Category: Defective Drugs

Hand Amputation Spurs Failure-to-Warn Invokana Lawsuit

By Emily Cox

Invokana Hand amputation Invokana Amputation Risks

A new lawsuit indicates that the new-generation diabetes drug Invokana caused numerous significant side effects that ultimately led to a left hand amputation.

Charlotte Nerio filed the hand amputation complaint earlier this month in the District of New Jersey. She alleges that Johnson & Johnson and its Janssen Pharmaceuticals subsidiary deliberately concealed serious Invokana risks from the public and the medical community to maximize the diabetes drug’s marketability and profits. Consequently, Neiro and countless other patients have suffered horrific and irreparable injuries that will follow them throughout their lives to serve J&J’s bottom line.

Neiro first began taking Invokana in 2015. The medication caused her to suffer severe tissue necrosis, dry gangrene, and blackening of her fingers. Eventually, her condition deteriorated to the point that hand amputation became necessary to ensure her survival. Furthermore, she also developed chronic kidney disease from use of the drug.

Neiro’s claim points to numerous serious safety concerns associated with Invokana. She maintains that she would have chosen a different diabetes drug if she had known about the risks. However, J&J and Janssen deprived her of the ability to make an informed decision regarding her healthcare, and she will have to bear the consequences of that deprivation for remainder of her life.

“Despite Defendants’ knowledge of the increased risk of severe injury among Invokana users, Defendants did not warn patients but instead continued to defend Invokana, mislead physicians and the public, and minimize unfavorable findings,” the lawsuit states. “Consumers, including Plaintiff, who have used INVOKANA for treatment of diabetes, have several alternative safer products available to treat the conditions.”

Invokana Hand Amputation and Other Risks

Manufacturers introduced Invokana (canagliflozin) in March 2013. It was the first member of a new generation of diabetes drugs called sodium-glucose cotransporter 2 (SGLT2) inhibitors. These drugs work in a unique way to eliminate excess glucose through urination by altering normal kidney functions. Other members of the SGLT2 class include Invokamet, Jardiance, Farxiga, and Xigduo, among others. However, Invokana remains the blockbuster of the class due to J&J’s excessively aggressive marketing strategies despite the drug’s dubious safety profile that the FDA has called into question several times in recent years.

In December 2015, the FDA mandated new diabetic ketoacidosis warnings for Invokana to indicate that the medication increases the risk of this serious condition. This condition generally requires emergency treatment to prevent life-threatening harm. Prior to this update, the Invokana label didn’t warn of the importance of seeking immediate medical attention for symptoms such as fatigue, nausea, abdominal pain, respiratory problems, or vomiting.

In May 2017, the FDA intervened once again, requiring J&J to update Invokana warning labels about the risk of leg and foot amputations. Manufacturers of other SGLT2 inhibitors continue to maintain that this risk is unique to Invokana alone.

Nerio’s hand amputation case will join other federal Invokana lawsuits pending in the ongoing multidistrict litigation (MDL) in New Jersey for pretrial proceedings.



National Academics Developing New Opioid Prescribing Guidelines

By Emily Cox
opioid prescribing guidelines

Federal regulators have announced a plan to develop scientific-based opioid prescribing guidelines to prevent overexposure to the powerful painkillers that are currently linked to more than 40 fatal overdoses every day in the United States.

FDA Commissioner Scott Gottlieb issued a statement August 22 to announce a new study to help provide evidence-based guidelines for opioids to create more rational prescribing practices.

The FDA also announced that the National Academics of Sciences, Engineering, and Medicine (NASEM) will help develop the new scientific-based and indication-specific opioid prescribing guidelines by reexamining how physicians are currently prescribing opioid analgesics and when these medical professions consider them an appropriate course of treatment.

NASEM plans to conduct a consensus study to identify and prioritize medical procedures and conditions that have incumbent acute pain that medically necessitates opioid prescriptions and determine the length of time that opioids are necessary to regulate that pain.

