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First Circuit Finds Federal Preemption of State Tort Claims That Conflict With A Medication’s FDA-Approved Labeling & Warnings

An opinion issued by the U.S. Court of Appeals for the First Circuit on February 20, 2015 held that the Federal Food, Drug, and Cosmetic Act (“FDCA”) preempted claims that Lexapro’s U.S. Food and Drug Administration (FDA)...more

Olympus Sued Over “Superbug” Infections

The New York Times recently reported that 179 patients at the UCLA Ronald Reagan Medical Center were exposed to a potentially deadly “superbug” between October of 2014 and January of 2015. As of February 18, the infection of...more

Advertising Law - February 2015 #3

FCC Chair Announces New Net Neutrality Regs - The battle over net neutrality took a new turn when Federal Communications Commission Chairman Tom Wheeler announced his intention to reclassify broadband service as a...more

Arizona Applies Consumer Fraud Act to Pharmaceutical Manufacturers

Arizona has joined two other states in applying its consumer fraud law to pharmaceutical manufacturers. The Arizona Court of Appeals decision came in a products liability action against Medicis Corporation, related to a...more

Gingko, Roses, or Just Filler? The New York Attorney General's Attack on Supplements

We all know that a rose by any other name would smell as sweet. But what if the roses you give to your sweetheart are actually painted daisies or thorns without flowers? Or worse, if they do not contain flowers at all but...more

Some Ideas About 3D Printing

The other day we read a thoughtful Bloomberg piece on 3D printing in the medical device context by a trio of Alston & Bird litigators. We’ve given you the link, but it might be behind a paywall. The article indicates...more

SPECIAL FOCUS: D.C. Circuit Limits FTC’s Ability to Require Two Randomized Clinical Trials to Substantiate Disease Claims in...

On January 30, 2015, the U.S. Court of Appeals for the District of Columbia Circuit issued its long-awaited opinion in the POM case. In a press release, the Federal Trade Commission (FTC or the Commission) Chairwoman Edith...more

Advertising Law - February 2015

FTC Consumer Protection Head Addresses Do’s, Don’ts for Privacy - Calling the current advertising climate “a technological revolution at the intersection of marketing and consumer data,” Director of the Federal Trade...more

B.C. Court Finds Methodology to Prove Causation is Required to Certify Pharmaceutical Class Actions

On January 22, 2015, the British Columbia Court of Appeal set aside certification of a class action against Apotex Inc. and Abbott Laboratories Ltd. in Charlton v. Abbott Laboratories Ltd. (Charlton), in which the plaintiffs...more

Proposition 65: OEHHA Proposes Revisions to Proposition 65 Warning Regulations

On January 12, 2015, the Office of Environmental Health Hazard Assessment (OEHHA) proposed important new regulations that would repeal and replace the existing Article 6 regulations regarding the all-important "clear and...more

The Learned Intermediary Defense Advances in Nevada

The learned intermediary doctrine can be a legal defense against product liability claims. It is most commonly applied in cases involving drugs and medical devices. A learned intermediary is a medical expert, such as a...more

The Internet of Things: The Inevitable Collision with Product Liability

The IoT – Internet of Things – is undergoing a rapid development that will continue to transform how we interact, conduct business and live our lives. The movement toward IoT’s ubiquitous application and use does not come...more

2014 Year in Review: OPDP Warning and Untitled Letters

In 2014, the Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) issued a total of 10 enforcement letters to pharmaceutical manufacturers. Of the 10 letters, nine were Untitled...more

CPSC’s Proposed Rule Would Expand Phthalate Ban

The Consumer Product Safety Commission (CPSC) recently published a long-awaited proposed rule that, if finalized in its current form, would permanently ban certain additional phthalates from children’s toys and child care...more

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

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