Massachusetts Federal Court In Multi-District Litigation Holds Under Six States’ Laws That Manufacturer Of Brand-Name Pharmaceutical Is Not Liable For Injuries Caused By Generic Equivalents Whose Manufacturers Were Required To Adopt Branded Manufacturer’s Allegedly Inadequate Warnings -

In In re Zofran (Ondansetron) Products Liability Litigation, 2017 U.S. Dist. LEXIS 130965 (D. Mass. Aug. 4, 2017), a multi-district litigation (“MDL”) in the United States District Court for the District of Massachusetts, parents and guardians of children with birth defects sued the manufacturer of a brand-name prescription anti-nausea drug, asserting claims for misrepresentation and negligent undertaking in promoting the drug off-label for pregnancy-related nausea and not adequately disclosing birth defect risks. A number of the plaintiffs alleged maternal exposure only to generic equivalents of the brand-name drug, but asserted the branded or innovator manufacturer was liable as it had “created a market” for pregnancy use, should have known generic alternatives would enter that market and knew generic manufacturers were legally required to copy the branded manufacturer’s labeling. Defendant moved to dismiss these “innovator liability” claims on the ground that its product had not caused plaintiffs’ harm.