The lawsuit was filed by Patricia W., a woman from California who was implanted with the Eclipse® Inferior Vena Cava Filter (“IVC Filter”) manufactured by C.R. Bard and Bard Peripheral Vascular, Inc.
The filter was surgically implanted in her body on December 31, 2011 at a hospital in Texas, but she was injured in California.
IVC filters were originally designed for long-term use, with approval based on a careful risk-benefit assessment in the 1970s. These permanent filters were never popular due to the risk of side effects.
Permanent filters were also only recommended for patients with diagnosed blood clots or pulmonary embolisms who could not take blood-thinning drugs.
That all changed in 2003 when the FDA began approving temporary IVC filters for short-term protection against blood clots. Hospitals changed their guidelines and doctors started routinely implanting IVC filters in patients without blood clots, even patients who could take blood-thinning drugs.
The problem was that hospitals rarely followed up with patients after implanting the filters, so less than 30% were ever removed. Temporary filters were essentially treated as permanent devices with a retrieval hook. The difference was that temporary filters were made of flexible metals like nitinol (nickel-titanium) rather than stainless steel or solid titanium.
Another difference was that the safety studies lasted just a few weeks. The studies were only intended to prove that temporary filters could be removed within a few weeks. In actual practice, very few were removed within a few weeks, and many were impossible to remove by the time the patient decided to schedule a follow-up procedure.
The result was a skyrocketing number of IVC filters, as well as the number of injuries. It was only after hundreds of thousands of people were implanted with unnecessary filters that studies began finding alarmingly high rates of complications, particularly when filters remain implanted for more than 2-3 months.
This prompted the FDA to issue an advisory to doctors in the summer of 2010, recommending follow-up care and warning against leaving retrievable IVC filters in place too long:
If a patient has a retrievable IVC filter that should be removed based on his or her individual risk/benefit profile, the primary care physician and/or those providing ongoing patient care should refer the patient for IVC filter removal when feasible and clinically indicated.”
Lawyers accuse the manufacturers of IVC filters of downplaying the importance of removing short-term filters as soon as possible, overstating the benefits, and inadequately studying them for safety.
The defendants are charged with 14 counts of liability:
- Strict Products Liability — Manufacturing Defect
- Strict Products Liability — Information Defect (Failure to Warn)
- Strict Products Liability — Design Defect
- Negligence — Design
- Negligence — Manufacture
- Negligence — Failure to Warn
- Negligent Misrepresentation
- Negligence per se
- Breach of Express Warranty
- Breach of Implied Warranty
- Fraudulent Misrepresentation
- Fraudulent Concealment
- Violations of Applicable State Law Prohibiting Consumer Fraud and Unfair and Deceptive Trade Practices
- Punitive Damages
The lawsuit was filed on April 10, 2017 in the U.S. District Court for the District of Arizona — Case No. 2:17-cv-01048.
C.R. Bard is now facing 1,700 other IVC filter lawsuits in a centralized Multi-District Litigation (MDL No. 2641) — In Re: Bard IVC Filters Products Liability Litigation.
The plaintiff is represented by Ben C. Martin of The Law Offices of Ben C. Martin in Dallas, Texas. He serves on the plaintiffs’ steering committee of the Bard IVC Filter MDL.