Special Report: A son died, his parents tried to sue. How U.S. courts protect Big Pharma

GlaxoSmithKline Pharmaceuticals

26/06/2023 11:00

(For more Reuters Special Reports, click on  SPECIAL/ )
    By Dan Levine, Robin Respaut, Kristina Cooke, Mike Spector
and Benjamin Lesser
       June 26 (Reuters) - Nicholas England, a healthy
22-year-old from Virginia, shot himself in the head in 2017,
less than two weeks after he started taking an allergy medicine
that had been linked for years to episodes of depression and
suicidal thinking.
    His parents soon started exploring a lawsuit against Merck
 MRK.N , the developer of the blockbuster asthma and allergy
drug, Singulair, along with the manufacturer of the generic
version their son took. Nicholas had no history of mental-health
problems, they said.
    The Englands were shocked to learn from legal advisers that
they had no case. Like countless other potential plaintiffs,
they had run into one of Corporate America’s most effective
liability shields: the legal doctrine of preemption, the
principle that federal law supersedes state law.
    Armed with U.S. Supreme Court rulings on preemption starting
in the 1990s, companies increasingly argue that federally
regulated products or services should be immune from lawsuits
alleging state-law violations. In a new reading of an old
constitutional principle, judges have held that federal law,
including the decisions of U.S. regulatory agencies, should
preempt, or override, state statutes that seek to hold companies
accountable for harming consumers.
    State laws historically have provided the legal basis for
some of the most common lawsuits against U.S. companies alleging
injuries, deaths or illnesses caused by negligence or defective
products.
    These legal dynamics left the England family with no legal
remedy at all. A pair of U.S. Supreme Court rulings, in 2011 and
2013, essentially barred lawsuits against generic drugmakers
based on state laws that enabled claims over design defects or a
failure to warn consumers of potential dangers. The court’s
reasoning: Such claims were preempted by federal regulations
preventing generic drugmakers, when copying name-brand drugs,
from changing the formulation or the warning label.
    That meant Merck had written the warning label, with federal
approval, on the generic version of Singulair that Nicholas
England took. But his parents couldn’t sue Merck, either,
because their son had never taken its name-brand version of
Singulair.
    “The emotion of losing your child is so difficult on its
own,” said Jennifer England, Nicholas’s mother. “It is very
frustrating to realize that’s a loophole. I’m a small person in
southwestern Virginia, and that’s a loophole there to protect
companies much bigger than we could fight.”
    Merck declined to comment for this report, referring all
questions to Organon, a Merck spinoff created in 2021 that now
markets Singulair. Organon declined to answer detailed questions
from Reuters but said in a statement that it’s confident doctors
and patients have gotten “complete and appropriate information”
on Singulair’s safety. The generic drug manufacturer that made
the pills England took, Teva Pharmaceuticals  TEVA.TA , did not
respond to inquiries.
    Corporate preemption defenses have proved broadly effective,
according to a Reuters analysis of court cases and dozens of
interviews with attorneys, legal scholars and plaintiffs or
potential plaintiffs affected by preemption rulings. The
analysis of federal appeals and Supreme Court rulings involving
preemption found that judges ruled two-thirds of the time to
weaken or kill lawsuits alleging deaths or injuries caused by
corporate negligence or defective products.
    Preemption defenses often deliver companies a swift
procedural win, allowing them to avoid addressing the substance
of plaintiffs’ allegations. It has been used across a range of
federally regulated sectors, from railroads to agricultural
chemicals to airlines and automobiles, the Reuters review found.
    The preemption defense has had a particularly profound
impact in the pharmaceutical industry, the review showed. The
high court’s ban on certain lawsuits against generic drug
manufacturers has extraordinary reach because generics account
for 91% of U.S. prescriptions, according to data from the U.S.
Food and Drug Administration (FDA).
    Name-brand drugmakers can still be sued, but preemption
defenses can make it much harder for plaintiffs to prevail,
drug-industry litigation experts said. In many product-liability
cases, plaintiffs must prove simply that a company’s product was
unsafe. Those facing drugmakers’ preemption defenses must often
demonstrate that a company failed to disclose safety information
to federal regulators – and that the information could have
spurred new government restrictions or warnings before the
alleged harm occurred.
    Pending lawsuits against Merck allege that the company’s own
early research indicated the drug could impact the brain but
that Merck downplayed any risks in statements to regulators.
England’s family had hoped to force executives from Merck and
the generic manufacturer to reveal what they knew, and when,
about the drug’s dangers. In the decade before England’s death,
the FDA received more than 4,800 reports of patients, including
many children, experiencing depression, suicidal thoughts or
other psychiatric problems after taking Singulair or a generic
version, according to a Reuters review of FDA data.
    But it wasn’t until 2020 that the FDA slapped its most
serious warning, called a “black box,” on the drug’s label. By
that time, the FDA had received more than 80 reports of suicides
in people taking the medicine.
    Singulair, one of the best-selling drugs in U.S. history,
has provided Merck with about $50 billion in revenue, company
disclosures show. Since Merck’s patent on Singulair expired in
2012, major generic drug manufacturers have sold millions of
prescriptions under the drug’s scientific name, montelukast.
    The FDA said in a statement that it has “diligently
monitored reports of side effects possibly associated with
montelukast, as well as communicated findings and taken
regulatory action, when appropriate.” The agency said it
“continues to monitor and investigate this important issue.”
The FDA declined to comment on how modern preemption defenses
and court rulings have impacted pharmaceutical regulation and
litigation.
    
