Daily Local News (West Chester, PA)
Legal woes grow for area opioid makers
Endo, Teva, Janssen, AmerisourceBergen face more investigations and lawsuits related to nation’s opioid crisis
The steady drip, drip, drip of litigation that has plagued area drug makers and distributors for the last year became a full flow of legal activity last week.
Coming under the microscope for their alleged roles in the nation’s opioid crisis are Chester County-based drug makers Endo Pharmaceuticals and Cephalon (now part of Teva, which has North American headquarters in North Wales, Montgomery County), and Janssen Pharmaceuticals, which has offices in Horsham, Montgomery County. Drug distributor AmerisourceBergen of Tredyffrin also has been named in a number of the legal actions, including a coordinated investigation of manufacturers and distributors of prescription opioids announced Tuesday by 41 state attorneys general.
“To any parent, family or friend of someone lost to addiction, we hear you,” Pennsylvania Attorney General Shapiro said at a news conference at an Upper Dublin High School athletic field in Montgomery County. “I’m announcing today a major step forward in our investigation into the manufacturing, marketing, sale and distribution of opioids – a class of drugs so dangerous the Centers for Disease Control warns they are “just as addictive as heroin.”
Closer to home, Delaware County on Thursday joined Bensalem, Bucks County, in suing the companies seeking damages from the opioid manufacturers, claiming they downplayed the dangers of the addictive painkillers.
“Delaware County didn’t want to wait any longer. These brave leaders are tired
“This was a finely orchestrated blitzkrieg by the opioid manufacturing industry to change public opinions and to convince doctors that opioids were safety and nonaddictive when in fact they were deadly and deadly addictive.”
– attorney Robert Mongeluzzi
of seeing their constituents whose loved ones have been killed,” said attorney Robert Mongeluzzi of Saltz, Mongeluzzi, Barrett and Bendesky of Philadelphia, who will represent the county in the case.
“They aren’t waiting. They are being proactive, and they are taking the first step.”
The suit alleges that four top pharmaceutical companies — Endo, Purdue, Cephalon and Janssen — systematically put doctors on the payroll who wrote medical opinions that called for doctors to prescribe opioids to treat their patients, the Delaware County Times reported.
“This was a finely orchestrated blitzkrieg by the opioid manufacturing industry to change public opinions and to convince doctors that opioids were safety and non-addictive when in fact they were deadly and deadly addictive,” Mongeluzzi said.
For their part, the drugmakers say they are working to be part of the solution to the opioid crisis.
“At Endo, our top priorities include patient safety and ensuring that patients with chronic pain have access to safe and effective therapeutic options,” read an emailed statement from Heather Zoumas Lubeski, senior director of corporate affairs. “We share in the FDA’s goal of appropriately supporting the needs of patients with chronic pain while preventing misuse and diversion of opioid products.
“It is Endo’s policy not to comment on current litigation or investigations,” Friday’s statement concluded.
In July, Endo, based in East Whiteland near Malvern, said it would voluntarily stop selling the opioid Opana ER, approved for use in patients with severe, constant pain, after consulting with the U.S. Food and Drug Administration. It’s the first opioid drug the FDA has sought to remove from the market due to abuse.
The drugmaker said in a statement at the time and repeated last week that the extended-release opioid is safe and effective when used as intended, and that Endo still believes Opana ER’s benefits outweigh its risks. It no longer sells Opana ER and has no plans to resume sales of the drug, Zoumas Lubeski said. The company also eliminated its 375-member U.S. Branded pain sales force late last year and is focusing its efforts elsewhere now, the spokeswoman added.
Janssen spokesperson William Foster also said his company is cooperating.
“We recognize opioid abuse is a serious public health issue,” he said. “We have received and plan to address the request from the coalition of state attorneys general, and will continue to work with stakeholders to support solutions. Janssen has acted responsibly and in the best interests of patients and physicians with regard to these medicines, which are FDA-approved and carry FDA-mandated warnings about possible risks on every product label.”
Cephalon, meanwhile, admitted in the past to wrongly marketing its opioid, Actiq. In 2008, it settled a case with the U.S. Attorney’s Office in Philadelphia for its off-label marketing practices of Actiq and two other drugs. It agreed to pay $425 million in criminal and civil fines to settle the case.
