After the Netherlands, Slovakia, and the UK, it is now France’s turn to impose Sunshine-like obligations on the pharmaceutical industry. Soon, similar obligations will apply to all EU countries, after EFPIA, the European trade association for the pharmaceutical industry, adopts a code of conduct on disclosure of transfers of value between pharmaceutical companies and health care professionals or institutions ...
The United States Court of Appeals for the Fourth Circuit, applying North Carolina law, held that a liability insurer may properly withdraw from the defense of its policyholder after obtaining a judicial declaration of no coverage, despite the policyholder’s pending appeal, provided the insurer offers to continue defending if the policyholder wins a stay of the trial court’s decision. Auto-Owners Ins. Co. v. Potter et al ...
Don't bank just yet on putting your marketing muscle behind the safe and effective off-label uses of your FDA-approved drugs, or defending your next mass consumer class action on First Amendment grounds. But you can start giving those multi-billion dollar prospects some serious thought, because constitutional winds are blowing through the Code of Federal Regulations ...
On Capitol Hill, U.S. lawmakers are considering legislation that would authorize the U.S. Food and Drug Administration (FDA) to approve generic versions of biological products. Representative Henry Waxman (D, CA), of “Hatch-Waxman” fame, has introduced the “Access to Life Saving Medicine Act” (H.R. 1038) to advance this change to U.S. law. In introducing the legislation, Rep ...
IN OUR JUNE 2005 “FDA WATCH” column, we provided an overview of the regulatory, political, and scientific landscape for follow-on biological products in the U.S. As reported a year ago, the biogenerics debate centers around whether generic biologics are scientifically possible (i.e ...
On April 14, 2015, the White House announced that President Obama intends to remove Cuba from the government’s list of nations that sponsor terrorism. This decision follows a series of important changes to US policies and regulations affecting business and commercial transactions between the United States and Cuba ...
The Florida Supreme Court issued an opinion on March 7, 2013 that eliminated an oft-used tool in the defense arsenal by limiting application of the economic loss rule to products liability cases. The DecisionIn a 5-2 decision authored by Justice Jorge Labarga, the court held unequivocally that "the application of the economic loss rule is limited to products liability cases." Tiara Condo. Ass’n, Inc. v. Marsh & McLennan Cos., Inc., __ So.3d __, 2013 WL 828003, *8 (Fla. Mar. 7, 2013) ...
The Florida Supreme Court has held that defective work performed by a subcontractor that damages a general contractor’s completed work constitutes “property damage” caused by an “occurrence” under a commercial general liability (CGL) policy. U.S. Fire Ins. Co. v. J.S.U.B., Inc., No. SC05-1295 (Fla. Dec. 20, 2007) ...
In a case of significance to property owners, contractors and real estate developers alike, a federal court in Florida recently rejected an insurer’s attempt to avoid coverage for $23 million of damage caused by defective work, finding that the policyholder’s claim raised several genuine issues of material fact. The case is Pavarani Construction Co. (SE) Inc. v. ACE American Insurance Company, Case No.14-cv-20524-KING (S.D.Fla., Feb. 25, 2015) ...
On Tuesday, December 22, 2105, the US Court of Appeals for the Federal Circuit issued a much- anticipated opinion regarding the constitutionality of the prohibition against “disparaging” trademarks. In an 9-3 en banc opinion, the Federal Circuit held that the exclusion of disparaging trademarks under Section 2(a) of the Lanham Act violates the First Amendment.Many of the marks rejected as disparaging convey hurtful speech that harms members of stigmatized communities ...
