Lawsuit charges negligence and other wrongs by medical device manufacturers C.R. Bard and Bard Peripheral Vascular arising from the implantation of an allegedly defective Bard-branded blood filter marketed as the Bard G2 IVC Filter.
December 14, 2015, New York, NY — Wendy R. Fleishman of the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP, announced that Gary Leigh Piazza has filed a personal injury product liability lawsuit against C.R. Bard and Bard Peripheral Vascular, Inc. (“Bard”) for injuries she allegedly sustained as a result of surgical implantation of the Bard G2 IVC Filter.
I feel I was wronged by the manufacturer,” stated Ms. Piazza. “I was in great pain for months. I was on pins and needles, thinking, ‘is this thing going to kill me tonight?’ Now I have a humongous scar on my belly that wraps around my waist. It’s a constant reminder. This reminder — this big scar on my belly forever — I feel maimed. And I’m still swollen across my abdomen, even today.
In January of 2010, Ms. Piazza had a Bard G2 IVC Filter implanted into the vessel leading to her heart in order to filter out any dangerous blood clots. In May 2015, she started to feel an extremely powerful stabbing and burning pain in her abdomen and lower back.
Ms. Piazza’s doctors learned that the IVC filter had moved out of place and broken. Little pieces of the filter were floating in her blood vessels toward her heart, lungs, and brain. The IVC filter had actually cut into her aorta and possibly other organs as well. Her doctors performed a “massive” surgical removal operation. She suffered grievously as a result.
Background on Inferior Vena Cava Blood Filters
The inferior vena cava is a vein that returns blood to the heart from the lower portions of the body. An inferior vena cava (“IVC”) filter is a device designed to filter or “catch” dangerous blood clots that can travel from the lower portions of the body to the heart and lungs. IVC filters are designed to be implanted, either permanently or temporarily, in the inferior vena cava.
For those patients at high risk for blood clots, or who cannot manage their conditions with medications, physicians may recommend implanting an IVC filter to prevent the clots from traveling and causing serious, even fatal, health issues.
The FDA Warning Letter to Bard
On July 13, 2015, the FDA issued a Warning Letter to Bard notifying that its IVC filters were adulterated and misbranded under federal law because the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation were not in conformity with the current good manufacturing practice requirements of the Quality System Regulations.
The FDA also notified Bard that it had failed to comply with adverse patient event reporting requirements, including a consistent pattern of Bard underreporting the severity of injuries caused by device failures and failing to report device malfunctions all together. The FDA cited numerous examples of Bard reporting G2 and other IVC filter failures resulting in deaths and other serious injuries as if there was no patient injury involved.
“As a medical device manufacturer, Bard has an obligation to develop, test, and validate the safety of its products prior to selling them. Had Bard done this rather than sell a defective and unreasonably dangerous device, Gary Leigh Piazza would not have been severely injured as described in the complaint,” stated Fleishman. “We want other patients to know about the risks and potential danger the IVC filter may cause so they continue to have their doctors monitor the placement of the filters.”
The lawsuit was filed on December 14, 2015, in United States District Court in the Western District of New York. Ms. Piazza is a resident of Buffalo, New York.
Legal Resources for IVC Blood Filter Patients and Their Families
Answers to common questions on the IVC blood filter injuries and legal resources for affected patients and their families can be found on Lieff Cabraser’s IVC filter injuries web page.
If you or a family member have been injured as a result of the implantation of an IVC filter, please call Wendy Fleishman toll-free at 1 888 321-1510 or complete our IVC filter injury contact form to reach out to an experienced injury lawyer at Lieff Cabraser. There is no charge or obligation for our review of your case.
About Lieff Cabraser
Recognized as “one of the nation’s premier plaintiffs’ firms” by The American Lawyer, Lieff Cabraser Heimann & Bernstein, LLP is a sixty-plus attorney law firm with offices in San Francisco, New York, and Nashville. Our firm has successfully represented thousands of patients across America in individual lawsuits due to the injuries they suffered from defective medical devices. U.S. News and Best Lawyers have named Lieff Cabraser as a 2016 “Law Firm of the Year” for representing plaintiffs in class actions and mass torts.
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Wendy R. Fleishman
Lieff Cabraser Heimann & Bernstein, LLP