Synthes Sued for Death Caused by Unapproved Bone Cement

August 1, 2012 — Eva Sloan has filed a wrongful death lawsuit after her mother, Lois L. Eskind, died of a heart attack after a surgeon injected bone cement mixed with barium sulfate into her spine.

The lawsuit, filed in the U.S. District Court for the Eastern District of Pennsylvania, alleges that Synthes “concealed the illegality, experimental nature and substantial risks of the surgery.” Synthes executives have already been convicted of felonies and misdemeanors and served prison time in the matter.

Sloan accuses Synthes of negligence, fraud, reckless misconduct, conspiracy, loss of consortium, and failure to warn. She claims the company conspired to circumvent the expensive, time-consuming legal procedures that the U.S. Food and Drug Administration (FDA) requires for clinical testing of new products.

In the late 1990s, Synthes executives noticed that some doctors performing back surgeries were using bone-cement off-label. Another company, Noridian Corp., already sold a type of bone cement that was FDA-approved for use in the arm or parts of the skull. Synthes purchased Noridian, and executives began encouraging surgeons to use the product in back surgeries. Unfortunately, there is a major vein in the spine that carries blood directly to the heart and lungs.

In 2003, Eskind underwent surgery to treat a crumbled vertebrae. Her doctors used the bone cement mixed with barium sulfate. Soon after she received the injection, she suffered a cardiac arrest and died in the operating room. After three people died of heart attacks, the FDA finally investigated in 2004. Four executives at Synthes were indicted by a grand jury in 2009. Last year, the courts ordered them to serve prison sentences between five and eight months. The company was forced to pay a $23.5 million fine, and has since been acquired by Johnson & Johnson for nearly $20 billion.

Family members representing the two other victims of bone cement (Ryoici Kikuchi and Barbara Marcelino) filed wrongful death lawsuits in California last year.