Opioid Prescribing Guidelines in Response to Ongoing Crisis

The United States opioid epidemic continues to ravage the country, killing more and more people each year. The FDA and the Centers for Disease Control and Prevention (CDC) have indicated that deaths related to the opioid crisis are at an all-time high with fatal overdoses increasing nearly 140 percent. From 2015 to 2016, drug overdoses increased 21.5 percent, causing 64,000 deaths with more than 66 percent, or 42,000, of those involving the prescription painkillers.

Most individuals who become addicted to opioids are first prescribed these powerful synthetic medications through physicians. An analysis of current prescribing practices indicates that most individuals are given a 30-day supply of prescription opioids when the patients only theoretically require the potent drugs for a few days. Officials suggest that patients can develop opioid addiction within the first couple days or weeks.

Excess opioid medications commonly wind up on the illicit market, abused, or misused by family members and friends of those with opioid prescriptions. Patients who receive prescriptions for more opioids than medically necessary can also find themselves more prone to abusing or misusing the drugs, leading to overdoses.

The organization will hold a series of public workshops and meetings over the next couple months for stakeholders to collaborate on ideas and analyze current opioid prescribing guidelines to further develop better prescription policies that more closely adhere to clinical need while reducing patients’ overexposure to the highly addictive drugs.


Remaining Claims in Prozac Birth Defects Suit to Proceed

By Emily Cox
prozac birth defects

A Kentucky federal court ruled Thursday that a father whose son was born with heart defects after his wife took Prozac during her pregnancy can proceed with his failure-to-warn claims against the antidepressant’s manufacturer, Eli Lilly and Co., after cutting all his other claims from the Prozac birth defects lawsuit.

In the 13-page order in response to Eli Lilly’s motion to dismiss, District Judge Karen K. Caldwell said plaintiff Tim Robinson’s breach of warranty, fraudulent concealment, and negligent misrepresentation claims, as well as his design and manufacturing defect claims were all either preempted by federal law or lacked adequate evidence.

However, Judge Caldwell did give the green light to Robinson’s failure-to-warn claims, alleging that Eli Lilly knew about Prozac birth defects risks but deliberately withheld this information from doctors and patients to protect Prozac’s marketability.

“At this stage, Robinson has sufficiently alleged that the warnings provided by Eli Lilly were inadequate, and that they caused the relevant injury,” Judge Caldwell wrote. “In his complaint, Robinson adequately set out the specific means by which Eli Lilly knew or should have known of Prozac’s alleged connection to cardiac birth defects.”

Robinson’s wife, Gina, took Prozac while she was in her first pregnancy trimester in 2000. The couple’s son was born with significant cardiac defects, necessitating corrective heart surgery at the age of nine.

Prozac Birth Defects Lawsuit Claims Dismissed

In her Thursday order, Judge Caldwell tossed all of Robinson’s claims in his Prozac birth defects lawsuit except for the failure-to-warn claims. However, she granted him 21 days to file a motion to amend, leaving the door open for him to re-plead the dismissed claims.

Judge Caldwell ruled federal law preempted Robinson’s negligence claim, because it accuses Eli Lilly of designing a defective drug. She also found he didn’t provide enough evidence to support a claim that Eli Lilly improperly manufactured it.

Judge Caldwell dismissed Robinson’s breach of warrant claims on the grounds that he hadn’t alleged “any kind of contractual privity between Lilly and the consumer.”

She continued that Robinson had noted “a litany of entities to which Eli Lilly supposedly made express warranties,” but that he didn’t “point to even one specific communication directed to the consumer of the product — and certainly not one in which Lilly represented that Prozac was safe for or intended to be used during pregnancy.”

Judge Caldwell tossed Robinson’s negligent misrepresentation and fraudulent concealment claims for this reason as well. Specifically, she found that Robinson didn’t provide enough specific evidence to support his claims that Eli Lilly “conducted a sales and marketing campaign to … willingly deceive … Ms. Robinson and her prescribing physicians and healthcare providers, the medical, scientific, pharmaceutical and healthcare communities, the Food and Drug Administration and the public in general.”

According to Judge Caldwell, both claims involved the “same sweeping cast of characters” and “broad time frame” but only at a “high level of generality.”

Eli Lilly had contended that federal law should also preempt Robinson’s failure-to-warn claims as well. However, Judge Caldwell ultimately decided they were not due to the Supreme Court precedent has determined that “brand-name pharmaceuticals bear the responsibility for the contents of a drug’s label at all times.”

