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Tag: opioid manufacturers

  • Jury Selection Begins In Federal Opioid Trial

    Jury Selection Begins In Federal Opioid Trial

    The trial that begins next week technically will focus on Cuyahoga and Summit counties in Ohio.

    Jury selection began on Wednesday in the first federal opioid trial, which is slated to begin on Monday (Oct. 21). 

    The lawsuit that begins next week is part of the National Prescription Opiate Litigation, which brings together more than 2,000 lawsuits against opioid manufacturers and distributors, according to NPR.

    The trial that begins next week technically has two plaintiffs—Cuyahoga and Summit counties in Ohio—but they will gauge how other trials will unfold.

    U.S. District Judge Dan Polster, who is overseeing the trial, has been clear about his desire to see parties settle out of court. 

    Negotiation Class

    In fact, last month Polster said that he will approve a “negotiation class.” Under this model, 49 governments would participate in negotiating a deal that would apply to every city and county in the country, unless the municipality explicitly opts out. The representatives of the 49 municipalities would have the opportunity to vote on potential settlements, potentially streamlining settlements between governments and manufacturers. 

    University of Connecticut law professor Alexandra Lahav said that this is an unusual approach.

    “The usual class action—the way it works is you have a class representative and they decide whether it’s a good settlement or not. Here we’re letting people vote. We have a much bigger input—that’s the novel thing here,” she said. “This is totally uncharted territory. There’s no model for any of it.”

    Time Is Of The Essence

    Polster has spoken out about his belief that the opioid cases are unique, and therefore call for unusual approaches to resolution. He has spoken about his belief that time is of the essence, so that settlement funds can be used to support people affected by opioid use disorder. Writing in a pretrial ruling, he said, “Ordinarily, the resolution of a social epidemic should be the responsibility of our other two branches of government, but these are not ordinary times.”

    While the National Prescription Opiate Litigation could result in a so-called “global settlement” that would resolve lawsuits, opioid manufacturers and producers could potentially still face criminal charges for their role in the epidemic. New York representative Max Rose (a democrat), has said, “The Sackler family does not belong in bankruptcy court, they belong in handcuffs.” 

    However, Rutgers Law School professor David Noll said that criminal charges could complicate the national litigation, which is likely why no states have filed criminal charges. 

    “There is a possibility that they’ll have to pay restitution,” he explained. “And their position will be, ‘The money which we had earmarked for the settlement now can’t be used for that purpose because we have to preserve our ability to satisfy a criminal judgment.’ That may explain why nobody has pulled the trigger on filing a criminal action against them.”

    View the original article at thefix.com

  • Johnson & Johnson Settles Opioid Lawsuits With Two Ohio Counties

    Johnson & Johnson Settles Opioid Lawsuits With Two Ohio Counties

    The settlement is tiny compared to a recent $572 million ruling against Johnson & Johnson for its role in the opioid epidemic in Oklahoma.

    Johnson & Johnson has reached a settlement deal with two Ohio counties in the “bellwether” case for the national opioid lawsuits. 

    Johnson & Johnson has agreed to pay a $20.4 million settlement to Summit and Cuyahoga counties. That includes $10 million in cash and $5 million in legal fee reimbursement. Another $5.4 million will be donated to addiction treatment and opioid-related programs in the counties. 

    “This settlement represents yet another milestone in this litigation as it gets much-needed funding into the community while at the same time providing support for programs addressing opioid-exposed babies and their families,” the counties’ attorney, Frank L. Gallucci, told The Washington Post. 

    Johnson & Johnson argued previously that its opioid products made up fewer than 1% of opioid sales in the two counties, and therefore could not be held responsible for addiction in the counties. However, it decided not to take that argument to trial. 

    “The settlement allows the company to avoid the resource demands and uncertainty of a trial as it continues to seek meaningful progress in addressing the nation’s opioid crisis,” the company said in a statement. “The company recognizes the opioid crisis is a complex public health challenge and is working collaboratively to help communities and people in need.”

