First State Court Opioid Crisis Trial Set In Oklahoma With May 2019 Start Date

By Mark A. York (May 24, 2018)

 

 

 

 

 

 

 

May 28, 2019 trial date set in the first opioid litigation case to go to trial where a  state filed suit versus the opioid pharmaceutical companies

(MASS TORT NEXUS MEDIA) The first of many opioid litigation trials where states, counties and cities have filed lawsuits against the Opioid Big Pharma industry and it’s affiliates, is now set in Oklahoma where Cleveland County District Judge Thad Balkman set May 28, 2019 for the start of the trial.  The trial date date has been anticipated in the lawsuit by the State of Oklahoma against pharmaceutical companies over the opioid epidemic, according to Oklahoma‘s attorney general Mike Hunter. See Original Complaint – State of Oklahoma vs. Purdue Pharma et al, June 30, 2017 (Cleveland County, OK District Court)

To summarize the view in Oklahoma and other states who are pursuing the Opioid prescription drugmakers in courts all across the country, Oklahoma Attorney General Mike Hunter stated in his filings  “Defendants created the worst public health crisis in modern history. Families destroyed,”adding “Children killed. Babies addicted. Morgues overflowing. Prisons full.” This is a common view across the entire United States at this point.

Oklahoma, one of at least 13 states that have filed lawsuits against drugmakers, alleges fraudulent marketing of drugs that fueled the opioid epidemic in the lawsuit filed in June 2017, and seeks unspecified damages from Purdue Pharma, Allergan, Janssen Pharmaceuticals, Teva Pharmaceuticals and several of their subsidiaries.

“We appreciate the urgency Judge (Thad) Balkman saw in getting the case to trial,” Attorney General Mike Hunter said. “Oklahomans who have suffered immeasurably from the years of fraudulent marketing campaigns will see this case resolved sooner rather than later.” Hunter said Balkman scheduled the trial to begin May 28, 2019.

For up to date information on the Opioid Litigation across the country see, OPIOID-CRISIS-BRIEFCASE-INCLUDING-MDL-2804-OPIATE-PRESCRIPTION-LITIGATION (https://www.masstortnexus.com/Briefcases/Drugs/254/)

Within the last 2 weeks, state attorneys general of Nevada, Texas, Florida, North Carolina, North Dakota and Tennessee lawsuits have now joined many other states who have filed lawsuits asserting that Purdue Pharma violated state consumer protection laws by falsely denying or downplaying the addiction risk while overstating the benefits of opioids. The lawsuits also names pharmaceutical manufacturers Endo Pharmaceuticals, Allergan, Teva Pharmaceutical Industries and Mallinckrodt, as well as drug distributors AmerisourceBergen, Cardinal Health and McKesson Corporation.

“It’s time the defendants pay for the pain and the destruction they’ve caused,” Florida State Attorney General Pam Bondi told a press conference.

Joining, Oklahoma are states who’ve previously filed claims against opiate drugmakers are Ohio, AlaskaKentuckyLouisianaMississippiMissouriMontanaNew HampshireNew JerseyNew MexicoSouth Carolina and Washington state. West Virginia has been catastrophically affected by the opioid crisis and has previously attempted to stop Opioid Big Pharma from pushing opiates into their communities, without much success.  See How drug companies submerged West Virginia in opioids for years: “A small West Virginia town of 3,000 people got 21 million pills”

Medical professionals say a shift in the 1990s to “institutionalize” pain management opened the doors for pharmaceutical companies to encourage doctors to massively increase painkiller prescriptions, and Purdue Pharma led that effort. Which is now directly linked to the massive increase in drug overdoses, now see as the leading cause of accidental death for Americans under age 50, killing more than 64,000 people in 2016, according to the Centers for Disease Control and Prevention.

OxyContin was launched in the mid-90s by Purdue Pharma and aggressively marketed as a safe way to treat chronic pain. But it created dependency in many even as prescribed, and the pills were easy to abuse. Mass overprescribing has led to an addiction and overdose catastrophe across the US, more recently rippling out into rising heroin and fentanyl deaths.

Opioid overdoses made up a staggering 66 percent of all drug overdose deaths in 2016, surpassing the annual number of lives lost to breast cancer.

Florida and the other states also, named drug makers Endo Pharmaceuticals Inc., Allergan, units of Johnson & Johnson and Teva Pharmaceutical Industries, and Mallinckrodt, as well as drug distributors AmerisourceBergen Corp., Cardinal Health Inc. and McKesson Corp. The distributors played a part in opioid abuse through oversupply, including failing to identify suspicious orders and report them to authorities, including the DEA and other oversight agencies, contributing to an illegal secondary market in prescription opioids, such as Purdue’s OxyContin, Endo’s Percocet and Insys Therapeutics fentanyl drug Subsys, a fast acting and extremely addictive drug.

The companies deny wrongdoing and say they complied with Federal Drug Administration requirements that include warning labels showing potential risks that come with using their drugs. “We are deeply troubled by the prescription and illicit opioid abuse crisis, and are dedicated to being part of the solution,” Purdue Pharma said in a statement Friday. “We vigorously deny these allegations and look forward to the opportunity to present our defense.”

Ohio Filed First

In announcing his office’s lawsuit in May 2017, Ohio Attorney General DeWine said the drug companies helped unleash the crisis by spending millions of dollars marketing and promoting such drugs as Purdue’s OxyContin, without consideration of the long term effects of the related addiction, which Purdue was absolutely aware of throughout the years of profits that now total billions of dollars.

The lawsuit said the drug companies disseminated misleading statements about the risks and benefits of opioids as part of a marketing scheme aimed at persuading doctors and patients that drugs should be used for chronic rather than short-term pain.  Pain centers and medical practices across the country started writing an ever increasing number of high dose opioid prescriptions for what would be considered low to mid-level pain treatment.

Similar lawsuits have been filed by local governments, including those in several California counties, as well as the cities of Chicago, Illinois and Dayton, Ohio, three Tennessee district attorneys, and nine New York counties have also filed individual suits.

It is unknown at this time, if all of the legal actions filed by governmental entities across the country will be consolidated into MDL 2804, which may be the most effective way to manage the soon to be massive number of legal claims against Big Pharma and their long term opiate profit centers. Municipalities across the country seeking to recoup the enormous financial losses brought on by the opioid crisis.

The state lawsuits are separate from pending lawsuits in Ohio by dozens of local governments, and lawsuits by Native American tribes in the Dakotas and Oklahoma.

In South Dakota, the Rosebud Sioux Tribe, Flandreau Santee Sioux Tribe and the Sisseton Wahpeton Oyate filed a federal lawsuit in January against 24 opioid industry groups. See https://www.indianz.com/News/2018/04/11/navajonationopioid.pdf.  n Oklahoma, a federal judge has ruled that another similar lawsuit by the Cherokee Nation cannot be tried in tribal court, and Cherokee Nation Attorney General Todd Hembree told the Tulsa World that the tribe will re-file the lawsuit in state court.

Lawsuits have already been filed by 16 other U.S. states and Puerto Rico against Purdue and the related opioid drug companies and distributors. Purdue, which is a privately held company, owned by the Sackler brothers and family, in February said it stopped promoting opioids to physicians after widespread criticism of the ways drugmakers market highly addictive painkillers.

Purdue Pharma is owned by the Sackler family, listed at 19th on the annual Forbes list of wealthiest families in the country at a worth of $13 billion. The family’s fortune largely comes from OxyContin sales, which its company branded and introduced as an extended release painkiller in 1995.

Two branches of the Sackler family control Purdue, which developed and continues to make OxyContin, the narcotic prescription painkiller regarded as the “ground zero” of America’s opioids crisis.

Bondi said state attorneys general from New York, California and Massachusetts were preparing similar lawsuits, with Massachusetts last week sending a letter to Purdue notifying the company of its intention to sue. The California and New York attorney general offices did not immediately respond to a request for comment.

Stamford, Connecticut-based Purdue, in a statement, denied the accusations, saying its drugs were approved by the U.S. Food and Drug Administration and accounted for only 2 percent of all opioid prescriptions, seemingly ignoring the 600 lawsuits filed against them in the last year, as well as the minimum of 15 federal and state criminal investigations that are underway across the country.  At the forefront of the criminal investigations is the U.S. Attorney, John H. Durham, District of Connecticut, U.S. Department of Justice, Criminal Division, based in New Haven, CT the state which is also where Purdue Pharma is headquartered, who is leading a multi-group task force looking into the potential criminal conduct of not only Purdue, but the entire Opiate Big Pharma industry as a whole.

“We are disappointed that after months of good faith negotiations working toward a meaningful resolution to help these states address the opioid crisis, this group of attorneys general have unilaterally decided to pursue a costly and protracted litigation process,” Purdue said.

Opioids were involved in more than 42,000 overdose deaths in 2016, the last year for which data was available, according to the U.S. Centers for Disease Control and Prevention. Kentucky, one of the nation’s hardest-hit states, lost more than 1,400 people to drug overdoses that year.

Separate litigation involving at least 433 lawsuits by U.S. cities and counties were consolidated in a federal court in Cleveland, Ohio. The defendants include Purdue, J&J, Teva, Endo, AmerisourceBergen, Cardinal Health and McKesson. The federal litigation is growing daily see, Opiate Prescription MDL 2804, US District Court of Ohio link.

The federal lawsuits which accuse drugmakers and the opioid industry as a whole, of deceptively marketing opioids and the distributors of ignoring indications that the painkillers were being diverted for improper uses.

U.S. District Judge Dan Polster, who is overseeing the consolidated litigation, has been pushing for a global settlement. He had previously invited state attorneys general with cases not before him to participate in those talks, from the start of the MDL 2804 litigation being assigned to his courtroom.

Despite filing separate lawsuits, the six attorneys general on Tuesday said they would continue to engage in settlement discussions with Purdue and other companies. “You always want to settle and prevent a prolonged litigation,” said Florida’s Bondi. “But we’re sending a message that we’re fully prepared to go to war.”

Will litigation in most every state in the union paired with the National Opiate Prescription MDL 2804 reign in the Opioid industry that’s earned billions and billions of dollars over the last 20 years, all at the expense of the people of the United States and their families?  If history is a gauge of how things will end up, chances are a big “NO” as money and greed at the corporate levels have traditionally overruled anything affiliated with long term public health concerns in our for-profit healthcare system currently entrenched in the United States.

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More States Are Now Filing Lawsuits Against Big Pharma’s Opioid Rx Cash Cow Industry

Florida, Texas, Nevada, North Carolina, North Dakota and Tennessee Join Opioid Litigation

 

 

 

 

 

 

(Mass Tort Nexus Media) Litigation against OxyContin maker Purdue Pharma LP and the rest of the Opioid Big Pharma industry just jumped significantly, as six more states have filed lawsuits against Purdue Pharma, et al. The ongoing allegations against the opioid pharmaceutical industry as a whole, where numerous governmental entities from across the country have asserted that the opiate makers have fueled a national opioid crisis. This is primarily based on corporate boardroom designed deceptive opioid marketing campaigns, designed to sell prescription opioids, and minimize the previously well-known medical risks, including addiction and overdose, while generating billions of dollars in sales.

