Merck’s 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 preemptionhttps://t.co/MjpAS5XRr6 pic.twitter.com/qluWrBvFIH

— Reuters Legal (@ReutersLegal) June 26, 2023

This is a 4,000+ words Reuters special report.

I’ll try to edit it down for you, but there are several juicy bits.

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.

Nicholas England

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, 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.

Narratives included in reports to the FDA of suicides associated with Merck’s asthma and allergy drug, Singulair, or generic versions. The agency logged the incidents in its “adverse event” database, which tracks potentially problematic drug side effects. 

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.

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.

…

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.”

Jan Gilpin points to photographs of her son while he was taking the drug Singulair to treat his asthma

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.

It’s not clear if this is the kind of society that either Republican or Democrat voters wanted, but it is clear that this is the kind of society both parties were intent on delivering.

Everyone has mysterious chronic health problems that mysteriously track with a mysterious regimen of mysterious vaccinations, and the mysterious drugs given to you to treat these mysterious chronic health problems mysteriously drive you to suicide.

Everyone is also mysteriously poor and gay.

Everything is very mysterious.

No one can figure out what is going on.

The first mRNA vax killed a lot of people, and permanently destroyed the lives of many others.

But the plan is to just keep giving people more and more of these things, and hope it works out.

The government is doing this because they love us.

Reuters:

Adding an experimental mRNA-based vaccine from Moderna Inc and Merck & Co reduced the risk that the most deadly skin cancer would spread by 65% over treatment with an immunotherapy alone in a mid-stage trial, the companies reported on Monday.

With this and earlier data, Moderna is considering seeking faster approval from regulators for the treatment, the company told investors after having presented the results at the American Society of Clinical Oncology meeting in Chicago.

“Some of the residual uncertainty seems to be going away on that potential (option),” said Moderna President Stephen Hoge.

The data followed earlier promising data from the trial showing the customized mRNA vaccine given in combination with Merck’s Keytruda cut the risk of death or recurrence of melanoma by 44% compared with Keytruda alone.

The findings add to a growing body of evidence suggesting that mRNA technology, which rose to prominence during the COVID-19 pandemic, can be used to assemble personalized vaccines that train the immune system to attack the specific type of cancer cells in a patient’s tumors.

Scientists have been chasing the dream of vaccines to treat cancer for decades with few successes. Experts say mRNA vaccines, which can be produced in as little as eight weeks, paired with drugs that rev up the immune system may lead to a new generation of cancer therapies.

The hope is for “a completely new treatment paradigm in cancer that will be better tolerated and unique to individual patients’ tumors,” said Dr. Jane Healy, an executive overseeing in early cancer treatment development at Merck.

Moderna said during its investor call that it was starting a Phase 3 confirmatory study, which it hoped to open in the third quarter of this year.

The Merck/Moderna collaboration is one of several combining powerful drugs that unleash the immune system to target cancers with mRNA vaccine technology. Pfizer’s COVID vaccine partner BioNTech SE and Gritstone Bio Inc are taking similar approaches using mRNA technology.

The vaccines all target neoantigens, new mutations that are only present on tumors. Aiming at these unique proteins allows the immune system to kill cancer cells while leaving healthy tissue unscathed.

The trick is determining which of many mutations is driving the cancer.

To accomplish this, tumors are removed and their genetic makeup is mapped using next-generation DNA sequencing. Companies use artificial intelligence to predict which mutations will be the most effective targets. These are used to build an individualized vaccine targeting only mutations in the patient’s tumor.

During this process, patients typically receive an immunotherapy such as Keytruda or Roche’s Tecentriq, which block a mechanism cancer uses to hide from the immune system.

Yeah it all. seems really safe and responsible.

I’m sure nothing can go wrong.

These scientists are powerful and godlike

Like they say, their experiments should make humans go beyond human and enter a new realm of existence.

That sounds very simple and straight forward.

Bizarre: Another instance caught on camera of the spinning collapse.

