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Opioid Lawsuit: News and Trial Updates

Opioid News and Updates

• October 9, 2018

Opioid Lawsuit News: Opioid MDL Defendants Lose Bid to Have Bellwether Tossed

Rejecting arguments presented by defendant drug companies, pharmacies, and distributors, which argued that claims brought against them by plaintiff Summit County, Ohio should be tossed out, a magistrate judge has paved the way for trial in one of three planned bellwether cases within massive and complex multidistrict litigation (MDL) over the ongoing opioid crisis, Law360 has reported .

For example, the defendant companies had urged US Magistrate Judge David Ruiz to dismiss the plaintiff municipality’s state law claims alleging the defendants mislead the public as to the safety and efficacy of opioid painkillers while downplaying the risk of addiction, saying those claims were preempted by federal law and the drugs’ approval by the US Food and Drug Administration (FDA). However, Judge Ruiz disagreed, allowing Summit County’s claim to stand.

The outcome of Summit County’s case will have enormous ramifications for the numerous other municipalities who have sued those they feel are responsible for the ongoing opioid crisis that continues to ravage their communities. Attorneys for plaintiffs in the MDL applauded the magistrate’s decision.

“This is a major step forward for the over 1,000 communities working to hold the pharmaceutical industry accountable for the countless lives that have been lost to opioid addiction,” the three co-lead attorneys on the plaintiffs’ executive committee wrote in a statement issued following Judge Ruiz’s decision. “This litigation is the most effective way to secure the resources communities need to address the opioid epidemic for decades to come.”

The first three bellwether trials in the opioid MDL are scheduled to begin in 2019.

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Law360

• August 27, 2018

Wrongful Death - Opioid Lawsuit News: Family of Rock Star Prince Bring Wrongful Death Claims Against Walgreens, Doctor, Hospital Group

In a tragic situation that mirrors tens of thousands of lower-profile instances across the nation, the family of deceased rock star Prince continues to seek accountability from those they believe to be legally responsible for their loved one’s premature death from an opioid overdose. In their latest move, on Friday, August 24, 2018, they brought a wrongful death suit in Minnesota state court, alleging that the drug-store chain Walgreen’s, a doctor who treated Prince in the months preceding his death, the healthcare group that employed the doctor, and a separate hospital group each failed in their duty to recognize the decedent’s opioid addiction and to intervene with appropriate treatment in a timely manner.

Instead, the lawsuit alleges, each party turned a blind eye to the patient’s condition and continued to provide him with the highly addictive, potentially fatal drugs that ultimately would cause his death at his Paisley Park estate on April 21, 2016.

“For an unknown but considerable period of time before his death…Prince suffered from addiction to opioid pain medications,” the complaint says, according to Law360. “All of the defendants had an opportunity and duty during the weeks before Prince’s death to diagnose and treat Prince’s opioid addiction, and to prevent his death. They failed to do so.”

In addition to Walgreen Co., the defendants also include Dr. Michael T. Schulenberg, his employer North Memorial Health Care, and Iowa Health System. Iowa Health System runs a family of affiliated hospitals and clinics doing business under the name UnityPoint Health.

The lawsuit follows a similar wrongful death suit Prince’s family brought in Illinois state court earlier this year. Like the family’s Minnesota claim, the Illinois lawsuit also named Walgreen’s and UnityPoint as defendants. However, the cases involve two different doctors, both of which allegedly provided Prince with prescriptions for opioid medication despite his demonstrating clear signs of addiction and potential abuse.

Both lawsuits came following the conclusion of a two-year criminal investigation examining the circumstances surrounding Prince’s death. Though investigators concluded that Dr. Schulenberg had committed violations of the federal Controlled Substances Act, the doctor entered into an agreement with prosecutors under which he agreed to pay only a $30,000 fine as punishment.

The experience of Prince’s family is significant not for its uniqueness but for the way in which this high-profile case—which has gained widespread notoriety on the basis of Prince’s fame—reflects similar tragedies that continue to impact tens of thousands of families every single year. And while Prince’s family has the resources necessary to properly investigate the circumstances of his death and to bring these multiple claims, the sad reality is that most victims of the ongoing opioid epidemic aren’t so fortunate.

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Law360

• August 23, 2018

Opioid Lawsuit Update: Attorneys for Opioid Babies Continue Push for Separate MDL Track

Babies born to opioid-addicted mothers are among the most innocent of victims to suffer from the ongoing opioid epidemic that continues to ravish individuals, families, and communities across the United States and around the world. Through no fault of their own, infants born with Neonatal Abstinence Syndrome (NAS) come into the world already suffering from an addiction that has proven debilitating and even deadly for millions of full-grown adults. In addition to seizures and other withdrawal symptoms, babies with NAS also are at an increased risk of low birth weight, cognitive impacts, and other afflictions.

Despite prior rejections, attorneys representing babies born with NAS in federal multidistrict litigation (MDL) over the opioid epidemic continue to push for their clients to be granted their own track within the highly complex MDL. The babies’ lawyers argue that that committee comprised of different plaintiff groups has failed to adequately reflect their clients’ interests and even has actively excluded them from the ongoing discovery process, according to Law360.

Lawyers for babies born with NAS assert that their clients, who literally lack a voice in the matter and who face an entire lifetime of challenges resulting from their mothers’ opioid addiction, are at risk of being overlooked by the legal process.

In a new motion filed Tuesday, August 21, 2018, attorneys for the infant plaintiffs wrote, “The court created the Native American track so that they would not be marginalized," citing an example of a separate track that has been approved. "Here the [NAS] babies are currently marginalized completely."

In addition to Native American tribes, third-party payors also have been granted a separate track within the MDL, which is being overseen by Judge Dan Aaron Polster in US District Court for the Northern District of Ohio.

“Voiceless children deserve to have separate counsel and these NAS babies deserve to be heard and represented in this opioid crisis," said attorney Scott Bickford, who represents opioid-addicted babies, according to Law360. "Despite thousands of NAS babies being born each year, the states and local governments have done little to address this epidemic or the life-long issues which follow these children. We are hoping the court reconsiders its position, recognizes the plight of these children and allows them a clear voice in the multidistrict litigation."

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Law360

• August 20, 2018

Opioid Lawsuit News: First Opioid MDL Bellwether Moved Back to September 2019

In a nod to the incredible complexity of the litigation under his purview, an Ohio district court judge overseeing multidistrict litigation (MDL) over the ongoing opioid epidemic has pushed back the anticipated start date of the first bellwether trial to September 2019, a delay of six months from the previous date of March 2019. The trial will feature local governments in Ohio who have sued the manufacturers of opioid drugs over the financial and social costs the opioid epidemic has wrought on their communities.

The announcement marks a concession of sorts for US District Court Judge Dan Aaron Polster, who at the outset of the consolidated MDL proceedings had said he sought a speedy settlement to resolve the matter, going so far as to say “people aren't interested in depositions and discovery and trials,” according to Law360.

The delay had been requested by the plaintiffs in order to provide time to conduct full discovery and was a response to arguments by the defendant drug companies that they could not comply with certain evidentiary requests due to a lack of time. An attorney representing several Ohio local governments told Law360 that the judge’s ruling closely matched the timeline of the plaintiffs’ request.

The opioid MDL presently contains over 1,000 lawsuits, including other bellwethers involving local municipalities in Florida, Illinois, Michigan, and West Virginia, as well as Native American tribes and a Florida hospital.

In addition to the opioid drugmakers , plaintiffs also have sued distributors and pharmacies for their role in allowing a flood of highly addictive, highly deadly drugs to flood American streets, resulting in tens of thousands of deaths annually in the United States alone.

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Law360

• August 20, 2018

Opioid Lawsuit News: Idaho, Georgia and Minnesota Tribes Latest to Sue Opioid Makers, Drugstores Over Crisis

With the opioid epidemic still ravishing individuals, families, and communities across the nation, new lawsuits continue be filed against drug makers, distributors, and drugstores, seeking to hold them accountable for the highly addictive, highly deadly drugs that have flooded America’s streets to catastrophic effect.

In just the past week, amidst a Center for Disease Control report revealing that there were 72,000 opioid-related deaths in the United States in 2017 alone and statements from President Trump indicating that he may push for Justice Department action against opioid makers and distributors, new plaintiffs include counties across Idaho, Georgia municipalities, and several Native American tribes in Minnesota.

Idaho

The Idaho Statesman reported August 17 that 11 counties in the state have brought suit against drug makers and drugstore chains, alleging that the companies were aware of the dangers posed by opioid drugs and that the drugs were being used for improper purposes.

Pharmaceutical companies named in the suit include Purdue, Janssen, Johnson & Johnson, and Teva. Other named defendants include the popular drugstore chains Walmart, Kroger, CVS, and Rite Aid.

The Idaho counties accuse the companies of fueling the rise in opioid-related deaths within the state, citing reports that “prescription opioid-related overdose deaths increased from 45 to 77 between 2012 and 2016” and that “[i]n 2016, there were 119 opioid-related overdose deaths in Idaho (including non-prescription opioids).”

Among overdose deaths and other harms, the lawsuit highlights the devastating effect the opioid crisis has had on children.

