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Products Liability Consumer Protection

Read Products Liability updates, alerts, news, and legal analysis from leading lawyers and law firms:

PhRMA Comment on the FDA’s Proposed Off-label Rule: The Rule of Law is the Best Medicine

by Reed Smith on

The FDA cannot get out of its own way on the issue of off-label communications. Its power to punish off-label promotion comes from an odd regulatory two-step, whereby off-label promotions are said to prove an indicated use...more

Artificial Intelligence and Learned Intermediaries

by Reed Smith on

In the July 7, 2017, “Artificial Intelligence” issue of Science, we were intrigued by a short piece in the “Insights” section on “Artificial Intelligence in Research” that discussed the future use of autonomous robots in...more

CPSC Recall Snapshot - Annual Report

by Alston & Bird on

Welcome to the July edition of the Alston & Bird CPSC Recall Snapshot. Last month, the CPSC released its 2016 Annual Report. The Annual Report was divided among five key strategies: (1) hazard identification and...more

A Sometimes Overlooked Fact About Express Warranty

by Reed Smith on

The warranty is “express.” Before you say, “Well, duh,” this sometimes actually does matter. Here’s how. Most complaints in product liability actions involving prescription medical products that include express warranty...more

At the One-Year Mark, the EPA’s Existing Chemical Review Process is Taking Shape: What Does That Mean for Your Business?

On Thursday, June 22, 2017, the Environmental Protection Agency (EPA) announced a series of actions implementing its new authority to review the safety of chemicals already in U.S. commerce under the recently amended Toxic...more

California Adopts First Green Chemistry Regulations for Children’s Nap Mats and Provides Important Guidance for Its Alternatives...

by Morrison & Foerster LLP on

California took two important steps forward to implement its new Green Chemistry Initiative, also known as the Safer Consumer Products (SCP) Program, to regulate and encourage replacement of toxic chemicals in consumer...more

FDA’s Denial of Citizen’s Petition “Clear” Enough for Preemption of Failure-to-Warn Claims

The Tenth Circuit recently upheld a Utah district court’s finding that a branded drug manufacturer could not be held liable for failing to warn consumers about alleged birth defect risks when the FDA had previously rejected a...more

UPDATE: The Revival of ECJ Lawsuits*

On June 8, 2017, Judge Carney dismissed Plaintiff’s class action Complaint because she failed to provide specifics about her own Sports Beans purchase. The court held that the Complaint was implausible because it only...more

Food, Dietary Supplement & Cosmetics Update | Vol. IV, Issue 5

by Jones Day on

On June 13, 2017, FDA delayed the compliance date for the Nutrition Facts and Supplement Facts Label and Serving Size final rules, providing additional time for implementation. The rules were finalized in May 2016 and...more

A Double Whammy for California Design Defect Claims

by Reed Smith on

Finally, some good news out of California – at least when personal jurisdiction isn’t the issue. Design and warning defects were the questions presented in Trejo v. Johnson & Johnson, ___ Cal. Rptr.3d ___, 2017 WL 2825803...more

CPSC Requests Feedback to Reduce Compliance Burdens

by Kelley Drye & Warren LLP on

Have ideas to lighten the load for complying with consumer product safety regulations? The Consumer Product Safety Commission (“CPSC” or “Commission”) wants to hear about them. The Commission has asked for comments and...more

FTC Submits Comment To Aid NTIA In Developing Internet of Things Guidance

by Ballard Spahr LLP on

In its latest effort to address security concerns about Internet of Things (IoT) devices, the Federal Trade Commission (FTC) has submitted public comments to the National Telecommunications and Information Administration's...more

FDA Extends Compliance Dates for Nutrition and Supplement Facts Label and Serving Size Final Rules

by Baker Donelson on

On Tuesday, June 13, the United States Food and Drug Administration (FDA) announced it was extending the compliance dates for its final rules for Nutrition and Supplement Facts Labeling and Serving Sizes....more

FSVP compliance dates arrive, challenges to food industry increase

by Thompson Coburn LLP on

On May 30, 2017, the FDA’s Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals went into effect, placing new compliance requirements on food importers. As readers will recall, in 2011,...more

Lawsuit Challenges GRAS Rule on Food Substance Safety

by Morgan Lewis on

Public interest groups challenge FDA’s “Generally Recognized as Safe” Rule as failing to ensure food ingredients are safe for consumers....more

Dietary Supplement & Cosmetics Legal Bulletin | May 2017

Senators Call For Removal of Dioxane from Cosmetic Products - U.S. Sens. Chuck Schumer (DN. Y.) and Kirsten Gillibrand (DN. Y.) have petitioned the Food and Drug Administration to prohibit detectable levels of 1,4dioxane...more

Closing the Door on Hybrid Product Defect-Fraud Claims

by Morrison & Foerster LLP on

On April 13, 2017, in Azoulai v. BMW of N. Am. LLC (Case No. 16-cv-00589), the U.S. District Court for the Northern District of California dismissed a proposed consumer fraud class action against BMW of North America LLC...more

Ninth Circuit Affirms No Private Right of Action to Enforce Lack of Substantiation Claims in SeroVital False Advertising Class...

The Ninth Circuit recently affirmed a district court’s dismissal of plaintiff’s unfair competition law and consumer legal remedies claims, finding that neither claim provided plaintiff with a private cause of action to...more

European Food Safety Authority Launches Public Consultation on the Risk Assessment of GMO at Low Level

by Jones Day on

The European Food Safety Authority ("EFSA") has launched a public consultation on a draft guidance document on the risk assessment of genetically modified organisms ("GMOs") present at low levels in food and feed material....more

The European Commission Amends Plastic Food Contact Materials Legislation

by Jones Day on

On April 28, 2017, the European Commission issued Regulation 2017/752, amending Regulation 10/2011 on plastic materials and articles intended to come into contact with food...more

Food, Dietary Supplement & Cosmetics Regulatory Update Vol. IV | Issue 4

by Jones Day on

On May 9, 2017, the Senate confirmed Dr. Scott Gottlieb as the next FDA commissioner. With a 57-42 vote, the Senate filled the commissioner position most recently held by Dr. Robert Califf, who resigned in January 2017 and...more

CPSC Recall Snapshot - Tensions Rise on Mandatory Standards

by Alston & Bird on

Welcome to the May edition of the Alston & Bird CPSC Recall Snapshot. In late April, the CPSC voted 3-2 to issue a notice of proposed rulemaking (NPR) “to address the risk of blade-contact injuries on table saws.”...more

What Parents Need to Know About the Spike in Child Product Safety Recalls

A recent report published by Kids in Danger (KID), a non-profit group dedicated to protecting child safety through recalls, indicates that child product safety recalls rose in 2016 over the previous year, peaking to its...more

“Pre-Approval” Design Defects - No Such Thing

by Reed Smith on

As our post-Levine preemption cheat sheet demonstrates, Mensing/Bartlett preemption is breathing down the necks of all prescription drug design defect claims. Recent cases finding preemption of design defect claims due to...more

Closing the Door on Hybrid Product Defect/Fraud Claims

On April 13, 2017, in Azoulai v. BMW of N. Am. LLC (Case No. 16-cv-00589), the U.S. District Court for the Northern District of California dismissed a proposed consumer fraud class action against BMW of North America LLC...more

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