Product Safety

Corporate Criminals Await Sentencing

A federal court in California will soon decide whether a bold move by the Consumer Product Safety Commission and the Justice Department will pay off. At issue is whether two corporate executives should face prison time for endangering the public.

Judge Dale Fischer is considering what sentence to impose on Simon Chu and Charley Loh, who were convicted last November of conspiracy to defraud the CPSC in the first-ever criminal prosecution brought under the 1972 Consumer Product Safety Act. The two men were part owners and top officers of Gree USA, Inc., a subsidiary of the Chinese-owned Hong Kong Gree Electric Appliances Sales Co., Ltd. Chu and Loh were charged with deliberately withholding information about defective dehumidifiers that could catch fire and selling these units with false certification marks stating that the products met applicable safety standards. They were convicted of conspiracy to defraud the CPSC and failure to meet reporting requirements, though they were acquitted of wire fraud.

The CPSC worked with the Justice Department to prosecute Chu and Loh individually after first bringing a criminal action against the company. That case was resolved through a 2021 deferred prosecution agreement under which Gree was able to avoid a conviction by paying a penalty of $91 million and agreeing to provide restitution for any uncompensated victims of fires caused by its defective dehumidifiers.

It is unusual for a deferred prosecution or non-prosecution deal with a company to be followed by criminal charges against executives at the firm. Given the uncertainties related to cases against individual corporate executives, the convictions won by DOJ sent a strong signal.

The question now is whether Chu and Loh will face a strong punishment. Not surprisingly, lawyers for each of the men submitted filings to the court arguing for no prison time as all. Loh’s filing makes a case for leniency based on the fact that the CPSC failed to bring criminal charges in other instances in which companies and executives failed to promptly report hazards. At the same time, the document tried to downplay Loh’s culpability, claiming his “actions were not those of a ‘typical’ criminal or felon – though those are labels he will have to live with for the rest of his life – but of a well-intentioned man who wrongly opted for self-preservation over economic suicide.”

For good measure, the filing goes on to state: “Numerous family members, friends, and colleagues have written testimonial letters to the Court attesting to Mr. Loh’s true nature, integrity, and charitable endeavors. Their letter provide [sic] a true sense of his good character. They also confirm that he is the sole caretaker for two elderly and infirm people: his 101 year old father who has Alzheimer’s disease and his 90 year old godmother who has advanced stage cancer.”

It remains to be seen whether the judge is swayed by any of this. Prosecutors clearly are not. They are seeking ten-year prison sentences for each of the men.

Although it may not provide justification for leniency in his sentence, Loh’s argument that CPSC had failed to pursue criminal charges in similar cases does raise an awkward issue for the agency. Its position might be stronger if the actions against Loh and Chu were part of a broader effort to tighten enforcement.

That does not appear to be the case. There has been no wave of additional product safety criminal prosecutions. In fact, there has not even been a rise in civil enforcement. The CPSC has not announced any penalty actions in more than six months, and there were only half a dozen in all of last year.

It is commendable that the CPSC has acted aggressively against Gree and its executives, but it should not be a one-off. The agency needs to punish all manufacturers that fail to protect the public.

PFAS Payouts

BP and its drilling partners were hit with over $60 billion in fines and settlements in connection with the 2010 Deepwater Horizon disaster in the Gulf of Mexico. That remains the largest payout in any environmental case, but the legal costs associated with another issue are starting to catch up.

That issue is the widespread contamination of drinking water supplies with synthetic chemicals called per- and polyfluoroalkyl substances (PFAS). These substances, which are considered possible carcinogens, do not break down in the body or the environment and thus have been dubbed forever chemicals. Detectible level of PFAS can be found in just about everyone alive.

PFAS cases first gained attention in relation to the effort in West Virginia, dramatized in the film Dark Waters, to hold DuPont accountable for contaminating water with chemicals used as coatings for non-stick cookware. In 2017 DuPont and its spinoff Chemours each paid $335 million to settle litigation over the issue.

Now the settlement amounts have grown larger. Last year, 3M agreed to pay over $10 billion to public water suppliers around the country. The case is awaiting final court approval.

Final approval was recently given to a $1.85 billion settlement reached by DuPont, Chemours and DuPont’s other spinoff Corteva with a group of municipal water suppliers relating to contamination caused by PFAS in firefighting foam.

