On June 23, 2011, the Supreme Court ruled in Pliva, Inc. v. Mensing that federal law preempts state tort law suits against generic drug manufacturers for failure to provide adequate warning labels. The decision comes two years after Wyeth v. Levine in which the Court held that federal drug laws did not preempt such suits against brand-name manufacturers. Learn More
On June 14, 2011, the U.S. Government Accountability Office (GAO) released a new report on the U.S. Food and Drug … Learn More
On March 23, 2011, President Obama signed into law the Patient Protection and Affordable Care Act (PPACA). On March 30, 2011, he signed the Health Care and Education Reconciliation Act of 2010, amending the PPACA (collectively “the Act”). Learn More
As we previously reported here, National Taxpayer Advocate Nina Olson reported numerous problems with the Internal Revenue Service’s (IRS) reliance on automated customer service available through Taxpayer Assistance Centers (TACs). Learn More
Switzerland is seeking to resolve “past fiscal problems” with the US while discussing the implementation of the new U.S. Foreign Account Tax Compliance Act (FATCA). Learn More
Tax practitioners recently commented on the IRS’s guidance regarding the benefits of its second Offshore Voluntary Disclosure Initiative (OVDI). Several … Learn More
After three days of a full floor debate, the U.S. House of Representatives approved the 2012 Agriculture Appropriations Bill on June 16, 2011. Learn More
On June 8, 2011, the U.S. Food and Drug Administration (FDA) announced the release of the final guidance document regarding citizen petitions subject to section 505(q) of the Federal, Food, Drug, and Cosmetic Act. Section 505(q), which was added by the FDA Amendments Act (FDAAA), states that the FDA shall not delay approval of pending Abbreviated New Drug Applications (ANDAs) for generic drugs as a result of citizen petitions that request FDA action. Learn More
On June 23, 2011, the Consumer Financial Protection Bureau (“CFPB”) announced a Notice and Request for Comment regarding the expansion of its nonbank supervision program. A copy of the U.S. Department of the Treasury press release can be read here. Learn More
Four tax and banking professionals were convicted on May 24, 2011 in Manhattan federal court for their roles in a tax shelter scheme, sending a clear message that dishonest tax professionals will be held accountable for their crimes. The verdict found former Jenkens & Gilchrist attorneys Paul M. Daugerdas and Donna M. Guerin, former BDO Seidman CEO Denis M. Field, and Deutsche Bank broker David Parse guilty of designing, marketing, and implementing fraudulent tax shelters used by the wealthy to avoid paying taxes to the IRS. According to the Justice Department, Daugerdas, Guerin, and Field collectively made $130 million in profits from the 10-year scheme. Learn More