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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

Health Alert (Australia) - February 23, 2015

In This Issue: Judgments; Legislation; and Reports. - Excerpt from Reports: Australia. Department of Health - Media releases - 18 February 2015 - Action on Hepatitis A - Assistant Minister for Health...more

New Product Safety Bills Address Child-Resistant Packaging for E-Cigarettes and Detergent Pods

Last year, we wrote about legislative efforts on Capitol Hill to require the CPSC to implement a rule requiring childproof packaging for liquid nicotine containers. Liquid nicotine typically refills the vials for...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

"Congressional Investigations Highlight Risks for Companies Across Industries"

An examination of congressional investigations in 2014 reminds us that such investigations can strike an industry or company at any time. Irrespective of the subjects, the investigations typically share one or more of the...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

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

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

EPA’s Recently Released Revised Human Health Risk Assessment for Chlorpyrifos Reflects New Implementation of EPA Policy

The spray drift and volatilization policies were discussed in an October 2014 webinar and discussed in our September 17, 2014, memorandum. EPA’s Revised Risk Assessment Methods for Workers, Children of Workers in Agricultural...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

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

Growing Safety Risk for Hospitals: Spiraling Medical Device Recalls

Everyone knows that the number of medical device recalls is on the rise. Here are two telling examples of the growth. In 2003 a total of 604 recalls were reported to the FDA, while last August a single manufacturer recalled...more

The Only Surprise Is That It Took This Long...The First Ebola Class Action Has Been Filed

I am always amused by the manner in which class action lawyers attempt to capitalize on current events and public fears in bringing a “cutting edge” lawsuit that will garner a great amount of media attention. Although the...more

Class Action Claims: Gluing Together Systemwide Judicial Relief

The award of class action certification is often the gateway for obtaining lifesaving systemwide judicial relief in broken correctional health care systems. It also can be the beginning of a decades-long, burdensome and...more

FDA Announces More Changes to FSMA Implementation Rules

On September 19, 2014, FDA announced potential changes to four rules that the agency proposed in 2013 to implement the Food Safety and Modernization Act (“FSMA”). FSMA was signed into law in January 2011 in response to many...more

The Pain Drain - The Continuing Impact of Pain Management on Health-Care Providers

Over a hundred million Americans suffer from chronic pain. To combat this epidemic, health-care providers have increasingly turned to opioid analgesics. As a result, opioid analgesic use has risen dramatically over the past...more

New Jersey Court Turns the Screws on the Insured, Holding That “Your Product” Exclusion Bars Coverage For Defective Product Claim

In Titanium Industries, Inc. v. Federal Ins. Co., No. A-1922-12T1, 2014 WL 4428324 (N.J. Super. Ct. App. Div. Sept. 10, 2014), the court held that the commercial general liability policy issued by defendant Federal Insurance...more

FDA Falls Asleep in Reporting Faulty Surgical Device

The FDA’s Medwatch program is supposed to enhance patient safety by publicizing adverse medical events, but you have to wonder how effective it is when the feds wait more than four months to post a serious problem with a...more

FDA Posts Largest-Ever Medical Device Recall

On August 29, 2014, the FDA issued 233 Class I medical device recalls for products manufactured by Customed. According to its website, Puerto Rico-based Customed is a medical supplies leader and distributes a wide range of...more

Eighth Circuit Dismisses Whistleblower's Suit Finding Facts Were Already Publicly Disclosed

In an August 7, 2014 opinion, the Eighth Circuit upheld the dismissal of a whistleblower’s suit alleging that a number of pain pump device makers had violated the False Claims Act (FCA) by marketing their pain pumps for...more

Coveting Characters: Navigating FDA's Draft Guidance on Social Media

Last week the U.S. Food and Drug Administration (FDA) issued two long-awaited draft guidances on social media: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and...more

Launch of openFDA Increases Accessibility to Adverse Drug Event Reports

On June 2, 2014, the Food and Drug Administration launched openFDA, a program designed to improve access to publicly available data beginning with adverse event reports. While greater accessibility to adverse event reports...more

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