TRENTON, N.J. (AP) -- Lawyers and advocates for women alleging Johnson & Johnson products injured them urged the U.S. Justice Department on Wednesday to investigate their claims the health care giant deliberately destroyed many documents critical to their lawsuits.
Corporate Action Network, a nonprofit group seeking to hold businesses accountable for their actions, said that it's written to Attorney General Eric Holder to look into whether J&J, based in New Brunswick, N.J., and CEO Alex Gorsky committed the crimes of obstructing justice and destroying records in a federal probe.
"Hundreds of thousands of women continue to suffer ongoing, severe harm," from J&J's pelvic mesh implants, network spokeswoman Levana Layendecker said during a call with reporters. "I hope Johnson & Johnson is held accountable for their failure to warn."
The implants are widely used to hike up sagging pelvic organs, common in older women and those who've had children — and often the cause of embarrassing bladder leaks when they laugh, sneeze or lift something heavy. More than 22,000 women suing J&J blame its implants for crippling pain, infections and bleeding.
Last month, U.S. District Court Judge Cheryl Eifert in southern West Virginia, who is handling most of the implant lawsuits, concluded J&J destroyed thousands of documents regarding development of its pelvic mesh implants, but said there was no proof that was done intentionally. The documents would include reports on patient testing of the mesh implants and could show whether participants suffered serious complications.
Jane Akre, founder of an online network for pelvic mesh implant "survivors," said Johnson & Johnson was aware of possible harm and didn't warn the public.
"Evidence we've presented at trial showed they knew these implants would cause complications and they just didn't care. Many women are now disabled and they can't leave their beds, they're in so much pain," she said during the conference call.
"Women have killed themselves because the pain eclipses childbirth pain, it's that bad," Akre said in an interview.
Matthew Johnson, a spokesman for Johnson & Johnson's Ethicon unit, which makes the implants, said in a statement that the company "acted appropriately and responsibly in the research, development and marketing of our pelvic mesh products," which he said are considered a "gold standard" treatment.
"Ethicon has engaged in extensive efforts to preserve and produce evidence in the pelvic mesh (federal litigation) which has led to the production of millions of pages of documents to date. In the context of Ethicon's substantial document production, the inadvertent loss of certain, limited documents has not prejudiced plaintiffs in their ability to pursue their claims," he added.
Sagging pelvic organs were fixed with traditional surgery until the late 1990s, when J&J launched the first pelvic mesh implants, a twist on a similar product long used to repair hernias. The pelvic implants, which function like a sling attached to bones to lift fallen organs back up, were billed as more effective than just stitching organs into place. Six other companies then launched rival products.
Women soon began complaining of complications so severe they can't work, need strong painkillers around the clock and now find intercourse unbearably painful. That's because the mesh, similar to a window screen, over time can dig into the exterior tissue of the vagina or bladder, causing a sensation some have likened to having barbed wire twisting inside your body.
Attorneys have been advertising heavily for potential plaintiffs in recent years, and the litigation has grown into possibly the largest mass medical injury case in the country.
Plaintiff Linda Dotson of Loudon, Tenn., told reporters that after having mesh implanted in two areas of her pelvis in 2006, she quickly developed a dangerous blood clot and then suffered hemorrhaging, severe pain, unexplained fevers, fatigue and other flu-like symptoms. She had to have a couple of surgeries to remove much of the mesh, took antibiotics for months and still suffers.
Justice Department spokeswoman Allison Price said the department is reviewing the group's letter.
Corporate Action Network said it plans to bring injured patients to speak at J&J's annual shareholder meeting on April 24.
The group also alleges that J&J has harmed other patients, particularly women, with faulty hip implants — which the company has since taken off the market amid a crush of lawsuits — and with baby and beauty products containing undisclosed toxic ingredients. Under pressure from multiple consumer and environmental groups for the past several years, J&J has begun reformulating those shampoos, skin care and other personal care products with safer ingredients.
Johnson & Johnson, the world's biggest maker of health care products, has run afoul of the federal government previously.
It's operating under an agreement requiring it to make major upgrades to three medicine factories responsible for dozens of product recalls since 2009 for problems including drugs with the wrong level of active ingredient and liquid medicines with tiny metal or glass shavings in them.
Separately, after the Justice Department joined three whistleblower lawsuits alleging Johnson & Johnson marketed some of its powerful prescription drugs for unapproved uses, the company last November paid federal and state fines of more than $2.2 billion. It also entered a five-year agreement with the government to change the way it does business, particularly disclosing more information about its research and marketing practices.
Follow Linda A. Johnson at http://twitter.com/LindaJ_onPharma
- Health Care Industry
- Johnson & Johnson