    BIG TOBACCO PRECEDENT
    The doctrine of preemption is based on the U.S.
Constitution’s supremacy clause. The original intent: to resolve
conflicts between federal and state statutes and discourage
state legislatures from passing laws that undermine federal
policy.
    Preemption-based corporate defenses are a modern phenomenon.
American courts have historically viewed product-liability
lawsuits, largely based on state laws, as vital to holding
companies accountable when federal laws and regulations fail to
do so. Courts recognized drugmaker liability for harmful
medicines as early as the 1850s, according to a Supreme Court
filing. FDA regulations once routinely specified that its
decisions had no impact on drugmakers’ liability.
    That started to change in 1992, in a case involving a smoker
who died of cancer. The Supreme Court ruled that federal
requirements for cigarette labels, which had included smoking
warnings since the 1960s, overrode some of her family’s
state-law claims that a tobacco company failed to warn her about
smoking hazards.
    States ultimately used different theories to force Big
Tobacco into a $246 billion settlement. Still, the precedent
gave Corporate America a blueprint for defeating similar
lawsuits on preemption grounds.
    Corporations got more help in the political arena. U.S.
President George W. Bush had promised in his 2000 campaign to
attack what Republicans derided as frivolous litigation
targeting American industry. Administration officials undertook
what critics dubbed “stealth” tort reform: intervening in
lawsuits on the side of corporate defendants, with the goal of
convincing judges to set precedents making it harder to sue
companies.
    Bush’s FDA exemplified the tactic. Daniel Troy, the agency’s
chief counsel, interpreted preemption to mean that courts can’t
undermine federal regulators based on alleged state-law
violations. He aimed to make that argument in high-profile
lawsuits. At a 2003 conference, Troy invited an audience of
drug-industry lawyers to pitch the FDA on intervening in their
cases.
    “We can’t afford to get involved in every case – we have to
pick our shots,” he told the assembled lawyers. “So make it
sound like a Hollywood pitch.”
    Troy, now a veteran pharmaceutical industry lawyer himself,
said his goal at the time was simply to defend and strengthen
the FDA’s authority to regulate without interference.
    “If you believe in a strong FDA,” he said, “we can’t have
state courts, especially juries, second-guessing and
undercutting the FDA’s judgments.”
    The FDA formally changed its view of preemption in a 2006
regulation, stating the agency now believed that FDA labeling
approval “preempts conflicting or contrary State law.”
    In its statement to Reuters, the FDA declined to comment on
the 2006 regulation or the agency’s current view of preemption.
    One of the Bush-era FDA’s biggest victories came in 2008,
when the Supreme Court cited preemption in dismissing a New York
man’s lawsuit against Medtronic over a burst balloon catheter.
The precedent has since effectively barred wide swaths of
lawsuits against medical-device manufacturers.
    To examine the impact of preemption defenses, Reuters
reviewed 257 federal appeals and Supreme Court rulings, which
are the most influential in establishing precedents. In the
cases, dating back to 2001, the courts determined whether
preemption nullified plaintiffs’ claims that deaths or injuries
were caused by corporate negligence or defective products.
Judges threw out some or all of the claims on preemption grounds
in two-thirds of the cases.
    Another industry benefit can’t be quantified: The number of
potential lawsuits that were never filed – like the one over
Nicholas England’s death – because preemption precedents favor
corporations, legal experts said.
    Adam Zimmerman, a professor at the University of Southern
California’s Gould School of Law, said the Reuters analysis
underscores how these preemption precedents, which bind lower
courts, have delivered corporations critical courtroom wins and
leverage in settlement negotiations.
    “It is really meaningful for the business community,”
Zimmerman said.
    Jay Lefkowitz, a Kirkland & Ellis partner who has
represented companies before the Supreme Court, called
preemption a “firmly enshrined” constitutional principle. State
court juries, he said, shouldn’t be deciding how drug labels
read based on the evidence in one case.
    “We want the scientists and doctors at the FDA to do so,” he
said, “based on all of the accumulated data from clinical trials
and real world experience.”
    
