Two years ago, in the first bellwether case against medical device manufacturer C.R. Bard for production of its transvaginal mesh products, jurors awarded plaintiff $2 million in damages. Of that, $250,000 was for compensatory damages (intended to compensate for actual losses) and $1.75 million was for punitive damages (intended to punish defendant).
In Cisson v. C.R. Bard, both sides had appealed the final order, but for very different reasons.
Defendant appealed on the grounds certain evidence should have been kept from the jury and that the court should have allowed the defense to propose a special jury instruction. Also, defense argued the damage award was excessive. Plaintiff, meanwhile, appealed the split-recovery ruling, pursuant to Georgia law, that grants 75 percent of punitive damages to the state.
The U.S. Court of Appeals for the Fourth Circuit affirmed on all grounds. That means plaintiff will receive about $680,000 in damages for her claim, which involved intense pain and suffering and a requirement of revision surgery after she was implanted with defendant’s transvaginal mesh.
These devices became common in recent years to treat pelvic organ prolapse and certain bladder disorders in women. Pelvic prolapse is when a pelvic organ (like the bladder) prolapses from its normal place in the lower belly and pushes against the walls of the vagina. This happens typically as a result of the muscles becoming weakened or stretched due to surgery or childbirth.
The problem is these devices used to treat the condition? At least insofar as C.R. Bard goes, evidence shows the material of which they were made was not safe for long-term implantation in humans – and internal memos proved executives knew it.
Women who have been affected usually have to undergo surgery to help relieve the chronic pain, and many are left scarred for life and endure ongoing loss of sexual feeling.
The Cisson case was the first of 70,000 that are pending against C.R. Bard in multi-district litigation. Other manufacturers, including Johnson & Johnson, are facing a similarly large number of cases.
One important thing the Fourth Circuit established in its ruling on this appeal was that the trial court was correct in prohibiting the company from using as a defense the fact that it complied with the U.S. Food & Drug Administration’s Section 510(k) medical device process. Defendant insisted its product was necessarily safe in the eyes of the FDA, and it should have been granted permission to tell the jury that. This position was supported via briefs submitted to the court by a number of pro-business groups.
However, the court rejected it. Basically, the fact that a device follows the FDA’s medical device process doesn’t necessarily mean the product is safe. All the process allows is clearance to sell the device based on the fact that it is substantially equivalent to another that’s already on the market. The fact that a product is approved under this process doesn’t mean it’s undergone any new regulatory requirements and it doesn’t mean it’s automatically safe.
The court determined compliance with the FDA’s procedure is “of little or no evidentiary value” in this product liability lawsuit.
Call Allred & Allred P.C. at 334.396.9200 to speak with a Montgomery personal injury lawyer.
Cisson v. C.R. Bard, Jan. 14, 2016, U.S. Court of Appeals for the Fourth Circuit
More Blog Entries:
Fasanello v. Ledyard – Child Injury and Statute of Limitations, Jan. 14, 2016, Montgomery Product Liability Lawyer Blog