“The deceptive marketing, overprescribing, and oversupply of opioids also had a significant detrimental impact on children in Idaho,” the complaint reads, according to the Statesman. “Young children have access to opioids, nearly all of which were prescribed or supplied to adults in their household, and children have themselves been injured or killed. Children of parents addicted to opiates, described as the ‘invisible victims of the epidemic’ are flooding the child protection system.”

Georgia

Meanwhile, according to an in-depth piece published August 17 by the Atlanta Journal-Constitution, to date over 70 municipalities in Georgia have sued drug makers and others they allege to be responsible for the opioid epidemic’s impact on their communities.

Fulton County, the first Georgia municipality to sue, did so in fall 2017, and since then several dozen others have followed suit.

At the time, Rod Edmond, an attorney representing Fulton County as well as a family doctor, explained the basis for the allegations.

“This is serious for our community,” Edmond told reporters, according to the Journal-Constitution. “The claim that we have is very simple: These opioid manufacturers and distributors have been flooding our nation with these dangerous drugs for money — for greed.”

Minnesota

Additionally, the Bemidji Pioneer has reported that on August 16, four Native American tribes in Minnesota have joined 11 other tribes nationally in bringing suit against drug makers and distributors, accusing them of downplaying the addictive qualities of opioid drugs while failing to comply with federal laws intended to prevent their improper distribution and illicit use.

The Minnesota tribes filing suit this week include Prairie Island Indian Community, Lower Sioux Indian Community, the Upper Sioux Indian Community, and the Shakopee Mdewakanton Sioux Community. All four tribes are located in southern Minnesota.

Opioid-related deaths in Minnesota totaled approximately 400 annually for 2016 and 2017, according to preliminary state department of health data cited by the Pioneer.

Stay Tuned to TheLawFirm.com for the latest updates on the legal fallout from the ongoing opioid epidemic.

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THe Idaho Statesman - Idaho Lawsuits

The Atlanta Journal Constitution - Georgia Lawsuits

The Bemidji Pioneer - Minnesota Lawsuits

• August 13, 2018

Opioid Lawsuit Settlement News: Insys Agrees To Pay At Least $150 Million Over Doctor Bribery Claims

Insys Therapeutics Inc. reportedly has reached a settlement with the US Department of Justice (DOJ) over claims that it bribed doctors to prescribe its fentanyl spray Subsys, agreeing to pay at least $150 million to stop ongoing criminal and civil investigations into its alleged misconduct, according to Law360.

However, the settlement hardly marks the end of Insys’ legal entanglements over its role in the ongoing opioid epidemic. Under the agreement, the company could be on the hook for as much as $75 million more, while its founder and several former executives continue to face criminal fraud and racketeering charges in Massachusetts.

A number of doctors across several states have pled guilty to accepting bribes from Insys representatives in exchange for increasing their prescriptions of Subsys. According to the DOJ, the scheme caused government programs such as Medicare and Medicaid to pay for tens of millions of dollars in unnecessary prescriptions.

The settlement with the DOJ also does not resolve a number of state law claims the drug maker faces in states such as New York, New Jersey, and South Carolina. On Wednesday, August 8, 2018, several states also filed a consolidated claim against Insys under the federal False Claims Act. Those states include California, Colorado, Indiana, Minnesota, New York, North Carolina and Virginia.

The cases against Insys represent just a small subset of the broader legal fallout over opioid makers’ role in the epidemic of addiction and overdoses that has ravaged families and communities across the nation. Drug makers face legal action from a wide range of impacted parties, including the federal government, states, municipalities, Native American tribes, insurance companies, and aggrieved individuals. A large number of those proceedings have been consolidated in massive multidistrict litigation (MDL) being overseen by a federal district court in Ohio.

Stay tuned to TheLawFirm.com for the latest news on the legal fallout from the opioid epidemic.

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Law360

• August 13, 2018

Opioid Lawsuit News: Cherokee Nation, Perdue Battle Over Venue in Opioid Lawsuit

Seeking to avoid having what it argues are state-court claims wrapped up in massive federal multidistrict litigation (MDL), the Cherokee Nation mounted a spirited legal effort Monday, August 6, 2018 to convince a federal district court judge that its claims against Perdue Pharma over the company’s role in the opioid epidemic belong in Oklahoma court.

The Cherokee Nation originally brought its claims in Oklahoma state court, alleging that Perdue Pharma LP, Purdue Pharma Manufacturing Inc., Perdue Frederick Co. Inc., and Perdue Pharma Inc. collectively share a high degree of culpability for the ongoing opioid epidemic that continues to ravage communities across the nation. The companies are the makers of OxyContin, an early and highly popular form of opioid painkiller.

In its original petition to an Oklahoma state court, the Cherokee Nation asserted, “Despite all of the known dangers of OxyContin and other opioid drugs they have produced, the defendant companies have employed long-running, deceptive and deceitful marketing campaigns, advocating for the drug’s expanded use while downplaying or outright misstating the dangers of opioid drugs, and by allowing opioids to be diverted into improper channels to fuel the epidemic.”

Now, the tribe accuses Perdue of pushing the lawsuit into federal court without an adequate basis for federal jurisdiction, with the sole intent of delaying justice. In its petition to have the case removed back to Oklahoma state court, the Cherokee Nation wrote, “This court should see Purdue’s removal for what it is: a naked attempt to delay any accountability for years of misconduct. Purdue—along with other opioid manufacturers and distributors—has repeatedly tried this tactic in other cases.”

The motion continued, “If this court does not swiftly remand this case to Oklahoma state court, the Cherokee Nation’s case will be caught up in the MDL and delayed for an unknowable period of time, despite the absence of federal jurisdiction. Delaying this action not only prolongs complex litigation. It threatens the lives and wellbeing of the Cherokee Nation’s citizens.”

The Cherokee Nation knows from experience of what it speaks. In an earlier lawsuit filed by the tribe against McKesson Corp., the defendant company succeeded in having the case pushed to federal district court, from where the US Judicial Panel on Multidistrict Litigation assigned the case to the Ohio district court overseeing the massive federal opioid MDL.

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Law360

• August 13, 2018

Opioid Lawsuit Update: Hospital Coalition Urges Judge Not to Dismiss Bellwether Opioid Case

A group representing nearly four-dozen hospitals has come to the aid of a plaintiff health-care provider in an important bellwether case that is part of massive multidistrict litigation (MDL) over the nation’s ongoing opioid epidemic.

On Friday, August 3, 2018, 44 hospitals requested permission to file a joint brief aimed at rebutting claims made by drugmakers and distributors seeking to have the court dismiss the case summarily.

The plaintiff, Florida-based West Boca Medical Center, argues that the defendants should be held accountable for the unreimbursed costs incurred by it and other health-care providers forced by law to provide emergency care for individuals suffering from opioid overdoses and other opioid-related conditions.

The outcome of the case could have enormous implications for the potential liability of pharmaceutical companies and drug distributors over not just the opioid epidemic but future cases as well.

As the hospital coalition’s brief argues, “While third-party insurers and state Medicaid programs provide some reimbursement to hospitals for such care, a significant amount of the expense goes un- or undercompensated. Amici hospitals are concerned that if the medical community is excluded from this MDL proceeding, recoveries against the manufacturer and distributor defendants will never actually reach the front lines, especially for prevention and future care.”

In arguing that hospitals and other health-care providers should be excluded from the opioid MDL, defendant drugmakers and distributors have relied heavily on the precedent-setting cases against the tobacco industry, in which hospitals similarly attempted to hold companies responsible for unreimbursed costs of care stemming from tobacco-related ailments.

Health-care providers, for their part, have sought to minimize the precedential impact on the present case, even arguing that a Third Circuit decision reached in 2000 demonstrates the importance of allowing hospitals and other providers to have a role in such proceedings. That decision also famously found that the harm suffered by providers was too remote from tobacco manufacture and sale to hold the tobacco companies liable.

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Law360

• August 6, 2018

Opioid Lawsuit News: Allergan Seeks Indemnity from Pfizer Over Opioid Claims

Arguing that it should not be held responsible for claims predating its acquisition of the opioid drug Kadian, Allergan Finance LLC has filed third-party claims against drugmaker Pfizer Inc. and its subsidiary King Pharmaceuticals LLC seeking indemnity for legal costs over claims arising prior to 2009. The third-party claims were filed as part of massive, ongoing multidistrict litigation (MDL) over the nation’s opioid epidemic, which is being overseen by a federal district court in Ohio.

According to Allergan, which previously went under the name Actavis, the company purchased the prescription opioid Kadian from King Pharmaceuticals in a deal dated December 2008. Therefore, it asserts, Pfizer and King should be responsible for covering Allergan’s costs in defending claims that arise from actions taken before the sale.

“Allergan’s damages to date include the costs and legal fees that Allergan has expended defending the claims in the lawsuits and civil investigations based on pre-2009 marketing and sale of Kadian,” Allergan’s attorneys argue in the third-party complaint, according to Law360. “Allergan will continue to accrue damages as it continues to defend these claims.”

King Pharmaceuticals was required to divest its interest in Kadian as a Federal Trade Commission-imposed condition of the company’s 2008 proposed merger with Alpharma Inc.

