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Opioid Usage, lawsuits, Side Effects, Settlements and Updates

opioid pills opened bottle

Opioid usage, side effects and addiction

When you’ve had surgery, and especially a major surgery like a hip transplant, the recovery is often painful. Traditionally doctors often prescribe opioids such as Oxycodone, Vicodin, and Percocet to manage their patients’ pain.  

But now a recently concluded large-scale research study from Stanford University found that very few people are able to stop taking the powerful drugs, and are becoming addicted to the opioids. This is nothing new to the attorneys at TheLawFirm.com: we have been witnessing this unfortunate result for years.   

The research study compared the medical records of about 642,000 adults under 65 who underwent a knee replacement or other type of surgery to those of just over 18 million people who didn’t. Neither group had taken opioids in the year before the study period.    

Researchers found that nearly all the surgeries were associated with a patient filling 10 or more opioid prescriptions, or receiving more than a four-months’ supply of the drugs, in a single year. These patients are defined as having a higher risk of chronic opioid use.  

When are opioids prescribed?

After about 3 months prior to a surgical procedure it is generally viewed as highly unusual for a patient to still need opioids to relieve pain. While complications could account for a small subset of patients that experience chronic pain, it is also extremely likely that some patients are vulnerable to opioid dependence, and wind up taking the drugs long term.  

Of the 11 common procedures studied, knee surgery was most likely to lead to long-term opioid use. The study found that 1 out of every 100 patients who had a knee replacement surgery became a chronic opioid user. That is still a lot of people, an estimated 7,200 Americans a year who weren’t taking opioids before knee surgery, wind up taking the drugs for a long time afterward.     

Risk Of Addiction

Could you be at risk? Prescription painkillers such as Oxycontin, Percocet, or Vicodin can be as addictive as heroin. Even people who are not addicted can become physically dependent on the drugs if they take them continuously for more than two weeks. Not surprisingly, the risk for chronic opioid use was higher in people undergoing more extensive surgeries, than those having minor procedures. Other factors that increased risk included a history of substance abuse or taking an antidepressant or a medication which includes anti-anxiety drugs and sedatives such as Xanax, Klonopin, Valium and, Ativan.  

Having risk factors for opioid dependence doesn’t mean you shouldn’t have a needed surgery, or that you should do without pain medication, but you should be aware of the risks when planning your treatment with your doctor.

If you do wind up taking opioids continuously for more than a couple of weeks, stopping the drugs abruptly can trigger withdrawal symptoms such as worsening pain, severe stomach upset, anxiety, and sleeplessness.  

Alternatives to Opioids

There are alternatives for pain relief as opposed to taking the highly addictive pharmaceutical drugs such as ice packs, local anesthetics, and over the counter medication like Tylenol, Advil, Motrin, and Aleve. Also talk with your doctor about how soon you can start moving again as physical activity is shown to speed recovery and reduce pain. 

The attorneys at TheLawFirm.com are huge advocates of educating yourself as much as possible to make sure that you don’t get taken advantage of by a medical system that may not have your best interests at heart.

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Opioid Fact:
Opioids killed more than 33,000 people in 2015

Opioid News and Updates

• August 28, 2017
many prescription drug containers

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 21, 2017
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DEA GIVEN GO-AHEAD TO PREVENT DRUG MAKER FROM SELLING OPIOIDS

The D.C. Circuit Court has lifted a stay that had prevented drugmaker Masters Pharmaceutical from selling controlled substances, including opioid medications. At the same time, the Drug Enforcement Administration (DEA) issued a challenge to Masters’ putative compliance with federal controlled-substance standards.

Masters’ drug-selling certificate was first revoked in 2008 on suspicion that the company was not acting to adequately prevent its drugs from being diverted into illegal channels. Masters was then ordered to spend $500,000 to establish a compliance program.

The company came under suspicion again in 2013, when the DEA alleged that Masters had provided millions of doses of the powerful opioid oxycodone to eight illegitimate pharmacies. Masters was found to be out of compliance, but was granted a stay. That stay has now been revoked, giving the DEA full authority to shut down Masters’ drug distribution operations.

The D.C. Circuit Court refused to hear Masters’ appeal.

• August 2, 2017
soldier who looks very sad

VA WATCHDOG URGES ACTION TO ADDRESS RISKS OF OPIOID MEDICATIONS TO VETERANS

The Office of the Inspector General (OIG), a watchdog agency for the Veterans Affairs Administration (VA), has urged the VA to take steps to monitor opioid prescriptions and abuse among veterans, stating that the powerful medications pose a particular risk to vets.

The OIG warned that veterans with chronic pain and mental illness are particularly vulnerable to the overeager prescription of opioid painkillers, and that the VA should use all available means to curtail the abuse of the drugs.

The agency pointed specifically to such programs as the Veterans Choice Program, which allows veterans to visit community health centers, as those centers may not be sufficiently informed of the risks that opioids pose to vets, who have experienced greater rates of opioid abuse and death than the general population.

The VA has in place an Opioid Safety Initiative, but the OIG found that community health centers are often unaware of its provisions, largely due to poor communication between the centers and VA hospitals.

The VA responded to the OIG report by stating that it will encourage veterans to fill their prescriptions at VA pharmacies whenever possible. The VA is reportedly looking into strengthening its guidelines that pertain to opioid prescriptions, as well.

