Panera Halts Sales of “Charged” Lemonade Drinks Following Lawsuits Claiming Caffeine Overdose Deaths -- UPDATED

May 13, 2024  [Update at the end below]

Last December  I reported on several lawsuits filed against Panera Bread Co. alleging it should be liable for the deaths of customers who suffered cardiac arrest after drinking Panera's "charged lemonade" which allegedly contained more than 300 ml of caffeine at the time.  See here and here.

Today, I am writing to report that Panera has decided to stop selling the product in question.  As reported in AboutLawsuits.com, 

Reports suggest that Panera Bread will no longer sell its “charged” lemonade products, after at least two consumer deaths were linked to excessive levels of caffeine in some of the drinks, leading to wrongful death lawsuits by the families.

Panera Charged Lemonade was introduced in 2022, featuring high levels of caffeine marketed as an alternative to coffee or energy drinks. However, at least two wrongful death lawsuits were filed against Panera last year, claiming that high levels of caffeine in the beverage led to fatal heart attacks or other heart complications.

While Panera claimed their charged lemonade as plant-based and clean, a 30oz lemonade could contain up to 390 milligrams of caffeine, which is the equivalent of four cups of coffee or three-and-a-half 12-oz cans of Red Bull. In addition, since Panera’s employees mix the lemonade, caffeine levels can vary drastically in different drinks, potentially providing potentially dangerous amounts for some consumers, especially those with certain pre-existing conditions.

Various news reports now indicate that employees are now being told that Panera Charged Lemonade will be phased out, and the chain is no longer ordering some key ingredients used to mix the products in stores.  

Go here for the full story. 

UPDATE 10/13/24:  The Hill is reporting that Panera has settled one of the lawsuits.  See here.

Panera faces second wrongful death lawsuit related to its ‘Charged Lemonade’

 About a week ago I reported that a recently filed lawsuit against Panera Bread Co. alleges it should be liable for the death of a young woman who suffered cardiac arrest after drinking Panera's "charged lemonade" which allegedly contained more than 300 ml of caffeine at the time.  

Now comes news that a second wrongful death lawsuit (on behalf of the beneficiaries of a 46-year old man) based on similar allegations has been filed in Delaware.  The Hill has the story.  NPR also has coverage.

Panera Bread Co sued for wrongful death allegedly caused by Panera's highly caffeinated lemonade

December 4, 2023

Back in 2012-2013 there was a lot of discussion on possible claims for damages caused by "high energy" (read: highly caffeinated) drinks.  Go here and scroll down to refresh your memory.

The topic is now back in the news.  A recently filed lawsuit against Panera Bread Co. alleges it should be liable for the death of a young woman who suffered cardiac arrest after drinking Panera's "charged lemonade" which allegedly contained more than 300 ml of caffeine at the time.  

The Legal Eagle YouTube channel has a detailed explanation of the case.

UPDATE 12/10/23:

Additional coverage on the case at The Legal Examiner 

A second wrongful death lawsuit has been filed in Delaware.  See here.

Oklahoma Supreme Court reverses judgment against opioid manufacturers in public nuisance case; but lower court in Ohio finds against pharmacies

About three weeks ago, (on November 7) I posted a story about a decision in California dismissing a claim for public nuisance against several opioid manufacturers and distributors.  Two days after that, the Supreme Court of Oklahoma announced a decision reversing a trial court's judgment against opioid manufacturers in a similar case.  The case is State ex rel. Hunter v. Johnson and Johnson and you can find it here.

These two decisions resulted in an article in the NY Times with the very descriptive title "The Core Legal Strategy Against Opioid Companies May Be Faltering."  You can read it here.

Yet, a couple of weeks later a jury in Ohio found that three retail pharmacy chains created a public nuisance by recklessly distributing vast amounts of pain pills in two Ohio counties.  See here.  I have no doubt this verdict will be appealed. 

Evidently, the litigation over the opioid crisis is a big deal.  There are thousands of pending cases and how each is decided ultimately will influence how the issue is addressed in other jurisdictions.  

If we go by history, the use of public nuisance as a way to address social problems created by distribution of products has not been successful.  The vast majority of cases that attempted it failed, including cases against tobacco companies, lead paint manufacturers and gun manufacturers and distributors.  For this reason, the cases against opioid manufacturers are going to be difficult to win.  But it is possible courts will change their view on this.  I am very interested in following this story which will not go away any time soon.

Here is a short PBS News report that summarizes many of the issues involved in the current litigation.  (While you are at it, if you are interested, you can find many other videos on the topic of the opioid crisis on YouTube.)

More coverage on the verdict against the pharmacy chains here:  AboutLawsuits.com, ABA Journal, NPR, The Guardian, and Courthouse News.

Judge recently issued a "tentative decision" against the plaintiffs in California case related to opioid crisis

If you have been watching "Dopesick" on Hulu or "Goliath" on Amazon Primes, you might be disappointed to hear that this week a judge in California issued a "tentative decision" holding that a lawsuit seeking to hold drug companies liable for the opioid crisis must fail because the plaintiffs didn’t show that false and misleading marketing caused an increase in medically inappropriate prescriptions.  The defendants included Johnson & Johnson, Teva Pharmaceutical Industries, Endo International and AbbVie Inc.’s Allergan unit.

More than 3,300 lawsuits have been filed by state and local governments over the opioid crisis. In the only other case that went to trial, an Oklahoma judge found Johnson & Johnson liable for $465 million. 

The ABA Journal has the full story here.  Reuters has more here, and NPR's coverage is here.