For up to date information on the Opioid Litigation across the country see, OPIOID-CRISIS-BRIEFCASE-INCLUDING-MDL-2804-OPIATE-PRESCRIPTION-LITIGATION (https://www.masstortnexus.com/Briefcases/Drugs/254/)

Prescription and illegal opioids account for more than 60 percent of overdose deaths in the United States, a toll that has quadrupled over the past two decades, according to the U.S. Centers for Disease Control. Drug overdose deaths in 2015 far outnumbered deaths from auto accidents or guns.

Texas saw 1,186 opioid-related deaths in 2015, while the nation as a whole had 33,000 such deaths that year. Researchers have flagged opioids as one possible factor in Texas’ staggering rise in women’s deaths during and shortly after pregnancy.

State attorneys general of Nevada, Texas, Florida, North Carolina, North Dakota and Tennessee assert that Purdue Pharma violated state consumer protection laws by falsely denying or downplaying the addiction risk while overstating the benefits of opioids. The lawsuits also names pharmaceutical manufacturers Endo Pharmaceuticals, Allergan, Teva Pharmaceutical Industries and Mallinckrodt, as well as drug distributors AmerisourceBergen, Cardinal Health and McKesson Corporation.

“It’s time the defendants pay for the pain and the destruction they’ve caused,” Florida State Attorney General Pam Bondi told a press conference.

Medical professionals say a shift in the 1990s to “institutionalize” pain management opened the doors for pharmaceutical companies to encourage doctors to massively increase painkiller prescriptions, and Purdue Pharma led that effort. Which is now directly linked to the massive increase in drug overdoses, now see as the leading cause of accidental death for Americans under age 50, killing more than 64,000 people in 2016, according to the Centers for Disease Control and Prevention.

OxyContin was launched in the mid-90s by Purdue Pharma and aggressively marketed as a safe way to treat chronic pain. But it created dependency in many even as prescribed, and the pills were easy to abuse. Mass overprescribing has led to an addiction and overdose catastrophe across the US, more recently rippling out into rising heroin and fentanyl deaths.

Opioid overdoses made up a staggering 66 percent of all drug overdose deaths in 2016, surpassing the annual number of lives lost to breast cancer.

Florida and the other states also, named drug makers Endo Pharmaceuticals Inc., Allergan, units of Johnson & Johnson and Teva Pharmaceutical Industries, and Mallinckrodt, as well as drug distributors AmerisourceBergen Corp., Cardinal Health Inc. and McKesson Corp. The distributors played a part in opioid abuse through oversupply, including failing to identify suspicious orders and report them to authorities, including the DEA and other oversight agencies, contributing to an illegal secondary market in prescription opioids, such as Purdue’s OxyContin, Endo’s Percocet and Insys Therapeutics fentanyl drug Subsys, a fast acting and extremely addictive drug.

Teva, in a statement, emphasized the importance of safely using opioids, while AmerisourceBergen said it was committed to collaborating with all stakeholders to combat opioid abuse.

The Healthcare Distribution Alliance, an umbrella group for drug distributors, said in a statement that accusations that distributors were responsible for the abuse of opioid prescriptions defied common sense and lacked understanding of the pharmaceutical supply chain.

BILLIONS IN PROFITS

The pharmaceutical industry spent a vast $6.4 billion in “direct-to-consumer” advertisements to hype new drugs in 2016, according tracking firm Kantar Media. That figure has gone up by 62% since 2012, Kantar Media says. This number may seem large at first but compared to the multi-billions in yearly profits just by opioid manufacturers over the last 15 years, the numbers is small.  Corporate earnings have risen every year since the push to increase opioid prescriptions in every way possible, to became an accepted business model in Big Pharma boardrooms across the country.

THE SACKLERS AND PURDUE

Lawsuits have already been filed by 16 other U.S. states and Puerto Rico against Purdue and the related opioid drug companies and distributors. Purdue, which is a privately held company, owned by the Sackler brothers and family, in February said it stopped promoting opioids to physicians after widespread criticism of the ways drugmakers market highly addictive painkillers.

Purdue Pharma is owned by the Sackler family, listed at 19th on the annual Forbes list of wealthiest families in the country at a worth of $13 billion. The family’s fortune largely comes from OxyContin sales, which its company branded and introduced as an extended release painkiller in 1995.

Two branches of the Sackler family control Purdue, which developed and continues to make OxyContin, the narcotic prescription painkiller regarded as the “ground zero” of America’s opioids crisis.

Bondi said state attorneys general from New York, California and Massachusetts were preparing similar lawsuits, with Massachusetts last week sending a letter to Purdue notifying the company of its intention to sue. The California and New York attorney general offices did not immediately respond to a request for comment.

Stamford, Connecticut-based Purdue, in a statement, denied the accusations, saying its drugs were approved by the U.S. Food and Drug Administration and accounted for only 2 percent of all opioid prescriptions, seemingly ignoring the 600 lawsuits filed against them in the last year, as well as the minimum of 15 federal and state criminal investigations that are underway across the country.  At the forefront of the criminal investigations is the U.S. Attorney, John H. Durham, District of Connecticut, U.S. Department of Justice, Criminal Division, based in New Haven, CT the state which is also where Purdue Pharma is headquartered, who is leading a multi-group task force looking into the potential criminal conduct of not only Purdue, but the entire Opiate Big Pharma industry as a whole.

“We are disappointed that after months of good faith negotiations working toward a meaningful resolution to help these states address the opioid crisis, this group of attorneys general have unilaterally decided to pursue a costly and protracted litigation process,” Purdue said.

Opioids were involved in more than 42,000 overdose deaths in 2016, the last year for which data was available, according to the U.S. Centers for Disease Control and Prevention. Kentucky, one of the nation’s hardest-hit states, lost more than 1,400 people to drug overdoses that year.

Separate litigation involving at least 433 lawsuits by U.S. cities and counties were consolidated in a federal court in Cleveland, Ohio. The defendants include Purdue, J&J, Teva, Endo, AmerisourceBergen, Cardinal Health and McKesson. The federal litigation is growing daily see, Opiate Prescription MDL 2804, US District Court of Ohio link.

The federal lawsuits which accuse drugmakers and the opioid industry as a whole, of deceptively marketing opioids and the distributors of ignoring indications that the painkillers were being diverted for improper uses.

U.S. District Judge Dan Polster, who is overseeing the consolidated litigation, has been pushing for a global settlement. He had previously invited state attorneys general with cases not before him to participate in those talks, from the start of the MDL 2804 litigation being assigned to his courtroom.

Despite filing separate lawsuits, the six attorneys general on Tuesday said they would continue to engage in settlement discussions with Purdue and other companies. “You always want to settle and prevent a prolonged litigation,” said Florida’s Bondi. “But we’re sending a message that we’re fully prepared to go to war.”

PURDUE-OXYCONTIN HISTORY

On December 12, 1995, the Food and Drug Administration approved the opioid analgesic OxyContin. It hit the market in 1996. In its first year, OxyContin accounted for $45 million in sales for its manufacturer, Stamford, Connecticut-based pharmaceutical company Purdue Pharma. By 2000 that number would balloon to $1.1 billion, an increase of well over 2,000 percent in a span of just four years. Ten years later, the profits would inflate still further, to $3.1 billion. By then the potent opioid accounted for about 30 percent of the painkiller market. What’s more, Purdue Pharma’s patent for the original OxyContin formula didn’t expire until 2013. This meant that a single private, family-owned pharmaceutical company with non-descript headquarters in the Northeast controlled nearly a third of the entire United States market for pain pills.

OxyContin’s ball-of-lightning emergence in the health care marketplace was close to unprecedented for a new painkiller in an age where synthetic opiates like Vicodin, Percocet, and Fentanyl had already been competing for decades in doctors’ offices and pharmacies for their piece of the market share of pain-relieving drugs. In retrospect, it almost didn’t make sense. Why was OxyContin so much more popular? Had it been approved for a wider range of ailments than its opioid cousins? Did doctors prefer prescribing it to their patients?

During its rise in popularity, there was a suspicious undercurrent to the drug’s spectrum of approved uses and Purdue Pharma’s relationship to the physicians that were suddenly privileging OxyContin over other meds to combat everything from back pain to arthritis to post-operative discomfort. It would take years to discover that there was much more to the story than the benign introduction of a new, highly effective painkiller.

US DEPT OF JUSTICE INDICTMENTS

While the FDA has failed, the US Department of Justice has launched a massive crackdown on opiate drug makers including indictments of company executives, sales & marketing personnel as well as the doctors and pharmacies that have enabled the flood of easy access narcotics into the US market for over 15 years. The question is “how and why” did the FDA drop the ball or was this an intentional lack of enforcement and oversight by the FDA and other agencies due to Big Pharma influence over Congressional members who would blunt any true oversight of drug companies.

For criminal opioid cases see: Federal Venues and Courts Where Opioid Indictments Are Pending As Of July 2017

FORMER PRESIDENT BILL CLINTON SPEAKS TO THE OPIATE CRISIS ISSUES”

Former President Bill Clinton pulled no punches as he focused directly on the opiate issues “Nobody gets out of this for free,” which seems to be where most of the finger pointing and blame game rests, which is one of the prime issues of the highest importance. The checkbook to pull the country out of this national opiate epidemic will be in the hundreds of billions of dollars and even then, the costs of social and economic damage to date, will never be recovered. Clinton further commented on how the opioid epidemic “creeps into every nook and cranny of our country” and needs to be addressed as both a huge national problem and a community-by-community tragedy, adding “this can rob our country of the future.”

RURAL vs. BIG CITY OPIATES

Almost 2.75 million opioid prescriptions were filled in New York City each year from 2014 to 2016. Which is a very high number for a major city, but not nearly the millions of opiate prescriptions written in the more rural regions of Ohio, West Virginia and Kentucky, where the number of opiates prescribed equaled 100 plus pills per month for every resident in these states, with West Virginia numbers being, 780 million painkillers prescribed in six years.

As more and more cities, states and counties files suits against the opiate drug industry as a whole, there will be a point where Opiate Big Pharm will have to decide whether to admit it’s fault in the opioid crisis, or simply continue to evade responsibility and leave the process up to lawyers and the courts to assign a financial penalty for the alleged corporate opioid abuses.

FDA Failed to Cite Opioid Big Pharma

Perhaps a look at former US Representative Tom Price, will provide insight into how our lawmakers work within the healthcare industry. Rep. Price was appointed by President Trump to head the Department of Health and Human Services, which the FDA reports to, was forced to resign as HHS head due to various transgression within 6 months of being appointed, as well as leaks that while a sitting congressman he enacted a bill favoring a medical device makers extension of a multi-year government contract. Not only did Price enact the bill, he purchased stock in the company prior to the bill introduction and secured a massive profit on the stock price increase after the contract extension was announced. In normal business circles this is considered “insider trading” and is illegal, but when you’re one of those people in charge of creating the rules and regulations, there’s an apparent “get out of jail card” that comes with your congressional seat.

As long as the US Congress fails to correct the lack of oversight by the FDA and other regulatory agencies into what and how dangerous drugs and products are placed into the US marketplace, there will always be bad drugs entering the healthcare pipeline in the United States, with the now enduring default misnomer of “Profits Before Patients” firmly in place in boardrooms and within our government.

