By Rebecca Mayo, J.D.
An Oklahoma trial court found that the drug manufacturer caused a public nuisance in Oklahoma by contributing to the state’s opioid crisis through false, misleading, and dangerous marketing campaigns.
The court found that Johnson & Johnson engaged in false and misleading marketing of both its drugs and opioids generally through a campaign that spread messages that pain was undertreated and that opioids were an effective and low-risk solution—statements which the Food and Drug Administration (FDA) and Johnson & Johnson’s own experts informed them were prone to mislead or outright false. The court held that the increase in opioid addiction and overdose deaths following the parallel increase in opioid sales in Oklahoma were causally linked and ordered Johnson & Johnson to pay Oklahoma for the costs of the state’s Opioid Crisis Abatement Plan for year one (Oklahoma v. Johnson & Johnson, August 26, 2019, Balkman, T.).
Opioid manufacturing. Johnson & Johnson manufactured and sold its own branded opioid drugs, which included Duragesic, Ultram, Ultracet, Nucynta, and Tylox. From the 1990s through at least 2016, Johnson & Johnson owned two subsidiaries, Noramco, Inc. and Tasmanian Alkaloids Limited, through which it supplied oxycodone, hydrocodone, morphine, codeine, fentanyl, sufentanil, buprenorphine, hydromorphone, and naloxone to other drug manufacturers. By 2015, the combined subsidiaries became the number one supplier of narcotic APIs (active pharmaceutical ingredients) in the United States, which was the world’s largest market.
Opioid marketing. In 1997, Johnson & Johnson relaunched the Duragesic patch for the chronic, non-cancer pain market and embarked on a major campaign to disseminate the message that pain was being undertreated. The campaign claimed that there was a low risk of abuse and low danger in prescribing opioids, and it overstated the efficacy of opioids. Johnson & Johnson trained sales representatives to use "emotional selling" by convincing physicians that undertreated pain was harming patients and that undertreated acute pain inevitably would turn to chronic pain. They convinced doctors that patients who asked for higher doses of opioids or asked for early refills were suffering because of undertreatment of pain rather than addiction and that physicians should prescribe more opioids. Sales representatives were trained to avoid negatives (addiction) and emphasize the positives (supposed efficacy) in sales calls.
Johnson & Johnson made substantial payments of money to different pain advocacy groups and organizations that influenced prescribing physicians. Two of those organizations issued a statement in 1996 claiming that pain was undertreated and that doctors should prescribe more opioids. Johnson & Johnson also created and funded the National Pain Education Council (NPEC), whose stated purpose was to provide continuing medical education related to pain and opioids; however, internal Johnson & Johnson business plan documents indicated that it was to benefit Duragesic and all future pain products.
False and misleading statements. In 1998, the FDA found that posters Johnson & Johnson used to promote Duragesic contained false and misleading marketing messages. In 2001, a scientific advisory board hired by Johnson & Johnson informed them that many of the primary marketing messages used to promote opioids in general, and Duragesic specifically, were misleading and should not be disseminated. They also specifically noted that Purdue had gotten "in trouble" for using similar misleading statements. In 2004, the FDA sent Johnson & Johnson a letter requesting that it cease using some Duragesic promotional materials that contained false or misleading claims about the abuse potential and other risks and that included unsubstantiated effectiveness claims.
Public nuisance. The court found that an actionable nuisance does not require the use of a connection to real or personal property. However, if it did, it found that Johnson & Johnson sales representatives were trained in their Oklahoma homes, conducted their marketing and sales efforts in doctors’ offices, hospitals, restaurants, and other venues, used company cars traveling on state and country roads to disseminate those messages, paid speakers to deliver messages to doctors in Oklahoma offices, and sent their messages into the homes of thousands of Oklahomans via computers, smart phones, and other devices, all of which involved the use of property, real and personal, to create and exacerbate the public nuisance.
