Cook Medical, already facing more than 3,000 lawsuits over defective IVC filters, was targeted in several more complaints filed this month by injured parties from California to New York. The lawsuits name two different models: the Günther Tulip® and the Celect®. At the same time, Rex Medical L.P. and Argon Medical Devices Inc. have been targeted by plaintiffs in Michigan and New Jersey over their OptionTM ELITE IVC Filter. In both of the latter cases, the device tilted, puncturing the artery wall, and surgeons were unable to remove them.
The Michigan plaintiff is a woman whose doctor had an OptionTM ELITE implanted in order to catch potential blood clots and avoid a possible pulmonary embolism in 2011. The plaintiff from New Jersey received his IVC filter in September of 2015. Both plaintiffs allege that the defendants knowingly sold a defective product and failed to provide adequate warnings of the risks involved.
Cook Medical faces the same allegations in the numerous lawsuits that were filed in September. The first bellwether trial involved a Florida woman who had received a “removable” Celect IVC filter in 2010. Five months later, doctors were unable to remove the device. Ultimately, the IVC filter migrated into her small intestine, causing “persistent severe gastrointestinal symptoms, fatigue, diarrhea, vomiting and abdominal pain.” Nonetheless, the jury found in favor of the defendant in that case. Another case, involving the Günther Tulip, was dismissed last spring because the statute of limitations had passed.
In May, however, a jury in Texas ordered the defendant to pay $1.2 million to a Houston firefighter who suffered perforations of the aorta and duodenum after his IVC filter tilted. Although the jury did not find Cook Medical to have knowingly produced a negligent design, they did find that the company failed to warn the plaintiff's physician about the risks of internal injury.
Together, Cook Medical and rival C.R. Bard are facing over 8,000 lawsuits which have been consolidated into two major multidistrict litigations. Cook, Bard, and two other medical device manufacturers continue to face allegations that include failure to warn, defective design, fraudulent concealment and breach of warranty. So far, approximately 40 deaths have been attributed to IVC filter failures.
Despite the demonstrated design defects, Bard has claimed that all lawsuits pending against the company should be dismissed because its products had FDA approval. This highlights an issue that comes up repeatedly in litigation over defective medical devices: the infamous 510(k) Premarket Notification process.
This “fast track” path to approval requires only that a manufacturer demonstrates that its “new” product is “substantially equivalent” to a previously approved one (also known as a “predicate” device). This has led to a seemingly unending stream of dangerous and defective medical products coming onto the market – and has been fueling an increasing number of injury lawsuits.
Cook Medical could be the poster child for everything that is wrong with the FDA's “fast track” process. In 2009, the company conducted its own safety study, concluding that the Celect filter was completely safe and readily removable. However, an independent study published three years later found signs of perforation with both the Celect and the Günther Tulip in every subject after 71 days. Cook did not issue recalls for either model but managed to get FDA approval for an “upgraded” version of the Celect under 510(k).
The results of bellwether trials so far have been inconclusive, despite early victories for Cook Medical and Bard. Neither company has yet offered to enter into a global settlement with all plaintiffs. Currently, a trial in which Bard is named defendant is underway in Arizona. Depending on the outcome, these manufacturers may be pressured to settle the remaining cases – or they will all be remanded to their original jurisdictions, and litigation will continue.