County opioid lawsuit adds defendants

The litigation Suffolk County has lodged against 15 pharmaceutical companies and their subsidiaries who manufacture prescription opioids, including Purdue Pharma and Purdue-related additional defendants, which had been appealed, is back on track. Following the appeal, the county amended its complaint to additional defendants, including alleged retail and wholesale distributors that the lawsuit claims failed to detect suspicious orders and failed to prevent diversion of these dangerous products.

The new defendants include CVS, Rite Aid of Maryland Inc., Walgreens and Walmart Inc., according to the amended complaint dated Oct. 23, 2018 and filed in the New York State Supreme Court. Also added to the defendants is the Mortimer Sackler family.

The lawsuit, first introduced as a resolution by Legis. Rob Calarco (D-Patchogue) in 2014 to investigate its feasibility, wound its way through the county’s legal department, and was deemed a credible legal challenge by county attorneys Dennis Brown and Lynn Bizarro in an announcement by county executive Steve Bellone in August 2016.

Paul J. Hanly Jr., chairman, Complex Litigation, Simmons Hanly Conroy,

a Manhattan firm, is handling the case for the county.

The lawsuit alleges Purdue Pharma engaged in deceptive acts and practices, false advertising, unjust enrichment and negligence among its seven causes of action.

The lawsuit claims that the Sackler family jointly managed and controlled all of the Purdue-associated companies: “The families owned and knowingly aided, abetted, participated in and benefited from the wrongdoing of Purdue as alleged in the complaint.”

Hanly said the next step in the legal process is taking sworn testimony of the defendant companies and reviewing millions of their documents to find additional evidence of their wrongdoing. “My firm is representing about 200 cities and counties around the nation, including the city of New York, 30 other counties, Cook County, Ill., Riverside County, Calif., and many others,” he said in an email. “Also, we added the entire Sackler family, including the descendants of Mortimer, Arthur and Raymond Sackler.”

“With all the arguments, there were 30 or so motions to have it dismissed; Judge Jerry Garguilo ruled against it,” said Calarco. “He ruled for it to move forward and we believe there are merits to our case. “[The drug companies in the lawsuit] knowingly marketed the product as not doing harm without physicians knowing the harm.”

The lawsuit claims members of the Sackler family were aware of risks associated with OxyContin no later than the summer of 1999, pointing to a secretary at Purdue who was tasked with doing research to learn about the nature and scope of abuse after a sales representative wrote to the president of Purdue reporting widespread abuse of OxyContin. It alleges the secretary prepared a memo summarizing her research into the misuse of OxyContin and described how users would remove the coating on the OxyContin pills, crush them, cook them and snort or shoot them. It was sent to the president of Purdue, its general counsel and to Purdue’s medical director, as well as the Sackler family, the lawsuit said, and they were aware early on of its addictive nature.

The lawsuit states that Richard Sackler, who resigned as president in 2003, was actively involved in the invention, development, marketing, promotion and sale of Purdue’s opioid products including OxyContin and, along with his father and uncle, launched OxyContin with one of the biggest pharmaceutical marketing campaigns in history, deploying many persuasive techniques pioneered by his uncle Arthur. Even though oxycodone did not have the same stigma as morphine, in focus groups conducted before OxyContin’s release, Purdue learned that doctors were concerned about the abuse potential of opioids, the lawsuit said, adding the focus group concluded that the perceived abuse potential of opioids was the “biggest negative that might prevent widespread use of the drug.”

From 2001 to 2007, Purdue was investigated by 26 states and the U.S. Department of Justice, the lawsuit said. In 2007, PFC (collectively Purdue) agreed to pay nearly $700 million and pleaded guilty to a felony for misleading doctors and patients about opioids.

“The Sackler family owns Purdue Pharma; it’s a privately owned business,” Calarco continued. “We believe very firmly that the Sackler family as well as marketing officials were leading the misrepresentation of its opioid products. It shows Richard Sackler directing this company knowing there was potential harm. The attorney general of Massachusetts also filed against the Sackler family. What’s important is that the effort to create these opioid painkillers for acute pain was driven from high up as safe and that there was knowledge there was risk and potential harm.”

“By and large, Europe hasn’t approved these drugs,” Calarco pointed out. “[Those drug companies] tried and the Europeans resisted.”