Unresolved Claims Disclosures Ordered in Invokana Settlement

By Emily Cox

Invokana Amputation Invokana risks Invokana settlement

In the wake of the recent success in reaching an Invokana settlement in the ongoing multidistrict litigation (MDL) over claims that the manufacturer deliberately concealed the type II diabetes drug’s diabetic ketoacidosis, kidney injury, and amputation risks, the District Judge presiding over the federal litigation is ordering new and existing plaintiffs with unresolved claims to submit documentation regarding their cases.

District Judge Brian Martinotti issued the Invokana settlement administrative order August 16. Judge Martinotti acknowledged the “tremendous efforts of the parties to achieve resolutions for various injuries claimed in this complicated multidistrict litigation” but indicated that plaintiffs who had no reached a resolution for their claims must produce specific information for the court.

The order requires plaintiffs to notify treating physicians and pharmaceutical dispensaries to preserve evidence and provide any available medical, pharmacy, and death records, as well as fact sheets pertaining to their claim. These requirements go into effect immediately for new cases. However, the court is staying the order until October 30 for existing plaintiffs.

Side Effects Behind Invokana Settlement

Johnson & Johnson and its Janssen Pharmaceuticals unit released Invokana (canagliflozin) in March 2013. It was the first member of a new class of diabetes medications, known as sodium-glucose cotransporter 2 (SGLT2) inhibitors. These eliminate the body’s excess glucose through urination by altering normal kidney functions. Other members of the class include Invokamet, Jardiance, Farxiga, Xigduo, and others. However, J&J and Janssen’s aggressive marketing has kept Invokana at the head of the pack in terms of sales.

As Invokana’s sales skyrocketed, so did the steady stream of significant, life-altering health concerns from post-marketing adverse event reports. Consequently, the FDA has required the manufacturers to update warning labels several times over the past few years.

In December 2015, the FDA mandated new diabetic ketoacidosis warnings for Invokana. The serious medical condition typically necessitates emergency treatment to avoid life-threatening injuries. Before this update, Invokana warnings didn’t alert patients about the importance of seeking immediate medical attention for symptoms such as abdominal pain, fatigue, nausea, vomiting, or respiratory problems.

In June 2016, federal regulators required additional Invokana label warnings about kidney risks to inform patients of the risk of acute kidney injury and other severe health problems from the medication.

In May 2017, the FDA mandated still more Invokana warnings. This time it was regarding the risk of leg and foot amputations. Manufacturers of other SGLT2 inhibitors continue to maintain that this risk is unique to Invokana and does not apply to their drugs.

Invokana Settlement MDL

J&J and Janssen have faced hundreds of product liability lawsuits recently over deliberately concealing substantial Invokana side effects to bolster sales growth.

Due to inherent similarities in lawsuits pending in the federal court system, the Judicial Panel on Multidistrict Litigation (JPML) centralized the federal litigation to expedite pretrial proceedings in the District of New Jersey.

As the court began establishing a bellwether program to prepare a small group of representative Invokana cases for early trial dates to help parties evaluate the relative strengths and weaknesses in their cases, the manufacturers began negotiating for an Invokana settlement with several law firms involved in the MDL.

If the drug makers fail to resolve the cases remaining in the MDL, Judge Martinotti may set additional trials for remaining cases or start remanding lawsuits back to District Courts across the country for separate trial dates.


Xarelto “Greatly” Increases Brain Bleeds Risks

By Emily Cox
brain bleeds
flickr/A Health Blog

A new study indicates that Xarelto use is connected to much higher risks of brain bleeds compared to aspirin, spiking concerns about the new-generation anticoagulant’s safety.

JAMA Neurology published the Taiwan researchers’ findings this past week. They found that Xarelto use carries three times the intracranial hemorrhaging risks as aspirin. But, the elevated brain bleed risks appear to only be associated with 15mg to 20mg doses.

