Supreme Court denies cert in case against gun manufacturer related to Sandy Hook school shooting

This is the big news of the week in the world of Torts.  

Back in March, I reported that the Connecticut Supreme Court cleared the way for families of children killed in 2012 at Sandy Hook Elementary School to proceed with a lawsuit against Remington, which manufactured the AR-15 Bushmaster semi-automatic rifle that was used during the school shooting.  After that ruling Remington appealed arguing it should be immune from liability because of the federal Protection of Lawful Commerce in Arms Act (2006) which grants gun manufacturers broad immunity from civil lawsuits that arise out of the criminal misuse of a weapon.

However, the Supreme Court denied review of the case on Nov. 12.  As explained by Prof. Timothy Lytton in the best analysis of the decision I saw this week,

". . . [the immunity granted by the federal statute] does not apply where a manufacturer “knowingly violated a state or federal statute applicable to the sale or marketing” of a firearm. 

The Sandy Hook families allege that Remington, by marketing certain guns to civilians, engaged in “unethical” business methods in violation of the Connecticut Unfair Trade Practices Act. Specifically, they argued Remington “marketed, advertised and promoted the Bushmaster XM15-E2S for civilians to use to carry out offensive, military-style combat missions against their perceived enemies.” 

Remington asked the court to throw out the lawsuit based on the federal immunity statute, but the Connecticut Supreme Court held that a violation of the state’s unfair trade practices law qualifies as an exception to the industry’s liability shield. 

Now that the U.S. Supreme Court has refused to hear Remington’s appeal, the case will move into discovery and, potentially, trial in a Connecticut state court. 

Since many states have unfair trade practices laws like Connecticut’s, gun violence victims are likely to bring similar claims elsewhere, effectively ending the gun industry’s federal immunity from civil lawsuits."

 For more links to the story go to:

Politico

NPR

Courthouse News

The ABA Journal

TortsProf Blog

Lawsuit filed against gun manufacturers related to Las Vegas Music Festival shooting

Back in March I reported (here) that the Connecticut Supreme Court allowed to proceed a lawsuit against Remington, the manufacturer of the rifle that was used during the school shooting at Sandy Hook Elementary School. 

Now, Courthouse News is reporting that attorneys for victims of the Newtown school shooting have filed a new lawsuit against the companies whose assault rifles were used by the gunman in the shooting at the Harvest Musical Festival in Las Vegas.  You can read the full story here.

For my recent posts related to the gun industry go 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.”

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.

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.

Video on the first U.S. wrongful death suit related to the Ethiopian Airlines crash

After Ethiopia released preliminary findings from an ongoing investigation into the Ethiopian Airlines flight that crashed last month and after the first American wrongful death lawsuit against Boeing was filed, Boeing CEO Dennis Muilenburg stated that "It’s our responsibility to eliminate this risk. We own it. And we know how to do it."  (See here.)

Democracy now, has a report including an interview with the plaintiffs in that first lawsuit, filed against Boeing and the Federal Aviation Administration here.  The first part of the report are statements by family members expressing their emotional loss.

At the 22:46 mark, the attorney for the plaintiffs explains some of the evidence in support of their claims.

Connecticut Supreme Court reverses lower court allowing case against gun manufacturer to go forward -- UPDATED

In a 4-3 opinion issued on March 14 (available here), the Connecticut Supreme Court has cleared the way for families of children killed in 2012 at Sandy Hook Elementary School to proceed with a lawsuit against Remington, which manufactured the AR-15 Bushmaster semi-automatic rifle that was used during the school shooting. 

The court held that Remington can be sued over its marketing practices under a Connecticut state law, despite protections offered to gun manufacturers by federal law.  Specifically, the court held that the federal Protection of Lawful Commerce in Arms Act protects gun manufacturers and sellers from liability for the acts of people who use their weapons, but not from a claim under the Connecticut Unfair Trade Practices Act based on allegations that Remington and other defendants were involved in the selling of a weapon that was designed for military use, knowing it had no legitimate civilian purposes and could only be effectively used by civilians for criminal activity.

You can read more details on the story in NPR, AboutLawsuits, Jurist, Courthouse news, the Legal Profession blog and The ABA Journal.

UPDATE (3/19/19):  TortsProf blog has posted a comment here.

Supreme Court hears oral argument on FDA preemption claim

A couple of days ago, the Supreme Court heard oral arguments on the most recent case on whether claims against prescription drug manufacturers are preempted by FDA regulations.  The case is called Merck Sharp & Dohme Corp. v. Albrecht.

The SCotUS blog has a good short summary of the case here and an analysis of the oral argument here.

FDA No Longer Pursuing Rule Update to Require Generic Drug Makers To Warn Of Known Side Effects

Back in November, 2013, I posted that the FDA proposed a new regulations that would allow (and presumably encourage) generic drug manufacturers to add or update the safety warnings on their products.  In a nutshell, the key is that generics are required to use the exact same label and warnings as the brand name manufacturers.  They can't deviate and update the warnings on their own. 