As the Opioid litigation expands across the country in both state and federal courtrooms, it remains to be seen if the anticipated payouts will surpass the $200 billion payday for governments in the 1998 Big Tobacco Litigation settlement.

What remains to be seen is where and how the directly affected “individuals” who were prescribed millions of addictive opiates and subsequently became addicted and where thousands more overdosed and died, remains to be seen.

Who will be the advocate to make sure that these individuals as well as their children, families and communities as a whole are placed on the road to recovery. Historically, Big Pharma is not an industry to put the best interests of the paying consumer at the forefront of their agendas.

 

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“PELVIC MESH” – WHAT’S CHANGED SINCE JANUARY 2016? HAS THE FDA LOOKED CLOSER AT THE THOUSANDS OF FILED ADVERSE EVENTS? MESH IS NOW A CLASS III HIGH RISK MEDICAL DEVICE

Who’s Telling Who About The High Risk Of Synthetic Surgical Mesh?

By Mark A. York (February 21, 2018)

Do you want polypropylene “fishing line” in your body? That’s what surgical mesh is made of.

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) FDA labels pelvic mesh as a “High Risk Medical Device” yet minimal review, investigation or action has been undertaken regarding the thousands of annual adverse events that are recognized in the medical industry as caused by “plastic or synthetic mesh” which is comparative to high quality polypropylene fishing line, which in both mesh and fishing line is available in various strengths. Is this something that’s either disclosed by your doctor and would it have an affect on your surgical decision?

WHO DISCLOSES RISK?

In January 2016, the FDA said vaginal mesh will now be classified as a “high-risk” medical device with a class III warning. Previously the implants were considered “moderate-risk” devices and carried a class II warning. Are healthcare professionals and surgical mesh manufacturers making sure this is a known factor in pre-surgical decisions? If notice to the public of the high risk designation of surgical mesh devices follows historical medical device manufacturers standards, that answer is an emphatic “NO”- medical device makers and their sales and marketing staff do not advertise or declare FDA and other regulatory defined risks to the public unless forced to, which includes patients undergoing surgeries. You physician may disclose whatever minimal product warning or risk statements that they’ve been provided by the medical product manufacturer.

DOES THIS HELP PATIENTS?

Mesh surgical implants used to repair pelvic organ prolapse in women, a condition that frequently develops after childbirth, will face tougher federal scrutiny following thousands of injuries reported with these devices.

The Food and Drug Administration said Monday that pelvic mesh will now be considered a class III, or high-risk, medical device, and manufacturers will be required to submit premarket approval applications demonstrating the safety and effectiveness of their products.

The change follows years of reports of pain, bleeding and infection among women who had the devices implanted to correct pelvic organ prolapse (POP). The condition occurs when the bladder or other reproductive organs slip out of place, causing pain, constipation and urinary issues. The new FDA requirements do not apply to mesh products used to treat other conditions such as hernias or urinary incontinence.

Plastic mesh is often used to strengthen the pelvic wall and support internal organs in cases of prolapse. The mesh is often inserted through the vagina, using a small surgical incision. The Washington Post recently reported that as many as half of women may experience pelvic floor symptoms in their lifetime, and 200,000 undergo such operations each year.

Surgical mesh is a medical device that is used to provide additional support when repairing weakened or damaged tissue. The majority of surgical mesh devices currently available for use are made from man-made (synthetic) materials or animal tissue.

Surgical mesh made of synthetic materials can be found in knitted mesh or non-knitted sheet forms. The synthetic materials used can be either absorbable, non-absorbable, or a combination of absorbable and non-absorbable materials.

WHAT IS MESH?

Animal-derived mesh are made of animal tissue, such as intestine or skin, that have been processed and disinfected to be suitable for use as an implanted device. These animal-derived mesh are absorbable. The majority of tissue used to produce these mesh implants are from a pig (porcine) or cow (bovine).

Non-absorbable mesh will remain in the body indefinitely and is considered a permanent implant. It is used to provide permanent reinforcement in strength to the urogynecologic repair. Absorbable mesh will degrade and lose strength over time. It is not intended to provide long-term reinforcement to the repair site. As the material degrades, new tissue growth is intended to provide strength to the repair.

Surgical mesh can be used for urogynecologic procedures, including repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is permanently implanted to reinforce the weakened vaginal wall for POP repair or support the urethra or bladder neck for the repair of SUI. There are three main surgical procedures performed to treat pelvic floor disorders with surgical mesh:

  • Transvaginal mesh to treat POP
  • Transabdominal mesh to treat POP
  • Mesh sling to treat SUI

MESH REPAIR VERSUS SUTURES

The FDA action comes more than four years after the agency concluded that women getting vaginal mesh have more complications than women who undergo traditional surgery with stitches. Mesh products were introduced for pelvic repair in the 1990s and promoted as a way to speed patients’ recovery time. But the FDA said in 2011 that about ten percent of women experienced complications from mesh, sometimes requiring multiple surgeries to reposition or remove it.

50,000+ MESH LAWSUITS FILED

Patients have filed tens of thousands of lawsuits against mesh manufacturers, including Johnson & Johnson, Boston Scientific and Endo International. In 2014, Ireland-based Endo said it would pay $830 million to settle more than 20,000 personal injury lawsuits.  For more information see Mesh Litigation Briefcase -50,000 Cases Pending and More Each Day along with TVM mesh cases there are now two more “hernia mesh” multidistrict litigation cases , designated as “Ethicon Physiomesh MDL 2782 (Ethicon Physiomesh MDL 2782 Briefcase Re: Hernia-Mesh-Litigation) and the Atrium Medical C-Qur Hernia Mesh MDL 2753 (ATRIUM MDL 2753 Re: C-QUR-HERNIA-PATCH Briefcase) these case apply to synthetic hernia mesh complication with adverse systems and long term medical complications, being the same as those alleged in the massive TVM litigation, which are pending in federal court across the country.

In a second rule, the FDA said vaginal mesh will now be classified as a “high-risk” medical device with a class III warning. Previously the implants were considered “moderate-risk” devices and carried a class II warning.

FDA recommends that women be aware of the risks associated with surgical mesh. On an advice page on the FDA website, the agency writes: “Ask your surgeon about all POP treatment options, including surgical repair with or without mesh and non-surgical options.”

Non-surgical options include pelvic floor exercises known as Kegels. There are also non-invasive devices such as the PeriCoach, a smartphone-connected pelvic floor muscle training device for incontinence.

WHY WAS THERE AN FDA DELAY?

The FDA first proposed the 2016 changes in 2014 draft orders, why would a regulatory safety agency wait two years to announce the high risk designation of a product being used over 200 thousand times a year in the USA? This reflects the back office control and influence of the medical manufacturing industry as a whole and how they use influence to defer and often stop disclosure of adverse risk s related to the medical products they sell to consumers. Profits before patient in the general rule in most device manufacturer boardrooms..

Like 90 percent of medical devices sold in the U.S., pelvic mesh was originally cleared under a streamlined FDA review process for devices deemed similar to older products. This has resulted in billions of dollars in profits for major medical manufacturers and the medical field as a whole, while thousands and thousands of patients have been afflicted with life changing post-surgical complications and until the FDA or other parties make the high risks known, many thousands more patients will have plastic products surgically implanted into their bodies, without knowing the true risks.

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$28 Million Xarelto Jury Verdict Reversed by Judge in Philadelphia Court

Defense gets fourth win in the four Xarelto bellwether trials

By Mark York (January 11, 2018)

 Xarelto Blood Thinner Developed by Bayer and Janssen

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) The December 2017 Xarelto jury verdict of $27.8 million awarded to an Indiana couple, was overturned earlier this week, when the trial judge vacated the verdict. The plaintiffs had accused Bayer AG and Janssen Pharmaceuticals, Inc., a Johnson & Johnson subsidiary, of failing to warn of internal bleeding risks of their drug Xarelto.

Judge Michael Erdos, Philadelphia County Court of Common Pleas, heard arguments on January 9, 2018 in a motion hearing to reverse the December verdict, which was the first defense trial loss in litigation over the Xarelto blood thinner, and also the first trial outside the Xarelto MDL 2592, (see XARELTO MDL 2592 US District Court ED Louisiana briefcase) in front of Judge Eldon Fallon, US District Court of Louisiana.

Judge Erdos issued his ruling from the bench after the hearing on defense motions for a new trial or alternatively, for a judgement notwithstanding the verdict, and at the close of a full day of arguments stating, “a new trial is not necessary because plaintiff did not adequately demonstrate responsible cause,” and he then entered judgement for the defendants.

“J&J’s Janssen Pharmaceuticals Inc and Bayer, which jointly developed Xarelto, welcomed the decision and issued statements saying they will continue to defend against the allegations in all Xarelto litigation, with a total of more than 20,000 pending lawsuits now in both state and federal Xarelto dockets.

Bayer stated “Bayer stands behind the safety and efficacy of Xarelto and will continue to vigorously defend it.”

The December 5, 2017 verdict came in a lawsuit filed by Lynn Hartman, who was prescribed Xarelto as treatment for an irregular heartbeat also known as atrial fibrillation, to prevent strokes. The testimony and opinions of Ms. Hartman’s treating physician and views on continued willingness to prescribe Xarelto, had a significant impact on the final ruling to overturn the verdict by Judge Erdos.

Hartman claimed she was prescribed the drug for a little more than a year, starting in February 2013, and was hospitalized with severe gastrointestinal bleeding in June 2014, at age 72, with the bleed attributed to taking Xarelto. The court record reflected that Ms. Hartman has since recovered from the hospitalization.

Lynn Hartman and her husband filed their complaint against the drugmakers in 2015, (see XARELTO Case No. 2349 Philadelphia Court of Common Pleas briefcase) with the six week trial starting the first week of November 2017, resulting in the jury awarding $1.8 million in compensatory damages and $26 million in punitive damages. This verdict was seen as a high note for plaintiff counsel in the Xarelto litigation, after three prior trial losses, in Xarelto MDL 2592 bellwether trials in Louisiana and Mississippi.

The Hartman trial is just one of about 21,400 against Bayer and Janssen pending in federal and state courts blaming injuries on Xarelto, and the first selected for trial from more than 1,400 Xarelto cases pending in the Complex Litigation docket of the Philadelphia court.

Plaintiff trial counsel Michael Weinkowitz, said the decision related to a “very narrow issue related to Mrs. Hartman’s prescribing physician.” He said he looked forward to trying the next series of Xarelto-related cases in Philadelphia. The post trial legal arguments were related to the “learned intermediary doctrine and proximate cause” and was raised by defense in post trial motions and aggressively argued, which plaintiff counsel was unable to overcome in the full day hearing.

The U.S. Food and Drug Administration approved Xarelto in 2011, to be prescribed for people with atrial fibrillation, a common heart rhythm disorder, and to treat and reduce the risk of deep vein thrombosis and pulmonary embolisms, often after implant surgeries.

Plaintiffs in the Hartman trial as well as in thousands of other Xarelto lawsuits, alleged that the drug was unreasonably dangerous and that Janssen (J&J) and Bayer failed to warn patients about a serious risk of uncontrollable, irreversible bleeding in emergencies and were aware of adverse events for a long period of time. These allegations will be argued aggressively by defense in all forthcoming trials, as the defendants do not seem to be willing to bend on their winning trial strategy.

