PENNSYLVANIA RECORD

A Philadelphia woman is suing the makers of the Nuvaring birth control system over claims that she sustained injuries as a result of using the product during a seven-year time period.

Louisiana attorneys Allan Berger and Andrew J. Geiger filed a product liability complaint Feb. 25 at the U.S. District Court for the Eastern District of Pennsylvania on behalf of Wilma Romelien, who alleges that she was diagnosed with a venous sinus thrombosis and an intracranial hemorrhage in July of last year, what she claims was a result of her use of Nuvaring for the past seven years.

Romelien is currently on a daily Coumadin regimen to treat her injuries, and she experiences bouts of social anxiety and depression as a result of her ordeal, the complaint states.

The defendants who are named in the lawsuit are Organon Pharmaceuticals USA Inc., Organon International Inc. and Schering-Plough Corp.

The companies are accused of marketing, promoting and advertising Nuvaring to doctors and the general public as equally or more safe than oral contraceptive pills, whereas it was actually less safe than other birth control methods.

The defendants allegedly failed to warn prescribing physicians and the public that the product was associated with more thrombotic events than other methods of birth control, the lawsuit says, and the companies failed to provide proper and full information as to the safety of the product to the U.S. Food and Drug Administration, which regulated the sale of Nuvaring.

The plaintiff accuses the defendants of obtaining permission to market Nuvaring by presenting safety data derived from studies on the pill but failing to do proper clinical investigation with actual users of the product.

“Defendants were aware of the substantial risks from taking Nuvaring, but failed to fully disclose same,” the complaint reads. “Defendants failed to meet the applicable standards of care which were intended for the benefit of individual consumers such as the Plaintiff, making the Defendants liable for the Plaintiff’s injuries.”

The lawsuit contains counts of negligence, breach of express and implied warranties, negligent misrepresentation, fraudulent misrepresentation and concealment.

The plaintiff claims that as a result of her injuries, she has experience pain and suffering, disability, impairment, lost capacity to enjoy life, mental anguish, and lost earnings.

She also claims she has been caused to undergo medical treatment and monitoring and is expected to do the same for the rest of her life.

Romelien seeks unspecified compensatory damages, pre-and-post-judgment interest, attorney’s fees and costs.

The federal case number is 2:13-cv-00991-TON.