There have also been numerous settlements below $1 billion but still substantial. Last year the Belgian chemical company Solvay agreed to pay $393 million to the state of New Jersey for PFAS contamination at a plant in Gloucester County. The footwear company Wolverine World Wide paid a total of $96 million in two lawsuits connected to contamination in Michigan.

Saint-Gobain Performance Plastics, Honeywell International and 3M agreed to pay a total of $65 million in another firefighting foam case in upstate New York. DuPont is also a defendant in the case but has refused to settle.

It is encouraging to see these companies held responsible for their role in the proliferation of PFAS, but it is unclear whether the payouts will be sufficient to pay for the long-term cost of exposure to the chemicals. That is because we still don’t know the full extent of contamination, and there is growing evidence that the problem is massive. For example, NRDC has just come out with a report estimating that in California alone, water systems serving some 25 million residents—over 60 percent of the state’s population—are contaminated. The levels are likely higher in other parts of the country that have been less aggressive in limiting PFAS use.

Under pressure from lawsuits, regulators and activists, many companies have been phasing out their use of the chemicals. 3M has promised to cease its use of PFAS by the end of 2025. Yet many products containing the chemicals are still being imported from countries with less restrictive practices.

The Deepwater Horizon disaster caused widespread harm in the Gulf of Mexico and the communities along its shores, but the scope of PFAS contamination appears to be much wider and could end up standing with global warming as the two leading environmental crises of our era.

Philips Exits a Scandal-Ridden Business

It has taken a long time, but Royal Philips finally did the right thing with regard to its troubled machines for sleep apnea and other respiratory problems: the company has stopped selling the devices in the United States.

The Dutch company took the step as part of a settlement it has been negotiating with the Justice Department and the Food and Drug Administration, which pressed the company to deal more aggressively with a longstanding defect in its continuous positive airway pressure (CPAP) machines. The problem stemmed from an industrial foam used in the devices to reduce noise but which could break apart and cause users to inhale potentially dangerous particles.

This issue has been known for years. In 2021 Philips voluntarily recalled several million devices, but it appears the company was aware of the foam problem long before taking that action. An investigation by ProPublica and the Pittsburgh Post-Gazette found that the company was receiving complaints as early as 2010, yet it failed to make the FDA aware of the magnitude of the problem as the volume of those complaints reached into the thousands: “Again and again, previously undisclosed records and interviews with company insiders show, Philips suppressed mounting evidence that its profitable breathing machines threatened the health of the people relying on them, in some cases to stay alive.”

Philips is likely to end up paying billions of dollars in legal settlements. It has already agreed to a $479 million settlement with plaintiffs claiming economic damages from having to replace defective machines affected by the recall. Tens of thousands of personal injury cases have been filed and will probably get aggregated. The monetary penalties in the settlement with the Justice Department are not yet known.

This scandal is a major blow to the reputation of a company once known for benign products such as electric shavers and video cassette recorders. Yet in recent years the company has had other problems as well. As documented in Violation Tracker, it has paid over $450 million in fines and settlements over the past two decades.

About half of this total comes from cases involving alleged price-fixing of electronic equipment, and $62 million comes from a Foreign Corrupt Practices Act case stemming from allegations of making improper payments to officials in China to promote sales of medical equipment.

Another $151 million in penalties stems from False Claim Act cases in which the company was accused of defrauding the federal government. Half a dozen of these cases involved the Respironics business Philips acquired in 2008 as its way into the CPAP field. Philips paid over $50 million to settle allegations that it gave illegal kickbacks to medical equipment suppliers to induce them to order its products.

Given this track record, the accusation that Philips tried to cover up the magnitude of the foam problem does not come as a surprise. What is surprising is that it has taken the Justice Department so long to resolve its case against Philips, while it remains unclear whether the company will face criminal charges. Many of its customers would like to see that happen.

Getting Tougher on Product Safety

For most of its history, the Consumer Product Safety Commission has not been the most aggressive federal regulator. Created in 1972, the agency has depended primarily on voluntary recalls of dangerous products by manufacturers. Its budget is below $200 million and its staff numbers around 500, both tiny by DC standards.

While the CPSC has the ability to use monetary penalties when companies fail to disclose hazards, it is relatively restrained in its use of that power. As shown in Violation Tracker, the agency has imposed a total of $397 million in fines against companies since 2000. More than half of that total has come since the Biden Administration took office. By comparison, the Consumer Financial Protection Bureau, which started operating in 2011, has racked up more than $17 billion in fines and settlements.

