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FDA Proposes to Delay Off-Label “Intended Use” Rule

by Reed Smith on

Perhaps you have heard that elections have consequences. That is true not only for high-profile issues that hog the headlines on CNN and Fox News, but it is also true for drug and device litigation regulation. Such drug and...more

No Old Kentucky Home for Parallel FDCA-Based Tort Claims

by Reed Smith on

Several years ago, in a post entitled “Negligence Per Se Trivia,” we included the following: "In Kentucky, negligence per se has been codified, and claims based on federal (but not state) statutes or regulations (like the...more

Connected Devices Bring New Product Liability Challenges

"My Google Home Mini was inadvertently spying on me 24/7 due to a hardware flaw,” wrote a tech blogger who purchased Google Inc.’s latest internet of things (IoT) device. Following the incident, a pact of consumer advocacy...more

Where To Find Our Research 3.0

by Reed Smith on

Happy New Year! - It’s been 3 ½ years since we last updated our index to our online research resources. That’s almost ? of the total life of the blog, which started in way back in 2006. We’ve been blogging now for well...more

The Highs - Celebrating the Ten Best Prescription Drug/Medical Device Decisions of 2017

by Reed Smith on

Ending the year on a high note is one thing that the blog tries to do – with the top ten drug/device product liability decisions of the year. Occasionally, a court will do something that ruins the party, with an eleventh-hour...more

Breaking News: TH v. Novartis – California Supreme Court Recognizes New Tort Duties as Traditional Limits Slide into the Sea

by Reed Smith on

We posted our 2017 “Worst 10 decisions” list a day too soon, because the California Supreme Court issued its anticipated decision in TH v. Novartis, No. S233898, slip op. (Cal. Dec. 22, 2017) today, and if it is not the worst...more

The Lows - Mourning the Worst Prescription Drug/Medical Device Decisions of 2017

by Reed Smith on

The second most successful college basketball coach of all time (in terms of NCAA Division 1 national championships) has said “All of life is peaks and valleys. Don’t let the peaks get too high and the valleys too low.” ...more

Is Your Company Ready For Artificial Intelligence?

by Morrison & Foerster LLP on

“The rise of powerful AI will be either the best or the worst thing ever to happen to humanity. We do not know which.” –Stephen Hawking Artificial Intelligence (AI) and autonomous technology will shape the future, affect...more

Innovator Liability – A Word to the Wise

by Reed Smith on

A lot of us attended the annual ACI Drug & Medical Device Litigation Conference in New York City last week. One of the messages sent loud and clear from the initial client round table panel is that our clients don’t like...more

Third Circuit Splits with the Seventh Over Standing To Sue For Alleged Inefficient Design of Eye Drop Dispenser

In a surprising decision and split with the Seventh Circuit, the Third Circuit recently held that plaintiffs have standing to sue for unfair trade practices under the theory that a manufacturer is obligated to optimize the...more

Still No “Newly Acquired Information,” Eliquis Claims Still Preempted

by Reed Smith on

The defendants in the Eliquis MDL have turned somewhat of a preemption hat trick. The latest order is In re Eliquis (Apixaban) Prods. Liab. Litig., No 17-md-2754 (S.D.N.Y. Nov. 29, 2017), where the district court dismissed...more

Unavoidably Unsafe PMA Medical Devices

by Reed Smith on

When it comes to design defect claims and FDA pre-market approved (“PMA”) medical devices, “preemption” is our reflexive reaction. That’s entirely reasonable, given the many decisions that preempt state-law design-related...more

Expiring Soon: Temporary BPA Warning Regs Under Prop 65

With the holidays and end of the year quickly approaching, here is what food and beverage manufacturers and sellers need to know before the temporary Proposition 65 safe harbor warning for Bisphenol A (BPA) exposures expires...more

PMA Preemption & Fraud by Omission/Concealment

by Reed Smith on

As our PMA preemption scorecard makes clear, warning claims are preempted under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), because the preemptive language, “different from or in addition to,” precludes plaintiffs from...more

Third Circuit Eyes Up Consumers’ Standing, Splits With Seventh Circuit

by Foley & Lardner LLP on

Last month, the Third Circuit issued a 2-1 decision in Cottrell v. Alcon Labs., reversing a district court’s dismissal of a class action lawsuit on standing grounds. The putative class in Cottrell is comprised of consumers of...more

The Opioid Epidemic – What Kind of a Problem Is It?

by Reed Smith on

We know that our blogposts are carried by legal aggregating services, such as Lexology and JDSupra. Some of you may even be reading this post via one of these services. In addition to writing for them, we actually read...more

Food, Dietary Supplement & Cosmetics Update | Vol. IV, Issue 7

by Jones Day on

USDA Inspector General Recommends Reform of AMS Organic Program for Imports - The USDA Inspector General ("IG") reviewed the Agricultural Marketing Service's ("AMS") process used in determining whether exporting...more

C.D. Cal. Excludes Three Plaintiff Experts in Breast Implant Case

by Reed Smith on

It is not as if we are delighted to see efforts to resuscitate breast implant litigation, but we won’t groan when the rulings are as good as they are in Laux v. Mentor Worldwide, LLC, No. 2:16-cv-01026-ODW(AGR) (C.D. Cal....more

Non-News: Warnings Claims For A Generic Drug Preempted (Still)

by Reed Smith on

We can be inundated with news. Old news. New news. Fake news. Breaking news. News that makes you want to break something. News that makes you want to go back to bed. In trying to be discerning consumers of the news, it...more

No Voluntary Dismissal for Plaintiffs, and a Summary Judgment Win for Defendants, in Central District of California Risperdal Case

by Reed Smith on

In the mass torts world in which we find ourselves, glimmers of jurisprudential light can seem few and far between. Two things we love are good warnings causation decisions and sneaky plaintiffs getting caught at their own...more

A Second Look at Eye-Drop Litigation

by Reed Smith on

Just two days ago, Bexis lowered the boom on the Third Circuit’s recent decision in Cottrell v. Alcon Labs, ___ F.3d ___, 2017 WL 4657402 (3d Cir. Oct. 18, 2017). In a 2-1 decision, the Cottrell court permitted the...more

Full Disclosure: New Labeling for Cleaning Products

by Morrison & Foerster LLP on

On October 15, 2017, California Governor Jerry Brown signed into law Senate Bill 258, known as the Cleaning Product Right to Know Act of 2017 (the “Act”). The Act requires manufacturers of most cleaning products sold in...more

Guest Post – Accutane Amici Say: Relax Somewhere Else – Expert Testimony in New Jersey Should Be Held to a Higher Standard

by Reed Smith on

The Accutane litigation in New Jersey has been covered closely by this Blog for its duration. The Blog’s most recent Accutane post evaluated the Appellate Division’s decision to reverse the trial court’s order excluding...more

Medtronic v. Lohr Has Two Shadows

by Reed Smith on

For over fifty years, the BBC has been chronicling the exploits of that ultimate learned intermediary, Dr. Who. Over the decades, successive Doctors have crossed swords (or sonic screwdrivers) with a wide variety of enemies,...more

Preemption as a Mass Tort Talisman?

by Reed Smith on

A talisman is something thought to protect whoever has it from evil or harm. In the old days a talisman might be something like garlic to ward off vampires or the Seal of Solomon to keep away various evil spirits. Nowadays,...more

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