“The allegations in the various opioids complaints reveal that the primary basis for the claims against Allergan is the allegedly improper marketing and sale of Kadian by Alpharma in the months and years before Actavis acquired Kadian in December 2008,” Allergan argued, according to Law360. “Yet Alpharma, King, and Pfizer are not named in the vast majority of the lawsuits both in this MDL and in dozens if not hundreds of state courts throughout the country.”

In response, Pfizer Inc. issued a statement reading, “Allergan’s claims relate to a product that Pfizer never manufactured, marketed or sold. Instead they arise from a historical 2008 contract belonging to King Pharmaceuticals, a company we acquired in 2010. We will review Allergan’s suit and respond accordingly.”

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Law360

• July 24, 2018

Opioid Lawsuit News: Pharmaceuticals Seek to Avoid Liability, Blaming “Drug Dealers” in TN Case

Drug makers seeking to avoid liability under a Tennessee anti-drug-dealing law have taken the unusual step of filing a third-party complaint blaming street drug dealers, dark web distributors, crooked health care providers, and even local municipalities themselves for fueling the ongoing opioid epidemic, Endo Pharmaceuticals Inc. and Mallinckrodt LLC announced on Friday, July 20, 2018.

The aggressive new tactic comes after local attorneys general across the state brought suit against opioid makers last year, seeking to hold them liable under the Tennessee Drug Dealer Liability Act. Among the allegations included in a complaint filed last year are accusations that Endo and Mallinckrodt along with other drug makers are responsible for the wave of neonatal abstinence syndrome that has swept the state. The syndrome occurs in babies born to opioid addicted mothers.

Endo and Mallinckrodt called the allegations against them “a tortured, misguided legal theory,” according to Law360, arguing that the opioid crisis instead has been the fault of “unregulated, illegal and unfortunately long-ignored actors whose sole motive is to sell illicit drugs to anyone willing to pay.”

However, the third-party complaint filed by the drug makers goes beyond blaming street drug dealers and “pill mill” doctors. It also seeks to add as defendants a number of local municipalities represented by the attorneys general bringing the original suit.

In essence, the pharmaceutical companies have asserted that the municipalities themselves are responsible for the opioid crisis that has ravaged their communities, arguing in the third-party complaint that these local governments “could have more closely monitored doctors for signs of fraudulent prescribing, reviewing prescribing data to assess the amount of opioid prescriptions being filled,” according to Law360.

An attorney representing the local attorneys general in the suit described the drug makers’ response as “reckless,” saying, “In essence, they are blaming law enforcement, civil servants and elected officials for not being able to keep up with overwhelming rates of addiction, neonatal abstinence syndrome and overdose deaths. They are blaming small, rural towns for not having enough body bags or morgue space to adequately deal with the mess they’ve created, and it’s a direct slap in the face of all those on the front lines of suffering and loss.”

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Law360

• July 17, 2018

Opioid Trial News: Judge Skeptical of Government RICO Charges Against Opioid Execs

On Tuesday, July 17, 2018, a federal district court judge in Massachusetts conducted a hearing over a motion to dismiss filed by the defendant opioid executives in a Racketeer Influenced and Corrupt Organizations Act (RICO) case brought against seven employees of Insys Therapeutics Inc. for allegedly engaging in illicit schemes designed to increase prescriptions of its costly and highly addictive fentanyl spray medication.

From the outset, US District Court Judge Allison D. Burroughs demonstrated a great deal of skepticism over the government’s case, according to Law360.

“For the life of me, I can’t understand this indictment,” Law360 quoted the judge as saying to the five government lawyers present. “I can’t understand why you’d want to go to a jury with this indictment, I can’t understand how we’d instruct them in any way that makes sense.”

The judge’s chastising continued. “I feel like the people who approved these indictments never tried a case. Can you imagine the jury charge? I know that’s not today’s problem, but just thinking ahead. I’m not even sure what the difference is between counts two and three, other than the words ‘mail’ and ‘wire.’ I don’t even know how to explain that to the jury.”

The remarkable display represented not only an embarrassment for the government attorneys but also a major setback to efforts to hold pharmaceutical executives accountable for their role in the ongoing opioid epidemic that has impacted communities across the country.

Beneath the judge’s confusion lies allegations that executives of Insys engaged in numerous schemes—including paying bribes to doctors—to boost sales of its opioid-based painkiller, potentially leading to unnecessary addictions and overdoses and contributing to the flood of opioids that have hit the US market.

K. Nathaniel Yeager of the US attorney’s office retorted that the indictments contained sufficient evidence to support the charges brought against the executives.

“They bribed doctors repeatedly, glaringly, in black and white, to prescribe the drug to people,” Yeager said, according to Law360. “This case is remarkably different than any case Your Honor has ever seen, and I know who I am talking to when I say this, Your Honor has extensive experience in pharmaceuticals.”

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Law360

Opioid News and Updates

• July 12, 2018

Opioid Lawsuit News: Doctor Convicted of Running Opioid Pill Mill Denied Appeal

Sometime around 2010, then-Doctor Richard Evans began to receive an increased number of Louisiana residents at his Texas medical practice. Coincidentally, approximately two years earlier, in 2008, Louisiana lawmakers had significantly tightened the state’s control over opioid prescriptions. Two dental assistants who worked in the same building as Evans began to take notice. As they later would testify at Evans’ trial, they observed that these patients demonstrated telltale signs of both opioid addiction and impairment.

When the two dental assistants reported Evans to federal authorities, investigators unearthed a massive “pill mill” scheme in which Evans had written in excess of 11,000 prescriptions for the opioid painkiller oxycodone in a little over two years’ time. In total, Evans had provided over 1.6 million opioid pills in exchange for almost $2.5 million in payment.

Following trial, Evans was found guilty of mail fraud and money laundering in addition to writing illegal prescriptions for the highly addictive, potentially fatal drugs. After he was sentenced to five years in prison followed by three years of supervised release, Evans appealed to the Fifth Circuit Court of Appeals, but on Friday, July 7, 2018, a three-judge panel denied the former doctor’s attempt to have his convictions overturned.

Finding that a reasonable jury could have reached the conclusions it did based on the evidence presented, the panel denied Evans’ request, writing in part, “In light of the substantial evidence that Evans ran an illegitimate practice, every fact Evans brings to his defense does little to move the needle in his favor. The jury could reasonably dismiss each precaution or prudent act Evans cites as either wholly inadequate, a vestige of his prior legitimate practice, or in fact a sham designed to hide his operation’s nefarious purpose.”

While doctors such as Evans are being convicted and sent to prison in increased numbers, the Big Pharma drug companies who made billions by downplaying the risks of opioid painkillers while overstating their usefulness continue to muddle their way through complex litigation centered mostly around financial reimbursements. It remains to be seen whether Big Pharma executives will be held accountable for their actions in the same manner as pill mill doctors like Richard Evans, who, though culpable, have acted on a much smaller scale.

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Law360

• July 10, 2018

Opioid Lawsuit News: Big Pharma Attacks Hospital in Effort to Have Opioid Bellwether Trial Tossed

On June 29, 2018, attorneys representing opioid makers, drug distributors, and pharmacies in multidistrict litigation (MDL) over the ongoing opioid epidemic filed multiple motions in an effort to have dismissed the claims of West Boca Medical Center, a Florida-based hospital that sued the companies seeking compensation for unreimbursed costs it incurred providing opioid-related treatment to uninsured patients.

Citing Third Circuit precedent, attorneys for the defendant companies argued vehemently that the case could set a dangerous precedent that potentially would allow hospitals and other health care providers to sue drug companies, medical device makers, or any other business that arguably had caused harm to uninsured patients.

“The [Third Circuit] explained that permitting these types of claims would set a ‘dangerous’ and flawed precedent that hospitals ‘have standing to sue any company that causes a nonpaying patient’s illness,’” lawyers for the opioid makers argued in their motion to dismiss, according to Law360.

For their part, lawyers representing defendant drug distribution companies went after the foundation of the hospital’s claims against their clients, arguing that they owed West Boca Medical Center no duty to monitor and/or refuse to fulfill suspicious pharmaceutical orders. Further, they took aim at the hospital’s allegations of unjust enrichment, asserting that hospitals are required by law to provide emergency care to uninsured individuals and that there is nothing “unjust” about a hospital following federal law and suffering the financial consequences thereof.

Attorneys for defendant pharmacies echoed the arguments made on behalf of drug makers and distributors, saying the claims against them should be dismissed because the allegations against pharmacies are even weaker and more tenuous than those made against the other two groups of defendants.

The MDL involves over 800 separate cases, mostly municipalities and local government entities seeking to recover costs associated with the ongoing opioid crisis that continues to ravage communities across the nation. Though hospitals are involved in a relatively small number of these cases, the aggressiveness of the defendants’ tactics in seeking to have the case dismissed belies the fact that, should West Boca Medical Center succeed at trial, many other health care providers likely would follow suit by bringing their own claims.

The unreimbursed costs of opioid-related treatments incurred by health care providers nationwide potentially run into the billions of dollars.

