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Products Liability Science, Computers & Technology

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

U.S. watchdogs tally $1.5 billion cost for one type of defective medical device

Big medical device makers, like Big Pharma, have complained Big medical device makers, like Big Pharma, have complained relentlessly that Uncle Sam hamstrings them with red tape and bureaucracy that slows or prevents...more

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

Double Preemption Win in Amiodarone Litigation

by Reed Smith on

With PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), preemption arguments in cases involving generic prescription drugs has become a little like shooting fish in...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

Empty Gestures – Pennsylvania’s Right To Try Legislation

by Reed Smith on

For the second time in three years the Pennsylvania legislature has proven itself entirely unable to carry out its most basic function, which is to pass a budget – any budget – which is balanced and otherwise meets...more

Worldwide Group of Data Privacy Regulators Issues Guidance on Connected-Car Technologies

by Ballard Spahr LLP on

A global group of data privacy regulators has, for the first time, set forth data privacy and security guidance on the development of automated and connected-car technologies. ...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

Fraud on the FDA? If Not Preempted, It Is Trumpery

by Reed Smith on

With Bexis having originally conceived the preemption argument that became Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), we are always on the lookout for ways in which plaintiffs attempt to circumvent...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

N.Y. Court Holds that Manufacturer Cannot be Responsible for Medical Malpractice

by Reed Smith on

We harbor a suspicion that half the drug/device tort cases we encounter are really medical malpractice cases in search of a deeper pocket (thank you medmal damage cap statutes). We’ve said before that both Levine and Riegel...more

No Causation, No “Parallel Claim”

by Reed Smith on

The district court’s order dismissing claims in Ebrahimi v. Mentor Worldwide LLC, No. CV 16-7316, 2017 WL 4128976 (C.D. Cal. Sept. 15, 2017), is a good antidote to the Ninth Circuit’s wrongly decided opinion in Stengel v....more

Sham Affidavits

by Reed Smith on

We’re quite familiar with people who say one thing, when they think that’s in their interest, and later when circumstances change, say something quite different. For example, as the late, great Molly Ivins pointed out in...more

Stout Issues Third Annual Warranty and Recall Report

by Foley & Lardner LLP on

Massive automotive recalls continue to grab headlines and raise concerns industry-wide. Recalls of light vehicles topped 50 million units in 2016, representing the third consecutive year of elevated – and record setting –...more

FDA Weighs in on Off-Label Use and Preemption

by Reed Smith on

Back in 2013, Ramirez v. Medtronic Inc., 961 F. Supp.2d 977 (D. Ariz. 2013), made it to #9 on our worst cases of the year list – which is pretty good (actually, pretty bad) for a trial court decision. Purporting to apply...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

Missouri Adopts High Burden for Venue Challenges and Affirms a $23 Million Punitive Damages Award Based, in Part, on a...

by Lathrop Gage on

On September 12, 2017 the Missouri Supreme Court handed down its 4-3 opinion in Barron v. Abbott Laboratories, Inc., SC96151, dealing a significant blow to businesses who seek to transfer cases from Missouri trial venues...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

Connecting the Dots: Key Developments and Best Practices for Evaluating Privacy and Security Risks in IoT Investments

by Shearman & Sterling LLP on

The market for internet-connected devices (often referred to as the Internet of Things, or IoT) is growing rapidly. Investment in this burgeoning space can be attractive, and according to research firm IDC, the worldwide...more

Healthcare Law Update: September 2017

by Holland & Knight LLP on

OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more

August 2017: Product Liability Litigation Update

Hot Topic: Plaintiffs’ Efforts to Evade the Burden of Supporting Products Liability Claims with Expert Testimony. The core allegations in many product liability cases are that the manufacturer failed to adequately warn of its...more

Federal Right To Try Legislation – Is It Any Better?

by Reed Smith on

We’ve generally been skeptical of state “Right To Try” statutes, for several reasons. First, to the extent that they try to circumvent the FDCA, they’re likely to be preempted. Second, drugmakers aren’t likely to distribute...more

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