Rural health clinics claim drug makers and distributors 'created and engineered' opioid epidemic, seek national class action

"Two rural Kentucky health clinics are trying to open a new front in the legal battle against drug companies that allegedly used improper tactics to fan an epidemic of addiction to powerful painkillers called opioids," Bill Estep reports for the Lexington Herald-Leader.

“These pharmaceutical companies aggressively advertised to and persuaded practitioners to prescribe highly addictive, dangerous opioids, and turned patients into drug addicts or dependents for their own corporate profit,” charges the complaint by Family Practice Clinic of Booneville Inc., and Family Health Care Clinic PSC of Richmond. It says the firms "created and engineered" the epidemic.

"Their lawsuit lists more than 20 defendant pharmaceutical manufacturers and distributors," Estep reports. "Some of the companies are subsidiaries of others in the complaint. Three attorneys with the Lexington firm of McBrayer, McGinnis, Leslie & Kirkland, along with a firm from Georgia, filed the lawsuit for the clinics."

Estep notes, "Lawsuits seeking damages from drug companies for conduct that allegedly worsened the drug crisis in Kentucky and the nation are not new. There are hundreds of such cases pending around the country." But this one is the first by rural health clinics, according to David J. Guarnieri, one of the Lexington attorneys.

The suit seeks unspecified damages and asks that it be made a class action on behalf of more than 4,100 rural health clinics, including 745 in Appalachian areas of Kentucky (which has 191), Alabama, Mississippi, North Carolina, Ohio and Tennessee. “They’re on the front lines dealing with the opioid crisis,” Guarnieri said.

"The lawsuit argues that drug makers used false and misleading claims to push their products, such as down-playing the risk of addiction; claiming that it is easy to manage opioid dependence and withdrawal; and denying risks from using higher doses of the drugs," Estep reports. "It also alleges the companies targeted vulnerable patient populations, including people served by rural health clinics in Appalachia. There is a high prevalence of “societal risk factors which contribute to an increased and widespread abuse of opioids” in the region, the lawsuit says, including lower income; lower educational attainment; depression; a higher portion of jobs prone to injuries; and poor health status."

The suit claims distributors of the drugs failed "to stop suspiciously large shipments of painkillers and by not reporting red flags about possible diversion of prescription pills to the government as required," Estep reports. It says addiction to opioids "drives up costs for rural health clinics, not just for providing treatment but for added needs such as regulatory compliance and security; lost employee productivity; and having to kick out patients for abusing or diverting prescribed drugs."

Conway gets $24 million from Purdue Pharma to settle Oxycontin claim, $15.5 million from J & J subsidiary in Risperdal case

Purdue Pharma will pay the state $24 million to settle a lawsuit that claimed the drug maker "illegally misrepresented and/or concealed the highly addictive nature of OxyContin and encouraged doctors who weren’t trained in pain management to overprescribe the opioid pain reliever to Kentucky patients," Attorney General Jack Conway announced Dec. 23.

The company did not admit liability, but Conway said, “Purdue Pharma created havoc in Kentucky, and I am glad it will be held accountable. Purdue lit a fire of addiction with OxyContin that spread across this state, and Kentucky is still reeling from its effects.” Bill Estep of the Lexington Herald-Leader notes, "Abuse of OxyContin snowballed in Eastern Kentucky beginning in the late 1990s, driving up overdose deaths."

Read more here: http://www.kentucky.com/news/state/article51291770.html#storylink=cpy

In 2007, Purdue Pharma and three of its executives pleaded guilty to federal charges in Virginia that they had made misleading claims about OxyContin's potential for addiction. "A judge ordered the company to pay more than $630 million in that case," Estep notes. "The same year, 49 states settled their own claims against the company. Kentucky was the lone holdout. That was because the company offered the state only $500,000, Conway said."

Pike County joined then-Attorney General Greg Stumbo's lawsuit seeking an unspecified amount of damages, and reportedly settled in 2013 for $4 million. The case had been delayed after Purdue Pharma got it moved to federal court, where a judge sent it back to Pike Circuit Court.

Circuit Judge Steve Combs ruled the company had missed a deadline to deny allegations in the suit, meaning it had admitted the claims by default, "giving the state a huge advantage in the case," Estep writes. "The company appealed the ruling to the state Supreme Court, which has not ruled. The company will drop the appeal as part of the settlement."

The settlement calls for Purdue Pharma to make an initial payment of $12 million and eight annual payments of $1.5 million each, with the money after payment of legal fees to be used "to expand addiction treatment in Kentucky," Conway's news release said.

Conway, who was defeated in the November election for governor, is leaving office after the maximum two four-year terms.

Risperdal settlement

Concurrently, Conway announced that Janssen Pharmaceuticals will pay the state $15.5 million to settle a claim that the Johnson & Johnson subsidiary misled consumers about its dangers and marketed the drug for purposes other than those approved by the U.S. Food and Drug Administration.

"Janssen marketed Risperdal to children before it was approved to do so in 2007 by the FDA," the release said. "It failed to disclose to parents, physicians and patients that Risperdal may cause a hormonal imbalance, which could cause breast tissue development and infertility in both boys and girls. Janssen was aware of the risk and did not update the drug’s warning label because it felt awareness of the risks could cost the company up to $150 million per year.

"Janssen also marketed Risperdal for a non-FDA approved use in treating dementia in non-schizophrenic elderly patients. It even created an elder-care sales force, despite having its own study that showed Risperdal doubled the risk of death in the elderly. Risperdal’s label did not disclose this risk to the public until 2003, even though a Janssen-funded trial indicated the risk in 1997. In 2013, Janssen pleaded guilty to federal charges of misbranding the drug regarding the promotions to the elderly.

"Additionally, Janssen marketed Risperdal as an atypical anti-psychotic with low weight gain and diabetes risk. However, its internal studies indicated that after one year, patients on Risperdal had as much weight gain as its main competitor and a greater risk of diabetes."

Kentucky to get $811,000 from drug company as settlement of federal suit alleging unfounded promotion of three medications

Attorney General Jack Conway has confirmed that the state will receive almost $811,000 for its share of recoveries in a settlement reached in a lawsuit filed by the federal government against Boehringer Ingelheim Pharmaceuticals Inc. In all, the drug company has agreed to pay $95 million to settle allegations that it promoted three drugs for uses in Kentucky and other states that were not medically accepted.  The Associated Press reports that the stroke-prevention drug Aggrenox, the chronic obstructive pulmonary disease drug Combivent, and the high-blood-pressure drug Micardis are the drugs named in the suit. The Justice Department said the company also promoted the use of the heart drug Atrovent at doses exceeding those covered by federal health programs. (Read more)