Thoughtful Insight and Updates on Legal Issues that Matter to You

Perspectives

FDA/McNeil Consent Decree Highlights Increased Government Efforts At Regulating Drug Recalls

As we previously reported, on March 10, 2011, the FDA in cooperation with the Department of Justice announced that a consent decree has been filed against McNeil, PPC, a division of Johnson & Johnson, for failing to comply with current good manufacturing practice (“cGMP”) regulations.

Stem Cell Research Flourishes Abroad

Outside the United States, stem cell research is thriving, in part due to the availability of government funding. As reported here, the stringent requirements for obtaining federal funding for stem cell research in the U.S. may have unintended consequences, such as the migration of research abroad.

Senate Passes the America Invents Act Promoting Taxpayer Rights at the Expense of Intellectual Property Rights

On March 8, 2011, the Senate passed the America Invents Act, which “most notably, includes a provision preventing patents on tax strategies, which will reduce the cost of compliance for […]

Movie Theaters and Grocery Stores fight Calorie Disclosure Rule

Movie theater chains and grocery stores may have to disclose the nutritional content of their prepared foods. As we previously posted (here and here), the Patient Protection and Affordable Care […]

FDA Considering Enhanced Regulation or Ban On Menthol Cigarettes

With the passage of the Family Smoking Prevention and Tobacco Control Act of 2009, (“Tobacco Act”) Congress granted the FDA the authority to regulate all tobacco products marketed within the […]

FDA To Take Over Three Tylenol Manufacturing Plants As Part Of Consent Decree

On March 10, 2011, the FDA in cooperation with the Department of Justice announced that a consent decree had been filed against McNeil PPC (“McNeil”) and two of its executives for failing to comply with current good manufacturing practice (“cGMP”) regulations. In accordance with the consent decree, McNeil, a division of Johnson & Johnson, has agreed to place three of its Tylenol manufacturing plants, in Puerto Rico, Lancaster, Pa. and Fort Washington, Pa., under FDA supervision.

Tax Court’s Ruling in Canal Corp. v. Commissioner calls into question the ability to rely on formal tax opinions

In CANAL CORPORATION AND SUBSIDIARIES, FORMERLY CHESAPEAKE CORPORATION AND SUBSIDIARIES, Petitioner v. COMMISSIONER OF INTERNAL REVENUE, Respondent, 135 T.C. 9 (2010), the Tax Court ruled against the taxpayer in a leverage partnership distribution. Judge Kroupa’s blistering decision railed against the taxpayer who, in part, relied on a tax opinion from a national accounting firm.

11th Circuit Affirms Conviction in Tax Fraud Case Under 18 U.S.C. section 286

On August 17, 2010, the 11th Circuit affirmed the conviction of the Defendant in the case of the United States of America v. Maritiza Valiente, docket # 09-14493.

Andrew Ittleman of Fuerst Ittleman to Instruct at 2011 US Money Transmitter Seminar in Los Angeles

On April 14 and 15, 2011, Andrew Ittleman, Esq. CAMS of Fuerst Ittleman will participate as an instructor at the US Money Transmitter Seminar at the Hotel Intercontinental in Los Angeles, California. […]

New Test Shortens Time for Determining Pluripotency of Stem Cells

In a study published this week, researchers at Scripps Research Institute in La Jolla, California have released findings that could solve a major issue that scientists have faced when developing […]