Malignant Marketing

Large corporations are fond of saying that they are all about giving customers what they want. But what happens when the product, though legal, is harmful or addictive? Should companies be allowed to satisfy consumer demand, no matter what the consequences?

Some high-profile settlements announced in recent weeks show that, as far as state attorneys general are concerned, there should be much stricter controls on the marketing of dangerous products and that corporations should be heavily penalized for abuses.

The most recent case involves JUUL Labs, which just agreed to pay $438 million to resolve multistate litigation accusing it of improperly marketing vaping products to minors. The announcement of the settlement, reach with a bipartisan group of 34 states and territories, alleged that JUUL “relentlessly marketed to underage users with launch parties, advertisements using young and trendy-looking models, social media posts and free samples. It marketed a technology-focused, sleek design that could be easily concealed and sold its product in flavors known to be attractive to underage users. JUUL also manipulated the chemical composition of its product to make the vapor less harsh on the throats of the young and inexperienced users. To preserve its young customer base, JUUL relied on age verification techniques that it knew were ineffective.”

Earlier this summer, groups of state AGs announced several massive settlements with companies involved in the production and marketing of opioids. Teva Pharmaceuticals agreed to pay up to $4.25 billion to state and localities to settle allegations that it promoted two powerful fentanyl products designed for cancer patients to others while downplaying the risks of addiction. According to the AGs’ press release, Teva’s actions included “encouraging the myth that signs of addiction are actually ‘pseudoaddiction’ treated by prescribing more opioids.”

Several days later, Allergan agreed to pay up to $2.4 billion to settle a similar multistate case alleging the company had “deceptively marketed opioids by downplaying the risk of addiction, overstating their benefits, and encouraging doctors to treat patients showing signs of addiction by prescribing them more opioids.” Allergan was also accused of failing to maintain effective controls to prevent the diversion of opioids into improper channels.

And a couple of weeks after that, Endo International agreed to pay $450 million in yet another multistate lawsuit stemming from accusations of deceptive marketing. In Endo’s case, this involved allegations that it “falsely peddled its opioids as abuse-deterrent with deadly consequences.” Under the weight of this and other litigation, Endo has filed for bankruptcy.

The theme running through all these cases is the tendency of corporations, obsessed with the desire to increase sales, to engage in shockingly unethical behavior. Both the slick techniques of JUUL to lure young vapers and the seemingly scientific claims of the opioid producers to reassure pain patients demonstrate an apparent willingness to use deceit and manipulation to push dangerous products on vulnerable populations. The monetary penalties, however large, and promises to end the abuses hardly seem a sufficient penalty for the harm caused by this behavior.

The Pill Mills of the Fortune 500

The downfall of Purdue Pharma illustrated the role played by drugmakers in the opioid crisis. Large settlements paid by the likes of McKesson and AmerisourceBergen highlighted the culpability of the major drug wholesalers. Now more attention is being paid to the other players in the corrupt supply chain: pharmacies.

The assumption used to be that the main retail culprits were small pharmacies in places such as West Virginia that readily filled far more oxycontin prescriptions than would be expected to arise from legitimate use in their communities. Those businesses, like the unscrupulous clinics that wrote the prescriptions, are often called pill mills.

A decision just handed down by a federal court in San Francisco indicates that our understanding of that phrase needs to be revised. Following a bench trial, U.S. District Judge Charles Breyer ruled that the giant pharmacy chain Walgreens improperly dispensed hundreds of thousands of suspicious prescriptions for narcotic painkillers in the Bay Area over more than a decade.

“In exchange for the privilege of distributing and dispensing prescription opioids,” Judge Breyer wrote, “Walgreens has regulatory obligations to take reasonable steps to prevent the drugs from being diverted and harming the public. The evidence at trial established that Walgreens breached these obligations.”

Those regulatory obligations come from the Controlled Substances Act (CSA), a federal law which regulates the distribution of drugs ranging from Xanax to fentanyl. As shown in Violation Tracker, the U.S. Justice Department and the Drug Enforcement Administration have brought about two dozen successful CSA actions against large pharmacy chains, including those operated by the big supermarket companies.

