A federal judge in New Jersey has ruled that a pharmaceutical company that manufactured generic Lipitor with tiny glass particles in it does not have to widen its voluntary recall.
The ruling is considered a setback for the plaintiffs who filed suit against Ranbaxy Pharmaceuticals, which makes a generic Lipitor called Atorvastatin. According to the suit, after five Atorvastatin-users took the glass-tainted drug, they suffered minor irritations such as diarrhea and upset stomach. Ranbaxy launched the voluntary recall in November 2012 after glass particles were discovered in the drug. The five Atorvastatin-users who became ill filed suit on behalf of all consumers who took the cholesterol drug regardless of whether it was tainted. They also asked Judge Peter Sheridan to make Ranbaxy broaden its voluntary of the generic Lipitor.
But last week Judge Sheridan refused to do so, saying that the Food and Drug Administration (FDA) has jurisdiction in the case, is already conducting its own investigation of the voluntary recall and should be allowed to complete it before any new action is taken.
The FDA found in late November that the risk of injury from taking Atorvastatin was low, and users should continue to take the drug unless otherwise instructed by their doctors.
Read more about this case in Thomson Reuters.
For more InsideCounsel stories involving the pharmaceutical industry, see:
Pfizer settles Chantix suits for $273 million
Johnson & Johnson will pay $63 million in Motrin case
Drug maker's legal battle with the FDA delays generic competition
2nd Circuit decision throws FDA’s drug misbranding cases into question
