Gardiner Harris’s new book No More Tears, the Dark Secrets of Johnson & Johnson is scarier than any horror movie you’ll see this year.
I imagine myself facing a skill-testing question, on a topic I know a lot about, prescription drugs: Which American pharmaceutical company holds the record for the most criminal and civil penalties related to illegal marketing and fraud?
I guess, hmm, maybe Pfizer? I say that because I remember a US judge once called Pfizer a “recidivist” organization that routinely breaks the law, pays fines, and then goes out to break the law some more. Pfizer’s $2.3 billion fine (the largest health-care fraud settlement in history) for marketing drugs for off-label purposes, is only slightly more than Johnson & Johnson’s settlement of $2.2 billion for illegal marketing of Risperdal and related drugs.
However the overall winner of the highest volume of criminal or civil penalties for deceptive marketing, kickbacks, fraud against public health programs, and ripping off Medicare/Medicaid, goes to that American of all companies, Johnson & Johnson. J&J has paid an estimated $8.5 billion in marketing-related penalties across multiple cases, tied to illegal promotions, fraud, deceptive marketing and Pfizer is a distant second at $3.4 billion. It helps to remember those fines are only paid after they get caught, mostly in cases that have woven their way through an obstacle course of delay, obfuscation, negotiation, secret settlements, and sometimes excruciating waits by patients and families hoping for some recognition and compensation for the death or injuries experienced by their loved ones.
Why is this relevant?
Because the second biggest thing drug companies should be known for, after developing and marketing blockbuster drugs, is crime: committing it, trying to avoid punishment, and then only when forced to, paying for it. Those massive legal costs, of course, are ultimately paid by you, the pill-consuming public.
Johnson & Johnson’s famous and well-respected reputation, built on iconic blockbuster brands such as Tylenol, Band-Aids, Baby Powder, and Baby Shampoo comes under direct fire in Gardiner Harris’s excellent new book No More Tears: The Dark Secrets of Johnson & Johnson (Random House, 2025). He delivers an impressively-researched catalogue of fraudulent activities in the marketing of drugs and medical devices that are shocking in their brazenness and scope.
All major pharmaceutical companies spend substantial amounts of money to defend themselves against litigation, partly because their constant and inventive levels of lawbreaking are an essential part of their business model. Resolving US Department of Justice allegations of off-label marketing, kickbacks, and violations of the FCA (False Claims Act) is a very expensive line item and in that category, Johnson & Johnson leads as well.
“Between 2010 and 2021 J&J spent $25 billion on litigation, a number that is likely higher than that of any other company in the Fortune 500.”
As Harris writes: “Johnson & Johnson has long been one of the biggest individual patrons of corporate law firms in the world.” A company this big and this powerful eventually skews how law is actually practiced in the US, and helps explain why so many drug companies find it more rewarding for their shareholders to break the law than to follow it.
What this means on the ground is that any law firm in the US hungry to build their own enterprises would much rather represent Johnson & Johnson than work prosecuting them. For example, even though J&J’s illegal marketing caused tens of thousands of boys to be permanently disfigured and resulted in the premature deaths of thousands of dementia payments (related to the antipsychotic Risperidal) none of the doctors who prescribed these drugs, the salespeople who bamboozled doctors, or the executives who orchestrated these illegal marketing schemes ever went to prison. If any law firm really pushed hard for the kind of justice deserved in these atrocious cases, and worked to put doctors or executives behind bars for their nefarious activity, that firm would carry a black mark forever. So guess what? It almost never happens.
Since it is estimated that the cumulative death toll due to prescription drugs is estimated to be somewhere between the fourth and sixth most common cause of death among Americans, gigantic law firms are there putting the best face forward for the companies that illegally market those drugs.
Harris’s point is crystal clear: both the legal and the drug regulatory systems in the US are in need of deep reform and he doesn’t mince words when he writes:
“For all intents and purposes, Johnson & Johnson was a criminal enterprise…And if one of the most admired corporations in the world is in reality a criminal enterprise and a killing machine, what else are we missing? How many other killers are out there?”
How many indeed?
