Generic Drug Liability Considered by US Supreme Court

Drug manufacturing is a huge, lucrative industry. All too often, however, defective drugs cause horrific injuries to unsuspecting patients. The federal Food and Drug Administration (FDA) is charged with protecting consumers from dangerous drugs and inadequate labeling, but the agency is overmatched by drug corporations and reliant on their cooperation to ensure its standards are met. It is estimated that 75% of the market is dominated by generic drugs.

In most states (not Michigan, where drug makers have long had complete immunity for injuries caused by FDA-approved drugs) drug companies could be held accountable under state law if they unreasonably endangered patients. That changed last year when the US Supreme Court decided Pliva Inc v Mensing, a case dealing with the adequacy of warning labels on generic drugs. The Court held that FDA regulations on labeling requirements for generic drugs trumped state laws, effectively preventing injured patients from holding drug companies accountable in state courts.

The Supreme Court has now agreed to consider whether this protection should extend to defectively designed generic drugs. In Mutual Pharmaceutical Co. v Bartlett, a patient suffered blindness and severe skin reactions after taking a generic anti-inflammatory drug. A New Hampshire court, after hearing all the evidence from both sides, awarded her $21 million. The Court of Appeals upheld the award. Mutual is appealing because it does not believe it should have to be held accountable for its wrongdoing.

This latest development is another example of corporations attempting to restrict peoples’ right to jury trials. For years, access to justice has become more and more difficult as large companies are granted privilege and immunity. Contact your Senators and Representative and tell them “enough is enough.”