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As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of New York raises interesting issues regarding the First Amendment and how it...more
Recent environmental developments may impact the health care industry and should continue to be monitored.
Several environmental developments related to the discarding of pharmaceutical products (including veterinary...more
The FDA has long sought to ban drug manufacturers from promoting off-label uses for approved drugs. The ban – which applies only to manufacturers and their agents – is intended to safeguard the public against misbranded...more
A potentially significant case being watched by the pharmaceutical industry is Amarin Pharma, et al., v. U.S. Food and Drug Administration, et al., Civ. A. 15-cv-3588 (S.D.N.Y.). The complaint, filed in May 2015, is a “First...more
The opinion from the Philadelphia Court of Common Pleas reinforces lack of standing as a defense for companies facing data breach–related class actions.
On March 25, the Philadelphia Court of Common Pleas provided...more
Late last week, Texas telemedicine practitioners received a temporary reprieve from a new regulation issued by the Texas Medical Board (the “Board”) when a Texas federal court prohibited implementation of the new rule that...more
The United States Supreme Court has declined to hear a challenge to the Alameda County Drug Disposal Ordinance (“Ordinance”) brought by three pharmaceutical trade organizations. The Court’s decision leaves in force the Ninth...more
Drug makers and the Food and Drug Administration (FDA) have often disagreed over whether drug makers can discuss unapproved uses for their products with physicians. While courts have sided with drug makers in certain...more
Data breaches are becoming increasingly common. These incidents have spawned considerable litigation, including class action lawsuits brought by individuals whose personal information has been compromised. But many of these...more
A New Jersey federal district court recently dismissed the putative class action claims of four plaintiffs against a health care defendant following the theft of two password-protected laptops allegedly containing personal...more
Congress enacted the Biologics Price Competition and Innovation Act (BPCIA) in 2009 to create a framework for the introduction of biosimilar and interchangeable drugs into the US market. Like the predecessor Hatch-Waxman Act,...more
On Feb. 25, 2015, nearly two years after argument, the South Carolina Supreme Court directed entry of a $136 million judgment against Janssen Pharmaceuticals Inc. These civil penalties stemmed from a suit brought by the...more
On February 11, 2015, the U.S. District Court for the Southern District of Texas dismissed a class action complaint against the St. Joseph Health System arising out of a data security breach that occurred after hackers...more
On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more
Dismissing a class action based on a data breach, the Southern District of Texas added to the growing number of decisions that find an alleged risk of future identity theft due to a data breach is not an injury that creates...more
On December 29, 2014, the Pharmaceutical Research and Manufacturers of America (“PhRMA”), the Biotechnology Industry Organization (“BIO”), and the Generic Pharmaceutical Association (“GPhA”) jointly filed a Petition for a...more
As many of our life sciences clients know, 2014 brought long-awaited draft guidance documents from the FDA regarding three social media-related topics of interest. The FDA provided its much-anticipated views on...more
If your medicine cabinet is filled with old prescriptions and other medications that you no longer want or can use, you might have asked: how and where should I get rid of these?
Local governments are beginning to...more
On September 30, 2014, the U.S. Court of Appeals for the 9th Circuit unanimously upheld a lower court’s finding that a California county ordinance requiring prescription drug manufacturers to operate and finance certain drug...more
On September 30, 2014, the Ninth Circuit affirmed the Northern District of California’s summary judgment that the Alameda Safe Drug Disposal Ordinance (the “Ordinance”) does not violate the dormant Commerce Clause of the...more
It is a very common practice. Drug sales reps visit a client, usually a hospital, a clinic or a doctor, with the sole purpose of selling a drug or medical device. That is the primary way a doctor learns about a drug or...more
A professor at the University of Texas Health Science Center has petitioned the U.S. Supreme Court to determine the standard for imposing liability on state universities (and their related entities, such as hospitals and...more
Last month in its decision in In re Sci. Applications Int’l Corp. (SAIC) Backup Tape Data Theft Litigation, 2014 U.S. Dist. LEXIS 64125, the United States District Court for the District of Columbia dismissed all but two...more
The U.S. Food and Drug Administration (FDA or the Agency) issued the June 6, 2014, draft guidance (Draft Guidance) in response to stakeholder inquiries into the Agency’s views on disseminating new scientific or medical...more
On June 6, 2014, the Food and Drug Administration (“FDA”) issued two documents that reflect the agency’s ongoing effort to clarify its regulatory approach regarding manufacturer communication of scientific and medical...more
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