Article on the use of public nuisance claims as product liability cases

Back in 2010 I posted a link to an article on the tort of "public nuisance" that stated:

The National Law Journal has published a short article on the tort of "public nuisance" interestingly called "The tort that refuses to die." Here is the first paragraph: "The tort of public nuisance has seen its fortunes rise and fall dramatically during the past several years. It was once hailed by the legal literati as the next big tort. More than one court described it as a monster threatening to devour tort law because of its propensity for reaching conduct that other tort theories could not. . . . Recent events confirm that analogy to a degree. Public nuisance resembles nothing so much as a zombie — a mindless creature perhaps not particularly dangerous at first glance but incredibly difficult to kill once and for all." The authors then discuss how the recent reversal of a case against former lead paint manufacturers alleging that lead paint was a public nuisance in Rhode Island, suggested public nuisance would not be an effective legal theory. But there have been many other cases that have challenged this conclusion. The article can be found here ..."

 I am bringing this up again today because I just read a new short article discussing the use of public nuisance claims related to opioid products, which starts as follows:  "Manufacturers are used to defending strict product liability actions when plaintiffs claim that their products are defective. But in the opioid litigation, plaintiffs have filed something else: more than 2,500 public nuisance cases so far."

The article is titled Trending in Tort Law: Transforming Product Liability Claims into Public Nuisance Actions and you can read it here.

States Will Investigate Juul’s Marketing to Teens

A coalition of 39 states will look into the marketing and sales of vaping products by Juul Labs, including whether the company targeted youths and made misleading claims about nicotine content in its devices, officials said Tuesday.  Go here for more details.

Idaho lower court rejects so-called "innovator liability"

Long time readers of this blog will remember the debate over the so called "innovator liability" about which I have posted in the past. You can find some of those posts by going to the "warnings" label and scrolling down.

In an nutshell, the debate is this:  Current FDA regulations require manufacturers of generic prescription drugs to use exactly the same warnings that the name brand manufacturers use.  By "name brand manufacturers" I mean the manufacturers of the original drugs of which the generics are now an option.  The manufacturers of generics are not allowed to deviate from those warnings even if they think that they should provide better warnings that could make the product safer.  And, the language of the warnings are largely determined by the name brand manufacturers themselves, not by the FDA.

Because of this, manufacturers of generics can say that it is not their fault that the warning is inadequate since their hands are tied when it comes to deciding what the warning should say.  For that reason, at some point plaintiffs' lawyers started to file claims against the name brand manufacturers arguing that since the problem was that the warning was inadequate, it is the party that decided what the warning should be who should be liable, even if that defendant was not the person who manufactured the drug used by the plaintiff.  This theory of liability is what is not often referred to as "innovator liability."

To me, it makes perfect sense because the claim is not based on a manufacturing problem, but on the lack of, or adequacy of, a warning.  But, not surprisingly, brand name manufacturers and their lawyers have reacted negatively to the possibility of liability.

Some courts have adopted innovator liability as a possible way to support a claim; others have rejected it, and just a few days ago I heard of a recent decision by a state court in Idaho rejecting it.  The case is called Sterling v. Novartis and you can read the opinion here.

It is interesting that the court starts its discussion of the issue by pointing out what it refers to as the “crucial fact” that “Novartis did not manufacture the drug that caused the injuries.”

Obviously, sated that way it sound like imposing liability on the defendant would be contrary to basic principles of tort law.  After all, as the court also points out the common law generally does not impose  liability on a company for injuries caused by other companies.

But here is the thing.  That "crucial fact" is also irrelevant.

That fact would be crucial if the claim was for an injury related to the manufacturing or design of the product because in a case like that the plaintiff would be trying to impose liability on the defendant for the conduct of the generics manufacturer.

This claim is based on an inadequate warning and the brand name manufacturer is the one whose conduct is related to the warning.  Thus, the possible liability is not for the conduct of another but for the conduct of the defendant.

The question is whether the duty owed by the defendant to its customers should extend to the customers of the generics manufacturers.  Applying the most commonly adopted analysis for this question, we would say the duty should extend to those whose injuries are a foreseeable consequence of the risk created.  If the risk was created by the defendant given its role in determining the content of the warning, then it makes sense to extend the duty and to recognize the possibility of liability for the resulting injuries.

Here is a comment from the perspective of the defendant which argues against my view.

Podcast on e-cigarettes, vaping claims, and regulation

Yesterday I posted a note about a new case filed against the manufacturer of a popular e-cigarette product.

Here is a link to a podcast on Ringler Radio in which hosts Larry Cohen and Ford Swift talk with attorney Joseph VanZandt about claims of false and deceptive sales, marketing, and labeling against JUUL, and the failure to warn of the products’ highly addictive levels of nicotine, all targeting young people.

New lawsuit filed arguing injuries caused by "vaping"

An 18-year-old from Illinois has filed a product liability lawsuit against the makers of JUUL (a "vaping" device) arguing that the side effects of vaping caused a respiratory injury, which has left the teen with the lungs of a 70 year old man.  This appears to be one of the first lawsuits filed claiming injuries caused by vaping.  AboutLawusuits has a little more information 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.

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.

NY Times article on lawsuits against Purdue Pharma for its role in fostering the opioid crisis

This morning the New York Times has posted an article on the lawsuits filed against the Sackler family and Purdue Pharmaceuticals for its role in the opioid crisis.  You can read it here.

How the Cosmetics Industry Got to Regulate Itself and Downplayed Cancer Risks

Interesting article related to products' regulation, and possible liability.  Take a look 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.

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.

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.)