Three medical device executives are going to prison for the death of three patients who were subjected to an experimental bone cement they produced. Three former executives of West Chester, Pa-based Synthes, North American president Michael Huggins, 54, and former executive VP Thomas Higgins, 55, each received a nine month sentence in federal prison. They must also pay $100,000 in fines each.
The former director of regulatory and clinical affairs, John Walsh, was sentenced to five months in federal prison for being complicit. A fourth executive former VP Richard Bohner will be sentenced soon. His lawyer collapsed in the courtroom and was wheeled out. The sentences were handed down in the U.S. District Court for Eastern Pennsylvania.
Three Patient Deaths During Unauthorized Trials
The three patients died on the operating table during back surgeries when their blood pressure dropped after they were injected with bone cements SRS with barium sulfate into their vertebrae, reports Philly.com. (here) Norian makes the bone cement, a subsidiary of Synthes.
The idea was the bone cement would fill in vertebrae gaps, however Synthes did not have FDA approval to use Cement for vertebral compression fractures. Also a problem – the company didn’t seek informed consentfor the unauthorized human trial. Instead surgeons were supplied with the bone cement, they were trained by the company and its reps often appeared in the operating room.
A news release from October 2010 says the company withheld information from the FDA about the patient deaths, therefore avoiding a recall of the product.
In addition the four went beyond that by actively participating in the illegal promotion of the device, marketing it for spinal fractures even after pilot studies showed a link to blood clots in the lungs.
Judge Legrome D. Davis said Davis and Huggins showed a “knowing disregard” for the safety of patients. (here)
The case is U.S. v. Norian Corp., 09-00403, U.S. District Court, Eastern District of Pennsylvania (Philadelphia).
1975 Park Doctrine
It is unusual for any white-collar pharmaceutical or medical device executives to go to prison, but in a break from tradition, executive may be held liable when the law is broken, whether they intended to or not, under the 1975 Park Doctrine.
A responsible corporate officer is supposed to know what is going on during his watch and can be held responsible for illegal activity, in this case a violation of food and drug laws. The doctrine is named after a U.S. Supreme Court decision United States v. Park, that allowed the government to charge company officials with misdemeanors if they participated in or failed to prevent a violation of the Federal Food, Drug, and Cosmetic Act (FDCA), even with no proof they intended to violate FDCA.
Norian Bone Cement Trials
The executives were indicted in June and charged with misdemeanors for the off-label use of the bone cement. The company is also facing 52 felony counts, including conspiracy to “commit crimes against the United States” by obstructing the Food and Drug Administration. It has not been established that the three who were enrolled in a trial died from the Norian XR bone filler used to treat fractures which was cleared by the FDA in 2002.
Johnson & Johnson is buying Synthes for $21.3 billion, reports the Philadelphia Inquirer, (here) to capture the market on bone-related medical devices. Synthes will pay $24.3 to settle the criminal charges.