Alabama Court Will Reconsider Allowing Generic Reglan Lawsuits

The Alabama Supreme Court has agreed to hold a new hearing to reconsider its previous decision to allow generic Reglan lawsuits to proceed against Pfizer under the doctrine of innovator liability. Innovator liability would allow Pfizer to be sued by patients who were injured by generic copies of Pfizer’s drugs even if Pfizer itself did not manufacture the particular doses that caused the injury. The theory behind innovator liability holds that Pfizer’s duty to properly test its products and warn the public about their dangers extends to all consumers who take the drugs Pfizer invents, whether they buy those products from Pfizer or from another company.

Reglan patients suffer permanent disability

According to a company Reglan lawyer, over 6,300 complaints have been filed against Pfizer nationwide by patients alleging injury from Reglan or its active ingredient, metoclopramide. Serious side effects from Reglan include movement and neurological disorders such as akathisia (severe restlessness), dizziness, drowsiness, focal dystonia (uncontrollable muscle contractions), neuroleptic malignant syndrome (a potentially fatal autonomic condition accompanied by severe hyperthermia), and tardive dyskinesia.

Tardive dyskinesia is a disorder resulting in repetitive, involuntary bodily movements, often including facial tics like grimacing, tongue protrusion, lip smacking, puckering and pursing, and rapid eye blinking. The disease can also cause involuntary movements in the limbs, resulting in difficulty walking, and in severe cases can cause difficulty breathing, as well. Tardive dyskinesia and other movement disorders caused by Reglan can persist even after discontinuation of the drug and can be long-term or even permanent. Many patients who’ve filed Reglan lawsuits have been left permanently disabled by this condition.

Supreme Court rules out justice for Reglan generics victims

The United States Supreme Court held, in Pliva, Inc. v. Mensing, that producers of generic drugs cannot be held liable for failing to warn consumers of the dangers of their drugs because these companies are bound by FDA rules to issue the exact same warnings as their brand-name counterparts. According to this decision, the sole responsibility for updating product warning labels rests with drug inventors and innovators, not with third-party manufacturers. This decision meant that patients who developed permanent disabilities, like tardive dyskinesia from metoclopramide were unable to get compensation from the companies who manufactured and sold the dangerous drug without regard for public safety.

For many people injured by generic medications, this ruling meant that no one could be held liable for injuries and victims would be unable to seek compensation until Congress or the FDA acted to amend federal laws and rules to close the generics loophole. However, Under Alabama law, a third party can be held liable for injury if they provided false or misleading information that led to that injury, as Pfizer subsidiary Wyeth did in the case of Reglan. The Alabama Supreme Court ruled that since generic products are required to use the same warnings as branded products, it was foreseeable that doctors and patients would rely on the Reglan warning for assessing the generic products’ safety, meaning that Wyeth’s incomplete product warnings factually and legally caused injuries to consumers of generic Reglan. Therefore, Pfizer could be sued for those injuries.

Future of generic Reglan claims against Pfizer still uncertain

Pfizer asked the Alabama court for a rehearing, claiming that the decision to allow the Reglan lawsuits against Pfizer was extraordinary and went against the established body of law in other U.S. jurisdictions. Pfizer was granted the rehearing, and will be allowed to present oral arguments to the court in support of their position. If the court ends up reversing its decision, it will mean that consumers of generic products will be denied the legal protections that consumers of branded products currently enjoy.