A lawsuit for, among other things, wrongful death, was recently filed against two Pennsylvania companies for their role in the death of a woman while undergoing surgery. According to the lawsuit the woman died due to the use of bone cement to treat spinal fractures. Though the product known as Norian Skeletal Repair System, had been approved by the Federal Drug Administration for certain uses, it had not yet been approved for use with spinal fractures.

The wrongful death complaint alleges that rather than following the prescribed FDA procedures to obtain approval, it "conspired to circumvent clinical testing procedures." This was reportedly accomplished by combining and using the SRS with barium sulfate during procedures known as vertebroplasties and kyphoplasties. Further, it asserts that the defendant companies, Synthes and Norian Corp., not only knew that using the product in that way was against the law, but that it could in fact lead to death.

According to the complaint, this is in fact what happened to the petitioner's mother. She reportedly died on the operating table after receiving an injection of the mixture into her back.

This civil lawsuit comes on the heels of a criminal case. Four executives with Synthes reportedly received prison sentences after a federal indictment of conspiring to get the "adulterated and misbranded bone cement into interstate commerce."

Clearly there is nothing that can be done to bring the deceased woman back to life. If successful, in addition to being an additional punishment to the named defendants, the financial damages the woman's daughter would likely receive could however make things easier for her in the future.

Source: Courthouse News, "Woman Calls Drug Companies Unconscionable," Reuben Kramer, July 31, 2012