Johnson & Johnson was ordered to pay $344 million for misrepresenting the risks of vaginal-mesh implants to consumers in California, the first state to bring its claim against the company to trial after thousands of U.S. women sued and some products were recalled.
Lawyers for California Attorney General Xavier Becerra proved J&J and its Ethicon unit “deceptively marketed their pelvic mesh products” for years to doctors and consumers without fully disclosing the risks of the devices, misleading users in violation of state consumer-protection laws, San Diego Superior Court Judge Eddie Sturgeon concluded in his ruling Thursday.
The company had faced more than 100,000 lawsuits over the products, which were intended to bolster sagging organs or treat incontinence in women. Many of those cases have been settled. Becerra had sought a fine of as much as $800 million, even though J&J resolved similar claims by 41 other states for $117 million.
J&J officials vowed to appeal the finding of the California judge, who heard the trial last year without a jury.
“Ethicon responsibly communicated the risks and benefits of its transvaginal mesh products to doctors and patients, and the decision disregards the company’s full compliance” with federal law governing medical-device communications, Mindy Tinsley, an Ethicon spokeswoman, said in an emailed statement.
California was the first of the states that sued J&J to get its case to trial. Officials in Washington agreed to a $10 million settlement last year on the eve of trial. J&J withdrew some of its vaginal-mesh lines from the market in 2012 after facing complaints by thousands of women that the products — threaded into place through incisions in the vagina — eroded over time, causing pain and injuries.
J&J was accused by California of wrongfully engaging in a “surround-sound marketing campaign to both patients and doctors” that trampled state law, according to court filings. The company still faces lawsuits filed by the attorneys general of Oregon, West Virginia, Kentucky and Mississippi.
Marketing efforts included thousands of sales calls in which J&J officials misled doctors about the devices’ risks at meetings in their offices or at dinner, the filings show. J&J also made false or misleading statements about the safety of vaginal-mesh products in magazine ads, on the internet and in brochures, the state alleged.
Sturgeon arrived at his damage award by imposing a penalty of $1,250 for each of the 153,351 violations of the state’s unfair competition law and 121,844 violations of false advertising statutes.
The fine “represents less than 1% of J&J’s $70.4 billion total net worth and is not unconstitutionally excessive or disproportionate,” the judge said in his ruling.
Side Effects Known
During closing arguments in the California case, Deputy Attorney General Jinsook Ohta told the judge that the evidence showed J&J officials aggressively marketed mesh even though they knew it could have long-term and devastating side effects, and that they were aware of the problems before the product went on the U.S. market in 1998.
“They knew then that these products had life-threatening complications,” Ohta told Sturgeon. “This case turns on the fact that the defendants concealed and misrepresented facts to California women and California doctors.”
Ohta played videos of a woman who testified, “I feel like damaged goods” and that her husband blamed her mesh failure operation for “the death of our sex life.”
Defense attorney William Gage told the judge J&J and Ethicon didn’t mislead consumers or physicians about the risks, and noted the state didn’t produce testimony from any doctor who said he was duped. He said the state relied on language in mesh safety labels and random comments by sales reps to make its case.
Gage said it’s “laughable” to argue doctors base their treatment decisions on warnings printed on a device’s packaging. “Reasonable surgeons practice evidence-based medicine,” J&J’s lawyer said. A physician’s treatment is based on “clinical experience, medical literature, conversations with other doctors and medical conferences,” he said.
The case is People of the State of California v. Johnson & Johnson, No. 37-2016-00017229-CU-MC-CTL, Superior Court of the State of California (San Diego).
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