You would think that manufacturers interested in making sure their products are safe would welcome the new rule.  However, because the current system works to immunize generics manufacturers, a change that would work to make the products safer would also open the door to possible liability.  Thus, as you would expect from those who are more interested in profits than safety, the manufacturers hired a consulting firm  to conduct a cost-beneift analysis of the consequences of the new rule.  And, not surprisingly, the analysis concludes that the change is not good for consumers.  You can read the report here.  Then, go here for a report by Center for Justice & Democracy (called "America’s Unaccountable Generic Drug Industry; How Legal Immunity Could Be Making You Sick") which explains how deficient the current system is. You can then form your own opinion.  For more on this issue go here, here, here, here and here (video).

In April 2015, the New York Times published story stating that

The pharmaceutical industry mounted a new challenge on Friday to a federal plan that would require generic drug companies to take the initiative to update their labels to warn consumers whenever health risks were discovered, a shift that would expose the companies to legal liability.

During a public meeting at the Food and Drug Administration, the industry proposed instead that the F.D.A. itself should decide whether new warnings on drug labels are required and, if so, order companies to make the changes. But consumer advocacy groups said the companies were trying to shift responsibility to an agency that lacks the resources to track the vast array of drugs on the market.

Not much has happened since. The rules were supposed to have been finalized in December 2015, but the FDA delayed taking action until July 2016.  Yet, no action was taken, and two weeks ago, despite years of work, and calls from both inside and outside of the agency to ensure accurate and up-to-date warnings are provided to consumers by generic drug manufacturers, the FDA posted a notice announcing the withdrawal of the proposed rule involving label changes.

AboutLawsuits has the story here.

Comment on documentary "Bleeding Edge" and the medical device industry

Netflix recently released a documentary called "The Bleeding Edge" which details many problems with medical devices today, with emphasis on the suffering of thousands of people due to Bayer’s Essure contraceptive, DePuy’s ASR hip implant, Johnson & Johnson’s transvaginal mesh, and the Da Vinci surgical robot.  Most medical devices aren’t tested with clinical trials. The medical devices which are tested can pass with a minimal showing, and Congress has adopted laws that shut the courthouse doors on injured victims. 

You can read a good comment on the documentary and the issues it raises by Max Kennerly at Litigation and Trial.

Lawsuit filed against manufacturers of "bump stocks" in response to Las Vegas shooting

The Torts Prof blog is reporting that witnesses to the mass shooting in Las Vegas have filed a would-be class action lawsuit against manufacturers of bump stocks, the device used by shooter Stephen Paddock to accelerate gunfire from his semi-automatic weapon.  Causes of action include negligence, infliction of emotional distress, products liability, and public nuisance.  The ABA Journal has more details.

Unfortunately, given the state of the law, the lawsuit is not likely to be successful.  Again, The ABA Journal has more information here.

Article on the Trump administration and tort reform

Over at HuffPost, Joanne Doroshow, executive director of the Center for Justice and Democracy at NYU Law School, has posted a short article on the Trump administration's policies as they relate to tort reform and medical malpractice issues.  You can read the article here.

Nearly a third of drugs approved by the FDA between 2001 and 2010 had major safety issues

A prevalent argument used by the pharmaceutical industries in product liability cases is that the courts (and the judicial system) are not the proper venue to determine whether prescription drugs are dangerous. According to the argument, that type of decision should be left to the "experts" - in this case, to the FDA.  Plaintiffs and consumer advocates counter that the FDA is not efficient in its work and that, if anything, the best plan is to have a combination of mechanisms to improve the safety of the products in the market.

A new study by the Yale School of Medicine now provides support for those who argue that the FDA procedures are not particularly adequate when it comes to determining the safety of prescription drugs.  It found that nearly a third of those approved from 2001 through 2010 had major safety issues.  This information is particularly important now that the Trump administration has made it clear it prefers to eliminate regulation rather than strengthen it.

For more information on the recent study go here.

Podcast: Challenges of self driving cars

The program Case in Point (Univ. of Pennsylvania Law School) has posted a new 20 minute podcast on "Challenges of Self-Driving Vehicles." 

National pharmacists' association calls for end of direct to consumer advertising

Back in December I reported that the American Medical Association called for a ban on direct to consumer advertising.  Now comes news that the American Society of Health-System Pharmacists has also joined the call, arguing that much of of the information provided in consumer advertising is misleading and contributes to the overuse of pharmaceutical drugs.  Go here for more information.

I have long held the same position, but I think it is naive to expect the FDA to go back to the day when direct to consumer advertising was banned.  The United States is one of only three countries in the world that allow direct to consumer ads for prescription drugs.  (New Zeland and Brazil are the other two.) 

