Opioid News and Updates
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.
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.
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.
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?”
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.
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.”
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.
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.
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.
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.”
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Opioids killed more than 33,000 people in 2015
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.
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.