In 2013 Walgreens had to pay $80 million to resolve a DEA case involving what the agency called “an unprecedented number of record-keeping and dispensing violations.” CVS, another pharmacy goliath, has paid out over $130 million in a dozen CSA cases.

These amounts are likely to be dwarfed by the damages against Walgreens in the San Francisco case, which have yet to be determined. Walgreens and CVS, along with Walmart, are also embroiled in an opioid test case brought by two counties in Ohio. The plaintiffs are seeking a payout of several billion dollars to help pay for addiction services.

If those Ohio counties are successful, it would give a green light to several thousand other cases that have been filed around the country and are being treated as a multidistrict action. On top of that, Walgreens, CVS and Walmart are facing a slew of opioid cases brought by the Cherokee Nation and other tribes.

It is unlikely that Walgreens or CVS will suffer the same fate as Purdue Pharma, which had to file for bankruptcy and agree to turn itself into a public benefit company while its owners, the Sackler Family, had to promise to pay out billions. CVS, which generated nearly $8 billion in profits last year, is particularly well positioned to handle the massive settlements to come.

The real question is whether it and Walgreens will own up to their misconduct and get serious about complying with their obligations to prevent opioid abuse.

Holding Corporations Accountable for Defective Products

A federal judge in Michigan just shot down a motion by Fiat Chrysler to derail litigation alleging it sold 800,00 vehicles with faulty gearshifts. The company could end up paying many millions in damages. At about the same time, a federal judge in New York gave final approval to a $5.2 million settlement of class action litigation claiming that DevaCurl products caused hair loss and scalp damage.

These are two recent examples of actions in an arena in which corporations are held accountable for causing harm to their customers: product liability lawsuits. These kinds of court cases are the latest category of class-action and multi-district litigation to be added to Violation Tracker.

The database now contains entries covering 120 of the most significant product lawsuits of the past two decades in which corporations paid substantial damages or a monetary settlement to large groups of plaintiffs.  The total paid out by the companies in these cases is more than $54 billion.

Fourteen of the cases involved payouts of $1 billion or more, the largest of which was the $9.6 billion Bayer agreed to pay to resolve tens of thousands of suits alleging that the weedkiller Roundup, produced by its subsidiary Monsanto, causes cancer. Bayer, which produces pharmaceuticals as well as chemicals, was involved in five other cases on the list, bringing its aggregate payout to more than $12 billion, the most for any corporation.

Next in line are Pfizer and Johnson & Johnson, each with payout totals of about $5.5 billion for cases involving harm caused by products ranging from hip implants and diabetes drugs to heartburn medication and talcum powder. These two companies and other pharmaceutical and medical equipment producers account for one-third of the cases on the list and half of the payout total. The giant settlements involving opioid producers and distributors are not included here, since they are treated as matters of illegal marketing rather than defective products—and because those cases are most often brought by state attorneys general rather than as private litigation.

The motor vehicle industry also features prominently, with 32 cases and total payouts of $9 billion. The largest portion of that is linked to Toyota, with $5.3 billion in payouts in cases involving issues such as unintended acceleration, defective airbags and premature corrosion. Volkswagen has actually paid out much more in class action settlements due to its emissions cheating scandal, but Violation Tracker categorizes those as environmental rather than product liability cases.

Among the remaining cases are a $1 billion settlement by the German company Knauf involving drywall that emitted noxious odors and a $500 million settlement by Sears Roebuck of allegations that it sold stoves that had a tendency to tip over.

Yet perhaps the most surprising of the cases were two involving the Brazilian company Taurus, which paid a total of $277 million to resolve allegations that it produced firearms with a defect that caused them to go off when dropped. The irony is that gunmakers are shielded from liability when their weapons are used in criminal activities.

Product liability class action and multi-district cases—like similar litigation involving issues such as toxic chemicals, wage theft and privacy violations—are reminders that the courts are an important complement to the regulatory system in addressing corporate misconduct.