For all these reasons, it is significant that the CPSC and the Justice Department recently announced that a federal jury in Los Angeles had returned a guilty verdict in the first-ever criminal prosecution brought against corporate executives under the Consumer Product Safety Act.

The defendants in the case were the chief administrative officer and the chief executive officer of Gree USA, Inc., a subsidiary of the Chinese-owned Hong Kong Gree Electric Appliances Sales Co., Ltd. The two men were charged with deliberately withholding information about defective dehumidifiers that could catch fire and selling these units with false certification marks that the products met applicable safety standards. They were convicted of conspiracy to defraud the CPSC and failure to meet reporting requirements, though they were acquitted of wire fraud.

Gree itself has also been targeted by the CPSC. The company has paid more in fines to the CPSC than any other company over the past two decades. That includes a $91 million penalty that was by far the largest single fine brought by the agency during this period. It was also the first criminal enforcement action under the Consumer Product Safety Act.

The impact of that was softened by the decision of the Justice Department to offer Gree a leniency deal in the form of a deferred prosecution agreement by which the company was able to avoid pleading guilty to the charges.

On the other hand, DOJ and CPSC took the bold step of going after the two Gree officials individually. It took four years from the time the two men were indicted, but their conviction sends a powerful message to executives that they can be held personally responsible for brazen disregard of product risks. The Gree executives are scheduled to be sentenced next March and could receive up to five years in prison.

The debate over how to deal with corporate crime is often framed as a choice between penalizing the company and prosecuting executives. The Gree case shows the value of using both approaches at the same time. That makes it more likely the message will get through to everyone in a rogue company that it has to change its practices in a fundamental way.

3M’s Sticky Legal Situation

For the past decade, Johnson & Johnson has symbolized the deterioration of a well-regarded consumer products corporation into the target of multiple lawsuits over alleged disregard for product safety. Now another familiar company is following the same path.

3M, best known as the producer of Scotch Brand adhesive tape and Post-it sticky notes, has been embroiled in two major lawsuits that will probably result in the payment of billions of dollars in settlements. The litigation does not involve office supplies but rather two of the thousands of other products produced by a company originally known as Minnesota Mining and Manufacturing Company.

In one of the cases, 3M has been sued by some 250,000 military veterans who accuse the company of producing foam earplugs that failed to protect them from service-related hearing loss. This stems from a 2018 False Claims Act case brought by the U.S. Justice Department in which the company paid a penalty of $9.1 million. Last year, in what is called a bellwether case, a jury awarded a single plaintiff $50 million in damages.

In an attempt to limit its wider liability, 3M filed for bankruptcy for the subsidiary, Aearo Technologies, that produced the earplugs. Lawyers for the plaintiffs cried foul, and earlier this month a federal bankruptcy judge dismissed the filing, calling it premature. 3M is appealing the dismissal, but the Wall Street Journal reports that the company is in settlement talks.

3M is also said to be deeply involved in negotiating a settlement of its other major legal woe: lawsuits accusing the company of being responsible for the contamination of water supplies with per- and polyfluoroalkyl (or PFAS) chemicals used in the production of its firefighting foam. These substances, which have been linked to numerous adverse health effects, have become known as forever chemicals because they do not break down in the human body or the environment.

A federal judge in South Carolina, where the PFAS cases have been consolidated, recently halted a bellwether trial after the parties in the wider litigation reported that a settlement seemed imminent. This was just after DuPont and its spinoff companies Chemours and Corteva announced they had agreed to pay more than $1 billion to settle their own PFAS cases.

3M’s record apart from these two cases has not been entirely unblemished. In 2018 the company paid $850 million to the Minnesota Attorney General’s office to settle allegations that its disposal of perflourochemicals, or PFCs, over many years had damaged drinking water and natural resources in the Twin Cities area.

It has also been accused of antitrust violations. In 2006 the company paid over $28 million to settle litigation alleging it monopolized the market for adhesive tape. In 2011 3M paid $3 million to settle an age discrimination case brought by the Equal Employment Opportunity Commission. Violation Tracker contains more than 100 other penalties the company has paid in environmental, workplace safety, and employment cases.

With the earplug and PFAS cases, it appears that the company’s aggregate penalty total will soon reach a much higher level. 3M is going to have to sell a lot more Post-its.