    TRAIN WRECK
    Corporate preemption defenses are now common across a host
of federally regulated industries.
    After a February train derailment in East Palestine, Ohio,
released toxic chemicals, train operator Norfolk Southern
 NSC.N  invoked preemption to counter pending lawsuits.
    Asked about the legal strategy, the company told Reuters it
was “following the legal process” and that it was committed to
paying for the environmental clean-up and any damage to
residents’ health, water supply or property values.
    The Reuters analysis found about three dozen examples over
the past two decades of companies in the railroad industry
invoking preemption to avoid liability. They cite federal laws
regulating the safety of railroads and hazardous materials
transportation. In 2015, for instance, a Union Pacific  UNP.N 
train struck a pickup in Louisiana, killing three people,
according to court records. The truck’s driver was the last in a
convoy, waiting to proceed through a gate that hadn’t yet
opened. Seconds later, a Union Pacific train barreled down the
tracks at about 50 miles an hour.
    The crash victims’ families sued and lost, in part because
the Federal Railroad Safety Act preempted their claims that a
horn sounded by the conductor failed to adequately warn of the
oncoming train. Plaintiffs had argued that several short horn
blasts, for instance, would have been more effective. An appeals
court ruled their case was preempted because federal regulation
defers to an engineer’s “sole judgment” on sounding a horn in
such instances.
    Union Pacific said in a statement that the engineer complied
with federal law and that preemption provides a “consistent,
uniform law” for train operators transporting goods across state
lines.
    In another pharmaceutical case involving suicide, a woman
whose husband threw himself in front of a train shortly after he
started taking the antidepressant paroxetine was barred by
preemption from suing the generic manufacturer. Then, an appeals
court cited preemption in overturning a $3 million verdict the
woman had won against GlaxoSmithKline  GLAX.NS , which made the
brand-name version of the drug and controlled its label. The
court found that the FDA would have rejected an adult suicide
warning at the time her husband took it.
    GlaxoSmithKline said in a statement that preemption is a
“well-established legal principle grounded in the U.S.
Constitution” to address conflicts between federal and state
law. The company said it repeatedly asked the FDA to add a
warning about suicidal thinking in adults to the label but the
agency refused. The FDA instead mandated the same label for all
drugs in the class that included paroxetine, which did not
include such a warning.
    Agricultural giant Monsanto is now pinning its hopes on
preemption to help defeat or weaken tens of thousands of legal
claims alleging it failed to warn consumers that its popular
weed killer Roundup could cause cancer. In June, the company,
owned by Bayer  BAYGn.DE , urged a federal appeals court in
Atlanta to dismiss one of those cases on preemption grounds,
arguing federal regulators did not require a cancer warning on
Roundup’s label.
    Bayer said in a statement that these state-based claims are
preempted because federal law expressly forbids states from
instituting different labeling requirements. Federal regulators,
Bayer said, have consistently found that Roundup and similar
herbicides can be used safely and are not carcinogenic.
    While preemption precedents favor corporations, judges’
tolerance for the argument has its limits. The Supreme Court in
2009 rejected the contention from drugmaker Wyeth, along with
industry groups, that FDA approval should give name-brand
drugmakers blanket immunity from certain types of lawsuits. The
court ruled in favor of a Vermont woman who alleged the firm’s
drug Phenegran led to the amputation of her arm.

