In a perhaps unexpected comeback following its legal woes the past few years, Purdue Pharma L.P. recently began reoccupying space in its former downtown Stamford corporate headquarters, the result of a need for additional room amid a renewed business outlook.
Now, the company”™s former leadership group hopes to launch its own comeback.
In October, former Purdue Pharma CEO Michael Friedman asked for a declaratory judgment from a judge, hoping to a lift a U.S. Dept. of Health and Human Services ban that bars him from working in jobs that involve Medicare, Medicaid or other federal health care programs ”“ effectively a near-universal ban from working in the health care industry.
Also suing HHS are Purdue Pharma”™s former corporate counsel Howard Udell, who lists a Westport address, and the company”™s former research director Paul Goldenheim. In addition to a declaratory judgment removing the ban, the men are asking to have their legal costs reimbursed; and to have the HHS inspector general office remove from its website any references to the exclusions.
According to the trade publication General Counsel, Udell was the first general counsel known to have been debarred from working at companies that do business with federal agencies. In the lawsuit, Udell said he is working in a consultant capacity, without providing further details.
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The men were convicted under the legal concept of “strict liability,” which holds liable “responsible corporate officers” who fail to prevent federal drug violations that occur in their organizations, even if there is no evidence of any misconduct on their part. The publication reported that the legal community is closely watching the proceeding as a result.
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Friedman, a resident of Stamford, and Udell received the HHS ban after pleading guilty along with Purdue Pharma to a misdemeanor charge that the company illegally marketed its blockbuster Oxycontin drug, which in addition to being highly effective in relieving pain also was highly addictive, creating what became a deadly black market and spawning the sobriquet “hillbilly heroin.”
As part of a settlement, Purdue Pharma agreed to pay a $600 million penalty and Friedman, Udell and the Massachusetts resident Goldenheim received a $34.5 million fine, while avoiding jail time.
Even as they accepted the fine, the three are fighting the work exclusion. After a federal judge directed them to appeal through HHS administrative processes, Friedman, Udell and Guggenheim said they have exhausted that option and are now seeking a court reversal of the ban.
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In a lawsuit filed two months ago, Friedman and Udell argue that the HHS industry ban is in violation of the Administrative Procedure Act and “contrary to law, arbitrary and capricious, an abuse of discretion, and not supported by substantial evidence,” in the words of their lawsuit.
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Friedman and Udell argue they cooperated with federal authorities and launched “a myriad of programs” to stem the illicit sale and use of Oxycontin. Purdue Pharma was the first pharmaceutical company to help doctors monitor prescription patterns and detect illegal prescriptions and so-called “doctor shopping,” they claim. They say they created a mechanism for field-based employees to notify Udell”™s office of abuse or diversion of Oxycontin for unapproved uses. They add that they greatly assisted law enforcement officials, from training sessions that have been attended by thousands of officials to databases that track crimes involving Oxycontin.
Most significantly, they argue that Purdue Pharma suffered no such exclusion, despite the massive penalty levied on the company.
Indeed, Purdue Pharma appears to be experiencing a revival after winning extensions on patents it holds. After moving its headquarters operation from Tresser Boulevard. in downtown Stamford to Summer Street farther north, the company is in the process of relocating its headquarters personnel back to Tresser Boulevard.
