Anne Bucher  |  August 18, 2014

Category: Legal News

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class action lawsuitsOn Friday, the Alabama Supreme Court held its ground in the controversial ruling against Pfizer subsidiary Wyeth when it ruled that prescription drug makers can be sued for damages allegedly caused by generic versions of drugs made by different companies.

The Alabama case involved the generic version of a drug called Reglan (generic metoclopramide), which is prescribed for acid reflux. After the plaintiff developed tardive dyskinesia, he filed a lawsuit against Wyeth, a subsidiary of Pfizer, alleging the drug maker failed to warn about the risks associated with long-term use of Reglan. Pfizer argued that it did not have responsibility for the plaintiff because he did not take the brand-name version of the drug.

In a 6-3 decision, the state’s high court held that the makers of the prescription drug Reglan could be found liable for failing to warn about the risks associated with metoclopramide, upholding its decision from last year. The Alabama Supreme Court’s decision is one of the few cases in which a court has held that the maker of a brand-name drug can be sued by a plaintiff who alleges an injury caused by the generic version of the drug.

The Alabama Supreme Court disagreed with Pfizer, finding that its argument “completely ignored the nature of prescription medication.” In its ruling, the court stressed the importance of drug warnings for the physician making the prescriptions. “When the warning to the prescribing health care professional is inadequate, … the manufacturer is directly liable to the patient for damage resulting from that failure,” the court wrote, noting that the current law requires brand-name drug makers to list the warnings before generic drug makers are allowed to do so.

Legally, the makers of generic versions of drugs cannot change their labels until the maker of the brand-name counterpart has done so and the change has been approved by the U.S. Food and Drug Administration (FDA). The Alabama court found that, under the current law, “it is not fundamentally unfair to hold the brand-name manufacturer liable for warnings on a product it did not produce.”

Wyeth expressed its disappointment at the Alabama Supreme Court’s refusal to refuse last year’s decision in the case, declaring the decision an “outlier” among those reached by other U.S. courts. “Virtually every other court that has considered the issue since the Alabama Supreme Court’s initial decision has rejected the assertion that brand-name drug manufacturers can be liable for injuries caused by a plaintiff’s ingestion of a generic drug product,” Wyeth said in a statement. “Those courts have recognized that subjecting brand-name manufacturers to perpetual liability for injuries resulting from generic products would stifle innovation, including the research and development of new life-saving medicines.”

Generic Drug Liability in the United States

In 2011, the U.S. Supreme Court ruled that generic drug makers cannot make changes to product labeling, even if they become aware of significant side effects, unless the maker of the brand-name version changes the label. The court also ruled that patients who allege they were harmed by generic drugs cannot sue the drug’s manufacturer if it used an FDA-mandated label. Essentially, this ruling means that generic drug makers should not be held accountable for failing to warn about drug risks.

However, the FDA is proposing a rule that will allow the makers of generic drugs to update their labels in response to new information about side effects and other drug risks. If the new rule is implemented, generic drug makers are likely to face liability in failure to warn lawsuits. Generic drug manufacturers have argued that changing the current regulations would substantially increase the costs of health care in the United States due to the possibility of increased litigation. Further, the generic drug makers argue that the proposed regulation change would cause confusion among consumers due to the different warning labels for the same drug.

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