LawyersUSA

Litigation against the maker of the contraceptive NuvaRing has expanded to over 150 cases filed in state and federal court.

In August, all federal cases were consolidated in multi-district litigation in Missouri under U.S. District Court Judge Rodney Sippel, who met for the first time with lawyers today.

NuvaRing is a vaginal contraceptive that releases estrogen and progestin. Its main advantage is convenience because it can be left in place for three weeks instead of taking a pill every day.

The lawsuits allege that the product has a design defect in the dosage and type of progestin used and that the manufacturers failed to warn about side effects including blood clotting, pulmonary embolism, heart attack, stroke and deep vein thrombosis.

"We're just getting the ball rolling on these cases," said Ronald Miller, a partner at Miller & Zois in Glen Burnie, Md., who is currently investigating three NuvaRing cases.

The suits name NuvaRing's manufacturer, Organon Inc., as well as Organon's new parent company, Schering-Plough Corp., and former Dutch parent company, Akzo Nobel N.V.

Third-generation progestin

The women bringing the lawsuits claim that NuvaRing releases a high dosage of a type of progestin called etonogestrel – a metabolite of desogestrel, a third-generation progestin that is more dangerous than previous generations of progestin.

"Our claim is that a lot of literature shows the association with third-generation progestin turning blood toward clots [more] than second-generation progestin used in birth control pills," said Paul Rheingold, a partner at Rheingold, Valet, Rheingold, Shkolnik & McCarthy in New York and the likely spokesperson for the plaintiffs in the MDL.

Rheingold noted that last year Public Citizen petitioned the FDA to ban third-generation oral contraceptives containing desogestrel.

The plaintiffs are also claiming that the defendants failed to warn of the drug's dangers when they "knew or should have known about the risks and labeled accordingly, as well [failed to] properly categorize the degree of risk in a meaningful way so doctors [could] make proper determinations," said Miller.

Rheingold alleges that NuvaRing "is often promoted to doctors' … offices that [it] is as safe as the pill but easier to use. Our claim is it's more dangerous."

Other claims include negligence, breach of warranty, consumer fraud and common law fraud.

A number of claims are pending in New Jersey state court after a federal magistrate judge rejected the defendants' argument that the claims were preempted by federal drug regulations.

Schering-Plough communications director Rosemarie Yancosek released a statement to Lawyers USA that said "blood clots have long been known as a rare risk associated with all combined [estrogen-progestin] hormonal contraceptives," and that NuvaRing's "FDA-approved patient and physician package labeling includes this important safety information."

She also added that the company has reported adverse effects to the FDA and that there have been no FDA-mandated labeling changes based on this data.

Not a massive mass tort

Plaintiffs' attorneys say the NuvaRing cases are strong and expect to see settlements similar to cases involving the Ortho Evra birth control patch.

In particular, plaintiffs' lawyers say that in NuvaRing cases it will be relatively easy to prove causation compared to other types of mass torts.

For example, in cases alleging that antidepressants like Paxil create a higher risk of suicide, causation is a challenge because those who are depressed may already be predisposed to suicide.

"It's unlikely that a 26 year old is going to have a heart attack," said Miller, adding that the fact that most of the plaintiffs are young will tend to increase the value of their personal injury or a wrongful death claims.

He said that once the general causation is shown, in that the progestin in NuvaRing causes blood clotting, specific causation will follow.

However, because the device has not had as widespread use as other drugs and devices, plaintiffs' attorneys are not expecting a mass tort on the level of others, such as Vioxx, which was taken by an estimated 20 million patients.

"These are great cases – there just aren't a lot of them," said Miller.

Although new cases are still being filed, Rheingold predicted they will ultimately total around 500 in number.

Questions or comments can be directed to the writer at: sylvia.hsieh@lawyersusaonline.com