https://reuters.com/investigates/special-report/usa-lawsuits-merck-
singulair/

Merck�s best-selling asthma medicine, Singulair, has been linked for years
to suicides and psychiatric problems, often in children. But lawsuits over
the drug are stymied by one of Corporate America�s most effective
liability shields: the doctrine of federal preemption.

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, 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.

�The emotion of losing your child is so difficult on its own. 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.�

Jennifer England, whose son died by suicide after taking an allergy
medicine tied to psychiatric problems.
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, 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.