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Drug manufacturers listed in lawsuit only distributed 18 percent of total painkillers in Tri-Cities

Zach Vance • Updated Jun 17, 2017 at 11:13 PM

Three drug manufacturers named in a lawsuit filed last week by three Northeast Tennessee district attorneys general distributed millions of painkillers in the region in recent years, according to data compiled by QuintilesIMS.

But it appears Endo International Pharmaceuticals, Purdue Pharma LLC and Mallinckrodt PLC were responsible for a drop in the bucket compared to the total number of painkillers shipped into the region between 2012 and 2016.

Roughly 426 million opioid tablets, capsules, oral solutions and injectable vials distributed by more than a hundred different companies, according to the data, helped solidify Northeast Tennessee as a hotbed for addiction the past four years.

The millions were enough to supply each person in the Tri-Cities with about 213 pills for a one-year period.

The three companies listed as defendants in the lawsuit filed by local district attorneys Tony Clark, Barry Staubus and Dan Armstrong were responsible for only 18 percent, or 80 million, of the total opioid units, 78 million not counting injectable vials.

Endo International Pharmaceuticals held the largest share of the three, making up about 17 percent of the 426 million painkillers, while Purdue contributed to only 1.51 percent of the total. Mallinckrodt’s share was even smaller, just 0.02 percent.

Actavis Inc. and Covidien held the largest shares, both collectively making up about 39 percent of the opioids found in the region, according to the QuintilesIMS data. By units, Actavis, Inc. was responsible for about 86 million and Covidien was responsible for about 83 million.

Endo was the third-largest distributor of painkillers in the Tri-Cities, making up 17 percent of the share.

But in terms of total value, or wholesale acquisition cost, the QuintilesIMS data indicated Endo led every other manufacturer by distributing $56 million worth of painkillers, nearly $10 million more than the second-place company. Purdue was ranked fourth with $46 million worth of painkillers. Mallinckrodt shipped $780,000 worth of opioid medication.

Why these three manufacturers?

Tony Clark, First Judicial District attorney general, gave a variety of general reasons why Purdue, Mallinckrodt and Endo were selected for the lawsuit. 

“There were other manufacturers, but these seemed to be, as far as the distributions, the largest,” Clark said.

“Part of it was what was said at the beginning when these companies first started (distributing painkillers). Part of the basis to the lawsuit was that people were told, ‘Doctors, if you dispense this, or hospitals, if you utilize this, or patients, if you take this, it’s not going to be addictive. It’s not going to be a problem down the road and it’s not going to produce these long-term effects.’

“I’m not saying that’s necessarily what each one of these companies did, but that’s the basis for part of the lawsuit.”

Clark said the defendants’ marketing approach led to pregnant women becoming addicted, and ultimately led to the influx of neonatal abstinence syndrome in the region. The lawsuit was brought on behalf of a “Baby Doe” that represents all newborns that have experienced withdrawal symptoms because of addicted mothers.

Citing the 78 to 80 million opioids distributed by the three plaintiffs, Barry Staubus, Second Judicial District attorney general, said the statistics just corroborate the basis to the lawsuit.

“It just validates the idea that there are way too many of these drugs being prescribed to way too many people for way too many bad reasons,” Staubus said.

“When you flood the market with these highly addictive powerful medicines and you overprescribe them to all these people, what you get is a culture of addiction, you get drug-dependent babies (and) you get rising crime because people on drugs commit crimes to support their habits.”

Reaction from Painkiller Manufacturers

In a statement to the Johnson City Press, Bob Josephson, Purdue’s director of communications, pointed out that his companies’ largest painkiller, OxyContin, accounted for only about 2 percent of opioid prescriptions in Tennessee between 2012 and 2016, citing the same QuintilesIMS data.

“While we vigorously deny the allegations in the complaint, we share public officials’ concerns about the opioid crisis and we are committed to working collaboratively to find solutions,” Josephson said.

Josephson said his company is taking various means to address the public health crisis, including developing abuse-deterrent technology, advocating for the use of prescription drug monitoring programs and supporting access to Naloxone.

“Addiction and drug abuse are multi-faceted problems that require multi-faceted solutions. Pointing fingers will not solve the problem, nor will it help those who are suffering. We urge all stakeholders to seize the opportunity to work together so that collectively we can address this crisis,” he said.

Steve Mock, spokesman for Endo, said it was his company’s policy not to comment on current litigation. He did state Endo’s top priorities include patient safety and ensuring patients with chronic pain have access to safe and effective therapeutic options.

Mallinckrodt did not respond to a request for comment.

Similar Litigation

The Northeast Tennessee lawsuit is far from the only lawsuit brought against these three drug manufacturers.

In May, Fortune reported that Orange County, New York, had filed litigation against Purdue, Endo and Teva Pharmaceutical Industries because of marketing strategies related to opioid painkillers.

“The lawsuit claims the drugmakers through deceptive marketing misrepresented the dangers of long-term opioid use to doctors, pharmacists and patients,” Fortune reported.

A report published by the Washington Post in April detailed the Drug Enforcement Agency’s attempts to bring a lawsuit against Mallinckrodt over what the DEA alleged were violations of laws designed to prevent diversion of legal narcotics to the black market.

“Ultimately, the DEA and federal prosecutors would contend that the company ignored its responsibility to report suspicious orders as 500 million of its pills ended up in Florida between 2008 and 2012,” the article stated.

Despite its efforts, the DEA was never successful in bringing legal action against Mallinckrodt, despite its being termed the largest prescription-drug case the agency had ever pursued. Instead, prosecutors reached a tentative settlement outside of court, the Washington Post reported.

Called the “Know Your Customer” policy, the DEA Suspicious Orders Task Force met in 1997 and created recommendations to the drug industry on what constitutes a suspicious order.

“It is fundamental for sound operations that handlers take reasonable measure to identify their customers, understand the normal and expected transactions typically conducted by those customers, and, consequently, identify those transactions conducted by their customers that are suspicious in nature,” the DEA’s website states.

In a report on its website responding to allegations made in a Los Angeles Times article, Purdue stated it could not simply order a wholesaler to stop shipping a product, but the company could reduce products shipped to a wholesaler if there are concerns about a pharmacy’s customer.

Clark said he was not aware of the “Know Your Customer” policy and allegations of suspicious orders had not been made in the lawsuit.

“I don’t know what the regulations are on a federal level about amounts that can be shipped in or amounts that can be shipped through the mail,” Clark said.

“We really don’t deal with that on a state level. One would think if there were over 70 million pills just in this area, there should be some red flags raised somewhere.”

Email Zach Vance at zvance@johnsoncitypress.com. Follow Zach Vance on Twitter at @ZachVanceJCP. Like him on Facebook at Facebook.com/ZachVanceJCP.

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