States vs. Big Business

Twenty twenty-one is turning out to be a banner year for state government prosecution of corporate crime and misconduct. The biggest events are, of course, the settlements with pharmaceutical companies Purdue Pharma and Johnson & Johnson along with the three big drug distributors—Cardinal Health, AmerisourceBergen and McKesson—for their role in creating and prolonging the opioid epidemic.

While some argue that the amounts are not sufficient, those cases will result in billions of dollars in payments to state governments from the corporations and the family, the Sacklers, who controlled the now bankrupt Purdue and grew enormously wealthy from its operations.

In all, the states will rack up more than $30 billion in 2021, which would be the largest amount since 2008, when the states received about $53 billion in payments, largely as the result of a series of billion-dollar-plus settlements with the likes of Merrill Lynch, Morgan Stanley and Goldman Sachs to resolve allegations that the Wall Street banks misled investors in the marketing of auction-rate securities.

This year’s total is not entirely the result of the opioid litigation. There have also been numerous other cases resolved by state attorneys general that may not involve billions but are still quite significant. Here are some examples.

In July, the New York AG announced that TIAA-CREF, a subsidiary of retirement-services giant TIAA, had agreed to pay $97 million to resolve allegations that it fraudulently misled tens of thousands of customers into moving their retirement investments into higher-fee accounts offered by the company.

Also in July, the Oregon AG announced that L Brands, the owner of Victoria’s Secret and other retail chains, had agreed to commit $90 million of company funds to protect employees from sexual harassment and discrimination and require accountability from executives when misconduct occurs. The settlement came in the wake of allegations by the Oregon Public Employees Retirement Fund and other shareholders that the company’s board of directors failed to investigate former CEO and Chairman Emeritus Leslie Wexner’s close personal ties with convicted sex offender Jeffrey Epstein, and ignored a widespread and pervasive culture of sexual harassment at the company.

In June, the Ohio AG announced that Centene Corp. agreed to pay $88 million to resolve allegations of overcharging Medicaid by charging more than the capped industry-standard prices for drugs while acting as a pharmacy benefit manager. Centene paid $55 million to settle a similar case with the state of Mississippi, while Bristol Myers Squibb paid $75 million in an overcharging settlement with a group of states.

Also in June, the North Carolina AG announced that JUUL Labs would pay $40 million and change its practices to resolve allegations that it was responsible for misleading teenagers into becoming addicted to nicotine-based vaping products.  

Last month, the Pennsylvania AG announced that Glenn O. Hawbaker, Inc. would pay more than $20 million to resolve criminal charges that it misdirected retirement contributions meant specifically for employees working on prevailing-wage projects into a company-wide plan that covered executives and owners of the firm.

Also in August, the Georgia AG announced that Turtle Creek Assets, Ltd would pay more than $19 million to resolve allegations that the company committed multiple violations of the federal Fair Debt Collection Practices Act and the Georgia Fair Business Practices Act.

What this sampling of cases shows is that amid all the controversy over their policies on issues such as voting rights and abortion, many states of varying ideological orientation continue to carry out their responsibility to protect citizens from irresponsible corporate behavior.

Note: These cases will appear in an update of Violation Tracker that will be posted later this month.

Public Money and Public Health

When a company is the subject of front-page stories about serious misconduct, the firm would normally have a track record of regulatory infractions documented in Violation Tracker. Yet Emergent BioSolutions, which has had to throw out millions of doses of Covid-19 vaccine because of serious production flaws, does not have a single entry in the database.

This is not because Emergent has had a perfect track record until the present. On the contrary, investigations by the New York Times, the Washington Post and the Associated Press have reported that probes by two federal agencies and by Johnson & Johnson, which contracted with Emergent to manufacture the vaccine, had found serious deficiencies, especially with regard to its efforts to prevent contamination.

