XARELTO STUDIES FAIL IN BAYER/J&J ATTEMPTS TO EXPAND MARKET CONTROL

THE RECENT FAILURE OF TWO XARELTO STUDIES STOPPED BAYER AND JOHNSON & JOHNSON ATTEMPTS TO INCREASE BLOOD THINNER MARKET-SHARE

By Mark A. York (August 28, 2018)

 

 

 

 

 

 

 

Two recent Xarelto studies fail to show additional benefits when Bayer and Johnson & Johnson’s attempted to expand the patient group for their heart drug Xarelto.

The recent Xarelto blood thinner “Commander HF” study, (see  https://clinicaltrials.gov/ct2/Bayer/J&J (Commander AF Study), could not show any statistical improvements in helping heart failure patients after an acute decline in their condition, results from the so-called study showed on Monday. The primary study goal of reduction in the risk of death, heart attack and stroke was unsuccessful.

A second Bayer/J&J study known as “Mariner” also failed to produce clear evidence that Xarelto is able to reduced the rate of blood clots in certain high-risk patients after a hospital release.

Bayer earned $3.84 billion in sales of Xarelto revenues last year, primarily from stroke prevention in the elderly, with projected annual sales to rise above $5 billion in 2019 and beyond.

Bayer retains marketing rights for Xarelto outside the United States while partner J&J sells Xarelto in the U.S., with Bayer being eligible for royalties on U.S. sales of 20 to 30 percent.

Both Bayer and J&J’s Janssen R&D are facing thousands of lawsuits across the country over failure to warn and disclose the significant dangers of being prescribed Xarelto and the inability to stop the bleeding as there hasn’t been an antidote for Xarelto until 2018.

XARELTO MDL 2804 AND PHILADELPHIA COMPLEX LITIGATION DOCKET

Between the Xarelto MDL 2804 federal docket of 25,000 plus and the 1,700 in Philadelphia Court of Common Pleas there seems to be significant concern for the use of Xarelto when a comparison is made to the pre-Xarelto blood thinners i.e. Coumadin and Warfarin which required additional monitoring, are not known as a drug that can kill you.

Mass Tort Nexus Briefcase Re: XARELTO-Case-No-2349-in-Philadephia-Court-of-Common-Pleas–Complex-Litigation-(PA-State-Court)

Mass Tort Nexus Briefcase Re: XARELTO-MDL-2592-US-District-Court-ED-Louisiana

HOW XARELTO WAS APPROVED BY THE FDA

Xarelto was first approved by the FDA July 2011, representing a major advancement in blood thinning (anticoagulant) medication according to Bayer and Johnson & Johnson, developed to prevent serious conditions that sometimes arise after surgeries (such as artificial hip and knee surgeries). As an anticoagulant, it was intended to prevent pulmonary embolism (PE) and deep vein thrombosis (DVT) and strokes. Xarelto was also intended to help those patients with atrial fibrillation, a group of people more vulnerable to PE, DVT, and stroke after surgery. Eventually, the FDA expanded approval of Xarelto to treat all patients with PE, DVT and atrial fibrillation.

More than one study has shown Xarelto can cause a higher rate of internal bleeding, than other anticoagulant drugs and there is no available “antidote” for stopping internal bleeding in patients taking Xarelto. With warfarin, vitamin K has been shown to stop bleeding, but there is no vitamin K “parallel” for people taking Xarelto. For Xarelto, it can take 24 hours for a dose to get out of the body. That means that if internal bleeding starts, the patient may simply have to wait it out and hope it stops on its own.

 MAYO CLINIC XARELTO STUDY RESULTS NOT POSITIVE

In the journal Gastroenterology, a team of physicians and researchers from the Mayo Clinic studied thousands of patients who took Xarelto (rivaroxaban), Pradaxa (dabigatran), and Eliquis (apixaban). The goal was to figure out which of these three anticoagulant drugs had “the most favorable GI safety profile,” which is medical-research-speak for “which one of these drugs is least likely to hurt patients.”

This is how the study worked: The researchers studied health insurance administrative claims information on thousands of patients between October 1, 2010 and February 28, 2015. These patients had atrial fibrillation, or Afib, which is a heart arrhythmia, a quivering or irregular heartbeat. Afib can lead to serious health problems such as stroke, blood clots, heart failure and other health complications. The researchers looked at the incidents of gastrointestinal bleeding among the thousands of patients who took Xarelto or Pradaxa or Eliquis.

MAYO STUDY SHOWS NEGATIVE RESULTS

Patients who took Xarelto had a higher incidence of gastrointestinal (GI) bleeding patients who took Pradaxa or Eliquis. The statistics show that patients taking Xarelto may have a 20% greater risk of internal bleeding than with those taking Pradaxa or Eliquis, with the rates of GI bleeding increased in patients over seventy-five (75) years old. Turns out, Eliquis “had the most favorable GI safety profile among all age-groups.” While clearly showing Xarelto, unfortunately, had the “least favorable” safety profile among the three prescription anticoagulant drugs.

FDA Investigation of Xarelto Trials

The approval history for Xarelto was actually pretty controversial. FDA reviewers originally said that they recommended against approval, then there was an FDA advisory committee (independent group of key opinion leaders) and they voted in favor, so the FDA approved the drug. Their concern was with how the Phase III trials were run and whether Xarelto had really proved its efficacy. The tests compared patients on warfarin to patients on Xarelto, but the patients on the warfarin run had poor TTR. That means the patients weren’t well controlled on warfarin to begin with, which skews the data in favor of Xarelto.

During the approval process, Xarelto actually wanted a superiority label, which would say that the drug was better than warfarin and other blood thinners. Because of the concerns with the Phase III data, the FDA only gave them a non-inferior label, which says they’re essentially the same in terms of effectiveness.

One of the clinical trials that played a key role in its approval for stroke prevention in patients with atrial fibrillation is now under investigation by the FDA. This trial compared Xarelto’s performance to warfarin’s, but it used a device called INRatio to test the warfarin patients.

The INRatio device was the subject of two FDA warning letters about inaccurate readings just as the trial was starting in 2005 and 2006. In 2014, the device was recalled. The use of the INRatio device may have skewed the results with inaccurate readings, making Xarelto look better in comparison with warfarin.

The FDA’s medical experts originally recommended against improving the drug due to concerns about its efficacy. They found that Xarelto was not as effective as warfarin. However, a review board eventually approved the drug over the objections.

The FDA has issued a number of warnings about Xarelto and has required the makers of the drug to change its labeling multiple times. Specifically, the FDA warned about the risks of uncontrolled bleeding. It also added a black-box warning, its most serious kind of warning, about the increased risk of stroke when patients prematurely stop taking Xarelto and about the increased risk for swelling and damage associated with the use of epidural anesthesia while taking Xarelto.

The makers of Xarelto recently applied to the FDA to expand the approved uses of the drug to include treatment for acute coronary syndrome (ACS). For the third time, the FDA unanimously denied the expansion. Johnson & Johnson and Bayer are expected to continue to apply for approval due to the high value of that market. More than 1 million patients are hospitalized with ACS each year. That offers serious potential for growth for Xarelto, which already earns almost $1 billion in sales annually.

Johnson & Johnson also is claiming that Xarelto helps patients with peripheral artery disease (PAD) in reducing their heart attack and blood clot risks.

WHAT THE VETERANS ADMINISTRATION SAYS ON XARELTO USE

“The good news is you now have an alternative to warfarin … The bad news is you can kill a patient as easily with the new drug as you could with the old drug.”Dr. Alan Jacobson, Director of anti-coagulation services at the VA in Loma Linda, Calif.

The makers of Xarelto say it takes time for doctors to get up to speed on new types of treatments and how to best administer them outside the controls of clinical trials.

“This is a shift in medical practice,” said Dr. John Smith, senior vice president for clinical development at Boehringer. “Individual physicians have to determine what the follow-up plan will be, to use common medical-sense judgment.”

XARELTO MAKERS SAY NO FOLLW-UP CARE REQUIRED

Dr. Peter Wildgoose, a senior director of clinical development at J&J, said the company has not provided special advice on follow-up care for patients on Xarelto.

“There’s nothing more than for any other drug that people regularly take,” he said, adding that most atrial fibrillation patients probably see their doctors on a regular basis. “These drugs have been tested long term, for several years at a time, with very good outcomes.”

Johnson & Johnson officials stressed there was far less evidence in trials of brain bleeding – the most worrisome side effect of anti-coagulants – in patients taking Pradaxa and Xarelto than those taking warfarin.

WAS XARELTO EVEN NEEDED?

Even though warfarin (Coumadin) has been the standard in anticoagulant (blood thinner) drugs for more than 50 years, it lacked perfection, making way for a new generation of blood thinners, including Xarelto. In clinical studies, Xarelto was shown to be more effective than warfarin in treating patients with atrial fibrillation (AF) who are at an increased risk for stroke. And while Xarelto had less cranial hemorrhage (bleeding in the brain) incidents than warfarin, it was shown to have a similar overall number of bleeding incidences when compared to the number of bleeding events in patients taking warfarin.

Despite this finding, and – until recently – its lack of antidote (reversal agent) for serious bleeding, Xarelto rose to popularity, making up a significant portion of the billion-dollar anticoagulant drug industry in the United States. Even after an investigation into into the clinical trial ROCKET-AF study, upon which its U.S. Food and Drug Administration (FDA) approval hinged, the drug continues to be prescribed by doctors to patients with AF and as a prophylaxis for deep vein thrombosis (DVT), which can lead to pulmonary embolism (PE) after total hip and knee replacement surgeries.

But as more evidence surfaced regarding the drug risks for patients taking Xarelto, including an increased risk of wound complications following surgical procedures, severe bleeding with no easily available antidote to stop its serious consequences, as well as reports of platelet deficiencies, hepatitis and Stevens-Johnson syndrome (SJS) (a severe skin reaction), some heart doctors are becoming a bit more cautious with the blood thinner.

Xarelto and Internal Bleeding?

