Two Pelvic Mesh Juries Give Two Differing Results

Over the last two weeks, two strikingly different results have occurred involving transvaginal mesh trials.

A jury in a West Virginia federal court slammed Johnson & Johnson subsidiary Ethicon Inc., with a $3.27 million verdict last Friday in a bellwether trial. The jury found Ethicon's transvaginal sling was defectively designed and the company failed to warn of its potential risks. 

It was reported that the jury returned the compensatory damages verdict after deliberating for just three hours and found for the plaintiff on all counts. The trial lasted two weeks.

Johnson and Johnson faces nearly 33,000 similar lawsuits.

On August 29, the previous Friday, a Massachusetts jury sided with Boston Scientific Corp., in the second bellwether trial involving the company’s pelvic mesh devices. The jury found that a transvaginal sling was not defectively designed and the company adequately warned of risks associated with the device. That trial lasted two weeks and the jury deliberated for over two days. This trial was heard in state court.

These bellwether trials illustrate the multitude of different outcomes in transvaginal mesh litigation on both the state and federal level. On one hand, we have seen summary judgment granted for the defendants, while on the other we have seen near Billion dollar settlements (see my previous blog posts regarding such). The MDL system and bellwether trials are designed to help both sides of the aisle evaluate their positions reasonably. These latest bellwether trials will probably do little to help either side assess their positions and instead push them to keep trying cases.                                         

J&J Staple Accessory Kit Recall

Johnson and Johnson has recalled more than 157,000 surgical stapler devices and accessories used in hemorrhoids treatment procedures due to potential malfunctions that pose a serious safety risk. The recall is a Class 1 recall, the most serious classification of recalls. Class 1 recalls are only issued when a defective medical device is likely to cause serious health problems or death. 

These products are commonly referred to as “Staple Accessory Kits” or “Internal Hemorrhoid Staples”. They are manufactured by J&J's Ethicon Endo-Surgery division. 

The recalled products are:

Transtar Circular Stapler Procedure Set

Proximate HCS Hemorrhoidal Circular Stapler and Accessories

Proximate PPH Hemorrhoidal Circular Stapler and Accessories

The FDA issued a recall based on issues related to the firing of the device which may result in incomplete staple formation. An incomplete staple formation is similar to when you attempt to staple too many pieces of paper together and the staple does not puncture through all of the pieces and does not fasten correctly.

Failure of an incomplete staple formation can result in severe pain, sphincter dysfunction, rectal wall damage, sepsis, bleeding, occlusion of the rectal canal, and splitting of rectal wall staple line and bleeding.

The affected products were manufactured and distributed between April 2011 and July 2012.

J&J said its Proximate HCS hemorrhoidal circular stapler and accessories with product code "PPH01" have been discontinued in the U.S. However, the Proximate PPH stapler remains available.

Pittman, Dutton & Hellums, P.C. is currently investigating “Staple Accessory Kit” injury claims. If you or a loved one were injured as a result of this product, please contact Booth Samuels at    1-866-515-8880 or by email at booths@pittmandutton.com.

Jury Hits Johnson & Johnson in Mesh Case with $7.6M in Punitive Damages

A month-long jury trial against Johnson & Johnson’s Ethicon subsidiary ended badly last week for the mega-corporation (Gross v. Gynecare Inc., Superior Court of Atlantic County, New Jersey, Atl-L-6966-10). A New Jersey jury came out with a $3.35 million verdict in favor of the plaintiff and hit the company for $7.76 million in punitive damages.

The case was tried in Atlantic City over J&J’s Gynecare Prolift vaginal mesh implant. J&J is the world’s largest seller of healthcare products. The New Jersey transvaginal mesh lawsuit is one of 1,800 pending against J&J and its Ethicon division in a multicounty litigation underway in Atlantic County Superior Court. There are approximately 2,000 cases nationwide in various US district federal courts, while most are consolidated in West Virginia.

The Plaintiff, Linda Gross, recounted from the stand that her life since receiving Ethicon’s Gynecare Prolift device as being a “living hell.” Despite undergoing 18 corrective surgeries, the 47-year-old former nurse from South Dakota said she is unable to sit or stand for long periods of time without feeling pain. In urging the jury to award punitive damages, the Plaintiffs’ attorneys said Johnson & Johnson was a “big giant” and jurors must send a “loud message” to punish the company for its conduct, according to Bloomberg.

The $3.35 million compensatory damage verdict in favor of Ms. Gross includes economic loss, pain and suffering, and more. Under New Jersey state law, punitive damages are capped at five times the compensatory damages. Her allegations were that J&J knew it sold a defective device despite knowing the risk of scar and pain, organ damage and perforation.

The jury found that J&J failed to warn the plaintiff’s surgeon of the risks of its Gynecare Prolift implant and fraudulently misled her about the risks. This is the first trial involving 2,100 New Jersey lawsuits and about 2,000 cases nationwide in US District federal court, consolidated in West Virginia - all of which are over J&J’s vaginal mesh.

It is believed that J&J is worth $121 billion and has a net worth of about $65 billion. Last year it spent $21 billion on marketing and advertising alone, which translates to $57 million per day. This behemoth medical company spends $3.5 million on advertising every 45 minutes, which is the same sum that the jury awarded Linda Gross.

J&J is also in serious legal hot water over their subsidiary DePuy and their manufacturing of metal-on-metal hips such as the ASR and Pinnacle. Litigation in regards to those products have both been consolidated into MDL’s.

Transvaginal mesh devices are used to treat pelvic organ prolapse and stress urinary incontinence. They have been the subject of growing safety concerns since October 2008, when the U.S. Food & Drug Administration (FDA) issued a Public Heath Notification advising it had received more than 1,000 complaints over a three year period relating to vaginal mesh products. In July 2011, the FDA issued another alert, noting that it had received a total of 2,864 additional reports of complications. The agency concluded that serious injuries associated with surgical mesh for transvaginal repair of pelvic organ prolapse, were “not rare,” and further advised that transvaginal prolapse repair with mesh “does not improve symptomatic results or quality of life over traditional non mesh repair.”

The attorneys at Pittman, Dutton & Hellums are currently investigating claims against the manufacturers of mesh products. If you or a loved one experienced injuries from a mesh product, please contact Booth Samuels at booths@pittmandutton.com or toll free at 1-866-515-8880.