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Johnson & Johnson to Pay $572 Million in Opioid Crisis Lawsuit

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This week, a judge in Oklahoma ordered pharmaceutical company Johnson & Johnson to pay $572 million for its role in the opioid crisis that has ravaged the country and killed more than 6,000 people in Oklahoma alone. The ruling is the first to hold a drug manufacturer responsible for the crisis, which was fueled by companies flooding the market with addictive painkillers and pushing doctors to overprescribe the drugs. The amount is far less than the $17.5 billion that the state’s attorney general sought, and the company says it plans to appeal the ruling.

Cleveland County District Judge Thad Balkman ruled that the state met its burden in arguing that the company created a “temporary public nuisance” by using “misleading marketing and promotion of opioids,” and added in his ruling that “those actions annoyed, injured or endangered the comfort, repose, health or safety of Oklahomans.”

Judge Balkman cited Johnson & Johnson’s deceptive and aggressive marketing of painkillers to doctors, and the company’s practice of discouraging its sales representatives from discussing addiction or other negative consequences of using the drugs, while encouraging their prescription for both moderate and severe pain. The company also sought to convince doctors that they were under-prescribing pain medications and that having patients ask for higher doses was not a sign of addiction, just indicative of needing more to address their pain.

Johnson & Johnson markets the painkillers Duragesic (fentanyl) and Nucynta, both of which contain opioids. The company has also long manufactured the raw ingredients for other companies’ opioid-based painkillers, having bought a company in Tasmania in the 1980s that grows poppies and processed opium. According to the New York Times, by the height of the opioid epidemic, the company had become “the leading supplier for the ingredients in painkillers in the United States,” having developed a specific strain of poppy that provided the basis for Purdue’s Oxycontin, as well as manufacturing and supplying ingredients for “a range of other drugs, including hydrocodone, morphine, codeine and buprenorphine.”

Michael Ullmann, Johnson & Johnson’s general counsel, released a statement calling the judgement “a misapplication of public nuisance law that has already been rejected by judges in other states.” He also noted, “The unprecedented award for the state’s ‘abatement plan’ has sweeping ramifications for many industries and bears no relation to the company’s medicine or conduct.”

The amount decided for damages may actually seem low—$572 million will reportedly only fund a single year of Oklahoma’s opioid recovery plan, which the state estimates will cost $12.7 billion to $17.5 billion over 20 to 30 years. The company’s stock even rose this week, which some attribute to relief over the relatively low damages.

However, many are cheering the Oklahoma ruling as other lawsuits near their court dates. This includes a massive federal lawsuit scheduled for October in Cleveland, Ohio, that brings together more than 2,000 separate cases. Judge Balkman’s decision that the company’s activities constituted a public nuisance opens the door for similar rulings in other state cases, and an additional legal avenue for holding companies responsible for their part in the epidemic.

Also this week, Oxycontin manufacturer Purdue Pharma pledged to pay $10 billion to $12 billion to settle thousands opioid-related claims, according to NBC News. Purdue had been part of the Oklahoma suit, but to avoid the lawsuit, Purdue agreed in March to pay a $270 million settlement to establish an addiction treatment and research center at Oklahoma State University, and provide continued funding over five years. Purdue’s owners the Sackler family also agreed to pay $75 million to the center for five years. In May, Israel-based Teva Pharmaceuticals also settled with Oklahoma for $85 million, which will further fund the state’s effort to combat opioid addiction.

Workforce Drug Positivity Rate Still Peaking

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Workforce use of illicit drugs across the board—including cocaine, marijuana and methamphetamine—remains at its highest rate in a decade, a new study by Quest Diagnostics found.

Overall positivity in urine drug testing among the combined U.S. workforce in 2017 continued to hold at 4.2%, which is still 0.7% higher than the positivity rate from 2012, which represented a 30-year low. The findings were made from analysis of more than 10 million workforce drug test results.

“It’s unfortunate that we mark 30 years of the Drug-Free Workplace Act with clear evidence that drugs continue to invade the country’s workplaces. Not only have declines appeared to have bottomed out, but also in some drug classes and areas of the country drug positivity rates are increasing,” Barry Sample, senior director of science and technology at Quest Diagnostics, said in a statement.