Xarelto (rivaroxaban) is the leading drug in a new generation of oral anticoagulants. Manufacturers continue to aggressive market them as superior alternatives to drugs like Coumadin (warfarin) to prevent blood clots with atrial fibrillation and other conditions even though the drugs have been linked to tens of thousands of reports over uncontrollable and fatal bleeding events when doctors were unable to reverse the drugs’ blood thinning effects.

Xarelto Brain Bleeds Study

In this most recent study, researchers analyzed data from clinical trials that lasted three months or longer from multiple databases up to May 2018. They compared patient outcomes and brain bleeding events with Xarelto, Pradaxa, and Eliquis compared to those taking aspirin.

Researchers indicate that only 15mg to 20mg daily doses of Xarelto increased brain bleeds risks. However, this risk was triple that of the risk of daily aspirin use. Researchers did not observe the same risks with 10mg Xarelto.

“A 15-mg to 20-mg dose of rivaroxaban once daily is associated with substantially increased risks of intracranial hemorrhage, while smaller daily doses of rivaroxaban and (Eliquis) were not, implying that risk increase is dose dependent,” the researchers concluded. “It may be worthwhile to conduct randomized clinical trials comparing specific NOACs in specific doses and aspirin in patients without atrial fibrillation, but with potential sources of cardiac emboli that could cause stroke.”

The study comes on the heels of the New England Journal of Medicine’s publication of a study that showed that Xarelto does not even outperform aspirin at preventing blood clots.

Xarelto Internal Hemorrhaging and Brain Bleeds Litigation

Incidents of severe bleeding have led to tens of thousands of injury and death reports from Xarelto patients and their families. Currently, there are more than 20,000 Xarelto lawsuits pending in the sprawling multidistrict litigation (MDL). District Judge Eldon Fallon is presiding over the MDL in the Eastern District of Louisiana.

The MDL claims all raise similar allegations that Johnson & Johnson and its Janssen Pharmaceuticals subsidiary, as well as Bayer consciously concealed Xarelto’s significant bleeding risks to boost sales of their billion-dollar baby.

After a handful of bellwether trials to help parties evaluate the relative strengths and weaknesses in their cases and hopefully help them navigate settlement agreements, parties still have not made any progress in resolving the Xarelto litigation.

Consequently, Judge Fallon recently ordered the parties to identify 1,200 Xarelto cases for discovery. The court may then remand these cases back to District Courts nationwide for individual trial dates later this year.


Opioid Lawyers Renew Bid for NAS Babies Track in MDL

By Emily Cox
opioid lawyers NAS
flickr/Daniel Lobo

Opioid lawyers representing babies born to mothers who took prescription painkillers during their pregnancies relaunched their initiative Tuesday for a separate track in the sprawling opioid multidistrict litigation (MDL), asserting that the plaintiffs’ executive committee is overtly hindering their attempts to secure justice.

The opioid lawyers are requesting to file a new motion for a separate MDL track, claiming that the current plaintiffs’ committee still has not dedicated a representative for babies born with neonatal abstinence syndrome (NAS) and that the committee is singularly composed of local government and institution attorneys who interests clash with those of the infants. Furthermore, while discovery is underway, the committee is officially refusing to inform babies’ opioid lawyers if it involves or relates to any of their claims.

Since the Judicial Panel on Multidistrict Litigation (JMPL) formed the MDL in December, the court has created separate tracks for third-party payors and Native American tribes. Much like the local governments, these parties generally claim that opioid manufacturers and distributors fueled the opioid crisis by downplaying opioid risks and refusing to report suspicious orders.

“The court created the Native American track so that they would not be marginalized,” the attorneys said. “Here the [neonatal abstinence syndrome] babies are currently marginalized completely.”

Opioid Lawyers Fight for Separate NAS Track

NAS can cause low birth weight, short-term withdrawal symptoms, such as seizures, and long-term cognitive difficulties. So far, seven proposed class actions for NAS babies have been transferred into the MDL.

Since the opioid lawyers first requested a separate track for the infants in May, more than 5,000 babies have been born with NAS. However, in late June, District Judge Dan Polster shot down the request in a text order.

“Judge Polster considered most if not all of the arguments made by the representatives when they made their original motion,” plaintiffs’ executive committee member Paul Hanly said. “The PEC believes that his decision not to create a separate track or add PEC members was and remains correct, but it is the Court’s decision, not that of the PEC.”

