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Otsuka’s Orphan Drug Exclusivity Claims: FDA Rips Off the Band-Aid Early

On April 20, 2015, FDA filed a brief in Opposition to Plaintiff’s Motion for Temporary Restraining Order (“TRO”) or Preliminary Injunction (“PI”), addressed how Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical...more

Federal Courts in the Third Circuit are Following the National Trend and Dismissing Data Breach Cases for Lack of Standing

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

Amicus Briefs on Biosimilar Patent Litigation

Amgen has appealed the district court decision denying its motion for a preliminary injunction to keep Sandoz’ biosimilar version of Neupogen® off the market. The appeal is on an expedited briefing schedule at the Federal...more

Data Breach Class Actions: Don’t Overlook Standing Defense Just Because Plaintiff Alleges Identity Theft

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

Breaking News - Caplinger Infuse Preemption Dismissal Affirmed

We thought our readers would like to know that today the InFuse preemption decision in Caplinger was affirmed by the 10th Circuit in a 2-1 opinion (here’s a link). Our non-Reed Smith bloggers will undoubtedly have more to...more

Maryland, My Maryland: Aldara Case Dismissed for Multiple Reasons

Today’s date is rich in literary history. It is the birthday of Vladimir Nabokov, one of two writers whose prose style makes us want to snap our Pilot Varsity pens in despair, so great is the gap between those authors'...more

Whistleblower Pays Price for Frivolous Suit

On Wednesday of this week, the federal court for the Southern District of New York rejected Fox’s plea to spare it from the $169,000 bill submitted by the white shoe law firm that successfully defended Managed Health Care...more

Telemedicine Providers Need to Keep Up with State Laws

Tech-savvy health care providers and tech-savvy patients in California can be grateful for California’s policies regarding telehealth practices. Consider the turmoil in Texas: telehealth practitioners who want to treat...more

Otsuka’s Pediatric Labeling Dispute Seeks to Expand Orphan Drug Exclusivity

On April 13, 2015, the U.S. District Court for the District of Maryland issued an Order granting Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization, Inc., and Otsuka America...more

Health Plan Lawsuits and Data Breach Claims: Recent Developments and Implications

Five class action lawsuits have been filed against Premera Blue Cross in federal court in Seattle, Washington following the recent report of a data breach that affected approximately 11 million individuals. The lawsuits make...more

Court Declines to Certify Class Alleging Off-Label Marketing of Cancer Drug

Third party payors (“TPPs”) responsible for paying the costs of prescriptions for their beneficiaries sued Cephalon, Inc., alleging that it engaged in unlawful off-label marketing of Actiq, a drug approved to manage...more

Data breach class action suit against Horizon Blue Cross dismissed

Late last week, a federal court judge in New Jersey dismissed a putative class action lawsuit against Horizon Blue Cross for a data breach involving two unencrypted laptops that were lost in 2013. The case alleged that close...more

District Court Holds Individual Issues of Fact Predominate in Unjust Enrichment Class Action

The US District Court for the Eastern District of Pennsylvania recently denied class certification to a proposed class of third-party payors of prescription drugs. The plaintiffs brought a class action for unjust enrichment,...more

Successful Rule 9(b) Defense of False Claims Act Whistleblower Litigation

The lure of significant monetary awards continues to stimulate high-risk whistleblower actions under the False Claims Act (FCA), and these claims are increasingly common in the pharmaceutical and medical device industry. The...more

Software Company to Face Suit Over Contract Restructuring

The United States District Court for the Northern District of California sustained a securities fraud complaint alleging that the defendants, a software company and its executives, had defrauded investors by failing to...more

Fourth Circuit Sustains Securities Fraud Claim Against Drug Manufacturer

On March 6, the US Court of Appeals for the Fourth Circuit found that the United States District Court for the Western District of North Carolina had erred in dismissing a class action lawsuit filed under Section 10(b) of the...more

Multiple class action lawsuits filed against Premera Blue Cross for data breach

Days following Premera Blue Cross’s public announcement that it had experienced a data breach affecting approximately 11 million, it has been sued five times (as of the time of this writing) in proposed class action lawsuits...more

N.D. Cal Interprets the Biological Price Competition Act

Amgen Inc., et al. v. Sandoz Inc., et al., No. 14-cv-04741RS - On March 19, the Northern District of California became the first court to interpret two key provisions of the Biological Price Competition Act: whether...more

Omnicare: Section 11 Liability and Opinions

The Supreme Court defined the circumstances under which liability can be imposed for opinion statements under Securities Act Section 11. Specifically, the Court held that such liability could be imposed on two theories: One...more

Also In The News - Health Headlines - March 2015 #2

Committee on Energy and Commerce Subcommittee on Health Hearing Regarding 340B Drug Pricing Program – On Thursday, March 5, 2015, the Subcommittee on Health, chaired by Rep. Joe Pitts (R-PA), is holding a hearing titled...more

Biosimilars in the US: still at the starting line?

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

A Change of Pace for Product Liability Class Actions: Certification Denied in Two Recent Cases

Oft-referred to as “quintessential class actions”, the majority of product liability actions that have sought certification as class proceedings in the last 10 years have been granted certification. However, two recent...more

Direct Purchasers and End Payors Accuse Brand Pharma of Delaying Generic Entry

Americans want access to inexpensive pharmaceutical drugs. This demand must be balanced with the fact that brand-name, innovator pharmaceutical companies typically invest tremendous resources to research and develop new...more

PHIPA offers “no shelter” to Ontario Hospital from class proceedings for breach of privacy

Back in 2012, the Ontario Court of Appeal recognized the tort of invasion of privacy – fast forward to the recent string of privacy breaches of personal information held by health care facilities in Ontario. Along comes...more

Federal Court Decision Demonstrates Ongoing Challenges Faced by Plaintiffs in Data Breach Litigation

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

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