NuvaRing Comprehensive Litigation Update

Mass tort litigation has been pending against the manufacturers of NuvaRing for many years now and is hopefully drawing to a close in the coming months.  The litigation is primarily based in federal court in St. Louis, Missouri, where MDL No. 1964 has been pending since 2008.  The MDL is presided over by United States District Court Judge Rodney W. Sippel.  There are nearly 1,200 individual lawsuits pending in the MDL against Oraganon USA, the manufacturer of NuvaRing.  There are also several individual cases pending in consolidated proceedings in New Jersey state court before Judge Martinotti.

NuvaRing is a clear, flexible vaginal ring that contains the drugs etonogestrel and ethinyl estradiol, and is used for contraception.  The lawsuits pending against Organon, Akzo Nobel NV, Schering-Plough Corporation and related entities focus on the failure of NuvaRing’s manufacturer to timely report the results of internal safety studies and adverse event reports of patient injuries to the FDA and to provide adequate warnings to patients and prescribing physicians of the risks posed by the contraceptive device.  The lawsuits also claim Organon was negligent in failing to complete the Phase IV post-marketing safety studies that were required as a part of the FDA’s clearance of the product for marketing in 2001.  Claims of over-promotion of benefits and understanding of risks are also included in the complaints filed in the national litigation for patients who suffered thromboembolic or blood clot-related injuries, including deep vein thrombosis, pulmonary emboli, stroke, and heart attack.

All birth control products carry some risk of patients developing blood clots in their legs or lungs, but NuvaRing is alleged to cause a much higher incidence of these patient injuries than other birth control products on the market with similar effectiveness.  The allegations in the NuvaRing litigation are similar to claims that have successfully been made against the manufacturers of OrthoEvra, Yaz, Yasmin, Ocella, Gianvi, BeYaz, Safryal, and Loryna (all of which at one time had a warning label that indicated that the products carried similar blood clot risks to older, safer birth control products, which was subsequently proven false).

This litigation is unique because the product defect stems from NuvaRing’s unique delivery system which is alleged to fail to deliver hormones in a steady and controlled manner.  The lawsuits allege this defect in the design of the device permit the release of “bursts” of hormones that can lead to the formation of dangerous blood clots.  The lawsuits also contend that the progestin drug used in NuvaRing does not provide the same counterbalancing to the pro-thrombotic effects of estrogen, as the progestins utilized in safer forms of birth control.  The result of these product defects are that NuvaRing subjects patients to the same level of risk of disfavored first generation birth control products from decades ago (responsible for numerous patient injuries and deaths due to increased blood clot risks).

A trial in the MDL is scheduled to begin on January 27, 2014, for plaintiff Marianne Prather, a Missouri woman who suffered a DVT and bilateral pulmonary emboli within weeks of being implanted with a NuvaRing device in 2003.  This trial had been scheduled to occur earlier this year, but was postponed by the judge over the summer.  At the same time, the judge entered several orders denying motions for summary judgment filed by the defendants, which were a tremendous victory for the plaintiffs.  Organon contended its warning label, which does mention risks of blood clot-related injuries, was sufficient as a matter of law.  The court rejected this argument, and ruled that a jury should consider evidence from both parties on the sufficiency of the warning label, especially the failure of the warning label to alert physicians and consumers that NuvaRing poses greater risks to patients than safer, second-generation birth control products on the market.  The judge in the New Jersey proceedings considered similar issues in a case pending in that court, and entered summary judgment in favor of the Defendants.  An appeal is pending of this order.

The MDL court granted the summary judgment motion regarding insufficient evidence of a manufacturing defect in the NuvaRing product implanted in this particular plaintiff.   Organon also sought dismissal of the plaintiff’s claim that the manufacturer should be held liable for punitive damages (damages that are meant to punish a defendant after the plaintiff has shown that the wrongdoer knew or had reason to know that a high probability existed that the manufacturer’s actions would result in injuries – (essentially the same as the criminal manslaughter standard).  The court found that the warning label on the NuvaRing product (which did not explicitly note an increased risk of harm with that particular product but instead hid behind “class wide” risks) exhibited “agnosticism” rather than “evidence care towards consumers.”  Ms. Prather may ask the jury at her trial in January of 2014 to award punitive damages to punish Organon for its wrongdoing besides compensating her for economic losses and pain and suffering stemming from her DVT and pulmonary emboli.   In the New Jersey proceedings, Judge Martinotti denied the plaintiff’s ability to request punitive damages (applying New Jersey law); the Prather decision was made under Missouri law.

The MDL judge also issued an order suspending activity in the other pending cases until October 21, 2013, which may mean the court is exploring potential settlement of some or all of the pending cases (although this is pure speculation ).  The next hearing is scheduled for November 6, 2013.  On August 20, 2013, Judge Martinotti issued a similar order suspending activity in the New Jersey consolidated proceedings until October 21^st and scheduled a status conference for November 13, 2013, at which time preparation for upcoming trials is to be discussed.