Janssen and parent company Johnson & Johnson market its anticoagulant drug Xarelto as a safe and more convenient choice in blood thinners compared to warfarin. But pre-market clinical studies and post-marketing reports have shown that taking Xarelto leaves many patients vulnerable to internal bleeding that can result in death for some users.

In a 2017 annual report issued by the Institute for Safe Medication Practices (ISMP), it was stated that oral anticoagulant drugs, including Xarelto (rivaroxaban), showed “unacceptably high risks,” according to two government data sources, the FAERS adverse events reports for 2016 and a new systematic study by the Centers for Disease Control and Prevention (CDC).

XARELTO ACCOUNTS FOR 75 PERCENT OF ALL AE’s IN ANTI-COAGULANTS

Of the 22,000 reports of serious injuries resulting from anticoagulant drugs, Xarelto accounted for 15,043 cases alone, the FDA said.

“According to an analysis of 2016 FDA adverse event data conducted by the ISMP, anticoagulant (blood thinner) drugs accounted for nearly 22,000 reports of serious injuries in the United States, led by Xarelto, which accounted for 15,043 cases alone. These numbers also included 3,018 reported deaths, with most injuries being the result of hemorrhages, making bleeding one of the most adverse events.”

Gastrointestinal hemorrhages made up the MOST INJURIES, followed by cerebral hemorrhages. From early testing, hemorrhage has always been an apparent increased risk associated with lowering the risk of strokes from blood clots.

In late 2016, the CDC released a separate study that found that “anticoagulant drugs accounted for more emergency department visits for outpatient adverse effects than any other class of drugs currently in therapeutic use, including opioids (non-abuse visits), antibiotics and diabetes drugs.” Most of these adverse events were severe, with nearly 50 percent requiring a hospital stay. The ISMP estimated in its QuarterWatch report that just over 6 percent of patients using anticoagulants for one year will need to visit the emergency room, with about half of those patients requiring hospitalization. That is a major number of injuries that can be attributed to a drug that is advertised as life saving and designed to prevent injuries.

Overall, the CDC found in its systematic study that the FDA’s FAERS voluntary reporting underestimates anticoagulant drug-related injuries. The CDC discovered that approximately 228,600 emergency department visits occur each year due to the use of blood thinner drugs, including Xarelto, which is 10 times more than the FAERS total number of voluntary reports.

The Symptoms of Internal Bleeding

At its onset, unless it’s a severe hemorrhage, internal bleeding may not cause any symptoms apparent to the patient taking Xarelto. However, dependent on where the bleed is located in the body, the patient will soon begin exhibiting signs and symptoms that will be their indication to seek immediate medical attention. Patients who are in poor health or are over the age of 64 and the targeted audience seem more likely to suffer serious, potentially life-threatening bleeding complications.

The end result of Bayer and J&J’s attempts to secure the blood thinner market may continue unabated until the more than 25,000 lawsuits over the injuries and deaths that are affiliated with taking Xarelto will force both companies to come to either the settlement table or begin trying the Xarelto MDL 2592 lawsuits being remanded back to original courts for trials and blocks of 1200 cases at a time. Xarelto MDL Judge Eldon Fallon, USDC Eastern District of Louisiana has already started the remand process for 23,000 cases pending in his federal court, due to the lack of progress in settlements and cooperation by Bayer and Johnson & Johnson.

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How Rudy Giuliani Was Able To Let Purdue Pharma (OxyContin) Slip Out Of A 2006 Criminal Indictment By DC Back Office Maneuvering

How was Purdue able to slip through the 2006 criminal indictment noose and continue to market, sell and prescribe Oxycontin for another 10 years? Guiliani and GW Bush DoJ lawyers agreed to have Purdue Pharma parent “Purdue Fredrick Company” take the guilty plea, thereby permitting Purdue Pharma to continue selling Oxycontin and furthering the current opioid crisis. See the Purdue Frederick Co. (not Purdue Pharma) Criminal Guilty Plea Outline May 9, 2007 (USDC Virginia)

By Mark A. York (August 21, 2018)

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) The US government secured a criminal conviction against Purdue Pharma in the mid-2000s but failed to curb sales of the drug after Rudy Giuliani reached a deal to avoid a ban on Purdue doing business including the federal government. The George W. Bush administration opted to settle the case instead, with the executives and the company paying $634.5 million in fines in 2007. How Rudy Guiliani slipped a fast legal maneuver past everyone is explained below.

That year, Purdue also reached a $19.5 million settlement with 26 states, including Massachusetts and the District of Columbia. But Healey’s office alleges Purdue continued deceptively marketing opioids after 2007. These settlement by various states are being used as ammunition in the current wave of opiate lawsuits versus Purdue Pharma.

2018 CONGRESS INQUIRIES INTO 2007 PLEA IGNORED

Congressman Mark DeSaulnier (D-CA) and Cummings Request Subpoena for Internal DOJ Report Indicating Purdue Pharma Concealed Knowledge of OxyContin Abuses

Washington, DC – Today, Congressman Mark DeSaulnier  and Ranking Member of the Oversight and Government Reform Committee Elijah E. Cummings sent a letter requesting that Chairman Trey Gowdy issue a subpoena to compel the Department of Justice (DOJ) to produce documents it is withholding related to an internal 2006 report that Purdue Pharma knew of significant abuses of its drug OxyContin shortly after it was brought to market in 1996.

“If this report is accurate, Purdue’s actions demonstrate a stunning disregard for human life and the law.  While Purdue Pharma made billions of dollars from OxyContin, thousands of Americans succumbed to addiction and its consequences,” the Members wrote.

The 120-page report, obtained by the New York Times, reportedly indicates that Purdue Pharma knew OxyContin was highly addictive, but the company concealed this information and vehemently denied that it had knowledge of the growing illicit use until years after it had been on the market.  Despite this deception, Purdue’s top executives managed to effectively avoid any responsibility.

According to the New York Times, the 2006 DOJ report recommended the indictment of “three of Purdue’s top executives on felony charges, including conspiracy to defraud. However, the political appointees at the Department of Justice under then-President George W. Bush reportedly overturned the prosecutors’ recommendations.

On June 12, 2018, DeSaulnier and Cummings sent a letter to DOJ requesting that it produce this report by June 25, 2018. DOJ did not respond to this request.

A full copy of the letter to Chairman Gowdy can be found here.

PURDUE PHARMA KNEW OF OXYCONTIN ABUSES

According to the New York Times’ report on the DOJ document, Purdue’s general counsel wrote in early 1999, “We have in fact picked up references to abuse of our opioid products on the internet.”

That same year, an OxyContin sales representative wrote in an email, “I feel like we have a credibility problem with our product,” after a doctor in Florida was arrested for illegally prescribing the drug. Sales representatives were discouraged by Purdue from raising concerns about abuse, with one saying his manager told him that “his job was to sell drugs, not to determine if a ‘doctor was a drug pusher.’”

PURDUE OPIATE PRESCRIPTION LAWSUITS IN 2018  

Connecticut-based Purdue Pharma is facing a wave of civil lawsuits as more than 25 states including New York, Texas, Florida, Illinois and other states have joined a growing number actions against Purdue Pharma, with Massachusetts filing a lawsuit naming not only Purdue Pharma, but Purdue executives and the Sackler family members who’ve profited from Oxycntin sales. Here is the June 12, 2018 Massachusetts complaint naming the Sackler family as defendants, State of Massachusetts Complaint vs. Purdue Pharma and the Individual Sackler Family Members.

More than 600 opiate based lawsuits are now filed against Purdue Pharma and other opiate drugmakers, distributors and pharmacies. However the primary target in every lawsuit filed is always Purdue Pharma.  These states, counties and local governments have independently sued opioid drugmakers in both state and federal courts across the country, (see OPIOID-CRISIS-BRIEFCASE-MDL-2804-OPIATE-PRESCRIPTION-LITIGATION by Mass Tort Nexus) with claims alleging the opiate drug makers, distributors and now the pharmacies engaged in fraudulent marketing to sell the powerful painkillers. They also failed to monitor and report the massive increases in opioid prescriptions flooding the US marketplace. Which has now resulted in fueling the nationwide epidemic, that’s reported to have killed over a quarter million people. The now organized approach steps up those efforts as officials sift evidence and are now holding not only the companies, but the executives and owners culpable in the designing the opioid crisis.

Purdue Pharma is facing a legal assault on many fronts, as cities, counties and states have either filed suit or are probing the company for an alleged role in the United States’ opioid and addiction epidemic.

The US government missed the opportunity to curb sales of the drug that kickstarted the opioid epidemic when it secured the only criminal conviction against the maker of OxyContin a decade ago.

Purdue Pharma hired Rudolph Giuliani, the former New York mayor and now Donald Trump’s lawyer, to head off a federal investigation in the mid-2000s into the company’s marketing of the powerful prescription painkiller at the center  of an epidemic estimated to have claimed at least 300,000 lives.

While Giuliani was not able to prevent the criminal conviction over Purdue’s fraudulent claims for OxyContin’s safety and effectiveness, he was able to reach a deal to avoid a bar on Purdue doing business with the federal government which would have killed a large part of the multibillion-dollar market for the drug.

The former New York mayor also secured an agreement that greatly restricted further prosecution of the pharmaceutical company and kept its senior executives out of prison.

The US attorney who led the investigation, John Brownlee, has defended the compromise but also expressed surprise that Purdue did not face stronger action from federal regulators and further criminal investigation given its central role in the rise of the epidemic.

Connecticut-based Purdue is now facing a wave of civil lawsuits as New York, Texas and five other states have joined a growing number actions against the company. But Brownlee was the first, and so far only, prosecutor to secure a criminal conviction against the drug maker.

Brownlee launched his investigation shortly after being appointed US attorney for the western district of Virginia as the region struggled with escalating overdoses and deaths from opioids in the early 2000s. When he looked at the source of the epidemic he found OxyContin, a drug several times more powerful than any other prescription painkiller on the market at the time.