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Law360

• July 10, 2018

Opioid News: Doctor Convicted of Running Opioid Pill Mill Denied Appeal

Sometime around 2010, then-Doctor Richard Evans began to receive an increased number of Louisiana residents at his Texas medical practice. Coincidentally, approximately two years earlier, in 2008, Louisiana lawmakers had significantly tightened the state’s control over opioid prescriptions. Two dental assistants who worked in the same building as Evans began to take notice. As they later would testify at Evans’ trial, they observed that these patients demonstrated telltale signs of both opioid addiction and impairment.

When the two dental assistants reported Evans to federal authorities, investigators unearthed a massive “pill mill” scheme in which Evans had written in excess of 11,000 prescriptions for the opioid painkiller oxycodone in a little over two years’ time. In total, Evans had provided over 1.6 million opioid pills in exchange for almost $2.5 million in payment.

Following trial, Evans was found guilty of mail fraud and money laundering in addition to writing illegal prescriptions for the highly addictive, potentially fatal drugs. After he was sentenced to five years in prison followed by three years of supervised release, Evans appealed to the Fifth Circuit Court of Appeals, but on Friday, July 7, 2018, a three-judge panel denied the former doctor’s attempt to have his convictions overturned.

Finding that a reasonable jury could have reached the conclusions it did based on the evidence presented, the panel denied Evans’ request, writing in part, “In light of the substantial evidence that Evans ran an illegitimate practice, every fact Evans brings to his defense does little to move the needle in his favor. The jury could reasonably dismiss each precaution or prudent act Evans cites as either wholly inadequate, a vestige of his prior legitimate practice, or in fact a sham designed to hide his operation’s nefarious purpose.”

While doctors such as Evans are being convicted and sent to prison in increased numbers, the Big Pharma drug companies who made billions by downplaying the risks of opioid painkillers while overstating their usefulness continue to muddle their way through complex litigation centered mostly around financial reimbursements. It remains to be seen whether Big Pharma executives will be held accountable for their actions in the same manner as pill mill doctors like Richard Evans, who, though culpable, have acted on a much smaller scale.

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Law360

• July 4, 2018

Opioid News: Special Master Denies Drug Maker Request to Limit Disclosure of Opioid Data

A Special Master overseeing the discovery process in complex multidistrict litigation (MDL) over the opioid crisis presently making its way through Ohio federal court dealt a blow to drug makers on Saturday, June 30, 2018, when he declared that discovery dates would be linked to when certain drugs were approved by the US Food and Drug Administration (FDA). Drug makers had urged the Special Master to severely limit the scope of data they would be compelled to turn over has part of the pretrial discovery process.

In addition, Special Master David Cohen also denied the drug makers’ request to have information related to generic drugs omitted from the discovery process. In rejecting these efforts, Cohen wrote that, while branded drugs were at the heart of the litigation, “the allegations clearly also support claims premised on the manufacture, sale and distribution of generic drugs.”

In requiring the broader scope of discovery, Cohen sided with local Ohio governments suing the drug makers for the vast harms the opioid crisis has unleashed on their communities. Plaintiffs allege that the ongoing nationwide opioid epidemic has been fueled in large part by the improper conduct of drug companies, such as downplaying the addictive qualities of the drugs, urging doctors to prescribe them to patients who did not require them, and providing kickbacks to doctors who prescribed large quantities of the highly addictive, potentially deadly drugs to patients.

During the discovery process for the first three bellwether trials of the opioid MDL, local governments had urged the Special Master to require the drug makers to submit all relevant data extending back to 1995. Noting the wide range of FDA approval dates for the various drugs at issue, Special Master Cohen concluded that discovery would be required going back as far as the original FDA-approval date for the drug in question.

In terms of geographic scope, Special Master Cohen has required full disclosure of opioid sales taking place in the states of Ohio, Kentucky, Pennsylvania, West Virginia, Illinois, Georgia, and Florida, arguing that this compromise effectively balances the interests of the plaintiffs—who require geographical data to demonstrate the movement of various drugs—while reducing somewhat the burden on the defendant drug makers in producing the copious volumes of information.

Stay tuned to TheLawFirm.com for the latest updates on fast-changing litigation involving the ongoing opioid epidemic. And if you or a loved one has suffered harm as a result of a dangerous prescription pharmaceutical or medical device, contact the experienced team of attorneys at TheLawFirm.com today for a free consultation!

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Law360

Opioid News and Updates

• July 3, 2018

Opioids Lawsuit Update: Judge Denies Separate Track for Babies in Ohio Opioid MDL

On June 27, 2018, Judge Dan Aaron Polster, who is responsible for overseeing massive multidistrict litigation (MDL) over the ongoing national opioid crisis, issued an order denying a request for a separate track within the MDL for infants born to mothers who were taking opioids during pregnancy. Advocates for the separate track had argued that it was required due to the special medical costs associated with those unique plaintiffs.

Other groups such as Native American tribes also have requested separate tracks within the MDL. Separate tracks allow for bellwether trials specific to those plaintiffs and their associated legal issues, where novel legal theories often can be tested.

In May 2018, representatives for babies born with Neonatal Abstinence Syndrome (NAS) formally requested the separate track, citing the increased medical costs of children with NAS versus healthy children. NAS is associated with seizures and other withdrawal symptoms as well as low birth weight.

“The period of hospitalization for NAS averages 16 days, and hospital costs for a typical newborn with NAS are $159,000-$238,000 greater than those of healthy newborns,” they write in the May filing requesting a separate track.

With tens of thousands of babies born with NAS each year, advocates proposed a massive fund aimed at compensating victims and helping to cover the astronomical medical costs.

“Plaintiffs envision an irrevocable, court-administered, replenishing medical trust to which health care professionals providing NAS-related treatment or testing would submit invoices directly to the trust administrator for direct payment and data release,” the May filing stated. “This trust would also pay for the cost of ongoing epidemiological research which will assist in the evolution of medical knowledge regarding latent health impacts of NAS.”

According to advocates, the denial of the separate track likely will have ramifications on the “opioid babies” that will last a lifetime.

As attorney Scott Bickford told Law360, “The NAS babies are not going away.”

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Law360

• June 25, 2018

Opioid Lawsuit Settlement Update: Ohio Opioid MDL Judge Approves DOJ Participation In Settlement Talks

On Tuesday, June 19, 2018, US District Court Judge Dan Aaron Polster announced his approval of a request by the United States Department of Justice (DOJ) to participate in settlement negotiations taking place as part of massive multidistrict litigation (MDL) being overseen by his Ohio federal court. In its request to act as a friend of the court, initially submitted in April 2018, the DOJ argued that it could provide a unique national perspective while ensuring that any settlement is “structured to serve the public interest.”

As part of its participation in the MDL, the federal government also will be seeking reimbursement from pharmaceutical companies for medical and other expenses incurred as a result of fraud or other wrongdoing, per the DOJ’s April filing.

The Ohio MDL involves hundreds of individual lawsuits that claim opioid makers overstated the benefits of the drugs while concealing the potential risks, including opioids’ highly addictive nature. Many of the plaintiffs are state and local municipalities seeking to hold drug makers and distributors accountable for the devastation opioids have wrought in communities across the nation.

While attorneys for non-government plaintiffs welcome the resources and access to data that the federal government’s participation brings, they also have expressed concern that the federal government might try to capture resources that otherwise would have flowed to other plaintiffs, according to Law360.

In March 2018, the federal Drug Enforcement Administration (DEA) agreed to share with litigants some information from its massive database of drug-distribution information, a move that had been long sought by plaintiffs but which pharmaceutical companies and distributors had fought to block.

Some observers have watched the federal government’s actions with skepticism, largely because federal agencies such as the DEA and the Food and Drug Administration (FDA) have long been accused by critics of enjoying an overly cozy relationship with the industries under their oversight.

Stay tuned to TheLawFirm.com for the latest legal developments on the opioid epidemic.

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Law360

• June 20, 2018

Opioid Lawsuit News: KY AG Accuses Walgreens of Major Role In Opioid Epidemic

As the nation continues to investigate the causes and culprits of the ongoing opioid epidemic, large pharmacy chains increasingly are finding themselves the subject of lawsuits and the target of law enforcement investigations.

In the latest example of this growing trend, on June 14, 2018, the Kentucky attorney general filed a lawsuit against pharmacy giant Walgreens alleging the company aided in the distribution of unnecessary prescription opioids, thereby defrauding Medicare and spurring a wave of armed-robberies in the process.

The Kentucky AG’s suit also focuses on Walgreens’ dual—and potentially conflicting—roles as both a pharmacy chain and a drug distributor, with Walgreens owning just over one quarter of AmerisourceBergen, a top pharmaceutical distributor.

While this combined role potentially creates a financial conflict of interest for Walgreens, the Kentucky AG also argues that it put the company in possession of data that should have made it acutely aware of the suspicious nature of many of its Kentucky opioid shipments.

“From at least 2006 through the present Walgreens disregarded and overrode its own safeguard systems and raised its own opioid order thresholds, purportedly set in accordance with each pharmacy’s anticipated order size,” Kentucky Attorney General Andy Beshear’s lawsuit alleges. “Walgreens made the most dangerous and addictive drugs in America also the most accessible.”