In the course of researching and writing about the drug industry and pharma policy for over 30 years, I’ve collected quite a personal library. My shelves sag with books on pharma policy, drug safety, evidence-based medicine, pharmacy regulation, and prescribing. Taking a closer look at my bookshelves, I ask myself: do I even have a book written specifically about the corporate malfeasance of a single drug company? I can’t find one and reckon that No More Tears is the only compilation of drug disasters committed by a single company that I have ever encountered.
As a first rate pharmaco-journalist, Harris clearly has the chops to cover this company. He’s been reporting on the pharmaceutical industry for some of the biggest media outlets in the US for years, and knows where the bodies are buried.
The “dark secrets” of Johnson & Johnson are a litany of jaw-dropping misdeeds: willfully marketing asbestos-laced baby powder, glossing over the well-studied dangers of the most swallowed drug in human history (Tylenol—also known as acetaminophen or paracetamol), egregiously marketing the antipsychotic drug Risperdal (risperidone) to demented people (despite warnings that it would increase death rates in those people) and children (causing boys to grow breasts and lactate). On top of this, their marketing of the opioid Duragesic (fentanyl transdermal patch) and their outsized role in the opioid epidemic across much of North America means that many of the unnecessary thousands of overdose deaths could be laid at their feet.
Harris’s hefty book of 40 chapters (and 444 pages) reminds us that drug companies like J&J aren’t philanthropic enterprises. They are corporations, structured to be legally accountable only to shareholders, a fact that should trouble us all. Why? Because in case after case of J&J’s checkered history, replete with criminality and disturbing abuses of authority, law and human ethics, profit comes first. If vulnerable patients suffer and die, that’s simply the cost of doing business.
Where Is the Regulator in All of This?
In every chapter, you’d be compelled to ask, “Where was the FDA when all the bribing, coercing, and criminality at the hands of J&J was going on?” It’s a good question and Harris doesn’t hold back his criticisms. The magic of this book is that it’s not just about Johnson & Johnson; it’s a parable about the kind of lax drug regulation Americans live with, in a world where hundreds of products vie for their right to be swallowed by you.
Maybe the insight in No More Tears is that the US FDA, the regulator whose job it is to keep unsafe drugs off the market, and to punish companies who illegally market and promote their products, is a watchdog without teeth. Or worse, a dog that doesn’t bark or bite. More of a lapdog than a watchdog, perhaps?
Unlike airplane travel which is one of the safest activities humans do, when there is a crash or near miss, federal aviation safety inspectors meticulously and rigorously seek out the source of the problem so it won’t happen again. Over 5 months there were 346 fatalities involving two Boeing 737 MAX crashes (in 2018 and 2019). These accidents prompted extensive investigations and grounding of the complete 737 MAX fleet worldwide for nearly two years while safety evaluations and software updates were conducted.
Compare that to the safety regulation of prescription drugs. The Food and Drug Administration both approves drugs and later evaluates their safety (all the while being paid by the companies whose drugs they are approving) which most people would agree is an obvious conflict of interest. On the ground, therefore, they end up doing both poorly, and when there is the hint of an impending drug disaster, the FDA will typically bend over backwards to see things from the companies’ perspective. For example, the back and forth between J&J and the FDA around the safety of Tylenol makes for a good case study in how not to regulate unsafe drugs.
Despite it being a massive chunk of the pain-relieving market, acetaminophen, often sold as J&J’s Tylenol trend-setting “Extra Strength” Tylenol version, is the leading cause of liver failure in the US, yet most consumers wouldn’t know this. The Tylenol chapter in Harris’s book demonstrates how the FDA’s safety evaluations are mostly performative.
“In any given year if the US FDA was in charge of airline safety, it wouldn’t be able to tell you how many planes fell out of the sky.”
Part of the song and dance between drug companies and the FDA are the company officials who frequently—and publicly—whine and complain about how tough the FDA is, and how difficult it is to get drugs approved, etc., etc. This is a helpful fiction which flies in the face of what happens on the ground, and only serves to impart a cozy feeling of “safety” over the FDA’s decision-making. For those who don’t believe me I have one word: Vioxx.