Bayer and Janssen have defended Xarelto’s label stating that the label adequately warns of bleeding risks. After four trials verdicts, all in their favor, defense seems to be using an effective trial strategy that has worked in venues across the country.

The three bellwether trials in the Xarelto MDL 2592, all resulted in defense wins for Bayer and Janssen, with this Philadelphia trial shifting the focus from the federal Xarelto docket to the Philadelphia court and the Hartman trial. What impact the initial plaintiff’s trial win followed by the Judge Erdos reversal this week has on both Xarelto dockets remains to be seen.

 

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The Week In Mass Torts By Mass Tort Nexus for December 18, 2017

 

 

 

 

 

 

 

 

By Mark York, Mass Tort Nexus Media

(December 21, 2017)

New Jersey Supreme Court Review Reinstatement Of Accutane Experts

The New Jersey Supreme Court recently granted petitions and cross-petitions to appeal a state appellate court’s reversal of expert exclusions in the state’s Accutane multicounty litigation and the reinstatement of 2,076 dismissed cases (In Re:  Accutane Litigation, C-388 September Term 2017, C-329 September Term 2017 and C-390 September Term 2017, N.J. Sup.) See Mass Tort Nexus Accutane Briefcase Accutane New Jersey State Court Litigation.

New Trial Denied in 3rd Xarelto MDL Bellwether Case After Defense Verdict

Judge Eldon Fallon, overseeing the Xarelto multidistrict litigation, recently denied a motion for a new trial by the plaintiff in the third bellwether trial, where Bayer was found not liable in the Dora Mingo trial that took place in a Mississippi federal court in front of Judge Fallon. He ruled that plaintiff was unsuccessful in presenting new findings, among other things, that the plaintiff’s “newly discovered evidence” is actually cumulative of previously known and admitted evidence (In Re:  Xarelto [Rivaroxaban] Products Liability Litigation, MDL Docket No. 2592, E.D. La., 2017 U.S. Dist. LEXIS 205422). See Mass Tort Xarelto Briefcase for the entire Mingo trial transcripts as well as full transcripts of the Orr and Boudreaux trials, XARELTO MDL 2592 US District Court ED Louisiana Including Trial Transcripts.

 With Last 2 Cases Gone, Pradaxa MDL Judge Again Recommends Termination

With the final two pending cases now closed, the Illinois federal judge overseeing the Pradaxa multidistrict litigation on Dec. 11 again recommended that the Judicial Panel on Multidistrict Litigation (JPMDL) terminate the MDL (In Re:  Pradaxa [Dabigatran Etexilate]Products Liability Litigation, MDL No. 2385, No. 12-md-2385, S.D. Ill.).  After a global settlement was reached in 2014 with defendant Boehringer Ingelheim Pharmaceuticals Inc., the JPMDL suspended the transfer of tag-along actions into the MDL, and now the judge has moved for termination of the Pradaxa MDL. However, there remains over 700 Pradaxa cases pending in the State Court of Connecticut, Complex Litigation Docket, known as “Connecticut Pradaxa Actions”, see Mass Tort Nexus Pradaxa Case Briefcase,  Connecticut Consolidated Pradaxa Litigation.

Boehringer To Pay $13.5M To End Off-Label Marketing Claims

Drugmaker Boehringer Ingelheim Pharmaceuticals Inc. has agreed to distribute $13.5 million among all 50 states and the District of Columbia to end allegations that it marketed four of its prescription drugs for off-label uses, attorneys general announced Wednesday.
The settlement would resolve allegations that Boehringer marketed its prescription drugs Micardis, Aggrenox, Atrovent and Combivent for uses that weren’t approved by their labels or backed by scientific evidence. (Getty) The settlement, of which New York will receive about $490,000, would resolve allegations that the drugmaker marketed it products for off-label use, which often leads to unknown or studied adverse events and medical complications for patients taking these drugs for unapproved purposes.

 J&J Fined $30 Million Over French Opioid Drug Smear Campaign In Efforts To Sell Fentanyl Patch

France’s antitrust enforcer fined Johnson & Johnson and its Janssen-Cilag unit €25 million ($29.7 million) on Wednesday for hindering the marketing and sale of a generic version of the company’s Durogesic pain patch.The French Competition Authority found that Janssen and J&J had not only successfully delayed a generic competitor for the powerful opioid for several months, but had also done lasting damage by discrediting rival versions of the drug with doctors and pharmacists in a country where medical professionals still remain reluctant to opt for prescribing opioids.  The J&J conduct reflects the same claims being asserted against opioid drug makers in the US, where lawsuits have been consolidate into Opiate Prescription Litigation MDL No. 2804, in the US District Court of Ohio, see Mass Tort Nexus Opioid Crisis Briefcase, OPIOID CRISIS MATERIALS INCLUDING: MDL 2804 OPIATE PRESCRIPTION LITIGATION.

11th Circuit Affirms Pelvic Mesh Group Trial, Exclusion Of 510(k) Status

(October 24, 2017, 1:25 PM EDT) -The 11th Circuit U.S. Court of Appeals on Oct. 19 said multidistrict litigation court judge did not err in consolidating four pelvic mesh cases for a bellwether trial and in excluding the so-called 510(k) defense raised by defendant Boston Scientific Corp. (BSC) (Amal Eghnayem, et al. v. Boston Scientific Corporation, No. 16-11818, 11th Cir., 2017)   See Mass Tort Nexus Mesh Case Briefcase, All Pelvic Mesh Litigation Case Files.

Preemption Summary Judgment Reversed By 9th Circuit In Incretin Mimetic MDL Appeal

The Ninth Circuit U.S. Court of Appeals on Dec. 6 unsealed its Nov. 28 opinion reversing summary judgment in the incretin mimetic multidistrict litigation, saying the MDL judge misapplied a U.S. Supreme Court precedent, improperly blocked discovery, misinterpreted what constituted new evidence and improperly disqualified a plaintiff expert (In Re:  Incretin-Based Therapies Products Liability Litigation, Jean Adams, et al. v. Merck Sharp & Dohme Corp., et al., No. 15-56997, 9th Cir., 2017 )

Pennsylvania Appeals Court Affirms $29.6M Remitted Zimmer Knee Judgment

A Pennsylvania appeals court panel on Dec. 15 said a trial judge did not err when remitting a Zimmer Inc. knee verdict to $29.6 million and said it declined to substitute its judgment in place of the jury’s (Margo Polett, et al. v. Public Communications, Inc., et al., No. 80 EDA 2017, Pa. Super., 2017 Pa. Superior Court)

Risperdal Gynecomastia Cases Barred By Michigan Shield Law, Pennsylvania Panel Says

A Pennsylvania state appeals panel on Nov. 28 affirmed the dismissal of 13 Risperdal gynecomastia cases, agreeing with a trial judge that the plaintiffs’ claims are preempted by Michigan’s drug shield law and that the plaintiffs could not prove that the fraud exception

applied to their claims (In Re:  Risperdal Litigation versus Janssen Pharmaceuticals Inc., et al., No. 55 EDA 2015, et al., Pennsylvania Court of Appeals, 2017.

U.S. Supreme Court Asks Solicitor General To Weigh In On Fosamax Preemption

The U.S. Supreme Court on has invited the U.S. solicitor general to express the views of the United States on whether there is “clear and convincing evidence” that the Food and Drug Administration would have rejected a stronger warning about femur fractures from the osteoporosis drug Fosamax (Merck Sharpe & Dohme Corp. v. Doris Albrecht, et al., No. 17-290, U.S. Supreme Court)  This is a unique turn when the Supreme Court is seeking input from an outside agency in what is now a common legal issue placed in front of the court, where dug makers are using the FDA regulatory process as a shield in defending thousands of claims where warnings of drug dangers are not clear or not provided. See Mass Tort Nexus Fosamax Case Briefcase, FOSAMAX MDL 2243 (FEMUR FRACTURE CLAIMS).

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WEEKLY MDL UPDATE by MASS TORT NEXUS for Week of November 13, 2017

The week in mass torts around the country:

By Mark York, Mass Tort Nexus (November 16, 2017)

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MASS TORT NEXUS

 Verdicts on November 16, 2017: 

J&J gets hit hard again, in a $247 million Pinnacle hip implant verdict, DePuy Orthopaedics Pinnacle Implant MDL 2244, in bellwether trial of 3:15-cv-03489 Alicea et al v. DePuy Orthopaedics Inc et al. (DePuy Pinnacle Hip Implant MDL 2244 Briefcase)

Drug maker Auxilium won a defense verdict in their Testim product bellwether trial, where plaintiffs claimed it caused a heart attack in a verdict reached in the US District Court Northern District of Illinois, Judge Kennelly, in MDL 2545 Testosterone Replacement Therapy. (Testosterone Therapy MDL 2545 USDC ND Illinois)

Johnson & Johnson Wins a Defense Verdict in Los Angeles Court Talcum Powder Mesothelioma Trial, Jury Finds J&J Not Liable in Tina Herford et al. v. Johnson & Johnson Case number BC646315, consolidated in LAOSD Asbestos Cases, case number JCCP4674, in the Superior Court of the State of California, County of Los Angeles.  (J&J Talcum Powder Cancer Litigation Briefcase)

Senator Bob Menendez  judge declares a mistrial in New Jersey federal court trial, after a hung jury cannot agree unanimously on charges. Question is- Are the Senator and his doctor friend in Florida, just that-were they just friends or was there active bribery taking place?

Recent Case Updates:

>Plaintiff in DePuy Pinnacle Hip Implant Trial Asks Texas Jury For A Hundred Million + In Punitive Damages

At the close of arguments in the latest DePuy MDL 2244 trial on Monday November 13, 2017, six New York plaintiffs asked a Texas federal jury to hit Johnson & Johnson and it’s DePuy subsidiary, with at least a nine-figure punitive damages award. Attorneys asked that J&J and DePuy be punished for making and marketing their Pinnacle model hip implants, an alleged defective line of metal-on-metal hip implants, that have caused many thousands of injuries to unsuspecting patients. If this jury follows suit on prior Pinnacle bellwether jury awards, then J&J and DePuy should be ready for a massive verdict, as the last jury awarded California plaintiffs over one billion dollars in December 2016, sending a clear message that the company’s Pinnacle design and subsequent marketing policies have failed.

METALLSOIS DAMAGE

Closing arguments wrapped up on the two-month bellwether trial, where plaintiffs claimed they suffered “metallosis” which caused tissue damage and negative reactions to the Pinnacle Ultamet line of metal-on-metal hip implants made by J&J’s DePuy Orthopaedics Inc. unit. Depending on the jury verdict, perhaps J&J will consider coming to the settlement table if another massive verdict is awarded, or they may continue the aggressive “we’ve done no wrong stance” resulting in more plaintiff verdicts in the future..