    'I WAS POISONING HIM'
    Preemption defenses rely in part on the notion that state
laws are not needed to protect citizens who are already
safeguarded by federal regulators. But in the case of
Singulair’s potentially deadly side effects, the FDA waited
years, despite thousands of reported psychiatric problems, to
require its most serious warning on the drug’s label.
    By the time Nicholas England killed himself, the FDA had
been reviewing Merck’s disclosures about health risks for nearly
two decades. Parents who argue Singulair endangered their
children view the FDA’s 2020 decision to add a black box warning
as vindication, but many still want to sue Merck for not acting
sooner.
    In the years after Singulair’s 1998 launch, reports of
related neuropsychiatric episodes piled up on internet forums
and in the FDA’s early-warning detection system. The system
compiles reports of “adverse events” from patients, doctors and
others to track potential dangers discovered after a drug hits
the market.
    Jan Gilpin’s son was first prescribed Singulair for asthma
in 2003, at age three. The boy soon seemed withdrawn and sullen.
He would sometimes go “into a strange trance, mumbling to
himself,” Gilpin wrote in 2008 in a report to the FDA. “Worst of
all, he started talking about death – wanting to die, wishing he
was dead, saying that he hated himself.”
    Gilpin didn’t suspect Singulair for more than three years.
In 2007, she stopped giving her son the drug after she stumbled
on parents’ online posts about their children experiencing
social anxiety while taking the medicine.
    Soon, she noticed he began to skip and laugh.
    “I realized he hadn’t laughed in two years,” said Gilpin,
speaking through tears. “I didn’t realize that I was poisoning
him with this medicine.”
    The boy’s obsessive thoughts about death disappeared after
he quit the medicine, Gilpin said, but he seemed to have some
lingering effects, such as anxiety, that took longer to go away.
    In August 2007, a 15-year-old boy in New York killed himself
17 days after first taking Singulair. Two months later, Merck
proposed, and the FDA agreed, to amend Singulair’s label to add
suicidal thinking and behavior to a list of adverse events
reported to the company.
    But the mention of suicidal thinking appeared in the middle
of a list of more than three dozen side effects. Parent
advocates argue the new label was grossly inadequate to warn of
such a grave risk.
    Three weeks after proposing the label change, Merck asked
the FDA about getting permission to sell Singulair
over-the-counter, without a prescription, for adults with hay
fever. The FDA agreed to consider it but also wanted to
understand more about suicide risks. A 2008 FDA review of the
drug’s psychiatric affects and suicide risks recommended
“further studies in animals and humans” and suggested the agency
consider asking Merck to conduct an observational study.
    The FDA did not require such a study, reasoning in part that
serious side effects including suicidal thinking “were expected
to be quite rare.”
    In 2011, the agency rejected a petition from Gilpin and
other parents seeking a black box warning, citing what it called
insufficient evidence that the drug caused suicidal behavior.

    82 SUICIDES
    After Merck’s patent on Singulair expired in 2012, generic
manufacturers started producing the drug. The number of patients
prescribed the medicine climbed from about 7 million annually to
more than 9 million, according to the FDA. Some years, nearly
half of these patients were 16 or younger.
    The FDA convened an advisory panel in 2014 to consider
Merck’s request to offer Singulair over-the-counter. At the
FDA’s request, Merck had re-analyzed its Singulair
clinical-trial data in 2009. The company had reported that an
18-year-old trial participant had attempted suicide and a
12-year-old was hospitalized for depression and suicidal
thoughts. In both cases, the trial investigator determined the
events were not related to Singulair. In 2014, Stephane
Bissonnette, a Merck manager at the time, told the FDA panel
that “suicidality was quite rare” in the trials.
    The FDA also analyzed Merck’s data and generally agreed with
its conclusion, though the agency acknowledged the trials were
short and not designed to detect neuropsychiatric effects.
The FDA panel recommended rejecting the request to sell
Singulair over-the-counter because of safety concerns. The panel
also called for new studies on its neuropsychiatric side
effects, a patient registry, and an assessment of how well
patients understood Singulair’s label.
    Reports of neuropsychiatric side effects “really should give
us pause that there may be something there we don’t understand,”
Dr. Judith Kramer, Duke medical professor and an advisory
committee member, said at the 2014 meeting.
    The FDA followed only half the recommendation: It declined
to authorize over-the-counter sales but also refused to order
new studies, in part because neuropsychiatric side effects were
already a “known safety issue,” an agency safety official said
at the time.
    The FDA told Reuters it declined to order more research
because of “feasibility concerns.”
    In 2019, the FDA convened another advisory panel on whether
the drug’s side effects merited a black box warning. Before the
meeting, the FDA tallied 82 suicides linked to Singulair and its
generic versions reported to its adverse-event database since
1998. Only 64 of the reports provided an age; of those, 31
involved someone 19 or younger.
    Still, agency staffers again said there was not enough
evidence to merit a black box warning, noting that the label
already warned of potential neuropsychiatric events.
    FDA staff acknowledged the agency had the authority to
require new studies. But Merck now had little incentive to
conduct expensive research because its patent on Singulair had
expired and its profits on the drug had plummeted. Instead,
Merck might just pull Singulair off the market, an FDA official
told the advisory committee in 2019.
    Instead of requiring new studies, the FDA announced in March
2020 that it would add a black box to the labels of Singulair
and its generic variations, warning of serious neuropsychiatric
side effects including suicidal thinking and behavior. The
agency cited independent research from 2015 showing the drug’s
distribution in the brain. The FDA advised restricting use of
the drug for treating allergies, saying it should not be the
first-choice treatment.
    