According to the Kentucky AG, Walgreens has over 70 locations in the state, putting it in a unique position to note wider trends and tag suspicious activity. However, the suit alleges that the company instead chose to look the other way while profiting greatly off questionable opioid sales, sales that ultimately pushed a huge number of dangerous drugs onto the streets.

The AG’s suit cites the damage the opioid epidemic has wrought in the state, one of the nation’s hardest hit. In 2016 alone, over 1,400 Kentuckians died of drug overdoses, the third-highest per capita rate in the country.

As for the increased number of armed robberies, the suit states: “A report from a 2012 Prescription Drug Abuse Summit in Kentucky noted that the ‘pill explosion’ had increased armed robberies to six per month in areas of Kentucky, where there were previously two to three per year in the same area.”

Stay tuned to TheLawFirm.com for the latest legal news stemming from the ongoing opioid crisis.

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Law360

• June 8, 2018

Opioid Lawsuit News: Medicaid Groups Vie For Place on Opioid MDL Plaintiffs Committee

Arguing that they represent perhaps the largest group of plaintiffs involved in multidistrict litigation (MDL) over the opioid epidemic but lack an adequate voice in the proceedings, attorneys representing Medicaid managed care groups are seeking a place on an executive committee for plaintiffs, making a formal request before an Ohio-based federal judge on Friday, June 1.

According to their filing, Medicaid managed care groups often act as “payors of last resort”, frequently entering into agreements with government agencies to provide healthcare services to Medicaid beneficiaries. In a line of argument mirroring that of state and local municipalities also involved in the MDL, the Medicaid managed care groups contend that they paid out potentially billions of dollars-worth of opioid-related expenses. Further, the Medicaid managed care groups fear that governments will receive reimbursement for costs actually paid out by the groups themselves, justifying the groups’ having a larger role in the plaintiffs executive committee as well as in settlement negotiations.

The move by the Medicaid managed care groups highlights the massive complexity of the litigation, which features not only the typical legal battles among plaintiffs and defendants, but also its fair share of wrangling within the parties themselves. As just one example, the Medicaid managed care groups’ attempt to secure a spot on the executive committee has faced some resistance from the committee’s existing members.

According to attorney Paul Geller who presently sits on the plaintiffs executive committee, “I disagree with [the groups’] motion. The existing leadership structure is broad, encompassing, and inclusive.”

The Medicaid groups previously have filed two separate proposed class action lawsuits related to the opioid crisis, both of which have been absorbed into the Ohio MDL.

The plaintiffs executive committee was formed on the order of US District Court Judge Dan Polster in January 2018.

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Law360

• June 8, 2018

Opioid Lawsuit News: Ohio MDL Judge Orders Separate Track for Native Tribes

Recognizing that Native Americans have been disproportionately impacted by the ongoing opioid epidemic, a federal judge in Ohio overseeing multidistrict litigation (MDL) pertaining to the crisis agreed Monday, June 6, 2018 to begin setting up within the MDL a separate track exclusively for Native American plaintiffs.

The decision follows a May hearing in which US District Judge Dan A. Polster had expressed a commitment to ensuring that Native American plaintiffs played a large role in any ultimate resolution to the litigation, whether as central plaintiffs within the main MDL or as their own track.

“If there is a resolution, there won’t be one without [Native American plaintiffs],” Judge Polster promised at the time, according to Law360. “This court is not going to marginalize them…whether they’re on a separate track or an integral part of the plaintiffs’ track.”

With his June 6 order, Polster made clear which route he intends to follow with regards to the Native American plaintiffs, putting one of the MDL’s three special masters in charge of working with Native American tribes to develop a their own track.

Attorneys representing Native American tribes, who had argued in favor of a separate track, applauded the move.

“[Judge Polster] has reassured Native American people that their needs are going to be addressed straight up, and not as an afterthought or an accommodation,” said David A. Domina, who represents several Nebraska tribes in the MDL, according to Law360. Domina hailed the order as “really good news for Native American tribes.”

Echoing these sentiments, attorney Timothy Q. Purdon, who also represents tribes in the opioid litigation, told Law360 he considered Judge Polster’s decision a “much needed and welcome move.”

While the opioid crisis has wrought devastation across racial and ethnic lines, according to 2014 data, no group has been harder hit than Native Americans, who had the highest rate of opioid overdose deaths of any ethnic group in the United States.

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Law360

• May 28, 2018

Opioid News: Prosecutors Take Aim At Drug Users In Opioid Crisis

“You owe me for that dead kid.”

This, according to a recent report published in The New York Times, is the view of a prosecutor in Minnesota with regards to the epidemic of opioid-related overdose deaths sweeping his local area.

According to Pete Orput of Washington County, outside Minneapolis: “I look at it in a real micro way.”

Who exactly “owes” Orput for the “kid” dead of an opioid overdose?

The pharmaceutical companies that profited to the tune of billions of dollars while they lied through their teeth about the dangers and highly addictive qualities of their opioid painkillers?

The doctors who accepted six-figure kickbacks from Big Pharma sales reps in exchange for prescribing high doses of opioid painkillers to patients for whom less dangerous medications were suitable, many of whom became addicted to opioids as a result?

The government “overseers”—long-since captured by industry—at agencies like the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Department of Justice (DOJ), all of which repeatedly turned a blind eye to the epidemic while tens of thousands of lives still could have been saved?

The street-level dealers profiting by illegally peddling opioids, fentanyl, and heroin to vulnerable addicts, many of whom overdose because they don’t know which drugs they actually are taking?

Of course not. Don’t be so naïve.

Instead, in a growing trend documented by the Times, prosecutors across the United States are engaging in so-called “overdose arrests”, charging fellow drug users for crimes related to overdose deaths. These serious criminal charges range from involuntary manslaughter to first-degree murder.

In Breckenridge, Colorado, this meant charging an addict with the opioid-related death of his older brother.

In Minnesota, a man taking speedballs with a woman who overdosed was sentenced to 11 years in prison.

In Louisiana, a man who regularly took drugs with his also-addicted fiancée received life without parole for injecting her with the drugs that took her life.

In Pennsylvania, a man killed himself after being charged in the death of his girlfriend, who passed away after taking drugs the man had ordered off the internet, which he believed to be Adderall but turned out to be fentanyl.

Oftentimes called “murder by overdose”, these cases have seen a staggering increase in recent years as authorities clamor to deal with—or to give the appearance of dealing with—the ongoing opioid epidemic. According to the Times, the state of Minnesota has seen a four-fold increase in such cases over the past decade. In Pennsylvania, after laws were passed to aid in such prosecutions, the number of cases rose from just 4 in 2011 to over 170 in 2017.

While nearly everyone agrees that drastic measures are necessary to deal with this devastating and ongoing crisis, these “murder by overdose” cases amount to scapegoating at best and to further punishing victims at worst. Precious government resources presently being expended on throwing drug addicts in jail simply for being addicted to drugs and using them with other addicts could and should better be utilized on addiction treatment and prevention programs.

Decades of failed war-on-drugs policies have shown that greater criminal penalties do not assuage addicts, treatment and prevention do. Rather than further punishing those who already have suffered from the opioid crisis, America’s authorities should put their focus on the true culprits: the giant pharmaceutical companies that got America addicted in the first place, and that have largely gotten away with the massive profits gained from doing so.

As Michael Malcom—father of both the older son who died from an opioid overdose and the younger son arrested in the death—told the Times, “It’s kind of like blaming the leaves on the tree, you know? What about the roots?”

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The New York Times

• May 21, 2018

Opioid Lawsuit News: Perdue Faces Lawsuits From 6 States Over Opioid Marketing Practices

The avalanche of lawsuits against Big Pharma over the opioid epidemic continues, with the attorney generals of six states announcing May 15 lawsuits against pharmaceutical giant Perdue Pharma LP over claims that the company engaged in deceptive marketing practices pertaining to its prescription opioid painkillers, practices that contributed to the ongoing nationwide crisis that continues to kill tens of thousands of Americans each year.

The top lawyers for the states of Texas, Florida, Nevada, North Carolina, and Tennessee allege that Perdue improperly downplayed the addictive qualities of its opioid-based painkillers, while pushing physicians to prescribe ever-greater quantities of addictive and potentially fatal drugs such as the popular OxyContin, of which Perdue sold billions of dollars’ worth annually.

Although the lawsuits were announced separately and will be pursued independently through the respective state court systems, the attorneys general expressed in their statements solidarity of concern over the crisis and similarity of intent in holding those responsible to account.

“My office is holding Purdue Pharma accountable for fueling the nation’s opioid epidemic by deceptively marketing prescription painkillers including OxyContin when it knew their drugs were potentially dangerous and that its use had a high likelihood of leading to addiction,” read a statement issued by Texas Attorney General Ken Paxton. “As Purdue got rich from sales of its opioids, Texans and others across the nation were swept up in a public health crisis that led to tens of thousands of deaths each year due to opioid overdoses.”

Similarly, North Dakota Attorney General Wayne Stenehjem’s statement said, “Today’s opioid crisis is inextricably linked to Perdue’s pervasive and deceptive marketing campaign. Purdue initiated the expansion of the opioid market that created the opioid crisis.”

