Mass. high court allows generic-drug consumer to sue Big Pharma for reckless labeling

Just more than a week ago, the Massachusetts Supreme Judicial Court (SJC) issued an adroit and important decision on drug manufacturer liability.  In a decision worthy of other states’ attention, the SJC allowed a common law recklessness claim for failure to warn, unobstructed by federal preemption.  The case is Rafferty v. Merck & Co., No. SJC-12347 (Mar. 16, 2018) (PDF), per Chief Justice Ralph Gants.

It was in the last season of Boston Legal in 2008 (s5e02) that Alan Shore (James Spader), maybe my favorite TV lawyer, took on Big Pharma, right on the heels of victory over Big Tobacco.  In real life, Big Pharma has long been about the business of avoiding tort liability.  When labeling defects have been alleged, the Big Pharma defense has found traction in federal preemption, owing to the FDA’s close supervision of labeling under the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301, et seq.

One thread of this debate involves the relative responsibilities of brand-name and generic manufacturers.  In 2011, in PLIVA, Inc. v. Mensing, 564 U.S. 604, the U.S. Supreme Court, 5-4, rejected liability for a generic drug maker accused of failure to warn of side effects when the label matched that of the brand-name equivalent.

In the SJC last week, the plaintiff also was injured taking a generic drug, but sought to hold the brand-name maker accountable in negligence and consumer protection, accusing the maker of failure to warn on the label that the generic provider copied.  The plaintiff took the generic drug finasteride, in lieu of defendant Merck’s brand-name drug Proscar, to treat an enlarged prostate.  The label warned of sexual dysfunction as a temporary side effect, but the plaintiff experienced persistent dysfunction.  The plaintiff alleged that Merck was aware of the risk from several studies and had changed the warning label accordingly in some foreign markets, including Italy, Sweden, and the United Kingdom.

Significantly, then, the plaintiff admittedly complained against a defendant whose drug he did not take.  But the plaintiff traced causation to Merck, because FDA regulation of generic drugs compelled the generic maker to copy the Merck label, and PLIVA precluded liability for the generic maker.  The trial court dismissed, holding that brand-name-maker liability to a patient who did not take the maker’s drug also would “disturb the balance struck” by statute and regulation for the approval of generic drugs.

The SJC regarded the problem as one of duty.  Typically, the court explained, a manufacturer owes a duty of care only to consumers of the manufacturer’s own products.  The First Circuit upheld that logic in a 1983 case under Massachusetts law, Carrier v. Riddell, Inc., 721 F.2d 867.  The court, per then-Circuit Judge Stephen Breyer, denied recovery to a high school football player who blamed a helmet defect for his severe spinal injury.  He had not used the defendant-manufacturer’s helmet, but teammates had.  He alleged that had the defendant properly labeled its helmets, he would have been informed properly about his own.  The SJC further analogized the problem to the effort to hold responsible for a shooting an earlier-in-time actor accused of failing to secure the firearm.  The key to this duty analysis, the court explained, is the foreseeability of a plaintiff-victim—reminiscent of Judge Cardozo’s classic “orbit of duty” analysis in Palsgraf.

Duty in the drug liability problem, the SJC reasoned, is not the same as the product liability analysis in Carrier.  Rather, consistently with the federal regulatory scheme, Merck knows that generic manufacturers will be compelled to rely on its labeling.  Merck therefore has control over the generic label, and duty follows control.  One might say that the consumers of the generic drug are therefore foreseeable victims, for duty purposes, or that the chain of proximate causation runs intact through the intermediary generic maker, because the intermediary lacks control over the label.  Like Palsgraf itself, the case demonstrates the fluid interchangeability of duty and causation.

However, the court further reasoned, negligence, like strict liability, might be too low a liability threshold.  Shifting the liability of generic consumers on to brand-name makers adds to the cost of drug research and development in a way that might interfere with the legislative-regulatory scheme.  Under PLIVA, the brand-name maker could not share joint liability with the generic maker.  At the same time, allowing the brand-name maker wholly to escape liability would allow an injured plaintiff no recovery under any circumstances.  A balance may be struck, the court concluded, when the plaintiff can prove recklessness, or more, intent, on the part of the brand-name maker.

The court wrote: “We have nevertheless consistently recognized that there is a certain core duty—a certain irreducible minimum duty of care, owed to all persons—that as a matter of public policy cannot be abrogated: that is, the duty not to intentionally or recklessly cause harm to others.”  The court analogized to the duty of care owed by defendants in other exceptional areas of Massachusetts tort law: landowner to trespasser, defamation defendant to public figure, bailee to bailor, and athletes and coaches to competitors.

Otherwise put, the court maintained the essential balance of tort law upon its four fundamental elements, duty, breach, proximate cause, and injury.  The extension of liability to a defendant-manufacturer who did not actually make the injurious product depressed the thresholds for duty and causation.  To maintain balance, the requisite standard of breach is amplified to recklessness or intent.  Physical injury remains constant. 