The opioid lawyers for the infants indicate that the infants represent the largest category of plaintiffs and are “undisputedly free of fault and critically the most vulnerable in this litigation due to their inability to speak for themselves.”

Initially, NAS attorneys argued for the court to create a trust to fund research and treatment for the syndrome. They also pushed for direct compensation for the victims with some of it relating to out-of-pocket expenses for opioid-weaning treatment after babies are born.

“Voiceless children deserve to have separate counsel and these NAS babies deserve to be heard and represented in this opioid crisis,” one of attorneys representing the babies said.

“Despite thousands of NAS babies being born each year, the states and local governments have done little to address this epidemic or the life-long issues which follow these children.,” he continued. “We are hoping the court reconsiders its position, recognizes the plight of these children and allows them a clear voice in the multidistrict litigation.”

Insys Expert Witness Switches Sides

By Emily Cox

Insys expert witness

The former top executive and founder of opioid manufacturer Insys Therapeutics told a federal judge Monday that an Insys expert witness double-crossed him and other executives facing racketeering charges with plans to testify against them in the government’s case over an illegal kickback scheme to bribe doctors to prescribe the fentanyl spray, Subsys.

According to the government’s case, billionaire Insys founder John Kapoor and his CEO predecessor Michael Babich created a sham speaker program to lure prescribers and feloniously boost Subsys sales. Earlier this month, the government named five pain management experts who would be testifying on its behalf. To their “great surprise,” the executives found that Insys expert witness Dr. Christopher Gilligan is among them.

Insys Expert Witness Decides to Go to Bat for the Government in Racketeering Case

Before the government retained him, Gilligan repeatedly met with Insys attorneys and discussed confidential case strategy with them throughout this past spring. At this time, Gilligan told the attorneys that he had not discussed the case with the government and would be open to acting as an Insys expert witness.

However, in May, Gilligan told Insys attorneys that his employers wouldn’t permit him to serve as an Insys expert witness in the case and offered to help find a replacement.

Following the government’s announcement that Gilligan would be a potential expert for their cause, the executives claim they tried to figure out what happened. They notified the government about their involvement with Gilligan and requested assurance that the government would drop him as a witness.

The executives said that the government told them that it informed the doctor that it would not communicate with him until the matter was settled.

Executives Fight Government Retention of Insys Expert Witness

Then, the government wrote in a letter Friday that an assistant U.S. attorney had first spoken to Gilligan five days before the expert witness disclosure deadline and that Gilligan had told the attorney of his previous encounters with Insys lawyers. But, no one on the prosecution team asked the Insys executives if they had engaged in confidential conversations with the Gilligan.

“Instead, in an apparent rush to meet its expert disclosure deadline, the government relied on the descriptions and understandings of Dr. Gilligan — who is not an attorney — to assess the incomplete background of the conflict issue in a vacuum,” the executives wrote.

Based on the government’s letter, the executives claim Gilligan misrepresented the “substantial, confidential” nature of his communications with their attorneys, including the number and length of these conversations, as well as his previous desire to serve as an Insys expert witness until his employer said no to his involvement.

The executives further maintained that the government already has four additional pain management expert witnesses with two of them expected to produce testimony similar to Gilligan’s.

“More fundamentally, prosecutors should not be excused for waiting until the last moment to conduct their expert search, or for failing to timely consult with Defendants about the conflict issue,” the executives wrote. “The government has had plenty of time to identify and consult with experts, having investigated this case for over five years and presented two indictments to the grand jury alleging life-altering charges against defendants that have caused irreparable damage to their reputations and livelihood.”

The Case Behind the Insys Expert Witness Double-Cross

According to the federal indictment, at least nine doctors and one nurse took bribes to distribute the fentanyl spray at or after intimate meetings or social parties that Insys organized and disguised as speaking events. These medical professionals went on to distribute the powerful opioid spray to people who did not need it for the FDA-approved purpose – to treat breakthrough cancer pain. Babich and company executive Michael J. Curry also directed the Insys call center to fraudulently tell insurance companies that patients required to spray to get them to cover the prescription cost.

