A woman is suing two companies based in West Chester, Pennsylvania, Synthes and Norian Corp., for the wrongful death of her mother in 2003. According to its website, Synthes, “develops, produces and markets instruments, implants and biomaterials for the surgical fixation, correction and regeneration of the human skeleton and its soft tissues.”
One of the products the companies produce is called “Norian Skeletal Repair System,” or SRS, which is a so-called bone cement. According to the lawsuit, the companies wanted SRS to be used in procedures used to fix spinal fractures. The product never received FDA approval for such use, though.
In 2003, the plaintiff’s mother had a procedure done, in which a spinal surgeon injected a combination of SRS and another compound into her back. The compounds had been mixed together in the operating room, which resulted in them being “adulterated and misbranded” according to the lawsuit. The FDA had not approved SRS for use in these types of cases.
Allegedly, the companies intentionally bypassed the requirements necessary to use products on humans and conspired to avoid required clinical tests. The daughter of the deceased believes the companies knew their actions were against the law and could result in patients’ deaths. The lawsuit contends, “One of (the) defendants’ sales consultants was present in the operating room throughout the surgery, including when the Norian SRS was mixed with barium sulfate, the mixture was injected, and when the death occurred.”
Among the claims the woman established in her complaint are allegations of wrongful death, gross negligence, failure to warn, fraud and conspiracy.
Source: Courthouse News Service, “Woman Calls Drug Companies Unconscionable,” Reuben Kramer, July 31, 2012.
Our firm handles similar situations to the one described in this post. If you would like to learn more about our practice, please visit our Pittsburgh wrongful death page.