HOW OXYCONTIN FUELED THE OPIOID CRISIS

Almost 100 people are dying every day across America from opioid overdoses – more than car crashes and shootings combined. The majority of these fatalities reveal widespread addiction to powerful prescription painkillers. The crisis unfolded in the mid-90s when the US pharmaceutical industry began marketing legal narcotics, particularly OxyContin, to treat everyday pain. This slow-release opioid was vigorously promoted to doctors and, amid lax regulation and slick sales tactics, people were assured it was safe. But the drug was akin to luxury morphine, doled out like super aspirin, and highly addictive. What resulted was a commercial triumph and a public health tragedy. Belated efforts to rein in distribution fueled a resurgence of heroin and the emergence of a deadly, black market version of the synthetic opioid fentanyl. The crisis is so deep because it affects all races, regions and incomes

Purdue turned OxyContin into a multibillion-dollar drug after its launch in 1996 with an unprecedented campaign marketing the painkiller to doctors. OxyContin contained a much higher dose of narcotic than other painkillers because it was designed to bleed slowly into a patient’s system over 12 hours and save having to take lower dosage pills more regularly. Purdue told doctors that not only was this more effective at subduing pain but it was less likely to cause addiction and more resistant to abuse by people hooked on drugs.

These were important selling points to a medical profession still wary of opioids because of concerns about addiction, and demand for OxyContin quickly surged. But it almost as swiftly became apparent to prosecutors that neither claim was true as doctors reported increasing numbers of people becoming addicted to the high dosage, and that those already hooked on opioids found it easy to extract the narcotic by crushing the pills.

OxyContin became the go-to drug for people looking for an instant high by snorting or injecting.

“This was the magic pill, right? This was a long-acting pill that the addicts wouldn’t like and you couldn’t get dependent on, and that is the magic bullet. The reality is it just wasn’t true,” said Brownlee. “It was highly deceptive and then they trained their sales force to go out and to push that deception on physicians.”

Investigators waded through several million of Purdue’s internal memos, marketing documents and notes from sales representatives. Brownlee’s office discovered training videos in which reps acted out selling the drug using the false claims. “This was pushed by the company to be marketed in an illegal way, pushed from the highest levels of the company, that in my view made them a criminal enterprise that needed to be dealt with,” said Brownlee.

When Purdue discovered it was under investigation it dispatched Giuliani, fresh from his term as mayor of New York during the 9/11 attacks, in the twin roles of heavyweight lawyer to confront the young prosecutor while also working his powerful connections in Washington. Giuliani met repeatedly with Brownlee. At first the Purdue lawyer tried to persuade the prosecutor that he had got it all wrong.

“It was basically, you need to look at the company differently. All we do is make a product and we give it to doctors and doctors ultimately make the choice,” said Brownlee.

The prosecutor heard Giuliani out but regarded his attempts to load responsibility on to doctors as missing the point. “What were the doctors being told? That was the real rub. To me the biggest evidence were the videos of the training sessions. When I saw that, you now know that this is what the corporation wants the doctors to know, and it just wasn’t true,” said Brownlee.

The US attorney had six meetings with Giuliani. They moved from how to interpret the evidence and questions around discovery to negotiations over the final settlement.

HOW GUILIANI WORKED BACK OFFICE DC CONNECTIONS

But Giuliani and his team seemed to be also working their Washington contacts. The Purdue lawyers complained to the office of the then deputy attorney general, James Comey, whose tenure as head of the FBI lay ahead of him, that Brownlee was exceeding his legal authority in pursuit of documents from the company.

“The defense lawyers contacted Mr Comey unbeknownst to us and said those guys down there are crazy,” said Brownlee. The US attorney went to Washington to explain to Comey in person. Purdue was not instantly recognizable as a pharmaceutical company to most people in DC. The name was easily mistaken for Perdue Farms, a regional chicken producer well known for its television ads featuring the owner, Frank Perdue. “Mr Comey said, why are you prosecuting the chicken guy?” said Brownlee.

Once that misunderstanding was cleared up, Comey signed off on Brownlee’s actions and Purdue was forced to hand over the documents. Brownlee set the drug maker a deadline in October 2006 to agree to the plea deal or face a trial. Hours before it expired, the federal prosecutor received a call at home from a senior justice department official, Michael Elston, chief of staff to the new deputy attorney general, Paul McNulty.

Elston asked why the case was being pushed along so rapidly and pressed for a delay. The prosecutor again saw the influence of Purdue’s lawyers at work and cut the call short. It wasn’t unusual for corporate lawyers to try to get leverage with senior justice department officials but Elston’s call, just as Purdue had its back to the wall, seemed to the then prosecutor unusually interventionist because he had shown no interest in the case before. Elston’s lawyer has since claimed that his client called Brownlee on instructions from above.

Within hours of Brownlee hanging up on Elston, Purdue accepted a plea deal admitting to criminal charges of mis-selling OxyContin with “intent to defraud or mislead”. In 2007, after a court hearing confirming the conviction, Brownlee hailed it as a “crushing defeat” for the drug maker.

But Giuliani won an important concession for Purdue. Corporations with criminal convictions are mostly barred from doing business with the federal government. If Purdue Pharma’s name was on the conviction it would probably have forced OxyContin from public health programs such as Medicaid and Medicare and the Veterans Administration health system. That in turn was likely to diminish its prescribing in the private health system.

Brownlee said he did not want to be responsible for taking OxyContin off the market and so agreed with Giuliani to target the prosecution at the parent company, Purdue Frederick. That left Purdue Pharma, cleaved out as a separate painkiller manufacturer in 1991, to continue selling the painkiller without restriction even though opioid deaths were escalating.

“I didn’t feel as a lawyer I could be in a position to bar anyone from getting OxyContin. Faced with that decision, I was just simply not prepared to take it off the market. I didn’t feel like that was my role. My role was to address prior criminal conduct. Hold them accountable. Fine them. Make sure the public knew what they did. ” said Brownlee.

Brownlee said he expected federal regulators, particularly the Food and Drug Administration, and other agencies to use the criminal conviction to look more closely at Purdue and its drug. But there was no follow-up and OxyContin went on being widely prescribed.

Purdue was fined $640m, a fraction of its total profits from OxyContin. Three Purdue executives pleaded guilty to misdemeanors and were fined a total of $34.5m between them, a reflection of their earnings from the drug.

Giuliani also won a second concession that immunized Purdue from further prosecution even though its criminal conduct continued after the period covered by the plea agreement. The prosecution covered its crimes committed up until 2001, but the mis-selling went on for years afterwards. Giuliani negotiated an agreement which immunized the company from further prosecution for its actions up to 2007 when the guilty plea was finalized in court.

Critics of the deal, such as the watchdog Public Citizen, said the company sold nearly $5bn worth of OxyContin between the two dates.

A decade later, with tens of thousands more lives claimed by the epidemic kickstarted by OxyContin, Brownlee said he does not regret his handling of the case but said he had expected other prosecutors and federal regulators to pick up the baton to rein in the spread of OxyContin.

“I think convicting the company, the fines and all of that had its impact. I guess as I sit here now, I’m a little surprised that it’s the only one of its kind. That with the nature of the abuse and the nature of the problem, that as we sit here that there’s no other out there,” he said.

PURDUE PHARMA FIRES ENTIRE SALES FORCE

As of June 20, 2018 in what is either an amazing coincidence or a look at corporate political maneuvering, just more than a week after the Sacklers and company executives were named individually in the latest Purdue Pharma opiate lawsuit, the OxyContin maker laid off its entire sales force.  This puts an end to an era for Purdue that at one point, was the top-selling opioid drug in the country, and became synonymous with the nation’s opioid crisis, while the Sacklers collected billions in profits from Oxycontin sales.

Purdue, had already laid off half of its 600 sales reps in February 2018, as part of the corporate political maneuvering to curry favor with the numerous state and federal investigation that were taking place, when it announced that it would no longer be promoting OxyContin to doctors. On July 19, 2018 six days after the State of Massachusetts filed a complaint naming the company, the founding Sackler family and the executive suite as defendants in a an opioid litigation complaint,  Purdue Pharma confirmed that they had terminated the the remaining 220 employees in its sales force.

While Purdue still manufactures Oxycontin, which accounts for more than 80 percent of the company’s, they will be shifting its focus away from the highly lucrative opiate painkiller market, according to company sources.

WHY DIDN’T THE DEA, DRUG DISTRIBUTORS AND PHARMACIES TAKE NOTICE BEFORE THE OXYCONTIN AND OPIOID CRISIS SPREAD ACROSS THE COUNTRY LIKE WILDFIRE? WAS IT BECAUSE OF THE BILLIONS IN PROFITS, QUARTERLY BONUSES AND DIVIDENDS? STOCK OPTIONS CASHED IN BY BOARDROOMS AT EVERY OPIOID BIG PHARMA COMPANY?  STAY TUNED FOR HOW “PROFITS BEFORE PATIENTS” BECAME THE NORM

(article excerpts and quotes have been taken from publicly available media sources and court records)

 

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Has California Rules Change In Novartis AG Litigation Changed Lawsuits Over Generic Drug Injuries?

Will Big Pharma Change Labeling Today-If They Have To Pay Tomorrow?

By Mark York (August 15, 2018)

 

 

 

 

 

 

 

 

(Mass Tort Nexus Media) In December of 2017, California’s Supreme court ruled that consumers are now able to file lawsuits against Novartis AG and other makers of brand-name pharmaceutical products over injuries blamed on generic versions of the drugs manufactured by other companies.

The California Court’s ruling broke with the recent legal leanings nationally to the contrary and created potentially massive exposure for brand-name drugmakers who could be sued in the state for failing to warn users about the risks of cheaper, generic versions of their drugs. This has generally been an area of law that name brand drugmakers have been excluded from and now it seems that the litigation flood gates may open wide, at least in the State of California.

Generic Drug Opinion in T.H. (a Minor) vs. Novartis-Pharmaceuticals (California S.Ct. December 2017)

Leslie Brueckner, the plaintiffs’ lawyer, said this decision was the only current one where a state’s top court ruled in favor of consumers who were prescribed generic drugs, and have legally been prevented from filing suit against generic drugmakers for not warning about their products’ risks.

“This is just a huge victory for public health and safety, and this victory will be felt nationwide,” she said.

