On January 20, 2015, the judge who oversaw the first federal transvaginal mesh trial against C.R. Bard Inc. (“Bard”) that resulted in a $2 million jury verdict for the plaintiffs ($250,000 in compensatory damages and $1.75 million in punitive damages) in federal court in West Virginia during August 2013 denied the defense motion to set aside the jury’s verdict. There are seven multidistrict federal actions involving transvaginal mesh claims (transvaginal surgical mesh is implanted in patients to treat pelvic organ prolapse and stress urinary incontinence).
The female plaintiff had been surgically implanted with Bard’s Avaulta Plus Posterior Biosynthetic Support System transvaginal mesh device to treat her pelvic organ prolapse in May 2009, after which she experienced significant mental and physical pain and suffering.
The defendant had challenged in its motion for a new trial the trial court’s exclusion of evidence regarding the defendant’s compliance with the FDA rule that requires medical device manufacturers to notify the FDA 90 days prior to marketing a medical device. In denying the defense motion for new trial, the federal judge stated that the FDA rule does not pertain to whether a medical device is safe and effective, and that the proffered evidence would have resulted in a substantial risk of misleading and confusing the jury.
The federal judge also determined that it was not error to allow the jury to consider a material safety data sheet that cautions that polypropylene resin, which is used in manufacturing Bard’s transvaginal mesh product, should not be used in a permanent medical implant.
The defense’s argument that the plaintiffs should not have been allowed to mention Bard’s decision to not perform pre-market clinical testing was also rejected by the judge because Bard’s duty to exercise reasonable care includes its duty to properly test its medical device.
The plaintiffs’ argument that Georgia’s law on punitive damages that requires that 75% of any punitive damages award be paid to the state was unconstitutional was also rejected by the federal judge, finding that the Georgia law furthers a legitimate state interest in deterring conduct that could potentially harm Georgia citizens (not just the plaintiffs) and the plaintiffs had no property interest in the jury’s award of punitive damages.
In denying Bard’s motion to reduce the punitive damages award to a one-to-one ratio with the jury’s compensatory damages award, the judge stated that the evidence introduced during the trial demonstrated the defendant’s indifference and reckless disregard of the health and safety of the plaintiff, and the judge further stated that the evidence “demonstrated that during the market life of the Avaulta Plus, Bard knew about the risks posed by the product and its complication rates, but time and again, Bard did not act to correct the problems. This longstanding and continuous behavior strongly indicates reprehensibility.”
If you or a loved one were injured as a result of implanted vaginal mesh or another medical device in the United States, you should promptly seek the legal advice of a medical malpractice lawyer (medical device lawyer) in your state who may investigate your vaginal mesh/medical device claim for you and represent you in a claim against the manufacturer and/or other(s), if appropriate.
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