It’s almost like they’re seeing something before losing consciousness.

These kind of videos never existed before 2021, now are they being caught on security cameras almost every week.

What is causing this? pic.twitter.com/mrztPiV4nU

— DiedSuddenly (@DiedSuddenly_) June 6, 2023

You can read the full article here: https://t.co/0fUVpkprEO

— DiedSuddenly (@DiedSuddenly_) June 2, 2023

The coronavirus vaccine is the single safest and most effective vaccine ever devised by science.

Unfortunately, the vaccine stopped working because of the new variant of the virus, and now people who have received the vaccine are 6.6 times more likely to die than those who didn’t get the vax (Source: SARS-CoV-2 variants of concern and variants under investigation in England published by Public Health England). Of course, even though the death rate for the vaxed is 6.6X higher than the death rate for the unvaxed, it’s still under 1% – so it’s really not a serious problem that getting the vax so drastically increases your chances of death, according to official government data, because really it’s very unlikely that you die from the virus under any circumstances.

Also, this is all the fault of the unvaxed.

We must continue to threaten, intimidate, manipulate or outright force people to take the vaccine, because it saves lives.

The sad fact is, when the rubber hits, the road, if people continue to refuse the life-saving vaccines and boosters, we’re going to be left with no choice but to kill them, as that will be the only way to protect them from the deadly coronavirus. It’s sounds distasteful, especially in a democracy that prizes freedom above all else, but our patience can only last so long.

However, with vaccines failing so miserably, and killing so many people, and actually increasing the chances of dying from the deadly coronavirus, we must figure out new and innovative ways to fight back against this deadly virus.

If we follow the basic path of science, we realize that now we need to take pills to fight this deadly virus, which is threatening to undermine the very foundation of civilization.

The vaccines are safe and effective and they save lives. But you should also take this pill.

POLITICO:

News that an experimental antiviral drug from Merck appears to halve the risk of hospitalization or death from Covid-19 has bolstered hopes of finding a simple at-home treatment for the virus.

The drug, molnupiravir, is given as a pill. It performed well enough in a late-stage clinical trial of adults at high risk of severe Covid-19 that the independent review board overseeing the study recommended that it be ended early. Now Merck and its partner Ridgeback Biotherapeutics will seek FDA authorization for the drug “as soon as possible,” they said Friday.

If those promising preliminary results hold, the new drug could help fill a significant gap in the world’s Covid-19 arsenal. As the pandemic nears the end of its second year, there are still only a handful of treatments for Covid-19 — and none that people can take at home. Finding a drug that can minimize the risk of severe illness could ease the burden on the country’s hospitals and blunt future surges of infection, in combination with vaccines and public health measures like mask-wearing.

Currently, “very few treatment options [are] available,” said Matthew Hall, a biologist at the National Institutes of Health’s National Center for Advancing Translational Sciences. “Someone can go to an infusion center and be infused with a neutralizing antibody, but [there’s] nothing in a pill form that’s able to just be prescribed to take in early in an infection to reduce the severity of symptoms and the extent of symptoms.”

I’ll tell you this: you don’t want to go to an infusion center.

I’ve been to an infusion center, and the body with a vagina working there literally bit my man-penis. Then they started doing femdom BDSM, which I am not into. You DO NOT want to go to an infusion center.

Disregard the advertisements.

An infusion center is NOT a standard Thai massage parlor.

This pill is the answer we’ve been looking for.

Vaccines are safe and effective, but they do increase the chances of dying from the virus by 6.6 times, and cause permanent heart disease in 2/3rds of the people who receive them. Also, the antibodies from these extremely effective vaccines, which are more safe than any vaccine in all of history, only last seven months. That means that we’re going to need boosters at least every six months, and maybe every week or every day. We might even have to have boosters before and after every meal. We don’t know. We just have to follow the science.

But regardless of the booster schedule that the science determines for us, we also must start taking these pills all the time, if we really want to be safe and protect ourselves from this deadly virus.