If you read those articles carefully, you will see that the findings come from unpublished documents obtained through Freedom of Information Act requests or that were leaked to reporters. In other words, the public was unaware of the deficiencies being found by inspectors from the Food and Drug Administration and J&J auditors. There were no public enforcement actions against the company that would have shown up in the regulatory data collected for Violation Tracker. There are also no substantive references to regulatory issues in the publicly traded company’s 10-K filing.

I also searched the Nexis news archive for articles or press releases about Emergent. Prior to the recent revelations, almost all the coverage about the company focused on the numerous government contracts it has received. Two decades ago, it was the nation’s sole producer of the anthrax vaccine, as a result of which it received many millions of dollars in federal contracts. It also received funding to work on drugs for Ebola and Zika prior to getting on the Covid-19 gravy train.

Among the agencies providing this backing has been the Biomedical Advanced Research and Development Authority, an office within the Department of Health and Human Services. BARDA was apparently aware of shortcomings at Emergent but did little about them. The Times investigation found that in dealing with the company the agency “acted more as a partner than a policeman.”

Along with the federal largesse, Emergent has received millions of dollars in state economic development incentives. In 2004, Maryland provided up to $10 million in assistance for the facility that was producing the anthrax vaccine. The state provided a $2 million loan when Emergent built a new headquarters in 2013, with Montgomery County and the city of Gaithersburg kicking in another $1 million. More public money was provided to the company’s Baltimore operations, where the Covid-19 work has been performed pursuant to an estimated $1.5 billion in manufacturing contracts.

While the production problems were kept quiet, Emergent was able to pretend that all was well at the company. Its CEO Robert Kramer’s total compensation jumped to $5.6 million last year. The company’s stock price at one point last summer soared to $135.

Now all that is over. The stock price is at less than half that level. The company is facing multiple investigations whose results are likely to be made public. Kramer should not expect a big boost in pay.

It is unclear how much Emergent’s practices have set back the country’s campaign to defeat the coronavirus. Yet it seems clear this was an egregious case of a corporation living high on public money without paying adequate attention to public health.

AstraZeneca’s Vaccine Stumbles

It’s difficult to decide whether to be more suspicious of the Trump Administration or the major drugmakers when evaluating the coming covid vaccine rollout.

The administration, eager to take credit for the unusually quick development of at least two products, is now revealed to have passed up the opportunity to lock in larger supplies of the Pfizer offering, prompting the company to make deals with other countries. Trump tried to cover up the error with an America First executive order, but that action is said to be unenforceable. Unless some of the other vaccines in development come to fruition soon, it may take a lot longer than promised to inoculate the U.S. population. The situation is worsened by the decision of the administration to leave states to work out distribution plans on their own.  

Pfizer, meanwhile, was getting showered with praise as its vaccine began to be administered in the United Kingdom, yet it soon had to contend with reports of several serious allergic reactions. The company, it turns out, had excluded people with a history of significant adverse reaction to vaccines from late-stage trials. UK officials are now telling those with serious allergies to put off getting the shot.

Then there is AstraZeneca, whose vaccine developed with the University of Oxford appears to be effective, but exactly how effective is in doubt given that researchers initially screwed up the doses given during the clinical trial and had to improvise.

Back in September, AstraZeneca had to halt the clinical trial after a participant fell ill. The company apparently infuriated the Food and Drug Administration by failing to warn it about the problem before the story became public. The New York Times called the incident “part of a pattern of communication blunders by AstraZeneca that has damaged the company’s relationship with regulators, [and] raised doubts about whether its vaccine will stand up to intense public and scientific scrutiny.”

AstraZeneca’s shortcomings did not start with its covid project. Like Pfizer, AstraZeneca has been accused of engaging in illegal marketing. In 2010 it paid $520 million to the U.S. Justice Department to resolve allegations that it promoted its anti-psychotic drug Seroquel for uses not approved as safe and effective by the FDA. Among other things, the company was accused of having paid doctors to give speeches and publish articles (ghostwritten by the company) promoting those unapproved uses.

