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Generic Drug Cos. Face Failure-To-Warn Claims In Calif.

On Jan. 20, 2015, the U.S. Supreme Court declined to hear an appeal involving failure-to-warn claims against generic pharmaceutical manufacturers. Teva Pharms. USA Inc. v. Super. Ct., No. 13-956 (U.S. Jan. 20, 2015). This...more

OIG Reports Lack of Oversight on Hospital Use of Compounded Drugs

On January 22, 2015, the HHS OIG released a report regarding CMS’s oversight of compounded sterile preparations (CSPs) used in hospitals. After reviewing oversight efforts at CMS and the entities that accredit hospitals to...more

Life Sciences and Health Care Industries Reap the Benefits of 3-D Printing

The past few years have seen 3-D printing – a process that involves the creation of a three-dimensional object from a pre-conceived design – evolve from a futuristic idea into a multi-billion dollar business, and few...more

Product Liability Alert: Failure-To-Warn Suit Against Generic Drug Maker Proceeds Despite Argument of Federal Preemption

On January 20, 2015, the U.S Supreme Court denied cert in Teva v. Superior Court of California, Orange County, refusing to review a California state court ruling allowing patients to proceed with claims that Teva...more

RICO Indictment of NECC Executives for Acts of Second-Degree Murder

An Unprecedented Approach to Regulatory Violations - In December 2014, the United States Attorney for the District of Massachusetts obtained a sweeping indictment that charges business executives of the New England...more

There’s a Wrinkle in Your Advertising Claims: L’Oréal Settles with the FTC

L’Oreal’s Deceptive Advertising - The Federal Trade Commission (“FTC”) accused L’Oréal of making deceptive advertising claims regarding the benefits of two of its product lines. L’Oréal claimed that its Génifique...more

State of the GMO Union

Just how hot is GMO-labeling legislation? On Jan. 6, 2015, a Republican state senator introduced just such a bill - in Indiana, the nation’s breadbasket. Still, federal legislation on both sides of the issue has stalled, the...more

Advertising Law - January 2015 #2

Safeway Must Pay Customers for Higher Online Prices - A California federal court judge has ruled in a breach of contract suit that Safeway is liable to customers who paid more for items online than in the store. ...more

Generic Drug Manufacturers to Face Failure-to-Warn Claims in California

On January 20, 2015, the Supreme Court declined to hear an appeal involving failure-to-warn claims against generic pharmaceutical manufacturers. Teva Pharms. USA Inc. v. Super. Ct., No. 13-956, 2015 WL 231967 (U.S. Jan. 20,...more

Third Ethicon Bellwether Trial Set for March 2015

Judge Goodwin is presiding over seven different federal multidistrict litigation established for similar cases filed against various medical device manufacturers, including American Medical Systems, Boston Scientific,...more

Product Liability Update - January 2015

In This Issue: - First Circuit Holds Plaintiff Lacks Standing to Recover for Allegedly Defective Product Based on Risk of Future Harm From Lightning Strike Where Complaint Contained Insufficient Facts to Demonstrate...more

Canada's New Substances Program Publishes Risk Assessment Summary for Multi-Wall Carbon Nanotubes

Canada announced on January 9, 2015, that the New Substances Program has published six new risk assessment summaries for chemicals and polymers, including a summary for multi-wall carbon nanotubes. Environment Canada and...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

Advertiser Jumps the Gun With Brochure Touting Tests; Fifth Circuit Brushes Off First Amendment Challenge to Lanham Act Claims

Like claims for defamation or commercial disparagement, Lanham Act claims are viable only if they involve statements of fact, rather than opinion. But what happens if an advertising statement concerns an issue that is a...more

Punitive Damages Claims May Proceed Against Boston Scientific

Several plaintiffs that were implanted with Boston Scientific’s Obtryx transobturator Mid-Urethral Sling System alleged in their lawsuits that the manufacturer, Boston Scientific, ignored warning that devices containing...more

Preemption and Primary Jurisdiction After Pom Wonderful

After the U.S. Supreme Court decision in Pom Wonderful LLC v. The Coca-Cola Co., __ U.S. __, 134 S.Ct. 2228 (2014), fear arose among national marketers that the decision would produce a wave of class actions challenging food,...more

What’s The “Internet of Things” and What Are Its Legal Challenges?

The “Internet of Things” is the universe of smart devices that talk to the internet or to one another. The devices have unique identifiers and the ability to automatically transfer data over a network on their own, without...more

CPSC Proposes Additional Phthalate Restrictions

The U.S. Consumer Product Safety Commission (CPSC) has published a notice of proposed rulemaking in the Federal Register proposing to make more stringent a federal prohibition on phthalates in many children’s products....more

Federal Prosecutors Charge NECC Employees with Second Degree Murder: A Shot Across the Bow to Healthcare Companies Navigating...

Federal prosecutors charged the head pharmacist and the president of New England Compounding Center (NECC), a now-bankrupt Massachusetts compounding pharmacy, with second-degree murder and racketeering in the U.S. District...more

Post Wisely

Two FDA Guidelines Help Life Sciences Companies Solve Social Media Conundrums - Social media presents new challenges for life sciences companies. Companies that post about their products on space-constrained social...more

PSC to Discuss Draft Phthalates Rule at December 5th Meeting

On December 5, 2014 the U.S. Consumer Product Safety Commission (CPSC) will be briefed by staff on a recommendation to issue a proposed rule to permanently prohibit five phthalates – DINP, DIBP, DPENP, DHEXP, DCHP – from...more

December 2014: Life Sciences Litigation Update: MDL Court Strikes Plaintiffs’ Experts’ Testimony on Human Causation in Zoloft®...

MDL Court Strikes Plaintiffs’ Experts’ Testimony on Human Causation in Zoloft® Products Liability Litigation. This summer, the U.S. District Court presiding over a multi-district products liability litigation issued a pair of...more

CPSC Focusing on Three Areas for Reduction of CPSIA Testing Burdens

At their April Senate confirmation hearing, both incoming CPSC Chairman Elliot Kaye and Commissioner Joe Mohorovic pledged to Senator John Thune (R-SD) to submit plans for reducing third party testing burdens within 60 days...more

Enforcement Priorities and Trends in Children's and Minors' Advertising and Privacy

BakerHostetler's Alan Friel recently interviewed FTC staff lawyer Kandi Parsons and Assistant New Jersey Attorney General Elliot Sibers at the opening session of the Children's Advertising Review Unit ("CARU") of the...more

"Generic" Logic Helps Branded Drug Achieve Dismissal

A federal district court has held that design defect claims against a brand pharmaceutical manufacturer are preempted by federal law. Booker v. Johnson & Johnson, No. 3:12 oe 40000, 2014 WL 5113305 (N.D. Ohio Oct. 10,...more

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