A California federal judge has remanded an Onglyza lawsuit to state court after finding that claims levied against distributor McKesson Corp. could be viable.
According to HarrisMartin.com, the case was initially filed last May in San Francisco County Superior Court. The complaint accused McKesson and the drug’s manufacturers – Bristol-Myers Squibb Co. and AstraZeneca – of misrepresenting the safety of Onglyza and concealing its alleged association with congestive heart failure, cardiac failure, and other adverse effects.
Defendants removed the Onglyza lawsuit to federal court on the grounds that the court had subject matter jurisdiction based on diversity of the parties, arguing that McKesson was fraudulently joined to destroy complete diversity. The plaintiff then moved to remand, asserting that McKesson has failed to show that his claim is impossible because sufficient discovery has yet to take place.
In ruling for the plaintiff, Judge Jon S. Tigar of the U.S. District Court, Northern District of California, found that the matter raised “complex issues of state law” that should be decided on the state level.
“California law remains unsettled on the question of whether a plaintiff may bring a strict liability action against a distributor who is not part of the vertical chain of distribution that provided a plaintiff with the product that caused him or her harm,” he wrote in his April 24th order.
“Similarly here, whether McKesson remains liable under Plaintiff’s strict liability theory remains a question properly decided by the state court,” Judge Tigar concluded. “That a defendant might be dismissed, particularly after a close call in an evolving area of state law, does not mean that the defendant was fraudulently joined. Rather, these are ‘complex issues of state law’ that should be decided in the first instance by state, not federal, courts.”
Onglyza was approved by the U.S. Food & Drug Administration (FDA) in 2009 to treat Type 2 diabetes. In 2014, the agency launched a review of Onglyza and other saxagliptin-containing medications after data from the SAVOR-TMI clinical trial indicated that patients treated with the drug were 27% more likely to be hospitalized for heart failure compared to those who were not. Saxagliptin also appeared to be associated with a higher risk of all-cause mortality.
In April 2015, the agency’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 14-to-1 to recommend that new information regarding a potential association with heart failure be included on the labels of all saxagliptin-containing drugs. Label modifications were made in April 2016.