pelvic mesh Archives - Medical Design Sourcing

Supreme Court denies J&J appeal of $302M vaginal mesh ruling

The U.S. Supreme Court today declined to hear Johnson & Johnson‘s (NYSE:JNJ) appeal of a $302 million judgment for false and deceptive marketing of its vaginal mesh implants.

The nation’s highest court denied the medtech maker’s bid for review without comment, allowing the California ruling to stand.

Attorneys for the state sued Johnson & Johnson and its Ethicon subsidiary in 2016, alleging the company neglected to tell patients and physicians about potentially severe complications and misrepresented the frequency and severity of the risk.

The case went to trial in front of a San Diego County judge in 2019 and resulted in a $343.99 million judgment against the companies in early 2020. The Fourth District Court of Appeals in California cut the civil penalties by $42 million last year.

J&J wanted a review of the case, saying it wasn’t fairly notified of the penalties and that attorneys for the state of California didn&#…

J&J settles big Australian pelvic mesh case

[Image from Unsplash]Johnson & Johnson (NYSE: JNJ) has settled an Australian pelvic mesh class action suit for AU$300 million (roughly U.S. $205 million), according to media reports.

Shine Lawyers, which handled the suit, confirmed the settlement. It still requires court approval. More than 11,000 claimants in Australia had sought relief, according to Reuters.

In a statement shared with MassDevice by a spokesperson, Johnson & Johnson and its Ethicon subsidiary said that pending Federal Court approval, they are pleased to reach a settlement that “provides certainty and a path forward for eligible Australian patients.”

The statement added: “Ethicon empathizes with all women who experience medical complications related to pelvic organ prolapse or stress urinary incontinence. These are extremely complex medical conditions, and Ethicon has strived to support the availability of treatment options for women with these conditions.” Read more

Coloplast wins summary judgement in transvaginal mesh suit in Minnesota

A federal judge in Minnesota granted summary judgment to Coloplast in a lawsuit over the company’s transvaginal mesh.

Angela Dawn Cantrell received the Restorelle L mesh implant as part of a surgery to correct vaginal prolapse in January 2018. Cantrell continued to experience pain and pelvic floor dysfunction after the surgery and underwent additional surgeries.

In 2020, Cantrell commenced action, advancing 11 claims against Coloplast, which now moves for summary judgment and to exclude the opinions and testimony of Cantrell’s six expert witnesses. Cantrell opposed the motions but only contests the motion for summary judgment as to three of the 11 claims: negligent design, design defect and failure to warn.

Coloplast argued that the negligent design claim fails because of a lack of admissible specific causation evidence. The court excluded testimony of Cantrell’s two specific causation experts, meaning she can’t succeed on the cla…

California appeals court orders Johnson & Johnson to pay $302M in pelvic mesh case

[Image from Unsplash]A California appeals court mostly agreed that Johnson & Johnson must pay the state hundreds of millions of dollars over misleading marketing around the risks of pelvic mesh products.

The Fourth District Court of Appeals in California, in its April 11 ruling, reduced the size of the civil penalties against J&J’s Ethicon subsidiary by $42 million. The reasoning was that Ethicon couldn’t be fined over oral communications because there was no evidence of what its employees actually said in one-on-one communications with doctors.

However, the appeals court allowed most of the penalties levied by the Superior Court in San Diego County to stand, with J&J expected to pay the state $302 million.

The appeals court disagreed that the fines were excessive, noting that $302 million makes us less than 0.5% of Johnson & Johnson’s net worth.

A J&J spokesperson told media outlets that the company plans to app…

AdvaMed supports effort to overturn J&J pelvic mesh ruling in California

Medical device trade group AdvaMed announced today that it has filed an amicus curiae brief supporting an appeal to overturn a $344 million pelvic mesh ruling against Johnson & Johnson in California.

Lawyers for AdvaMed tell the California Court of Appeal that the San Diego Superior Court judgment violated safe harbor protections because the case involved J&J communications about pelvic mesh that were FDA-approved.

“We believe the trial court misapplied California’s Unfair Competition Law and Fair Advertising Law by failing to judge the communications from the perspective of the target audience — trained physicians who treat pelvic floor conditions — over 80 of whom confirmed that the marketing materials were not likely to mislead them,” said Pat Fogarty, AdvaMed’s SVP, deputy general counsel and director of litigation.

“The decision undermines a manufacturer’s ability to rely on FDA input when it comes to the adequacy of …

Boston Sci settles host of state pelvic mesh lawsuits for nearly $189M

Boston Scientific (NYSE:BSX) has agreed to pay $188.6 million to 47 states and the District of Columbia to resolve claims that it deceptively marketed transvaginal surgical mesh devices, state AGs announced today.

Pelvic mesh products have been one of the medical device industry’s worst failures so far in the 21st century. First cleared nearly two decades ago, pelvic mesh products were meant to treat the weakening of the muscles and ligaments supporting a woman’s pelvic organs. But they became the subject of thousands of lawsuits and millions of dollars in settlements as women reported pain, excessive bleeding and loss of sexual function.

Boston Sci and Coloplast were the final two companies to sell the devices. FDA ordered a halt to pelvic mesh sales in 2019.

The multistate complaint against Boston Sci claimed that it failed to disclose the full range of potentially serious and irreversible complications caused by mesh. On top of paying the money,…

N.J. appeals court tosses $83M pelvic mesh verdicts against J&J, Bard

A New Jersey appeals court yesterday threw out jury verdicts totaling $83 million in separate pelvic mesh lawsuits against Johnson & Johnson’s (NYSE:JNJ) Ethicon division and Becton Dickinson (NYSE:BDX) subsidiary C.R. Bard.

In both cases, Bergen County, N.J. judges erred by disallowing evidence showing that each company’s mesh product had received FDA 510 (k) clearance, according to the appeals court panel.

In the case against J&J’s Ethicon, a jury had awarded Elizabeth and Tadeusz Hrymoc $5 million in compensatory damages and $10 million in punitive damages after finding the companies liable for violating New Jersey laws on defective design of their ProLift pelvic mesh and failing to warn patients of product risk.

The jury in the case brought by Mary McGinnis and Thomas Walsh McGinnis found Bard liable for design and failure-to-warn defects under the product liability laws of North Carolina, the plaintiffs’ home state, …

Federal lawsuit over Boston Sci pelvic mesh heads to trial

A federal judge in Arkansas has ruled that most counts in a pelvic mesh lawsuit against Boston Scientific can go to trial.

Kortney Cline sued Boston Sci in 2014, claiming that she suffered injuries after implantation with the company’s Obtryx trans-obturator mid-urethral sling in 2009.

Cline’s case was recently transferred to federal court in Arkansas from West Virginia, where it had been one of seven multi-district litigations. U.S. Judge Timothy L. Brooks in Arkansas, in an order dated Feb. 11, found that seven of the 10 counts in Cline’s lawsuit can proceed to trial.

Brooks among other things found “genuine, material disputes of fact” over whether Boston Sci should have used Marlex polypropylene in the Obtryx device. The judge also found that Cline had raised a “triable question of fact” over whether Boston Sci failed to entirely warn the doctor who implanted the Obtryx device in Cline.

Brooks also said…