The statement from the Texas attorney general’s office contained some chilling statistics that help capture the horrifying extent of the continuing epidemic. According to these figures, there were 42,249 opioid-related overdoses in 2016 alone, with the level of annual opioid overdoses having risen 400% over just two decades.

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Law360

• April 27, 2018

Opioid Lawsuit: Princes Estate Sues Walgreens Over Musician’s Death

On April 20, almost two years to the day after the untimely death of musician Prince by accidental opioid overdose, his estate filed suit in Illinois state court against drugstore chain Walgreens and an Illinois hospital, alleging wrongful death. The complaint further alleges wrongful conduct on the part of certain individuals, including a doctor at the defendant hospital—where Prince had been treated following a previous overdose—and employees at a Walgreens pharmacy.

Six days prior to his tragic death, Prince was on a private flight following a concert in Atlanta when he suffered an opioid overdose, forcing his plane to make an emergency landing in Moline, Illinois, where he was rushed to Trinity Medical Center. The complaint alleges that Dr. Nicole F. Mancha and other hospital staff failed to properly investigate the causes of Prince’s overdose or to provide him with appropriate counseling regarding the dangers of opioid addiction following the incident, leading to his death by another overdose less than a week later.

The complaint further claims that the overdoses were a result of opioid drugs provided by employees at a Walgreens drug store on April 14, 2016, and potentially on other occasions as well. Prince’s estate claims that Walgreens violated its duty of care by, via its employees, providing opioid medications that were, in the words of the complaint, “not valid for a legitimate medical purpose” and for which the pharmacy should have conducted “appropriate drug utilization review”.

An autopsy of the entertainer born Prince Rogers Nelson previously had determined that the late singer was killed by an overdose of the powerful opioid painkiller fentanyl, a fate tragically shared by thousands of Americans in the ongoing opioid epidemic.

“What happened to Prince is happening to families across America,” George Loucas, attorney for Prince’s estate, told Law360 through a written statement. “The family wishes through its investigation to shed light on this epidemic and how to better the fight to save lives. If Prince’s death helps save lives, then all was not lost.”

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Law360

• April 27, 2018

Opioid Lawsuit: Biotech Execs Arrested On Fraud Charges

In yet another example of authorities cracking down on those seeking to profit fraudulently off the ongoing opioid epidemic by marketing products that promise to end addiction or offer a safe alternative to opioids, law enforcement officials in Massachusetts and New York arrested two biotech executives accused of making false claims about a time-release painkiller injection their company supposedly has had in development for years. Additionally, the two executives and a company shareholder have been charged with securities fraud for alleged improper manipulation of the company’s share price.

Biotech company PixarBio Corp.—founded in Boston before relocating to New Hampshire—had promoted its NeuroRelease painkiller system as, among other things, capable of bringing to an end “thousands of years of morphine and opioid addiction.”

Instead, on April 24, Francis M. Reynolds, 55—CEO, CFO, and president of PixarBio—and his long-time friend and PixarBio investor M. Jay Herrod, 51, appeared before a federal court in Boston facing charges of fraudulently raising over $12.5 million from investors. Kenneth Stromsland, 45, PixarBio’s vice president of investor relations, had been arrested in New York.

Meanwhile, the US Securities and Exchange Commission (SEC) brought a parallel action, charging each of the three men with one count of securities fraud. The SEC has requested that all of their assets be frozen pending trial.

In sharp contrast to the assertions made by PixarBio to potential investors, the government alleges that the company’s “signature” product, the NeuroRelease painkiller system, was nowhere near getting approval for clinical trials, and that Reynolds in particular had intentionally grossly misrepresented both the product’s potential and his own background.

From 2015 to 2017, the government’s charging documents allege, Reynolds regularly sought to elevate himself in the eyes of investors by significantly overstating his past achievements, inaccurately presenting himself as the co-inventor of the NeuroScaffold spinal support system and misrepresenting what had been a forced departure from a former biotech employer.

The SEC filings allege that over 200 investors had contributed the approximately $12.7 million raised by PixarBio. too many,” Morrisey’s statement read, according to Law360.

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Law360

• April 27, 2018

Opioid Lawsuit: CA Court Tosses Whistleblower Lawsuit Against Janssen for Off-Label Opioid Marketing

On April 19, a federal court in California dismissed a False Claims Act (FCA) lawsuit filed by a whistleblower alleging that Janssen Pharmaceutical NV, a subsidiary of consumer-goods giant Johnson & Johnson, engaged in unlawful marketing of its opioid drugs for off-label purposes. The case was tossed out on a legal technicality over a change in the alias used by the whistleblower, which the court ruled was in violation of the FCA’s first-to-file doctrine.

The whistleblower complaint brought by a former sales representative for Janssen claims that the pharmaceutical company provided financial kickbacks to doctors who prescribed its opioid pain medications for off-label uses. “Off-label” is industry shorthand for a use that has not been approved by the US Food and Drug Administration (FDA). All FDA-approved uses for a prescription medication are required to be stated on the drug’s label.

In a pattern of behavior similar to that alleged in cases involving other opioid manufacturers, the whistleblower complaint—originally filed in September 2016—accused Janssen of arranging sham speaking engagements for which it could compensate cooperating physicians with cash payments, lavish meals, and expensive entertainment in what amounted to a thinly veiled kickback scheme. The complaint also claims that Janssen accepted artificially elevated compensation from government programs Medicaid and Medicare.

In the initial complaint, the whistleblower identified his or herself under the pseudonym “Alexander Volkhoff, LLC”. Later, the whistleblower was identified in court documents under the pseudonym “Jane Doe”. The court held that this change of identity violated the first-to-file doctrine of the FCA.

“Alexander Volkhoff, LLC is an independent legal entity while Jane Doe is a natural person, so the two are distinct ‘persons’ for purposes of the first-to-file rule,” the court’s decision reads, per Law360. “It is well-established that ‘LLCs are distinct legal entities, separate from their stockholders or members,’ and here, the court takes judicial notice that Alexander Volhoff, LLC is a limited liability company officially registered with the Delaware secretary of state.”

Along with the federal FCA claims, the court also tossed the whistleblower’s state law claims, saying that, with the dismissal of the federal claims, the state claims lost their footing for being heard in federal court. The whistleblower now is free to bring those claims before an appropriate state court.

If you or a loved one has been a victim of the ongoing opioid epidemic across the country, the experienced team of attorneys at TheLawFirm.com are standing by ready to defend your rights. Contact us today for a free legal consultation with one of our attorneys.

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Law360

• April 22, 2018

Opioid News: DEA Proposes New Rule Limited Opioid Production

In a new proposed rule, the details of which were released Tuesday, April 17, the US Drug Enforcement Administration (DEA) showed an intent to further limit nationwide opioid production in coming years, potentially marking a significant departure from the agency’s well-earned reputation of deference to the pharmaceutical industry. Among other changes, the proposed rule would require the DEA to take into account the number of opioids being diverted into the illicit drug trade in so-called “drug diversions” when setting its opioid production quotas.

The proposed rule, announced Tuesday by US Attorney General Jeff Sessions, would give the federal government the authority to significantly cut manufacturers opioid production quotas should there be evidence of diversion or other abuse.

“Under this proposed new rule, if DEA believes that a company’s opioids are being diverted for misuse, then they will reduce the amount of opioids that company can make,” said Sessions, reading from prepared remarks, adding that the opioid crisis—defined to include abuse of prescription painkillers, heroin and synthetic fentanyl—resulted in the death of an estimated 42,000 Americans in 2016.

The proposed rule comes at a time when the DEA is walking a fine line between responding to the opioid epidemic with the drastic policy moves it requires while not alienating a powerful, multibillion-dollar industry with which it has sometimes enjoyed a cozy relationship. Among other pressures, the agency faces a lawsuit from the state of West Virginia—a region particularly hard hit by the opioid crisis—alleging that federal policy has played a role in the devastation.

In a statement, West Virginia Attorney General Patrick Morrisey announced his support for the proposed rule, taking credit for the DEA adopting one of his recommendations. Among the allegations contained in West Virginia’s suit is the claim that federal opioid quotas have in the past been based more on pharmaceutical companies’ sale projections than on demonstrated patient and scientific need.

“The reform sought by DEA proves the impact of our lawsuit is still reverberating in Washington and producing real results capable of ending the oversupply of deadly and addictive painkillers that has killed far too many,” Morrisey’s statement read, according to Law360.

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Law360

Law360

• April 6, 2018

Opioid News: Employer Spending on Opioid-Related Costs Skyrocketing

According to the results released of a joint study released April 5 by the Peterson Center on Healthcare and the Kaiser Family Foundation, employer spending related to opioid addiction and abuse treatment has skyrocketed in recent years, ballooning from $300 million in 2004 to $2.6 billion in 2016. This accelerated growth—representing a more than 900% increase in just over a decade—comes in spite of opioid prescription rates being among their lowest levels of the past decade. The study examined only employers with 1,000 employees or more.

Attempting to explain the apparent inconsistency between lower prescription rates and increased spending by employers on opioid treatment, Matthew Rae, a senior policy analyst with the Kaiser Family Foundation and a lead author on the study, hypothesized that illegal drug use—rather than prescription drugs—were to blame. This as-yet-unproven theory is, however, supported by available evidence, including data showing that as many as 4 out of 5 heroin addicts in the United States initially became addicted to prescription drugs but turned to illegal street drugs when prescription drugs proved too expensive or too hard to come by.