    A Small Price To Pay

    The settlement is tiny compared to a recent $572 million ruling against Johnson & Johnson for its role in the opioid epidemic in Oklahoma. The company was one of the only defendants in that case that did not reach a settlement before trial. The company is appealing that ruling.

    Johnson & Johnson’s stock rose after the Ohio settlement was announced, indicating that investors see this as a win for the company. 

    Purdue Pharma and Mallinckrodt Pharmaceuticals have also reached settlements in the bellwether case, which is meant to set the stage for more than 2,000 opioid-related lawsuits from around the country. So far, the two counties reached settlements worth a total of $60 million, The New York Times reported. However, six defendants are still slated to go to trial, which will begin at the end of the month. The jury selection will begin within two weeks. 

    More Counties To Come

    Attorneys for the counties said that they are preparing for the trial. “We continue our preparation ahead of the October 21st trial where we plan to hold the remaining opioid makers and distributors accountable for fueling the crisis that has led to thousands of deaths in Ohio and across the country.”

    View the original article at thefix.com

  • Two Drugmakers Settle Ahead Of Federal Cases

    Two Drugmakers Settle Ahead Of Federal Cases

    Endo and Allergan will still face ongoing litigation with dozens of other municipalities.

    Two drug makers have settled with two Ohio counties ahead of an upcoming federal opioid trial in Cleveland.

    Endo International and Allergan will pay a combined $15 million in damages to Cuyahoga and Summit counties in Ohio. Both companies avoided admitting any wrongdoing. 

    The settlement comes ahead of a landmark trial slated to start Oct. 21—which will hear arguments by local governments, Native American tribes and more from around the country alleging that the drug companies fueled the opioid crisis.

    Right now, other major drug manufacturers and distributors including Purdue Pharma, Teva, Johnson & Johnson, McKesson, and AmerisourceBergen will still proceed to trial in the fall, according to STAT News. 

    Although Endo settled, the company faces ongoing litigation with other municipalities, including more than 2,300 cases filed by counties and cities. 

    The Deal

    Endo’s deal with the Ohio counties indicates that the company could settle its suits globally for about $1.8 billion, according to FiercePharma. That’s lower than the $4 billion in settlements that was initially predicted for the company. One analyst said that the lower-than-expected settlement amount indicates that drug manufacturers may be “out of the woods.”

    After the settlement was announced, Endo and other pharmaceutical stocks were trading higher, indicating that investors were pleased with the settlement amount. Although Allergan did not comment on the settlement, Matthew Maletta, Endo’s executive vice president and chief legal officer said that the agreement was a “favorable outcome.”

    One analyst, John Leppard, said that the settlement amount from Endo was likely calculated based on what the company thought it would cost to go to trial. 

    The agreement “appears designed only to spare Endo the expense of the bellwether trial, rather than satisfying their overall potential costs in a comprehensive resolution of government-related opioid claims with the approximately 2,000 cities and counties party to the multi-district litigation,” he wrote. “The cash portion of this settlement appears intended to reflect Endo’s estimated costs of having to participate in the bellwether trial itself, rather than their overall liability or culpability.”

    In addition to the $10 million cash settlement, Endo agreed to provide the counties with up to $1 million of the drugs Vasostrict and Adrenalin free of charge. Vasostrict is a hormone used to treat diabetes, blood pressure and other conditions. Adrenalin is used in EpiPens. 

    The settlement could be an indication of the amounts that other pharmaceutical companies may settle for ahead of thousands of other upcoming lawsuits. 

    View the original article at thefix.com

  • How 76 Billion Opioid Pills Flooded The Country

    How 76 Billion Opioid Pills Flooded The Country

    Shocking data from a federal opioid lawsuit has been unsealed and made available to the public.

    Data that was recently unsealed by a panel of federal judges has revealed that drug companies flooded the country with 76 billion opioid pills between 2006 and 2012, enough to supply every American adult and child with 36 pills each year.

    In some rural areas in Appalachia, the rate was more than 300 pills a year for every resident. 

    The data was reported on by The Washington Post. It comes from a database maintained by the Drug Enforcement Administration (DEA), the Automation of Reports and Consolidated Orders System, or ARCOS. The ARCOS maintains a record of every legal drug sale in the country. 

