Feature

Experts discuss future opioid lawsuit strategies, lawsuits’ impact on manufacturers

Jennifer Oliva  
Jennifer Oliva
Amanda Pustilnik 
Amanda Pustilnik

Last month, Johnson & Johnson was ordered to pay more than $572 million in damages for its role in the opioid epidemic in Oklahoma. Purdue Pharma previously agreed to pay the state $270 million, and Teva Pharmaceuticals agreed to pay Oklahoma $85 million, rather than face trial.

The recent judgment against Johnson & Johnson may not be indicative of how future lawsuits against opioid manufacturers are resolved, experts told Healio Primary Care. However, some said the recent flurry of legal action may ultimately result in the development of opioid formulations that are safer for patients.

Healio Primary Care spoke with several legal and clinical leaders about the health and legal implications of the Oklahoma lawsuit and the numerous others that have yet to be decided.

Impact on multidistrict lawsuits

Many court and medical observers have turned their attention to the federal multidistrict litigation in Ohio, where the nearly 2,000 cases filed by state, tribal and local governments against opioid manufacturers including Purdue Pharma, Johnson & Johnson, Teva Pharmaceutical Industries and Endo International, and drug distributors such as AmerisourceBergen Corp, Cardinal Health Inc. and McKesson are currently consolidated for pre-trial proceedings.

NBC News recently reported that Purdue Pharma, and its owners, the Sackler family, are offering to settle the lawsuits for $10 to $12 billion. Reuters has reported that Purdue Pharma is “preparing to seek bankruptcy protection” before the end of September if the company cannot reach a settlement with U.S. communities in these lawsuits.

It is uncertain what impact any settlements among the manufacturers, distributors and state, tribal and local governments prior to start of the Ohio lawsuits would have on the remaining defendants and plaintiffs, according to Jennifer D. Oliva, JD, associate professor of law at the Seton Hall University School of Law in New Jersey.

Gavel 
The recent judgment against Johnson & Johnson may not be indicative of how future lawsuits against opioid manufacturers are resolved, experts told Healio Primary Care.

Source:Adobe

“Providing predictions is difficult because it is currently unclear what measure the parties will agree on to allocate fault or culpability,” she said in an interview. “In addition, the measure used to calculate the damages allocation among the defendants is important in assessing the impact of an individual defendant’s global settlement.”

Amanda C. Pustilnik, JD, a law professor at the University of Maryland, said the companies involved in the Ohio opioid litigation likely learned a few things from the Oklahoma cases.

“Johnson and Johnson chose to go to trial because Oklahoma’s claims under state nuisance law, as applied to consumer products in this case, involved a novel and untested legal approach,” she said. “Purdue Pharma’s Oklahoma lawsuit, had it gone to trial, would have centered around how much the company knew and when it knew it. Those are two different legal arguments, largely because those two companies identified their role in the opioid crisis differently. Such identification is a key factor in how they are determining their legal strategy in regards to the federal lawsuit in Ohio.”

Oliva noted that the discussions surrounding the Ohio trial are not limited to the employees of Purdue Pharma.

“All parties in these cases are actively negotiating potential settlements. The plaintiffs will, of course, attempt to leverage the State of Oklahoma’s victory over Johnson & Johnson in those discussions while the defendants are incentivized to avoid public trials and the additional negative publicity that is likely to arise from such public battles,” she told Healio Primary Care.

“The situation, however, is complex because there are so many different entities and claims involved in the federal suits. The pharmaceutical defendants’ ultimate goal is to achieve global peace by settling all the state and federal claims they face in one fell swoop. Under the circumstances, it remains to be seen whether the disparate structure of this litigation is conducive to such an outcome,” Oliva continued.

The first bellwether case in the federal multidistrict lawsuit is scheduled to start Oct. 21, 2019, Oliva said.

Johnson & Johnson’s appeal

Within hours of Judge Thad Balkman’s announcement in the Oklahoma case, Johnson & Johnson said it will appeal the decision.

“The decision in this case is flawed,” the company said in a statement. “The state failed to present evidence that the company’s products or actions caused a public nuisance in Oklahoma. The state’s claims violate fundamental principles of due process by seeking to hold a company liable for conduct permitted under federal law and regulations. It also disregards 100 years of precedent in public nuisance law, which traditionally has been applied to resolve property disputes, not lawsuits involving the sale of goods.”

Johnson & Johnson had also made the argument that their product is a legitimate treatment for patients who experience severe pain.

Oliva previewed some of the other arguments that Johnson & Johnson might make on appeal.

“Johnson & Johnson will contend that the chain of causation between the behavior with which it is charged — the manufacture, marketing and sale of raw opioid ingredients and prescription opioid products — and poor public health outcomes, the diversion of prescription opioids outside the health care delivery system and the development of illicit drug use disorder and overdose deaths in Oklahoma, are simply too attenuated,” she said. “Johnson & Johnson will maintain that other opioid manufacturers as well as opioid distributors and pharmacies failed to satisfy their duties under the Controlled Substance Act and, therefore, broke the chain of causation.”

