged product misrepresentations; FDA may be burdened with discovery requests if suit proceeds to discovery and trial.
While DOJ probes have declined in last few years, 13 of top 25 pharma companies are dealing with ongoing inquiries of marketing and pricing practices.
Supreme Court To Clarify Whether Manufacturers Are Shielded From Failure-To-Warn Suits When FDA Rejects Label Warnings
Merck v. Albrecht will resolve interpretation of high court's landmark Wyeth v. Levine ruling and could shield companies from certain litigation; case involves adequacy of Fosamax labeling of bone fracture risk.