Update: Plaintiffs’ attorneys reported that 3M has agreed to pay over $12 billion to public water systems to resolve the PFAS litigation.

Exercising Enforcement

It is not surprising that Peloton Interactive Inc. thought it could refuse to tell the Consumer Product Safety Commission the identity of a child who was killed in an accident involving one of the company’s treadmills. And it was not surprising that Peloton was shocked when the CPSC unilaterally issued a press release urging owners of the Tread+ to stop using the machine in homes with small children or pets.

The reason is that the CPSC has long been one of the more toothless of the federal regulatory agencies. As shown in Violation Tracker, over the past decade it has brought only about 50 enforcement actions involving monetary penalties. During the Trump Administration, the agency almost faded away, bringing only seven actions. There were none at all during the final two years of Trump’s tenure.

Instead, the CPSC has relied on the willingness of manufacturers to reveal safety problems on their own and voluntarily recall defective products. Peloton did disclose the fatal accident on its website and to the CPSC, but by withholding key details it thwarted the agency’s ability to investigate the matter. It also softened the negative impact of the announcement by making the disingenuous claim that it was protecting the privacy of the family involved.

Peloton also applied more of its own spin in the announcement by suggesting it was enough for users to “make sure” that the space around the equipment is clear. By contrast, the CPSC press release, which the company denounced as “inaccurate and misleading,” noted that it was aware of 39 incidents involving the Tread+, including at least one that occurred while a parent was running on the treadmill. The agency said this indicated that the risks were not limited to situations in which a child has unsupervised access to the treadmills, which cost more than $4,000.

Issuing the release without the company’s consent was a remarkable step for the CPSC, given that a provision of the Consumer Product Safety Act known as Section 6(b) restricts the ability of the agency to reveal company-specific information.

The agency is also limited in its ability to impose mandatory recalls. To do so, the CPSC would need a court order, meaning that a recalcitrant manufacturer could tie up the matter in protracted litigation, all while continuing to sell the dangerous product.

All of this is to say that the less than dazzling enforcement record of the CPSC is to some extent the result of structural impediments. Past attempts to remove those restrictions were not successful, but the Peloton dispute has prompted a renewal of those efforts. U.S. Senator Richard Blumenthal (D-CT) and U.S. Representatives Jan Schakowsky (D-IL) and Bobby L. Rush (D-IL) recently introduced legislation that would repeal Section 6(b).

Corporate lobbyists have worked so hard to promote the idea of over-regulation that many people will be surprised to hear the extent to which an agency such as the CPSC is prevented from taking strong action. The Peloton case is a reminder that the real problem is often not too much regulation but too little.

A Reputation for Purity is Now in Tatters

For the tens of millions of baby boomers in the United States, the first large corporation whose products they encountered was probably Johnson & Johnson. That’s because the vast majority of parents in the postwar period used the company’s baby shampoo, oil and powder on their precious bundles of joy. Carefully cultivating an image of purity, J&J established itself as an indispensable part of infant care.

That image is now in tatters. The company just disclosed that it is being investigated by the Justice Department, the Securities and Exchange Commission and Congress in connection with possible asbestos contamination of its baby powder and other talc-based products. These probes were prompted by investigative reporting in outlets such as the New York Times alleging that J&J executives raised internal concerns about the asbestos issue decades ago but the company never acknowledged these publicly.

These revelations gave more credence to thousands of lawsuits filed against J&J in recent years by women, including many who used the company’s baby powder on themselves as well as their infants, charging that the products caused them to develop ovarian cancer. J&J has been losing a lot of these cases, including one in which a jury awarded $4.7 billion in damages to a group of 22 women.

Rarely has a product’s reputation fallen so far, and rarely has a company once held in such high esteem come to be regarded as morally equivalent to cigarette manufacturers. Yet a closer look at J&J’s track record shows that its immaculate reputation has been deteriorating for quite some time.

Over the past decade the company has been involved in a series of scandals and has been forced it to pay out large sums in civil settlements and criminal fines.

The most serious of those cases involved allegations that several of its subsidiaries marketed prescription drugs for purposes not approved as safe by the Food and Drug Administration, thus creating potentially life-threatening risks for patients.

For example, in 2013 the Justice Department announced that J&J and several of its subsidiaries would pay more than $2.2 billion in criminal fines and civil settlements to resolve allegations that the company had marketed it 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. The amount included $485 million in criminal fines and forfeiture and $1.72 billion in civil settlements with both the federal government and 45 states that had also sued the company.

