October 21, 2012
In May 2004, a Food and Drug Administration (FDA) investigator triggered a years-long inquiry and trial of Synthes, a multinational medical device manufacturer, uncovering multiple cases of what amounted to human experiments that left five unwitting patients dead.
The four business-people found responsible served between five and nine paltry months in prison. The families of the dead were only recently informed that their loved ones had perished on the tables of surgeons using an experimental bone cement.
They sued Synthes’ elusive yet
“forceful,” “hands-on,” “800-pound gorilla” CEO, Hansjörg Wyss,
to no avail.
The promising product was more effective
than acrylic alternatives, but the FDA demanded clinical trials.
Wyss and his executives, whom he hand-picked and groomed for company
success, knew this would cost time and money.
When Chapman injected Norian XR into a pig’s bloodstream,
The following month, executives Michael Huggins and Tom Higgins met with Wyss.
This was neither the first nor the last meeting in which all parties would agree to proceed with illegal testing of a high-risk device on uninformed patients. Market potential was,
Whistleblowers and concerned employees like Michael Sharp were at first reassured that the rumors were unfounded and Synthes wouldn’t dare flout the FDA.
Then they were
terminated for, supposedly, other reasons.
Because the FDA’s approval process is
notoriously slow, many “orthopods” see the idea of reading labels on
medical devices like Norian XR as unnecessary.
Although the act of mixing Norian XR with any other substance - a procedure necessary to inject it into spines - was expressly prohibited by the FDA, many surgeons mixed and injected as instructed by the Synthes representative.
surgeons ended up with corpses on their table.
Of course, he was also named to the Hansjörg Wyss
chair at UW, to which Wyss gave a $2 million endowment.
Meanwhile, in June of this year, Johnson & Johnson - under attack of late for product recalls and marketing Risperdal for unapproved use - splurged and bought Synthes, controversy and all, for $20 billion.