Johnson & Johnson and Another Medical Product Problem – Bone Cement

Whether it’s a tooth pull or a transplant, every surgical procedure involves both risk and trust, risk that something might not go as planned, and trust that the surgeon, the surgical team, and all of the products and tools they employ are safe, appropriate and proven to be in the patient’s best interest. Patients must acknowledge and accept risk as part of surgery, but negligence on the part of the surgical team or product manufacturers is never acceptable.

Eva Sloan, daughter of one unfortunate victim of broken medical trust, is currently suing Synthes, a Johnson & Johnson company, in U.S. District Court, alleging that the company and the operating surgeon in her mother’s case “concealed the illegality, experimental nature and substantial risks of the surgery,” that lead to her mother’s death in 2003. Ms. Sloan’s mother, Lois Eskind, underwent spinal surgery to help alleviate pain in two vertebrae due to osteoporosis. During the procedure, Mrs. Eskind was injected with a combination of a Synthes’ bone cement and barium sulfate. Moments later she suffered cardiac arrest and died.

Mrs. Eskind was one of three patients who lost their lives as a result of unapproved and illegal use of the bone cements in 2003 and 2004. According to a statement released by the U.S. Department of Justice, Eastern Pennsylvania Division, both Norian (then owned by Synthes) and Synthes executives conspired to conduct illegal clinical trials into the use of Norian XR and Norian SRS bone cements to treat vertebral compression fractures (“VCF’s”) in human patients, despite their knowledge that the bone cements combined with human blood during pilot studies produced blood clots. Furthermore, even after the third patient death, executives for the two medical companies did not recall the bone cements, but instead engaged in a cover-up of their unapproved use, and their culpability in the deaths of the three patients.

The case was so egregious in nature that Synthes, Norian, and four of their top executives pled guilty and were given prison sentences ranging from five to eight months for their parts in the unapproved trials. Synthes then agreed to sell Norian to Kensey Nash, which has since become part of Dutch medical company Royal DSM.

In the aftermath, Mrs. Sloan, joined by her father and brother, are suing Synthes/Johnson & Johnson for wrongful death, negligence and medical fraud. One possible difficulty for their suit is that the statute of limitations on similar cases is five years. Mrs. Sloan’s attorney, Laura Feldman of Philadelphia’s Feldman & Pinto, will argue that the statute should not apply in this case of broken medical trust, because Synthes failed to disclose its unauthorized and illegal use of the Norian bone cement on Mrs. Eskind, leaving the bereaved family to hear about the situation from a member of the media.