Among the study’s other findings was the revelation that more than half of all of employers’ spending on opioid addiction and overdose treatment was spent on the children of employees, with another nearly 20% being spent on addiction treatment for spouses. Further, although older individuals are statistically more likely to receive an opioid prescription than there younger counterparts, the study found that over 60% of the funds spent on opioid addiction and overdose treatment was spent on young adults, yet more evidence that illegally obtained drugs are to blame in a large number of cases.

“We know that we have an opioid health epidemic and that a lot of attention has been spent on the role Medicaid plays in treating people with opioid addiction,” said Rae, according to Law360. “I think [the study is] helping to quantify how all the ways which [sic.] the opioid epidemic is putting stress on the health system.”

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Law360

• April 4, 2018

Opioid Lawsuit: DOJ TO Enter MDL as Friend of Court

After indicating for months that it was mulling over the decision, the United States Department of Justice (DOJ) officially announced on Monday, April 2 that it would be joining ongoing multidistrict litigation (MDL) against defendant opioid makers as a friend of the court. In a statement, the DOJ indicated its intent to lend its expertise to the court while working to ensure that any settlement agreements reached serve the public interest.

“Today, we are taking a new step to help those who have suffered the consequences of the opioid epidemic by offering our assistance as friend of the Court in ongoing litigation against opioid manufacturers and distributors,” the statement attributed to Attorney General Jeff Sessions read. “We have already filed a statement of interest in the case, arguing that the taxpayer has paid a heavy price because of dishonest opioid marketing practices… We are determined to see that justice is done in this case and that ultimately we end this nation’s unprecedented drug crisis.”

In a motion filed with the court overseeing the MDL, the DOJ also stated that it possesses special expertise in developing non-monetary remedies that can help alleviate the harms caused by the ongoing opioid epidemic. Additionally, the DOJ expressed its willingness to help coordinate among the numerous governmental agencies involved in the complex MDL, as well as to gather information requested by the court.

According to Law360, attorneys on both sides of the MDL greeted the DOJ’s motion to join the case as a friend of the court as a welcome but not surprising development, saying essentially that in such a large, complicated case, they could use all the help they could get. One attorney representing plaintiffs in the case described the DOJ position as “effectively fence-sitting.”

After some initial reluctance, the federal government is showing an increased willingness to involve itself in the MDL, if largely in an information-gathering role. Following months of elaborate negotiations over the scope of the information to be released, the U.S. Drug Enforcement Agency (DEA) agreed earlier this year to allow parties to the MDL to access its Automation of Reports and Consolidated Orders System (ARCOS), an extensive government database containing detailed data on drug distribution and sales.

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Law360

• March 3, 2018

Opioid - MDL Judge Announces Scope of DEA Information Sharing

On March 1, the Ohio district court judge overseeing multidistrict litigation (MDL) pertaining to the opioid epidemic announced a long-awaited agreement regarding the scope of opioid manufacturer and distributor information to be handed over to plaintiffs by the United States Drug Enforcement Agency (DEA). The announcement comes on the heels of congressional hearings February 28 in which politicians highlighted the problematic “revolving door” among pharmaceutical companies, the DEA, law firms, and lobbying groups, which creates the strong perception of a conflict of interest, if not an actual conflict itself.

Attorneys for plaintiffs suing opioid makers and distributors over claims that the pharmaceutical companies had overstated the benefits of opioid medications while overly downplaying the potential risks—including addiction—have long sought access to the DEA’s comprehensive ARCOS database, which tracks opioid manufacturing, distribution, and sales data. The information is considered important because it is expected to identify which defendants have the most culpability and which localities were hardest hit by the alleged misdeeds of the pharmaceutical companies, both of which will play a large part in the allocation both of how damages are both imposed and rewarded.

The DEA has faced public criticism for its resistance to releasing comprehensive data pertaining to opioids, data that some deem essential to properly holding to account those most responsible for the opioid epidemic that has swept the nation, decimating local communities. Some have called into question the DEA’s apparently cozy relationship with the pharmaceutical companies.

In his order, District Court Judge Dan Aaron Polster announced that the DEA would hand over information relating to 95% of opioid sales in all 50 states during the period 2012-2013. Plaintiffs and the DEA are further seeking an arrangement to release additional data for the period 2006-2014 that would include total amounts of pills sold by company and percent market share on a state-by-state basis. The DEA has said it still needs to seek authorization prior to the release of certain information, authorization it is expected to receive within a matter of days.

The contentious, months-long battle between plaintiffs and the DEA illustrates the problematic nature of the close relationship between pharmaceutical manufacturers and distributors and the government agencies tasked with regulating them. Rather than freely make available to the public information with a strong public health component, critics argue, the DEA has sought to protect opioid makers and sellers from liability by keeping secret information collected using taxpayer dollars.

The experienced attorneys at TheLawFirm.com know this cozy relationship all too well, and they are expert in navigating the ins and outs of the law to get you the justice you deserve. Have you or a loved suffered from opioid addiction or been harmed by another dangerous medication? Call now for a free legal consultation.

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Law360

• February 28, 2018

Opioid MDL - DOJ May Enter Opioid MDL Seeking Reimbursement of Costs

On February 27, the United States Department of Justice (DOJ) initiated a new opioid task force, as well as announcing that its attorneys would be joining currently ongoing multidistrict litigation (MDL) over the opioid crisis in Ohio federal court, seeking reimbursement from drug makers for costs associated with the epidemic.

In the announcement regarding the Ohio MDL, the DOJ stated its intention to file a Statement of Information with the court, with the goal of reclaiming some of the billions of taxpayer dollars the DOJ alleges the opioid crisis has cost the federal government. These costs are claimed to cover government interventions such as enforcement actions, medical care associated with overdoses, and addiction treatment.

The new opioid task force, coined the Prescription Interdiction & Litigation Task Force, reportedly will work in conjunction with law enforcement agencies and the United States Department of Health and Human Services to increase oversight of opioid manufacturing and distribution, using both criminal and civil laws to hold offenders to account.

The announcement of the Prescription Interdiction & Litigation Task Force follows a declaration by Attorney General Jeff Sessions in August 2017 that he would be ordering a dozen assistant U.S. attorneys to focus solely on opioid-related issues for a 36-month period. It also comes on the heels of the creation in December 2017 of the role of Director of Opioid Enforcement and Prevention Efforts, to which position former federal prosecutor Mary Daly was assigned February 23.

In addition to the large multidistrict litigation (MDL) currently taking place in Ohio, opioid makers and distributors face additional claims across the country, with municipalities and states such as New York, New York City, Delaware, and Philadelphia suing over harms caused and costs incurred.

If you or a loved one has suffered harm as a result of opioid addiction or the treatment of that addiction, the expert attorneys at TheLawFirm.com are standing by now for a free consultation.

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Law360

• February 26, 2018

Opioid MDL - Plaintiffs Seek Access to DEA Data on Painkillers

In a sign that at an issue months in the making may be nearing a resolution, the judge overseeing multidistrict litigation (MDL) involving the opioid epidemic is set to rule on the right of plaintiffs to access information held by the United States Drug Enforcement Administration (DEA). Plaintiffs suing opioid makers have long been at odds with the DEA over issues pertaining to the scope of the information to be released.

The DEA holds extensive records relating to the drugs involved in the opioid epidemic presently sweeping the nation, and plaintiffs have been seeking access to information pertaining to drugs such as oxycodone, hydrocodone, hydromorphone, and fentanyl. Attorneys for plaintiffs believe that the DEA records contain information that will help prove their allegations that opioid makers fraudulently misrepresented the addictive and harmful nature of their opioid medications, helping to spur on if not outright cause the current crisis.

In a preliminary order on the issue released February 2, District Court Judge Dan Aaron Polster indicated that he would take a balanced approach, acknowledging both the interest of plaintiffs in obtaining relevant information but also recognizing that the DEA had an interest in protecting certain kinds of data, such as that which would jeopardize ongoing investigations or reveal locations where opioids are stored in large quantities.

An attorney representing local governments who are suing the opioid makers as part of the MDL expressed disbelief that the DEA would balk at providing information that might lead to holding accountable those responsible for the opioid epidemic.

“It’s just mind-boggling to me that the government is not jumping in and doing everything it can to help, and instead seems insistent on slowing it down and not producing the information,” said attorney Peter J. Mougey, according to Law360.

The opioid MDL is taking place in U.S. District Court in the Northern District of Ohio. The information being sought is held by the DEA in the ARCOS database, which contains an abundance of information about prescription painkiller sales in the United States, including which drugs were sold where and when and in what quantity.

Stay tuned to Law360 for the latest on litigation relating to the opioid epidemic. If you or a loved one has suffered harm as a result of a prescription medication, the expert attorneys at TheLawFirm.com are standing by now for a free consultation.

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Law360

• August 28, 2017
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WEST VIRGINIA DOCTOR SENTENCED TO 20 YEARS FOR IMPROPERLY PRESCRIBING OPIOIDS

A physician in West Virginia has been sentenced to 20 years in prison for improperly prescribing oxycodone, the powerful opioid painkiller, to his patients.