Novartis, whose appeal had the support of industry groups including the U.S. Chamber of Commerce, said it disagrees with the court’s decision to potentially hold it responsible for an injury caused by a different company’s product. This has been the primary defense of Big Pharma when defending themselves, from legal claims against generic makers of the products that Big Pharma brought to the marketplace originally, Big Pharma has had a get out of jail free card in play for years.  In many medical circles the view is, generics are based on the formula and R&D developed by Big Pharma labs, so why shouldn’t they be held responsible for their pharmaceutical progeny, which they created.

The decision came in a lawsuit centered on two twin children who were diagnosed with developmental delays and autism after their mother while pregnant took a generic version of Brethine to suppress premature labor. This may open a floodgate of litigation in many other states where the same medical issues are considered to be caused by Novartis designed drugs.

MASSACHUSETTS SUPREME COURT JOINS CALIFORNIA

Federal law prevents people injured by generic drugs from suing generic drugmakers, but in another recent court ruling plaintiffs injured by generic drugs can sue makers of the brand-name versions.

The rulings apply to people harmed by generic drugs in Massachusetts and California. Brand-name drugmakers may be liable for injuries caused by generic drugs they did not manufacture or sell.

Generic drugs can cause the same side effects as the brand-name drugs they’re copying. Generic drugs must carry the same label as the brand-name versions. Only makers of brand-name drugs may add warnings to drug labels without approval from the FDA.

The U.S. Supreme Court says courts may not order generic drugmakers to violate the law by changing their labels. So, federal law bars lawsuits that accuse generic drugmakers of failing to warn of dangerous side effects, based on preemption.

Now two state supreme courts said brand-name drugmakers may be responsible for problems caused by generic drug labels. They ruled to allow people harmed by generic drugs in the two states to sue the brand-name companies.

The latest ruling came March 16, 2018, from the Massachusetts Supreme Court. The case involved a generic version of Merck’s drug Proscar.

The court ruled patients who take generics may sue brand-name drugmakers when they intentionally fail to warn of dangers. Patients can also sue if a maker of a brand-name drug fails to warn when it should have known of serious danger. Lawsuits can’t just claim negligence, a lesser standard, the court said.

The Massachusetts ruling comes just three months after the December 2017 California Supreme Court ruling, which involved the Novartis drug Brethine.

In 2007, a pregnant woman with twins, who is unnamed in the lawsuit, was prescribed the generic version of the drug Terbutaline in order to prevent premature labor. Although Terbutaline is an asthma medication, it has been used “off-label” in order to prevent premature births. She claims that it caused the two children to suffer brain injuries that led to developmental problems, including autism.

Terbutaline was sold by the pharmaceutical company, Novartis, under the name Brethine until it sold the rights to the drug in 2001. Studies from as far back as the 1970s have shown that Terbutaline should not be used by pregnant women, but the Plaintiff’s alleged that Novartis shucked all responsibility for the children’s injuries during the trial by stating that it could do nothing about the warnings on the generic-product’s label.

Currently, generic-drug’s labels must only match the brand-name’s. The court’s decision further states that the brand-name manufacturer is still liable for discrepancies between its label and the generic’s, even if the brand-name drug has stopped being manufactured. Generic medication manufacturers cannot change the warning labels on the drugs they produce without approval from either the FDA or current generic manufacturer.

The generic-drug manufacturer, however, is still liable for injuries if they purposefully change the label from that of the brand-name counterpart, if there is an issue in the manufacturing process, and if the generic manufacturer suggests a use different from that of its FDA approved functions.

Will these rulings have large implications for the pharmaceutical industry since the ruling was so close, and it deviated from decades of precedent. It is possible that if other state courts rule with the same mindset as the California Supreme Courts, they will pressure the US Supreme Court into reviewing the existing federal regulations.

Under a 2011 ruling by the U.S. Supreme Court, generic drug companies cannot be sued for failing to provide adequate label warnings about potential side effects because federal law requires them to use the brand-name versions’ labels.

The father of the children, referred to in court papers as T.H. and C.H., instead sued Novartis, which made Brethine until 2001, and aaiPharma Inc, which bought the rights to it in 2007 while their mother was taking the generic version.

Novartis argued its duty to warn consumers did not cover those taking generics and that a contrary ruling would effectively make it the market’s insurer. Even though the genric maker uses the drug warning label developed and approved by Novartis.

The court disagreed. Justice Mariano-Florentino Cuéllar wrote that brand-name manufacturers are the only entities with the ability to strengthen a warning label. This seems correct since generic makers have zero ability to add warnings or change the label of a drug based on existing law. Perhaps now the long term view of Big Pharma and drug labelling may change if more states are holding them accountable tomorrow for their lack of ethical drug labelling conduct today.

“So a duty of care on behalf of all those who consume the brand-name drug or its bioequivalent ensures that the brand-name manufacturer has sufficient incentive to prevent a known or reasonably knowable harm,” Judge Cuéllar wrote.

The court also held 4-3 that Novartis could be sued despite divesting itself of Brethine because its failure to update the warning label before the sale could foreseeably cause the children harm.

The case is T.H. v. Novartis Pharmaceuticals Corporation, California Supreme Court, No. S233898

IN THE SUPREME COURT OF CALIFORNIA

(Dec. 21, 2017 Opinion Excerpt)

III. CONCLUSION

We do not doubt the wisdom of crowds in some settings. But the value of an

idea conveyed by or through a crowd depends not on how loudly it is proclaimed or

how often it is repeated, but on its underlying merit relative to the specific issue at hand.

Despite the impressive case authority Novartis has collected on its behalf,

none of it purports to interpret California law. Yet it is California law that we must construe

and apply in this case. In doing so, we find that brand-name drug manufacturers have a

duty to use ordinary care in warning about the safety risks of their drugs, regardless of

whether the injured party (in reliance on the brand-name manufacturer’s warning) was

dispensed the brand-name or generic version of the drug. We also conclude that a brand-

name manufacturer’s sale of the rights to a drug does not, as a matter of law,

terminate its liability for injuries foreseeably and proximately caused by

deficiencies present in the warning label prior to the sale.

We therefore affirm the Court of Appeal.

CUÉLLAR, J.

 

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State of New York Sues Purdue Pharma Over Oxycontin Sales and Years of Marketing Abuses

Purdue Avoided Prosecution in 2007 By Paying $600 Million Over Oxycontin Bad Marketing

Purdue Pharma Criminal Plea Agreement US Department of Justice May 10, 2007

Mark A. York (August 15, 2018)

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) The state of New York has joined in the opiate litigation being filed against Purdue Pharma claiming that Purdue misled doctors and patients about the risks and benefits of its opioids, including its multi-billion dollar per year seller OxyContin. The complaint states that Purdue continued to deceptively market its products after pleading guilty to criminal conduct in 2007 and agreeing to cease the misleading marketing per the 2015 agreement with the New York state Attorney General’s Office.

“Our investigation found a pattern of deception and reckless disregard for New Yorkers’ health and well-being — as Purdue lined its own pockets by deliberately exploiting our communities and fueling an opioid epidemic that’s destroyed families across the state,” New York state Attorney Gen. Barbara Underwood said in a statement. “We’re now holding Purdue to account for this reprehensible and illegal conduct.

According to the complaint filed in the state supreme court in Suffolk County, this enabled privately held Purdue to boost prescriptions and profits, at the cost of lost lives and “devastation” in communities now “awash” with the painkillers

Since the beginning of May, the attorneys general of Florida, Nevada, Massachusetts, North Carolina, North Dakota, Tennessee, Texas, Utah and Virginia have also filed lawsuits against the company.

New York City previously filed a $500 million suit  a lawsuit against pharmaceutical companies that make or distribute prescription opioids, on Tuesday the complaint was filed in New York state court, Superior Court of Manhattan, which is a break from other Opioid lawsuits filed by cities, who filed into federal court, see Mass Tort Nexus Briefcase,  OPIOID-CRISIS: MDL-2804-OPIATE-PRESCRIPTION-LITIGATION. The primary claims state that the opiate drug companies fueled the deadly epidemic now afflicting the most populous U.S. city, joining Chicago, Seattle, Milwaukee and other major cities across the country in holding Big Pharma drug makers accountable for the opioid crisis. The case docket information is: City of New York v Purdue Pharma LP et al, New York State Supreme Court, New York County, No. 450133/2018.

Major US Cities Filing Suit Against Opioid Big Pharma-New York, Seattle, Chicago Join MDL 2804

Gov. Andrew Cuomo said in a statement “The opioid epidemic was manufactured by unscrupulous manufacturers and distributors who developed a $400 billion industry pumping human misery into our communities”.

The suit comes three months after Underwood first announced her intention to sue the pharma giant, joining several other states that have already targeted Purdue for its alleged role in the epidemic that saw more than 3,000 New Yorkers die of opioid overdoses in 2016. Daniel Raymond, deputy director of the Harm Reduction Coalition, said that the cities and states are forced to file suits now, after realizing initially that the opioid overdose rates “were primarily driven by prescription painkillers — they weren’t concentrated in urban areas.”

“But the recent rises in prescription overdoses, which in turn has accelerated a major increase in heroin overdoses, and particularly fentanyl, and the latter seems particularly prevalent in urban drug markets,” said Raymond, whose organization is based in New York City. “That’s certainly true in places like Ohio and Philadelphia, which are seeing a lot of fentanyl-involved overdose deaths. That doesn’t mean the problems have waned in smaller cities and rural areas, which are also seeing fentanyl, but we are seeing increasing vulnerability in major urban centers.”

The only bright spot — and it’s a dim one at that — was that the CDC found decreases in opioid overdoses in states like West Virginia, New Hampshire and Kentucky that have been leading the nation in the category.

“We hope this is a positive sign,” said Schuchat, who credited leadership, particularly in West Virginia, with taking bold steps to combat the crisis. “But we have to be cautious in the areas that have reported decreases.”

Dr. Rahul Gupta, Director of Public Health for West Virginia has been at the forefront of addressing the opioid crisis in not only West Virginia but across the country, he stated “Sometimes places that have had such high rates have no place to go” but down, she added, with West Virginia being one of the states to address the issues pro-actively in all areas.

