A Medical Device Daily

Cook (Bloomington, Indiana) reported that the U.S. District Court for the Northern District of California has granted summary judgment in its favor, rejecting claims filed by Edwards Lifesciences (Irvine, California), alleging that Cook had infringed on Edwards’ patents for endovascular devices to treat aneurysms.

Cynthia Kretz, general counsel for Cook, called the ruling “a vindication of the validity of our extensive intellectual patent portfolio in the expanding field of endovascular treatment of aneurysms.” The company was represented by the law firm of Brinks Hofer Gilson & Lione in the litigation.

Edwards had claimed infringement by four of Cook’s Zenith endovascular stent-grafts for use in treating abdominal aortic aneurysms and thoracic aortic aneurysms.

The court rejected Edwards’ argument, ruling “that no reasonable jury could conclude that Cook’s accused devices” literally infringed the Edwards patents, and that Edwards failed to show that Cook’s “accused devices infringe the patents-in-suit under the doctrine of equivalents. Cook, therefore, is entitled to judgment in its favor on this basis as well.”

Cook says it was one of the first companies to introduce interventional devices in the U.S. It develops products for aortic intervention, interventional cardiology, critical care, gastroenterology, radiology, soft tissue repair urology and assisted reproductive technology.

In other legalities: Motley Rice LLC and D’Arcy, Johnson, Shober & Hassell (Mount Pleasant, South Carolina) have filed a wrongful death and survival action against the manufacuterers of the contraceptive NuvaRing alleging that the defendants’ negligence contributed to the death of 32-year-old Jackie Kelly Bozicev. The action is brought by her husband who is executor of her estate.

The complaint, filed in Superior Court of New Jersey in Essex County, charges that the defendants knew that NuvaRing was dangerous and ineffective but concealed these risks from Bozicev, physicians, pharmacists, other medical providers, the FDA and the public at large, and that it failed to issue adequate warnings concerning the product’s use.

After being prescribed NuvaRing, Bozicev experienced a seizure and was being taken to Community Medical Center (Toms River, New Jersey) but became unresponsive in the ambulance. She was pronounced dead at the emergency room and an autopsy found she had died as the result of massive pulmonary thromboemboli in the pelvic veins.

Named defendants include Organon USA, Organon Pharmaceuticals USA, Organon International, Akzo Nobel, Organon Biosciences and Schering-Plough. Organon manufactured and sold NuvaRing and Schering-Plough purchased Organon in 2007.

“Mr. Bozicev lost his young wife and has been left to raise his young children without her... . [W]e believe that by bringing this case to court and to the public’s attention, we can help prevent additional unnecessary loss of life,” said Motley Rice attorney Carmen Scott.

NuvaRing FDA-approved in 2001, is a combination therapy vaginal ring contraceptive that prevents pregnancy by releasing the drugs etonogestrel (a progestin) and ethinyl estradiol (an estrogen) near the cervix.

Attorney Andrew D’Arcy said, “We believe that the manufacturers of NuvaRing [promoted it to] specific populations of young women, without communicating the lack of thorough research on vaginal contraceptives.”