Pill bottle knocked over 
Some experts told Healio Primary Care the recent flurry of legal action may ultimately result in the development of opioid formulations that are safer for patients.
Source:Adobe

“They will also make the point that the prescribers and dispensers of opioids — doctors and pharmacists, for example, owe a duty to care to patients and are required to fulfill certain ethical obligations related to opioid prescribing and dispensing under their respective professional codes of ethics and state board licensing requirements and that their failure to comply with those obligations further broke the chain of causation,” Oliva continued.

She noted that Johnson & Johnson will also likely ask the appellate court to “reverse and remand” the trial court’s more than half-billion dollarabatement award, because the company had a small share of the opioid market in Oklahoma.

Oliva said Johnson & Johnson faces “a tough battle” ahead with regard to its appeal, but the company might succeed to have the abatement award reversed and potentially reduced.

Pustilnik said the novel application of the public nuisance law leaves “lots of wiggle room” for the law’s interpretation.

“Meaning there is a chance that the state’s nuisance theory will be rejected, the verdict overturned, and the judgment vacated,” Pustilnik told Healio Primary Care.

Future of opioids

Robert Freeman
Robert Freeman

Robert Freeman, PhD, a former professor of pharmacy administration at the University of Maryland's Eastern Shore campus, told Healio Primary Care that “it’s doubtful that opioids, even fentanyl, will be removed [from the market] because there are few options for the management of chronic, severe pain,”

“However, further restrictions on their use as well as the annual number of units allowed by the Drug Enforcement Administration are likely. I can see continued development of formulations that reduces the overdose potential,” he continued.

Lewis Nelson
Lewis Nelson

Lewis Nelson, MD, a former chair of FDA’s Drug Safety and Risk Management Advisory Committee, agreed with Freeman.

“Opioids remain an important therapeutic tool, and when used appropriately and responsibly they provide excellent relief for patients with severe acute pain. Opioids will not disappear, but the range of formulations and their ready availability may change,” Nelson, who is now chair of the department of emergency medicine at Rutgers New Jersey Medical School, said in an interview. – by Janel Miller

Disclosures : Neither Freeman, Nelson nor Pustilnik have previously reported any relevant financial disclosures. Healio Primary Care was unable to determine Oliva’s relevant financial disclosures prior to publication.

Jennifer Oliva  
Jennifer Oliva
Amanda Pustilnik 
Amanda Pustilnik

Last month, Johnson & Johnson was ordered to pay more than $572 million in damages for its role in the opioid epidemic in Oklahoma. Purdue Pharma previously agreed to pay the state $270 million, and Teva Pharmaceuticals agreed to pay Oklahoma $85 million, rather than face trial.

The recent judgment against Johnson & Johnson may not be indicative of how future lawsuits against opioid manufacturers are resolved, experts told Healio Primary Care. However, some said the recent flurry of legal action may ultimately result in the development of opioid formulations that are safer for patients.

Healio Primary Care spoke with several legal and clinical leaders about the health and legal implications of the Oklahoma lawsuit and the numerous others that have yet to be decided.

Impact on multidistrict lawsuits

Many court and medical observers have turned their attention to the federal multidistrict litigation in Ohio, where the nearly 2,000 cases filed by state, tribal and local governments against opioid manufacturers including Purdue Pharma, Johnson & Johnson, Teva Pharmaceutical Industries and Endo International, and drug distributors such as AmerisourceBergen Corp, Cardinal Health Inc. and McKesson are currently consolidated for pre-trial proceedings.

NBC News recently reported that Purdue Pharma, and its owners, the Sackler family, are offering to settle the lawsuits for $10 to $12 billion. Reuters has reported that Purdue Pharma is “preparing to seek bankruptcy protection” before the end of September if the company cannot reach a settlement with U.S. communities in these lawsuits.

It is uncertain what impact any settlements among the manufacturers, distributors and state, tribal and local governments prior to start of the Ohio lawsuits would have on the remaining defendants and plaintiffs, according to Jennifer D. Oliva, JD, associate professor of law at the Seton Hall University School of Law in New Jersey.

Gavel 
The recent judgment against Johnson & Johnson may not be indicative of how future lawsuits against opioid manufacturers are resolved, experts told Healio Primary Care.

Source:Adobe

“Providing predictions is difficult because it is currently unclear what measure the parties will agree on to allocate fault or culpability,” she said in an interview. “In addition, the measure used to calculate the damages allocation among the defendants is important in assessing the impact of an individual defendant’s global settlement.”

Amanda C. Pustilnik, JD, a law professor at the University of Maryland, said the companies involved in the Ohio opioid litigation likely learned a few things from the Oklahoma cases.

