Ethicon Loses Mesh Case with $57.1M Verdict

Earlier this month, a Philadelphia jury awarded $57.1 million in damages to a woman who accused Johnson & Johnson of manufacturing a defective pelvic mesh implant that scarred her urethra and left her incontinent. The award included $50 million in punitive damages. The plaintiff claimed that a pair of negligently and defectively designed mesh devices, the TVT-Secur and the standard TVT product, had left her with little control over her urinary flow.

The plaintiff was implanted with the TVT-Secur mesh device in May 2007 to treat symptoms of stress urinary incontinence and ultimately received a second TVT implant after a few months when her condition did not improve. Unfortunately, the mesh had eroded into her urethra, causing incontinence and with strong pelvic pain.

Ethicon had previously lost four out of five jury trials in Philadelphia. A jury in the fifth case decided in June that while the TVT-Secur had been defectively designed, it was not the cause of the plaintiff’s injuries. A judge, however, ruled a month later that the verdict was inconsistent and ordered a new trial on damages. Before this verdict, the largest verdict the company had faced in a mesh case in Philadelphia had been a $20 million award handed down in April. That award included $17.5 million in punitive damages.

Booth Samuels and the attorneys at Pittman, Dutton & Hellums, P.C. are currently investigating mesh injury cases. If you or someone you love was implanted with a pelvic or vaginal mesh device after the year 2008 and have had revision surgery, please contact Booth Samuels at 1-866-515-8880 or by email at booths@pittmandutton.com for a free consultation.

Philadelphia Jury Finds For Plaintiff Against J&J for Mesh Product

A state court jury in Philadelphia last week found in favor of the Plaintiff and against Johnson & Johnson regarding injuries the Plaintiff sustained due to a pelvic mesh device. The device was manufactured by the company’s Ethicon unit. The jury found for the Plaintiff in the amount of $2.16 million.

This was the latest of roughly 54,800 lawsuits pending against Johnson & Johnson in state and federal courts over vaginal-mesh devices produced by Ethicon. There have been several major Plaintiff victories over the last few years regarding mesh products manufactured by different companies. The verdict last week follows a $12.5 million jury verdict in a transvaginal mesh lawsuit against Johnson and Johnson’s Ethicon division on December 22, 2015. That Philadelphia jury found that the Plaintiff suffered injuries from a Prolift pelvic mesh implant, which was removed from the medical device market in 2012. The $12.5 million award included $7 million in punitive damages as the jury heard evidence of Ethicon’s document destruction.

Booth Samuels and the attorneys at Pittman, Dutton & Hellums, P.C. are currently investigating mesh injury cases. If you or someone you love was implanted with a pelvic or vaginal mesh device after the year 2008 and have had revision surgery, please contact Booth Samuels at 1-866-515-8880 or by email at booths@pittmandutton.com for a free consultation.

Endo Agrees To Settle Remaining TVM Claims

Earlier this month, Endo International announced it had reached agreements to settle up to 20,000 legal claims from women who said they were harmed by transvaginal mesh devices, ending nearly all of the U.S. cases against it and its American Medical Systems unit. The proposed settlement is valued at $400 Million.

Endo, which did not admit liability, said it would increase the amount of money it had set aside to cover vaginal mesh claims from $1.2 billion to approximately $1.6 billion in connection with the latest agreements.

Earlier this year in April, Endo announced it reached agreements to settle up to approximately 21,700 additional mesh claims. Last year, it settled an undisclosed number of cases for $54.5 million. See my previous blog posts for more on those settlements.

Transvaginal mesh manufacturers have faced a wave of litigation in the last few years over the devices, which are used to treat stress urinary incontinence and pelvic organ prolapse. The women suing the companies have accused the companies of selling subpar devices that caused injuries such as chronic pain, incontinence, bleeding and infection. Besides Endo, C.R. Bard Inc., and Johnson & Johnson's Ethicon are facing tens of thousands of lawsuits over similar products, with several trials scheduled for the fall.

