Science, Computers & Technology Consumer Protection Products Liability

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The Internet of Toys

Privacy advocates in both the United States and Europe are urging regulators to take a hard look at the privacy ramifications of internet-connected toys, which are often conventional toys augmented by companion mobile...more

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

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

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

FDA Adverse-Event Reports Go Public

Years of adverse-event reports documenting problems associated with compromised food, dangerous drugs and harmful cosmetics are now available to the public. The information can be obtained, free of charge, via a downloadable...more

FDA bans powdered gloves in human, animal medicine

Effective Jan. 18, 2017, the federal Food and Drug Administration has, by implementation of a final rule, banned the use of powdered gloves by a physician when treating humans or animals. Powdered gloves are now added to the...more

Lipitor MDL Court Grants Pfizer’s Omnibus Summary Judgment Motion: No Evidence of Causation

For those of us who spend large chunks of our professional lives in mass tort MDLs, expressions like “settlement inventory” are ubiquitous. It is too easy to lose sight of the fact that these expressions put the rabbit in the...more

The Peaks – The Ten Best Prescription Drug/Medical Device Decisions of 2016

Today we’re going peak bagging – no, not to the Canadian Rockies or Patagonia (we leave that to Bexis) – for the high points in this year’s drug/medical device product liability jurisprudence. Last week, we visited the...more

Fraud on the FDA Doesn’t Fly Under the FCA Either

Ever since Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), held that state-law claims alleging fraud on the FDA are preempted, plaintiffs have been attempting to find some other way of bringing claims that...more

The Pits – The Worst Prescription Drug/Medical Device Decisions Of 2016

The “pits of hell,” “black as a pit,” a “bad feeling in the pit of my stomach” – that’s how we feel about 2016’s bottom ten decisions of the year arising from prescription medical product liability litigation. This year’s...more

Is the FSMA a plaintiff’s lawyer’s dream and the food industry’s nightmare?

The Food Safety Modernization Act (FSMA) became law in 2011, signaling a sea change in U.S. food safety regulation and making prevention the cornerstone of safety measures. To achieve its lofty goals, while providing time for...more

Anything Worthwhile For Product Liability Defendants In The 21st Century Cures Act?

We blogged about possibly interesting nuggets in the 21st Century Cures Act (“21CCA”) back in February, 2015 – when it was only 400 pages long. In true congressional fashion, it’s now twice as long and loaded up with enough...more

Toxic Substances and Control Act Overhaul

Under the recently amended Toxic Substances and Control Act (TSCA), EPA is bound by new requirements and enforceable timetables to complete risk assessments for chemicals manufactured, distributed and imported to the United...more

Samsung Problems: Cell Phones, Washing Machines

Samsung’s products are injuring consumers with each passing day as cases of exploding cell phones and washing machines continue to mount. The U.S. Consumer Product Safety Commission (USCPSC) has received nearly 100...more

Landmark Reform of Federal Chemicals Law Will Significantly Impact Chemical Manufacturers and Users

On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety Act for the 21st Century Act (“Lautenberg Act”), a sweeping and historic overhaul of our nation’s primary chemical management law, the...more

Product Liability Update: October 2016

Massachusetts Federal Court Dismisses Putative Class Action Because Defendant’s Unconditional Checks for Named Plaintiff’s Maximum Damages, Even Though Uncashed, Mooted Suit - In Demmler v. ACH Food Companies, Civil No....more

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

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

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

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

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