Ranbaxy Laboratories Ltd.'s Atorvastatin Calcium Tablets IP Storvas 10 preparation container and tablets. Photo by Dhiraj Singh/Bloomberg

A federal judge in Trenton, New Jersey, has denied class certification in a suit by users of a drug made by Ranbaxy Pharmaceuticals that contained bits of broken glass.

The suit was brought on behalf of a potential class of consumers who may have purchased tainted Atorvastatin pills and want their money back. Certification was denied because figuring out which consumers were sold the contaminated pills would require conducting a minitrial for each plaintiff, U.S. District Judge Peter Sheridan said Nov. 13 in Fenwick v. Ranbaxy.

After workers noticed in September 2012 that an ingredient in Atorvastatin contained blue particles of glass, Ranbaxy instituted a recall of the tainted drugs from retailers but did not attempt to recall them from consumers. Before the recall, the pills that may have contained glass particles were shipped to pharmacies and mixed with other supplies of the drug that did not contain glass.

The plaintiffs suggested a plan for identifying consumers who received the tainted pills, but their proposal would inevitably yield a group containing some members who did not receive the pills containing glass fragments, Sheridan said. Because plaintiffs failed to demonstrate by a preponderance of the evidence that they can identify class members based on their proposed methodology, the motion for class certification was denied, Sheridan wrote.

Ranbaxy said the particles, which came from a glass-lined reactor used in the manufacturing process, were less than 1 millimeter in size. The Food and Drug Administration said the chance of health problems from ingesting the glass particles was extremely low, and said consumers should not stop taking the drug.

Atorvastatin is a generic version of Lipitor, and is used to reduce cholesterol.

Ranbaxy recalled 41 lots of Atorvastatin containing 480,425 bottles of pills. During the recall, 400,201 bottles were returned. Of the 35 pharmacy retailers and distributors that received lots of Atorvastatin from the recalled lots, nine sold the recalled pills to consumers. But the parties agreed that those companies did not keep track of lot numbers for drugs sold to consumers, and it's impossible to determine based on information from the pharmacies which consumers received drugs from the recalled lots.

Plaintiffs suggested class members could be identified under a plan developed by Gary French, a consulting economist. His methodology identifies a time frame during which pills that came from an inventory pool containing both recalled and nonrecalled pills were sold to customers. Based on a review of sales made within this time frame, the plaintiffs' expert claims he can identify the inventory pools that included recalled pills, class members who received pills from inventory pools that included recalled and nonrecalled pills, the date that the class member received the pills, the pharmacy that dispensed the pills, the quantity and dosage of pills dispensed to each class member, and the amount paid.

But Ranbaxy disputed the validity of that method, and Sheridan called it “insufficient for ascertaining all of the members of the proposed class. As such, it does not show that class members can actually be identified.” What's more, French conceded that his methodology would yield some consumers who did not buy the tainted pills.

Plaintiffs' reliance on National Drug Code identifying numbers and the chain of distribution to identify potential class members is flawed because the NDC number, while containing information about the type of drug, its manufacturer, and the specific dosage, does not provide any information to identify what batch the pills came from, Sheridan said.

Sheridan also found that the laws of the 50 states would apply to plaintiffs' claims of breach of express and implied warranty. Accordingly, class certification cannot be granted because common legal issues do not predominate over individual issues, he said.

Barry Gainey of Gainey, McKenna & Egleston in Paramus, who represents the plaintiffs and the class, said he was still studying the ruling and declined to comment. Michael Shumsky of Kirkland & Ellis in Washington, D.C., and Arnold Calmann of Saiber in Florham Park, who represent Ranbaxy, did not return calls.