A federal judge consolidated a new class action lawsuit — brought by patients in 16 states against C.R. Bard, Inc., makers of the defective Bard IVC Filter — into a multidistrict litigation docket in Arizona.
The class action charges that Bard executives:
- Promoted its defective blood clot filters starting in 2004 despite immediate and many reports of patient deaths.
- Lied to the government about the widespread extent of patient deaths and adverse events.
- Lied to its own sales force about the dangers of the medical device to preserve its market share and to boost its stock price.
- Repeatedly introduced new models that had the same design and manufacturing defects as the older models.
- Used a regulatory shortcut to bypass the FDA’s more rigorous approval process for new devices, and obtained “clearance” under Section 510(k) of the Medical Device Amendments to the Food, Drug, and Cosmetic Act
Tragically, it took the FDA 10 years to issue a safety communication stating on May 6, 2014 that “the risk of having an IVC filter in place is expected to outweigh the benefits.” Later that year the FDA started a nine-month investigation and issued two Form “483” letters in which it identified various deficiencies and violations by Bard at its IVC-filters facilities.
US District Judge David G. Campbell, acting on a stipulation by the parties on June 22, 2016, ordered that the case be heard together with hundreds of other cases in In Re Bard IVC Filters Product Liability Litigation, MDL 2641.
The case is Maria E. Barraza v. C.R. Bard, Inc., and Bard Peripheral Vascular, Inc., Case 2:16-cv-01374-DGC. The lead attorneys are Ramon R. Lopez of Lopez McHugh in Newport Beach, CA, and Wendy R. Fleishman of Lieff Cabraser Heimann & Bernstein of New York.
In a Master Answer, Bard denies that there is any factual or legal basis for relief.
The plaintiffs are seeking an injunction to create a court-supervised medical monitoring fund for plaintiffs. It would pay for:
- A notice campaign to all class members informing them of the availability and necessity of the medical motoring protocol
- A “catheter venography” to be performed on every class member who still has a Bard IVC filter installed by an interventional radiologist who will consult with the class member’s physician within 60 days to decide if retrieval is clinically necessary.
Also the plaintiffs seek +$5 million in damages for negligent design and manufacture, and fraudulent concealment of dangers Bard was aware of.
The lawsuit outlines the history of IVC filters that Bard rolled out:
- Recovery Filter System, launched in 2004
- G2 Filter System (permanent), launched in 2005
- G2 Express System (removable), launched in 2008
- Eclipse Filter System, launched in 2010
- G2X System, launched in 2011
- Meridian Filter System, launched in 2011
- Denali Filter, launched in 2013
“The design of the Meridian is based on the Eclipse filter, which, in turn, is based entirely on the G2 filter, which, in turn, is based on the Recovery Filter,” the complaint says. All the “IVC filters were fracturing, perforating, migrating, and/or tilting in the patients in which they were implanted.”
“These devices are potential ticking time bombs implanted in unsuspecting patients.” An IVC filter is designed purportedly to filter or “catch” blood clots that travel from the lower portions of the body to the heart and lungs.
Patient injuries include:
- Cardiac/pericardial tamponade (pressure caused by a collection of blood in the area around the heart)
- Cardiac arrhythmia and other symptoms similar to myocardial infarction
- Severe and persistent pain
- Perforations of tissue, vessels and organs
|Read our shocking report: How did IVC Filters Obtain FDA Approval without Proving they were Safe and Effective|
To rush the devices to the market, Bard repeatedly used the Section 510(k) shortcut to get a “clearance,” from the FDA, claiming the filter was substantially similar to its existing device. A 510(k) review is completed in an average of 20 hours by the FDA.
Bard avoided the more rigorous “premarket approval” (PMA) process, which must include data sufficient to demonstrate that the IVC Filters is safe and effective. The FDA takes 1,200 hours to complete a PMA review.
Section 510(k) notification requires little information, rarely elicits a negative response from the FDA, and gets processed quickly.
Once placed on the market, Bard immediately became aware of numerous confirmed events where its Recovery filter fractured, migrated, or perforated the inferior vena cava, caused blood clots, and caused serious injury, including death. About a month after the full-scale launch of the Recovery filter, on February 9, 2004, Bard received notice of the first death associated with this filter.
On July 9, 2004, a Bard safety analysis found that the Recovery filter had a reported failure rate that was 28 times higher than all other IVC filters. Peer-reviewed medical literature found that among 363 patients implanted with the Recovery filter and 658 patients implanted with the G2 filter, the devices experienced fracture rates of 40% and 37.5%, respectively, after five and a half years.
A review of the FDA MAUDE database from 2004 through 2008 shows that Bard IVC Filters are responsible for the following percentages of all IVC filter adverse event reports:
- 50% of all adverse events
- 64% of all occurrences of migration of the IVC Filters
- 69% of all occurrences of vena cava wall perforation
- 70% of all occurrences of filter fracture.
Instead of pulling the Recovery filter off the market, Bard started a coverup. By April of 2004, at least three deaths had been reported to Bard. The company concealed this information from doctors and patients and hired the public relations firm Hill & Knowlton to address anticipated publicity that could affect stock prices and sales.
Bard lied to its own sales force to keep pushing the IVC filters. By December 2004, Bard’s own internal safety procedure deemed the Recovery filter not reasonably safe for human use. Yet the company gave mandatory scripts to its Bard IVC filter sales force, which required salespeople to falsely tell physicians that the Recovery filter was safe because it had the same reported failure rates as all other filters, according to the complaint.
Meanwhile Bard gave false information to the FDA’s MAUDE adverse-events database. The FDA discovered that Bard had reported multiple serious injuries and a death as non-injurious “malfunctions.”
FDA finally acts
In 2010, the FDA issued an advisory to physicians and clinicians noting that it had received 921 device adverse event reports involving IVC filters. But the FDA said only that it was “concerned” about the retrievable IVC filters. It recommended that physicians consider removing the filter as soon as protection from a pulmonary embolism is no longer needed.
In 2014, the FDA issued Bard two Form “483” letters in which it identified various deficiencies and violations by Bard at its IVC filter facilities. An audit showed that Bard had underreported 274 out of 939 adverse events.
Finally, on May 6, 2014, the FDA issued an updated safety communication about IVC filters. The FDA reported that “the risk of having an IVC filter in place is expected to outweigh the benefits.”
Accordingly, the plaintiffs’ proposed Medical Monitoring Protocol aims to reduce complications by aiding in the detection and remediation of any malfunction and also generally provides awareness of the issue so it can be investigated. Without this protocol, many if not most patients implanted with these IVC Filters will not even be aware of the serious risk they are in.