In a significant move to protect those harmed by generic drugs, the Food and Drug Administration (FDA) recently indicated its intent to create a new rule in which generic drug manufacturers would be required to modify and strengthen safety labels to warn of side effects that become known after the prescription medication is on the market. Currently, there is no FDA rule requiring generic manufacturers to do this.

Since 2011, generic drug manufacturers have enjoyed protection from lawsuits alleging failure to warn of known risks and complications of its drugs as long as the safety label matched its brand-name counterpart.  This protection came via a landmark ruling by the U.S. Supreme Court in Pliva v. Mensing (131 S. Ct. 2567, Jun 23, 2011).  In Mensing, the Court said that under current FDA rules and federal law, generic manufacturers are required to mirror the brand-name drug safety label.  The majority reasoned that imposing more requirements on the generic manufacturers would create an untenable conflict. The ruling has been under fire by consumer-rights advocates and pharmaceutical attorneys ever since.

The FDA’s proposal to change the drug-label rules for generics followed another Supreme Court ruling last month that further eroded consumers’ protection against harmful drugs.  In Mutual Pharmaceutical v. Bartlett, U.S. Supreme Court, No. 12-142. Jun 24, 2013, the Court precluded lawsuits against generic drug manufacturers for design defects in their drugs that caused harm to patients.  The Supreme Court’s rationale for this ruling was the same as for its ruling on warning labels – that the generic drugmakers are required to follow the design of the FDA-approved name-brand drug, and therefore, cannot be subject to suits that call for different designs.

The FDA’s proposed rule change, if approved, will have a significant impact on protecting consumers’ rights by barring manufacturers from dispensing new drugs into the stream of commerce without updated warnings. Approximately 80% of all prescriptions are filled using generic prescription drugs.  Experts anticipate generic drug manufacturers to mount a vigorous opposition.

Marc Grossman, a partner with Phillips Grossman, says the FDA’s action is critical.  “Because 80% of prescription medications taken in the United States are generic, the FDA’s action is essential to allowing people seriously injured by defective generic drugs to have their day in court.”

Phillips Grossman, PLLC, is a joint venture of Sanders Viener Grossman, LLP, and Phillips Law Firm, PLLC, with offices in Washington, New York, New Jersey, and California, and representing people from all 50 states and Puerto Rico. Phillips Grossman provides national representation for those injured by pharmaceutical drugs and devices. If you or a loved one have been injured by a defective drug or device, please contact the attorneys at Phillips Grossman at 1-800-530-9800 or for a free consultation.