California Supreme Court to consider whether brand name drug manufacturer can be liable for injuries caused by inadequate warning in equivalent generic drug

A few years ago I reported on a decision by the Alabama Supreme Court holding that a brand name manufacturer could be held liable for injuries related to inadequate warnings when the plaintiff used a generic version of the drug.  The logic behind this reasoning, which has since come to be known as "innovator liability," is that federal law bans generic drug manufacturers from altering the warnings provided by the brand-name manufacturer (aka the "innovator") even if the generic manufacturers are aware that the brand name drug warnings are inadequate.  Thus, if the warning on the generic is inadequate, it is the innovator's "fault." 

Another reason for the development of this liability theory is that, as a result of the inability to independently alter the warning labels, generic drug makers are essentially immune from liability as long as they used the same warning as the innovator. As a result, those injured by generic drugs have been left with no recourse. Here is a discussion of the issue.

The Alabama decision was overridden by the state legislature last year, but the issue is back in the news because earlier this month the California Supreme Court granted review in a case on "whether brand name drug manufacturers should be held liable for failure to warn about risks associated with their medications when injuries are caused by generic equivalents."


Stay tuned.

FDA delays implementation of the generic drug labeling rules until July 2016 (at least)

Back in November, 2013, I posted that the FDA proposed a new regulations that would allow (and presumably encourage) generic drug manufacturers to add or update the safety warnings on their products.  Go here for my most recent post on the background on the controversy.

The rules were supposed to be finalized this month, but the FDA recently confirmed that implementation of the generic drug labeling rules will be delayed until at least July 2016.  This is not entirely surprising given the tremendous pressure the pharmaceutical industry has exerted on this issue and since it has taken this long to even get to this point.  It is disappointing, though, since the announcement back in 2013 gave some hope that the FDA would do something to improve the current state of the law.

As reported in AboutLawsuits.com, "[t]he prominent consumer watchdog group Public Citizen criticized the move in a press release issued December 3, indicating that the FDA’s decision to once-again delay implementing rules originally proposed several years ago, which would allow generic drug makers to up date their warning labels, will place consumers at serious risk."

American Medical Association calls for an end of direct to consumer advertising -- UPDATED

The American Medical Association, which represents 250,000 doctors, has called for an end to direct-to-consumer advertising for prescription drugs, a $4.5 billion-per-year industry in the United States, AdWeek reports.  The US is one of very few countries in the world that allows such a practice.  Of course, the AMA does not dictate policy for the FDA or Congress but its position may have some influence.

UPDATE (12/7/2015):  Torts Today and AboutLawsuits.com have more on the story.

UPDATE (12/13/15):  The New York Times has a short editorial on the issue here.

Illinois Court of Appeals decides case against drug manufacturer which could be the next big case to reach the Supreme Court on the issue of preemption

Readers of the blog will remember that I have been following the debate and the cases on preemption of claims against manufacturers of generic drugs based on inadequate warnings (most recently here and here.)  

In an interesting twist to the plot, now comes a decision of the Illinois Appellate Court involving a claim based on a design defect.  In this case, called Guvenoz v. Target Corp., 2015 IL App (1st) 133940 (March 27, 2015), the plaintiff Guvenoz alleged that her husband, Lewis Guvenoz, suffered severe brain damage and eventually died from a heart attack caused by prescribed dosages of propoxyphene, a generic version of a brand name drug known as Darvocet.  The plaintiff sued the manufacturer manufactured of the generic version taken by her husband.  Six months after the decedent's cardiac arrest resulted in anoxic encephalopathy, the Food and Drug Administration banned Darvocet as unreasonably dangerous. But Guvenoz argued the manufacturers knew about correlations between Darvocet and fatal heart arrhythmias, knew the medication wasn’t very effective and knew the risk of death and serious injury outweighed the drug’s benefits. 

Because the plaintiff argued that the drug was so dangerous and of so little benefit that it should not have been manufactured or sold (the essence of a design defect claim), the crucial question of law for the Illinois Appellate Court was whether Nicole Guvenoz’s state law claims were pre-empted by the Bartlett/Mensing line of cases which hold state claims for inadequate warnings against manufacturers of generic drugs are pre-empted by federal law (because federal law forces them to use the exact same warnings used by brand name manufacturers). 

Directly addressing this question, the court concluded that “the logic of Bartlett and Mensing does not apply to plaintiff’s claims, and their holdings do not pre-empt the state law claims in this case.”  According to the court, the facts in the case at bar are very different from the facts in both Bartlett and Mensing.  In the case at bar, plaintiff alleges that there was no group of patients for whom the drug’s benefits outweighed its risks. By contrast, in both Bartlett and Mensing, the drug was safe for the vast majority of patients taking it, and only a “very small number of patients” suffered an adverse and severe reaction.  In the case at bar, plaintiff alleged that the drug was simply unsafe and should not have been sold at all, and there was no warning which could have cured the problem.