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A class-action lawsuit filed in Niagara County Supreme Court could shape the futures of all babies in New York state who are born addicted to opioids.

The lawsuit, filed Aug. 22 on behalf of a 13-month-old boy in Niagara County, identified only by the initials C.E., seeks to provide long-term medical monitoring and health care for all state children born with neonatal abstinence syndrome (NAS) and whose mothers were prescribed opioids sometime before or during her pregnancy.

If successful, the named defendants, including nearly a dozen major pharmaceutical manufacturers and distributors, such as Purdue Pharma and Johnson & Johnson, would have to maintain a fund to pay for monitoring and treatment of such babies. They would also have to pay compensatory and punitive damages to Baby C.E. and his mother.

The lawsuit alleges these pharmaceutical manufacturers misled doctors and patients about the dangers and benefits of opioids, and that distributors did not uphold their legal obligations to ensure opioids weren’t being diverted to unauthorized users.

Opioid-addicted newborns

NAS occurs in most babies whose mothers are dependent on opioids during their pregnancies.

Baby C.E., like many NAS babies, spent his first five days “writing in agony” while detoxifying from opioids, according to the lawsuit.

The baby’s mother, identified only as A.M.H., was prescribed opioids before her pregnancy, became addicted and later turned to heroin.

Over the past decade, the number of infants born with NAS has skyrocketed.

According to state Department of Health data, incidence of NAS in babies in upstate New York shot from 1.7 per 1,000 births in 2005 to 8.5 per 1,000 births in 2014.

The problem is even worse in Niagara County, which reported the highest rate of NAS of any county in the state. Between 2006 and 2014, the rate of NAS increased from 3.2 to 28.8 per 1,000 births, according to state health department data.

“Baby C.E.’s experience is part of an opioid epidemic sweeping through the U.S., including New York, causing thousands of infants great suffering and continuing developmental physical, medical, occupational and psychological issues,” wrote the plaintiffs’ attorneys. “The epidemic is reportedly the largest health care crisis in U.S. history.”

Attorney Scott Bickford, who is part of the legal team representing Baby C.E., said these infants will require lifelong medical monitoring to identify and treat conditions that may be caused in part by their prenatal exposure to opioids.

One recent study in Tennessee — the first major study of NAS children conducted in the U.S. — linked the condition to increased rates of learning disabilities, including developmental delays and speech difficulties.

“There’s a dearth of academic data for children with NAS. ... There’s not really a morbidity study tracking the constellations of diseases in these kids” as they grow older, said Bickford, who is also representing plaintiffs in similar class-action suits filed in six other states.

“This is something that could be addressed with medical monitoring.”

Suing Big Pharma

The NAS infant suits are part of a wave of litigation against pharmaceutical companies that manufactured and distributed opioids, including hundreds filed by counties, municipalities and states seeking to recoup the expenses from the largest public health crisis in U.S. history.

Hundreds of those lawsuits have been consolidated into a single case before U.S. District Judge Dan Aaron Polster in Cleveland. More than 50 New York state counties, including Niagara and Erie counties, have filed similar suits, which have been consolidated into a multi-district suit before Suffolk County Supreme Court Justice Jerry Garguilo.

“Multi-district litigation is a complex animal with a lot of moving pieces, and a lot of parties representing different entities, different causes of action (and) different remedies,” Bickford said. “We think that if we were maintained within New York, within our own lawsuit, within our own class action, it would be a much more efficient manner in which to resolve the concerns of the NAS babies.”

The first trial, which combines suits filed by the city of Cleveland, Cuyahoga County and Summit County, is scheduled to begin on March 19, 2019.

The outcome of the trial could drastically impact practices of marketing, distributing and tracking opioids. And some commentators have speculated the case could result in the largest settlement since the $206 billion Tobacco Master Settlement Agreement, reached between the four largest U.S. tobacco companies and the attorneys general of 46 states.

Allegations

In the hundreds of lawsuits filed against opioid manufacturers and distributors, plaintiff attorneys are lodging similar allegations: that manufactures misled patients and doctors on the risk of opioids, and distributors failed to stop diversion of opioids to rogue pharmacies and physicians.

The lawsuit was filed against the pharmaceutical manufacturers Purdue Pharma, Teva Pharmaceutical Industries, Johnson & Johnson, Insys Therapeutics, Endo International and a number of manufacturers owned by those aforementioned companies.

Among the allegations against pharmaceutical manufacturers in the 72-page complaint:

• Purdue Pharma marketed OxyContin for providing 12 hours of pain relief, even though their own research showed it wore off in under six hours in 25 percent of patients and in under half 10 hours in over 50 percent of patients.

• The defendants claimed that doctors and patients could increase opioid dosages without a risk of the user becoming addicted.

One brochure by Actavis Generics (owned by Teva) allegedly claimed: “Over time, your body may become tolerant of your current dose. You may require a dose adjustment to get the right amount of pain relief. This is not addiction.”

• The defendants entered into agreements with “seemingly ... independent organizations” that generate guidelines for treating chronic pain, including the American Pain Society, American Geriatrics Society, the Federation of State Medical Boards, the American Chronic Pain Association and others.

• The defendants continued to market opioids as a long-term solution for pain even after the U.S. Center for Disease Control and Food and Drug Administration reported that there was insufficient evidence to support such claims.

Purdue Pharm, Endo International and Insys Therapeutics did not respond to requests for comment. A spokesperson for Teva, which owns Actavis and Cephalon, said the company does not comment on ongoing litigation.

Janssen Pharmaceuticals, which is owned by Johnson & Johnson, stated the company clearly spelled out the risks of opioid painkillers in its labeling.

The lawsuit also pegs responsibility of the crisis on the three largest drug distributors — Cardinal Health, McKesson Corporation and Amerisourcebergen — alleging they knew or should have known that the amount of opioids distributed in New York state outpaced the amount that could be consumed for medically-necessary purposes.

It also claimed that Cardinal and McKesson paid $34 million and $150 million, respectively, to the U.S. government to settle allegations that it allowed drug diversion at some distribution centers, and that Amerisourcebergen lost a license to send controlled substances to a distribution center amid allegations that it was not controlling shipments of opioids to internet pharmacies.

The Healthcare Distribution Alliance, which represents all three distribution companies, stated that the distributors reported every order to the Drug Enforcement Administration.

The HDA added that the DEA is responsible for approving and regulating entities that are allowed to prescribe and handle opioids.

“The misuse and abuse of prescription opioids is a complex public health challenge that requires a collaborative and systemic response that engages all stakeholders,” said John Parker, senior vice president of the HDA.

“Given our role, the idea that distributors are responsible for the number of opioid prescriptions written defies common sense and lacks understanding of how the pharmaceutical supply chain actually works and is regulated. Those bringing lawsuits would be better served addressing the root causes, rather than trying to redirect blame through litigation,” Parker said.

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