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“These changing patterns and geographical variations may challenge the ability of employers to anticipate the ‘drug of choice’ for their workforce or where to best focus their drug prevention efforts to ensure a safe and healthy work environment.”

The new data indicates shifting patterns of drug use, with cocaine and amphetamines positivity surging in some areas of the country and marijuana positivity rising sharply in states with newer recreational use statutes.

Opioids
The one bit of good news is that prescription opiate positivity rates declined dramatically on a national basis. Quest reported that the positivity rate for opiates in the general U.S. workforce in urine drug testing declined 17% between 2016 and 2017 (0.47% versus 0.39%). More notably, oxycodones (oxycodone and/or oxymorphone) positivity declined 12% between 2016 and 2017 (0.69% vs. 0.61%), hydrocodone positivity declined 17% (0.81% vs. 0.67%); and hydromorphone positivity declined 22% (0.59% vs. 0.46%). Opiates other than codeine were at their lowest positivity rate in more than a decade.

This data is supported by the Centers for Disease Control and Prevention (CDC), which shows that the overall national opioid prescribing rate in 2017 fell to the lowest it had been in more than 10 years, although rates vary by state and are high in some areas of the country.

The topic was explored during an educational session at RIMS 2018, where it was noted that the decrease in opioid use may be attributed to corporate initiatives like prescription drug monitoring policies (PDMP), which can limit employees’ ability to refill scripts, in addition to states that had comprehensive reforms.

“This shows that the more queries there are, the bigger the drop in opioid prescribing,” said John Ruser, president and CEO of the Workers Compensation Research Institute (WCRI), last month in San Antonio. He said WCRI used Kentucky as an example of a successful PDMP. Kentucky’s HB1 law mandated the use of the PDMP and between 2011 and 2013, WCRI information indicated a 10% decline in prescriptions in the state, whereas prescription levels were flat in others that did not have similar reforms.

Methamphetamine
Methamphetamine positivity, however, is increasing. An analysis of trends in the general U.S. workforce based on the four U.S. Census regions identified large increases of methamphetamine positivity rates. Between 2013 and 2017, methamphetamine positivity increased: 167% in the East North Central division of the Midwest (Illinois, Indiana, Michigan, Ohio, Wisconsin); 160% in the East South Central division of the South (Alabama, Kentucky, Mississippi, Tennessee); 150% in the Middle Atlantic division of the Northeast (New Jersey, New York, Pennsylvania); and 140% in the South Atlantic division of the South (Delaware, District of Columbia, Florida, Georgia, Maryland, North Carolina, South Carolina, Virginia, West Virginia). The percentage increase in these four divisions ranged between 9% and 25% between 2016 and 2017.

Marijuana
Overall, marijuana positivity continued its five-year upward climb for both the general U.S. workforce and the federally-mandated, safety-sensitive workforce. Marijuana positivity increased 4% in the general U.S. workforce (2.5% in 2016 versus 2.6% in 2017) and nearly 8% in the safety-sensitive workforce (0.78% versus 0.84%).

Increases in positivity rates for marijuana were most striking in states that have enacted recreational use statues since 2016. Those states include: Nevada (43%), Massachusetts (14%) and California (11%). These three states also saw significant increases in marijuana positivity in federally-mandated, safety-sensitive workers: Nevada (39%), California (20%), and Massachusetts (11%). Federally-mandated, safety-sensitive workers include pilots, rail, bus and truck drivers, and workers in nuclear power plants, for whom routine drug testing is required by the Department of Transportation.

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“These increases are similar to the increases we observed after recreational marijuana use statues were passed in Washington and Colorado,” Sample said. “While it is too early to tell if this is a trend, our data suggest that the recreational use of marijuana is spilling into the workforce, including among individuals most responsible for keeping our communities safe.”

2016 Drug Overdose Death Rate 3-Times Higher than in 1999

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Deaths from drug overdose have reached crisis proportions in the United States, with more than 63,600 deaths in 2016—more than three times that of 1999. The majority were males, whose deaths increased from 8.2 in 1999 to 26.2 in 2016; compared to females, whose rate rose from 3.9 in 1999 to 13.4 in 2016, according to the Centers for Disease Control and Prevention (CDC).