Chief Justice Gants’s opinion in Rafferty is insightful and masterful.  It takes account of the greater endeavor of tort law to define civil wrongs, while balancing the corrective role of the judiciary with the policy-making role of the legislative and executive branches, and also striking a balance in federalism between tort accountability in the states and market regulation under the Commerce Clause.  At the same time, the decision recognizes how these balances are struck across the body of tort law in areas that usually seem only distantly related, from premises liability to reputational harm to sports.  This would be one for the casebooks, if casebooks were still a thing.

City not liable for bullying that resulted in child's quadriplegia, Mass. supreme court holds (and note on infantilization of faculty in higher ed)

The Massachusetts Supreme Judicial Court (SJC) affirmed application of the Massachusetts Torts Claims Act (MTCA) to protect the City of Lynn, north of Boston, from liability in a tragic bullying incident that resulted in the permanent paralysis of the victim, a fourth grader.  The case is Corimer v. Lynn, No. SJC-12323 (Feb. 27, 2018).

The boy's mother had reported bullying and harassment of her son on "multiple occasions" in the 2007-08 school year.  Ultimately bullies pushed the boy down stairs, resulting in damage to his spinal cord and in quadriplegia.

The 1978 MTCA waives sovereign immunity, but a public actor may be held liable for the tort or violence of a third party only if the public actor "originally caused" the "harmful consequences."  Mass. G. L. c. 258, § 10 (j).  The courts have struggled to interpret that language, but have, as the SJC restated the rule, looked for "an affirmative act that materially contributed to creating a condition or situation that resulted in [plaintiff's] injuries."  A failure to act is distinguished.

The school left the bullies in class in proximity to the plaintiff, and we may assume arguendo that the school was negligent in failing to protect the plaintiff.  Even so, those failures were "'too remote as a matter of law'" to represent material contribution to the plaintiff's injuries.  In essence, then the "originally caused" standard seems to effect a causation-at-law analysis heightened above even the stringent inquiry invoked upon an intervening criminal actor.  On the same basis, the court rejected ancillary plaintiff theories predicated on negligent hiring, supervision, and retention of school staff.

The SJC acknowledged "that bullying is a serious issue" comprising "the emotional pain of day-to-day harassment" and sometimes, as here, "horrific physical consequences."  "[T]he elementary school could have and should have done more to protect [the plaintiff]."  Nevertheless, the operation of the MTCA is textbook, furthering the "public policy [of] some reasonable limits to governmental liability in order for taxpayers to avoid a potentially catastrophic financial burden."

Allow me a tangential observation about bullying policy:  

Many workplace entities, private and public, and including my own, are busily about the business of formulating "anti-bullying" policies.  At least in the academic context, I find these efforts nothing less than an end-run of contract, tenure, and academic freedom, calculated to suppress dissent and vigorous debate.  This SJC case indirectly illustrates the problem.  

Bullying is a concept derived from the K12 environment.  In the adult workplace—especially in the academic workplace, where the very job is the exercise of free expression—bullying is co-extensive with harassment, discrimination, tort, and crime.  All of those were present in Corimer, harassment even before the child was physically injured.  There is no need for a separate policy purportedly to enforce civility (as if such a thing even were possible) among adults.  Any effort to create such a policy is nothing more than an authoritarian perversion of modish terminology—on campus, the infantilization of the faculty—and a disservice to children who truly are bullied in school.

Janus-faced about 'Janus': Supreme Court hears major First Amendment labor case, and 'it's complicated'

The U.S. Supreme Court hears oral argument in Janus v. AFSCME (SCOTUSblog) on Monday, February 26.  The problem in a nutshell is the extent to which a public employee can be compelled to associate with a union consistently with the First Amendment freedoms of expression and association.

The Court already held, some years ago, that a public employee cannot be compelled to pay the portion of union dues that supports political activity.  But mandatory payments to support the union in collective bargaining have been upheld upon the logic that employees otherwise would be able to opt out and benefit from union collective bargaining as free-riders, and, ultimately, the union would be decertified for lack of members.  So it’s got to be all in with the union, or no union for anyone.

This is an agonizing problem for a libertarian.  One wishes to protect the right to organize but is loath to compel anyone to do so.  Honoring the latter priority undermines the former.

When I changed jobs in 2011 from the University of Arkansas system to the University of Massachusetts system, I moved from a non-union shop to a union shop.  My first years at UMass, I opted out of the political dues and paid only to be a member of the bargaining unit—“agency,” it’s called.  And I resented having to pay for that. 

Certainly Arkansas was not a bed-of-roses workplace experience.  I had my challenges there and had to spend a good chunk of my personal savings on legal fees.  Now faculty there are fighting to preserve tenure.  I can see where a union might help.

Nevertheless, moving to UMass, I resented being compelled to join the union.  My experience with unions had been that they too often protect people in the workplace who don’t pull their weight, and they prevent people in the workplace who pull more than their weight from being rewarded accordingly.

