This case arises from purportedly the largest healthcare fraud in U.S. history. The complaint – brought by a proposed class of health plans alleges that GlaxoSmithKline (GSK) fraudulently promoted its diabetes medication, Avandia, as reducing type two diabetics’ inherent cardiovascular risks. In reality, the drug does the opposite.
The complaint alleges the following: cardiovascular disease is leading cause of death for the 27 million Americans living with type-2 diabetes. Launched in 1999, GSK’s Avandia was considerable more expensive than metformin or sulfonylureas. Yet, it became the standard of care, bringing in billions annually, because GSK promised it would reduce type-2 diabetics’ inherent cardiovascular risks. Avandia does not reduce cardiovascular risk; it increases it. What’s worse, GSK knew this before it sold a single tablet of Avandia on the U.S. market. The company’s own clinical trials revealed Avandia elevated cholesterol ratios – a known risk factor for heart disease – and cardiac risk in type-2 diabetics. Yet, through a scientifically dishonest marketing campaign in combination with a selective publication strategy, GSK and its associates managed to conceal this lie for nearly a decade.
In 2007, the New England Journal of Medicine exposed GSK’s fraud. Two researchers aggregated data from GSK’s clinical trials and found Avandia was associated with increased, not reduced, cardiovascular risk. As a result of this revelation, the FDA required GSK to place a black box warning on Avandia’s label and Congress enacted a new law requiring pharmaceutical companies to disclose the results of all clinical trials. By 2012, GSK paid over $650 million to settle federal and state civil charges that it falsely promoted Avandia to physicians and other health care providers as providing cardiovascular benefits it did not. GSK also paid a $250 million criminal fine to settle charges that, between 2001 and 2007, GSK concealed data concerning the cardiovascular safety of Avandia.
In May 2010, health plans filed a class action lawsuit to recover for GSK fraudulent promotion of Avandia. They alleged violations of RICO and state consumer protection law. In the fall of 2010, GSK moved to dismiss the lawsuit. The district court denied that motion in October 2013. GSK filed an interlocutory appeal, but the Third Circuit affirmed the district court’s decision in October 2016. In 2017, the case returned to the district court for discovery. But before the plaintiff health plans could obtain discovery, the district court permitted GSK to move for summary judgment. At summary judgment, GSK asserted a preemption defense: that the FDA’s regulation of Avandia preempted the plaintiffs’ allegations that GSK should have warned of Avandia’s cardiovascular risks. GSK’s motion for summary judgment did not address the plaintiffs’ false marketing claims. Nonetheless, the district court granted complete summary judgment in GSK’s favor, ignoring the plaintiffs’ false marketing claims.
The plaintiffs are now appealing that ruling to the Third Circuit. The plaintiffs are also appealing the district court’s decision to seal the entire summary judgment record. Under the First Amendment right to access, these records should be disclosed.
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