Dive Brief:
- Joining the recent flurry of prescription painkiller litigation, South Carolina filed a lawsuit Tuesday against Purdue Pharma L.P., alleging the drugmaker contributed to the state's opioid epidemic by deceptively marketing its products.
- The lawsuit holds that Purdue violated South Carolina’s Unfair Trade Practices Act, created a public nuisance and didn't comply with a 2007 consent judgment on marketing tactics used for its drug Oxycontin. Among other things, Purdue told physicians that patients who were on prescription opioids to manage pain wouldn't become addicted, while those who did appear dependent on the drugs were actually "pseudoaddicted," according to Alan Wilson, South Carolina's attorney general.
- Purdue has contended that extended-release analgestics such as OxyContin make up a much smaller percentage of the total U.S. opioid prescription market than immediate-release drugs, and that the company remains committed to abuse deterrence through the development of new formulations.
Dive Insight:
"While we vigorously deny the allegations, we share South Carolina officials’ concerns about the opioid crisis and we are committed to working collaboratively to find solutions," Purdue said in a statement to BioPharma Dive.
"OxyContin accounts for less than 2% of the opioid analgesic prescription market nationally, but we are an industry leader in the development of abuse-deterrent technology, advocating for the use of prescription drug monitoring programs and supporting access to naloxone — all important components for combating the opioid crisis."
In June, Purdue announced the second phase of its partnership with the National Sheriffs' Association. The phase provides an additional $500,000 for funding naloxone kits, which are able to reverse overdose from some opioids, as well as training for front-line officers.
Still, efforts from Purdue and other opioid drugmakers to combat the crisis don't appear to be winning them back many points with advocacy groups or lawmakers. In March, for instance, U.S. Senator Claire McCaskill, D-MO, launched an investigation into Purdue, Johnson & Johnson, Insys Therapeutics Inc., Mylan N.V. and Depomed Inc. — manufacturers of the top five opioids on the market based on 2015 sales — to look at their role in opioid overuse and overprescribing. The Drug Enforcement Agency is also considering reducing opioid manufacturing by a fifth next year.
Late last week, President Donald Trump signaled he would declare the prescription opioid epidemic gripping the U.S. a national public health emergency. The decision came just days after the Trump-appointed Commission on Combating Drug Addiction and the Opioid Crisis reported roughly 140 people in the country die from drug overdoses every day. The Centers for Disease Control and Prevention has estimated that 33,000 people died in 2015 specifically from opioid overdoses.
Now, South Carolina is adding to the growing number of cases filed against drug manufacturers over the marketing and sales of opioids. These include lawsuits from states, counties and cities in California, Illinois, Mississippi, Missouri, New Hampshire, New York, Ohio, Oklahoma, Oregon and Tennessee.
Purdue has had a history of challenges over its opioid development and marketing. In 2007, the company plead guilty to misbranding and misleading regulators about the risks associated with its drug OxyContin (oxycodone), resulting in Purdue shelling out around $600 million in fines. Three executives, including the company's then-president and top lawyer, also plead guilty to misbranding and were hit with their own multi-million dollar fines.
In tandem with its guilty plea, the company issued a nearly $20 million payout to 26 states and the District of Columbia pertaining to its marketing strategy. And in December 2015, Purdue forked over $24 million to settle a misrepresentation case for OxyContin in Kentucky, after making an initial offer of $500,000 in 2007.
Specific allegations in the current South Carolina lawsuit include that, since 2007, Purdue has downplayed how addictive its opioids are and overstated their benefits compared with non-opioid pain management to increase its market share and profits. The complaint also accuses Purdue of continuing to "mislead and obfuscate" since the 2007 consent judgment, rather than taking steps to reform its marketing.