The same affects are in New York and other major metropolitan  areas now based on the ongoing marketing abuses by Purdue Pharma and other opiate industry drug makers and distributors.

The new CDC “Vital Signs” report was released a week after Attorney General Jeff Sessions issued a “statement of interest” in support of local governments that are suing the big pharmaceutical makers and distributors, accusing them of swamping many states with prescription painkillers and turning millions of Americans into junkies.

The new CDC numbers come from analysis of emergency room data from 16 states, including some hardest hit by the plague — Delaware, Illinois, Indiana, Kentucky, Massachusetts, Maine, Missouri, Nevada, New Hampshire, New Mexico, North Carolina, Ohio, Pennsylvania, Rhode Island, West Virginia and Wisconsin.

Dozens of states, counties and local governments have independently sued opioid drugmakers in both state and federal courts across the country, (see OPIOID-CRISIS-BRIEFCASE-MDL-2804-OPIATE-PRESCRIPTION-LITIGATION by Mass Tort Nexus) with claims alleging all opiate drug makers, distributors and now the pharmacies engaged in fraudulent marketing to sell the powerful painkillers. They also failed to monitor and report the massive increases in opioid prescriptions flooding the US marketplace. Which has now resulted in fueling the nationwide epidemic, that’s reported to have killed over a quarter million people. The now organized approach steps up those efforts as officials sift evidence and are now holding not only the companies, but the executives and owners culpable in the designing the opioid crisis.

Purdue Pharma is facing a legal assault on many fronts, as cities, counties and states have either filed suit or are probing the company for an alleged role in the United States’ opioid and addiction epidemic. Now, a lawsuit from Massachusetts’ attorney general Maura Healey is the first to bring the company’s current and former execs into the mix, including the billionaire family with sole ownership of Purdue.

At a news conference this week, Healey said she’s filing suit against the drugmaker, plus current and former executives and board members, “for their role in creating and profiting from this epidemic that has killed so many.” The suit alleges Purdue downplayed risks and overstated benefits of opioid painkillers, including OxyContin. It seeks to link the deaths of 670 Massachusetts residents to actions at the company.

A Purdue spokesman said the company shares concern about the opioid crisis. Purdue is “disappointed, however, that in the midst of good faith negotiations with many states, the Commonwealth has decided to pursue a costly and protracted litigation process,” he said.

Purdue is no stranger to litigation, in 2007 Purdue agreed to pay $19.5million in civil penalties, but did not admit wrongdoing, to settle lawsuits with 26 states – including Massachusetts – and the District of Columbia after being accused of aggressively marketing OxyContin to doctors while downplaying the risk of addiction. This is a consistent pattern, including the 2007 criminal indictment and plea of senior Purdue Pharma executives, where they agreed to pay over $600 million and plead guilty to a greatly reduced charge of “mislabelling drugs” which seems to have set the stage for the Purdue legal strategy of throwing money at all claim of abuse, thereby setting the Purdue Pharma marketing model loose on the US consumers and the healthcare industry, see USA vs. Purdue Criminal Plea “Oxycontin” usdc.virginia.gov/OPINIONS July 2007

In a statement, Purdue said it “vigorously” denies the allegations laid out in the state’s suit.

“The state claims Purdue acted improperly by communicating with prescribers about scientific and medical information that FDA has expressly considered and continues to approve. We believe it is inappropriate for the state to substitute its judgment for the judgment of the regulatory, scientific and medical experts at FDA,” the statement reads

In a statement, Purdue denied New York’s allegations but said it shared the state’s concerns about the “opioid crisis.”

The Stamford, Connecticut-based company said the U.S. Food and Drug Administration “continues to approve” of scientific and medical information it has provided to doctors.

New York is seeking to impose civil fines, recoup profits and obtain other damages, including for creating an alleged “criminal nuisance.”

Purdue sold $1.74 billion of OxyContin in 2017, according to Symphony Health Solutions.

Opioid makers and distributors face hundreds of lawsuits by U.S. states, counties and cities accusing them of using deceptive marketing to sell the painkillers.

New York joined at least 26 other U.S. states and Puerto Rico in filing lawsuits against Purdue Pharma over opioids and there is a 41-state coalition investigating the opioid industry.

Opioids, including prescription painkillers and heroin, played a role in a record 42,249 U.S. deaths in 2016, according to the U.S. Centers for Disease Control and Prevention.

This included at least 3,086 deaths in New York state and more than 1,100 in New York City.

In 2007, Purdue and three executives pleaded guilty to mis-branding OxyContin and agreed to pay $634.5 million to resolve a U.S. Department of Justice investigation, in the US District Court of Virginia, see Purdue Pharma Criminal Plea Agreement US Department of Justice May 10, 2007.

As Purdue Pharma comes to grips with the fact that they are being designated as the primary litigation targets of states, counties and cities across the country for being the Opiate Big Pharma leader in creating the current opioid crisis in the United States, they may need to determine how they will pay the billions of dollars in jury verdicts and affiliated legal settlements resulting from the lawsuits that now number close to one thousand in state and federal courts.

 

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Zostavax MDL 2848 (Shingles Vaccine) Consolidated In USDC ED Pennsylvania

Zostavax MDL 2848 Puts Merck Back on the MDL Hotseat

By Mark A. York (August 14, 2018)

 

 

 

 

 

 

 

The JPML has created the Zostavax MDL 2848 and assigned the lawsuits filed related to Merck’s shingles vaccine to the United States District Court of Pennsylvania and Judge Harvey Bartle III. See Mass Tort Nexus Zostavax brief case: ZOSTAVAX-(Zoster-Vaccine-Live)-MDL-2848-USDC-Eastern-District-of-Pennsylvania.

Shingles is a rash on the side of the face or body, usually affecting persons over 50. The U.S. Food and Drug Administration approved Zostavax as a shingles vaccine in 2006.

The August 2, 2018  order by the U.S. Judicial Panel on Multidistrict Litigation consolidates Zostavax MDL 2848 in the US District Court of Pennsylvania (Eastern District) in front of U.S. District Judge Harvey Bartle, who has been hearing one of the initial Zostavax cases filed in  016. The lawsuits, filed in courts across the country including, Pennsylvania, New Jersey, New York, Wisconsin and Massachusetts, allege that Merck failed to warn that the virus in the vaccine caused shingles, brain damage and death, among other things.

In a move not often seen, defense counsel for Merck had moved for an MDL assigned to Judge Bartle in Pennsylvania or U.S. District Judge James Moody of the Middle District of Florida.

“Issues concerning the design, testing, manufacture, regulatory approval, labeling, and marketing of Zostavax are common to all actions,” wrote the JPML chairwoman, Sarah Vance. “Seven actions are pending in this district, and they are the earliest filed and most advanced actions in this litigation.”

Lead Counsel Comments

“My cases pending before Judge Bartle are the most advanced in the Zostavax litigation,” said Mark Sadaka of The Law Offices of Sadaka Associates in Englewood, New Jersey, a plaintiffs lawyer who supported sending the cases to Bartle. “Merck has already produced millions of pages of documents in my cases in the Easter District of Pennsylvania. Judge Bartle has already decided two summary judgment motions. I look forward to working together with other plaintiffs counsel to finally move our cases to trial.”

Other plaintiffs lawyers had formally opposed creation of an MDL.

Marc J. Bern & Partners in New York, a firm with by far the most individual plaintiffs in the country—over 5,000 Zostavax clients stated “we will be looking to be leaders in this MDL” and “certainly, Judge Bartle is a judge with long experience, has handled successfully other MDL’s” said name partner Marc Bern.

Merck Previously Admits Shingles Vaccine Can Cause Eye Damage and Shingles

Two important FDA approved changes to the warning label of Merck Pharmaceutical’s shingles vaccine, Zostavax, have been made since the controversial drug was introduced in 2006.  The first was in August 2014, when, in addition to potentially causing chickenpox, another side effect was added: shingles! That’s right. The vaccine that had been – and continues to be — aggressively marketed to prevent seniors from contracting this excruciating condition was found to actually cause shingles in some individuals.

The FDA approved a label change to warn those who prescribe the Zostavax vaccine of another potential side effect: “Eye Disorders: necrotizing retinitis.”

According to the authors of a Health Sciences Institute (HSI) article in January, 2016, “UCLA researchers found that only one in 175 people who get the vaccine will be able to dodge a shingles flare-up.”  While Merck claims Zostavax is 50% effective, in the placebo group, 3.3 percent of the study participants developed shingles, compared to 1.6 percent in the vaccine group. So, while that is a 50% difference, the real, absolute risk reduction is just 1.7 percentage points.

The case criteria generally include the following injurie:

  • Autoimmune disorders, including Guillain-Barre Syndrome, Chronic Inflammatory Demyelinating Polyneuropathy, Meniere’s Disease
  • Bell’s Palsy (facial paralysis)
  • Cardiovascular event
  • Congestive heart failure
  • Death
  • Hearing loss
  • Herpetic Neuralgia (disorder in the nerves)
  • Myelitis (spinal cord inflammation)
  • Pneumonia
  • Postherpetic neuralgia, or PHN (pain continuing after shingles blister subside)
  • Serious neurological diseases or disorders, including brain inflammation (encephalitis)
  • Stroke
  • Vasculitis
  • Vision problems, including blindness, eye infections, retinal damage, acute retinal necrosis

The JPML was aware of certain issues related to creation of MDL 2858, may delay cases for some plaintiffs, many of whom are older, but coordination of the  litigation would help resolve all the cases, “even if some parties might experience inconvenience or delay.”

The JPML order does not apply to lawsuits brought on behalf of 300 plaintiffs in California state court and 800 plaintiffs in New Jersey state court.

One of the lawsuits filed by female plaintiff Joria Bentley from Nevada, claims she suffered high blood pressure, an eye injury and other side effects from Merck & Co.’s Zostavax shingles vaccine in Zostavax litigation filed in the Philadelphia’s Court of Common Pleas. Ms. Bentley claims in her complaint that the patient information sheet, label and prescribing information that accompanied the vaccine did not provide any warning of the risk of viral infection and cites to the many instances of adverse events and other reports on medical issues caused by Zostavax.

