PHILADELPHIA (CN) – Synthes knew it was breaking the law when it tested a dangerous bone cement on humans, and a mother died in an operating room while a Synthes sales consultant looked on, the woman’s daughter claims in Federal Court.
A federal indictmentfiled in June 2009 accused Synthes’ then-subsidiary Norian Corp. of conspiring to introduce “an adulterated and misbranded” bone cement into interstate commerce.
Four Synthes executives were sentenced to prison, according to court records.
A cement dubbed the Norian Skeletal Repair System (SRS) received FDA approval for use in the distal radius, but Synthes was bent on having SRS used to treat vertebral compression fractures, Eva Sloan says in her wrongful death complaint.
Sloan, of Kenefic, Okla., is the daughter of the late Lois Eskind. She claims Synthes and Norian found it too burdensome and expensive to follow the legal procedure to get FDA approval to use SRS to treat spinal fractures, so they conspired to circumvent clinical testing procedures mandated by the Food, Drug, and Cosmetic Act, and to test the cement on humans for treatment of those injuries.
Sloan claims that the companies knew the scheme was illegal, and that patients injected with the cement for the spinal procedures could die. The procedures at issue are called vetebroplasties and kyphoplasties.
Sloan claims the defendants had employees mix SRS with barium sulfate in the operating room, in a process called “back table mixing,” for surgeons to use in vertebroplasties and kyphoplasties.
She says her mother died after a spine surgeon injected the mixture into Eskind’s back during a procedure in January 2003.
“One of 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,” according to the 47-page complaint.
Sloan sued Synthes and Norian Corp., both of West Chester, Pa.
She seeks punitive damages for wrongful death, fraudulent concealment, negligence, gross negligence, failure to warn, reckless misconduct, fraud, conspiracy, and loss of consortium.
She is represented by Laura Feldman, of Feldman & Pinto, in Philadelphia.