Drugs & Devices Archives

The Wrong-Headedness of Hindsight Standards — Michelle Yeary | Drug & Device Law Blog

May 27th, 2019|Categories: Complex Business Litigation, HB Risk Notes, Mass Torts|Tags: Drug Laws, Drugs & Devices, Litigation & appeals, mass torts, Product Liability|

Dechert LLP attorney Michelle Yeary cautions against applying perfect hindsight to drug liability. "We all know hindsight is 20/20. And, it’s easy. There are dozens of television and radio programs that thrive on Monday morning quarterbacking. There’s no risk in saying the coach should have called for a pass when you already know the run didn’t work. It’s also dangerous because it’s easy. People are often too quick to point out that you should have taken path B after everyone learns path A is full of potholes. Pointing it out is one thing, holding you liable for it is another." Yeary takes a look at what happened in Holley v. Gilead Science, Inc., 2019 WL 2077845 (N.D. Cal. May 10, 2019). The case involves two of the main active ingredients in AIDS drugs: TDF and TAF. The plaintiff alleges that the defendant should be responsible for allegedly knowingly using TDF over TAF (allegedly a safer alternative). TDF was FDA approved first and TAF second. Unfortunately, Yeary wrote, hindsight "can be used to demand perfection," allowing plaintiffs to "proceed on what is essentially a stop-selling theory," that first-generation drugs should not be submitted to the FDA because, in hindsight, "later approved treatments were safer." That's what happened in Holley, she said. Read the complete post by Michelle Yeary on the Drug and [...]

The Need for Real MDL Rules Will Only Grow More Acute — Drug and Device Law Blog

April 16th, 2019|Categories: Complex Business Litigation, HB Tort Notes, Mass Torts|Tags: complex litigation, Drugs & Devices, emerging litigation, mass torts, mult--district litigation (MDL)|

By Bexis [one-half-first].[/one-half-first] [one-half]"In the ensuing procedural gamesmanship, plaintiffs are in the process of losing one of the main ways they gamed the system to keep diverse cases in state court – the so-called 'forum defendant rule' whereby even a diverse action could be kept in state court by the presence of defendant domiciled in the plaintiff’s chosen forum. The forum defendant rule applies only to parties 'properly joined and served,' and technologically-savvy defendants have discovered that, by monitoring electronic dockets, they can remove diverse cases faster than plaintiffs can serve forum defendants. We call this 'pre-service,' 'snap,' or 'wrinkle' removal, and we’ve chronicled (and advocated) its rise since 2007." Read the complete post by Bexis on Drug and Device Law Blog here. [/one-half] This is an excellent blog. One of my favorites. It's unapologetically defense-oriented, of course. A phrase like "gamed the system" is practically an invitation for rebuttal! So if you would like to respond, rebut, or rebuke, please write to us at Editor@LitigationConferences.com. --Tom Hagy, HB

A Generic Drug Failure to Warn Claim? –Michelle Hart Yeary

April 14th, 2019|Categories: Complex Business Litigation, HB Tort Notes, Mass Torts|Tags: Drugs & Devices, emerging litigation, Litigation & appeals, mass torts, Product Liability|

[one-half-first][/one-half-first] [one-half] "Rather than focusing on what plaintiff’s off-label marketing claim really was – a claim that defendant’s label should have contained different information or warnings about off-label uses – an impliedly preempted claim, the court got distracted trying to fit the case in under Bausch and started talking about parallel violation claims. "The court found that because plaintiff was alleging a violation of federal regulations, his claims “run parallel to [defendant’s] state law duties,” and thus were not preempted. The problem with this is that Mensing is not an express preemption case. It was an implied preemption case, and the district court had no business applying 'parallel claim' analysis to implied preemption, where a 'parallel claim' exception does not exist. It makes no difference whether plaintiff’s off-label promotion claim is 'parallel' to federal regulations, defendant could not have offered any different warning so any claim that the warning or information it provided was inadequate is preempted under Mensing. The court was trying to fit a square peg into a round whole – and the only way that works is to cut off the corners." Read the complete post by Dechert's Michelle Hart Yeary here! [/one-half]

Attorney General Ferguson of Washington Sues State’s Top Opioid Distributers

March 20th, 2019|Categories: Class Actions, Emerging Litigation & Risk, HB Risk Notes, HB Tort Notes, Mass Torts|Tags: class actions, Drug Laws, Drugs & Devices, Healthcare, mass torts|

“We are woefully under-resourced when it comes to treatment. The people who are responsible for this epidemic should being paying for it. We are going to hold these companies accountable and get more money into our communities for treatment.” --Washington AG Bob Ferguson The three largest distributors of prescription opioids in Washington State are being sued by Attorney General Bob Ferguson for fueling the state's opioid epidemic. Detailed in Ferguson's King County lawsuit are the billions of dollars made from these suspicious shipments of over 2 billion pills of unregulated oxycodone, fentanyl, hydrocodone and other opioids. "Prescriptions and sales of opioids in Washington skyrocketed more than 500 percent between 1997 and 2011. In 2011, at the peak of overall sales in Washington, more than 112 million daily doses of all prescription opioids were dispensed in the state — enough for a 16-day supply for every woman, man and child in Washington," according to the AG's announcement. "In 2014 McKesson, Cardinal Health and AmerisourceBergen shipped enough opioids to Pend Orielle County to supply every single resident with dozens of pills. In 2009, McKesson alone supplied enough for dozens of pills for every resident of the county. The specific shipment numbers are currently under seal." The accused distributors are in the top 15 Fortune 500 list based on 2017 revenue. In addition to the [...]

Class Actions Weekly Roundup from Top Class Actions

March 31st, 2018|Categories: Class Actions, HB Tort Notes, Mass Torts|Tags: class actions, Drugs & Devices, mass torts, Product Liability, Product Recall|

This roundup is prepared exclusively for HB Litigation Conferences by: Walmart Class Action Claims Glucosamine Tablets are Mislabeled Walmart has been hit with a class action lawsuit claiming that their store brand glucosamine tablets are mislabeled. Plaintiffs Cynthia Parker, Reba Garth, Margaret Herrin, and Shirley Reinhard allege that Walmart misrepresents its store-brand glucosamine sulfate dietary… Read More Sorin 3T Heater Cooler Lawsuit Alleges Serious M. Chimaera Bacterial Infection An Indiana man has filed a Sorin 3T heater cooler lawsuit against LivaNova PLC, alleging their cardiac heater cooler device had caused him to develop a potentially fatal infection. The claimant filed the Sorin 3T heater cooler… Read More Coca-Cola Seeks Dismissal of Diet Coke Class Action Lawsuit Coca-Cola asked a New York federal court to toss a class action lawsuit alleging the company’s use of the name “Diet Coke” is misleading. The company argues that claims against its use of the word “diet” in… Read More Couple Files Stryker Hip Recall Lawsuit Over Metallosis Complications Thousands of hip implants were affected by a Stryker hip recall after they were linked with serious complications, including metallosis. Some patients affected by these major side effects have turned to litigation, hoping to regain some… Read More Facebook Class Action Challenges Facial Recognition Technology Facebook faces a new class action lawsuit alleging that the social media site captured and stored biometric information of [...]