Government prosecutors allege that Kapoor and Babich hired four sales executives to network with prescribers to put the plan into action. Consequently, Alec Burlakoff, Richard M. Simon, Sunrise Lee, and Joseph A. Rowan are the four other defendants in the case.

The executives argue that the conspiracy was actually a series of perfectly legal marketing strategies that the law’s “safe harbors” specifically protect. They maintain the indictment fails to adequately allege that the executive targeted doctors they knew would break the law.


OxyContin Maker Blames Doctors, Patients, and Drug Dealers for Opioid Crisis

By Emily Cox
oxycontin prescriptions
flickr/Mike Licht

The manufacturer of the highly addictive and deadly prescription painkiller Oxycontin is trying to flip the script on the opioid crisis, asking a Tennessee court to toss a lawsuit by the state’s attorney general over its role in the ongoing epidemic, claiming that the blame for skyrocketing nationwide addiction lies directly on the shoulders of patients, prescribing doctors, and drug dealers.

Purdue Pharma is asking a Knox County judge to dismiss Tennessee Attorney General Herbert H. Slatery III’s lawsuit against the Big Pharma heavy-hitter that has made a fortune off a drug that is at the very heart of the opioid epidemic and is clinically the deadliest of all the opioids for state residents.

Purdue’s own records indicate that the company specifically directed high-pressure sales tactics at underqualified and overworked doctors to push ever escalating numbers of OxyContin prescriptions at increasingly high doses for a wide range of off-label uses from generalized pain to sleeplessness.

Slatery’s office is demanding the court to hold Purdue Pharma legally and financially responsible for pouring gasoline on the already burning opioid inferno that is currently engulfing the country after the company promised to change its marketing tactics in 2007.

However, Purdue is arguing that the opioid epidemic is not its fault. Instead, the drug maker is pointing the finger at doctors and patients, as well as drug-dealing addicts that dispensers and users of its drugs created.

“The alleged nuisance in this case is not caused by Purdue’s sale of its legal, FDA-regulated medications, but rather by doctors who wrote improper prescriptions and/or by third parties who caused persons without valid and medically necessary prescriptions to get opioid medications or illegal street drugs. Purdue has no control over those persons,” Purdue’s legal team wrote.

2007 Tennessee OxyContin Marketing Agreement

In a 2007 agreement, Purdue Pharma promised the state of Tennessee that it would stop lying about OxyContin’s benefits and safety profile; halt “aggressively” pushing doctor prescriptions; report over-prescribing doctors; and help doctors identify addicted patients.

In filing its lawsuit, Slatery’s office invoked that agreement’s terms to force Purdue to turn over internal records.

These records indicated that Purdue funneled money to “advocacy groups” to push OxyContin as safe and effective for a broad spectrum of general pain; made hundreds of doctor calls to pressure them to prescribe more of the drug to more people; kept calling “pill mill” doctors even after the medical providers had received indictments from opioid prescriptions; and disseminated false information about addiction.

These are all in direct violation of Purdue’s 2007 agreement with the state. Consequently, the lawsuit is accusing Purdue of clear agreement violations, as well as Tennessee consumer protection and public nuisance laws.

Purdue Fights Tennessee Opioid Lawsuit

Purdue wants Circuit Judge Kristi M. Davis to toss the state’s lawsuit. However, the company did not dispute in its motion the company’s detailed records and notes that the state lawsuit cites extensively. Instead, Purdue argue that Tennessee has no legal leg to stand on in court.

“The State does not allege that Purdue interfered with any right common to the public, such as clean air or water,” the motion to dismiss states. “Instead, the State alleges that Purdue sold medications to third parties, and that those third parties later provided the medications to some people who misused or abused them.

“There is no basis to radically expand and distort the law of public nuisance, or to ignore the State’s failure to plead a cognizable claim,” the motion continues. “If the Court were to permit this claim to survive, it would open the gates to a host of other public nuisance lawsuits that target complex, multifactorial, and ill-defined societal harms.”

The motion to dismiss also indicates that federal law trumps state law, saying Purdue has the full blessing and support of the FDA in how it labels and markets OxyContin.