Many of those cases have been consolidated before U.S. District Judge Joseph Goodwin in the Southern District of West Virginia, who is overseeing more than 60,000 mesh cases against seven manufacturers.

In 2008, the U.S. Food and Drug Administration notified transvaginal mesh manufacturers about reports of potential complications stemming from the devices. In 2012, the agency ordered AMS and other manufacturers to conduct post-market safety studies and monitor the rate at which adverse events were reported. The FDA announced earlier this year it is considering a proposal to tighten safety standards for mesh used to treat pelvic organ prolapse.

Boston Scientific Loses Pelvic Mesh Case

Following up on one of my blog posts from earlier this week, it was announced this morning that Boston Scientific was hit with a $73 Million verdict in a trial that took place in Dallas, Texas. The jury awarded $23 Million in compensatory damages and $50 Million in punitive damages to the Plaintiff. Boston Scientific faces upwards of 12,000 similar lawsuits.

It was reported the Texas jury deliberated for one day.

The defendant will certainly appeal.

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.                                         

New Mesh Studies Release and Update on Mesh Cases

A pair of new studies with mixed results suggests that removal of vaginal mesh -- a device implanted to help support a woman's pelvic organs – may not improve side effects such as pain and incontinence related to the device.

The findings, reported Monday at the American Urological Association's annual meeting, come at a time of growing safety concerns over vaginal mesh devices. Last month, the U.S. Food and Drug Administration (FDA) said it will require stricter oversight of the products -- specifically, as they are used to treat pelvic organ prolapse. The FDA now classifies these devices as "high-risk."

Unbelievably, the implants are still in use, and the recent FDA action applies only to vaginal mesh used for pelvic organ prolapse -- and not the other uses for mesh implants. Manufacturers will have to provide extensive safety data to the agency before it will approve future mesh devices for sale, unlike those that injured thousands of women, which were approved based on their similarity to mesh that has been used for decades to repair abdominal hernias.

In pelvic organ prolapse, the structures supporting the bladder, uterus and rectum weaken and stretch. The organs may drop from their normal position and protrude into the vagina, which can cause pelvic pain, discomfort during sex, and problems with urination and bowl movements.

Some women with pelvic organ prolapse eventually need surgery to reposition and secure the pelvic organs. Vaginal mesh implants were marketed to give extra support to the organs after corrective surgery.

However, the FDA began receiving reports of problems linked to the devices. There were cases where the mesh eroded, and women suffered infections, bleeding or pain.

The study followed 123 women who had surgery to remove either a mesh device or another synthetic device called suburethral tape. The results from this study was mostly good. Most of the women -- including 67 percent of those with the mesh device -- became pain-free after surgery. And on average, patients' pain ratings were much lower two to three years after surgery versus before the surgery.

The second study, by researchers at the University of California, Los Angeles, had less-positive results. It surveyed 214 women roughly three years after their mesh implants were surgically removed. Post-surgery, many women continued to have problems, the study found. Although two-thirds of the women said they had no pain or only mild symptoms, the rest had moderate to severe pain. Twenty-eight percent said they suffered from incontinence at least once a day, and half had pain during sex, according to the study.

There are a multitude of manufacturers of these products. As such, litigation over the various types of mesh implants have been going on for a few years. The results of trials that have occurred have been mixed. Last year, a major victory was achieved for the victims with a huge punitive damage judgment. See my previous blog post on that story.

Earlier this year however, U.S. District Judge Joseph Goodwin in Charleston, West Virginia, granted judgment for Johnson & Johnson on Carolyn Lewis’s claims that a TVT Retropubic sling implanted to treat incontinence was improperly designed, according to court records.

J&J is facing more than 12,000 federal-court claims that the TVT Retropubic slings and its other vaginal-mesh inserts degraded over time, causing pain and injuries. The cases have been consolidated before Goodwin for pretrial information exchanges. Lewis’s case was the first sling suit to go to trial. More than a million women have had the slings inserted since the device was approved in 1998.

