Experts agree that industry employees like this guy have good reason to be afraid of speaking publicly. Attorney, Mark Cohen, works with the Government Accountability Project which assists whistleblowers. People who come forward he says, do so at great personal risk. "Speaking up puts their current job in jeopardy and it threatens to brand them as trouble-makers with other employers."
This is especially true for those who go up against the Pharmaceutical industry, says attorney, Jason Zuckerman, of the Washington DC Law Office of Jason M. Zuckerman. "Whistleblowers in the pharmaceutical industry," he warns, "really face an uphill battle, a David versus Goliath struggle."
In fact, experts say whistleblowers who interfere with the highly profitable Medicate fraud often find themselves out of work permanently. "My clients whose only infraction was committing the truth," Mr Zuckerman states, "have found themselves unemployed and suffer permanent damage to career and reputation."
Medtronic no doubt will try hard to settle the Poteet lawsuit before it goes to trial, because under a key provision of the FCA, a jury can order the company to pay a triple damage award.
But in any event, Medtronic's entanglements with law enforcement officials are not limited to the Poteet case. According to its latest SEC filing, Medtronic received a subpoena from the Office of the US Attorney for the District of Massachusetts issued under the Health Insurance Portability & Accountability Act of 1996, on October 24, 2005, requesting documents relating to pacemakers and defibrillators; monitoring equipment and services; benefits to persons in a position to recommend purchases of such devices; and the company's training and compliance materials relating to the fraud and abuse and federal Anti-Kickback statutes.
"The Company intends to fully cooperate with the Office of the United States Attorney for the District of Massachusetts," the filing states, "with respect to this subpoena."
In addition to the lawsuit filed by Ms Poteet and the various investigations by government agencies, the company is also facing a wide range of other lawsuits related to its products.
On February 11, 2005, Medtronic began advising doctors about a potential battery shorting that may occur in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), including certain of the Marquis VR/DR and Maximo VR/DR ICDs and certain of the InSync I/II/III Marquis and InSync III CRT-D devices.
The company provided physicians with a list of potentially affected patients and recommended that physicians communicate with those patients so they could manage the issue in a manner they felt was appropriate for their patients.
Subsequently, the FDA classified the recall a Class II Recall, and a large number of lawsuits were filed against Medtronic by either individuals claiming personal injury or third party payors seeking reimbursement of costs associated with the recall, including a claim by an individual acting on behalf of the Center for Medicare & Medicaid Services.
The company waited until February 2005, to tell patients that their defibrillators might fail. However, company documents filed in the California lawsuit, Randall v Medtronic, No C-05-3707-JW, show Medtronic knew about the flaw back in 2003, and continued to sell the faulty devices for two more years.
"Medtronic has been taking products they know are not quite right and putting them into people rather than take the loss," according to Hunter Shkolnik, a New York attorney, who said in a February 13, 2006, interview with Bloomberg News that he represents more than 200 people whose Medtronic devices were recalled.
"If you know there's a problem with a component," he said, "you don't put it out and sell it to people."
Another batch of devices came under scrutiny six months after the first recall. In a June 9, 2005 letter, the FDA told Medtronic that it had failed to correct manufacturing problems and investigate its LifePak 12 external defibrillators and failed to follow through with preventive action after inspections of the company's Redmond, Washington plant.
The LifePak 12 defibrillators, used to shock the heart back to a normal rhythm, are similar to the LifePak 500 devices that the company had recalled. At the time, about 60,000 LifePak 12 defibrillators were in use worldwide, company spokesman Rob Clark said.
In the warning letter, the FDA said Medtronic did not investigate all complaints related to the malfunctions, including one involving a patient's death, and warned that failure to correct the problems could result in legal and civil penalties.
This is especially true for those who go up against the Pharmaceutical industry, says attorney, Jason Zuckerman, of the Washington DC Law Office of Jason M. Zuckerman. "Whistleblowers in the pharmaceutical industry," he warns, "really face an uphill battle, a David versus Goliath struggle."
In fact, experts say whistleblowers who interfere with the highly profitable Medicate fraud often find themselves out of work permanently. "My clients whose only infraction was committing the truth," Mr Zuckerman states, "have found themselves unemployed and suffer permanent damage to career and reputation."
Medtronic no doubt will try hard to settle the Poteet lawsuit before it goes to trial, because under a key provision of the FCA, a jury can order the company to pay a triple damage award.
"The Company intends to fully cooperate with the Office of the United States Attorney for the District of Massachusetts," the filing states, "with respect to this subpoena."
In addition to the lawsuit filed by Ms Poteet and the various investigations by government agencies, the company is also facing a wide range of other lawsuits related to its products.
On February 11, 2005, Medtronic began advising doctors about a potential battery shorting that may occur in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), including certain of the Marquis VR/DR and Maximo VR/DR ICDs and certain of the InSync I/II/III Marquis and InSync III CRT-D devices.
The company provided physicians with a list of potentially affected patients and recommended that physicians communicate with those patients so they could manage the issue in a manner they felt was appropriate for their patients.
Subsequently, the FDA classified the recall a Class II Recall, and a large number of lawsuits were filed against Medtronic by either individuals claiming personal injury or third party payors seeking reimbursement of costs associated with the recall, including a claim by an individual acting on behalf of the Center for Medicare & Medicaid Services.
The company waited until February 2005, to tell patients that their defibrillators might fail. However, company documents filed in the California lawsuit, Randall v Medtronic, No C-05-3707-JW, show Medtronic knew about the flaw back in 2003, and continued to sell the faulty devices for two more years.
"Medtronic has been taking products they know are not quite right and putting them into people rather than take the loss," according to Hunter Shkolnik, a New York attorney, who said in a February 13, 2006, interview with Bloomberg News that he represents more than 200 people whose Medtronic devices were recalled.
"If you know there's a problem with a component," he said, "you don't put it out and sell it to people."
Another batch of devices came under scrutiny six months after the first recall. In a June 9, 2005 letter, the FDA told Medtronic that it had failed to correct manufacturing problems and investigate its LifePak 12 external defibrillators and failed to follow through with preventive action after inspections of the company's Redmond, Washington plant.
The LifePak 12 defibrillators, used to shock the heart back to a normal rhythm, are similar to the LifePak 500 devices that the company had recalled. At the time, about 60,000 LifePak 12 defibrillators were in use worldwide, company spokesman Rob Clark said.
In the warning letter, the FDA said Medtronic did not investigate all complaints related to the malfunctions, including one involving a patient's death, and warned that failure to correct the problems could result in legal and civil penalties.
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