“Johnson and Johnson chose to go to trial because Oklahoma’s claims under state nuisance law, as applied to consumer products in this case, involved a novel and untested legal approach,” she said. “Purdue Pharma’s Oklahoma lawsuit, had it gone to trial, would have centered around how much the company knew and when it knew it. Those are two different legal arguments, largely because those two companies identified their role in the opioid crisis differently. Such identification is a key factor in how they are determining their legal strategy in regards to the federal lawsuit in Ohio.”

Oliva noted that the discussions surrounding the Ohio trial are not limited to the employees of Purdue Pharma.

“All parties in these cases are actively negotiating potential settlements. The plaintiffs will, of course, attempt to leverage the State of Oklahoma’s victory over Johnson & Johnson in those discussions while the defendants are incentivized to avoid public trials and the additional negative publicity that is likely to arise from such public battles,” she told Healio Primary Care.

“The situation, however, is complex because there are so many different entities and claims involved in the federal suits. The pharmaceutical defendants’ ultimate goal is to achieve global peace by settling all the state and federal claims they face in one fell swoop. Under the circumstances, it remains to be seen whether the disparate structure of this litigation is conducive to such an outcome,” Oliva continued.

The first bellwether case in the federal multidistrict lawsuit is scheduled to start Oct. 21, 2019, Oliva said.

Johnson & Johnson’s appeal

Within hours of Judge Thad Balkman’s announcement in the Oklahoma case, Johnson & Johnson said it will appeal the decision.

“The decision in this case is flawed,” the company said in a statement. “The state failed to present evidence that the company’s products or actions caused a public nuisance in Oklahoma. The state’s claims violate fundamental principles of due process by seeking to hold a company liable for conduct permitted under federal law and regulations. It also disregards 100 years of precedent in public nuisance law, which traditionally has been applied to resolve property disputes, not lawsuits involving the sale of goods.”

Johnson & Johnson had also made the argument that their product is a legitimate treatment for patients who experience severe pain.

Oliva previewed some of the other arguments that Johnson & Johnson might make on appeal.

“Johnson & Johnson will contend that the chain of causation between the behavior with which it is charged — the manufacture, marketing and sale of raw opioid ingredients and prescription opioid products — and poor public health outcomes, the diversion of prescription opioids outside the health care delivery system and the development of illicit drug use disorder and overdose deaths in Oklahoma, are simply too attenuated,” she said. “Johnson & Johnson will maintain that other opioid manufacturers as well as opioid distributors and pharmacies failed to satisfy their duties under the Controlled Substance Act and, therefore, broke the chain of causation.”

PAGE BREAK

Pill bottle knocked over 
Some experts told Healio Primary Care the recent flurry of legal action may ultimately result in the development of opioid formulations that are safer for patients.
Source:Adobe

“They will also make the point that the prescribers and dispensers of opioids — doctors and pharmacists, for example, owe a duty to care to patients and are required to fulfill certain ethical obligations related to opioid prescribing and dispensing under their respective professional codes of ethics and state board licensing requirements and that their failure to comply with those obligations further broke the chain of causation,” Oliva continued.

She noted that Johnson & Johnson will also likely ask the appellate court to “reverse and remand” the trial court’s more than half-billion dollarabatement award, because the company had a small share of the opioid market in Oklahoma.

Oliva said Johnson & Johnson faces “a tough battle” ahead with regard to its appeal, but the company might succeed to have the abatement award reversed and potentially reduced.

Pustilnik said the novel application of the public nuisance law leaves “lots of wiggle room” for the law’s interpretation.

“Meaning there is a chance that the state’s nuisance theory will be rejected, the verdict overturned, and the judgment vacated,” Pustilnik told Healio Primary Care.

Future of opioids

Robert Freeman
Robert Freeman

Robert Freeman, PhD, a former professor of pharmacy administration at the University of Maryland's Eastern Shore campus, told Healio Primary Care that “it’s doubtful that opioids, even fentanyl, will be removed [from the market] because there are few options for the management of chronic, severe pain,”

“However, further restrictions on their use as well as the annual number of units allowed by the Drug Enforcement Administration are likely. I can see continued development of formulations that reduces the overdose potential,” he continued.

Lewis Nelson
Lewis Nelson

Lewis Nelson, MD, a former chair of FDA’s Drug Safety and Risk Management Advisory Committee, agreed with Freeman.

“Opioids remain an important therapeutic tool, and when used appropriately and responsibly they provide excellent relief for patients with severe acute pain. Opioids will not disappear, but the range of formulations and their ready availability may change,” Nelson, who is now chair of the department of emergency medicine at Rutgers New Jersey Medical School, said in an interview. – by Janel Miller

Disclosures : Neither Freeman, Nelson nor Pustilnik have previously reported any relevant financial disclosures. Healio Primary Care was unable to determine Oliva’s relevant financial disclosures prior to publication.

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