How in the world can a company plead gulity to 10 felonies and nobody do time?
Firm Silent as Patients Died (washingtonpost.com)
From the article:
A major maker of medical devices pleaded guilty yesterday to covering up thousands of incidents in which its product malfunctioned as it was being inserted in patients’ bodies. Twelve patients died, and dozens needed emergency surgery.
EndoVascular Technologies Inc. of Menlo Park, Calif., a subsidiary of Guidant Corp., agreed to pay $92.4 million to settle federal civil and criminal charges and pleaded guilty to 10 felonies, including selling a “misbranded” medical device and making a false statement to the Food and Drug Administration.
Under federal law, the Guidant subsidiary was required to notify the FDA of serious malfunctions involving its product, a fabric graft inserted through incisions in the groin to reinforce weak spots or bulges in the aorta, a major artery. About one-third of the devices shipped by the manufacturer malfunctioned before the product was recalled and corrected two years ago, prosecutor Matthew J. Jacobs said.
The company reported 172 of those malfunctions but failed to disclose 2,628 others, court papers said. The device sometimes became stuck while being implanted, the plea agreement said. And during some failures, company sales representatives coached doctors in the operating room through untested, unapproved procedures to break part of the device and extract it from the patient’s body, potentially averting the need to notify the FDA, the government added.
After a patient died during one such attempted extraction, seven employees sent an anonymous letter to the company and the FDA, court papers said. That triggered an internal investigation that led to a recall of the product in early 2001 and to the federal investigation.
In court documents unsealed yesterday in San Francisco, the government did not charge any individual employee or say who participated in the misconduct, but it said the criminal investigation is continuing.
the reassuring part (if you lived, you’re OK):
The FDA said that the problems related only to the system for implanting the device, not to its performance once implanted.
The device, known as the Ancure Endograft System, was designed for treatment of abdominal aortic aneurysms, potentially fatal weaknesses in the artery that carries blood from the heart.
OK, so that’s a long quote, but I was just rivited to this article. The good news is that employees couldn’t stomach deaths at the hands of their medical device, but they didn’t tell the FDA.
I’m a doc, and I use medical devices all the time (though none are ‘cutting edge’; mine have been around for years, and are well proven). I would be furious, ragingly furious, if a company sold me a device they knew had problems and didn’t report. This goes to the heart of the doctor patient relationship, first do no harm.
A tiny caveat: the world needs such a treatment for aneurysms, which have a high mortality and morbidity rate. With some things I, harm can be done, falling into the you have to be alive to be inconvenienced category (from Dr. Peacock, Dept. of Surgery, TTUHSC:ElPaso; thanks!).
This is a cautionary tale, and I’d be willing to bet those involved in the whistleblower letter are mortified by the death(s) and concerned for their liberty, but someone deliberately covered this up and deserves to pay.