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New Favorable Risperdal Decisions

by Reed Smith on

Risperdal, an antipsychotic drug prescribed to treat serious mental conditions – schizophrenia, manic depression, and autism – allegedly causes some male users to develop abnormal breast tissue growth. Particularly when...more

Comment K and Non-Implanted Medical Devices

by Reed Smith on

About two years ago, in our post “How Does a Bad Idea Get Implanted,” we discussed what at the time seemed a California peculiar argument that the “unavoidably unsafe” product doctrine epitomized by Restatement (Second) of...more

Regulating the Internet of Toys

by McDermott Will & Emery on

New technologies and the expansion of the Internet of Things have allowed children of this generation to experience seamless interactive technologies through microphones, GPS devices, speech recognition, sensors, cameras and...more

Guest Post – Causation or No Causation, That Is the Question.

by Reed Smith on

Today we feature another guest post from our European correspondents, Reed Smith partner Marilyn Moberg and associate Kathryn Bond. There has been another EU development from the Court of Justice (its description, not ours)...more

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

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

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

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

“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

Product Liability Update: April 2017

by Foley Hoag LLP on

Massachusetts Federal Court In Prescription Drug Case Holds “Learned Intermediary” Rule Requiring Warnings Only To Prescribing Physician Applied Even Though Patient and Caregiver Were Physicians, But Experts’ Affidavits of...more

Guest Post – Come Together: Is UK Product Liability Law Getting More Like the U.S.?

by Reed Smith on

This guest post – only our second post ever on European issues is brought to you by Reed Smith partners Marilyn Moberg and (in the UK) associate Bond, Kathryn Bond (sorry, couldn’t resist). Our previous (and only) foray into...more

California Adds New Priority Consumer Product for Green Chemistry Regulation

by Morrison & Foerster LLP on

California’s innovative Safer Consumer Products regulations, also known as the Green Chemistry Initiative, are ready for another step forward with the proposed inclusion of Spray Polyurethane Foam (SPF) Systems containing...more

TSCA Amendment: Upcoming Inventory Rule

by Foley & Lardner LLP on

On June 22, 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (the Amendment), which amends the Toxic Substances Control Act (TSCA), was signed into law. Under this amendment, EPA was authorized, amongst...more

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

by Reed Smith on

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

by Reed Smith on

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

by Reed Smith on

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

by Bass, Berry & Sims PLC on

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

by Thompson Coburn LLP on

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

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