Opioid News and Updates
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.