Alabama Supreme Court: Brand Drugmakers Can Be Held Liable for Generic-Drug Labeling

Alabama Supreme Court basically say since Mensing doesn’t allow generic to change label, then the Brand Name Mfg (Innovator) is responsible for label that misleads doctors.
This ruling by a conservative state court shows how even conservative jurists are not will to stand by and allow the mechanical, unfair ruling by the SCOTUS Majority in Mensing to eliminate altogether an injured patient’s  right to recover when a label is inadequate.  

Here is the conclusion which tells you all you need to know —


We answer the question as follows: Under Alabama law, a brand-name drug company may be held liable for fraud or misrepresentation (by misstatement or omission), based on statements it made in connection with the manufacture of a brand-name prescription drug, by a plaintiff claiming physical injury caused by a generic drug manufactured by a different company.  Unlike other consumer products, prescription drugs are highly regulated by the FDA.  Before a prescription drug may be sold to a consumer, a physician or other qualified health-care provider must write a prescription.  The United States Supreme Court in Wyeth v. Levine recognized that Congress did not preempt common-law tort suits, and it appears that the FDA traditionally regarded state law as a complementary form of drug regulation: The FDA has limited resources to monitor the 11,000 drugs on the market, and manufacturers have superior access to information about their drugs, especially in the postmarketing phase as new risks emerge; state-law tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly and serve a distinct compensatory function that may motivate injured persons to come forward with information.  Wyeth v. Levine, 555 U.S. at 578-79.

FDA regulations provide that a generic-drug manufacturer’s labeling for a prescription drug must be exactly the same as the brand-name-drug manufacturer’s labeling.  The Supreme Court in PLIVA held that it would have been impossible for the generic-drug manufacturers to change their warning labels without violating the federal requirement that the warning on a generic drug must match the warning on the brand-name version, preempting failure-to-warn claims against generic manufacturers. 


In the context of inadequate warnings by the brand-name manufacturer placed on a prescription drug manufactured by a generic-drug manufacturer, it is not fundamentally unfair to hold the brand-name manufacturer liable for warnings on a product it did not produce because the manufacturing process is irrelevant to misrepresentation theories based, not on manufacturing defects in the product itself, but on information and warning deficiencies, when those alleged misrepresentations were drafted by the brand-name manufacturer and merely repeated by the generic manufacturer.