Patients who received the injections are filing product liability lawsuits against Merck, alleging the company produced and sold an “unreasonably dangerous vaccine” that caused serious injuries after vaccination. Hailing from a range of states including Louisiana, South Carolina, Tennessee, Michigan and Wisconsin, the plaintiffs filed their suit in Merck’s home state of New Jersey. Instead of preventing shingles, Zostavax caused the plaintiffs to “contract a persistent strain of herpes zoster,” according to the suit, resulting in painful outbreaks, hospital visits and post-herpetic neuralgia in two cases.

The common allegations in all complaints are negligence, defective design, failure to warn, breach of express and implied warranties, misrepresentation involving risk of physical harm and unjust enrichment.

“Merck knew, or should have known, that its product caused viral infection, and was therefore not safe for administration to consumers,” the suits claim. There are “thousands of complaints” yet to be filed according to one of the lead plaintiff attorneys, adding “I think Merck has failed terribly to warn about the very serious side effects and the failure of the vaccine to do what they claim it does” as Merck continues to profit from

National Vaccine Information Center

NVIC provides links and resources such as the manufacturer product information inserts for Zostavax and shingles.

What is Shingles?

  • This information is for educational purposes only and is not intended as medical advice.

What is Zostavax?

Zostavax is a vaccine made by pharmaceutical giant Merck, and approved by the U.S. Food and Drug Administration in 2006. It was the only approved shingles vaccine in the United States until late 2017, which allowed the company to earn as much as $749 million in sales from the vaccine in 2016, according to reports.

This vaccine is designed to reduce the risk of getting herpes zoster — a painful and debilitating condition commonly known as “shingles” — in individuals ages 50 years and older, who are at increased risk of developing the virus. Zostavax is typically recommended for people aged 60 years and older by the U.S. Centers for Disease Control and Prevention, and doctors commonly give the vaccine in a one-dose shot.

Zostavax differs from some vaccines in that it contains a live, but weakened form of the herpes zoster virus (this is officially referred to as a “live, attenuated virus”). People with weakened immune systems cannot receive these types of vaccines.

 

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VERDICT FOR PLAINTIFF! Monsanto Loses First “Roundup” Cancer Trial in San Francisco Courtroom

 Verdict of $288 Million Against Monsanto: “Trial Loss Shows There Was Collusion to Stop Release of Cancer Link For Years”

Regular Damages: $38,819,000 (million)

Punitive Damages: $250 million

Claims Proven by Plaintiffs: Design Defect, Failure to Perform, Design Factor Caused Cancer, Monsnato Failed to Warn of Cancer Risks, “NEGLIGENT FAILURE TO WARN” and others

By Mark A. York (August 10, 2018)

 

 

 

 

 

 

 

DeWayne Johnson vs. Monsanto Is The First Lymphoma Cancer Trial

A verdict in favor of plaintiff DeWayne Johnson was reached earlier today in the first trial versus Monsanto and claims that the weed-killer Roundup causes cancer.

On Thursday, afternoon, the jury requested additional data on the various studies referenced by expert witness in expert witness testimony.

Case is DeWayne Johnson vs. Monsanto Company Case No. CGC-16-550128 in the  SUPERIOR COURT OF CALIFORNIA, SAN FRANCISCO COUNTY, Judge Bolanos.

Johnson Trial Transcripts: Monsanto-roundup-lawsuit/dewayne-johnson-v-monsanto-transcripts(baum-hedlund)

Here is the day one opening statement by Brent Wisner, plaintiff trial counsel with Baum Hedlund Aristei & Goldman.

_________________________________________________________________________________________________________

(MASS TORT NEXUS MEDIA) Glyphosate is the most widely used agricultural based chemical product in history, starting when Monsanto introduced it in 1974, and worldwide use exploded after 1996 when Monsanto began selling “Roundup-ready” seeds- engineered to resist the herbicide, with now possibly catastrophic consequences in the United States.

More than 2.6 billion pounds of the chemical has been spread on U.S. farmlands and yards between 1992 and 2012, according to the U.S. Geological Survey. Roundup traces have been detected in over 50% of the food products being consumed in the US marketplace in numerous independent studies.

Monsanto earns $1.9 billion a year from Roundup and $10.2 billion from “seeds and genomics,” most of that category being Roundup-ready seeds.

In June, German pharmaceutical giant Bayer completed its $63 billion acquisition of Monsanto after approval by U.S. and European regulators, even though the Monsanto name may disappear, the link between cancer and glyphosate will remain long after the merger. Will Bayer decide to settle or take the thousands of lawsuits to trial that are pending in federal and state courts across the country? Although U.S. and European regulators have concluded Roundup’s active ingredient glyphosate is safe, the World Health Organization’s International Agency for Research on Cancer classified it in 2015 as a probable human carcinogen, triggering over 5,000 lawsuits against Monsanto in the United States.

Plaintiff DeWayne Johnson’s skin-based non-Hodgkin lymphoma, was caused by his use of Monsanto’s “Roundup Weed Killer” and Monsanto has gone to great lengths to suppress any links between Roundup and cancer.

The current state court trial in California has shown the extraordinary lengths that Monsanto has gone to in order to suppress and manipulate hard core science and research results around the world that showed clear links between Glyphosate and Cancer, specifically non-hodgkins lymphoma.

To show the high level of interest in the Monsanto “Roundup” abuses, last week musician Neil young and actress Darryl Hannah were in the DeWayne Johnson courtroom, which reflects Young’s ongoing campaign against the many abuses of Monsanto placed upon the US farmers and others around the world. He even released a 2015 album titled “The Monsanto Years” along with a documentary “Seeding Fear” of which Young co-produced related to Monsanto legal action against Alabama farmer Michael White, over its GMO patented seeds. Link to “Seeding Fear can be found here.

In addition to the Johnson state court case, there is the Monsanto Roundup Multidistrict Litigation No. 2741 in the US District Court of California, Northern District where the same cancer links are claimed. Documents released in the Johnson trial and in the MDL ( see Roundup (Monsanto) MDL 2741 USDC ND California) have raised many new questions about the company’s efforts to influence the public opinion by collusion and steering of data published by the media, authors and scientific research publications, and revealed internal debate over the safety of the Monsanto’s weed killer Roundup.

The active ingredient is glyphosate, the most common weed killer in the world and is used around the world on farm crops and by home gardeners, with the largest market being the USA. While Roundup’s relative safety has been upheld by most regulators, the thelitigation against Monsanto and Roundup, pending in US District Court in San Francisco continues to raise questions about the company’s practices and the product itself. Thousands of plaintiffs from across the USA have filed suit against Monsanto-Roundup and as details of Monsanto’s attempt to suppress and influence the release of damaging scientific data are released the number of cases will only increase. There has been documented evidence introduced that shows Monsanto influenced high level US Environmental Protection Agency (EPA) executives to suppress data and the release of reports that showed Roundup (glyphosate) was dangerous and suspected of causing cancer. Jess Rowland, EPA Regulatory Affairs Manager, stopped the release of a government study that was key in the investigation into the carcinogenic effects of Roundup’s primary ingredient glyphosate by the Agency for Toxic Substances and Disease Registry, see EPA’s Jess Rowland Stops Release of Report on Glyphosate as Cancer Agent. Rowland left the EPA in early 2017 and went on to become a highly paid consultant for Monsanto.

There are numerous documents and media articles that underscore the lengths to which the agrochemical company has taken to protect its image, and the dangers of Roundup.  Documents show that Henry I. Miller, an academic and a vocal proponent of genetically modified crops, asked Monsanto to draft an article for him that largely mirrored one that appeared under his name on Forbes’s website in 2015. Mr. Miller could not be reached for comment.

A similar issue appeared in academic research. An academic involved in writing research funded by Monsanto, John Acquavella, a former Monsanto employee, appeared to express concern with the process see Monsanto internal e-mail expressing concern over Roundup , in the 2015 email to a Monsanto executive, “I can’t be part of deceptive authorship on a presentation or publication.” He also said of the way the company was trying to present the authorship: “We call that ghost writing and it is unethical.”

A Monsanto official said the comments were the result of “a complete misunderstanding” that had been “worked out,” while Mr. Acquavella stated via mail that “there was no ghostwriting” and that his comments had been related to an early draft and a question over authorship that was resolved. Even though there are other documents that refute this version of Monsanto’s “official” statement.

Monsanto has been shown to have actively ghostwritten, drafted and offered direction on formal EPA studies, press releases and other “official” documents, introduced in the pending Roundup federal litigation.

The documents also show internal discussions about Roundup’s safety. “If somebody came to me and said they wanted to test Roundup I know how I would react — with serious concern,” one Monsanto scientist wrote in an internal email in 2001.

Monsanto said it was outraged by the documents’ release by a law firm involved in the litigation, although the documents are now public court records, which Monsanto attempted to suppress being introduced into the litigation again and again since the start of the Roundup lawsuits.

  1. Brent Wisner, a partner at Baum, Hedlund, Aristei & Goldman, the firm that released the documents, said Monsanto had erred by not filing a required motion seeking continued protection of the documents. Monsanto said no such filing was necessary.

“Now the world gets to see these documents that would otherwise remain secret”, per Mr. Wisner.

To reflect “official corporate collusion and influence”  see Mr. Miller’s 2015 article on Forbes’s website which was an attack on the findings of the International Agency for Research on Cancer, a branch of the World Health Organization that had labeled glyphosate a probable carcinogen, a finding disputed by other regulatory bodies. In the email traffic, Monsanto asked Mr. Miller if he would be interested in writing an article on the topic, and he said, “I would be if I could start from a high-quality draft.”

The article was authored by Mr. Miller and with the assertion that “opinions expressed by Forbes Contributors are their own.” The magazine did not mention any involvement by Monsanto in preparing the article, as most co-authored articles provide.

“That was a collaborative effort, a function of the outrage we were hearing from many people on the attacks on glyphosate,” Mr. Partridge of Monsanto said. “This is not a scientific, peer-reviewed journal. It’s an op-ed we collaborated with him on.”

