Background on bellwether cases and process
Approximately 200 lawsuits filed against Cook Medical, for issues relating to its inferior vena cava (IVC) filters, have been consolidated for a coordinated discovery and pretrial proceedings as part of a multidistrict litigation (MDL). Representatives for the plaintiffs and the defendants have each selected 5 cases (for a total of 10) that will collectively be identified as bellwether trials.
MDLs, or bellwethers, allow all parties involved to share resources for pretrial discovery. The purpose of bellwethers is to reduce the possibility of contradictory rulings across districts and avert duplicative discovery in future cases. But unlike class action lawsuits, MDL plaintiffs retain the right to an individual trial by jury. As bellwether cases play out in court, legal counsels will have the opportunity to assess how juries react to various evidence and testimony, which may prove useful in future trials.
The resolution of the bellwether trials requires plaintiffs to provide a statement of special damages. The defendants will then have 60 days to respond. The cases that are not resolved in the process will be transferred back to their home districts for trial. The bellwether trials are scheduled to begin in September of 2016 in the U.S. District Court for the Southern District of Indiana.
Common allegations in Cook vena cava filter lawsuits
All of the pending lawsuits against Cook Medical involve specific types of injuries caused by its IVC filters, which are implantable medical devices used to prevent blood clots from reaching the heart or lungs, where they can interfere with organ function or cause sudden death. The filters are implanted into the inferior vena cava, a large abdominal vein, with the intention of protecting patients who cannot safely take blood- thinning drugs, or patients who develop clots despite medication and remain at risk for pulmonary embolism (PE).
Most IVC filters are meant for temporary use (30-50 days), but removing them is often difficult. In a recent study, 26% of the filters could not be successfully removed because they either migrated, lodged in the wrong place, embedded into the vena cava vein, or changed position. Filters that are not removed can create additional medical complications over time. These types of issues are what prompted the litigation against Cook and other manufacturers.
The 200 or so plaintiffs who filed product liability lawsuits against Cook Medical claim that the devices were defective by design, which caused them to fracture, migrate or move out of position, and subsequently caused serious internal injuries, such as the perforation of the vena cava.
Problematic IVC filters made by Cook Medical and other manufacturers
The two most prominent manufacturers of IVC filters are Cook Medical and C.R. Bard. Cook produces two types of temporary IVC filters known as the Günther Tulip vena cava filter and the Celect vena cava filter. Bard produces the G2 vena cava filter, the G2 X vena cava filter, and the Eclipse vena cava filter.
In a consumer alert dated July 13, 2015, the FDA stated that these products, among others, are responsible for the majority of the injuries among IVC filter recipients. Additionally, complaints of the IVC filters included patients who were scheduled to remove an IVC filter and surgery failed to do so.
Other manufactures of IVC filter to be aware of include:
- Rex Medical’s Option retrievable vena cava filter
- Cordis OptEase retrievable vena cava filter
- ALN Implants Chirugicaux‘s ALN optional vena cava filter
Getting Legal Help
Despite the brevity of time within the body, retrievable IVC filters can create serious adverse events such as device movement, breaking apart within the inferior vena cava, relocation into or perforating organs, or removal failure.
If you have been harmed by an IVC filter, consulting an attorney who specializes in medical device malfunctions can help ensure that your legal rights are protected. Use Legal Advocate Link to find a local attorney with expertise in these types of cases.