A putative class action has been lodged in New Jersey against the Princeton-based maker of the cholesterol-reducing drug Atorvastatin, which was found to be tainted with glass particles.
The suit was filed on Nov. 29, the day after Ranbaxy Pharmaceuticals announced that it had recalled several lots of the drug and the day before the Food & Drug Administration issued a public advisory.
Ranbaxy has ceased production of Atorvastatin, a generic version of Pfizer’s statin, Lipitor, pending investigation of the issue, the FDA advised.
On Nov. 9, Ranbaxy voluntarily commenced a nationwide recall of the drug, sold as 10 mg, 20 mg and 40 mg tablets sold in 90- and 500-tablet plastic bottles. The company notified distributors and retailers via e-mail and FedEx about 41 affected lots, directing them to halt sales and return the bottles.
The plaintiffs, in Fenwick v. Ranbaxy Pharmaceuticals Inc., 12-cv-7354, filed in federal court in Trenton, seek damages under the state Consumer Fraud Act and on common-law causes of action, as well as injunctive relief.
Named plaintiff Francis Fenwick alleges the recall came up short because it “did not include notice to consumers who purchased the tainted product of the dangers … or what to do if they purchased the product or ingested it,” and “did not offer a refund.”
Fenwick claims he realized he bought a tainted bottle at a Montvale CVS after reading a Nov. 23 Wall Street Journal report about the recall.
On Nov. 28, Ranbaxy issued a public statement acknowledging “the possibility that the affected lots may contain very small glass particles resembling a fine grain of sand.
“The probability of an adverse event due to consumption of this product is unlikely but cannot be ruled out,” Ranbaxy said, noting that no reports of injuries had been received at that time.
Ranbaxy advised consumers to call a doctor if they’d experienced problems after taking Atorvastatin.
Two days later, on Nov. 30, the FDA announced that it “determined that the possibility of adverse health problems related to the recalled Atorvastatin is extremely low.” Consumers who’d bought tainted tablets could continue taking them unless otherwise advised by a doctor, the agency said.
The suit seeks certification for a nationwide class of people who bought the affected bottles, or a subclass of purchasers who are New Jersey residents. Plaintiff lawyer Barry Gainey says that as of Monday, he’d heard from about a dozen prospective class members living in and out of New Jersey.
The suit alleges, in addition to Consumer Fraud Act violations, common-law fraud, negligence, unjust enrichment, breach of warranty, and negligent misrepresentation.
The plaintiffs seeks compensatory damages — in the amount spent on each bottle, or possibly the cost to buy a replacement bottle that may not have been covered by health insurance — as well as disgorgement, treble damages under the CFA and attorney fees.
They also seek injunctive relief, including a court-ordered full recall of the product. “We believe that a total product recall would be proper at this time, separate and apart from whatever the FDA thinks,” says Gainey of Gainey & McKenna in Rochelle Park. “At this point, people are worried and uniformed, and we don’t think that’s right.”
Gainey says he might file an order to show cause in hopes that an expedited full recall is ordered by the court.
The plaintiffs are equally displeased with their pharmacists, for failing to warn them independently about the recall, he adds. Gainey says he doesn’t yet intend to add the pharmacies as defendants — because it’s not clear what duty, if any, they owed their customers in this scenario — “but I haven’t ruled it out, either in this case or a second case.”
Gainey says he’s is not aware of any other such actions being filed.
Ranbaxy has been under the government’s microscope dating back several years in connection with questionable manufacturing practices, particularly at its Indian plants and one in Gloversville, N.Y., that later was voluntarily shut down.
In September 2008, the FDA, citing these concerns, issued warnings letters and an import alert banning 30 drugs for sale in the U.S. In February 2009, the agency claimed that Ranbaxy had falsified data in FDA applications.
Last January, Ranbaxy and the U.S. Justice Department entered into a consent decree to settle the FDA’s regulatory actions, requiring the company to change its practices.
Ranbaxy spokesman Charles Caprariello declines to comment or indicate whether defense counsel had been hired yet for the newly filed suit.
He says that Atorvastatin has not been produced at any of the facilities affected by the 2008 import alert and the company is “actively remediating all the activities” at those plants, as per the consent decree.
Also named as defendants are Ranbaxy Laboratories Ltd., the India-based parent company, and Japanese pharmaceutical company Daiichi Sankyo Co. Ltd., the majority owner of the Indian company.
The matter has been assigned to U.S. District Judge Peter Sheridan and U.S. Magistrate Judge Douglas Arpert, who sit in Trenton.
David Gialanella is a reporter for the New Jersey Law Journal, a Legal affiliate.