Denise Bradley, senior vice president of corporate reputation, issued a statement last week for Teva, which bought Cephalon in 2011 for $6.8 billion. The North Wales company continues to have former Cephalon operations in West Goshen and Frazer.
“Teva is committed to the appropriate promotion and use of opioids,” the company said. “We have programs in place that educate prescribers, pharmacists and patients on the responsible and safe use of these products. We are committed to working with the health-care community, regulators and public officials to collaboratively find solutions.”
But the attorneys general in announcing their investigation indicated they would seek their own answers.
Nationwide and in Pennsylvania, opioids are the main driver of fatal drug overdoses, noted Shapiro, Pennsylvania’s attorney general, adding:
• Pennsylvania had 4,642 fatal drug overdoses in 2016 – a 37 percent increase over 2015.
• Thirteen Pennsylvanians die every day from overdoses.
• Eighty percent of persons suffering from heroin addiction began by abusing prescription drugs.
• A total of 7.3 million opioid prescription drugs were dispensed in Pennsylvania last year.
The attorneys general named the opioid manufacturers under investigation:
• Endo International, maker of drugs like Opana and Percocet;
• Janssen Pharmaceuticals, maker of opioids such as Duragesic, a fentanyl patch;
• Teva Pharmaceutical Industries and its US subsidiary Cephalon Inc., which manufactures many generic opioids and drugs such as Actiq, a fentanyl lollipop;
• Allergan Inc., maker of opioids like Kadian, based in Dublin, Ireland, with U.S. Administrative headquarters in Parsippany, N.J.;
• Purdue Pharma, the Stamford, Conn., maker of OxyContin.
Shapiro said the attorneys general are seeking documents and information about business practices from companies responsible for distributing nearly 90 percent of the nation’s opioids, identifying the opioid distributors under investigation as:
• AmerisourceBergen, which is based in the Chesterbrook development in eastern Chester County;
• Cardinal Health of Dublin, Ohio;
• McKesson of San Francisco.
AmerisourceBergen on Friday said it will cooperate with the investigation.
“We welcome the opportunity to educate the attorney general coalition on our role in the health-care supply chain,” read a statement provided by Lauren Moyer, director of the company’s external communications. “AmerisourceBergen has taken extensive action to help ensure the safe and secure delivery of these drugs, including reporting suspicious orders to the Drug Enforcement Agency and stopping tens of thousands of suspicious orders from being shipped. Our goal has been, and continues to be, to do everything we can as a distributor with no visibility into patient information to mitigate the diversion of these drugs in ways that do not interfere with clinical decisions made by licensed health-care providers. Our hope is that the investigation will be a step forward in driving productive conversation about how we, along with all other parts of the health-care supply chain, can work with regulatory, enforcement and legislative leaders to find meaningful solutions to address the opioid epidemic.”
The AGs have served subpoenas for documents and information - known as Civil Investigative Demands - on the pharmaceutical manufacturers. The multi-state investigation has also sent information demand letters to the distributors under investigation, Shapiro’s office said in a statement.
“We have the resources, expertise and legal authority to take on this fight, and we aren’t letting up,” Shapiro said of the group of 41 attorneys general. “We’re following the evidence wherever it leads so we can change behavior and save lives. Make no mistake: if the law was broken, this team will find it, and we will take action to change the course of this epidemic.”
Shapiro was joined at Tuesday’s news conference by Montgomery County District Attorney Kevin Steele, Hatboro Police Chief Jim Gardner, and Candy Decker, whose son John, a scholastic lacrosse star, became addicted to prescription painkillers following a sports injury, gravitated to heroin, and suffered a fatal overdose. Joe Lubowitz, an Upper Dublin graduate in long-term recovery from addiction who works as an advocate, also attended, along with a crowd of other advocates and persons in longterm recovery.
“As I promised the day I took office in January, we are confronting this epidemic on our street corners, in doctors’ offices and hospitals, and now – in the boardrooms of pharmaceutical companies,” Shapiro said. “We will follow the facts and the law, without fear or favor, and hold the responsible persons and companies accountable for the tragic loss of life and damage suffered by so many families across our Commonwealth.”
To contact Business Writer Brian McCullough, call 610-235-2655 or send an email to bmccullough@21stcenturymedia.com.