Class Action Lawsuit Information
The medical device company, C.R. Bard first obtained Food and Drug Administration (FDA) approval to market the Recovery IVC filter in 2003.
The IVC filter is placed in the vena cava (IVC) and is intended to capture any stray blood clots before they travel to the lungs where they can cause heart attack or stroke.
There are about 250,000 of these procedures performed in the U.S. every year, most without complication.
IVC filters are made by ten other companies beside Bard. Unfortunately, IVC filters made by Bard, the Recovery and G2, have a higher than usual complication rate.
The FDA had received more than 900 adverse event reports about the Bard IVC filter by 2010, including numerous deaths. Adverse event or complication reports included the device migrating to another side in the body, forming a blood clot in the lungs, perforating nearby organs or the filter breaking or fracturing.
Despite that, Bard redesigned its Recovery filter creating the G2 which has been implanted in more than 65,000 patients. Unfortunately those devices also have a high rate of fracturing.
Made of nickel and titanium the spindly legs are prone to breaking off and migrating inside the body. Filter fragments were also noted in the Bard G2 which had a filter fragmentation and embolization rate of 12 percent or 6 out of 52 patients at one Pennsylvania hospital.
Both the Recovery and G2 are now off the market. They were not recalled as one might expect.
Since the G2 was introduced in 2005, the adverse event reports submitted to the FDA include 328 reports of device migration; 146 reports of detachment of the device components also known as embolization; 70 report of the IVC perforating nearby organs and 56 IVC filter fractures.
The IVC filter is located dangerously close to the heart, lungs or inferior vena cava. When migration or fracturing occurs, those organs can be pierced. The device may erode in the body. Fluid buildup in the space around the heart has been noted which interferes with heart function.
Besides a filter migrating, fracturing or perforating, there are additional risks of an IVC filter tilting on its side making them useless as a device to catch blood clots.
If blood clots forms around the filter, they may essentially work to slow blood flow into the lungs. Other complications have arisen when a physician attempts to remove an IVC filter that has embedded in the vena cava making it a very dangerous surgery.
In 2010, the FDA issued a Safety Communication warning that surgeons should remove the IVC filter as soon as the risk of pulmonary embolism is passed. The risk of leaving in the filter outweighed its possible benefits, said the FDA.
At that time, plaintiffs began filing lawsuits around the country claiming they suffered complications. The families of those who had an IVC filter implanted with fatal results filed wrongful death and defective product lawsuits against the companies.
At the present time there are a number of lawsuits naming C.R. Bard, Cook Medical and other makers of IVC filters. Specifically, litigation involves the following products – the Bard Recovery filter, Bard G2, Bard G2 Express, Cook Gunther Tulip and Cook Celect filter.
In their actions, plaintiffs also claim the companies were negligent, they failed to warn doctors, the end users, of the medical device about its dangers. Also alleged is the IVC filters are defective in their design, their manufacture and that the companies breached an implied warranty.
In 2012, the first lawsuits naming Bard were filed in state court. There are now more than three class-action lawsuits filed in state courts in Florida, California and Pennsylvania.
Waiting for the other shoe to drop, the plaintiffs are asking for medical monitoring because the company misrepresented the safety of their devices. They feel their medical futures are uncertain. The company also withheld data patients would have liked to have as part of a full, true informed consent process.
Bard was negligent in its marketing of Recovery and G2 devices and the patients say they deserve medical monitoring expenses be covered, at the very least.
Most of these plaintiffs must take blood thinners for the rest of their lives. Some must have open heart surgery to retrieve the fragments of the IVC, which in itself carries a risk. The implant restricts one’s activity and can lead to anxiety and depression. Lost wages, pain and emotional suffering, scarring, loss of consortium are often included in plaintiff lawsuit complaints.
In 2014, the U.S. Judicial Panel on Multidistrict Litigation (JPML), a panel of judges who are forecasting large number of injuries and litigation, consolidated cases against Cook into the Southern District of Indiana. Cases naming C.R. Bard were consolidated in multidistrict litigation in the District of Arizona in August 2015.
Consolidating cases allows one federal judge to make consistent rulings to speed the litigation to a conclusion. The alternative is that judges in different states issue different rulings, which complicates the process. Frequently those differences will serve as a basis for appeal, not to mention confusion.
An MDL differs from a class action in that the recovery is based on a plaintiffs’ degree of injury. The most injured will receive more compensation than those less injured. Generally plaintiffs are grouped in Tiers of Injury just before a settlement is offered with the highest Tier receiving the most compensation.
In a class action litigation, the recovery is divided equally among plaintiffs, regardless of their degree of injury, unless the case is negotiated individually.
Expect a growing number of lawsuits to be filed in both the federal MDLs and state courts.
The MDL system chooses certain cases to serve as bellwethers or test cases. A bellwether tests legal theories before a jury to indicate how the litigation will proceed.
Frequently, if a defendant continues to lose cases before a jury, the bellwether system will serve as a basis for a settlement offer by the defendant company.