After disclosure of the stories origin, Forbes removed the story from its website and said that it ended its relationship with Mr. Miller amid the revelations.

“All contributors to Forbes sign an agreement requiring them to disclose any potential conflicts of interest and only publish content that is their own original writing,” stated a Forbes representative. “When it came to our attention that Mr. Miller violated these terms, we removed his blog from Forbes.com and ended our relationship with him.”

Mr. Miller’s work has also appeared in the opinion pages of The New York Times, which reflects the long reach of Monsanto’s attempts to influence public opinion.

“We have never paid Dr. Miller,” said Sam Murphey, a spokesman for Monsanto. “Our scientists have never collaborated with Dr. Miller on his submissions to The New York Times. Our scientists have on occasion collaborated with Dr. Miller on other pieces.” This statement alone reflects the formal relationship between Miller and Monsanto.

James Dao, the Op-Ed editor of The Times, said in a statement, “Op-Ed contributors to The Times must sign a contract requiring them to avoid any conflict of interest, and to disclose any financial interest in the subject matter of their piece.” Miller and Monsanto did not comment on the apparent violation of this Times policy.

The documents also show that the ongoing debate outside Monsanto about glyphosate safety and Roundup, was also taking place within the company.

In a 2002 email, a Monsanto executive said, “What I’ve been hearing from you is that this continues to be the case with these studies — Glyphosate is O.K. but the formulated product (and thus the surfactant) does the damage.”

As to the internal Monsanto views of a causation relationship between cancer and Roundup, where a different Monsanto executive tells others via e-mail see 2003 Monsanto email, “You cannot say that Roundup is not a carcinogen … we have not done the necessary testing on the formulation to make that statement.”

She adds, however, that “we can make that statement about glyphosate and can infer that there is no reason to believe that Roundup would cause cancer.”

The documents also show that A. Wallace Hayes, the former editor of a journal, Food and Chemical Toxicology, has had a contractual relationship with Monsanto. In a further example of Monsanto collusion and influence in 2013, while he was still editor, Mr. Hayes retracted a key study damaging to Monsanto that found that Roundup, and genetically modified corn, could cause cancer and early death in rats.

Mr. Hayes made a statement that he wasn’t under contract with Monsanto at the time of the retraction,  however he was compensated by Monsanto for the article after he left the journal. This seems to be a very indirect method of exerting influence on the public opinion via a direct method of paying for favorable treatment and influence by Monsanto.

“Monsanto played no role whatsoever in the decision that was made to retract,” he said. “It was based on input that I got from some very well-respected people, and also my own evaluation.” If this statement is accurate, why would Monsanto pay Mr. Hayes for an article determined to be inaccurate or misleading other than the retraction was of some benefit to Monsanto.

Monsanto has been proven time and time again to be directly responsible for corporate sponsored  collusion, influence peddling in both the public and private sectors and manipulation of data released to the public regarding the now known carcinogenic links of exposure to Monsanto’s primary product, Roundup and the main ingredient glyphosate.

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Monsanto “Roundup” Cancer Trial Closing: Was There Proof of Monsanto Collusion to Stop Release of Cancer Link to Roundup?

 

Monsanto Collusion to Stop Release of Cancer Link Now Known

By Mark A. York (August 8, 2018)

 

 

 

 

 

 

 

 

 

 

DeWayne Johnson vs. Monsanto Is The First Lymphoma Cancer Trial

Case is DeWayne Johnson vs. Monsanto Company Case No. CGC-16-550128 in the  SUPERIOR COURT OF CALIFORNIA, SAN FRANCISCO COUNTY, Judge Bolanos.

Johnson Trial Transcripts: Monsanto-roundup-lawsuit/dewayne-johnson-v-monsanto-transcripts(baum-hedlund)

Here is the day one opening statement by Brent Wisner, plaintiff trial counsel with Baum Hedlund Aristei & Goldman.

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(MASS TORT NEXUS MEDIA) Glyphosate is the most widely used agricultural based chemical product in history, starting when Monsanto introduced it in 1974, and worldwide use exploded after 1996 when Monsanto began selling “Roundup-ready” seeds- engineered to resist the herbicide, with now possibly catastrophic consequences in the United States.

More than 2.6 billion pounds of the chemical has been spread on U.S. farmlands and yards between 1992 and 2012, according to the U.S. Geological Survey. Roundup traces have been detected in over 50% of the food products being consumed in the US marketplace in numerous independent studies.

Monsanto earns $1.9 billion a year from Roundup and $10.2 billion from “seeds and genomics,” most of that category being Roundup-ready seeds.

In June, German pharmaceutical giant Bayer completed its $63 billion acquisition of Monsanto after approval by U.S. and European regulators, even though the Monsanto name may disappear, the link between cancer and glyphosate will remain long after the merger. Will Bayer decide to settle or take the thousands of lawsuits to trial that are pending in federal and state courts across the country? Although U.S. and European regulators have concluded Roundup’s active ingredient glyphosate is safe, the World Health Organization’s International Agency for Research on Cancer classified it in 2015 as a probable human carcinogen, triggering over 5,000 lawsuits against Monsanto in the United States.

Plaintiff DeWayne Johnson’s skin-based non-Hodgkin lymphoma, was caused by his use of Monsanto’s “Roundup Weed Killer” and Monsanto has gone to great lengths to suppress any links between Roundup and cancer.

The current state court trial in California has shown the extraordinary lengths that Monsanto has gone to in order to suppress and manipulate hard core science and research results around the world that showed clear links between Glyphosate and Cancer, specifically non-hodgkins lymphoma.

To show the high level of interest in the Monsanto “Roundup” abuses, last week musician Neil young and actress Darryl Hannah were in the DeWayne Johnson courtroom, which reflects Young’s ongoing campaign against the many abuses of Monsanto placed upon the US farmers and others around the world. He even released a 2015 album titled “The Monsanto Years” along with a documentary “Seeding Fear” of which Young co-produced related to Monsanto legal action against Alabama farmer Michael White, over its GMO patented seeds. Link to “Seeding Fear can be found here.

In addition to the Johnson state court case, there is the Monsanto Roundup Multidistrict Litigation No. 2741 in the US District Court of California, Northern District where the same cancer links are claimed. Documents released in the Johnson trial and in the MDL ( see Roundup (Monsanto) MDL 2741 USDC ND California) have raised many new questions about the company’s efforts to influence the public opinion by collusion and steering of data published by the media, authors and scientific research publications, and revealed internal debate over the safety of the Monsanto’s weed killer Roundup.

The active ingredient is glyphosate, the most common weed killer in the world and is used around the world on farm crops and by home gardeners, with the largest market being the USA. While Roundup’s relative safety has been upheld by most regulators, the thelitigation against Monsanto and Roundup, pending in US District Court in San Francisco continues to raise questions about the company’s practices and the product itself. Thousands of plaintiffs from across the USA have filed suit against Monsanto-Roundup and as details of Monsanto’s attempt to suppress and influence the release of damaging scientific data are released the number of cases will only increase. There has been documented evidence introduced that shows Monsanto influenced high level US Environmental Protection Agency (EPA) executives to suppress data and the release of reports that showed Roundup (glyphosate) was dangerous and suspected of causing cancer. Jess Rowland, EPA Regulatory Affairs Manager, stopped the release of a government study that was key in the investigation into the carcinogenic effects of Roundup’s primary ingredient glyphosate by the Agency for Toxic Substances and Disease Registry, see EPA’s Jess Rowland Stops Release of Report on Glyphosate as Cancer Agent. Rowland left the EPA in early 2017 and went on to become a highly paid consultant for Monsanto.

There are numerous documents and media articles that underscore the lengths to which the agrochemical company has taken to protect its image, and the dangers of Roundup.  Documents show that Henry I. Miller, an academic and a vocal proponent of genetically modified crops, asked Monsanto to draft an article for him that largely mirrored one that appeared under his name on Forbes’s website in 2015. Mr. Miller could not be reached for comment.

A similar issue appeared in academic research. An academic involved in writing research funded by Monsanto, John Acquavella, a former Monsanto employee, appeared to express concern with the process see Monsanto internal e-mail expressing concern over Roundup , in the 2015 email to a Monsanto executive, “I can’t be part of deceptive authorship on a presentation or publication.” He also said of the way the company was trying to present the authorship: “We call that ghost writing and it is unethical.”

A Monsanto official said the comments were the result of “a complete misunderstanding” that had been “worked out,” while Mr. Acquavella stated via mail that “there was no ghostwriting” and that his comments had been related to an early draft and a question over authorship that was resolved. Even though there are other documents that refute this version of Monsanto’s “official” statement.

Monsanto has been shown to have actively ghostwritten, drafted and offered direction on formal EPA studies, press releases and other “official” documents, introduced in the pending Roundup federal litigation.

The documents also show internal discussions about Roundup’s safety. “If somebody came to me and said they wanted to test Roundup I know how I would react — with serious concern,” one Monsanto scientist wrote in an internal email in 2001.

Monsanto said it was outraged by the documents’ release by a law firm involved in the litigation, although the documents are now public court records, which Monsanto attempted to suppress being introduced into the litigation again and again since the start of the Roundup lawsuits.

  1. Brent Wisner, a partner at Baum, Hedlund, Aristei & Goldman, the firm that released the documents, said Monsanto had erred by not filing a required motion seeking continued protection of the documents. Monsanto said no such filing was necessary.

“Now the world gets to see these documents that would otherwise remain secret”, per Mr. Wisner.

To reflect “official corporate collusion and influence”  see Mr. Miller’s 2015 article on Forbes’s website which was an attack on the findings of the International Agency for Research on Cancer, a branch of the World Health Organization that had labeled glyphosate a probable carcinogen, a finding disputed by other regulatory bodies. In the email traffic, Monsanto asked Mr. Miller if he would be interested in writing an article on the topic, and he said, “I would be if I could start from a high-quality draft.”

The article was authored by Mr. Miller and with the assertion that “opinions expressed by Forbes Contributors are their own.” The magazine did not mention any involvement by Monsanto in preparing the article, as most co-authored articles provide.

