Opioid News and Updates
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.