New update to Report on Medical Malpractice

The Center for Justice & Democracy at New York Law School recently released the 12th update to its Medical Malpractice: By The Numbers report. The fully-sourced 172-page volume includes the latest statistics and research on issues related to medical malpractice, including over 500 footnotes linking to original sources.  You can get a copy of the full report here; or a summary here.

House and Senate Democrats introduce bill to allow victims of gun violence to sue the gun industry

Last week House and Senate Democrats presented a bill called The Equal Access to Justice for Victims of Gun Violence Act which seeks to repeal federal protections blocking firearm and ammunition manufacturers, dealers and trade groups from most civil lawsuits when a firearm is used unlawfully or in a crime.  Given that Mitch McConnell has asserted he will not let any progressive legislation pass during his reign, the bill has little to no chance of ever becoming law, though.

NPR has the full story here.

Comment on recent Supreme Court case on preemption in prescription drug cases

A few days ago I reported that he Surpreme Court issued its opinion on Merck Sharpe & Dohme v. Albrecht, the latest decision in the Court's line of cases on pre-emption as a defense in cases for injuries caused by lack of adequate warnings regarding prescription drugs.  (See here).

Since then, Max Kennerly, of the excellent Litigation and Trial blog, has published a detailed discussion of the case. You should read the full article here.  Here is his conclusion:

On May 20, 2019, the United States Supreme Court decided Merck v. Albrecht ... destroying most of the arguments routinely used by drug companies to claim that plaintiffs’ cases are “preempted” and have to be dismissed. The law for people injured by branded prescription drugs is far better now than it was before Albrecht, and as a result, it is likely that far more victims will get to see their day in court. 

After Albrecht, a branded prescription drug manufacturer can only establish impossibility preemption — which happens when federal law makes it “impossible” for defendants to comply with state tort laws that enable victims to seek compensation — if they can show: 

-- The manufacturer “fully informed” the FDA by providing both all “material” safety information and an “evaluation or analysis concerning the specific dangers” raised by the plaintiff; and 

-- The FDA took action, “carrying the force of law,” to disapprove the warning proposed by the plaintiffs. 

The Supreme Court’s analysis in Albrecht is far more narrow than any preemption argument ever proposed by drug manufacturers, and far more narrow than the “clear evidence” tests many lower courts have been using since Wyeth v. Levine, 555 U.S. 555 (2009). As the Supreme Court itself said, “a drug manufacturer will not ordinarily be able to show that there is an actual conflict between state and federal law such that it was impossible to comply with both.”

Podcast on internet defamation

The most recent edition of the podcast "Digital Detectives" is devoted to a discussion of what lawyers need to look out for when handling a defamation case that originates in comments made on the internet.  You can listen to the program by going here.

New York Times article on Boeing's handling of the design of the 737 Max airplane; it's not a pretty picture.

The New York Times has published an article describing certain aspects of the process that led to the design and manufacture of the Boeing 737 Max airplane, the model recently involved in several crashes, which paints a really bad picture for the company.  If the article is accurate, and the statements can be proven in court, the picture is one of negligence, if not intentional or reckless, management of the design process which could be used against the company in a product liability case.  The article is called "Boeing Built Deadly Assumptions Into 737 Max, Blind to a Late Design Change" and you can read it in full here, but here is the gist of it:

The fatal flaws with Boeing’s 737 Max can be traced to a breakdown late in the plane’s development, when test pilots, engineers and regulators were left in the dark about a fundamental overhaul to an automated system that would ultimately play a role in two crashes.

A year before the plane was finished, Boeing made the system more aggressive and riskier. While the original version relied on data from at least two types of sensors, the final version used just one, leaving the system without a critical safeguard. In both doomed flights, pilots struggled as a single damaged sensor sent the planes into irrecoverable nose-dives within minutes, killing 346 people and prompting regulators around the world to ground the Max.

But many people involved in building, testing and approving the system, known as MCAS, said they hadn’t fully understood the changes. Current and former employees at Boeing and the Federal Aviation Administration who spoke with The New York Times said they had assumed the system relied on more sensors and would rarely, if ever, activate. Based on those misguided assumptions, many made critical decisions, affecting design, certification and training.

“It doesn’t make any sense,” said a former test pilot who worked on the Max. “I wish I had the full story.”