 >Travelers Insurance Wins Declaratory Judgment Suit Over Defense Coverage In Orange County and Chicago Opioid Lawsuits:

“California Appeals court says Watson not covered”

Watson Pharma, Inc. and it’s parent Activis, Inc. were denied insurance coverage in a November 6, 2017 ruling by the California State Court of Appeals in the 2014 Declaratory Judgment action filed by Travelers Insurance in an Orange County, CA court where Travelers successfully asserted claims that they were not required to defend or indemnify Watson in the underlying opioid based litigation filed by Santa Clara and Orange County against opioid manufacturers, due to Watson’s “intentional bad conduct” in their business practices related to sales and marketing of it’s opioid products. The Appeals Court also excluded Watson’s coverage in a similar opioid lawsuit against them in a Chicago, Illinois federal case where the City of Chicago filed similar claims against Watson over opioid marketing abuses in 2014. Perhaps other insurance carrier will take notice and look closer at denying policy coverage for many other opioid manufacturers who have been sued across the country in cases with almost the exact claims as those alleged by Santa Clara County and the City of Chicago.

>NEW XARELTO TRIAL:

Former FDA Commissioner Testifies in Philadelphia Xarelto Trial-

“Xarelto Warnings Are Inadequate”

— Former head of the Food and Drug Administration, Commissioner David Kessler testified during the first state court trial in Philadelphia, telling the jury on Tuesday that “warning labels for the blood thinner Xarelto failed to provide adequate information to doctors and consumers about the risk of bleeding that some patients could face when using the drug”.

David Kessler, FDA Commissioner under President George H.W. Bush and President Bill Clinton, told jurors that Bayer AG and Johnson & Johnson’s warning labels for the medication understated the risk of significant bleeding events that had been seen in television and print ads across the country for years, and failed to disclose the true risks associated with prescribing the blockbuster drug. This trial, expected to take six weeks, is the first state court bellwether trial for the blood thinner Xarelto, in the Philadelphia Court of Common Pleas, the prior trials took place in federal courts in Louisiana and Mississippi where the defense prevailed in all 3 trials earlier this year. Those trials were all bellwether trials, as part of the Xarelto MDL 2592 in front of Judge Eldon Fallon, US District Court, ED Louisiana. Will the change of venue to Pennsylvania State Court have a different outcome than the three prior Xeralto trial losses?

>Luzerene County, Pennsylvania Files RICO Suit Over Opioid Marketing Against Drug Makers

Luzerne County in Northeast Pennsylvania has filed a federal RICO based lawsuit accusing pharmaceutical companies including Purdue, Pharma, Endo, Janssen and Teva of violating the Racketeer Influenced and Corrupt Organizations Act by illegally marketing highly addictive painkillers that have contributed to a costly national opioid epidemic. The suit filed in US district Court of Pennsylvania by Luzerne County is one of many cases opioid drugmakers and distributors are facing as state and local governments seek to recoup costs they’ve incurred in the increased marketing and prescribing of opioid painkillers, and the resultant spikes in addiction and overdose.

OPIOID MARKETING ABUSES

“The manufacturers aggressively pushed highly addictive, dangerous opioids, falsely representing to doctors that patients would only rarely succumb to drug addiction,” the complaint, which was filed on Wednesday, said. “These pharmaceutical companies … turned patients into drug addicts for their own corporate profit.”
“The lawsuit accused the drugmakers of using false and deceptive marketing practices over the course of the last two decades, including pushing the opioid painkillers for treatment of chronic pain, to boost prescriptions for the drugs

COMMON CLAIMS AGAINST ALL OPIOiD MAKERS

Among the companies’ primary claims, cited by Luzerne county and others, evidence the manufacturers intentionally misled consumers, was that the drugs were not addictive when prescribed to treat legitimate pain. This is one of the key claims used by all parties filing suit against the opioid manufacturers, across the entire country.

Case heading is: Luzerne County v. Purdue Pharma LP et al., case number 3:17-cv-2043, in the U.S. District Court for the Middle District of Pennsylvania.

>Opioid Litigation Roundup: An Overview Of Recently Filed Cases and MDL 2804

In addition to the many counties and other communities from across the country that have filed lawsuits against opioid manufacturers in MDL 2802, set for a JPML consolidation hearing November 30, 2017 a new group of plaintiffs have joined the increasing pool of parties filing suit against Big Pharma opioid manufacturers and their distributors. Unions are now joining in the suits alleging that the business practices of the opioid makers and distributors caused catastrophic healthcare and related labor problems everywhere in the country over the last 15 years. Locals from the Electrical Workers; Commercial Food Service and Teamsters are now plaintiffs in the MDL 2804, which if approved at the upcoming JPML hearings in St Louis, will probably cause a flood of additional filings by unions across the country.

State attorneys general, a Native American tribe and individual consumers are among the ever increasing pool of plaintiffs who’ve brought lawsuits against drugmakers, pharmacies and distributors allegedly responsible for epidemic levels of opioid abuse. As word spreads among the network of local governments, and discussion take place about the municipal opioid lawsuits being filed, there will be a flood of new complaints filed, that will match or exceed the number of cases filed in the massive “Tobacco Litigation” which is quickly gaining comparison as the opioid case filings are looking to be comparable in size and probably exceed the tobacco litigation in damages.

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Nuedexta: The Drug Being Pushed “Off-Label” On The Elderly In Nursing Homes

“PROFITS OVER PATIENTS IN THE HEALTHCARE INDUSTRY CONTINUES“

By Mark A. York (October 19, 2017)

Mass Tort Nexus

Avanir Pharmaceuticals, the maker of Nuedexta, a prescription drug approved to treat a rare neurological condition is earning hundreds of millions of dollars a year  by aggressively targeting elderly nursing home residents in “off-label” use, for whom the drug may be unnecessary and now recognized as unsafe. Off-label use is when a company offers and markets a drug for reasons other than what it was initially approved for by the FDA.

The vast majority of the “off-label” related payments to nursing homes are coming straight from the federal government.

 

 

 

 

 

 

 

The pill, called Nuedexta, (dextromethorphan hydrobromide and quinidine sulfate), is approved to treat a disorder marked by sudden and uncontrollable laughing or crying — known as pseudobulbar affect, or PBA. This condition afflicts less than 1% of all Americans, based on a calculation using the drugmaker’s own figures, and it is most commonly associated with people who have multiple sclerosis (MS) or ALS, also known as Lou Gehrig’s disease.

Nuedexta’s financial success, however, is being propelled by a sales force focused on expanding the drug’s use among elderly patients suffering from dementia and Alzheimer’s disease, and high-volume prescribing and advocacy efforts by doctors receiving payments from the company.

An example is a nursing facility patient, Lenore Greenfield was diagnosed with PBA and prescribed Nuedexta by California psychiatrist Romeo Isidro, a physician who has received hundreds of thousands of dollars in promotional payments from Avanir.

Since 2012, more than half of all Nuedexta pills have gone to long-term care facilities. The number of pills rose to roughly 14 million in 2016, a jump of nearly 400% in just four years, according to data obtained from QuintilesIMS, which tracks pharmaceutical sales with total sales of Nuedexta reaching almost $300 million that year.

NUEDEXTA OFF-LABEL” USE UNDER REVIEW

Nuedexta is being increasingly prescribed in nursing homes even though drugmaker Avanir Pharmaceuticals acknowledges in prescribing information that the drug has not been extensively studied in elderly patients — prompting critics to liken its use to an uncontrolled experiment. The one study the company conducted solely on patients with Alzheimer’s (a type of dementia) had 194 subjects and found that those on Nuedexta experienced falls at more than twice the rate as those on a placebo.

Avanir declined repeated requests to be interviewed for this article. In an emailed statement, the company said PBA is often “misunderstood” and that the condition can affect people with dementia and other neurological disorders, which are common among residents in long-term care facilities. A company website states PBA can afflict up to roughly 40% of dementia patients — a figure that is based on an Avanir-funded survey and was repeatedly disputed by medical experts, including some of those paid by Avanir.

Nuedexta is approved by the Food and Drug Administration (FDA) to treat anyone with PBA, including those with a variety of neurological conditions such as dementia. But geriatric physicians, dementia researchers and other medical experts told CNN that PBA is extremely rare in dementia patients; several said it affects 5% or less. And state regulators have found doctors inappropriately diagnosing nursing home residents with PBA to justify using Nuedexta to treat patients whose confusion, agitation and unruly behavior make them difficult to manage.

“There has to be a diagnosis for every drug prescribed, and that diagnosis has to be real … it cannot be simply made up by a doctor,” said Kathryn Locatell, a geriatric physician who helps the California Department of Justice investigate cases of elder abuse in nursing homes. “There is little to no medical literature to support the drug’s use in nursing home residents (with dementia) — the population apparently being targeted.”

There are now confirmed instances of dozens of cases across the country since 2013 in which state nursing home inspectors questioned the use of Nuedexta.

In a Los Angeles nursing home last year, regulators found that more than a quarter of its residents — 46 of 162 — had been placed on Nuedexta, noting that a facility psychiatrist had given a talk about the drug to employees. This psychiatrist was a paid speaker for Avanir.

At another facility in 2015, also in Southern California, an employee admitted to inspectors that a resident had been given a diagnosis of PBA to “somehow justify the use” of Nuedexta, even though its intended purpose was to control the resident’s “mood disturbances” and yelling out.

And an Ohio doctor paid by Avanir has come under government investigation for allegedly receiving kickbacks for prescribing the drug and fraudulently diagnosing patients with PBA in order to secure Medicare coverage — though the doctor has denied any wrongdoing.

The federal government foots the bill for a big portion of the money being spent on Nuedexta in the form of Medicare Part D prescription drug funding, for people 65 and over and the disabled. In 2015, the most recent year for which data is available, this Medicare program spent $138 million on Nuedexta — up more than 400% from just three years earlier.

Medicare is supposed to pay for drug uses that have been proven safe and effective for the population they are intended to treat or that have been otherwise supported by a specific collection of medical research. Nuedexta is currently only approved by the FDA for patients who have PBA. So experts say that Medicare coverage of the drug, which has been crucial to its financial success, relies on the diagnosis of this single condition. So-called “off-label” prescribing, in which doctors use the drug to treat patients who have not been diagnosed with PBA, would typically not be covered, however there is a massive trend in Big pharma the last few years to increase revenues by pushing off-label” use in most every drug in major pharmaceutical maker inventories.

The Centers for Medicare & Medicaid Services (CMS) declined to comment on the growing use of Nuedexta in nursing homes.

Thousands of the doctors prescribing Nuedexta have received money, or at least a meal, from its maker — a legal but controversial practice in the industry. Between 2013 and 2016, Avanir and its parent company, Otsuka, paid doctors nearly $14 million for Nuedexta-related consulting, promotional speaking and other services, according to government data. The companies also spent $4.6 million on travel and dining costs, both for speakers and for doctors being targeted by salespeople.

Research has shown thata that nearly 50% of the Nuedexta claims filed with Medicare in 2015 came from doctors who had received money or other perks from the company (ranging from a few dollars’ worth of food or drink to hundreds of thousands of dollars in direct payments).

Pharmaceutical companies are allowed to pay a doctor to promote a drug to colleagues and other medical professionals. It is illegal, however, for doctors to prescribe the drug in exchange for kickback payments from a manufacturer.

Several of these paid advocates of Nuedexta argue that PBA manifests differently depending on the person. With dementia patients, they say, the typical crying or laughing outbursts seen in multiple sclerosis patients may be absent. Instead, symptoms may include moaning, wailing, hitting a wheelchair over and over again or repeating the same phrase. And they are adamant that the medication can be life-changing for patients, touting how safe and benign it is.