Johnson & Johnson’s own internal training documents indicated that false and misleading promotion included broadening of product indication, data taken out of context, minimization of safety issues, omission of material information, and comparative efficacy or safety claims without substantial evidence. The court found that Johnson & Johnson violated each of these rules and that the campaigns caused exponentially increased rates of addiction, overdose deaths, and Neonatal Abstinence Syndrome. These qualified as unlawful acts which annoy, injure, or endanger the comfort, repose, health, or safety of others as defined by the Oklahoma nuisance law. Further, there were no intervening causes that supervened or superseded Johnson & Johnson’s acts and omissions as a direct cause of Oklahoma’s injuries, and the nuisance negatively impacted the entire state.
Abatement. Oklahoma developed an Abatement Plan that included a number of costly programs, including Opioid Use Disorder Prevention, Treatment & Recovery Services, Addiction Treatment, public medication and disposal programs, Universal Screening, pain prevention and non-opioid pain management therapies, expanded naloxone distribution, and overdose prevention education. Based on the costs associated with these programs, the court determined that the sum necessary to carry out the Abatement Plan in year one is $572,102,028. Since Oklahoma did not present sufficient evidence of the amount of time and costs necessary, beyond year one, to abate the opioid crisis, the court ordered Johnson & Johnson to pay the costs associated with the Abatement Plan for year one.
Johnson & Johnson statement. In a news release, Johnson & Johnson stated that it and its subsidiaries, Janssen Pharmaceutical Companies, will appeal the $572 million judgment. The company said that it "is confident it has strong grounds to appeal th[e] decision." According to Johnson & Johnson, the court's judgment disregarded the drug maker's compliance with state and federal laws, "the unique role its medicines play in the lives of the people who need them, its responsible marketing practices," and that its opioid drugs have accounted for less than one percent of total opioid prescriptions in Oklahoma as well as the United States. Further, the news release maintains that the court's decision is flawed and the judgment is not consistent with the facts or the law. The company explains that the state did not present evidence that the company’s products or actions caused a public nuisance in Oklahoma; and that the state’s claims violate principles of due process by seeking to hold a company liable for conduct permitted under federal law and regulations. Finally, Johnson & Johnson asserts that the ruling "disregards 100 years of precedent in public nuisance law, which traditionally has been applied to resolve property disputes, not lawsuits involving the sale of goods." Michael Ullmann, Executive Vice President and General Counsel for Johnson & Johnson, stated, "This judgment is a misapplication of public nuisance law that has already been rejected by judges in other states."
Statement from the Office of the Oklahoma Attorney General. Oklahoma Attorney General Mike Hunter expressed his appreciation for Cleveland County District Judge Thad Balkman’s decision, noting that it was "the first of its kind in the country to find an opioid manufacturer liable for the harm caused from the opioid crisis in the United States." He further remarked that the judge had "affirmed our position that Johnson & Johnson maliciously and diabolically created the opioid epidemic in our state. Our evidence convincingly showed that this company did not just lie and mislead, they colluded with other companies in route to the deadliest manmade epidemic our nation has ever seen."
The statement issued by the Office of the Oklahoma Attorney General asserted that the evidence at trial showed that between 1999 and 2017, Oklahoma doctors were targeted over 150,000 times by Johnson & Johnson sales representatives, and that these representatives "aggressively marketed and bombarded doctors with pseudoscience and misleading information that downplayed the risks of opioids, leading to the public nuisance." Mr. Hunter said that he was hopeful that the judgment would provide a degree of solace to families affected by the opioid crisis.
The case is No. CJ-2016-816.
Attorneys: Michael Burrage (Whitten Burrage) and Mike Hunter, Attorney General for State of Oklahoma, for State of Oklahoma. John H. Sparks (Odom Sparks & Jones, PLLC), Larry Ottaway (Foliart Huff Ottaway & Bottom) and Stephen Brody (O'Melveny & Myers LLP) for Johnson & Johnson. Robert G. McCampbell (Gable Gotwals) and Nancy Patterson (Morgan, Lewis & Bockius LLP) for Cephalon Inc. and Teva Pharmaceuticals.
Companies: Johnson & Johnson; Cephalon Inc.; Teva Pharmaceuticals
MainStory: TopStory DamagesNews DrugsNews OklahomaNews
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