In re Baycol Products Litigation Lawsuit

In re Baycol Products Litigation

• Product: Baycol (cerivastatin), a cholesterol-lowering statin

• Manufacturer: Bayer A.G. (SmithKline Beecham, co-developer and co-settling party)

• Court: United States District Court for the District of Minnesota

• Judge: Michael J. Davis (Senior Judge)

• Docket: MDL No. 1431 (01-md-1431)

• Outcome: settlement (2007)

• MDL status: terminated

The product

Cerivastatin, marketed in the United States as Baycol (and as Lipobay in some other markets), was a prescription statin — an HMG-CoA reductase inhibitor — intended to lower cholesterol and reduce the risk of cardiovascular events. Bayer A.G. developed and marketed the drug in the late 1990s, where it competed against the established statin portfolio. It was the most potent member of its class at the time: it bound its target enzyme with far greater affinity than the older statins, so it worked at doses far below a milligram, and it was one of the few statins that could be dosed in the microgram range.

The alleged harm

The injury at issue was the muscle toxicity shared by the statin class — myopathy and, in its most severe form, rhabdomyolysis, the breakdown of muscle tissue that can lead to kidney failure and death. Postmarketing surveillance showed that fatal rhabdomyolysis occurred at a frequency many times higher with cerivastatin than with other statins. The risk was concentrated among patients taking the highest dose and among patients combining the drug with certain other agents, above all the fibrate gemfibrozil. Bayer added a contraindication for concomitant gemfibrozil to the label, but that change came roughly 18 months after the interaction had been identified. By the time of the withdrawal, 31 deaths in the United States — together with a further 21 deaths reported elsewhere — had been linked to cerivastatin use, along with 385 non-fatal rhabdomyolysis cases. Documents later produced in the litigation also showed that the drug induced dose-dependent myopathy even when used alone. In August 2001, Bayer voluntarily withdrew Baycol from the market worldwide.

The litigation

Patients and their families filed products-liability claims in courts across the country, and more than 9,000 cases were centralized in the United States District Court for the District of Minnesota as In re Baycol Products Litigation, MDL No. 1431 (01-md-1431), before Senior Judge Michael J. Davis.

The disputes focused on the strength of the causal link between Baycol — particularly in combination with gemfibrozil — and the plaintiffs' muscle injuries, on the adequacy and timing of the warnings, and on what the company's own previously unpublished documents showed about the risk.

A termination committee was established in November 2006. A status report on the court docket dated January 30, 2007, recorded 3,067 settled cases and showed the active docket down from 9,100 cases to roughly 1,200, with the overwhelming majority of claims resolved by settlement between Bayer and SmithKline Beecham, on one side, and the claimants, on the other. The aggregate settlement total was recorded on the docket.

Resolution

The federal MDL was resolved by settlement in 2007 and subsequently terminated. The Baycol program is frequently discussed as an example of a mass tort that centralized quickly after a global withdrawal and was overwhelmingly resolved on the settlement track rather than through trials.