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.

Judge Determines Johnson & Johnson Should Be Required to Pay $6.8M in Punitive Damage For Failing to Warn About Risperdal Risks

In a ruling issued last week, the judge presiding over a product liability action against Johnson & Johnson, reduced the award of punitive damages granted by the jury to $6.8 million, which is 10 times the amount of compensatory damages which is generally held to be the upper threshold for punitive damage awards that are constitutionally permitted.  The jury had originally awarded $8 billion in punitive damages.  Go here for more details on this story.

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.

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.

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.

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.) 

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.

West Virginia Legislatively Recognizes the Learned Intermediary Doctrine as a Product-Liability Defense

On February 26, West Virginia became the 38th state to adopt the learned intermediary doctrine when Governor Earl Ray Tomblin signed SB 15 into law.  The law effectively overrules a 2007 West Virginia Supreme Court decision that had rejected the defense.  Go here for more details.

New report finds FDA is failing to track side effects of drugs it approves

The Government Accountability Office (GAO) recently issued a report on drug safety which concludes that the FDA is approving too many drugs via the fast-track approval processes and then it is failing to monitor those drugs’ effects on patients to ensure they are actually safe.   AboutLawsuits has more details and links here. 

Reports like this one are important because they provide support against the argument that the pharmaceutical industry and its supporters use all the time:  that issues related to regulation of drugs should be left to the agency with expertise (ie, the FDA) and should be taken away from the courts. Given that the FDA is underfunded, understaffed and has a history of doing a poor job of overseeing the industry it is supposed to be regulating, the argument is pretty weak.

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.

FDA approves drug for sexual condition in women even though it has been found barely effective -- UPDATED

Long time readers of this blog will remember that since back in 2009, I have been following the debate as to whether the so-called Hypoactive Sexual Desire Disorder in women is really a medical condition or something the pharmaceutical industry came up with in order to convince women to buy a product they don't need. See here. The drugmaker (Boehringer Ingelheim) geared up an enormous publicity effort to promote the pill, but the FDA was not impressed and decided the pill was neither safe nor effective. See here.

What appears below is the same story I originally posted in August of this year.  The UPDATE appears at the end. 

At that time, all 11 members of the FDA advisory committee decided the side effects of the drug were unacceptable, and 10 ruled the pill is not effective. For the full story up to that point (including links to more information), go here.

Because of this failed effort, the manufacturer decided to discontinue development entirely. For more on the story go here.

Soon thereafter, however, Sprout Pharmaceuticals picked it up and again submitted it for approval in 2013. Since there was no new evidence to contradict the earlier findings, the FDA rejected it, again.

Somehow, however, with still no new evidence, two years later, the FDA has indeed approved the drug.  How, or why, did this happen?

Sprout smartly enlisted thousands of women’s activists and members of Congress in a campaign about gender double standards and sexual politics, in an attempt to avoid the discussion of the fact that the medical evidence that the drug actually works safely is weak and that the FDA rejected drug twice because its minimal benefits failed to outweigh the safety risks.  

Converting the discussion from one about health and safety into one about gender (based on the argument that it’s time that the agency gave the same priority to drugs to treat women’s sexual problems as it has to drugs for men) apparently provided enough pressure on the FDA to change its ruling, even though the scientific evidence is still the same.

It has been reported that the FDA approval comes with a requirement that the company take steps to ensure doctors prescribe the drug carefully and make women aware of its health risks.  But isn't that true of all drugs?  That statement adds absolutely nothing to current standards of the medical profession.

The FDA is also mandating that the drug will have with a black box warning — the strongest FDA warning language — to highlight the risk of severe blood pressure drops and fainting in patients who drink alcohol or use certain other drugs during treatment.  That is a good thing, but perversely, because of the state of the law regarding preemption in cases based on inadequate warnings, it will make it more difficult for plaintiffs to recover for injuries caused by the drug.

So, as I said in one of my recent posts on the subject, when the drug is shown to cause injuries, and the medical evidence and past history shows it more than likely will, it will inevitably result in litigation. The story is just beginning.

For more on the story you can go here, here and here.

Go here for videos on a documentary about this issue.

UPDATE (12-5-15):   The website VITALS has a very good overview of the debate and controversy over the now approved drug, which is now officially called "Addyi" here.  The article is called "Is the “Female Viagra” Worth It?" and it concludes that for most women, given the risks, costs and uncertainty, the answer is no.  If you are interested in the topic, the article (and the comments) are well worth reading.