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• July 31, 2017

FDA NIXES USE OF BLUE DYE IN OPIOID PAINKILLER

The U.S. Food and Drug Administration (FDA) voted overwhelmingly not to approve a version of Intellipharmaceutics International’s Rexista opioid that would attempt to discourage abuse by staining potential users with a blue dye that would be released upon a tamper attempt.

The FDA rejected the measure on the grounds that it would not mitigate the abuse of the drug via injection. The agency also scolded the drugmaker for not including enough information in its application about human studies that address the potential for the abuse of Rexista.

Rexista’s maker also included in the drug an irritant that would allegedly make it less attractive to those who wished to inhale it.

Rexista is a powerful opioid medication that is equivalent to OxyContin. It is intended for the treatment of severe, constant pain.

Intellipharmaceutics responded to the advisory panel’s decision by stating that it would commence further studies on the drug.

• 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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• July 20, 2017

DEA URGES COURT TO BLOCK OPIOID SUPPLIER’S SALES

The U.S. Drug Enforcement Administration has urged the D.C. Circuit Court to block Masters Pharmaceutical, a maker of opioids and other prescription painkillers, from selling controlled substances.

In 2013, Masters allegedly failed to report to the DEA a number of “suspicious” orders from Florida for its opioid-based oxycodone medications, leading the DEA to revoke Masters’ registration in 2015. The company petitioned that revocation, and has been operating under the terms of a court-ordered stay. Now, the DEA has urged that the stay be rescinded, thus effectively prohibiting Masters from selling opioid medications.

Florida’s governor declared that the state was in a “state of emergency” with regard to the opioid problem. Opioid abuse has killed some 30,000 Americans over the last several years.

Masters is one of several pharmaceutical manufacturers that have come under fire for their roles in supplying the drugs that are being fatally abused.

The results of the DEA’s request are pending.

• July 20, 2017

DEA CLEARED TO BLOCK OPIOID SUPPLIER’S SALES

The U.S. Drug Enforcement Administration has urged the D.C. Circuit Court to block Masters Pharmaceutical, a maker of opioids and other prescription painkillers, from selling controlled substances.

In 2013, Masters allegedly failed to report to the DEA a number of “suspicious” orders from Florida for its opioid-based oxycodone medications, leading the DEA to revoke Masters’ registration in 2015. The company petitioned that revocation, and has been operating under the terms of a court-ordered stay. Now, the DEA has urged that the stay be rescinded, thus effectively prohibiting Masters from selling opioid medications.

Florida’s governor declared that the state was in a “state of emergency” with regard to the opioid problem. Opioid abuse has killed some 30,000 Americans over the last several years.

Masters is one of several pharmaceutical manufacturers that have come under fire for their roles in supplying the drugs that are being fatally abused.

The results of the DEA’s request are pending.

• June 12, 2017
food and drug administration logo

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.

Lawsuits & Litigation

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OPIOID SUITS FILED IN ALABAMA AND OHIO

August 11, 2017
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.

dea logo

INVESTORS SUE MAKER OF “ABUSE-DETERRENT” OPIOID MEDICATION

August 2, 2017
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.

OPIOID USERS JOIN SUIT AGAINST DRUGMAKERS

July 11, 2017
A group of opioid users has sued the makers of the drugs in Arkansas federal court, alleging that the pharmaceutical corporations have contributed to the opioid epidemic in a grab for profits. Named in the suit are drugmakers Actavis, Endo, Johnson & Johnson, Purdue, Teva, and a number of those companies’ subsidiaries.

Opioid Fact:
91 Americans die every day from an opioid overdose

Settlement news and Updates

INSYS SETTLES ILLINOIS OPIOID LAWSUIT FOR $4.5 MILLION

August 7, 2017
Drugmaker Insys will pay $4.5 million to settle allegations of deceptively marketing its fentanyl-based cancer medication in a lawsuit brought by Illinois Attorney General Lisa Madigan.

The Arizona pharmaceutical manufacturer has been in a great deal of legal trouble lately, most of it stemming from several of its former officers confessing to having participated in a scheme to bribe doctors to promote its powerful opioid medication Subsys. Six former execs of the company have pleaded guilty, but former CEO Michael Babich and others have pleaded not guilty.

Subsys was the focus of the Illinois suit, as well, in which Madigan alleged that Insys had marketed the drug for purposes for which it had not received approval from the U.S. Food and Drug Administration (FDA).

Just this week, Insys, still an extant company, released a new drug called Syndros. The active ingredient in Syndros is THC, the active ingredient in cannabis; Insys intends the drug to be used for the treatment of chemotherapy-induced nausea.

Opioid addiction claims the lives of some 30,000 Americans every year.

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MALLINCKRODT PAYS $35 MILLION IN OPIOID SETTLEMENT

July 17, 2017
Pharmaceutical giant Mallinckrodt will pay a settlement of $35 million in a deal to make amends for its role in the opioid epidemic that has claimed the lives of some 30,000 Americans.

In settling for $35 million, Mallinckrodt will not formally admit any guilt in its role in the production and distribution of the prescription opioid painkiller oxycodone. Nevertheless, the company has been taken to task by the U.S. government for being too aggressive in its distribution of the potentially addictive medication, and for not taking sufficient steps to prevent the abuse of its pharmaceutical products.

Mallinckrodt had been under investigation by the U.S. Department of Justice for failing to detect and report “suspicious orders” of oxycodone. The company had, according to the government, distributed an “increasingly excessive quantity of oxycodone pulls without notifying DEA [the U.S. Drug Enforcement Administration.”

The settlement was reached in courts in New York and Michigan.

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