We’ve been looking at recent trial results in transvaginal mesh cases. In this (fourth) post we review two verdicts from October 2015, where juries concluded that the mesh manufacturers were not negligent. Thus, these injured women received no money for the failure of the transvaginal mesh. In a third case, decided on December 21, 2015, the jury awarded $12,500,000.00 to an injured woman. I will take a look at all three cases:
Cavness v. Kowalczyk et al. (Texas District Court, Dallas)
Product: Gynecare Prosima Pelvic Floor Repair System
Key Product Defendants: Ethicon, Inc. and Johnson & Johnson.
Jury Award: zero.
Date of Jury Verdict: October 5, 2015
Key Takeaway: A big win for Ethicon and Johnson & Johnson, defendants in the case.
Carol Cavness was implanted with the Gynecare Prosima Pelvic Floor Repair System in April 2012. The transvaginal mesh began causing her serious health problems, including pain, incontinence, infections, bleeding, odors, and other problems. Eventually, the mesh product was partially removed in an “explant surgery.”
Ms. Cavness sued Ethicon and Johnson & Johnson, claiming that the companies were negligent in manufacturing and selling the transvaginal mesh. She also brought claims for design defects, manufacturing defects, and a failure to warn her and her doctors about the risk of the mesh product. She also sued her doctor and the hospital where the surgery was performed.
As with so many of the failed medical products on the market these days, the Gynecare Prosima product was approved for the marketplace under the 510(k) process, where a product can be approved for sale if an existing product that is substantially the same has already been tested and approved.
A major part of Ms. Cavness’ case was her claim that the polypropylene material was not appropriate for implantation in the human body.
The jury rejected Ms. Cavness’ claims, finding that Ethicon and Johnson & Johnson were not negligent and that Ms. Cavness’ injuries were not caused by the Gynecare Prosima transvaginal mesh product.
Carlson v. Boston Scientific Corp. (Western District North Carolina)
Product: Uphold Vaginal Support System
Jury Award: zero
Date of Jury Verdict: October 16, 2015
Key Takeaway: “Learned intermediary doctrine” is a formidable defense for product manufacturers.
Martha Carlson was implanted with the Uphold Vaginal Support System transvaginal mesh. She then suffered vaginal pain, incontinence, and sexual discomfort. She also alleged that the TVM shrunk and hardened inside her and could not be removed (explanted).
Ms. Carlson sued in federal court in North Carolina. The case was moved to the multidistrict litigation (MDL) venue in West Virginia. In the MDL, the reviewed Boston Scientific’s motion for summary judgment and awarded partial summary judgment in favor of Boston Scientific on the failure to warn claim.
As with the Frankum case, which I wrote about in a previous post, summary judgment was awarded to Boston Scientific (the TVM manufacturer) on the failure to warn claim based in large part on the “learned intermediary doctrine.” Again: a manufacturer (like Boston Scientific) cannot be liable for negligence if it provides all necessary information to a “learned intermediary” (in this case the implanting surgeon), who then must communicate with the patient about the benefits, risks, etc. The surgeon in Ms. Carlson’s case did not rely on the directions for use (DFU) with the Uphold TVM product.
The MDL transferred the case back to North Carolina, and in October 2015 trial was held as to Ms. Carlson’s negligent design claim and her breach of implied warranty claim. As with many of these cases, Ms. Carlson’s attorneys argued that the polypropylene was not a suitable material for implantation in the body, and that the rubbery material hardens and degrades when implanted.
Hammonds v. Ethicon, Inc., et al. (Pennsylvania Court of Common Pleas, Philadelphia)
Product: Gynecare Prolift Pelvic Floor Repair System
Key Product Defendants: Ethicon, Inc. and Johnson & Johnson.
Jury Award: $12,500,000.00 ($5,500,000.00 compensatory damages; $7,000,000.00 punitives)
Date of Jury Verdict: December 21, 2015
Key Takeaway: A strong statement from the jury in support of the injured woman, Ms. Hammonds, with a large punitive damages award.
Patricia Hammonds was implanted with the Gynecare Prolift Pelvic Floor Repair System in 2009 to treat pelvic organ prolapse and stress urinary incontinence. You know what happened next: Ms. Hammonds began to suffer debilitating pain, particularly pain during intercourse, and other problems. She underwent revision surgery, but the pain and incontinence continued. The surgeon then attempted to remove the Prolift TVM but found that it was compressed near Ms. Hammonds’ bladder, and which likely was the cause of a hole (perforation) in the bladder. The Prolift TVM could not be removed surgically.
The Gynecare Prolift Pelvic Floor Repair System was approved for sale under the 510(k) process which I have written about repeatedly on this site. Check it out if you are interested.
The jury awarded Ms. Hammonds $5,500,000.00 in compensatory damages, which are damages related to actual loss and actual harm suffered by the plaintiff, and an impressive $7,000,000.000 in punitive damages, damages which serve as a kind of punishment to the negligent defendant, and is used as a tool to discourage negligent or other harmful actions in the future.
In any event, after the two defense verdicts from October 2015, it was encouraging to see a strong result for Ms. Hammonds in Philadelphia.
More transvaginal mesh information will follow in this blog. Stay tuned.