Generic Prescription Drug Injuries
If you take prescription drugs, the chances are that you are not using a name-brand drug, but are using a generic equivalent. In fact, current estimates say that seven out of 10 prescriptions filled in the United States are filled using generic drugs. Generic drug manufacturers rush in when a drug’s patent expires, selling a low-cost, but supposedly equivalent drug alternative. Generic drug manufacturers have claimed that they are immune to drug injury lawsuits, but a recent finding by a US District Court of Appeals extends legal action for drug injuries to people who use generic equivalents of prescription drugs.
If you have been injured by a generic prescription drug, you have legal rights. To learn more about those legal rights, please contact the pharmaceutical litigation lawyers at Schlichter, Bogard & Denton today.
Generic Reglan Lawsuit
A woman went to her doctor complaining of chronic heartburn and was prescribedReglan, generically known as metoclopramide. Her prescription continued to be reauthorized and refilled for four years. The woman developed tardive dyskinesia, a disorder that causes lack of muscle-control including involuntary muscle movements, which she claims is related to her long-term ingestion of Reglan. In response, she filed a lawsuit claiming that the drug’s manufacturers had failed to warn her about the risk of neurological disorder associated with long-term use of metoclopramide. The lawsuit named the drug’s original patent-holder, Wyeth Pharmaceuticals, and two generic manufacturers. Lawsuits against Wyeth and another generic manufacturer were dismissed when it was found that the woman’s pharmacy had only filled the prescription with a generic form of the drug, manufactured by Actavis.
Actavis attempted to have the lawsuit against it dismissed because, it claimed, it did not have the right to alter its label to include warnings that were not included in the label of the name-brand version of the prescription drug.
Generic Drugs: A Different Standard
In 1984, Congress passed amendments to the Food, Drugs, and Cosmetics Act to create a quicker method for the approval of generic drugs. Although the FDA approval process for new drugs remained the same, generic alternatives were allowed to be marketed after going through an abbreviated new drug application (ANDA) procedure. ANDA prescription drugs had to be the same as an already-marketed name-brand drug in terms of active ingredients, dosage, and most other characteristics. They didn’t have to do their own clinical trials, but had to carry labeling that “is the same as the labeling approved” for the name-brand drug.
Actavis argued that because its label had to be the same as the name-brand drug’s label, it couldn’t change its label without being charged with “misbranding” its drug.
The Court Gives Remedy to Generic Prescription Drug Users
However, the US Court of Appeals, Fifth Circuit, did not accept Actavis’ argument. It said that generic manufacturers have as much a duty to be pro-active in identifying and warning about potential drug dangers as name-brand manufacturers. It said that the regulations about the label for generic and name-brand labels being identical only applied to the ANDA process, and that once a generic prescription drug was approved, its label could deviate significantly from that of its name-brand equivalent.
Instead, the Fifth Circuit Court reiterated the central tenet of the Supreme Court’s finding in Wyeth v. Levine (March 4, 2009), ” it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times. It is charged both with crafting an adequate label and with ensuring that its warnings remain adequate as long as the drug is on the market.” The Fifth Circuit Court added in its own words, “the regulatory framework makes plain that manufacturers—name brand and generic alike—must act to warn customers when they learn that they may be marketing an unsafe drug.” Generic manufacturers are required to perform the same postmarket recordkeeping requirements and must report adverse events just like name brand manufacturers. As far as any possibility of misbranding, the Fifth Circuit Court said labeling changes would only be considered misbranding if they were inaccurate or not based on scientific evidence.
In short, the Fifth Circuit Court opinion says it doesn’t matter whether you used a name-brand or generic prescription drug, the manufacturer can still be held responsible if it knew of—and failed to warn about—a risk of serious injury.
If you have been injured by a dangerous prescription drug, it doesn’t matter to us whether you were taking a name-brand or generic version. The prescription drug liability lawyers at Schlichter, Bogard & Denton stand ready to help you. Please call or email us today for a free initial consultation.