Dr. Michael Kostenko, who worked in Raleigh County, West Virginia, was also ordered to pay a $50,000 fine and faces five years of supervised release.

Kostenko admitted to distributing oxycodone in December 2013 to 217 patients, pocketing more than $20,000 in cash from the illicit sales. On a single day, he is alleged to have written 370 prescriptions, for a total of more than 22,000 pills. He also is alleged to have prescribed opioids to patients with known drug problems.

Rural and impoverished areas such as West Virginia have been hit especially hard by the opioid epidemic, which claims the lives of approximately 30,000 Americans every year. Numerous states and cities have filed suits against drugmakers for the roles in furthering the crisis.

• August 23, 2017

ENDO LIED ABOUT OPIOID MED’S SAFETY, SUIT ALLEGES

A proposed class action suit states that drugmaker Endo misrepresented the safety of its opioid medication Opana ER, a situation that caused the company to pull the drug from the market and its stock price to plummet.

Shareholder Brandon Bier alleges that a formulation of Opana that was designed to make the drug crush-resistant and “abuse-deterrent” was based on false claims, and that the drug was no safer than previous.

Upon the release and rescinding of the new version, shares of Endo fell from about $35 to about $11 between May 2013 and July 2017. The suit alleges that the price drop had to do with the Food and Drug Administration’s (FDA) concerns about Endo’s failure to make Opana ER abuse-resistant.

Bier seeks to represent a class of investors who purchased Endo stock between Nov. 30, 2012, and July 6, 2017. He is alleging violation of federal securities laws.

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• August 11, 2017

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OPIOID SUITS FILED IN ALABAMA AND OHIO

The state of New Hampshire and Multnomah County in Oregon have joined California, Illinois, New York, and Ohio in filing suit against the makers of opioid painkillers for allegedly misrepresenting the drugs’ safety and addiction risks.

Central to both suits is the allegation that the manufacturers of opioid medications have placed profit at a higher premium than public health.

The Oregon suit asks for $250 million in damages and names numerous defendants, including Allergan and its subsidiary Watson Pharmaceuticals, AmerisourceBergen Drug Corp., Cardinal Health, Cephalon, Endo Health Solutions, Insys Therapeutics, Johnson & Johnson and its subsidiary Janssen Pharmaceuticals, Mallinckrodt, McKesson, Purdue Pharma, Teva Pharmaceutical Industries, and several individual doctors. The New Hampshire suit names only Purdue.

More than 30,000 Americans are killed every year by the powerful, highly addictive medications.

Both suits seek to force drugmakers to represent the effects of their drugs more accurately, and to communicate more openly about the drugs’ safety and addiction risks.

Representatives for the drugmakers responded to the filing of the suits with one or more variations of denials and pledges to address the growing opioid crisis.

• August 2, 2017

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INVESTORS SUE MAKER OF “ABUSE-DETERRENT” OPIOID MEDICATION

Investors in Intellipharmaceutics International, a manufacturer of opioid medications, have sued the company for allegedly lying to them about the efficacy of the abuse-deterrent measures it had included in the recent iteration of its painkiller Rexista. The suit comes on the heels of the U.S. Food and Drug Administration’s (FDA) denial of approval to Rexista, citing the inadequacy of the measures intended to deter abuse.

Upon release of the news of the FDA’s refusal to approve Rexista, the stock price of Intellipharmaceutics dropped in value overnight by 50 percent.

Central to the case is the allegation that the company lied to investors about having conducted studies about the abuse-deterrent properties of the new iteration of Rexista, a drug that is biochemically equivalent to OxyContin, a powerful opioid medication that is typically administered only to those who are in severe, round-the-clock pain.

The measures that the company enlisted for the purpose of deterring abuse of Rexista included the addition of an irritant to deter its inhalation, and a blue dye that is released if potential abusers tamper with the drug. The FDA found these measures to be inadequate, and scolded Intellipharmaceutics for failing to conduct necessary clinical studies.

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• July 24, 2017

CHEROKEE NATION LOBBIES TO PURSUE OPIOID CASE IN TRIBAL COURT

The Cherokee Nation has continued to lobby for the right to hold an upcoming lawsuit over opioid painkillers in its tribal court, arguing that its case is similar to those filed by state governments.

The Cherokee Nation’s suit is against numerous pharmaceutical merchants, including AmerisourceBergen, Cardinal Health, CVS Health, McKesson, Walgreens Boots Alliance, and Wal-Mart Stores. Cherokee Nation Attorney General Todd Hembree argues that these and other companies are partly to blame for the damage and deaths felt by Cherokee people in the current opioid epidemic, which has struck with particular force First Nations peoples.

Hembree argues that these and other companies have specifically injured the “health, welfare and economic security of the Cherokee Nation.

The defendants have claimed that tribal courts lack the jurisdiction to try the case, but Hembree cited an 1866 treaty with the federal government that endows tribal courts with “concurrent jurisdiction” over civil actions.

Hembree cited statistics from the Oklahoma Bureau of Narcotics and Dangerous Drugs, which showed that, in 2015 and 2016, pharmacies dispensed about 184 million opioid pills within the 14 counties of the state’s Cherokee Nation. That’s the equivalent of 153 doses for each person in those counties.

The Cherokee Nation alleges that the pharmaceutical vendors have a moral and legal obligation to pay for the damage wrought by the highly addictive medications.

• July 20, 2017

FENTANYL A LIKELY CAUSE OF DEATH OF FLORIDA BOY

According to Miami-Dade State Attorney Katherine Fernandez Rundle, preliminary toxicology reports concerning the death of 10-year-old Alton Banks suggest that the Miami resident died from a mixture of heroin and the powerful opioid fentanyl.

Some 30,000 Americans have died from the abuse or overdose of opioid painkiller medications in recent years, though few have been as young as Banks. Numerous lawsuits have been filed in various states concerning the responsibility of pharmaceutical manufacturers to take efforts to control the source of the “opioid epidemic.”

Rundle stressed that the drugs in Banks’s system may not have been ingested by him; the overdoes could have been caused by incidental physical contact with either or both drugs.

Banks resided in a crime-ridden neighborhood of Miami that has seen more than its share of opioid-related deaths. Florida as a whole saw more than 850 fentanyl deaths in 2016, nine of which occurred in children under the age of 18.

Fentanyl is an especially potent painkiller that is often prescribed for cancer patients.

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Opioid Fact:
Opioids killed more than 33,000 people in 2015
• June 12, 2017
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FDA URGES ENDO INTERNATION TO CEASE SALES OF OPANA

For the first time in history, the U.S. Food and Drug Administration has formally insisted that an opioid medication be removed by its manufacturer from the market. On June 8, the agency issued a statement urging Endo Pharmaceuticals to pull from circulation the powerful painkiller known as Opana.

In his remarks on Opana, FDA Commissioner Scott Gottlieb referred to the nation’s “opioid epidemic” as a “public health crisis.” Gottlieb said that the FDA was urging the removal of Opana from the healthcare marketplace because of the “public health consequences of abuse.”

According to the Centers for Disease Control and Prevention, opioid abuse killed more than 33,000 people in 2015.

Opana is even stronger that OxyContin, probably the best-known and most widely abused opioid painkiller. The drug is used to manage severe pain.

In recent years, Endo had taken some steps to reduce the potential for the abuse of Opana. Since crushing the pills release its active ingredients more rapidly (and at greater risk to the user), the company manufactured a version of the drug that had a hard-to-crush coating. Addicts circumvented this measure; some even took to injecting the medication. In a case in Indiana, needles shared by Opana addicts were linked to an HIV outbreak.

The FDA’s push for the recall of Opana was based on the agency’s finding that Endo had not taken sufficient steps to reformulate the drug or otherwise take steps that would decrease the likelihood of its abuse.

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• July 5, 2017

DRUG MANUFACTURERS ASK FDA TO REMOVE EASILY ABUSED OPIOIDS FROM MARKET

The Center for Lawful Access and Abuse Deterrence (CLAAD), a coalition funded largely by drag manufacturers, has urged the U.S. Food and Drug Administration (FDA) to remove from the market a class of prescription opioid painkillers that lack abuse-deterrent measures. The petition comes in advance of the FDA’s preparations to approve three opioids that contain the anti-abuse measures.

The FDA has approved 10 opioid painkillers that have been manufactured to include features that allegedly deter the drugs’ being abused. The drugs’ active ingredients are designed to be released at a slow trickle, thereby reducing the “high” that abusers seek.

Sales of abuse-deterring opioids have been hindered, CLAAD argues, by the fact that numerous opioid painkillers that lack the anti-abuse measures remain on the market. These older drugs tend to be less expensive than the newer, abuse-deterring drugs.

The abuse of opioid painkillers has been declared a nationwide epidemic, with more than 30,000 dying every year from the abuse of these prescription medications.

The FDA has said that it is considering the petition.

If you believe that the profit-hungry pharmaceutical industry is partly or fully to blame from any ill effects that you or loved one has suffered due to opioid painkillers, you may have a case. Contact TheLawFirm.com to learn how we can help you.

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