Opioid death toll shatters records as judge weighs pharmacy chain penalties

Mallinckrodtlogo-300x137Even as the opioid abuse and drug overdose crisis worsens and breaks annual records for its resulting death toll, the reckoning for parties blamed for fostering the national nightmare is grinding forward.

A federal judge in Cleveland has begun hearing arguments whether three giant pharmacy chains should be fined billions of dollars after a jury in November found them culpable for damages they caused in two Ohio counties in the opioid mess.

And new disclosures are emerging regarding bankrupt drug maker Mallinckrodt, which federal officials have described as the “the kingpin within the drug cartel” of legitimate companies driving the opioid epidemic.

Penalties weighed for pharmacies

Lawyers for CVS, Walgreens, and Walmart have started what is expected to be weeks of squaring off with counsel for Lake and Turnbull counties in the courtroom of U.S. District Judge Dan Polster. They had battled there a few months ago, with a jury slamming the pharmacy giants for creating a public nuisance by failing to ask appropriate questions and flooding the two counties with countless numbers of prescription painkillers.

The counties now must persuade Polster as to the penalties for the companies — sums that differ wildly, with the successful plaintiffs arguing the penalties should be $1 billion for each county to clean up damages caused in the two areas. As the news site cleveland.com described the counties’ claims:

The counties will have experts testify about how many people suffer from opioid addiction, how that affects their lives, how much money it costs for programs to help those with opioid addiction and how much it will cost to implement services to help connect people to treatment and jobs, according to the filings. They will argue that they need funding for programs ranging from addiction prevention to treatment, job placement and police training. Opioid addiction ‘continues to exact tragic costs from [the counties’] communities, including by increasing crime rates, overburdening law enforcement, crowding the counties’ jails and addiction treatment facilities, undermining the employability of the workforce and devastating families,’ one of the counties’ attorneys, Peter Weinberger, wrote in court documents.”

The pharmacy companies reject this claim and argue that the counties vastly overstate their damages and the duration of needed remedies, which the defendants assert could be covered by as little as $35 million.

The companies also continue to dispute the legality of jurors’ finding that they violated Ohio public nuisance laws, saying that, even if this is so, the pharmacies should be fined only a fraction of the potential harm with drug makers and others getting hit with a bigger share for their proportionate roles in the opioid crisis.

A pharmaceutical giant’s newly disclosed opioid shame

As part of the $1.7 billion 2020 bankruptcy action that let drug maker Mallinckrodt reorganize and deal with its whopping financial liabilities due to the opioid crisis, the firm was forced to hand over “1.4 million records, emails, audio recordings, videotaped depositions and other materials,” and to see the materials made public in an online archive, the Washington Post reported.

The newspaper got an exclusive, detailed first run through the materials, painting a damning picture of the relentless profit-seeking path that the drug maker and its executives pursued in pushing Mallinckrodt’s prescription painkiller, a version of the drug oxycodone. The ruthless sale of the drug has not, until now, blackened the company’s reputation as much as has occurred with the now-infamous, plutocratic Sackler clan and their peddling of Purdue Pharmaceutical’s OxyContin drug. But as the Washington Post reported:

“Between 2006 and 2014, Mallinckrodt accounted for 27% of the opioid market compared with 18% for Purdue Pharma, measured by the potency of the pills they produced, according to an analysis by The Post. While the Sackler family, which owned Purdue, attracted intense national attention and [infamy] … after the company’s introduction of its blockbuster pill OxyContin, the Mallinckrodt brand slipped under the radar. ‘Everybody thinks of Purdue when they think about the opioid epidemic, but Mallinckrodt was far worse,’ said Jim Geldhof, a [federal Drug Enforcement Administration] supervisor who investigated Mallinckrodt before retiring in 2016 … ‘They were up to their eyeballs in oxycodone, and they knew exactly what they were doing. Their drugs had become the most popular on the street and they jumped in with both feet.’”

The newspaper found that Mallinckrodt inundated the country with powerful painkillers, far in excess of any conceivable legitimate patient demand:

“As the opioid epidemic took hold of the nation, Mallinckrodt’s 30 mg oxycodone tablet became the preferred drug on the street, according to the DEA. The baby-blue-colored pills, the equivalent to a hit of heroin, became so ubiquitous that the smuggling route from Florida to Appalachia became known as the ‘Blue Highway.’ In Massachusetts, Mallinckrodt’s pain pills were supplied to more than half of those who died of opioid-related overdoses during the past 12 years …”

The newspaper said company records show the perfidy Mallinckrodt relied on to hustle its drug, including:

“The largest manufacturer of opioids in the United States once cultivated a reliable stable of hundreds of doctors it could count on to write a steady stream of prescriptions for pain pills. But one left the United States for Pakistan months before he was indicted on federal drug conspiracy and money laundering charges. Another was barred from practicing medicine after several of his patients died of drug overdoses. Another tried to leave the country in the face of charges that he was operating illegal pill dispensing operations, or pill mills, in two states. He was arrested and sent to prison for eight years. These doctors were among 239 medical professionals ranked by Mallinckrodt Pharmaceuticals as its top prescribers of opioids during the height of the pain pill epidemic, in 2013. That year, more than 14,000 Americans died of prescription opioid overdoses. More than a quarter of those prescribers — 65 — were later convicted of crimes related to their medical practices, had their medical licenses suspended or revoked, or paid state or federal fines after being accused of wrongdoing … Between April and September of that year, Mallinckrodt’s sales representatives contacted those 239 prescribers more than 7,000 times.”