“I never hear, ‘hey doc, we put a patient on this and had really bad side effects,'” said Jason Kellogg, a geriatric psychiatrist who sees patients at nursing homes across California. Kellogg has received $612,000 in payments, meals and travel from Avanir and its parent company between 2013 and 2016, according to government data. He was a top Medicare prescriber for the drug in 2015, the most recent year for which data is available.

Kellogg, who said he was involved in early company testing of the drug for PBA, said Nuedexta is “such a blessing in psychiatry.”

“In our treatments, we don’t have many meds that are well tolerated, and I would hate if someone took that away from me,” he said.

CONCERN BY DOCTORS RAISED DURING FDA APPROVAL

During the FDA approval process, two key doctors on the committee raised concerns about Nuedexta being used for PBA in Alzheimer’s patients. They both strongly recommended that Nuedexta only be approved for PBA in patients with MS or ALS. They argued that evidence it would be effective in other conditions was “weak,” that not enough was known about the safety of the drug in the elderly, and that it was unclear that PBA even existed in Alzheimer’s patients. Despite these concerns, the agency approved Nuedexta in 2010 for treating PBA in patients who have neurological conditions such as dementia.

Soon after Nuedexta hit the market in 2011, doctors, nurses and family members began filing reports of potential harm — ranging from rashes, dizziness and falls to comas and death. Nuedexta was listed as a “suspect” medication in nearly 1,000 so-called adverse event reports received by the FDA detailing side effects, drug interactions and other issues, CNN found. While the FDA uses these voluntary reports to monitor potential issues with a drug, a report does not mean that a suspected medication has been ruled the cause of the harm.

The FDA declined to comment on these adverse events or the concerns raised about Nuedexta during the approval process. But it did say that after any drug is approved, the agency continues to review safety information from a variety of sources (including adverse event data) and will take action as needed — such as updating a medication’s label, restricting its use or even taking it off the market entirely.

USC DIRECTOR WARNING

Lon Schneider, director of the University of Southern California’s California Alzheimer’s Disease Center, reviewed information from roughly 500 of the reports through a Freedom of Information Act request. Schneider, a physician specializing in geriatric and dementia care, said he was concerned about the problems stemming from potential interactions between Nuedexta and other powerful medications intended to treat problematic behaviors.

He warned that given how medicated the elderly typically are, adding just one more pill — especially one that hasn’t been extensively tested — could be dangerous.

REPORTS TO FDA BY MEDICAL PROFESSIONALS

One report filed by a nurse practitioner in 2015 detailed the rapid decline of an 86-year-old Alzheimer’s patient after Nuedexta was added to the psychotropic medications she took including Zoloft (an antidepressant), Xanax (an antianxiety drug) and Risperidone (an antipsychotic). Nuedexta had been prescribed to treat PBA and “weeping with underlying Alzheimer’s dementia.”

Almost immediately, the woman experienced weakness and fatigue to the point that she was barely able to talk and was described as being “almost unresponsive.” The dose of Nuedexta was increased, and her symptoms worsened. The drug was discontinued about a week later, but she failed to recover. She remained unable to eat or drink and her kidneys failed — ultimately leading to her death.

“The patient seemed to be doing fine,” the nurse practitioner reported, “until she was placed on Nuedexta.”

AGGRESSIVE SALES FORCE

The combination of two generic drugs that makes up Nuedexta — a cough suppressant and heart medication — was once available from specialty pharmacists willing to combine the ingredients for less than $1 a pill, according to a US Senate report on rising prescription drug prices.

Now the FDA-approved medication costs as much as $12.60 a pill, wholesale pricing data from First Databank shows. That can add up to more than $9,000 a year, though the amount a patient actually pays depends on factors including individual insurance coverage. Medicare Part D spending on the drug averaged $3,400 per patient in 2015.

It is Avanir’s main product and biggest moneymaker. It has gained attention with the public through its television commercial featuring actor Danny Glover seesawing between laughter and tears. And it was this drug’s financial potential that attracted Japanese pharmaceutical giant Otsuka to the boutique California firm, purchasing Avanir for $3.5 billion several years ago. Otsuka declined to comment for this story.

Avanir investor documents have stated that only a small fraction — 100,000 of the 1.8 million patients suffering from moderate to severe PBA — live in long-term care facilities. Yet the company has described nursing homes as key to its growth.

On a 2013 earnings call, Rohan Palekar, a top executive who eventually became CEO but is no longer with the company, said Avanir had “just scratched the surface of its full potential” in nursing homes, according to an online transcript. He said the company aimed to get Nuedexta prescribed in far more facilities. Palekar did not respond to requests for comment.

To rack up these prescriptions, salespeople identified doctors, nurses and pharmacists who could serve as advocates for the drug, according to interviews with former Avanir employees and internal documents and emails reviewed by CNN. Salespeople then worked closely with these advocates to identify potential patients. In one case, a salesperson worked with a doctor’s office manager to pull patients’ charts, identify those who should be screened for PBA and make sure that Nuedexta brochures were inserted in their files. The sales force also coached doctors and facility employees on how to fight for Medicare coverage of the drug if it was initially refused.

Federal laws restrict the tactics pharmaceutical sales representatives can use to sell a medication. They can’t give favor or payments in exchange for a doctor prescribing the drug. They can’t have any contact with private patient records, without the patient’s consent. And they can’t promote use of a drug off-label, in a way that hasn’t been approved by the FDA.

Internal company emails have shown a culture filled with intense pressure to get the drug sold and how Avanir sales representatives were encouraged to directly target dementia and Alzheimer’s patients — a practice which is legal as long as these patients also had PBA.

In an email from several years ago, one of the company’s regional managers, Kevin Tiffany, bluntly urged his salespeople to spend “99.9 percent” of their time focused on such patients.

Devoting time to other conditions more commonly associated with PBA amounted to “diluting your chances,” wrote Tiffany, a senior sales manager in California.

“Give yourself the best chance to win,” Tiffany added.

Tiffany, who no longer works for Avanir, declined to comment through an attorney.

Other emails from managers show how the government’s crackdown on dangerous antipsychotic drugs — which were once widely used to control unruly and erratic behavior in nursing home patients — created an opportunity for Avanir.

After receiving the FDA’s most severe “black box” warning for an increased risk of death in elderly dementia patients, antipsychotics are now closely monitored by government regulators, who penalize and lower the ratings of facilities that overuse them. Internal company communications show Avanir salespeople were directed to specifically target facilities that historically used high levels of antipsychotic medications — facilities that would see Nuedexta as an attractive alternative.

Some of these tactics employed by Avanir salespeople cross into ethical gray areas, said medical ethicists and other experts who were read the emails and sales training documents or provided with details from them.

“It definitely feels like it is too much in the business of prescribing and not in the business of conveying information,” said Michael Santoro, a Santa Clara University professor and an expert in pharmaceutical industry ethics.”It feels like (the salespeople) are actually participating in the prescribing decision.”

In its statement, Avanir said that the company was committed to “an ethical culture,” uses methods “that are consistent with the law” and that its goal is “to give doctors truthful, accurate and balanced information so they can decide on the proper treatment for their patients.”

Avanir executives have long touted plans for securing FDA approval for Nuedexta’s use to treat dementia patients who don’t have PBA — setting their sights on the more widespread condition of agitation in dementia and Alzheimer’s patients, characterized by emotional and physical outbursts and restless behaviors. The company announced clinical trials for testing a version of the medication for this use in 2015, but those have not yet been completed. Without additional FDA approval for the drug’s use in those conditions, salespeople cannot promote Nuedexta for that purpose. They can only market its use for dementia patients who also have PBA.

There are currently no FDA-approved drugs for treating dementia-related agitation, and other drug makers have been penalized for marketing drugs for this use. Abbott Laboratories Inc., for instance, pleaded guilty in 2012 to illegally marketing an anticonvulsant called Depakote in nursing homes as a way to control agitated and aggressive dementia patients. But the drug had only been approved for treating seizures, bipolar disorder and migraines. The company ultimately paid a total of $1.6 billion in civil and criminal penalties.

Those who care for the elderly remain eager for tools to manage these behaviors, however. Some caregivers say investments in increased staffing can reduce the need for medications. But such measures are expensive and don’t always work, so some facilities opt for pharmaceutical solutions that can help make their many patients easier to treat.”Rather than taking someone off an antipsychotic” and opting to treat the patient in ways that don’t require medication, “providers search for a different ‘magic bullet,'” said Helen Kales, a geriatric psychiatrist and University of Michigan professor.

NURSING FACILITIES PUSHED “OFF-LABLE” USE

In one case, the executive director of a California assisted living facility tried to push Nuedexta on a dementia patient to address her “aggressive” behavior, according to emails reviewed by CNN. The director at the facility, Oakmont of Mariner Point in Alameda, California, told the patient’s son, Jason Laveglia, that the medication wasn’t an antipsychotic and threatened to evict his mother if she wasn’t put on the medication.

“(I)f her behavior cannot be muted through prescription means, I would have no choice but to pursue delivering a 30-day eviction notice,” Joan Riordan wrote to Laveglia last year.

Laveglia turned to the state for help, and by the time officials investigated weeks later, Riordan no longer worked at the facility. Social service officials ultimately found that her eviction attempt had violated state law. A spokesperson for the facility would not comment on the state’s findings, but said it “does not endorse or recommend Nuedexta nor any other medication” and that staff should not be involved in medical decisions.

Riordan disputed the idea that her emails served as an official eviction notice. Riordan, who is not a doctor, said that she had recommended Nuedexta after learning about the medication from a local psychiatrist and had seen it help a number of other aggressive dementia patients without the dangers and sedative effects of an antipsychotic.

“I’ve seen it just work wonders with people,” she said. “It was the only intervention I could come up with. We needed to do something not only for her own benefit, but also for the people around her.”

When asked whether her residents had PBA, Riordan told CNN she had never heard of the condition and had no knowledge of whether they had received such a diagnosis.

RED FLAGS RAISED

Across the country, the use of Nuedexta in nursing homes has prompted concerns among state regulators whose job is to ensure adherence to federal guidelines and protect residents from being given unnecessary drugs — especially those used as chemical restraints. But to date, the red flags raised by these regulators have been largely left buried in nursing home inspection reports and have drawn little public attention.

There have been more than 80 cases in 19 states since 2013 where inspectors cited nursing homes for inappropriate monitoring and use of Nuedexta — often because residents hadn’t exhibited any symptoms of PBA. Many of the cases — about 40% — were clustered in Southern California, where Avanir is based and where former employees said there has been aggressive marketing.

At the Montrose Healthcare Center near Los Angeles, three nursing home residents were given Nuedexta without a doctor’s prescription or approval, according to one inspection report. All were cognitively impaired. One was known to call out for help, while another would cry when their family left the facility. But employees acknowledged that they had never seen the residents laugh or cry involuntarily — the hallmark indicators of PBA.

Regulators learned of these prescriptions in 2015, after a family member discovered that her relative was receiving Nuedexta without her consent. While researching the medication, she learned it could be dangerous for her family member because of other medications she took for a serious heart condition.

The doctors for all three residents denied ever prescribing Nuedexta. State investigators later discovered nursing staff had obtained the prescriptions without a doctor’s approval, which they are not authorized to do. They also found that at least two nurses at the facility had attended a sales seminar about Nuedexta, where they were given a doctor’s sample prescription for the medication. The facility said in a statement that it had addressed the concerns raised by the state inspection report and suggested that outside pressure had been at play.