I have more experience with unions now.  And I was right.  They often protect people who don’t pull their weight, and unionization prevents people who pull more than their weight from being rewarded accordingly.

At the same time, I’ve come to understand that plenty of fault for unions working, or not working, can be laid at the feet of employers, too.  It’s complicated.

I declined to become a union member at first at UMass and sought instead to leverage my own hard work for superior reward.  That didn’t work.  At best, I got into the highest echelons of the contractual raise pool.  We’re talking about a distinction of maybe a percentage point.  I could have gotten that with much less work.  I’ve hardly been able to negotiate my own terms of employment.

To the contrary, like many an employer, the university seems to have a love-hate relationship with the union.  Even while administrators seethe with loathing for their union adversaries, management is unwilling to dance with any other and jealously guards the bargaining table against rivals.  That’s the dirty little secret of public-sector union shops: management and labor are on the same side when it comes to making sure that no one else gets to play the game.  A truly free market, with full information and a healthy balance of labor supply and demand: if such a thing existed, it would be bad news for both sides.  Meanwhile the individual worker gets left on the sidelines.

So unable to make any headway for myself, and upon later experience and observation, I decided to throw in my lot with the labor movement.  Before union membership, my agency dues were $580 for the year in 2016.  That was deducted from my check, even though I was excluded from the bargaining table and stuck with whatever contract concessions someone else decided for me.  Now as a full member of the union, based on my last paycheck, my dues are about $1,285 per year.  So about two-thirds of my union dues go to political activity that I don’t necessarily agree with.

That’s my catch-22.  Membership is the only way to get a seat at the table, and having a seat at the table is the only way to work against abusive employment practices.  The labor market being what it is, there is abuse.  And there are good people in my union who are working hard to fight it.

I’ve been a student of the First Amendment for a long time, and I don’t know what should happen in Janus, whether from a detached scholarly perspective, or for my own best interests.  It rubs me the wrong way being compelled to participate in organized labor and forego my individual economic liberty.  To have my voice heard, I have to let my pocket be picked by political causes I disagree with.

At the same time, the unions are right:  The Janus challenge is about union busting and worker exploitation, not civil liberties and not economic liberty.  In academics, union busting is sure to hasten the end of tenure and the annihilation of academic freedom.  That hardly seems a result that honors the First Amendment.

I admit: I’m Janus-faced about Janus.  But on Monday, I'll be wearing my AFT T-shirt.

 

[UPDATE, Apr. 10, 2021.  Regrettably, my faith in the union was not enough.  The bargain of surrendering my beliefs became untenable.  See, e.g., this post in 2020.]

I pledge not to accept NRA donations: Gun control and denial of opportunity to wound and kill

Let the record reflect that I’m an occasional NRA member and supporter of the Second Amendment—not for hunting, and not just for personal security, but mostly for the real need to be able to overthrow the government if—when—it comes to that.

 

But the NRA should be at the table talking about gun control.  The simple reality of preventing violent crime is that denying opportunity to would-be offenders is the only thing that works well.

That was my over-simplistic take-away from Tom Gash’s The Truth About Why People Do Bad Things (2016) (Amazon), which I just read coincidentally with Parkland.  It’s a fabulous book even if you do not have much interest in criminal law and policy, which I do not.  It’s an important book for anyone just to be an informed voter.  Tom Gash is a senior fellow at the Institute for Government in the U.K.  Hat tip to my uncle in London for putting me on to it. 

Gash dispels 11 myths about crime prevention.  Those chapters are well worth reading, so we don’t find ourselves recycling foolish misconceptions as we make crime policy.  Indeed, to read Gash’s account, the cycle of crime prevention policy over decades seems like an exercise in Groundhog Day.  In the big picture, there are two predominant ways of thinking about crime, and they’re both wrong.  One view says criminals are innately bad actors, so we need to create powerful disincentives, such as three-strikes laws, to make them do the right thing.  The other view says that crime is a socio-economic problem we can fix with education and jobs.  Wrong and wrong.  Not wholly wrong, but too wrong for either redressive strategy to be effective.

Needless to say, crime is more complicated than one worldview, and there is no one panacea.  However, there is one thing that works a lot of the time: denial of opportunity.  A lot of crime happens in the moment and is not wholly irrational.  A modest deterrent gives a person’s better angels a chance to be heard.  Something as simple as a bike lock makes a potential thief not become one.

So we come to guns.  As the Parkland teens and parents have said, access to “weapons of war” is just too easy.  A regulation as modest as a waiting period can mean denial of opportunity for someone who is emotionally imbalanced, whether in the moment or by pathology.

I support the Second Amendment, and I’m wary of bans on weapons we would need to overthrow a tyrannical government.  I support the First and Fourth Amendments too, but I understand parade permitting and search incident to arrest.  I would like to see the NRA, which I respect as a key protector of civil liberties, as a responsible participant in the discussion about reasonable regulation, rather than an increasingly alienated fall guy.