Vioxx, a drug sold by Merck, was the Vietnam War of the modern drug era. Here’s a brief refresher: Between 1999 and 2004 nearly 60,000 Americans died from premature heart attacks and strokes due to an “innovative” arthritis drug that was widely, and fraudulently marketed. Despite very early warnings of fatalities, and a weakling regulator frequently getting sand kicked in its face by a 300-pound bully, it took five years before Vioxx was pulled from the market. The result? About 30 Americans—who took the drug for nothing more than simple arthritis pain—died unnecessarily each day. In aircraft terms, Vioxx alone was the equivalent of a Boeing 737 Max jet crashing and killing everyone onboard, every week for FIVE YEARS!
The analogy to Vietnam is deliberate given the similar death tolls. About 60,000 Americans died in the Vietnam War, during about 12 years of US involvement. By contrast Vioxx only took five years to kill that many Americans, demonstrating that the FDA was much more effective in killing Americans than the Viet Cong.
And how many profound drug safety reforms have arrived in the US since Vioxx that now makes it safer to enter a pharmacy? Hmmm. I can’t think of any. When you read how Johnson & Johnson repeatedly gets away with dealing with the FDA’s laissez-faire approach to drug safety you’ll understand why Vioxx is only the tip of the iceberg.
In their own documentation, FDA officials routinely brag about how well the FDA works with its “partners in industry,” including company executives like those at Johnson & Johnson where the revolving door between regulator and regulated is a perennial, and serious problem. This coziness leaves the FDA negotiating and composing believable narratives about a drug’s safety, and thus providing a service for those who pay for the FDA’s operations. In practice this allows recidivist drug manufacturers to criminally market products they know are lethal, pay fines when they are caught, and then go forth to kill again. On the scale of the problem, Harris notes that in 2003, of J&J’s top seven selling drugs, the company used “illegal marketing tactics—including bribes, kickbacks, and lies to the FDA—for six of them.”
I learned a lot from this book but the question I most asked myself was: How come J&J was never on my radar? No More Tears shows J&J’s mastery in not only having their way with the FDA, but deploying weapons-grade PR to continually polish its halo of corporate virtue. It did this by being one of the most successful drug companies in the history of the world, with mountains of cash to monopolize the two biggest weapons in a drug company’s arsenal: Big PR and Big Law. Big PR can help keep the bad news off the front pages of the nation’s newspapers by massaging journalists and rewarding media outlets with big advertising dollars. Big Law, including the same companies hired to plead the cases of Big Tobacco, chomp at the bit to work for J&J, ready, willing, and able to go to war on behalf of the company. As I said before, only a rare few law firms would be willing to challenge J&J’s legal firepower, or, conversely, to turn their backs on such a lucrative client.
Perhaps it is J&J’s role in the opioid epidemic that I found most surprising. While almost everyone knows that Purdue’s marketing of Oxycontin put jet fuel on the fire of the opioid epidemic, (paying huge fines for doing so) almost no one knows what Harris meticulously outlines halfway into the book: J&J’s central role. He cites Andrew Kolodny, the world‘s most foremost expert on the opioid crisis:
“J&J was clearly the kingpin of the opioid epidemic, not Purdue Pharma. They were not only marketing their own branded opioids but were supplying almost every manufacturer with the crucial active pharmaceutical ingredient.”
Where do we go from here?
Harris’s prescriptions for reform as he concludes No More Tears have been heard many times and are worth repeating. The FDA must eliminate the dark money from drug regulation, and start treating the American Public as its client, not the drug companies. It should crack down on prohibiting physicians from taking money or gifts from pharmaceutical companies while treating patients, banning continuing medical education funded by drug companies, and switching to a system where the US taxpayers (and not the drug companies) pay the bill for regulating and approving drugs. He also suggests the need to switch to an “airline-level” system of safety monitoring where approval of new planes and the investigation of crashes are done by separate agencies.
His final critique is hardly radical and echoes many of the themes found in the books lining my shelves: Until we stop allowing dirty money to write the rules of drug approval, marketing, and prescribing, our system will only continue to encourage big pharmaceutical companies, like Johnson & Johnson to kill, pay fines, and go forth to kill again.
(Note: a shorter version of this review is being published in the Indian Journal of Medical Ethics www.ijme.in)
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