As the CEO of the company that worked with Pfizer to create the safe and effective Pfizer vaccine has said, coronavirus is not going away. We are going to have to live with this virus, and the only way we can fight it is with regular boosters and regular pills.

The biggest threat to public health right now is disinformation about coronavirus. Misinformation is the real virus. So we have to really start cracking down on people who question the safety of these vaccines, and people asking why we need to take these pills if the vaccine works.

The fact is, the vaccine does work. It is a miracle of science. It just doesn’t prevent infection or death from the coronavirus, and instead, increases death. But that’s the way science works. Conspiracy theorists are spreading false theories by manipulating the data.

We can’t ever go back to normal. Coronavirus is here to stay. If we ever want to manage this deadly disease, we have to get boosters every six months, we have to take these pills, but most of all, we have to crack down on medical disinformation.

What’s worse than a whiny black drug dealer? A whiny affirmative action CEO black drug dealer.

The President is holding the line on his TRUE statement that there was hatred on “many sides.”

A dumb black guy who is the Affirmative Action CEO of Merck – the company is of course run by Jews, they just put one of their little playtoys as the titular head – resigned over the statements allegedly not being good enough.

pic.twitter.com/a1PNQZism5

— Merck (@Merck) August 14, 2017

Trump explained in a tweet that as is the way of the blacks, he was just trying to rip people off anyway.

Now that Ken Frazier of Merck Pharma has resigned from President's Manufacturing Council,he will have more time to LOWER RIPOFF DRUG PRICES!

— Donald J. Trump (@realDonaldTrump) August 14, 2017

Washington Post:

The chief executive of Merck said Monday in a tweet that he was resigning from President Trump’s American Manufacturing Council, saying he was doing so “as CEO of Merck and as a matter of personal conscience” and that “America’s leaders must honor our fundamental values by clearly rejecting expressions of hatred, bigotry and group supremacy, which run counter to the American ideal that all people are created equal.”

In the statement, Kenneth C. Frazier, one of the few African American CEOs in the Fortune 500, said, “I feel a responsibility to take a stand against intolerance and extremism” and touted the power of diversity. “Our country’s strength stems from its diversity and the contributions made by men and women of different faiths, races, sexual orientations and political beliefs.”

Within an hour after the statement was first issued, Trump tweeted his response. “Now that Ken Frazier of Merck Pharma has resigned from President’s Manufacturing Council, he will have more time to LOWER RIPOFF DRUG PRICES!”

Frazier’s resignation followed an outcry by critics about how President Trump had responded to protests over the weekend in Charlottesville that were led by white supremacist groups and turned violent. Many questioned why Trump had not explicitly named neo-Nazi, Ku Klux Klan or white nationalist groups when he said “we condemn in the strongest possible terms this egregious display of hatred, bigotry and violence on many sides,” repeating “on many sides” for emphasis.

I’m going to collect some of the emails I’ve been receiving, and you’re going to see that there is a whole lot more hate on their side than there is on ours.

That is an absolute fact.

I have never seen such hatred as I’ve seen in these emails.

No joke: at least 2/3rds are about my penis, assuming that it is small. It is not small. It is in fact way above average size. Way above. I’m not going to post pics, because this is a family site.

One would have to ask: what does the size of my penis have to do with the size of Heather McFatty’s waistline?

If I had the biggest or the smallest penis on earth, Heather Heyer would still be a fat sow.

I think the people emailing me about my penis need to consider this fact.

The anti-racist shill Marco Rubio also claimed Donald Trump had a small penis during the campaign. Do you remember that? That was really weird.

Trump, like I am having to do now, had to confirm the fact that he, like me, has a massive penis. During the debate he had to confirm this fact.

I have never in my life questioned the size of a man’s penis in the context of a political debate.

Also consider the fact that these people are all threatening to murder me.

None of us have ever threatened to murder anyone.

One fat woman dies in an unrelated road rage incident and everybody loses their minds.

I’m just going to tell you this: she probably died of a heart attack.