In the midst of the nationwide epidemic of opioid addiction and overdoses, states and local governments are turning to the courts in an effort to slow the overprescribing of opioid drugs and recover some of the costs for treating opioid addiction.
Ohio is the latest state to file a lawsuit against a host of drug makers and related entities, alleging they committed fraud by knowingly making false and misleading statements about their prescription opioid drugs. Ohio says the companies violated a number of laws, including consumer protection and product liability laws, and created a public nuisance.
Illinois, Mississippi, the city of Everett, Washington, Chicago, and several counties in California, New York, Tennessee, and West Virginia, are among those that have filed similar lawsuits, mostly in the last year, against opioid manufacturers.
Because opioids have a high potential to create dependency if used for more than a few days, the US Food and Drug Administration (FDA) has generally approved the use of opioids only to treat acute, short-term pain, such as that occurring after a surgery. According to the Ohio complaint, in order to boost sales, drug makers have engaged in allegedly false and misleading marketing campaigns to promote opioids for the treatment of chronic, long-lasting pain, such as back pain and migraines.
By misrepresenting the risks and benefits of those drugs, the lawsuit alleges, the drug companies increased prescriptions and fueled a crisis that saw over 4,000 overdose deaths in Ohio last year alone. In 2012, the number of opioids prescribed in Ohio amounted to 68 pills for every person in the state, including children. The state estimates there were 200,000 opioid addicts in Ohio last year, which is roughly equivalent to the population of Akron.
Ohio is seeking to recover the money its Medicaid and state workers’ compensation programs paid for excessive opioid prescriptions and the resulting costs to the state to treat opioid addiction. The lawsuit also seeks restitution for consumers who, like the state, were misled about the dangers of opioid use. That restitution could come in the form of money returned to consumers who purchased opioids because of the accused companies’ alleged practices. In addition, the state is seeking a court order prohibiting the drug companies from continuing their misleading practices.
Among other things, the Ohio complaint alleges that one of the defendants, Cephalon, promoted Actiq and another fentanyl-based opioid, Fentora, for chronic pain even though the FDA had expressly declined to approve them for chronic pain because of a high risk of adverse events and abuse.
This is not the first time Cephalon has been accused of this kind of misconduct. Ten years ago, Cephalon was sued under the False Claims Act by whistleblowers, including one represented by Phillips & Cohen LLP, and the federal government for harmful and illegal “off-label” marketing practices. One of the most concerning allegations in the law firm’s whistleblower case against Cephalon was that the company was marketing Actiq, a fentanyl-based opioid, to internists and general practitioners for general pain treatment even though the FDA had approved Actiq only to treat cancer patients when their usual pain medication doesn’t control episodes of extreme pain.
Cephalon paid $425 million to the federal government and several states in 2008 to settle the whistleblower cases and a related criminal charge.
Notably, the Ohio lawsuit also alleges that the companies used “front groups,” with names such as the American Pain Foundation and the American Academy of Pain Medicine, which gave the appearance of being independent medical bodies but in reality were financed largely by the same drug companies whose products they touted as safe.
The pharma companies named as defendants in the lawsuit include: Purdue Pharma, Teva, Cephalon, Johnson & Johnson, Janssen, Ortho-McNeil-Janssen (part of Johnson & Johnson), Endo Health Solutions, Allergan PLC, Watson Pharmaceuticals, and Actavis.