Your business in court: 2009-2010

During this period, FDA focused considerable effort on its transparency initiative, which is likely to continue into the coming year, as well as continuing to ramp up its enforcement activities, as we predicted last year. The scope of the agency's ability to pre-empt state laws in product liability litigation involving pharmaceutical products still is developing post-Levine, and we are likely to see new decisions in the coming year. Fraud and abuse enforcement still is a major factor facing the industry, with the added threat of personal exposure to criminal sentences, fines and debarment from participation in federal and state programs under the Responsible Corporate Officer doctrine, or under the authorities exercised by the Department of Health and Human Services Office of the Inspector General. Consequently, it is increasingly important that senior corporate officers ensure active oversight of an effective compliance program which should mitigate these risks. The Federal Trade Commission continues to battle consumer fraud, particularly respecting weight loss programs, and it appears to be fighting a losing battle in its effort to prevent "reverse" payments to generic manufacturers by Innovator Manufacturers to delay the introduction of generics to the market. The Securities and Exchange Commission continues to be actively enforcing the Foreign Corrupt Practices Act. The Supreme Court gave shareholders more leeway in bringing stockholder suits in situations where a company conceals information that, if revealed, could have a negative effect on stock prices.