The company has also been embroiled in controversies over pricing. In 2007 a federal judge ruled in a national class action case that AstraZeneca and two other companies had to pay damages in connection with overcharging Medicare and private insurance companies. The judge singled out AstraZeneca for acting “unfairly and deceptively” in its pricing of the prostate cancer drug Zoladex. The company was later hit with a $12.9 million judgment.

The combination of Trump Administration incompetence and the questionable track record of companies like AstraZeneca and Pfizer is giving ammunition to vaccine skeptics. We can only hope that the FDA review process makes a convincing case for the safety of the vaccines and that the new Biden Administration shows greater skill in working out the details for their distribution.

In Pfizer We Trust?

The world is in love with Pfizer and Moderna. The two pharmaceutical companies have each announced amazing results in their separate efforts to develop a coronavirus vaccine. Pfizer first announced that its product appeared to be 90 percent effective, only to be upstaged days later by Moderna and its claim of 94.5 percent. Pfizer then revised its efficacy rate to 95 percent.

Like everyone else, I am eager to see progress made in the fight against covid, but there is a part of me that wonders whether these announcements, coming in record-breaking time, are a bit too good to be true. Don’t get me wrong—I am not a vaccine skeptic. I recently got my flu shot and previously was inoculated against shingles and pneumonia.

Yet I am a wary when it comes to grand pronouncements by large corporations about advances that will generate vast amounts of profit. This is particularly the case with large drug companies, which have a long history of deception and malfeasance.

Pfizer is a prime example. Its track record is filled with cases in which it was accused of misleading regulators and the public about the safety of its products.

In the early 1990s, for example, Pfizer was embroiled in a controversy about scores of fatalities linked to heart valves produced by its Shiley division. In 1992 it agreed to pay up to $205 million to settle thousands of lawsuits. In 1994 the company agreed to pay $10.75 million to settle Justice Department charges that it lied to regulators in seeking approval for the valves.

In 2005 Pfizer had to stop advertising its arthritis medication Celebrex after a study showed that high doses were associated with an increased risk of heart attacks. Pfizer’s claims about the safety of the drug were further undermined when it came to light that the company had conducted a clinical trial back in 1999 that also pointed to the cardiac risk but which Pfizer kept secret.

Pfizer, which was a pioneer in the once controversial practice of advertising pharmaceuticals, has frequently been accused of making false or misleading claims about its products. It has paid millions of dollars to resolve state and federal allegations about these practices.

It has paid even larger amounts in cases involving allegations that the company promoted its drugs for uses not approved by the Food and Drug Administration. These include a $2.3 billion settlement in 2009 that covered criminal as well as civil allegations. Pfizer’s subsidiary Wyeth settled its own criminal-civil illegal marketing case for $490 million four years later. In 2016 Wyeth paid another $784 million to settle allegations that it reported false pricing information to the federal government.

Moderna has not been around long enough to get into much trouble, but other companies working on vaccines have track records similar to Pfizer’s. These include Johnson & Johnson, whose penalty total on Violation Tracker is $4.2 billion, AstraZeneca ($1.1 billion), GlaxoSmithKline ($4.4 billion) and Sanofi ($641 million).

We may have no choice but to depend on companies such as these to develop and produce the vaccines we need to overcome covid. Fortunately, their efficacy and safety claims will be subject to review by presumably independent experts before the vaccines are put into general distribution. I will continue to have my doubts about Pfizer, but I’m willing to trust Fauci.

The $8 Billion Slap on the Wrist

In the normal course of events, an $8 billion penalty and a guilty plea would represent a landmark event in the history of corporate crime enforcement. The newly announced resolution of charges against Purdue Pharma is, however, a disappointment and a missed opportunity to mete out appropriate punishment to one of the most egregious rogue companies this country has ever seen.

Let’s start with the monetary penalty. The $8 billion amount ranks 11th among all the fines and settlements collected in Violation Tracker. It is surpassed by penalties paid by companies such as BP, Volkswagen, Bank of America and JPMorgan Chase.

As bad as the environmental and financial conduct of those corporations may have been, it is likely that Purdue Pharma has caused much greater harm. It bears a significant amount of responsibility for the hundreds of thousands of people who have died from overdoses after becoming addicted to opioids the company recklessly promoted.