“Our Center does not condone the pressuring of nurses by pharmaceutical reps and physicians to favor certain medications,” the facility said. “Should they feel pressured to administer medications they do not feel are appropriate, our nurses can and should bring it to our immediate attention so we may assist them in advocating for their patients.”

In New Jersey, St. Vincent’s Healthcare and Rehab Center was cited by regulators last year because six residents were prescribed Nuedexta even though no symptoms of PBA had been documented. A representative of the facility has now stated “we take a close look at all medications prescribed to ensure appropriate use.”

DRUG TREATMENT NOT NEEDED

One resident in the report told the facility’s psychiatrist there was a legitimate reason for their sadness: “All I really want is a companion. I am lonely.” In the case of another resident given the medication, a nurse said the resident’s crying was an expression of frustration, and that this had improved with a change in routine.

Two other residents at the facility were originally prescribed Nuedexta for “Dementia with Behaviors.”

Those diagnoses were then crossed out or rewritten — replaced with “PBA.”

THE DRUG PUSHERS

At first, Alex Carington couldn’t figure out why her 85-year-old mother, Lenore Greenfield, was on Nuedexta, a pill Carington had never heard of. A psychiatrist had prescribed the medication after visiting the elderly woman in her Los Angeles nursing home while she was sleeping, Carington said. Even when the drug appeared to do nothing to ease her mother’s sadness, confusion or emotional outbursts as she battled dementia, she said the doctor kept her on it.

 

 

 

 

 

 

Alex Carington’s mother, now 88, is no longer on Nuedexta and lives at a new nursing home. But Carington still questions why she was prescribed the pill in the first place.

“Something about this whole thing made me think money was behind it,” Carington, who lived near her mother’s facility and visited her often, wrote at the time in an online comment on the blog of a psychiatrist who had questioned Nuedexta’s aggressive advertising.

As she began to look into her mother’s doctor, she discovered he had received more than $100,000 from Avanir in just over a year.

Outraged, she finally got her mother taken off Nuedexta for good. Now, around two years later, she is in a new nursing home and Carington believes she is doing much better.

Her mother’s doctor was Romeo Isidro, a speaker for Avanir and one of the physicians paid the most by the drugmaker. Between 2013 and 2016, Isidro received more than $500,000 in payments, travel and meals from Avanir and its parent company. According to internal company documents, he was an advocate for Nuedexta as early as 2012, the year after it hit the market.

ISIDRO HAD 100 PATIENTS AT 11 FACILITIES ON NUEDEXTRA

In Avanir training documents, a California salesperson explained how he worked to get Isidro to prescribe Nuedexta. Now a senior sales manager at the company, Chris Burch wrote in 2012 that he and his colleague saw or spoke to Isidro about twice a week — regularly calling and texting him, and visiting him at both his office and nursing homes. Burch wrote that Isidro was at first skeptical about the condition of PBA, but after he successfully used Nuedexta to treat possible symptoms of it in one patient, he became more comfortable prescribing the medication. Burch then explained how he had directly targeted facilities where Isidro worked, finding employees who could serve as “advocate(s)” to help identify potential Nuedexta candidates for Isidro.

SALES MANAGEMENT CAMPAIGN

“He is now a speaker and I ask him to advocate in his facilities, corporate facilities, and (to) other psychiatrists, internists and pharmacies,” Burch, who did not respond to requests for comment, wrote in a form used by the company to track certain prescribers.

Attempts to contact Dr. Isidro directly were by phone and at his office, where investigators saw two stacks of PBA and Nuedexta pamphlets sat on a table in the waiting room. He declined to be interviewed but ultimately provided a written statement saying that he had “never prescribed medication for financial incentives” and that he prescribes Nuedexta to patients who he has properly diagnosed with PBA.

He also wrote about the first success he had seen with the drug, and how it helped him wean an elderly patient off of dangerous psychotropic medications — noting that her inappropriate crying and screaming symptoms reminded him of a visit from a Nuedexta representative who had told him about PBA. He said Avanir approached him about becoming a speaker, and that he agreed in order to share his first-hand experience with the medication — not to promote it.

“Since learning about PBA, I have become more skilled at recognizing it in my patients, which would in turn produce increased numbers of patients on Nuedexta,” he wrote. “I am not an advocate for a particular drug or pharmaceutical companies. I am an advocate for my patients and their families.”

In response to questions about Carington’s mother, he said he couldn’t comment on specific patients but that memories are not “infallible.” He urged third parties to substantiate any claims with medical records about her case. Ms. Carington has provided her mother’s records to invesitigators, which confirmed that Isidro had diagnosed her with PBA and prescribed her Nuedexta, which she remained on for months.

 

 

 

 

 

 

A PHARMACIST PUSHING OFF-LABEL USE FOR FEES

A different speaker paid by Avanir, a pharmacist in northern California, appeared to suggest during a 2012 presentation that doctors could broaden the use of Nuedexta when prescribing, according to an audio recording obtained by CNN. A person in attendance, who recorded the event, identified the pharmacist as Flora Brahmbhatt.

“I’m definitely pushing this a little bit, perhaps considered off label … but maybe it’s effective on some of the other behaviors too that we find challenging,” the pharmacist said in her presentation, which was sponsored by Avanir. “There are certain nursing home chains, specifically in Southern California, that are saying, ‘Hey, if you have somebody with dementia that has a behavior issue, try them on Nuedexta before you put them on a psychotropic (medication.)’ It’s a little aggressive, I’ll say that. But CMS isn’t making it easy for us to use antipsychotics anymore.”

She went on to discuss how a PBA diagnosis was essential for the medication to be “covered by insurance and not be off-label,” as well as how PBA’s definition of inappropriate laughing and crying could be interpreted by physicians. At one point, she told an Avanir employee in the room that they could cover their ears.

Followed by “We don’t have anybody from the FDA in here. I’m telling you … you can extrapolate that to mean any kind of socially inappropriate behavior when you’ve ruled out other causes,” she said. “If they have an episodic behavior and they have an underlying neurological condition, you can pretty much come up with a diagnosis.”

When she was contacted about the event and asked about the recorded statements, Brahmbhatt said she hadn’t given presentations about Nuedexta for many years. She said she didn’t give permission to be recorded and didn’t recall making those statements. “I don’t know if I said this stuff,” she said. “It was five years ago, at best.” She was read several of the quotes from the recording but declined to listen to it. An attorney representing Brahmbhatt has said that Brahmbhatt denies making the statements in the audio recording. This is normal operating procedure for someone who’s discovered to be promoting off-label” use, they klawyer up and wait to see if there’s an invesitigation.

Former FDA investigator Larry Stevens, who now works for the consulting firm The FDA Group, said it is a violation of federal law for a paid speaker to promote a drug for anything other than its FDA-approved use.

Yet another paid speaker, the Ohio physician accused of accepting kickbacks in exchange for prescribing Nuedexta, has been under government investigation. Internal Avanir documents show Cleveland neurologist Deepak Raheja was a top prescriber of the drug from the beginning, in 2011. Between 2013 and 2016, he received $289,000 in payments, meals and travel.

In addition to allegedly accepting kickbacks, Raheja is accused of fraudulently diagnosing patients with PBA in order to secure Medicare coverage for off-label use and increasing dosages of Nuedexta beyond what is recommended, according to a letter obtained by CNN. The letter, circulated by the Centers for Medicare & Medicaid Services (CMS) in January, alerted insurance providers that work with Medicare about the fraud allegations so that they could take “appropriate measures.”

Medicare officials said the agency could not comment on pending or active investigations. When contacted by CNN, Raheja denied that he had received kickbacks or been involved in any kind of Medicare fraud in his 25 years of practice. Raheja also said he no longer prescribes Nuedexta.

This is another article in the ongoing Mass Tort Nexus series of strategic “Off-Label” marketing by Big Pharma and other healthcare industry companies, putting profits over patients.

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“THE OPIOID CRISIS IN AMERICA” – How Insys Theraputics, Inc. Sold Stock And Killed Americans At The Same Time With The Help Of Doctors

A REPORT BY MASS TORT NEXUS 

by Mark A. York ( September 26, 2017)

 

 

 

 

 

 

 

 

 

Subsys – an Insys Therapeutics, Inc. Pharmaceutical Opioid Product

      Here’s a perfect example of how corporate greed and licensed medical providers helped create the now rampant US opioid crisis– how payments to doctors and prescribers across the country caused addictive painkillers, like “Subsys” a fentanyl based opioid, to suddenly rip through our country like a flash fire.

Insys Therapeutics,a publicly traded pharmaceutical company based in Arizona, is just one small example of what Big Pharma has been doing for the last 10 years in every city and state in the United States, often increasing corporate earnings right alongside the catastrophic opioid related death rates. For Insys Theraputics executives, the sales team and its nationwide cadre of fraudulent doctors, the results have been felony indictments and long federal prison sentences, with many more to come.

INSYS EXECUTIVES INDICTED

December 2016 saw Insys Therapeutics CEO Michael Babich and five other senior executives indicted on criminal charges for paying kickbacks and bribes to medical professionals and committing fraud against insurance companies across the country for offering a highly addictive Fentanyl prescription product “Subsys” to the masses. The Insys boardroom was indicted in the US District Court of Massachusetts, where the entire team has engaged a stable of top national law firms to defend the indictments. The “Subsys” sales teams were charged in federal indictments across the country, including Arkansas, Connecticut, Alaska and New York and the indictments will only increase as those cases proceed and “cooperating witnesses” decide that prison isn’t an option.

To compound further harsh scrutiny for Insys, it’s new CEO Saeed Motahari, moved over from Purdue Pharmaceuticals, the Oxycontin maker, who’s also a major target of criminal and civil investigations across the country by local state and federal agencies. Purdue is charged with false marketing, off-label use and ignoring the Oxycontin highly addictive dangers for years, while bringing in literally billions of dollars in profits, but Purdue’s transgressions are in Part 2 of our ongoing reports on big pharma and opioid abuses.

DOCTORS FACING NUMEROUS CHARGES

Doctors and their pain clinics, medical centers and other healthcare facilities have been indicted for fraudulent prescription writing, submitting false claims to insurance companies and numerous other federal charges and all face a minimum of 20 to 50 years in federal prison. Two of the busiest “Subsys” prescription writers in the country were Alabama doctors, John Couch and Xiulu Ruan, who earned over $40 million from Insys, and were charged with running a pill mill between 2013 and 2015, have been convicted and sentenced to 20 years each in federal prison. The top “Subsys: prescriber of all, Dr. Gavin Awerbach, of Saginaw, MI pled guilty to defrauding Medicare and Blue Cross out of $3.1 million in improper Subsys prescriptions, his criminal sentence is pending. To show the far reach of Insys and it’s corporate plans to saturate the US market with opioids, in Anchorage, Alaska Dr. Mahmood Ahmad, was charged with heading a massive Subsys prescribing operation, which he denies, but immediately surrendered his Alaska medical license which the caused the revocation of his medical license in Arkansas.