Another manufacturer, American Medical Systems (AMS) and its parent company, Endo International Plc, announced an $830 million offer to settle approximately 20,000 pending vaginal mesh lawsuits. News of the settlement was reported on May 1, 2014.

The AMS settlement will resolve most of the lawsuits filed by women who allege they have suffered injuries after being implanted with the company’s Apogee, Perigee, and Elevate mesh devices that were meant to alleviate symptoms of pelvic organ prolapse and stress urinary incontinence. Each claimant will receive approximately $40,000, based on the total amount of the settlement. Many of the lawsuits have been consolidated into the MDL in front of Judge Goodwin. However, Endo is facing a number of lawsuits filed in various state courts throughout the country.

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.

$5.5 Million Verdict in Transvaginal Mesh Case

In the first transvaginal mesh lawsuit to go to trial, a jury in California ruled that transvaginal mesh implants manufacturer C.R. Bard was responsible for a patient’s injuries (Scott v. Kannappan, S-1500-CV-266034-WDE, Superior Court for Kern County, California, Bakersfield). In the jury trial, the Plaintiff, Christine Scott, was awarded $5 million for her injuries and $500,000 was awarded to her husband for loss of consortium. CR Bard was found 60% liable, while Scott’s doctor, Tillakarasi Kannappan, was found 40% liable. In Alabama, the percentage of fault would not have made a difference because of joint and several liability.

Scott had two Avaulta Plus transvaginal mesh devices implanted in her to treat urinary incontinence. She contended that the Bard Avaulta Plus vaginal mesh implant was defective and the manufacturer failed to warn about its safety risks. The Defendants included the manufacturer of the device CR Bard and her physician.

The transvaginal mesh caused complications that left her entirely incontinent, with chronic pain and the inability to have sex. She underwent nine revision surgeries and eight other procedures to try to get both devices removed that doctors said the devices could not be safely taken out of her body. Court documents report that the device has cut Scott’s colon and tissue, which continues to grow through the mesh holes. She will likely experience chronic pain for life and her runner lifestyle has been affected.

Although Scott is the first transvaginal mesh victim to get her day in court, hundreds of other women have filed their defective medical device lawsuits because of injuries and health complications they have suffered after getting a transvaginal mesh implant. Mesh product manufacturers named as defendants have included Boston Scientific Corp. (BSX), Murray Hill, Johnson & Johnson (JNJ), Endo Pharmaceutical Holdings Inc., and other companies. 

This verdict comes more than a month after Johnson& Johnson Ethicon discontinued four lines of vaginal mesh devices. Many filed cases have been streamlined into multiple MDL’s and  include C.R. Bard (MDL 2187), American Medical Systems (MDL 2325), Johnson & Johnson’s Ethicon (MDL 2327 ) and Boston Scientific (MDL 2326).

The vaginal mesh implant devices have been popular for treating Stress Urinary Incontinence and Pelvic Organ Prolapse. However, in the last few years, there have been reports of women suffering serious complications, including severe bleeding, pain during intercourse, infection, and erosion of the device. Between just 2005 and 2007 alone, the US Food and Drug Administration said it received over 1000 report of adverse events. Also, Scott is not the only woman to have undergone multiple procedures to try removing the device.

Last July, the FDA updated its Public Health Notification on transvaginal mesh products. While the original one from 2008 said that using transvaginal mesh in medical procedures could potentially cause a patient harm, the 2011 updated said that it is not unusual for someone undergoing a procedure involving this surgical device to suffer “serious complications.” The FDA also said that getting a transvaginal mesh does not give a patient a higher likelihood of a successful outcome than if she had undergone traditional surgery to treat the same condition.

C.R. Bard continued to keep its Avaulta products-- including the Avaulta Biosynthetic, Avaulta Plus and Avaulta Solo devices—on the market until they pulled it from the shelves in the US at the beginning of July 2012. The products were pulled only when the FDA asked for more clinical trials to determine their safety. Incredibly, Bard is still selling its Avaulta line in other countries.