Catherine Rowden, individually and on behalf of the estate of Johnny Rowden, filed a blood clot filter case in Missouri on Sept. 28, 2012 against C.R. Bard. Ms. Rowden alleges that Bard made a defective IVC filter which lead to the death of her husband, Johnny.
The case. – No. 4:15-cv-01489 – was filed in U.S. District Court Eastern District of Missouri Eastern Division.
Filter caused Plaintiff’s Death, says Petition
Johnny Rowden was implanted with a Bard G2 filter. “As a direct and proximate result of the Eclispe Filter’s manufacturing defect,” the petition alleges, “Mr. Rowden suffered serous physical injuries, including death, and economic damages in an amount to be determined at trial.”
Specific Allegations as to the Plaintiff
On November 16, 2006, Mr. Rowden underwent placement of a G2 Filter. The petition alleges the anchoring system of the G2 Filter subsequently failed, leading it to tilt and perforate the vena cava. As a result, “the ability of the device to prevent pulmonary embolisms was substantially reduced.” On September 28, 2012, Mr. Rowden died, says the petition, “as a result of the defective G2 Filter failing to perform its intended function of preventing clots from moving to the heart or lungs.”
Cause of Action: Negligence
Under the first cause of action, negligence, the petition states: “Bard knew or should have known that the G2 Filter was designed and manufactured in such way that it was defective in condition and unreasonably dangerous because it lacked adequate stability and structural integrity and posed an excessively high risk of perforation, all of which were known to substantially decrease its effectiveness.”
Under the fifth stated cause of action, the plaintiff lists breach of express warranty. Section 138 of the petition alleges: “The representations and warranties made by Bard were false, misleading, and inaccurate because the G2 filter was defective and unreasonably dangerous and the device was not of merchantable quality when used in its intended and/or reasonably foreseeable manner.”
High Fracture Rate
The petition alleges that Bard’s own investigations into comparative failure risks between the different available devices continually showed Bard that its “G2 filters posed a substantially higher risk of migration, tilt, perforation and fracture.”
The petition further claims that, “Recent medical studies report that the G2 will suffer a 38 to 40 percent fracture rate at four to five years.
Bard obtained clearance on July 30, 2008 to begin marketing the G2 Express® Filter (G2 Express) via the 510k process. The filter is identical in design to Bard’s previous G2 Filter, except that the Express has a hook at the top of the device, which allows it to be retrieved by snares, as well as Bard’s Recovery Cone.
IVC Filters no proven Benefit
The petition also alleges that, “Of note, Bard’s internal documents as well as recent medical literature establish that there is no proven benefit to these devices.”
Beginning in 2003, filter makers began marketing what are known as optional or retrievable filters. These filters are marketed as being designed to be left in permanently or having the option to retrieve once the risk of pulmonary embolism has passed.
Missouri IVC Blood Clot Filter case filed
The petition further states that an ex-Bard employee has testified in the past that she raised safety concerns regarding the G2 Express device prior to FDA clearance. She testified that her concerns were ignored and that she was threatened with retaliation if she did not drop those safety concerns. That ex employee could be called by plaintiffs’ attorneys to testify in the Rowden vs. Bard trial.
• Missouri IVC Blood Clot Filter case filed