INSURANCE COMPANIES FILED SUIT

Adding weight to this tragedy is Anthem Insurance — you may recognize them as Blue Cross, one of the largest insurers in the country, now setting their sights on Insys Theraputics and it’s executives.

Anthem is suing Insys Therapeutics, the maker of the powerful opioid Subsys, for allegedly lying, cheating and defrauding its way into the medicine cabinets of Anthem clients across the country. The drug according to Anthem’s complaint, was off market prescribed to thousands of patients for years. Review shows that 54% of patients who are taking Subsys don’t really have cancer — one of the requirements for prescribing the drug, Subsys was FDA approved for “treatment of pain related to cancer” and any other use is unauthorized or off-label use.

Anthem says that’s because Insys devised an elaborate scheme to get around Anthem’s system — by falsifying records and posing as medical professionals, often with the complete knowledge and cooperation of medical doctors across the country who then received thousands of dollars in kickbacks. These doctors chose to exchange high fees from Insys in exchange for writing off-label prescriptions to patients seeking pain relief for non-life threatening conditions.

Anthem claims it ultimately paid $19 million more for Subsys than it should have. “But the harm inflicted by Insys’s conduct is not merely financial in nature,” the complaint states “Insys put Anthem’s members’ health at risk.”

THE OFF LABEL CAMPAIGN

The only people who are supposed to be taking Subsys are adult cancer patients, according to the FDA “Subsys” approval files, anything other than that is an “off label” indication. Now you can take a drug to treat something off label if you want to, but you have to get your doctor to get pass a prior authorization.

Anthem alleges that Insys has an entire unit to get around this requirement — it’s titled the “reimbursement unit.” Investigative journalists exposed this fraud initially as far back as 2015 on behalf of the Southern Investigative Reporting Foundation, see Insys Therapeutics “Subsys” Off Label Rx Fraud.

The Reimbursement Unit claim was basically the company’s fraudulent  prescription approval factory, which helped participating doctors process claims (the doctors had so many they couldn’t handle them all). The unit falsified records to show patients had cancer and called insurers, pretending to be patients or other medical professionals, to facilitate approval of payment for off-label treatment.

This is the Unit’s script for obtaining off-label approval (taken from the Anthem suit):

The script read: “The physician is aware that the medication is intended for the management of breakthrough pain in cancer patients. The physician is treating the patient for their pain (or breakthrough pain, whichever is applicable).” The script deliberately omitted the word “cancer as applied to the patient treatment under discussion.”

DO STOCKS RISE AND FALL ON INDICTMENTS

 

 

 

 

 

 

 

In late 2016 the entire top level of Insys executives, including former CEO Michael Babich, and five others were indicted and charged with multiple counts of fraud and conspiracy. Since then a number of sales reps and medical practitioners have pled guilty to charges that they gave or accepted kickbacks in furtherance of the fraudulent prescription scheme. The manager of reimbursement services, Elizabeth Gurrieri, pleaded guilty to wire fraud in June. There have been numerous deaths and related overdoses attributed to the over prescribing of Subsys across the country, which to date, show most parties involved being able to avoid the scrutiny of criminal charges related to off-label marketing and prescribing. Insys has tried to re-shuffle the executive board by bringing in new members, but business as usual in the Big Pharma boardroom goes on, as they simply brought in other more experienced “opioid industry” insiders to help further the continued use of “Subsys” and purportedly the major Insys New Pharma” entry, a line of complex medical marijuana products, that may enable them to shake off the current Insys label as the United States leading “opioid abuse by boardroom design” corporation.

As part of the boardroom strategy to get doctors to prescribe Subsys, Insys spent millions paying them off through a fraudulent “speakers program” meant to educate medical professionals about the drug. The speaking engagements were a veiled attempt to cover-up the direct payment to doctors for writing prescriptions, the more prescriptions you wrote, the higher your “speaking fees” increased. There are e-mails, texts and other Insys communications from all levels of company personnel stating “if they not writing prescription, they’re off the speaking program”, this policy resulted in one Alabama sales rep being paid over $700 thousand in Subsys based Rx commissions for one year, while her base salary was $40 thousand.

“While the exact amount of those kickbacks has yet to be determined, criminal indictments of the recipients indicate that Insys paid “speaker fees” of millions, of dollars, which may result in additional criminal charges against the doctors as well as the doctors facility staff who often worked hand in hand with Insys staff.

SALES REP NATALIE REED PERHAC

In the plea, Perhacs admitted that she was hired to be the personal sales representative for one of Insys’s most important prescribers, Dr. Xiulu Ruan. Ruan is one of two Alabama doctors who picked up over $115,000 in speaker fees from 2012 to 2015, and earned in excess of $40 million in related medical earnings during the same period. Earlier this year they were sentenced to 20 years in jail each for running a “pill mill” and helping Insys sales rep Natalie Reed Perhacs sell Subsys, for which she was paid in excess of $700 thousand in commissions, see Perhac Guilty Plea in Alabama Federal Court.

Perhac Plea Excerpts:

Admision No. 78: . Perhacs admitted that her primary responsibility at Insys was to increase the volume of Subsys® prescribed by Dr. Ruan, and his partner Dr. John Patrick Couch. This… was accomplished by (1) handling prior authorizations for their patients who had been prescribed Subsys®; (2) identifying patients who had been at the same strength of Subsys® for several months and recommending that Dr. Ruan or Dr. Couch increase the patients’ prescription strength; and (3) setting up and attending paid speaker programs.

Admission No. 79:. Ms. Perhac admitted that because of her involvement in the prior authorization process, she knew that the vast majority of Dr. Ruan and Dr. Couch’s patients did not have breakthrough cancer pain.

As you can see by the Perhac admissions, numbers 78 and 79, which reflect the vast number of charges lodged against her, the federal government is cracking down on everyone involved with the “Subsys” fraud. According to confidential sources, the recent June 2017 FDA “Opioid Crisis” Conference and related strategic review of the opioid crisis, will result in many more indictments and charges against drug makers and the medical providers who’ve helped facilitate the opioid epidemic that is currently in place across the United States.

Coming in “The Opioid Crisis In America” Part 2: How Insys Therapeutics, Purdue Pharmaceuticals, Endo Health, J&J’s Janssen Pharmaceutical and other opioid manufacturers were allowed to place profits over patients for more than 15 years…

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ACTEMRA: Why Is Genentech Ignoring Wrongful Death, Heart Attack and Stroke Injuries?

ACTEMRA: Why Is Genentech-Roche Ignoring Ever Increasing Evidence Of Wrongful Deaths, Heart Attack and Stroke Injuries?

By Mark A. York

Mass Tort Nexus (September 26, 2017)

 

 

 

 

 

 

 

 

 

 

Many newer rheumatoid arthritis drugs have strong warnings known as black box warnings, dictated by FDA guidelines, which warn of the risk of heart attack, stroke, heart failure, lung disease, and other injuries, but Actemra warnings were not issued by the drug maker when the medication was introduced.

Actemra, a rheumatoid arthritis medication by Roche-Genentech, has now been linked to increased heart attacks, stroke and lung interstitial disease among other side effects that the maker, Genentech did not warn the public about.

Blockbuster Drug

Actemra is a humanized interleukin-6 (IL-6) receptor antagonist approved for treatment of adults with moderately to severely active rheumatoid arthritis. It was approved in 2010 and has been prescribed to more than 760,000 patients. The drug was responsible for $1.7 billion in revenue for Genentech and Roche last year and considered a blockbuster.

Actemra Wrongful Death

Actemra has been found to be the cause of thousands of deaths and critical illnesses, according to recent reports, it’s now documented that hundreds of patients taking the RA drug died from cardiovascular and pulmonary complications – medical issues not usually known to be  associated with the drug. According to the investigation, Actemra did not carry warning labels about the possible side effects, unlike many competing RA drugs. Stat said it investigated more than 500,000 side effect reports for RA drugs and “found clear evidence” that the risks of the side effects, such as heart attack or stroke, “were as high or higher for Actemra patients than for patients taking some competing drugs.” The difference Stat stressed is that Actemra, unlike the other RA drugs, does not carry a warning label for those side effects.

What is Actemra?

Actemra (tocilizumab) is Genentech’s newest blockbuster rheumatoid arthritis drug introduced by parent company Roche in 2010. It is given to patients as an intravenous infusion on a monthly basis or as a subcutaneous (under the skin) injection on a weekly or bi-weekly basis.

Actemra is a monoclonal antibody drug, approved by the FDA to treat autoimmune disorders including Rheumatoid Arthritis (RA), Polyarticular Juvenile Idiopathic Arthritis (PJIA), and Systemic Juvenile Idiopathic Arthritis (SJIA) and was recently approved for the treatment of Giant Cell Arteritis (GCA).

In autoimmune disorders like RA, the immune system begins to attack and destroy the body’s own joint or other tissue. Actemra works to suppress the immune system by blocking interleukin-6, an immune messenger.

Actemra is Genentech’s Poster Drug?

Roche-Genentech touted their new rheumatoid arthritis drug as a “unique” breakthrough treatment, and it has since become a blockbuster drug, generating $1.6 billion in sales in 2016. Actemra competes with other popular and widely used rheumatoid arthritis drugs already on the market, including Enbrel, Humira, and Remicade.

Actemra Has Caused Serious Heart and Lung Injuries

 

Competitor RA drugs Enbrel, Humira and Remicade contained strong warnings about the heart risks and other serious health problems, but Actemra warnings did not indicate that patients may develop heart attacks, stroke, heart failure, lung disease, pancreatitis or other serious side effects.

Unfortunately, many doctors and patients were falsely led to believe that Actemra was safer, and Actemra may have actually caused these same, or even increased a greater risk of heart problems, lung complications, and other injuries.

Report Highlights Failure to Warn About Actemra Risks

In June 2017, the national publication STATNews.com released a detailed review of adverse event reports submitted to the FDA involving Actemra problems. The report raised a serious question about the failure to warn about the risk of cardiovascular problems, pancreatitis, lung disease and other injuries that have been experienced by users nationwide.

STAT News researchers examined thousands of serious adverse event reports filed with the FDA and found that 1,128 cardiac and respiratory deaths in Actemra patients had been reported to the FDA, along with thousands of other serious adverse events including heart attack, stroke, interstitial lung disease, gastrointestinal perforation and others.

STAT identified at least 13,500 reports of issues following an Actemra infusion or injection, which were submitted to the FDA between 2010 and 2016.

Actemra was linked to a higher-than-expected number of serious adverse event reports when compared with the more widely used drugs Humira, Remicade and Enbrel, which each have warnings about risks that users may face.

Actemra Serious Adverse Events

Actemra patients were more likely to have a lung disease event than patients taking Remicade and just as likely as those using Humira.

Actemra patients were 1.5 times more likely to experience a heart attack or stroke as those using Enbrel.

Will Actemra Be The Next MDL?

According to law firm and other third party investigations reviewing the Actemra drug for potential legal action against Roche and Genentech, the drug maker placed their desire for profits before patient safety by withholding important warnings about the risk of heart attacks, strokes, heart failure, lung disease, pancreatitis and other harmful side effects. When the catastrophic adverse events started to be known to the company, a boardroom decision was made to disregard the ever increasing adverse events, including those of patients dying after taking the drug. Where the Actemra investigations lead to will be known later in 2017, as determinations on taking legal action are made.

 

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