In 2012, the Physicians for Responsible Opioid Prescriptions tried to get the FDA to regulate OxyContin by limiting how much and how long doctors can prescribe the painkiller, as well as limiting its uses to trauma patients and fatal disease sufferers. However, the organization failed to get the FDA to pass these protective restrictions.

Purdue says it has been labeling and marketing the drug per the FDA’s guidelines. This includes relying upon the American Pain Society (APS) prescribing guidelines.

Purdue Financially Incentivized OxyContin Prescriptions and Guidelines

Tennessee’s lawsuit cites Purdue’s own records, showing that the company was paying doctors to downplay OxyContin’s addictive properties. Furthermore, Purdue was funding advocacy groups, including APS, while the FDA relied on the organization as an independent voice on OxyContin’s safety.

The attorney general’s lawsuit revealed that Purdue paid the APS $3.1 million from 1997 to 2012. This includes $628,925 in “educational grants” from the time of its Tennessee marketing agreement in 2007 to 2016. Comparatively, other opioid manufacturers have given the APS $420,465 in the past five years combined.

The FDA relies on the APS and about a half-dozen similar groups that have financial connections to Big Pharma to decide if tighter controls are necessary on opioid prescriptions.

The regulatory agency credited the APS and other interest groups expertise over that of doctors in ruling against limitations on the amount of OxyContin that could be prescribed daily and for how long.

In 2009, the government forced the APS and the American Academy of Pain Medication, which also received “grants” from Big Pharma, to withdraw a “consensus statement” that indicated opioids were safe for long-term, non-cancer pain that the groups issued in 1996. A congressional reports indicates that Purdue was giving both groups money by 1997.

“Science moves fast and numerous studies have been published on opioid therapy since 1996,” APS said in defense of the consensus statement and its later withdrawal.

According to APS, its guideline now says “opioids are safe and effective for patients with chronic non-cancer pain, provided they are carefully selected, thoroughly counseled about the medication, and monitored regularly for side effects and possible abuse or aberrant drug behavior.”

The court is giving the attorney general’s office time to respond to Purdue’s dismissal motion. Davis will most likely schedule a hearing prior to issuing a ruling on the motion.







New York Jumps into Purdue Pharma Opioid Battle

By Emily Cox
Purdue Pharma opioid

In its new Purdue Pharma opioid lawsuit, the state of New York echoes hundreds of cases against the opioid manufacturer in its allegations that Purdue Pharma spread opioid addiction like a virus, laying waste to lives across the country and leaving death and financial ruin in its wake by overtly lying about the benefits and risks of its signature painkiller, OxyContin.

State Attorney General Barbara Underwood filed the lawsuit Tuesday. The case alleges that Connecticut-based Purdue profited enormously from a long-term scheme of deception to depict OxyContin as a wonder drug, leading to rampant nationwide addiction, thousands of fatal overdoses, and staggering economic costs due to law enforcement and health care.

“Through its actions, Purdue and its owners obtained billions of dollars in profits, at the cost of lost lives and tens of billions of dollars in devastation inflicted on communities that are now awash in opioids and their ill effects,” the Purdue Pharma opioid lawsuit states.

Purdue officials responded immediately Tuesday, releasing a statement saying that they “vigorously deny the state’s allegations.”

“We believe it is inappropriate for the state to substitute its judgment for the judgment of the [FDA’s] regulatory, scientific and medical experts,” the officials said in their statement.

According the federal government, more than 40,000 Americans died in 2016 from overdoses involving prescription and illicit opioids. The Purdue Pharma opioid lawsuit also maintains that New York saw almost 3,100 deaths from opioids. This included 2,400 deaths involving prescription opioids.

Purdue Pharma Opioid Lawsuit

New York’s claim resoundingly echoes claims made by other states’ recent Purdue Pharma opioid cases, including North Carolina, Tennessee, Texas, Utah, and Virginia. The Empire State also maintains many of the same allegations as hundreds of cases from local governments against Purdue and other opioid companies in the sprawling multidistrict litigation (MDL) over the opioid crisis.