Authors of the report noted, “The pattern of drugs involved in drug overdose deaths has changed in recent years. The rate of drug overdose deaths involving synthetic opioids other than methadone (drugs such as fentanyl, fentanyl analogs, and tramadol) doubled in a single year from 3.1 per 100,000 in 2015 to 6.2 in 2016. Additionally, it’s important to note that many drug overdose deaths may involve multiple drugs.”
Of people age 15 and above:

• Rates of drug overdose deaths increased from 1999 to 2016 for all groups studied.

• Rates in 2016 were highest for people between the ages of 25 and 54.

• From 2015 to 2016, the drug overdose death rates for adults age 45-54, 55-64 and 65 and above went up 15%, 17% and 7% respectively, the CDC said.
In 2016, 22 states and the District of Columbia had overdose death rates that were statistically higher than the national rate. States with the highest number of overdose deaths were: West Virginia, with 52 per 100,000; Ohio with 39.1; New Hampshire with 39; District of Columbia with 38.8; and Pennsylvania, which had 37.9 deaths per 100,000.

States with the lowest age-adjusted drug overdose rates were: Iowa, which had 10.6 deaths; North Dakota, 10.6; Texas, 10; South Dakota, 8.4; and Nebraska, which had 6.4 deaths.
In it’s most recent study, Quest Diagnostics found that workforce use of illicit drugs across the board—including cocaine, marijuana and methamphetamine—has climbed to the highest rate in 12 years.

Overall positivity in urine drug testing among the combined U.S. workforce in 2016 was 4.2%, a 5% relative increase over last year’s rate of 4%—the highest annual positivity rate since 2004 (4.5%), according to an analysis of more than 10 million workforce drug test results.

Opioids in the Office

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Narcotics abuse among the American public has received a good amount of publicity lately — and rightly so. There are now more workers addicted to opioids than ever before. And it seems physicians may not be doing all they can to regulate patient intake.

In fact, a new report by the Workers Compensation Research Institute (WRCI) states that one in 12 injured workers who started prescription narcotics were still using them three to six months later. “Longer-Term Use of Opioids” examined long-term use of narcotics in 21 states and how often physicians monitored injured patients after prescribing the drugs.

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“This study addressed a very serious issue: how often doctors followed recommended treatment guidelines for monitoring injured workers under their care, who are longer-term users of narcotics,” said Dr. Richard Victor, WCRI’s Executive Director. “This study will help public officials, employers, and other stakeholders understand as well as balance providing appropriate care to injured workers while reducing unnecessary risks to patients and costs to employers.

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”

Among the key findings were:

  • Longer-term use of opioids continued to be prevalent in workers compensation, especially in Louisiana and New York, as well as Texas, Pennsylvania, South Carolina, California and North Carolina.
  • Drug testing was used less frequently than recommended by medical treatment guidelines. Among claims with longer-term use of narcotics, 18-30% received drug testing in most states studied, with the 21-state median at 24%. Over the study period, the percentage of workers with longer-term use of narcotics who received at least one drug test increased from 14 to 24% in the median state.
  • Use of psychological evaluation and treatment services continued to be low. Only 4–7% of the injured workers with longer-term narcotic use received these services in the median state. Even in the state with the highest use of these services, only 1 in 4 injured workers with longer-term narcotic use had psychological evaluation and 1 in 6 received psychological treatment.
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    Little change was seen in the frequency of use of these services.

The graph below is disturbing, considering the addictive nature of opioids, especially the longer the patient is dependent on them.

In response to these findings and the media coverage surrounding them, the Office of National Drug Control Policy (ONDCP) issued a statement regarding an initiative aimed at addressing the problem. The agency unveiled its new web-based program that was developed to help doctors prescribe addictive medications, such as Oxycontin and Percocet, in a more safe and controlled manner.

Prescription drug abuse is the nation’s fastest-growing drug problem and affects everyone from teenagers to stay-at-home moms to, most likely, the very people you work with. We are dealing with what the Centers for Disease Control and Prevention classifies as an epidemic. And though the Obama Administration’s National Drug Control Strategy and the ONDCP’s 2011 Prescription Drug Abuse Prevention Plan are helpful in addressing the problem, they will in no way solve it. For that, education is key, not only in the homes and schools of the American public, but in the workplaces as well. It’s smart risk management.