Two Minneapolis Heart Institute doctors are opposing a $296 million plea agreement involving Boston Scientific Corp.’s (NYSE:BSX) Guidant division.
Earlier this month, Boston Scientific agreed to settle charges stemming from a four-year investigation into possible criminal violations of the Federal Food, Drug, and Cosmetic Act.
Under the terms of the plea, which must still be approved by Judge Donovan Frank of the U.S. District Court for Minnesota, Guidant pleaded guilty to withholding information from the FDA: specifically, to making a materially false statement about its Ventak Prizm 2DR implantable defibrillator in a required submission and to failing to notify the agency of a “correction” to its Contak Renewal defibrillators.
The cardiologists, Drs. Robert Hauser and Barry Maron, were the first to flag concerns five years ago that some Guidant defibrillators could short-circuit. Boston Scientific paid $26 billion to acquire Guidant in 2006.
In February 2002, Guidant discovered a design flaw in the Ventak device, after receiving reports of failures. By April 2002, according to court documents, it had fixed the flaws and begun producing a corrected version of the device — but didn’t recall the defective products.
On March 13, 2005, 21-year-old Joshua Oukrop’s Ventak Prizm 2 DR short-circuited, killing him. Guidant told his doctor of the problems with the device, disclosed that it knew of 25 other such cases and told the physician that about 24,000 ICDs similar to Oukrop’s had been sold. When the doctor asked Guidant whether the other recipients would be told, the company said no, it did not want to “alarm” anyone, according to court documents. The company kept its word in subsequent Securities & Exchange Commission filings and press releases, never mentioning the defect or Oukrop’s death until an impending New York Times article that was to reveal the device’s flaws forced the company’s hand.
In a letter (PDF) to Frank, Hauser and Maron detailed their opposition to the plea deal.
"We are physicians who cared for Joshua Okrup [sic], a 21-year-old college student, who died when his Guidant Prizm 2 implantable cardioverter-defibrillator (ICD) short-circuited and failed to deliver a life-saving shock. His unnecessary death was caused by a product defect that Guidant Inc. had known about for years and failed to inform patients, physicians, and the U.S. Food and Drug Administration,” they wrote. “Accordingly, we are extremely dismayed by the U.S. Attorney General’s decision to enter into a plea agreement with Guidant LLC, rather than prosecute the company and the individuals responsible for this egregious act. On behalf of the patients who died or suffered pain and mental anguish as the direct result of Guidant’s illegal and unethical behavior, we urge you not to accept the plea agreement.”
Hauser has been an outspoken advocate for greater accountability on the part of medical device makers. Last year, he helped lead the charge for more oversight of defibrillator manufacturers by the industry itself and the Food & Drug Administration.
Minnesota Public Radio News contributed to this report.