Products Liability Science, Computers & Technology

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California Adopts New Regulations For Warnings Under Proposition 65: CAVEAT VENDITOR (Sellers Beware)

Come August 30, 2018, consumer products to be released into the California marketplace must meet new regulations under California’s infamous Proposition 65. On August 30, 2016, the California Office of Administrative Law...more

Consumer Fraud Allegations For A Prescription Medical Device Do Not Pass The Test

When we think of prescription medical devices, we usually think of the sorts of devices that are implanted during surgery and tend to end up in litigation—artificial joints, pacemakers, surgical meshes, and bone cements, to...more

NHTSA Releases Guidance on Enforcement of Safety-Related Defects in Automated Vehicle Technologies - Agency’s stance raises...

Last week, the National Highway Traffic Safety Administration (NHTSA) released its final Enforcement Guidance Bulletin on Safety-Related Defects and Automated Safety Technologies. The Guidance makes clear that the agency’s...more

GMO Food Labeling And CRISPR

A new law targeted at GMO food labeling instructs the Secretary of Agriculture to establish standards for identifying “bioengineered” food. While many might think CRISPR-modified foods will be covered by such a law, certain...more

Defendant Did Not “Fail to Warn” Where It Warned of Exactly What Happened to the Plaintiff’s Artificial Hip

We (in its blog-specific singular version) are longstanding country music fans. There is backstory – call us when you are in Philadelphia and we will tell you about it over coffee. Suffice it to say that Nashville, the Grand...more

NHTSA Issues Guidance for Manufacturers of Highly Automated Vehicles

The Department of Transportation (DOT) and the National Highway Traffic Safety Administration (NHTSA) has provided much-anticipated guidance to manufactures of automated vehicles with the release of the new Federal Automated...more

The Impact of the Smart Home Revolution on Product Liability and Fire Cause Determinations

The concept of the Internet of Things (IoT) has existed for more than 15 years. Technology pioneer Kevin Ashton is widely credited with coining the term in 1999 to describe the connection of physical objects to the internet...more

FDA Regulatory and Compliance Monthly Recap — August 2016

FDA issues draft guidance on use of real-world data in medical device decision-making - The Food and Drug Administration’s draft guidance provides an overview of how the agency will determine the quality and reliability...more

Product Liability Update: April 2016

Massachusetts Superior Court Rejects “Innovator Liability” Failureto-Warn Claim, Holds Branded Pharmaceutical Manufacturer Owed No Duty to Plaintiff Alleging Injury From Equivalent Generic Drug That Copied Defendant’s...more

Pokémon GO: An Indicator of Product Liability in the App Economy

As a big law firm involved in the defense of Product Liability cases, of course we are interested in how Product Liability law will evolve to address the App Economy. Mobile apps (apps) are software applications designed...more

Pokémon Oh No! Augmented reality raises specter of personal injury claims: M&R Blog

There’s no denying it—Pokémon have taken over the country and, as of the popular app’s launch in more than 30 countries over the past few weeks, the world. As the media is eager to point out, the game’s launch has not been...more

Two Favorable Tysabri Rulings Add Clarity to “Clear Evidence” Preemption Standard – and More

Anyone who has checked our post-Levine innovator drug & vaccine cheat sheet lately has no doubt noticed our two most recent entries, Gentile v. Biogen Idec, Inc., 2016 WL 4128159 (Mass. Super. July 25, 2016), and Christison...more

New York Decision Not Good For Asbestos, But Not Bad For Drug/Device

The recent decision of the New York Court of Appeals in In re New York City Asbestos Litigation, ___ N.E.3d ___, 2016 WL 3495191 (N.Y. June 28, 2016) (“NYCAL”), was not too good for asbestos defendants – as it permitted,...more

California Court Clears The Way For Express Preemption

Not everyone sees eye to eye on federal preemption, including judges. Take for example the conflicting opinions from the California Court of Appeal applying the express preemption provision of the Medicare Prescription Drug,...more

Seen on the Screen

This is one of those stories you simply cannot make up. We were using technology to get some ideas about technology. That is, we were surfing around the internet to find descriptions of the successful use of technology...more

Conflicting Defence Evidence Not Sufficient to Deny Class Certification

The Divisonal Court’s recent decision in Dine v Biomet Inc, 2016 ONSC 4039 will be of particular interest to members of the class action bar in Ontario, as it will have implications for evidence led on certification motions....more

Guest Post – Benicar MDL Court: An Unconventional, but Relatively Simple, Remand Decision

This is a guest post, by Jaimee Farrer, an associate at Reed Smith. We’re always looking for new twists that can help in efforts to remove cases to federal court, and the case Jaimee describes does that, relying on an MDL...more

King & Spalding Lawyers Discuss The Regulatory Landscape At Medical Device Cybersecurity Risk Mitigation Conference

On July 25 and 26, 2016, industry stakeholders assembled in Arlington, Virginia, to participate in the Medical Device Cybersecurity Risk Mitigation Conference sponsored by Q1 Productions. The conference focused on the...more

Off-Label Marketing – Industry Groups Step into the Breach

We have been waiting, literally for years, for the FDA to revise, clarify, update, or simply pay attention to, its off-label promotion regulatory position in light of repeated governmental First Amendment losses in Sorrell v....more

New GMO Legislation Signed into Law

With Congress’s freshly enacted GMO labeling bill, the devil is in the implementing details. On July 29, US President Barack Obama signed legislation that establishes a national disclosure requirement for identifying...more

3D Printing: Health Care Miracle, Product Liability Nightmare, or Both? Insights from Nutter’s David Ferrera and Robyn Maguire

David Ferrera, partner in Nutter’s Litigation Department and chair of the firm’s Product Liability and Toxic Tort Litigation practice group, and Robyn Maguire, partner in Nutter’s Litigation Department and a member of the...more

Update: Unraveling the Toxic Substances Control Act Reform Bill

In June, the U.S. Senate and House of Representatives passed the long-pending Toxic Substances Control Act (TSCA) reform legislation, which will bolster the government’s power to regulate a wide variety of chemicals. The bill...more

Is the Rapidly Evolving Landscape for Vehicle Technology About to Hit Regulatory and Legal Speedbumps?

In a nation with over 250 million vehicles, accidents occur daily, and many of those result in injuries and fatalities. Rarely do they receive national attention. Yet, an incident involving a vehicle in early May has...more

July 2016: Product Liability Update

Curbing False Claims Act Liability for Off-Label Promotion. As class actions have become harder to certify following Wal-Mart v. Dukes and Comcast v. Behrend, the plaintiffs’ bar has increasingly turned to qui tam litigation...more

2016 Updates to Ediscovery for Defendants Cheat Sheet

We’ve been remiss in updating our cheat sheet devoted to ediscovery for defendants. Because of the broad nature of the topic – these cases can and do arise in a wide variety of non-drug/device contexts – we have to research...more

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