Manufacturers of defective IVC filter medical devices are settling cases behind the scenes, as litigation is building nationwide. The blood clot filters have been inserted in millions of patients over the last 40 years.
“All these products are defective,” said mass tort expert John Ray of Ft. Lauderdale, speaking in a webinar presented by The National Trial Lawyers. “I cannot say that one product is less defective than other.”
While specific settlements are suppressed by non-disclosure agreements, Ray said that a wrongful death case involving an IVC filter has a settlement value of $500,000. At the other extreme, a case involving the successful removal of an IVC filter without complications has a settlement value of $10,000.
- Bard IVC Filter Litigation is consolidated in MDL 2641 in US District Court in Arizona. Bard essentially announced that it was settling cases in its September 2015 10-Q filing, where it stated, “While the company intends to vigorously defend Filter Product Claims that do not settle, including through litigation, it cannot give any assurances that the resolution of these claims will not have a material adverse effect on the company’s business…” Ray says, “Bard has issues that will cause it to settle sooner rather than later. Bard got a lot of bad press about what they knew and when they knew it. Bottom line, Bard is going to settle, and they threw up the white flag in this statement to stockholders.”
- Cook Medical IVC Filter Litigation is consolidated in MDL 2570 in US District Court for the Southern District of Indiana. The defendants are Cook Medical, LLC and Cook Inc., both of Bloomington, IN, and William Cook Europe APS, Bjaeverskov, Denmark. “There are many stipulated dismissals where no motion to dismiss has been filed,” Ray says. “Generally when you see this, the company is settling cases, but doing so privately. Will there be a mass settlement? Probably. But I am 99% sure that they have already settled a lot of cases.”
- Cordis IVC Filter Litigation is centered in the California state courts, where hundreds of cases are up for consolidation. Cordis Corporation is organized under the laws of Florida, with its principal place of business in Fremont, California. According to Ray, plaintiffs can file cases there regardless of the original jurisdiction.
- There is no MDL for Boston Scientific Corp IVC Filter Litigation. “We believe it is possible that more cases will be filed and a motion for consolidation and transfer may be formed in an effort to form an MDL,” says Mass Tort Consultant John Ray.
- Similarly, there is no MDL for cases against Rex Medical and Argon Medical. Plaintiffs have filed cases in the Philadelphia Court of Common Pleas before Judge Arnold New, who has assigned them to the complex litigation track.
How were defective devices approved?
Ray said he solved the puzzle about how a group of medical devices so inherently defective won approval from the FDA. “It was a matter of timing,” he says. The first IVC filters were on the market prior to regulation by the Medical Device Act of 1976. The first IVC filter was approved using the 510(k) shortcut. “Once the first device was approved, every other device had a predicate device. They were all approved without ever being tested, without proving their satefy, without proving their efficacy.”
IVC filters are small, cage-like devices that are inserted into the inferior vena cava – a major vein leading directly to the heart. They were supposed to capture blood clots and prevent them from reaching the lungs.
However, attorney John Dalimonte of Boston identified three issues with the Cook Tulip and Celect IVC Filters.
- Migration downward and upward. The IVC Filters can tilt or shift, making them almost impossible to remove.
- Device fracture, causing blood clots (embolism) in the heart, lung, liver and kidneys. Research shows that the devices experienced fracture rates of 37% to 40% after five and a half years.
- Perforation, where stress on the IVC Filter struts leads to fractures that puncture adjacent organs and vessels.
“There are a lot of cases out there,” Dalimonte says, because the manufacturers conducted off-label marketing directly to bariatric patients, trauma patients and orthopedic surgery patients.
He will be part of the panel of the September Mass Tort Nexus Course. John serves on the Steering Committee for the Bard and Cook MDLs. Contact firstname.lastname@example.org or (954) 383-3932 for information on the September Course.