    The ARCOS data has been instrumental in the federal lawsuits involving opioid manufacturers. However, the data was sealed by federal judge Dan Polster, even though he had said “the vast oversupply of opioid drugs in the United States has caused a plague on its citizens” and that releasing the data “is a reasonable step toward defeating the disease.”

    Making It Public

    The Washington Post and Charleston Gazette-Mail in West Virginia sued for access to the data, and in response the ARCOS was made public this week. 

    “The data provides statistical insights that help pinpoint the origins and spread of the opioid epidemic—an epidemic that thousands of communities across the country argue was both sparked and inflamed by opioid manufacturers, distributors, and pharmacies,” said Paul T. Farrell Jr., a lawyer for the newspapers. 

    The data shows that the distribution of opioid pain pills increased rapidly during that six-year period. In 2006, 8.4 billion pills were distributed, and that rose more than 50% to 12.6 billion pills in 2012. For comparison, morphine doses remained relatively steady during that period, with about 500 million per year. 

    The Culprits

    The ARCOS also showed that the biggest players in the opioid epidemic are not the ones commonly talked about. The three biggest opioid manufacturers controlled the vast majority of sales: SpecGx with 37.7% of the market, Actavis Pharma with 34.6% of the market, and Par Pharmaceutical 15.7% of the market. Purdue Pharma was the fourth-largest manufacturer, but controlled just 3.3% of the market. 

    Likewise, the three largest drug distributors were responsible for distributing more than half of the opioid pills during that time. They were McKesson with 18.4% of the market, Walgreens with 16.5% and Cardinal Health with 14%. The fourth largest manufacturer, AmerisourceBergen, controlled 11.7% of the market. 

    A spokesperson for AmerisourceBergen told The Washington Post that the data “offers a very misleading picture.”

    The database also helps show that the areas that received the most opioid pills were also those with the highest overdose rates. West Virginia, which had the highest death rate between 2006-2012, received an average or 66.5 pills per person during that time period, nearly double the national average.

    Other hard-hit states also had very high opioid sales: Kentucky with 63.3 pills per person, South Carolina with 58, Tennessee with 57.7 and Nevada with 54.7.

    View the original article at thefix.com

  • New York Tries To Tax Prescription Opioids Again

    New York Tries To Tax Prescription Opioids Again

    Some people argue that the tax could push people to use illegal alternatives if prescription opioids become more expensive.

    New York state has passed a measure to tax opioid prescriptions in an attempt to fund addiction-recovery efforts, despite the fact that a court ruled a similar measure unconstitutional last year. 

    According to WXXI, the state said that the measure, part of the state budget, is intended to raise additional funds to pay for the response to the opioid crisis by taxing manufacturers.

    However, some people argue that the tax could have unintended effects, pushing people to use illegal substances if prescription opioids become more expensive. 

    “While the language of the proposed law attempts to place the burden of the tax on drug manufacturers, in practice market forces determine how the burden of the tax is shared between producers and consumers,” Lewis Davis, professor of economics at Union College, wrote in a report.

    The report was prepared last year and paid for by a pharmaceutical lobbying group, but echoed concerns shared by other organizations including the American Cancer Society Action Network.

    Davis pointed out that the tax policy could have a number of negative side effects. 

    “Most of the tax will be paid by non-consuming NY residents in the form of higher insurance premiums and higher taxes to cover public health programs. Second, to the extent that the cost of the tax is passed on to consumers, it will have a high cost to society in terms of reduced access to medically appropriate use of opioids,” he wrote. “Third, by increasing the cost of prescription opioids, the proposed tax will encourage NY residents suffering from opioid dependence to switch to cheaper illegal opioids, including heroin and fentanyl, with increased rates of accidental overdose.”

    He continued, “Because it fails to target opioid abuse, the proposed tax is poorly designed policy for addressing the opioid crisis.”

    Last year, a federal court struck down the tax because it would violate interstate commerce laws by treating New York residents differently from consumers in other states. The 2019 version of the bill works around that and should stand up in court, according to the state. 

