Product News and Recalls

Johnson & Johnson unit sued over Norian SRS death

Johnson & Johnson’s Synthes unit, a maker of tools and implants to treat damaged bones, has been sued by the family of a woman who died during an unapproved trial of a bone cement, Bloomberg reports.

It’s an ironic development for Johnson & Johnson, which recently purchased Synthes for $19.7 billion, largely in the hopes it would help offset revenue losses related to a series of recalls and legal problems over faulty medical devices.

Johnson & Johnson subsidiary DePuy Orthopaedics recalled a line of all-metal artificial hip implants in 2010 because nearly half of all recipients had to get a replacement within six years, and many also suffered toxic metal debris breaking off in their bodies.

And the company recently announced that it will stop selling four types of vaginal mesh implants used to treat urinary incontinence and pelvic organ prolapse, after more than 600 women filed lawsuits claiming the devices caused injuries and debilitating pain.

Citing a complaint filed in federal court in Philadelphia, Bloomberg says that Lois L. Eskind died on Jan. 13, 2003, after a surgeon injected Synthes’s Norian SRS drug into her spine mixed with barium sulfate. Moments after the mixture leaked into her venous system, she suffered cardiac arrest.

The complaint alleges that Synthes, its Norian unit and the operating surgeon “concealed the illegality, experimental nature and substantial risks of the surgery.”

Four Synthes executives were sentenced last year to prison terms ranging from five months to eight months for their roles in the unapproved trials, Bloomberg says. The cement, approved for use elsewhere in the body, was used in the spines of 200 patients with fractured vertebrae. Three patients, including Eskind, died during spinal surgeries.

You should consult with a doctor if you have any ongoing symptoms or health concerns from a Johnson & Johnson product. If you have significant injuries, you should also consult with a DePuy hip or transvaginal mesh lawyer to discuss your legal rights.

See the report here:

http://www.businessweek.com/news/2012-07-30/synthes-sued-over-death-related-to-unapproved-bone-cement-trial