While prosecutors and lawmakers try to piece together what went wrong, the current and former employees point to the single, fateful decision to change the system, which led to a series of design mistakes and regulatory oversights. As Boeing rushed to get the plane done, many of the employees say, they didn’t recognize the importance of the decision. They described a compartmentalized approach, each of them focusing on a small part of the plane. The process left them without a complete view of a critical and ultimately dangerous system. 

The company also played down the scope of the system to regulators. Boeing never disclosed the revamp of MCAS to Federal Aviation Administration officials involved in determining pilot training needs, according to three agency officials. When Boeing asked to remove the description of the system from the pilot’s manual, the F.A.A. agreed. As a result, most Max pilots did not know about the software until after the first crash, in October.

Court appoints plaintiffs' steering committee in multidistrict litigation against manufacturers of earplugs issued by the military

Last month I reported that the U.S. Judicial Panel on Multidistrict Litigation (JPML) agreed to consolidate and centralize all 3M Combat Arms Earplug lawsuits pending throughout the federal court system.  Currently, there are more than 813 product liability lawsuits filed against 3M Company and it’s Aearo Technologies subsidiary, each involving similar allegations that military veterans suffered hearing damage following use of Combat Arms earplugs, which were standard issue by the military between 2003 and 2015.  However, according to some, it is expected that ultimately thousands of cases will be brought by individuals nationwide.

The centralized litigation has been assigned to U.S. District Judge Casey Rodgers in the Northern District of Florida, which will help reduce duplicative discovery, and avoid conflicting pretrial rulings.

Now comes news that the Judge has appointed a group of 53 plaintiffs’ attorneys to serve in various leadership roles, taking actions that benefit all veterans who are pursuing claims for hearing loss linked to product defects.  AboutLawsuits has the story and links to the relevant documents.

Supreme Court decides new case on preemption in cases of prescription drugs

About a week ago, the Surpreme Court issued its opinion on Merck Sharpe & Dohme v. Albrecht, the latest decision in the Court's line of cases on pre-emption as a defense in cases for injuries caused by lack of adequate warnings regarding prescription drugs. 

According to the summary and analysis of the opinion in the SCotUS blog, the opinion offers "clarity on the procedure for deciding pre-emption defenses, but little additional elucidation on the contours of those defenses."

You should read the full article (here), which explains that "[a] decade ago in Wyeth v. Levine, the court held that to succeed with the impossibility pre-emption defense, defendants had to produce “clear evidence” that the FDA would have prohibited an additional warning. Yesterday’s opinion in Albrecht attempted to clarify Wyeth’s application by explaining abstractly that the “clear evidence” standard contemplates an irreconcilable conflict between federal and state law, rather than a heightened standard of evidentiary proof."

The court held that judges, rather than juries, should decide whether FDA actions pre-empt state tort suits alleging failure to warn consumers of adverse effects. This is a strategic win for drug manufacturers, clarifying that their go-to defense of “impossibility preemption” – the claim that federal regulation would have prohibited the additional warnings plaintiffs allege state tort law required – can be decided on motions before the case reaches a jury.

Jurist has a short summary here.

Podcast on autonomous vehicles

A recent University of Virginia School of Law podcast addresses the effect of autonomous vehicles on tort and insurance.  You can listen to the program here or read about it here.


Thanks to the TortsProf blog for the link.

Interview with the author of recent book on generic drug regulation and the FDA

Here is a link to an interview with the author of “Bottle of Lies: The Inside Story of the Generic Drug Boom.” In the book, investigative journalist Katherine Eban works with two industry whistleblowers to expose how some manufacturers are cutting corners at the cost of quality and safety.

The second part of the report is here.

Coincidentally, the Supreme Court also just issued a decision on preemption in drug related cases, about which I will post separately.

Going to the doctor? The robot will see you now...

I have written before about issues (both ethical and legal) related to artificial intelligence, driverless cars and the like.  So I am writing today to point out an article about artificial intelligence in medicine since it is clearly not inconceivable that at some point it will be possible to create databases of information that can be used to diagnose and treat matters of health.  You can read the article "The (A.I.) Doctor Will See You Now: What if artificial intelligence could accurately diagnose you—and save you a trip to the doctor’s office?" here.

I don't know if there a lot of literature on this topic, but it certainly is an interesting one that raises lots of questions.  How should the practice be regulated?  If mistakes are made and injuries caused, should the claims be considered medical malpractice or products liability?  Should they be evaluated under a negligence standard of strict liability?

I think it is just a matter of time before we face the need to ask these questions.