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Products Liability Science, Computers & Technology Consumer Protection

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

MDL Direct Filing & Personal Jurisdiction

by Reed Smith on

Bexis gave a talk the other day at the Washington Legal Foundation on personal jurisdiction after last term’s United States Supreme Court decisions in Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017)...more

Consumer Product Update - California's Green Chemistry Initiative Looks for New Products to Regulate

by Morrison & Foerster LLP on

On October 6, 2017, the California Department of Toxic Substances Control (DTSC) announced it is seeking public comment on its new 2018-2020 Priority Product Work Plan (Work Plan) under its Safer Consumer Products (SCP)...more

CPSC Heating Up Before New Commissioner Appointed: Approves a Petition for Rulemaking to Ban an Entire Class of Flame-Retardants

In a split across party lines, the U.S. Consumer Product Safety Commission (CPSC or the “Commission”) recently voted on a largely unprecedented course of action: to ban an entire class of chemicals from popular consumer...more

Food, Dietary Supplement & Cosmetics Update | Vol. IV, Issue 6

by Jones Day on

TOP NEWS - FDA Proposes New Compliance Dates for the Water Provisions of the Produce Safety Final Rule - On September 13, 2017, the Food and Drug Administration issued a proposed rule to extend, for covered produce...more

Off-Label Marketing Case Tossed

by Reed Smith on

Implied Preemption. Off-label promotion. TwIqbal. They make up a core of our posts, yet we never seem to tire of them. Maybe our readers, especially interlopers from the other side of the v., tire of reading about them,...more

Recall Highlights Medical Device Cybersecurity Issues

by Knobbe Martens on

On August 29, the FDA announced a recall of 465,000 implantable pacemakers, citing concerns that hackers may be able to take control of the pacemakers’ settings. This would open patients up to danger from improper pacing or...more

Medical Monitoring Class Certification Fails

by Reed Smith on

Normally, when we think of decisions relating to medical monitoring, the issue is whether a state will recognize medical monitoring for uninjured people as a separate claim or relief that can be sought under an existing...more

Northern District of New York (Quickly!) Holds that the MDA Expressly Preempts Essure Suit

by Reed Smith on

A couple of weeks ago, our co-blogger, Mr. McConnell, published a post on the benefits of brevity. That post sprang from an argument before the JPML, but we can riff on it today as we examine a short and lovely decision from...more

The Third Circuit Fosamax Preemption Error Has Got to Go

by Reed Smith on

Last week we were going through the regulatory record of a drug that is now the subject of mass tort litigation. This effort is central to assembling, per the SCOTUS Wyeth v. Levine case, “clear evidence” that the FDA would...more

A Client's Guide to FDA Inspections

A Food and Drug Administration (FDA) inspector has just knocked on your door and announced that he or she will now inspect your facility. What happens before, during and after this inspection, and what should your firm do to...more

Guest Post – Before the Flood: Fifth Circuit Oral Argument on Writ of Mandamus From Pinnacle Hip Implant MDL

by Reed Smith on

Today’s guest post is by Reed Smith Houston office associate Curtis Waldo. Given the Noachic weather down there recently, one might ask “where’s Waldo?” The answer is safe and sound, if not quite high and dry. Curt is...more

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

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