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Recent rulings of importance to your practice.

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Due to the rising cost of 'defensive medicine,' the U.S. House of Representatives recently passed legislation to limit or ban punitive damages in product liability lawsuits over injuries allegedly caused by FDA-approved products.

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On June 10, 2003, the United States General Accounting Office (GAO) issued its report responding to an October 21, 2002 request from Senator Charles E. Grassley, Chairman of the Senate Finance Committee, for the agency to review the Department of Health and Human Services (HHS) Office of the Inspector General (OIG). In performing its review of the OIG (from October 2002 through May 2003), the GAO interviewed over 200 current and former OIG employees, examined thousands of pages of documents, replicated a web-based employee survey conducted by the OIG in January 2003, spoke to representatives from the Department of Justice (DOJ) and various Medicaid Fraud Control Units (MFUCUs), and interviewed three current or former inspectors general from other federal agencies.

The Congressional response to the scandals of Enron and its corporate cousins was not exactly laser-guided. Much ado already has been made about many provisions of the Sarbanes-Oxley Act (the Act), but one that has drawn little comment is its unprecedented, sweeping and criminal whistleblower law.

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On May 9, 2003, the U.S. Attorney's Office for the District of Massachusetts announced that Bayer Corporation, the pharmaceutical manufacturer, had been sentenced and ordered to pay a criminal fine of $5,590,800 stemming from its earlier plea of guilty to violating the Federal Prescription Drug Marketing Act by failing to list with the FDA its drug product, Cipro, that was privately labeled for an HMO. Such listing is required under the federal Food, Drug & Cosmetic Act. The Federal Prescription Drug Marketing Act, Pub. L. 100-293, enacted on April 22, 1988, as modified on August 26, 1992 by the Prescription Drug Amendments (PDA) Pub. L. 102-353, 106 Stat. 941, amended sections 301, 303, 503, and 801 of the Federal Food, Drug, and Cosmetic Act, codified at 21 U.S.C. '' 331, 333, 353, 381, to establish requirements for distributing prescription drug samples.

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Way back in the 80s, companies in the U.S. Defense industry determined that it was in their best interests to band together and develop the Defense Industry Initiatives as a method to police themselves during a time when their industry was fraught with fraud and corruption. As an aftermath, ethics and compliance programs have been developed and implemented by the majority of U.S. companies. To further entice companies to establish an effective and proactive program designed to detect and, to the extent possible, prevent violations of law The Federal Sentencing Guidelines for Organizations, passed in November 1991, rewards these companies with relief when sentenced for violations of law.

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