The tablets in the identified lots contain tiny particles of glass about the size of a grain of sand that somehow got into the manufacturing process at the Ranbaxy plant in India sometime before November 9, 2012.
A generic version of Lipitor, Atorvastatin is widely used to reduce the risk of heart attack and stroke in patients with plaque buildup and high cholesterol levels.
Gainey currently represents six named plaintiffs in a class-action suit alleging they suffered adverse effects after ingesting the drugs. According to the documents filed, plaintiffs have suffered digestion problems, stomach ailments and even had to have surgery after swallowing glass particle-tainted Atorvastatin.
Aware of the glass particle problem, Ranbaxy informed pharmacies and did issue a voluntary retail recall in November of 2012.
The problem is, says Gainey, Ranbaxy failed to warn the people who use the drug of the potential dangers. “Consumers were not notified of the tainted product or the potential harm. No one told them what to do if they had pills from one of the lots, and Ranbaxy never even offered them a refund for the tainted pills,” says Gainey.
Only after the Wall Street Journal reported Ranbaxy had issued the voluntary recall to retailers did the company issue a press release, warning the public that complications could arise from ingesting Atorvastatin from the tainted lots.
The FDA followed, issuing a statement saying that consumers should not use the drug, and then, says Gainey, a day later, “they flip-flopped.” The FDA reconsidered and decided the risk of injury was very low and patients should check with their medical providers about whether to continue using Atorvastatin.
READ MORE ATORVASTATIN RECALL LEGAL NEWSGainey, a no-nonsense, experienced class-action lawyer, says Ranbaxy’s failure to speak up and tell the public about the contaminated lots combined with the FDA’s “confusing” position is an intolerable situation for consumers. “To suggest that the likelihood of injury is low and therefore there is no reason to recall the drug is not the standard we go by in America or Canada, or anywhere else,” says Gainey.
Atorvastatin complaints are popping up across the country. Gainey has taken dozens of calls from concerned consumers and client referrals from other attorneys contacted by Atorvastatin prescription users.
Barry Gainey is the founding partner at Gainey & McKenna in Rochelle Park, New Jersey. Gainey was educated at Washington and Lee University School of Law in Lexington, Virginia. The firm handles class action and regularly prosecutes cases on behalf of shareholders in securities litigation matters.