There is also the issue of the economic costs to society. The Society of Actuaries has estimated those costs to be as high as $214 billion a year. Looked at in comparison to the human and economic costs, the $8 billion penalty seems woefully inadequate—all the more so because it is unclear how much of that amount the bankrupt company will actually pay.

It is good that the Justice Department extracted a guilty plea from Purdue rather than its frequent practice of allowing large companies to sign deferred prosecution or non-prosecution agreements. Yet this is a case which called out for individual as well as corporate criminal charges. DOJ got the Sackler Family, which controls Purdue, to pay out $225 million—yet that is a pittance in relation to the billions the family has taken from the company.

One unusual feature of the case resolution is the provision that will require Purdue to emerge from bankruptcy as a benefit company supposedly dedicated to serving the public rather than maximizing profits. It remains to be seen how that would work, but it is already troubling that the creation of the trust would allow Purdue to reduce its criminal penalty substantially.

The good news is that the DOJ settlement is not the end of the story. The statement that the Sackler family has not been released from potential federal criminal liability is not expected to mean much, especially under a Trump Administration.

The possibility of more aggressive action can be found at the state level. Numerous state attorneys general have sharply criticized the deal and have vowed to pursue their own cases. “I am not done with Purdue and the Sacklers,” warned Massachusetts AG Maura Healey.

Let’s hope that state prosecutors do their job, because their federal counterparts have failed to adequately crack down on the worst corporate violators and the individuals behind them.

Relying on Drug Companies With Flawed Safety Records to Save Us from Covid-19

Among the many things that have changed drastically in the past few months is the public perception of the pharmaceutical industry. At the beginning of the year, the main news about Big Pharma was the possibility of a multi-billion-dollar opioid settlement with the states.

Now, rather than being held accountable for tens of thousands of overdose deaths, the industry is being hailed as our savior from Covid-19. The news is filled with laudatory stories about the efforts of the drug companies to come up with a treatment for those currently suffering from the virus and a vaccine that may be the only way for society to return to something approximating normal.

Of course, everyone wants these efforts to succeed, but we shouldn’t ignore the very checkered track record of the industry. The safety portion of that record suggests that pushing for extremely rapid results may be risky.

The pharmaceutical industry’s safety problems date back at least to the 1930s, when a company called S.E. Massengill introduced a liquid antibiotic without testing and the drug turned out to cause fatal kidney damage. In the 1950s Parke-Davis heavily promoted a typhoid drug for less serious ailments until it emerged that users were developing severe and irreversible anemia. During the same period, thousands of children around the world were born with birth defects after their mothers took the morning-sickness drug thalidomide during pregnancy.

Sometimes these scandals involved vaccines. In the mid-1950s a California company called Cutter Laboratories produced large stocks of the new polio vaccine that mistakenly contained the live virus. Scores of children who received the vaccine developed polio.

Defenders of the pharmaceutical industry will claim that safety practices are much more stringent these days. But consider the recent history of Johnson & Johnson, which is one of the companies actively pursuing a coronavirus vaccine.

J&J, whose baby products long enjoyed a reputation for purity, has in the past two decades been implicated in a seemingly endless series of controversies about product safety and the illegal marketing of drugs for uses not approved as safe by the Food and Drug Administration.

Some of the company’s problems stemmed from faulty production practices. During 2009 and 2010 J&J had to announce around a dozen recalls of medications, contact lenses and hip implants. The most serious of these was the massive recall of liquid Tylenol and Motrin for infants and children after batches of the medications were found to be contaminated with metal particles.

in 2013 Advanced Sterilization Products, a division of J&J subsidiary Ethicon Inc., had to pay $1.2 million to settle FDA allegations that it had produced and distributed adulterated and misbranded sterilization monitoring products.