Gov. Andrew Cuomo and attorney general Barbara Underwood announced a lawsuit against Purdue Pharma L.P., Purdue Pharma Inc., and Purdue Frederick Company Inc., alleging a decades-long and continuing pattern of consistent deceptive and illegal conduct, whereby Purdue misled prescribers and patients about the risks of its opioids, including OxyContin, intentionally understating the risks and overstating the benefits. “The opioid epidemic was manufactured by unscrupulous distributors who developed a $400 billion industry pumping human misery into our communities,” Cuomo said in a press release statement.

According to Jonah Bruno, director of communications for the New York State Department of Health, Cuomo has provided a commitment in the 2019-2020 executive budget to regulate out-of-state treatment providers, expand access to buprenorphine and naloxone and increase addiction services including medication-assisted treatment in prisons and jails.

According to the New York State Department of Health 2013-2015 Vital Statistics, as of May 2017 there were 618 overdose deaths involving any opioid in Suffolk County.

“When it used to be a recommended 30-day supply, I would prescribe it for a short time,” commented Legis. William “Doc” Spencer (D-Centerport), who heads up Long Island Otolaryngology & Pediatric Airway, P.C. He holds the position of chief of the division of otolaryngology at Huntington Hospital and is an assistant clinical professor at Stony Brook University Hospital.

“The trend is that there is an awareness now,” Spencer said. “I tell my patients that there is a subset towards addiction and this is a conversation I’m having with all of my patients. I also check the [I-STOP] data bank for any notice of doctor shopping. But some of my colleagues are prescribing less opioids. I recognize there are different pain thresholds, and I had a patient with a nasal fracture who asked for an opioid procedure. I explained the post-op pain is very little and opioids are not appropriate and there are things you can do to address your discomfort and didn’t prescribe it. So I come up with a strategy.”

John Rocco, Patchogue Ambulance Company Board of Directors chairman and CEO, commented about opioid overdoses. “I think they remained about the same,” he said. “They may be down slightly and I think the physicians are tightening it up.” The ambulance company gets 3,400 calls a year.

Suffolk County employs approximately 10,000 people in 22 departments and is one of the largest employers on Long Island. Should Suffolk County succeed, Calarco said it would help fund clinics for those addicted.

On March 22, 2016, the FDA issued a press release recognizing opioid abuse as a public health crisis that has a profound impact on individuals, families and communities across the country.

Purdue Pharma was asked to comment, and issued the following statement. “We share the county’s concerns about the opioid crisis. While Purdue Pharma’s opioid medicines account for less than 2 percent of total prescriptions, we will continue to work collaboratively with the state and county toward bringing meaningful solutions to address this public health challenge. We vigorously deny the county’s allegations. The county claims Purdue acted improperly by communicating with prescribers about scientific and medical information that FDA has expressly considered and continues to approve. We believe it is inappropriate for the county to substitute its judgment for the judgment of the regulatory, scientific and medical experts at FDA.” Purdue also added that the FDA has approved OxyContin and other Purdue opioid medications as safe and effective for their intended use, prescription opioids are among the most tightly controlled medicines in the United States and that in April 2010, the FDA approved a reformulated version of OxyContin, which Purdue developed with properties intended to deter abuse.

But Calarco countered. “There is a bit of an interaction by those lobbying the FDA and those employed by the FDA,” he said, “and FDA approvals alone are a shield of this misconduct.”

The 2011 Father’s Day murders that took place at Haven Drugs in Medford, when David Laffer, 33, walked into the pharmacy in his quest to steal oxycodone and other painkillers for his wife, Melinda Brady, was a terrible human climax of the dangers of the drug and its addiction fallout. After stealing 10,000 pills, Laffer shot and killed four local people. Officials were faced with a loud wakeup call.

“The good news is that the amount of opioid deaths is decreasing,” Calarco said. “The biggest culprit these days is fentanyl and heroin addiction. But I think we finally turned the corner. In an effort over the last three or four years, doctors and hospitals have pulled back on prescribing opioids and the general public and young people are more aware.”

As for a settlement, “We’re talking billions if not trillions when everything is settled,” Calarco said. “This isn’t pocket change.”