mcloudyn.png
Sunday December 8th, 2019 7:37AM

J&J agrees to $117M settlement over pelvic mesh devices

By The Associated Press
Related Articles
  Contact Editor

TRENTON, N.J. (AP) — Johnson & Johnson has agreed to a $117 million multistate settlement over allegations it deceptively marketed its pelvic mesh products, which support women's sagging pelvic organs.

Ohio's attorney general said Thursday an investigation found that J&J, the world's biggest health products maker, violated state consumer protection laws by not fully disclosing the devices' risks.

Numerous women who had the once-popular, hammock-like devices implanted claim they caused severe pain, bleeding, infections and other complications.

Johnson & Johnson and its Ethicon surgical products unit reached the settlement with 41 states and the District of Columbia.

"These companies didn't paint a clear picture of the device's medical risks, preventing patients from making well-informed decisions," Ohio Attorney General Dave Yost said in a statement.

The products, also called transvaginal mesh, are a synthetic material surgically implanted through the vagina of women whose pelvic organs have sagged or who suffer from stress urinary incontinence — bladder leakage when they cough, sneeze or lift heavy objects. Such incontinence is estimated to affect 3% to 17% of women and sometimes becomes severe after age 70.

Some of the products are still on the U.S. market, and hundreds of thousands of women have had the devices surgically implanted, according to Yost's office.

An Ethicon spokeswoman noted the settlement doesn't include admission of any misconduct, and said the devices "are considered by many to be the gold standard for the treatment of stress urinary incontinence."

"Ethicon has acted appropriately and responsibly in the research, development and marketing of our transvaginal mesh products," which were launched around the world in 1998, she added.

About 25,000 U.S. women with complications have sued Johnson & Johnson, the company said. Those lawsuits aren't affected by the settlement.

It comes as J&J is swamped with thousands of lawsuits claiming patients were harmed by products including baby powder, opioid painkillers and prescription drugs such as its schizophrenia drug Risperdal. Headlines about the litigation and big jury verdicts against J&J, including an $8 billion punitive award to a young man who grew breasts while taking Risperdal, have depressed J&J's stock price for nearly a year. Most of the verdicts against J&J have been overturned or are being appealed.

The pelvic mesh deal requires the company to cease its claims that surgical technique can eliminate any risks, as well as to disclose a list of risks, including loss of sexual function, mesh eroding into the vagina and the possible need for corrective surgery.

The settlement covers the District of Columbia and these states: Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia and Wisconsin.

Ethicon said it settled separately with Washington state and has cases pending in California, Kentucky, Mississippi and West Virginia.

J&J shares closed Thursday up $1.00 to $136.17, still well below their 52-week high of $148.99 late last fall.

___

Follow Linda A. Johnson at https://twitter.com/LindaJ_onPharma

  • Associated Categories: Associated Press (AP), AP Business, AP Business - Consumer News, AP Business - Corporate News, AP Online - Georgia News
© Copyright 2019 AccessWDUN.com
All rights reserved. This material may not be published, broadcast, rewritten, or redistributed without permission.
Chicago teachers' strike leaves parents, students in lurch
Chicago teachers are on strike after failing to reach a contract deal with the nation's third-largest school district
3:07PM ( 10 minutes ago )
Boris Johnson gets EU Brexit deal; next hurdle is Parliament
British Prime Minister Boris Johnson and European Union leaders have reached a long-sought Brexit deal
2:58PM ( 19 minutes ago )
US, Turkey agree on Turkish cease-fire with Syrian Kurds
Vice President Mike Pence is announcing that Turkey has agreed to a cease-fire in Syria to allow the Kurdish forces it was battling to withdraw from an area says that Turkey has agreed to a cease fire in Syria
2:58PM ( 19 minutes ago )
Associated Press (AP)
GM contract: worker pay hikes, factory closings move forward
A tentative four-year contract with striking General Motors gives workers a mix of pay raises, lump sum payments and an $11,000 signing bonus but it allows GM to proceed with plans to close some factories
2:32PM ( 45 minutes ago )
Juul halts sales of fruit, dessert flavors for e-cigarettes
Juul Labs stops selling fruit and dessert flavors for its electronic cigarettes
2:27PM ( 50 minutes ago )
IMF head says more needed to boost growth than US-China deal
The International Monetary Fund's new leader says a U.S.-China trade truce could trim expected losses to the world economy but won't be enough to produce strong global growth
2:27PM ( 50 minutes ago )
AP Business
Apple has a lot to lose if it crosses China's party bosses
Apple drops app that allows Hong Kong activists to report police movements from its online store following Chinese criticism
4:52PM ( 6 days ago )
Apple has a lot of lose if it crosses China's party bosses
Apple drops app that allows Hong Kong activists to report police movements from its online store following Chinese criticism
3:58PM ( 6 days ago )
Overhaul is proposed for decades-old Medicare fraud rules
Trump administration proposes overhaul of Medicare fraud rules seen as outdated
8:04AM ( 1 week ago )
AP Business - Consumer News
Chicago teachers' strike leaves parents, students in lurch
Chicago teachers are on strike after failing to reach a contract deal with the nation's third-largest school district
3:07PM ( 10 minutes ago )
Boris Johnson gets EU Brexit deal; next hurdle is Parliament
British Prime Minister Boris Johnson and European Union leaders have reached a long-sought Brexit deal
2:58PM ( 19 minutes ago )
US, Turkey agree on Turkish cease-fire with Syrian Kurds
Vice President Mike Pence is announcing that Turkey has agreed to a cease-fire in Syria to allow the Kurdish forces it was battling to withdraw from an area says that Turkey has agreed to a cease fire in Syria
2:58PM ( 19 minutes ago )
2 accused in probe of Giuliani associates are due in court
Two businessmen are being arraigned on charges they conspired with associates of Rudy Giuliani to make illegal campaign contributions
2:53PM ( 25 minutes ago )
Cummings provided strength, calm, for urban Baltimore
He stood up for the poor and the disadvantaged throughout urban America, but Elijah Cummings also provided a strong voice and calm presence for Baltimore
2:48PM ( 29 minutes ago )