Products Liability Consumer Protection

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On Alternative Design, Take Two - Negligence

Back in 2013, inspired by a win of our own that we were actually allowed to blog about, we put up a post entitled “On Alternative Design.” Taking the alternative design requirement for strict liability as a given, we...more

Sixth Circuit Affirms Branded Drug Preemption and Trial Win

In the aftermath of Levine, with its generous interpretation of the CBE regulation and its novel “clear evidence” standard, we wondered how long it would be until we saw a court holding that a failure to warn claim with a...more

The Failure to Warn of Cannabinoid Hyperemesis Syndrome

As more states legalize marijuana for recreational use, the long-term effects of marijuana use —the good and the bad — will continue to have a significant effect on the law, and in particular, products liability law. Products...more

Reexamination of “Healthy” Continues with an FDA Public Meeting in March 2017

As we’ve previously reported, FDA has signaled its interest in reviewing the scope and meaning of the nutrient content claim “healthy,” in part as result of a dispute with KIND LLC about label claims for its KIND Bar...more

FDA Changes Warning For Fluoroquinolones

Fluoroquinolones is a drug used to treat respiratory and urinary infections. Fluoroquinolones include these drugs: - Avelox (moxifloxacin); - Cipro (ciprofloxacin); - Cipro extended-release (Cirpofloxacin...more

Non-Physician Learned Intermediaries

One of us was asked a question the other day that we couldn’t answer immediately. “Does the learned intermediary rule apply to a physician’s assistant?” We didn’t remember any cases actually deciding that issue. So we did...more

Vermont Vapor Up in Smoke for Allegedly Deceptive E-Cig Marketing Practices

Last week, Vermont Vapor, Inc. (“Vermont Vapor”) announced that the Vermont Attorney General’s Office is seeking $50,000 in penalties in connection with Vermont Vapor’s e-cig marketing practices. How can e-cig...more

California Rule Change: Drug Labeling Requirements

Recently, the California Board of Pharmacy announced changes to its drug labeling rules that will take effect on April 1, 2017. The Board of Pharmacy amended Section 1744 of Article 5 of Division 17 of Title 16 of the...more

Don’t Game Your Players with False Advertising

Advertising for new games can present some troublesome legal issues, if due care is not taken. A recently concluded matter in the UK highlights an example of the potential issues. Hello Games was investigated by the...more

Missouri Court of Appeals Holds Ingredient List Label on Product Not an Absolute Defense to Claim for Deceptive Merchandising...

Murphy v. Stonewall Kitchen, LLC, No. 104072 (November 8, 2016)- The Missouri Court of Appeals, Eastern District, reversed a trial court’s order dismissing an action on the grounds that an ingredient list label was a...more

Reminder: Cigar Warning Statements and Warning Plans

The Deeming Regulations enacted by the Food and Drug Administration (FDA) on May 10, 2016, expanded the agency’s tobacco regulatory authority to cigars and certain other tobacco products. Among the regulatory provisions made...more

CPSC Recall Snapshot: February 2017

Welcome to the February edition of the Alston & Bird CPSC Recall Snapshot. This month, CPSC Chairman Elliot Kaye announced that the CPSC will not follow President Trump’s Executive Order requiring two regulations be ...more

Food industry sees one of first whistleblower suits under FSMA

As part of the massive overhaul of food safety regulations under the Food Safety Modernization Act, Life Sciences Decoded reported in August on new whistleblower protections for food industry employees. On Feb. 9, six months...more

District Court Sacks Ginkgo Biloba False Advertising Case

On February 2, 2017, the Central District of California terminated a false advertising lawsuit against Schwabe North America, Inc. and Nature’s Way Products, LLC (Defendants), based on allegations that the companies...more

FDA-Approved Labeling Does Not Equal Medical Standard Of Care

We’ve been defending the ability of physicians to engage in off-label use ever since the Bone Screw litigation of the 1990s. Buckman Co. v. Plaintiffs Legal Committee, where the United States Supreme Court affirmed that...more

Food contact goods and the FSVP: Deciphering the FDA’s stance

The last 18 months have seen a flurry of regulatory activity as the FDA has finalized and begun enforcing a number of new regulations based on the Food Safety Modernization Act (FSMA). Among these regulatory schemes is the...more

The Viability of the “Primary Jurisdiction Doctrine” Defense and Other Ways to Stem the Tide of Food & Beverage Class Actions

As our readers are well aware, in the past decade, food and beverage manufacturers have faced an unrelenting onslaught of putative class actions challenging allegedly false or misleading labels. In the January 2016 issue, we...more

Chairman Kaye Steps Down as CPSC Chair; Republican Buerkle Assumes Role of Acting Chair

Late Wednesday evening, Democrat Elliot Kaye resigned as chair of the Consumer Product Safety Commission. Republican Commissioner Ann Marie Buerkle has assumed the position of Acting Chair until a new chair is appointed by...more

FDA Issues Proposed Tobacco Product Standard for N-Nitrosonornicotine (NNN) in Finished Smokeless Tobacco Products

On January 23, 2017, the Food and Drug Administration (FDA) issued a proposed tobacco product standard that would establish a limit of N-nitrosonornicotine (NNN) in finished smokeless tobacco products not to exceed 1.0...more

Spectrum Facing Consumer Fraud Lawsuit Over Wireless Internet Speed Claim Practices

The Office of the Attorney General for the State of New York (“NYAG”) has filed a consumer fraud complaint against Charter Communications, Inc. and Spectrum Management Holding Company, LLC (“Spectrum”) for deceptive practices...more

Update: GMO labeling regs get Trumped

The Trump Administration’s latest executive orders have effectively prevented the USDA from promulgating rules on GMO food labeling. The development will likely throw a wrench in the USDA’s anticipated plans to give more...more

Stryker Accolade TMZF and L-Fit V40 Chrome/Cobalt Head Failures – Not Just a Large Head Problem, Or Is It a Head Problem At All?

For over four years I have been investigating problems associated with Stryker Accolade TMZF Titanium hip stems. Of course the Rejuvenate and ABG II failures and subsequent recall are well-known and much written about. But,...more

CPSC Recall Snapshot: 2016 Year in Review

Welcome to the Alston & Bird 2016 CPSC Recall Snapshot Year in Review. How did the activity by the CPSC in 2016 compare to that of 2015? As noted in our CPSC Year in Review, the CPSC issued its ...more

FDA Issues Draft Guidance on Communications That Are Consistent with FDA-Required Labeling

This On the Subject reviews the US Food and Drug Administration’s recently released draft guidance on promotional materials and communications that are consistent with FDA-required labeling. The guidance provides a...more

New CPSC Safety Standard on Baby Slings

In early January, the U.S. Consumer Product Safety Commission (CPSC) adopted a new federal safety standard for infant sling carriers. 82 Fed. Reg. 2326-1 (Jan. 9, 2017). CPSC’s new rule follows its 2010 warning that baby...more

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