J&J Takes Hits on Talc Lawsuit, Settles Xarelto Suit, Faces Pricing Criticism

Courtesy of Sundry Photography/Getty Images

Courtesy of Sundry Photography/Getty Images

Johnson & Johnson has lost several major lawsuits over allegations that asbestos in its talcum powder contributes to ovarian cancer.

Sundry Photography / Shutterstock.com

Johnson & Johnson has lost several major lawsuits over allegations that asbestos in its talcum powder contributes to ovarian cancer. For example, in a 2018 lawsuit, a St. Louis jury awarded almost $4.7 billion in total damages to 22 women and their families.

As a strategy, the company has tried to get 2,400 of its state-court cancer lawsuits transferred to a federal court in Delaware. This would allow it to develop a single defense strategy. However, U.S. District Judge Maryellen Noreika in Wilmington, Del. dismissed the request yesterday, “noting that the world’s largest maker of health care products is partly responsible for the boomlet of litigation over its transfer strategy that it now characterizes as a crisis,” reports Bloomberg.

J&J hoped that by invoking the legal rights of its talc supplier, Imerys Talc America, now bankrupt, it would create quicker trials and claims resolutions. But Noreika stated in her decision, “J&J cannot establish an emergency. J&J’s desire to centralize its own state-law litigation does not justify the finding of an emergency.”

Judges in California and South Carolina have chosen not to send more than 90 cases to Noreika, arguing that some of the plaintiffs are too close to death to delay the litigation. In her ruling, Noreika pointed out that J&J has not joined Imerys in Chapter 11 and hasn’t “established financial distress” related to the talc cases.

J&J is facing more than 14,000 claims alleging that its talc products caused ovarian cancer or mesothelioma because of asbestos contamination. More than 11,000 of them were filed in federal courts and have been consolidated before a federal judge in New Jersey.

In a separate group of lawsuits, J&J has agreed to pay a lump sum of $1 billion to resolve lawsuits related to defective metal-on-metal hip implants, which required later removal. This would resolve about 95% of the 6,000 lawsuits filed against the company related to the devices. There was an earlier $400 million settlement related to the metal-on-metal hips.

However, there are still about 4,500 lawsuits pending related to J&J’s artificial hips that were not made completely out of metal components or that had not been removed surgically.

And in March, J&J and Bayer AG agreed to settle more than 25,000 lawsuits in the U.S. over their Xarelto blood thinner. They agreed to pay a lump sum of $775 million. The amount will be shared equally between the two companies. They had jointly developed Xarelto.

The resolutions would wrap up all pre-existing U.S. lawsuits over Xarelto. Many of the allegations argued that the companies didn’t properly warn users of the severe bleeding risk, and that their injuries could have been prevented if doctors and patients had been given adequate information.

In a March 25, 2019 statement, Bayer said it believed the claims were without merit, stating, “However, this favorable settlement allows the company to avoid the distraction and significant cost of continued litigation.”

Although not a lawsuit, J&J took another hit. In March, the U.S. Food and Drug Administration (FDA) approved the company’s Spravato (esketamine) nasal spray for use with an oral antidepressant in adults with treatment-resistant depression. Esketamine is an animal tranquilizer but was used for some time off-label to treat depression.

The Institute for Clinical and Economic Review (ICER), an independent non-profit research institute that publishes research about the effectiveness and value of drugs and medical devices, criticized J&J’s pricing for Spravato. The final report will be published on May 23.

ICER argues that while Spravato has “promising” clinical benefit, its current list price is too high for the drug’s cost-effectiveness. ICER, whose reports are non-binding, called the drug’s supporting safety data “promising but inconclusive.”

David Rind, ICER’s chief medical officer, stated, “Esketamine shows some benefits for such patients and provides an FDA-approved treatment for TRD that may be covered by payers; however, it is concerning to have an overpriced therapy where there is such need for treatment.”