A Son Died, His Parents Tried to Sue. How U.S. Courts Protect Big Pharma

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From 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, 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.'”

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3 COMMENTS

  1. OH MY, THE LAW….

    I marvelled at the billions in fines Pharma paid THE GOVERNMENT (NIH-NIMH reported circa 2014) regarding psych drug damage lawsuits. Sigh.

    As I scrambled to unlock the psychiatric crypt in which I was entombed, while reeling from withdrawal, rebound, anaphylaxis, AND a brain lesion, (courtesy of antipsychotics)…and no family or friends support….
    I investigated legal representation-researched online for the 2-hours of my only daily function….calling, emailing law firms nationwide for insight, interest,, clues, advice, and representation.
    South Carolina, Chicago, Kansas City, to San Diego, and Phoenix…the credibility that had been snuffed out by the 11-year diagnosis, prevented my carefully documented & “evidence-based” presentation as being regarded as a winner.

    Everyone was polite. Occasionally I spoke to the attorney. My precise notes, established research (see above & much more), and documentation by independent medical entities were ineffective persuading them to engage. Some explained I had to show concrete $ damages…instead of a precise, concise timeline, ER reports, red-line labs, clinical notes (!) (that I had already requested & received)…it wouldn’t be enough for them to ‘invest’ in.

    It was business, not personal. None of them expressed surprise regarding my situation. Psychiatry was a loser for their firms…in business terms. This wasn’t Hollywood. I understood.

    I DID find the singular case/active lawsuit that paralleled mine in many ways.
    Except….’They’ had been a high-profile male, a high-achiever with re$ources and a spectacular Ivy-league education.
    I was an average citizen, worse-an aging female…already low on the cultural credibility (and value) scale.

    ‘They’ had also achieved vacation of their “Lifetime” bipolar diagnosis…and was at-that-moment…suing for over $30 million. It bounced from 1 state to another, 1 firm to another. I contacted the original journalist covering the lawsuit. He was helpful with small details.
    The distressing failure to overcome a dismissal on technicalities seemed to end it…

    By that time I was clutching MY vacated diagnosis and struggling with the damages left to my body & soul, & the VERY difficult re-entry (seizures & socially) back into the world…free of addiction from neurotoxins but cellular damages still apparent. There was no guide-book for this. It was messy.

    I have restored myself; changed, & understand SO much more now. The brittle pain has morphed into something else.

    The “Art of War”-Sun Tzu-still guides what I am carefully, effectivelly developing-knowing truth and balance will come to all involved…not vengeance.
    While it may be ‘unappreciated’ now, life is change & according to THEIR doctrine, they are uniquely qualified to manage it…& emerge better for it.
    My gift to them.
    It has already begun.

    Inadvertantly, they (& Sun Tzu) taught me patience, utilizing the ‘process’, & recognizing vulnerabilities.

    THE LAW taught me that it’s not about ‘right or wrong’.
    It’s about what’s most effective.

    And there’s this….

    “You either win or you learn”
    Michael Jeffrey Jordan

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