Other J&J problems resulted from faulty production practices. During 2009 and 2010 the company 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 medication were found to be contaminated with metal particles.

The company’s handling of the matter was so poor that its subsidiary McNeil-PPC became the subject of a criminal investigation and later entered a guilty plea and paid a criminal fine of $20 million and forfeited $5 million.

J&J also faced criminal charges in an investigation of questionable foreign transactions. In 2011 it agreed to pay a $21.4 million criminal penalty as part of a deferred prosecution agreement with the Justice Department resolving allegations of improper payments by J&J subsidiaries to government officials in Greece, Poland and Romania in violation of the Foreign Corrupt Practices Act. The settlement also covered kickbacks paid to the former government of Iraq under the United Nations Oil for Food Program.

All of this has been a humiliating comedown for a company that was once regarded as a model of corporate social responsibility and which set the standard for crisis management in its handling of the 1980s episode in which a madman laced packages of Tylenol with cyanide. While the company was then being victimized, in the subsequent crises it mainly has itself to blame. Off-label marketing, faulty production practices and foreign bribery are bad, but the current scandal over asbestos contamination and the alleged cover-up pose a threat to the survival of the company.

Exporting Hazards or Globalizing Regulation?

Americans may have initially felt a bit smug upon learning that the combustible material responsible for the Grenfell Tower disaster in London is largely banned in the United States. Perhaps our regulatory system is not as deficient as we thought.

That moral superiority went out the window when it came to light that the deadly cladding was purchased from an American-based company. Some of the outrage being exhibited toward public officials in Britain should also be aimed at Arconic, a company created from the break-up of the aluminum giant Alcoa. Arconic has announced that it will suspend sales of the cladding, known as Reynobond PE, for high-rises, but that does little good for the scores of people killed in the Grenfell fire or the thousands of others who have been forced to leave other apartment houses now found to contain the material.

Although most of the attention is on Arconic’s cladding and its role in spreading the conflagration, it turns out that fire itself was caused by another American product, a refrigerator made by Whirlpool under its Hotpoint brand. The appliance had a back made out of flammable plastic rather than the metal typically used in models sold in the United States. The London Fire Brigade had long lobbied, to no avail, to require new appliances to have fire-resistant backing.

The sale of banned products in offshore markets is, unfortunately, a longstanding practice among U.S-based multinational corporations. What’s unusual in this case is that the offshore market is a wealthy country such as Britain, whereas the dumping is normally done in poor countries.

As Russell Mokhiber points out in his 1988 book Corporate Crime and Violence, one of the earliest examples was that of the now defunct company A.H. Robins, which in the 1970s sold thousands of its Dalkon Shield intrauterine contraceptive devices in 42 countries even after it became apparent that thousands of U.S. women were experiencing severe and sometimes deadly ailments linked to the IUDs.

In 1972 the U.S. Environmental Protection Agency prohibited most uses of the insecticide DDT, yet American producers continued to sell in foreign markets for years until most other countries adopted their own bans.

U.S. companies also continued to export dangerous products such as asbestos, flammable children’s pajamas and lead-based house paint after being barred from selling them in domestic markets.

These practices illustrate the perverse way that most large companies regard the regulation of their business. They are not willing to admit that restrictions are legitimate — even when imposed in the wake or injuries and deaths — and will adhere to them only to the extent absolutely necessary. If they can continue to sell products they have been told are harmful to some customers, they will do so.

This mindset seems to result from both a knee-jerk ideological opposition to all regulation and an amoral pursuit of profits. The persistence of corporate crime suggests that attempting to reform big business from within — the dubious promise of corporate social responsibility — is far from adequate. Just as markets have superseded borders, so must regulation be globalized.

Regulation is Not Dead Yet

Donald Trump tries to give the impression that his crusade against business regulation is moving ahead rapidly. While several rules have been rescinded and more are threatened, it turns out that for now the enforcement systems at most agencies are functioning normally.

In preparing a forthcoming update of the Violation Tracker database, I’ve found that since the inauguration federal regulatory agencies have announced more than 160 case resolutions with fines and settlements totaling more than $1.6 billion. This two-month dollar amount does not compare to the $20 billion collected by the Obama Administration during its final tens weeks in office. Yet it does show that the so-called administrative state is not dead yet.

