CHARLESTON – The state court trial accusing Janssen, the drug arm of Johnson & Johnson, and opioid suppliers Teva, Cephalon and Allergen of causing an epidemic in the West Virginia has begun.
The trial began April 4 in Kanawha Circuit Court. It is being streamed live courtesy of Courtroom View Network. West Virginia Attorney General filed the lawsuits in late 2019 in Boone Circuit Court. They now are being heard by the state's Mass Litigation Panel and Judge Derek Swope. It's a bench trial, which means there is no jury. Swope will decide the outcome.
The latest of several state-conducted lawsuits including in Washington State and Florida against opioid distributors and manufacturers, plaintiff attorneys in West Virginia will seek to prove the companies ignored the addictive dangers of the drugs so they could profit by promoting them, and maintained ineffective anti-drug diversion programs. They will seek millions in damages to fund addiction-treatment programs.
Swope
Also originally included as a defendant was Endo, but Morrisey announced last week that company settled with West Virginia for $26 million.
The complaints filed separately in 2019 in the Boone Circuit Court alleging the companies deliberately promoted a misinformation campaign to deceive the public. The charges include the creation of a public nuisance and violations of the state's Consumer Credit & Protection Act.
West Virginia is considered ground zero in the opioid epidemic. According to wvparinatal.org the state has the nation's highest overdose rate (three times above the national average) and is highest in non-medical use of opioids. Native American tribal reservations also have high rates.
As they have in other opioid trials, defense attorneys will say societal problems and illegal misuse of drugs including heroin are responsible for the epidemic, not distributors and manufacturers legally responding to doctors prescriptions.
During opening remarks, plaintiff attorneys sought to portray a pill dispensing system in West Virginia that was out of control.
“The risks of addiction are clear,” Linda Singer, an attorney for the state from the Motley Rice law firm, said during Monday's opening arguments. “They understated the risks and overstated the benefits (of opioids). This tipped the balance.”
Plaintiff attorneys say the roots of the epidemic began in the 1990s when the medical community decided pain was being undertreated and expanded the use of opioids beyond cancer and end-of-life treatments. In addition, with the emergence of online pharmacies and loose-dispensing clinics called “pill mills,” the numbers of pills soared after 2006.
Singer challenged the notion that greater use of opioids and the expansion of what she called a “pain ladder” by the defendants was a benefit. A Centers for Disease Control exhibit chart read, “Longer than six weeks (taking opioids) shows consistent poor results and may impair functioning.”
"Janssen co-opted and expanded the pain ladder,” Singer said. “Allergan and Teva downplayed addiction.”
Singer said sales reps for the companies adopted a policy of downplaying the potential risks of opioids in order to sell them, to never mention the possibility of addiction. In a displayed graphic from the World Health Organization she said by 2015, 8 to 12 percent of users would develop some form of use disorder.
“That is not rare,” Singer said. “The FDA (Food & Drug Administration) repeatedly warned the defendants what they were saying was inappropriate; they were false messages. They (companies) knew that. The FDA told them. The defendants’ marketing was deceptive.”
The most commonly shipped opioid drugs include OxyContin, Hydrocodone, methadone and fentanyl.
“Fentanyl is the most potent of the drugs,” Singer said. “It was a breakthrough for cancer pain, but in 1998 it was so dangerous the FDA restricted its distribution. That wasn’t lucrative enough. So they (companies) expanded it, for migraine, or sickle cell pain. We started to see abuse and diversion.”
Singer exhibited a photo with a girl sucking on a “Perc-a-Pop,” a lollipop made with fentanyl. She said the U.S. Dept. of Justice had investigated and found company sales reps improperly promoting fentanyl products. She said J&J supplied the epidemic.
“The defendants helped change the standards of care,” Singer said. “The evidence will show the defendants spent millions marketing these drugs.”
Each of the defendants had their own attorney speak for them. Representing Teva Pharmaceuticals, Josh Barlow agreed there was an opioid misuse crisis in West Virginia. But it was one of illegal drugs he said, not from Teva doing it's legal business supplying drugs for the treatment of chronic pain.
"There are many factors (to the crisis), but not one has to do with our clients," Barlow said, adding that the medications were supplied for "medically appropriate, necessary prescriptions."
He said the court would find not a single case of the company exceeding drug limits, supplying unnecessary prescriptions, diverting orders or conducting inappropriate marketing.
"Absence of proof is no proof at all," Barlow said.
Barlow said Teva performed legally appropriate business supplying drugs under regulations of the FDA and that responsibility for prescribing a drug was that of a doctor.
“There is no evidence Teva caused any harm or anything in West Virginia that resulted in medically inappropriate prescriptions,” he said. The under-treatment of pain is a serious problem. When (drugs) are used as recommended it is most effective and safe. There is nothing unreasonable or unfair.”
Barlow indicated that state attorneys would present a distorted picture of the case.
“You will not hear a single order was diverted and caused harm,” he repeated.
Speaking for Janssen, Michael Yoder with O’Melveny & Myers said the company had acted in a responsible reasonable manner supplying crucial drugs to treat everything from cancer to the COVID pandemic. Two drugs the company supplied were Nucynta and the later-developed Nucynta ER.
“The issue is not an opioid crisis in the state,” Yoder said. “We understand lives have been lost and destroyed. We will not dispute that. But this (West Virginia) is a high drug trafficking area. The crisis has not been born of appropriate use, but unfortunately a history of illicit use.”
Yoder said all drugs from the companies undergo extensive testing and approvals from the FDA during a trial and error period that can take up to 10 years. He added that Janssen also conducted surveillance of the drug products after they were put on the market.
“The FDA has to determine a medication is safe and effective,” Yoder said. “The FDA and Janssen understand there are certain risks. The product label has to be complete and accurate and contains strong warnings. The risks were well known to doctors when Nucynta was launched (2009). Janssen did not engage in wrongful conduct in West Virginia and were not the cause of a public nuisance.”
After the opening arguments, Morrisey outlined the plaintiffs' plan.
"Today was a very important day," he said. "We’re going to continue to press. We’ve got a lot of big days in front of us as we go through the course of the case for the next month and a half.
"As many people are going to see, as we call our witnesses over the course of the upcoming weeks, we’re going to prove that argument. We feel good about it. We’re going to keep grinding it out and pushing very hard.
"There’s a lot at stake for West Virginia. It affects every single part of West Virginia."
