ORLANDO, Fla. — A recent investigation by Drugwatch finds that pharmaceutical companies have prioritized profits over safety, with lawsuits playing a critical role in exposing hidden risks and regulatory failures amid the opioid crisis.
Drugwatch’s analysis found that from 1991 to 2021, drugmakers paid more than $62 billion in fines while generating $1.9 trillion in net income, equating to $1 in penalties for every $31 in profit. The report also showed that litigation uncovered key data, including the distribution of 76 billion opioid pills based on DEA records.
According to journalist Terry Turner, senior writer for Drugwatch, a secret Drug Enforcement Administration database, the Automation of Reports and Consolidated Orders System (ARCOS), spent years mapping every opioid pill shipped from factories to pharmacies.
ARCOS allows lawyers to track opioids, resulting in large courtroom settlements. These multibillion-dollar payouts have hit the pharmaceutical industry’s bottom lines and led to concrete public health reform.
According to Turner, opioid lawsuits forced ARCOS into public view, revealing how millions of doses were being distributed into small towns. This has led to the opioid crisis, killing thousands and devastating communities.
Nora Freeman Engstrom, the Ernest W. McFarland Professor of Law at Stanford Law School, told Drugwatch that lawsuits serve as an “information-forcing function,” highlighting the information unearthed through tort law.
Engstrom calls the ARCOS data the “Rosetta Stone of the opioid crisis,” showing billions of oxycodone and hydrocodone pills flooding the United States from 2006 to 2019. Engstrom reports that some small-town pharmacies took millions of doses for their small populations.
Turner reports that large amounts of opioids were being diverted from patients who were prescribed pain medication to those addicted to pharmaceutical narcotics. People who were treated with opioids for operations or medical conditions became addicted to the pills.
This data was only uncovered when lawsuits forced ARCOS to go public, even though the DEA had all the data. Engstrom argues that this shows the complicity of distributors and pharmacies as they purposely distributed pills to poor communities.
Turner highlights the role of litigation in regulating the drug industry, noting that lawsuits can expose hidden evidence that pharmaceutical companies may use to profit, even at the expense of public health.
These claims are supported by reporters Shannon Brownlee and Jeanne Lenzer, investigative journalists who specialize in medical issues. Their recent publication examines the shortcomings of new drug testing and Big Pharma’s relationship with regulators.
Lenzer told Drugwatch, “We found that 73% of all drugs failed on at least one of those essential criteria, and a stunning number failed to have any of those essential criteria, and they’re getting on the market.”
Brownlee said their investigation found that early trials often lack the scale to detect rare drug-related harms.
Further, Louis Clark, executive director of the Government Accountability Project, told Drugwatch about his organization’s experience with Merck, an American multinational pharmaceutical company based in New Jersey.
David Graham, an FDA epidemiologist, exposed the deadly side effects of Vioxx, Merck’s prescription painkiller. The medication was removed from the market after it was linked to thousands of heart attacks, which Graham warned of and Merck was aware of but ignored.
According to Clark, that litigation yielded a $4.85 billion settlement. William Soliman, Ph.D., founder and CEO of the Accreditation Council for Medical Affairs and a former Merck sales representative, said the company encouraged physicians to use Vioxx for longer terms when it was indicated for short-term use.
He considered this an off-label push, which is when a drug is used for a condition that is not FDA-approved.
Soliman noticed the tendency of doctors to prescribe higher, long-term doses and for pharmaceutical companies to keep drugs on the market even after warning signs appeared. He said, “The manager of the team [at another top-five Big Pharma company] … came up to me [and said] ‘Hey, can you kind of quiet down those other medical liaisons? They just keep criticizing our data.’”
Turner noted that companies use strategies like the “Texas Two-Step” to avoid paying large sums to settle massive lawsuits when their products fail. For example, Johnson & Johnson used this when they faced thousands of talcum powder lawsuits claiming their products caused cancer.
Brownlee and Lenzer connect corporate strategies to FDA approvals, saying regulators sometimes spin or overlook flaws and red flags before drugs reach the market.
Lenzer highlighted Elmiron, a bladder pain treatment for interstitial cystitis patients, which the FDA approved on a “compassionate use” basis with post-market proof that never fully materialized.
Clark shared his experience with the industry’s typical response to internal alarms about problematic drugs, stating that there is significant pressure to silence those who raise concerns, which could adversely affect their careers.
Lenzer continued by focusing on failures in post-market surveillance, saying that warning signs are often ignored because companies prioritize profits over safety. Dr. Peter Kowey, a cardiologist and professor at Thomas Jefferson University, agreed that greed in direct-to-consumer marketing drives demand and justifies higher prices.
Kowey said, “We are being overcharged for medication, which means that many patients can’t access the medications.”
Drugwatch has compiled a list of the 10 largest government enforcement settlements, including settlements with the U.S. Department of Justice, state attorneys general, counties and municipalities. These cases and other federal and state actions show tens of billions of dollars flowing from a few firms, with opioids dominating recent payouts.
Turner reports on multidistrict litigation, which streamlines the legal process and consolidates scattered injuries. He notes that MDLs helped resolve the opioid crisis, as the opioid settlements were among the largest in history.
They funded remediation and created public records that regulators often miss.
According to Turner, “MDLs protect public health by holding corporations accountable for putting profits over safety.”
Drugwatch concludes with Clark’s statement that there should be a clear public record of what was reported, how it was evaluated and what action followed, urging more transparency in the regulatory process.
To this, Soliman adds his support for “standardized training and independent accreditation for medical affairs professionals, with post-marketing teams housed under medical—not marketing—leadership.”
Follow the Vanguard on Social Media – X, Instagram and Facebook. Subscribe the Vanguard News letters. To make a tax-deductible donation, please visit davisvanguard.org/donate or give directly through ActBlue. Your support will ensure that the vital work of the Vanguard continues.
