On behalf of Brown & Crouppen, P.C. posted in Defective Products on Friday, August 10, 2012
A medical device maker will pay $3.6 million to a patient who suffered complications from a pelvic mesh implant in 2008. The victim blamed mesh maker C.R. Bard for negligence. The lawsuit stated the woman required up to nine procedures to correct problems caused by the erosion of the device, including pelvic pain and incontinence.
Women’s groups from Missouri and around the country are pressuring the U.S. Food and Drug Administration to issue a recall for the surgical mesh, which was used to correct prolapses, bulges and incontinence. After a two-year side effects review, the FDA issued a recommendation last year for reclassifying the devices as high-risk products. This year, the government ordered over 30 vaginal mesh manufacturers to implement lengthy safety studies.
The Bard lawsuit is a precedent setter, the first of its kind to be decided by a jury. A group of federal lawsuits against Bard and two other vaginal mesh makers has been consolidated and will kick off in court next February.
Bard will be responsible for 60 percent of the medical malpractice damages totaling $5.5 million for medical expenses, pain and suffering and a loss of consortium. A jury found that the doctor who inserted the Avaulta Plus implant was 40 percent at fault, the equivalent of almost $2 million. According to the plaintiff’s attorney, the jury felt Bard neglected to test the vaginal mesh devices properly.
The surgeon will not be required to pay his part in the award because his name was dropped from the lawsuit last year. The plaintiff, who initially sought $11 million, plans to take the surgeon to court separately.
Bard argued that their Avaulta Plus devices were safe, effective and federally approved. The plaintiff, a jury and a collection of women named in federal lawsuits targeting vaginal mesh manufacturers disagree. They believe the devices cause harm and so far have shown evidence to prove it.
Source: Bloomberg, “Bard, Doctor Ordered To Pay $5.5 Million Over Implant,” Jef Feeley, July 25, 2012