PENNSYLVANIA RECORD

A central Pennsylvania woman is suing the makers of the NuvaRing birth

control system over allegations that she developed a blood clot in her lung as a result of her use of the product.

Sharon L. Young, who lives in York County, filed suit at the federal District Court in Harrisburg last week over claims that she developed a pulmonary embolism in the spring of 2012 as a result of using the NuvaRing.

The plaintiff, who began using the device around March of that year, says she began to experience chest discomfort with shortness of breath about a month later.

A subsequent CT scan ordered by a cardiologist revealed emboli in her right lung, the complaint states.

The woman was immediately admitted to Harrisburg Hospital and began a regimen of anticoagulation therapy.

Young, who was 41 years old at the time of her injuries, claims her health issues were a direct result of using NuvaRing.

The plaintiff continues to undergo follow-up medical care, including examinations, appointments and continued use of medications, the lawsuit states.

The defendants in the lawsuit – they are Organon USA Inc., N.V. Organon, Schering Corp., Merck & Co. Inc., and Merck Sharp & Dohme – are accused of failing to disclose the known safety hazards associated with NuvaRing.

The package insert accompanying the product, which says that the vaginal ring is expected to be associated with similar risks to that of birth control pills and that the safety information they provide to consumers is derived primarily from studies of birth control pills, is misleading, the complaint alleges.

The safety information, the suit states, was not derived primarily from studies of NuvaRing.

The defendants failed to warn of the extent of the risk of venous thromboembolism, including deep vein thrombosis and pulmonary embolism, and even death associated with the use of the product, according to the complaint.

The defendants knew, but failed to disclose that the NuvaRing had a higher risk of thromboembolic complications than birth control pills, the lawsuit says, due to the “markedly potentiated androgenic effects caused by the synthetic, third-generation progestin used in the NuvaRing.

“Defendants negligently and/or recklessly marketed the NuvaRing as a novel vaginal delivery system, and placed the product into the stream of commerce without conducting adequate tests to regulate the exposure and/or release rates of estrogen and Progestin to a user, including Plaintiff, of such product,” the complaint reads.

Instead, the suit claims, the defendants marketed the product as having a low risk of side effects and they continue to minimize the product’s side effects by focusing on the “incidence of minor side effects,” such as headaches, nausea and breast tenderness.

Young, the plaintiff, claims that she would have never used the NuvaRing had she known the true risks and dangers associated with the birth control system.

The lawsuit contains counts of strict products liability, breach of implied and express warranties, negligence, intentional and/or negligent misrepresentation, successor liability and violation of consumer protection laws.

The plaintiff seeks damages in excess of $75,000, plus attorneys’ fees and costs.

She is being represented by Charles E. Schmidt, Jr. of the Harrisburg law firm Schmidt Kramer Injury Lawyers.

The plaintiff’s counsel noted in the complaint that the matter should be transferred to the Eastern District of Missouri for inclusion in the NuvaRing Products Liability multidistrict litigation, but on Nov. 14, a day after the suit was filed, U.S. District Judge Sylvia H. Rambo, of the Middle District of Pennsylvania, issued an order that says the action cannot be transferred until the plaintiff complies with certain procedural rules for removal of so-called tag-along actions.

 

The federal case number is 1:13-cv-02777-SHR.