    Freeman Klopott, a spokesperson for the state budget office, said that New Yorkers who use prescription opioids won’t be affected by the measure, since most of the cost for the tax will be shouldered by insurance companies and drug manufacturers. 

    “We expect no significant change in the availability of these pharmaceuticals or any diversion to illicit alternatives,” said Klopott.

    View the original article at thefix.com

  • Former DEA Official Now A Paid Consultant For Purdue Pharma

    Former DEA Official Now A Paid Consultant For Purdue Pharma

    Insiders wonder if the former DEA official anticipated becoming a paid consultant for Big Pharma when she was with the agency.

    Demetra Ashley, former acting assistant administrator and senior official for the U.S. Drug Enforcement Administration (DEA), is currently a paid consultant for one of the top opioid drug manufacturers in the country, according to NBC News sources.

    As acting assistant administrator, Ashley warned the Senate in 2017 that a “robust regulatory program” would be needed in order to prevent the misuse of controlled prescription drugs such as Purdue Pharma’s OxyContin and other opioid medications.

    She specifically called out the over-prescribing of these drugs as “inextricably linked with the threat the United States faces from the trafficking of heroin, illicit fentanyl and fentanyl analogues,” and by extension, the entire opioid epidemic.

    At the same Senate hearing, Ashley argued for a law that made it very difficult for the DEA to use immediate suspension orders against companies like Purdue Pharma to either be revised or repealed.

    The Ensuring Patient Access and Effective Drug Enforcement Act, passed in 2016, made it nearly impossible for the DEA to take urgent action against a drug company when it “represents an imminent danger to public health or safety,” she said.

    Now, she is being paid by Purdue to advise them via her new consulting firm, Dashley Consulting, LLC. Purdue is currently facing around 2,000 lawsuits for its alleged role in the opioid epidemic via deceptive marketing tactics and encouraging doctors to over-prescribe OxyContin and similar drugs.

    After decades of specializing in preventing the diversion of prescription drugs, some are questioning whether Ashley did all she could to combat the alleged role of Purdue Pharma and other companies in the opioid epidemic and whether her new consulting position is a violation of ethics.

    While there is nothing technically illegal about this, Washington University law professor and government ethics expert Kathleen Clark says that Ashley’s new role with Purdue raises questions about “whether the prospect of a payday after leaving government tainted the actions of the regulator while still in government.”

    “Did this person act differently in government because they anticipated or wanted to get the payday from these very powerful economic actors who have huge amounts at stake?” Clark asks.

    When contacted by NBC News, Ashley did not confirm or deny consulting for Purdue Pharma, but acknowledged that she has “been consulting for members of the industry” since June 2018, three months after she retired from the DEA.

    She also confirmed that she has been subpoenaed as part of a consolidated lawsuit against opioid companies because of her former role in the DEA.

    View the original article at thefix.com

  • Johnson & Johnson Called Opioid "Kingpin" In Oklahoma Lawsuit

    Johnson & Johnson Called Opioid "Kingpin" In Oklahoma Lawsuit

    The lawsuit names the multinational company as a “top supplier, seller and lobbyist” for prescription opioids.

    Johnson & Johnson is being named as a “kingpin” of the opioid epidemic in the first big trial targeting opioid manufacturers, which is set to take place in May 2019.

    The lawsuit, brought by the state of Oklahoma, is naming the multinational company as a “top supplier, seller and lobbyist” for prescription opioids, according to a report by Axios.

    Although Purdue Pharma is the most commonly cited company associated with the opioid crisis, there are several other pharmaceutical companies being targeted by the many hundreds of lawsuits being brought to court by local governments as well as individuals.

    Johnson & Johnson, most often associated with baby powder and lotion products, is classified as a pharmaceutical company. 

    Prior to the Axios report, Johnson & Johnson came under fire when it was discovered that the brand’s baby powder contained asbestos. The company was ordered by a California judge on Wednesday to pay $29 million to a woman who sued based on the claim that the powder was a “substantial contributing factor” in the development of her terminal cancer.