The newspaper said that records also show that its own employees warned the drug maker of the sketchiness of doctors that the company held in high esteem and continued to reward for excessive prescribing of opioids. The company threw money at doctors to participate in speaker programs to extol prescription painkillers, with Mallinckrodt pushing the counter factual idea that opioid addiction was rare and that doctors should target the med at segments of patients, telling physicians, for example, in marketing pitches: “With older adults, start dose low, go slow. But go!!”

Mallinckrodt declined to discuss its actions and says simply they were part of a history taken care of, legally speaking, in its bankruptcy reorganization. Besides the deep dissection by the newspaper, the Mallinckrodt files, the Washington Post reported, will be kept and overseen by Johns Hopkins University and the University of California at San Francisco, as part of the Opioid Industry Document Archive — the digital repository of records and made public as part of national litigation involving nearly 4,000 cities, towns, counties, and Indian tribes. The documents are available at industrydocuments.ucsf.edu/opioids/

A record-shattering 2021

The opioid crisis isn’t fading into history — it’s shifting and worsening, federal officials say, confirming worst-case scenarios about the death toll from this public health menace in recent days. As the New York Times reported:

“After a catastrophic increase in 2020, deaths from drug overdoses rose again to record-breaking levels in 2021, nearing 108,000, the result of an ever-worsening fentanyl crisis, according to preliminary new data published … by the Centers for Disease Control and Prevention. The increase of nearly 15% followed a much steeper rise of almost 30% in 2020, an unrelenting crisis that has consumed federal and state drug policy officials. Since the 1970s, the number of drug overdose deaths has increased every year except 2018. A growing share of deaths continue to come from overdoses involving fentanyl, a class of potent synthetic opioids that are often mixed with other drugs, and methamphetamine, a synthetic stimulant. State health officials battling an influx of both drugs said many of the deaths appeared to be the result of combining the two. Drug overdoses, which long ago surged above the country’s peak deaths from AIDS, car crashes and guns, killed about a quarter as many Americans last year as Covid-19.”

The expert assessments of the opioid crisis are increasingly grim, the New York Times reported:

“Deaths involving synthetic opioids — largely fentanyl — rose to 71,000 from 58,000, while those associated with stimulants like methamphetamine, which has grown cheaper and more lethal in recent years, increased to 33,000 from 25,000. Because fentanyl is a white powder, it can be easily combined with other drugs, including opioids like heroin, and stimulants like meth and cocaine, and can be stamped into counterfeit pills for anti-anxiety drugs like Xanax. Such mixtures can prove lethal if drug users are unaware they are taking fentanyl or are unsure of the dose. Deaths from both classes of drugs have been rising in recent years. But there is growing evidence that mixing stimulants and opioids — into combinations known as ‘speedballs’ and ‘goofballs — is becoming more common, too.”

The Biden Administration, the newspaper reported, has announced steps to battle the opioid crisis, including offering a “national drug control strategy, and a plan to combat meth use.” As the news article noted:

“Mr. Biden is the first president to embrace harm reduction, an approach that has been criticized by some as enabling drug users, but praised by addiction experts as a way to keep drug users alive while providing access to treatment and support. Instead of pushing abstinence, the approach aims to lower the risk of dying or acquiring infectious diseases by offering sterile equipment — through needle exchanges, for example — or tools to check drugs for the presence of fentanyl. Strips that can detect fentanyl have become increasingly valuable resources for local health officials, and some states have moved recently to decriminalize them, even as others resist.”

The administration also is pushing to increase to wide availability drugs that can be given in emergencies and that reverse opioid overdoses.

In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damage that can be inflicted on them and their loved ones by dangerous drugs, especially prescribed products like addictive painkillers from Big Pharma.

The opioid crisis — fostered for years by Big Pharma, doctors, nurses, hospitals, insurers, and others in the U.S. health care system — has entered its latest and notably bad stage with easily and cheaply made, exceedingly powerful synthetic painkillers like fentanyl flooding the country. Public health and law enforcement officials have warned that criminals are tainting an array of illicit street products, now including marijuana, with fentanyl, promising a higher high to buyers. They may not realize, though, that dosage of so potent a drug can be tough to control. It can be lethal, especially to the unsuspecting.

The opioid horror has its roots in Big Pharma hype and misinformation about its hugely profitable products. Drug makers flooded the country with pills. These, in turn, opened the door to strong, familiar, and lethal street drugs, notably heroin and meth. At least a half million Americans lost their lives to the opioid crisis in a decade, experts estimated, even before the death toll spiked in recent times, especially due to the isolation, loneliness, and reduction in drug treatment and fighting efforts caused by the coronavirus pandemic.

We have much work to do to quell the opioid crisis and to bring to justice those who brought this killer on the country.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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