Products Liability Science, Computers & Technology

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SDNY Dismisses Manufacturing and Fraud Claims in Fertility Drug Case, But Conflates and Confuses the Rest

By all rights, it should be Sullivan writing about the Sullivan case. But John is taking a well-deserved vacation. We do not know if Sullivan’s travels more closely approximate a Bexis expedition, which involves long hikes...more

Preemption (and Other Things) Defanging Depakote Claims

It wasn’t a complete win, but the summary judgment outcome in Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 4743056 (S.D. Ohio Aug. 10, 2015), has to put a spring in the step of the defendants as they...more

Hacking Your Health: For Healthcare Providers, Risk Analysis Must Be Ongoing

Healthcare providers would be wise to keep in mind that if a patient is harmed by a hacked medical device, Exhibit A in the negligence suit against them may be that provider’s risk analysis, or lack thereof....more

California Dreaming: The Bite of Bauman, the Perfume of Preemption, the Stink of Stengel

This week the Drug and Device Law Son turns 20. It is apparently an age of discontent, of gripes and snipes. When we asked the DDLS what he wanted for his birthday, he said he wanted to move "back" to California. Something...more

More CAFA “Mass Action” Gamesmanship In The Ninth Circuit

Permitted gamesmanship versus prohibited conduct. That is the dichotomy that one district judge adopted to describe the transparent forum manipulation that some plaintiffs undertake under CAFA. To be honest, neither...more

Guest Post - Impossibility Preemption for Innovator Drug Manufacturers: Where Are We Now?

Today we have a guest post (her second - she's a glutton for punishment) from fellow Reed Smith associate Danielle Devens. This one brings together recent precedent recognizing post-Levine preemption in cases involving...more

How Does a Bad Idea Get Implanted?

Not so long ago we discussed how Pennsylvania law clearly precludes prescription medical product strict liability, but plaintiffs keep asserting that cause of action anyway. The plaintiff bar is nothing if not persistent. ...more

District Court Holds That FDCA Does Not Prohibit and Criminalize Truthful Off-Label Promotion of FDA-Approved Prescription Drugs

On August 7, 2015, the U.S. District Court for the Southern District of New York released its Amarin opinion addressing whether truthful, non-misleading off-label promotion of U.S. Food and Drug Administration (FDA)-approved...more

More Lawsuits Filed Against the Makers of Zofran

Zofran (ondansetron) is an anti-nausea medication made by GlaxoSmithKline (“GSK”). In 1991, the Food and Drug Administration (“FDA”) approved it for chemotherapy patients with severe nausea and vomiting. However, it has been...more

Product Liability Update - July 2015

Massachusetts Supreme Judicial Court Holds Failure-to-Warn Claim Against Drug Manufacturer Not Preempted Because There Was No “Clear Evidence” FDA Would Not Have Approved Plaintiffs’ Suggested Warning; Also Holds...more

The Internet of Things and the Inevitable Collision with Products Liability PART 3: Initial Contact

This is the third in a series of blogs examining the rapid development of the Internet of Things (IoT) and its consequential impact on product liability risk. The development of the IoT has been so rapid and the applications...more

Cymbalta Class Certification Denied Again

Is there a tougher federal district judge than Stephen Wilson in Los Angeles? By “tougher,” we do not mean in the usual sense when applied to judges: handing out long criminal sentences – though that certainly does apply to...more

ABA Resolution 105 on Punitive Damages Is Dead for Now

On the eve of the ABA's Annual Meeting next week, the ABA's Standing Committee on Medical Professional Liability announced its withdrawal of proposed Resolution 105 from consideration by the ABA House of Delegates. The...more

Little Reprieve for Prisoner Zyprexa Suit

Happy birthday, Louise Fletcher, who won an Academy Award for her portrayal of the sadistic Nurse Ratched in One Flew Over the Cuckoo’s Nest (1975). Happy birthday also to Albert Brooks, writer/director/star of Modern...more

The Internet of Things and the Inevitable Collision with Products Liability PART 2: One Step Closer

The Internet of Things and the Inevitable Collision with Products Liability, published in February 2015, identified a number of factors leading to the emergence and phenomenal growth of the Internet of Things (IoT). It also...more

Medicinal Product Regulation and Product Liability in Australia: Overview

The Therapeutic Goods Act 1989 (Cth)(TG Act): - Provides a national framework for the regulation of medicinal products. - Provides a national system to control the quality, safety, efficacy and timely availability...more

The Revolution that Wasn’t: New Jersey’s Direct-To-Consumer Exception to the Learned Intermediary Doctrine

The learned intermediary doctrine – in which a manufacturer’s duty to warn runs to the physician, not to the patient – is one of the most potent weapons in the arsenal for a pharmaceutical or medical device manufacturer faced...more

Unfortunately Disappointing 3D Printing Law Review Article

We’ve blogged before about the interesting product liability issues created by 3D printing/additive manufacturing, in particular the novel separation that these techniques create (at least potentially) between “manufacturing”...more

No Prescription For Consumer Protection

Allowing plaintiffs to pursue claims under consumer protection statutes in prescription medical product liability litigation is trying to pound a square peg into a ham sandwich. It doesn’t fit, and the combination isn’t very...more

Louisiana Appellate Court Overturns Improper Application of “Law of the Case” Doctrine

Today is the day when we will learn whether the Governor of Louisiana will enter the 2016 presidential race. That reminds us of Louisiana’s rather colorful collection of politicians, including Huey Long and Edwin Edwards....more

FDA Gives Food Industry Three Years to Phase Out Partially Hydrogenated Oils from Food Products

On June 16, 2015, the Food and Drug Administration ("FDA") issued a declaratory order, requiring a phasing out of the use of partially hydrogenated oils ("PHOs"). In its order, the FDA stated that partially hydrogenated oils...more

California Passes Bill To Ban Biobased Microbeads

On May 22, 2015, the California State Assembly passed the Plastic Microbeads Nuisance Prevention Law, a bill designed to ban the use of microbeads in beauty products and prevent the environment harm that occurs when they...more

PHOs Banned in the U.S.: Landmark FDA Order Declares Partially Hydrogenated Oils No Longer Generally Regarded as Safe

On June 17, 2015, the U.S. Food and Drug Administration (FDA) issued its much-anticipated Final Determination Regarding Partially Hydrogenated Oils (Order), finding there is “no longer a consensus that partially hydrogenated...more

Advertising Law - June 2015 #3

CARU Stresses Out Over Claims for Spa Product - The Children’s Advertising Review Unit (CARU) was stressed out over implied claims made by The Maya Group for its Orbeez Body Spa. The product consists of an...more

Schadenfreude

Many of the more senior among the current prescription medical product liability defense bar cut our teeth during the vaccine wars of the 1980s/1990s. Thus, we noted with grim satisfaction when the junk science progenitor of...more

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