    In addition to everyday home products, Johnson & Johnson “produced raw narcotics in Tasmanian poppy fields, created other active opioid ingredients, and then supplied the products to other opioid makers—including Purdue Pharma,” according to the report.

    The company also allegedly boasted about the high morphine content of its poppies, targeted children and the elderly in its marketing, and funded multiple “pro-opioid groups.” A brochure made by one of the company’s subsidiaries even claimed that “opioids are rarely addictive.”

    The lawyers representing Oklahoma in the upcoming case have asked a court to release millions of pages of Johnson & Johnson’s confidential documents to the public, based on the fact that the company has divested from the opioid business and therefore shouldn’t have to worry about losing trade secrets.

    “The public interest in this information is urgent, enduring and overwhelming,” wrote Oklahoma Attorney General Mike Hunter.

    Johnson & Johnson provided Axios with a statement in the company’s defense, claiming that it “appropriately and responsibly met all laws and regulations on the manufacturing, sale and distribution of APIs (active pharmaceutical ingredients) and the raw materials that go into them” and that its “actions in the marketing and promotion of these important prescription pain medications were appropriate and responsible.”

    The company claims that it accounted for “less than one percent” of the total market share for opioid medications.

    However, the Axios report points out that Johnson & Johnson made $1 billion in 2015 by selling the opioid Nucynta and $2 billion from the fentanyl patch Duragesic, which it still sells to this day.

    View the original article at thefix.com

  • Doctor Who Made 6K A Day For Prescribing Oxy: "I Was A Scapegoat"

    Doctor Who Made 6K A Day For Prescribing Oxy: "I Was A Scapegoat"

    “When I started treating people with chronic non-cancer pain. I felt it was unethical and discriminatory to limit the dose of medication.”

    Florida physician Barry Schultz was convicted to 157 years in prison for illegally prescribing enormous amounts of opioids to his patients.

    Now he calls himself a “scapegoat” for the pharmaceutical companies who produce, distribute and advocate for the prescription of opioids.

    Mallinckrodt pharmaceutical company was the provider of opioids in Schultz’s practice. The company eventually paid a fine for its part. Mallinckrodt provided 500 million oxycodone pills to the state of Florida, which has a population of 20 million people.

    Even after Mallinckrodt’s own internal investigation concluded that Dr. Schultz’s prescriptions had “a suspicious pattern indicating diversion” the company continued to supply him with opioids.

    Barry Schultz interviewed from prison with 60 Minutes to announce that he was a “scapegoat” for those really to blame—the opioid manufacturers.

    State Attorney Dave Aronberg’s office prosecuted Barry Schultz. Aronberg blamed Florida’s lax laws at the time for fueling the opioid overdose crisis. Pain clinics in Florida allowed patients to visit, pick up pills, and pay in cash. As a result, people from other states began coming to Florida to obtain opioids, creating a frenzy where waiting rooms would be overflowing.

    This was the kind of pain clinic that Schultz operated in Delray Beach, Florida. DEA records show in 2010 that Dr. Schultz was prescribing some patients as many as 100 pills a day, and making more than $6,000 a day from prescribing opioids.

    Despite this, Dr. Schultz refuses to take responsibility for his actions. “When I started treating people with chronic non-cancer pain,” he told 60 Minutes, “I felt it was unethical and discriminatory to limit the dose of medication. And if I had known that the overdose incidents had increased dramatically the way it had, I would have moderated my approach.”

    Carol Tain’s son David died in 2010 of an opioid overdose from pills prescribed by Dr. Schultz for pain management after a car accident. Tain’s mother considers Dr. Schultz responsible for her son’s death.

    “He didn’t even examine him. He hadn’t seen him in four-and-a-half years,” Tain said to 60 Minutes of the doctor’s prescriptions for her son. “He just—just wrote—wrote out these scripts… As far as I’m concerned, he’s a murderer and—and not a doctor. He murdered my son. He – he didn’t need a gun. He used his pen to murder my son.”

    View the original article at thefix.com