The United States Supreme Court has made a ruling that has caused concern for people taking generic versions of drugs rather than brand-name drugs. In PLIVIA v. Mensing, which was heard in 2011, the Court found that federal statutes and Food and Drug Administration regulations pre-empt state tort claims.
This case involved two individuals who after being prescribed the brand-name drug Reglan, were actually given the generic version of the drug by their pharmacist. Several years of taking the generic drug led both to develop a severe neurological disorder and they sued due to inadequate warning labels. The brand-name Reglan had recognized such risk associated with long-term use and strengthened its labeling to convey the risk where as the generic brand did not.
The Court’s reasoning for not requiring generic drug manufacturers to comply with both federal regulations and state court judgments is because as the law stands they must use the exact same label as the name-brand equivalent and cannot change their labels unilaterally.
There have been attempts by consumer attorneys to try cases similar to that of Mensing by taking differing approaches such as distinguishing the claim from a label claim or by asserting the generic drug’s label was not updated quickly enough after the name-brand equivalent changed its labeling.
Since the decision in Mensing there has been some argument over whether failure to change generic drug labels liability is on the brand-name manufacturers, who responsible for changing the generic’s label. Some Courts take the opposite approach by holding that a plaintiff cannot sue the maker of a drug they never used.
Though Courts appear unwilling to in cases allow a plaintiff to bring suit against a brand-name manufacturer for claims about the generic version of its drug, however in Wyeth v. Weeks, the Court held that Alabama law permitted suits even by users of the brand-name’s generic version to bring suit for misrepresentations on the brand-name’s labeling.
In this case a consumer who developed a neurological disorder like that of the Mensing case but under these facts the plaintiff alleged that it was due to lack of warning of the risks associated with the brand-name Reglan that misled his doctor and led to excessive use of the drug beyond the period they knew its use to be safe.
It’s important to be well informed about the drugs your prescribed and the risks associated with them. There are benefits and disadvantages in choosing to use a generic version or a drug over the brand-name. Discuss the decision with your doctor or pharmacist when deciding whether to buy a generic version of a drug.