Other major companies in the coronavirus vaccine race have been involved in their own controversies. In 2012 GlaxoSmithKline, which is partnering with Sanofi in its vaccine effort, had to pay $3 billion to settle various criminal and civil charges, among which were allegations that the company withheld data on safety problems with its diabetes drug Avandia from the FDA.

Pfizer, which is working with a smaller company called BioNTech, has had safety problems dating back to the 1980s, when defective heart valves made by its Shiley division caused the death of more than 100 people. An FDA task force concluded that the company had withheld crucial safety information.

We are all desperate for drugs to treat and prevent coronavirus, but we should make sure that the urgency of the situation does not lead to safety shortcuts that can have disastrous consequences.

Trump’s Risky Covid-19 Infomercials

Donald Trump has declared himself a wartime president, but in many of his briefings these days he comes across more as one of those hucksters of late-night television touting miracle cures. He relentlessly promotes the anti-malaria drug hydroxychloroquine as a treatment for Covid-19, even though it has not been proven safe or effective for that purpose. “What do you have to lose?” Trump keeps saying, ignoring evidence that the drug can have serious cardiac side effects.

It is understandable that those suffering from coronavirus disease may be willing to try anything to survive, and some doctors are treating seriously ill patients with hydroxychloroquine as a last-ditch measure. There are also clinical trials under way to see if the drug really does work against Covid-19. But all that is entirely different from the president’s using the White House podium to suggest that everyone should try the medication as if it were a new brand of mouthwash.

Not only is that dangerous – Trump’s comments have caused a run on the drug that has affected those who need it to treat diseases such as lupus and rheumatoid arthritis – but it also stands in contradiction to several decades of efforts to discourage widespread promotion of prescription drugs for uses not approved by the Food and Drug Administration.

Data in Violation Tracker show that over the past two decades pharmaceutical companies have paid out more than $20 billion in fines and settlements to resolve Justice Department, FDA and state attorneys general cases involving the improper marketing of drugs. These include three dozen cases in which the penalty amount exceeded $100 million and five in which the amount was more than $1 billion.

The largest single penalty of this kind was the $3 billion paid by GlaxoSmithKline in 2012 for off-label promotion of drugs such as the anti-depressant Paxil as well as its failure to report certain safety data. In 2009 Pfizer and its subsidiary Pharmacia & Upjohn agreed to pay $2.3 billion to resolve allegations that they illegally promoted drugs such as the anti-inflammatory Bextra.

In 2013 Johnson & Johnson and several subsidiaries paid $2.2 billion in criminal fines and civil settlements to resolve allegations they had marketed the anti-psychotic medication Risperdal and other drugs for unapproved uses as well as allegations that they had paid kickbacks to physicians and pharmacists to encourage off-label usage. At a press conference announcing the resolution of the case, U.S. Attorney General Eric Holder said the company’s practices ”recklessly put at risk the health of some of the most vulnerable members of our society — including young children, the elderly and the disabled.”

In the current situation, it is an elected leader rather than a drug maker doing the improper promotion, but a corporation — the French firm Sanofi, which produces hydroxychloroquine under the brand name Plaquenil – stands to benefit. As a result of Trump’s hype, a sleepy product dating back to the 1950s, is now the most sought-after pharmaceutical on the planet.

Sanofi is being cautious, stating on its website that Plaquenil “can cause serious adverse reactions and should not be taken without medical prescription or advice,” adding that it has not been approved for use in Covid-19 patients. Yet the site goes right on to state: “According to some preliminary results from independent pilot studies, hydroxychloroquine was reported as having a potential anti-viral effect on the virus that causes COVID-19.”

Other companies such as Amneal Pharmaceuticals, which produces a generic version of hydroxychloroquine, may have their own pot of gold. The company has ramped up production of the drug and has generated good p.r. by donating a quantity of the medication to the state of Texas.

The risk here is that Trump’s unbridled advocacy for the drug will steamroll the FDA into opening the floodgates and making it available not just to the desperately ill, but also to millions of others who have a mild form of the disease or are not infected at all. And we may never know for sure if those millions benefited from the medication or were needlessly exposed to cardiac and other risks.