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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

Court Dismisses Data Breach Class Complaint For Lack Of Standing

On February 11, 2015, the U.S. District Court for the Southern District of Texas held that a plaintiff lacked standing to pursue claims for alleged violations of the Fair Credit Reporting Act, 15 U.S.C. § 1681 et seq....more

No Harm, No Standing: Texas Federal Court Dismisses Data Breach Class Action

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

Cybersecurity Attack on Anthem, Inc. Highlights the Cybersecurity Risks for All Companies Handling Electronic Medical Records

Health care providers, insurers and all who handle information on their behalf were put on notice last week that cybersecurity must be a high priority for their organizations. ...more

The Fraudulent Joinder Doctrine...It’s Not Just For Fraud Or Joinder

In Weidman v. ExxonMobil Corporation, et al., No. 13-2007 (4th Cir., January 8, 2015), the Fourth Circuit confirmed that the “fraudulent joinder” doctrine requires neither an allegation of fraud nor a situation involving a...more

Can Digital Healthcare Innovation Be Patented? Eligibility of Digital Healthcare Technologies Under the New USPTO Eligibility...

Digital healthcare, the confluence of digital technology with medical and other biological fields, has become an ever-increasing presence in our daily lives. Ideas that seemed nearly impossible just a few years ago (such as...more

When Is a Pharmacist Not a Pharmacist?

On January 14 the Texas Supreme Court will hear argument in an appeal that asks the question, When is a pharmacist not a pharmacist? The appeal is from a Texas Court of Appeals decision that answered the question this way: ...more

Florida Federal Court Retains Jurisdiction Over Knee Implant Case

Debra Kilmer filed suit against Stryker Corporation, Stryker Sales Corporation and Howmedica Osteonics Corporation (“Defendants”), asserting that she had been injured by a defective knee implanted in her in Florida state...more

Data Breach Plaintiff Given Second Chance to Certify Class Action Suit

Recently, the Pennsylvania Superior Court ruled in favor of data breach plaintiff Avrum Baum, giving him a second chance to certify a class action suit against Keystone Mercy Health Plan. Baum brought suit against the...more

Employer Liability for Employees’ Privacy Violations: What your organization should learn from Walgreens’ expensive lesson (hint:...

You may already have read the scintillating facts surrounding a jury award of $1.44 million (recently challenged unsuccessfully on appeal) against Walgreen Co. (Walgreens) following its pharmacist’s alleged inappropriate...more

News from Abroad: Research Exemptions and Active Ingredient Manufacture

After a series of papers, reports and consultations on the scope of the research exemptions to patent infringement stretching over 10 years, section 60 of the Patents Act 1977 was finally amended on 1 October 2014 by the...more

Another Patent Challenge for Personalized Medicine

The U.S. Supreme Court’s recent trilogy of patent-eligibility decisions (Prometheus, Myriad and Alice) have called into question the validity of many U.S. patents on diagnostic medical methods. Nevertheless, legal battles...more

Federal Judge Awards Attorneys’ Fees to Defendant in Dismissed Qui Tam Case, Calls Whistleblower a “Serial Relator”

In November 2013 and this past October, Mintz Levin’s Health Care Qui Tam Update highlighted three separate qui tam False Claims Act (FCA) cases filed by Fox RX, Inc. (Fox), a former Medicare Part D plan sponsor. Fox filed...more

Seventh Circuit Holds Pharmacy Billing Medicaid For Drug Prices Above Private Rates Is Not Fraudulent

On November 12, 2014, the Seventh Circuit upheld the dismissal of a False Claims Act action challenging a retail pharmacy chain’s practice of billing Medicaid for the price differential between the higher Medicaid-negotiated...more

Connecticut Supreme Court Issues Decision That Could Expand State Law Liability in Data Breach Class Actions for Businesses...

Health care providers have not escaped the recent proliferation of data breach class actions, but plaintiffs generally have been unsuccessful in bringing claims based on the Health Insurance Portability and Accountability Act...more

The Seventh Circuit Rejects Medicaid False Claims Act Suit

The United States Court of Appeals for the Seventh Circuit affirmed the dismissal of a False Claims Act (“FCA”) case against Shopko Operating Stores, LLC, in which a former Shopko pharmacist asserted Medicaid billing...more

California Health Care Providers Successfully Ward Off Data Breach Lawsuits

In a pair of recent cases, two California health care providers successfully warded off lawsuits arising from unauthorized data breaches of patient files. These cases illustrate that improper disclosure of electronically...more

White Collar Watch - October 2014

In This Issue: - Government demonstrates willingness to enforce Affordable Care Act provision that could cost providers millions of dollars - Words can come back to haunt you: Boilerplate pleading could lead...more

Dr. Reddy’s Laboratories Settles on Eve of Trial – Agrees to Cooperate with Plaintiffs

Much has happened since our last post on the Nexium “pay for delay” class action lawsuit. Jury selection began in the District of Massachusetts on Monday, October 20, 2014. The day prior, one of the generic drug makers, Dr....more

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