Among other serious allegations, New York is accusing Purdue of consciously concealing addiction risks and fraudulently claiming that OxyContin provides 12 hours of continuous pain relief. The company also falsely claimed that addicts were actually suffering from undertreatment and “pseudoaddiction.” The treatment? More OxyContin, according to Tuesday’s Purdue Pharma opioid lawsuit.

Furthermore, Purdue hired doctors on as “key opinion leaders” and funded “front groups” to add credibility to its marketing messaging. The company also continued to distribute misinformation about OxyContin even after it reached agreements with state and federal authorities to cease virtually identical misstatements.

“Despite its pledges to improve its conduct, Purdue continued to aggressively promote its drugs directly through in-person marketing visits to health care providers and facilities,” the Purdue Pharma opioid lawsuit states.

In February, Purdue stopped promoting opioids in physician offices. In June, the company laid off its entire sales force and indicated that it intended to focus less on opioids and more on developing drugs targeting cancer and central nervous system disorders.

New York’s suit has nine specific causes of action. This includes public nuisance, deceptive advertising, unjust enrichment, and “repeated and persistent fraud.” The state seeks disgorgement of ill-gotten gains, civil penalties, and additional funds for addiction treatment, and prescriber education, among other remedies.

States Fight Against Opioid Dismissal Bids in MDL

By Emily Cox
opioid dismissal
flickr/Find Rehab Centers

Dozens of states are attacking an opioid dismissal bid by drug manufacturers and distributor McKesson Corp. to dismiss claims that they ignited the opioid crisis, arguing to the Ohio federal judge overseeing the opioid multidistrict litigation (MDL) that the court must not restrict states’ abilities to protect its citizens’ health.

The states filed two amicus briefs. The first brief is aimed at the drug manufacturers, while the other focuses on McKesson. The companies have moved to dismiss an Alabama lawsuit in one of the bellwether cases in the massive litigation that alleges drug makers and distributors fueled the opioid epidemic by downplaying significant risks and failing to report outrageously large orders. In their McKesson brief, states attacked the pharmaceutical distributor’s assertion that it didn’t play a role in the crisis, claiming that distribution companies’ expansive role in the pharmaceutical industry negates a certain amount of responsibility on their part.

“But, more importantly for purposes of this brief, McKesson ignores the distributor’s legal duties to prevent diversion and to monitor, detect, investigate, refuse, and report suspicious orders of opioids,” the states said.

The Alabama lawsuit claims that McKesson violated specific federal Controlled Substances Act (CSA) duties to prevent the diversion of opioids and to spot suspicious orders. However, in its opioid dismissal motion, McKesson argued that the CSA prevents states from suing it.

“But states do not rely solely on the federal Controlled Substances Act to regulate distributors. State laws themselves prohibit opioid distributors from facilitating diversion and from turning a blind eye to suspicious orders,” the states said. “State attorneys general, including the attorney general of Alabama, are empowered to enforce violations of those laws.”

Opioid Dismissal Bids Within the Uniform Controlled Substances Act

Except for New Hampshire and Vermont, all the states have also adopted the Uniform Controlled Substances Act. According to the states, this requires controlled substance distributors to annually register with the appropriate state agency. This law also mandates that distributors prevent the diversion of controlled substances, like opioids, into non-legal channels.

In the brief pertaining to the drugmakers’ opioid dismissal bid, the states allege that the companies failed to recognize the role of state attorneys general as legal protectors of citizens doesn’t make them “super plaintiffs” trying to recoup individual damages of their constituents. The states insist that attorneys general are only seeking to protect the well-being and health of their citizens.

The drug makers further claim that Alabama hasn’t shown causation, as it hasn’t identified individual physicians who were allegedly influenced and acted on misrepresentations about opioid safety.

However, these arguments wrongly assume that Alabama is seeking to recover for prescriptions rather than vindicating its residents’ rights to be free from conduct that directly threatens public health, safety, and welfare by recouping the costs of abating the problem.

“State attorneys general have long been both protectors of the health and well-being of their citizens and also the primary enforcers of state consumer protection laws,” the states said.

Delaware, Illinois, New York, New Jersey, Florida, Texas, Pennsylvania, and the District of Columbia are among the states in the amicus briefs, fighting the opioid dismissal bid.

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