Teva, Par Face Lawsuit Over RLS Drug

Teva Pharmaceuticals and Par Pharmaceutical are facing a lawsuit in which the plaintiff alleges the companies’ generic pergolide, a treatment for Parkinson’s disease and restless leg syndrome (RLS), caused her valvular heart disease.

The companies “misrepresented the safety and efficacy of pergolide and concealed or understated [these] dangerous side effects,” plaintiff Leigh Ann Karnell alleges in court documents. A generic version of Valeant’s Permax (pergolide mesylate), the drug is a member of a class of ergot derivatives that has been associated with certain cardiovascular conditions. 

Karnell says she took pergolide from February 2003 until March 2007 for RLS and suffered “serious and permanent injuries including, but not limited to, valvular heart disease” as a result, according to court documents.

She is asking the court for compensatory damages in excess of $75,000, a full refund of costs associated with her purchase of the drug, pre- and post-judgment interest, attorney’s fees and other costs related to the litigation.

In March 2007, Valeant withdrew Permax after two studies showed patients taking it increased their chance of serious heart damage compared with patients taking other Parkinson’s drugs, according to the FDA. Par and Teva also withdrew their generic versions of the drug from the market at that time.

The two studies were published in the Jan. 4, 2007, New England Journal of Medicine. They showed the use of either Permax or Pfizer’s Dostinex (cabergoline), a drug indicated to treat hyperprolactinemia, was associated with an increased risk in heart valve damage not seen in patients taking non-ergot-derived dopamine agonists.