Swiss medical manufacturer Synthes, along with 4 U.S. executives, is facing a lawsuit alleging that an illegal off-label use of its bone cement led to the perioperative deaths of 2 California women.

Ryoichi Kikuchi and Barbara Marcelino, both 83, died during surgeries in 2003 and 2004 respectively after the product, Norian XR, was injected into their spines. The bone cement product, developed to stabilize orthopedic implants, had been approved for injection into the arms, but not into the spine.

In 2010, Synthes and subsidiary company Norian (which manufactured the product) pleaded guilty to fraud for running unauthorized clinical trials of the product and agreed to pay $23.5 million in fines. That plea deal also saw the 4 former executives (Michael Huggins, Thomas Higgins, Richard Bohner and John Walsh) admitting guilt for illegally steering surgeons into the off-label spinal use of the cement and receiving prison sentences.

In the current wrongful death suit, Synthes chairman Hansjorg Wyss and biotech firm Kensey Nash, which bought Norian from Synthes after it sold the subsidiary as part of the plea deal, are also named as defendants. According to published reports, however, the surgeons at John Muir Medical Center in Walnut Creek, Calif., who injected the bone cement into Ms. Kikuchi and Ms. Marcellino, were not included in the lawsuit.

Johnson & Johnson has announced plans to purchase Synthes for $21.3 billion, pending approval from the European Commission.

David Bernard