A large portion of the Trump collections come from enforcement actions against a single company that are in line with the new president’s views. The Chinese telecommunications company ZTE was penalized $1.2 billion for violating economic sanctions against Iran and North Korea by supplying them with prohibited items. The Commerce Department’s Bureau of Industry and Security imposed a $661 million civil penalty and the Treasury’s Office of Foreign Assets Control collected another $106 million while the Justice Department got ZTE to plead guilty and pay $430 million in fines and criminal forfeiture.

The remaining $422 million was collected in cases brought by 21 different agencies and four divisions of the Justice Department. Among the larger actions:

The Commodity Futures Trading Commission reached an $85 million settlement with the Royal Bank of Scotland to resolve allegations that it attempted to manipulate interest-rate benchmarks.
The Federal Energy Regulatory Commission reached an $81 million settlement with GDF Suez to resolve allegations that it manipulated energy markets.
TeamHealth Holdings agreed to pay $60 million to settle Justice Department allegations that its subsidiary IPC Healthcare Inc. violated the False Claims Act by overbilling Medicare, Medicaid, the Defense Health Agency and the Federal Employees Health Benefits Program.
Offshore oil driller Wood Group PSN was ordered to pay a total of $9.5 million to resolve criminal charges that it falsely reported over several years that its personnel had performed safety inspections on offshore facilities and that it negligently discharged oil into the Gulf of Mexico.
Keurig Green Mountain agreed to pay $5.8 million to settle allegations by the Consumer Product Safety Commission that it failed to report a defect in its Mini Plus Brewing System that had caused scores of serious burn injuries.
The Consumer Financial Protection Bureau imposed a $3 million penalty on Experian for deceptively marketing credit scores.

The list also includes: 14 settlements with the Equal Employment Opportunity Commission by employers in cases involving gender, pregnancy and disability discrimination; six cases in which private sponsors of Medicare Advantage plans violated consumer protection rules; two cases in which companies were charged with violating the Controlled Substances Act by failing to properly monitor opioid prescriptions; and much more.

On the other hand, the situation remains puzzling at the Labor Department, where agencies such as OSHA have not announced a single enforcement action since Trump took office. [UPDATE: It’s been pointed out to me that despite the absence of OSHA press releases the agency is still posting enforcement actions on its website on this page, which shows numerous cases since Inauguration Day.]

It is likely that most of the 160 cases were initiated while the Obama Administration was in office, but it is heartening that they have gotten resolved under the new management. The career officials in the various agencies should be commended for continuing to do their job in difficult circumstances. Let’s hope they can convince their new bosses that there is a value to protecting consumers, workers and the public against corporate misconduct in its many forms.

Johnson & Johnson’s Self-Inflicted Wounds

Baby powder, the product along with Band-Aids that for decades gave Johnson & Johnson a benign image, is now the latest symbol of its deterioration into one of the most unreliable of large corporations. Juries have recently awarded a total of $127 million to women with ovarian cancer who charge that their disease was caused by the talc in the company’s powder.

J&J, which disputes the allegations and is appealing the verdicts, faces some 1,400 additional similar lawsuits brought by plaintiffs’ lawyers armed with company documents they say show that J&J was concerned about a link between talcum powder and ovarian cancer as early as the 1970s. It is unclear what will happen with the litigation, but the lawsuits are part of a long string of scandals that have plagued the giant medical products firm during the past decade and forced it to pay out vast sums in civil settlements and criminal fines.

In 2010 J&J subsidiaries Ortho-McNeil Pharmaceutical and Ortho-McNeil-Janssen had to pay $81 million to settle charges that they promoted their epilepsy drug Topamax for uses not approved as safe. The following year, J&J subsidiary Scios Inc. had to pay $85 million to settle similar charges relating to its heart failure drug Natrecor.

In 2013 the Justice Department announced that J&J and several of its subsidiaries would pay more than $2.2 billion in criminal fines and civil settlements to resolve allegations that the company had marketed it 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. The amount included $485 million in criminal fines and forfeiture and $1.72 billion in civil settlements with both the federal government and 45 states that had also sued the company.

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.”

The company’s handling of the matter was so poor that J&J subsidiary McNeil-PPC became the subject of a criminal investigation and later entered a guilty plea and paid a criminal fine of $20 million and forfeited $5 million.

—————————-

Note: This piece is drawn from my new Corporate Rap Sheet on Johnson & Johnson, which can be found here.