    'THIS DOES NOT MAKE SENSE'
    Reuters interviewed 16 patients or their parents who suspect
that Singulair caused psychiatric side effects. Many, like
Nicholas England, took a generic version.
    England grew up in the rural town of Wise, Virginia. He was
easygoing and physically fit, and would refuse junk food when
the rest of the family was having it, said his father, Robert
England. He believed his son may have struggled to sleep after
taking the drug, but otherwise seemed normal.
    After Nicholas died, a police report noted that he didn’t
have illicit drugs in his system. The case puzzled sheriff’s
investigators, Robert said: “All these guys looked at me and
said, ‘This does not make sense.’”
    In the years when the FDA delayed action on Singulair, some
parents began contacting lawyers to explore taking legal action.
Most, like the Englands, were barred by court precedents from
suing because their children took a generic version of the drug.
Kim Beck, an attorney who eventually filed hundreds of lawsuits
against Merck over Singulair, said her firm turned away
thousands more potential clients who had taken generics.
    The FDA’s 2020 regulatory action encouraged some patients to
sue Merck. Most of those lawsuits are in early stages, but Merck
has had some success with preemption defenses.
    In Wisconsin, for instance, a mother sued Merck in 2020
claiming Singulair caused her son to be institutionalized with
severe depression. The boy was prescribed Singulair in 2010, but
switched to the generic version in 2012.
    Merck argued the plaintiff couldn’t show the FDA would have
approved a stronger warning before 2012, when the boy was taking
brand-name Singulair. The drugmaker cited the agency’s 2011
rejection of the petition by Gilpin and other parents to add
such a warning.
    A judge agreed, ruling that “the relevant federal and state
laws in this case irreconcilably conflict.” He dismissed nearly
every claim in the lawsuit, which the mother then dropped.
    
------
DATA METHODOLOGY: Reuters focused on federal appeals and Supreme
Court decisions to measure the success of the preemption defense
in lawsuits that alleged corporate negligence or defective
products caused injuries or deaths. These cases are important
because they usually establish legal precedents that other
judges across the United States must follow.
    Reporters worked with a specialist at Westlaw, a legal
research service owned by Thomson Reuters, to identify cases
since 2001 that involved the defense. They searched Westlaw’s
database of federal court decisions for opinions that contained
the phrase “preempt” as well as additional key words or phrases,
such as “product liability,” “negligence,” “strict liability,”
and “failure to warn.” Reporters consulted with several outside
legal experts in developing the search terms.
    The searches yielded nearly 800 opinions that a team of
Reuters reporters manually reviewed to determine if the
preemption defense was at issue in the opinion and if the case
included allegations of physical harm to at least one person.
The review narrowed the potential universe to 257 relevant
cases.
    The reporters then read each opinion in those 257 decisions
to determine the outcome of the preemption defense. They marked
cases “successful” when judges granted all preemption claims.
Cases were marked “partially successful” when some claims were
preempted but others were not. Cases were marked “unsuccessful”
when no claims were preempted.
    Each opinion was reviewed separately by two reporters to
ensure the accuracy of the coding.

    <^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
Read online with visuals, sidebar    https://www.reuters.com/investigates/special-report/usa-lawsuits-merck-singulair/
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 (Reporting by Dan Levine, Robin Respaut, Kristina Cooke, Mike
Spector and Benjamin Lesser; Westlaw research by Eliot Warren;
editing by Janet Roberts and Brian Thevenot)
 ((dan.levine@thomsonreuters.com
robin.respaut@thomsonreuters.com
kristina.cooke@thomsonreuters.com 
mike.spector@thomsonreuters.com 
benjamin.lesser@thomsonreuters.com))