In a controversial ruling, the Alabama Supreme Court allowed a man injured by a generic version of Reglan to sue the drug's brand-name manufacturer, Pfizer. Although this is not the first time a high court has taken this type of stand, it is still significant as courts face similar lawsuits across the country. Dangerous drug lawyers at Pintas & Mullins unpack this ruling and how the plaintiff won his case.
Reglan is a heartburn medication originally developed by Pfizer to treat gastric esophageal reflux disease (GERD) along with nausea, gastroparesis, and other heartburn-related issues. Among the listed side effects of Reglan include tardive dyskinesia, which is an irreversible disorder involving abnormal or delayed movement.
One heartburn patient in Alabama, Danny Weeks, developed tardive dyskinesia after taking the generic version of Reglan, called metoclopramide. Weeks sued Pfizer for failing to inform him and his doctor of the serious risks of long-term Reglan use. As the named defendant, Pfizer argued that it had no direct relationship with Weeks or his doctor since he was prescribed the generic version of the drug.
Big Pharma has been using this argument to protect itself from liability for decades, often with much success. The tides started turning in 2011, however, when the U.S. Supreme Court ruled that generic drug makers had to produce drugs with the exact same ingredients and labels as their generic equivalents. This shielded generic drug makers from injury liability, as they could not be held accountable for any failures to warn against risks. Thus, the generic version of Reglan that Week's was prescribed was, in accordance with federal law, the exact same drug as Reglan in every way.
Regarding Pfizer's argument denying direct relationships with its consumers, the Alabama high court noted that the company completely ignored the nature of its medications. The court stated that consumers (obviously) cannot buy prescriptions directly from drug makers - the only way to obtain medications is to be prescribed by a medical professional.
Further, the court stated that brand-name drug makers are indeed responsible for patient's injuries, if the patient was not adequately warned of the risks. In essence, Pfizer was told that since it failed to properly list tardive dyskinesia as a side effect on its labels, it should be held responsible for the damage done to unsuspecting patients.
This is a controversial ruling because of how prevalent these types of cases are in U.S.
courts. To date, nearly 30 other courts have made opposing rulings in favor of Big Pharma. Pfizer and other similar companies claim that being held responsible for injuries from generic drugs would "stifle innovation." Other courts can see right through this argument, such as the appeals court that recently allowed a drug claim against GlaxoSmithKline over the generic version of its drug Paxil. This case was filed by the widow of a man who took the generic Paxil antidepressant and later committed suicide.
The appeals court in that case ruled that since Glaxo was singularly responsible for the drugs' design and labelling, it was largely irrelevant that it not directly produce its generic version. There are some efforts being made to clarify this issue - the FDA, for its part, recently proposed a new rule that would allow generic manufacturers to add their own labels and warnings. This would be an important step forward, as most of the drugs consumed in the U.S. are generic, putting patients at risk of inadequate or out-of-date warnings.
Unsurprisingly, generic drug makers are less than thrilled about this proposal. They claim that it would add $4 billion to national health care costs. Where exactly this $4 billion would come from, however, remains unclear.