“That was a collaborative effort, a function of the outrage we were hearing from many people on the attacks on glyphosate,” Mr. Partridge of Monsanto said. “This is not a scientific, peer-reviewed journal. It’s an op-ed we collaborated with him on.”

After disclosure of the stories origin, Forbes removed the story from its website and said that it ended its relationship with Mr. Miller amid the revelations.

“All contributors to Forbes sign an agreement requiring them to disclose any potential conflicts of interest and only publish content that is their own original writing,” stated a Forbes representative. “When it came to our attention that Mr. Miller violated these terms, we removed his blog from Forbes.com and ended our relationship with him.”

Mr. Miller’s work has also appeared in the opinion pages of The New York Times, which reflects the long reach of Monsanto’s attempts to influence public opinion.

“We have never paid Dr. Miller,” said Sam Murphey, a spokesman for Monsanto. “Our scientists have never collaborated with Dr. Miller on his submissions to The New York Times. Our scientists have on occasion collaborated with Dr. Miller on other pieces.” This statement alone reflects the formal relationship between Miller and Monsanto.

James Dao, the Op-Ed editor of The Times, said in a statement, “Op-Ed contributors to The Times must sign a contract requiring them to avoid any conflict of interest, and to disclose any financial interest in the subject matter of their piece.” Miller and Monsanto did not comment on the apparent violation of this Times policy.

The documents also show that the ongoing debate outside Monsanto about glyphosate safety and Roundup, was also taking place within the company.

In a 2002 email, a Monsanto executive said, “What I’ve been hearing from you is that this continues to be the case with these studies — Glyphosate is O.K. but the formulated product (and thus the surfactant) does the damage.”

As to the internal Monsanto views of a causation relationship between cancer and Roundup, where a different Monsanto executive tells others via e-mail see 2003 Monsanto email, “You cannot say that Roundup is not a carcinogen … we have not done the necessary testing on the formulation to make that statement.”

She adds, however, that “we can make that statement about glyphosate and can infer that there is no reason to believe that Roundup would cause cancer.”

The documents also show that A. Wallace Hayes, the former editor of a journal, Food and Chemical Toxicology, has had a contractual relationship with Monsanto. In a further example of Monsanto collusion and influence in 2013, while he was still editor, Mr. Hayes retracted a key study damaging to Monsanto that found that Roundup, and genetically modified corn, could cause cancer and early death in rats.

Mr. Hayes made a statement that he wasn’t under contract with Monsanto at the time of the retraction,  however he was compensated by Monsanto for the article after he left the journal. This seems to be a very indirect method of exerting influence on the public opinion via a direct method of paying for favorable treatment and influence by Monsanto.

“Monsanto played no role whatsoever in the decision that was made to retract,” he said. “It was based on input that I got from some very well-respected people, and also my own evaluation.” If this statement is accurate, why would Monsanto pay Mr. Hayes for an article determined to be inaccurate or misleading other than the retraction was of some benefit to Monsanto.

Monsanto has been proven time and time again to be directly responsible for corporate sponsored  collusion, influence peddling in both the public and private sectors and manipulation of data released to the public regarding the now known carcinogenic links of exposure to Monsanto’s primary product, Roundup and the main ingredient glyphosate.

The Johnson vs. Monsanto trial verdict will be posted as soon as it becomes available.

For additional MDL and mass tort updates at no cost visit: www.masstortnexus.com/news and register for newsletters

 

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Opioid Addiction In 2016: Employer Costs Pass $2.6 Billion Per Year With 50% Used to Cover Children

Employer Costs Pass $2.6 Billion Per Year With 50% Used to Cover Children

By Mark A. York (August 3, 2018)

  • Employers spent $2.6 billion on opioid addiction in 2016

  • $1.5 billion+ was spent on children with opiate addiction issues

(MASS TORT NEXUS MEDIA) The now commonly known costs associated with employers treating opioid addiction and the affiliated issues have increased eight hundred percent  since 2004 to an eye-watering $2.6 billion in 2016, a new report reveals.

The latest analysis shows that half of the cost was spent covering employees’ children.

A recent Kaiser Family Foundation report found that prescription use of addictive painkillers among people with employer offered health coverage is now at the lowest levels in 10 years.

This comes shortly after a CDC study revealed there was been a nearly 30 percent increase in overdoses between 2015 and 2016.

 

 

 

 

 

 

 

 

According to the Centers for Disease Control and Prevention, opioids killed more than 42,000 people in 2016, more than any year on record.

With 40 percent of those deaths involving a prescription opioid such as Oxycontin and Vicodin and other widely prescribed opiates. This has also resulted in the multi-billion lawsuits filed against Opioid Big Pharma drug makers and distributors by cities, counties and states across the country, see Mass Tort Nexus Briefcase “Opioid Litigation Versus Opiate Prescription Industry MDL 2804, US District Court of Ohio” with the drug makers and distributors scrambling to defend the opiate marketing strategies that have caused billions and billions of dollars in costs, medical damages and loss of productivity annually in the United States.  

The Kaiser Family Foundation found that the $2.6 billion spending cost companies and workers about $26 per enrollee in 2016, which now appears to be a “man-made” healthcare cost increase associated with the widely accepted Opiate Big Pharma marketing practices over the last 20 years. This include telling doctors and the healthcare industry that “opiates are not as addictive as they used to be” and “we’ve altered the drug compound to control opiate release” which was the widely used Purdue Pharma marketing strategy.

Employers have been limiting insurance coverage of opioids because of concerns about addiction. The report found that spending on opioid prescriptions falling 27 percent from a peak in 2009 – when 17.3 percent of large employer plan enrollees had at least one opioid prescription during that year.  However, by 2016, that number dropped to 13.6 percent.

These drugs relieve pain by attaching to specific proteins called opioid receptors, which are found on nerve cells in the brain, spinal cord, gastrointestinal tract, and other organs in the body. When they attach to these receptors, they reduce the perception of pain.

RESIDUAL ISSUE OF FOSTER CARE

 

 

 

 

 

 

 

 

 

 

OPIOID USE DISORDER IN PREGNANT WOMEN:

  • “Treating Women Who Are Pregnant and Parenting for Opioid Use Disorder and the Concurrent Care of Their Infants and Children: Literature Review to Support National Guidance.  https://www.ncbi.nlm.nih.gov/pubmed/28406856
  • [STUDY OBJECTIVES:The prevalence of opioid use disorder (OUD) during pregnancy is increasing. Practical recommendations will help providers treat pregnant women with OUD and reduce potentially negative health consequences for mother, fetus, and child. This article summarizes the literature review conducted using the RAND/University of California, Los Angeles Appropriateness Method project completed by the US Department of Health and Human Services Substance Abuse and Mental Health Services Administration to obtain current evidence on treatment approaches for pregnant and parenting women with OUD and their infants and children]

Prescription opioids and illicit drugs have become incredibly pervasive throughout the US, and things are only getting worse.

In the early 2000s, the FDA and CDC started to notice a steady increase in cases of opioid addiction and overdose. In 2013, they issued guidelines to curb addiction.

However, that same year – now regarded as the year the epidemic took hold – a CDC report revealed an unprecedented surge in rates of opioid addiction.

Overdose deaths are now the leading cause of death among young Americans – killing more in a year than were ever killed annually by HIV, gun violence or car crashes.

Preliminary CDC data published by the New York Times shows US drug overdose deaths surged 19 percent to at least 59,000 in 2016.

That is up from 52,404 in 2015, and double the death rate a decade ago.

It means that for the first time drug overdoses are the leading cause of death for Americans under 50 years old.

The data lays bare the bleak state of America’s opioid addiction crisis fueled by deadly manufactured drugs like fentanyl.

These drugs also effect the brain regions involved in reward, so it can also produce a sense of pleasure by triggering the same processes that make people feel good when they are having fun or sex.

Experts say many people’s first contact with opioids is through some form of social contact: either a friend who was sent home with Oxycontin after a surgical procedure or a relative who received an opioid prescription for chronic pain.

‘Opioids are not infectious in terms of [being] an agent,’ Columbia University epidemiologist Dr Guohua Li previously told Daily Mail Online.

‘Opioids, are not a bacteria virus, but the drug, in this case, spreads through social networks…even in some ways a virus, like HIV, is spread to a great degree through social networks,’ he added.

Due to the link between hospitals and the opioid crisis, doctors have been coming up with innovative ways to curb the epidemic.

However, hospitals have been doing their part in trying to curb the opioid epidemic.

For instance, the ER department at St. Joseph University Medical Center in New Jersey managed to halve the rate of opioid prescriptions by using dry needles and laughing gas to treat chronic pain.

In 2016, the department launched an Alternative to Opiates program that uses trigger point injections and a local anesthetics in lieu of opioids to relieve pain. Other alternative pain relieving methods they used was warm compressors and  music – they have a harpist roam the halls playing tunes to soothe the patients.

Dr Mark Rosenberg, chair of emergency medicine, said he and his colleagues founded the program after they realized chronic pain was one of the reasons most patients came to their emergency department.

‘We wanted to develop an aggressive acute pain management program that focused on evidence based principles but avoided opioids,’ Dr Rosenberg said.

St. Joseph University Medical Center isn’t the only hospital to implement this program, Kaiser Permanente has implemented an Integrated Pain Service, an eight-week course designed to educate high-risk opioid patients about pain management.

Some experts have stated that  the beginning of the end of the epidemic may be near due to tightened regulations on opioid prescription monitoring, local-level efforts to make naloxone, an anti-overdose drug, and drug-assisted rehabilitation more accessible to high-risk populations. Then there are many more “experts” who state that the opioid crisis and the future affiliated issues are going to be on the healthcare, insurance and socio-economic forefront of America for at least the next generation.

Broken Families, Less Funding

The patterns of parent addiction that overflows into child addiction is something that wasn’t part of the opiate equation until fairly recently, where employer issues now mirror a national trend of multiple generations being addicted to opiates. Largely because of the opioid epidemic, there were 30,000 more children in foster care in 2015 than there were in 2012—an 8 percent increase. In 14 states, from New Hampshire to North Dakota, the number of foster kids rose by more than a quarter between 2011 and 2015, according to data amassed by the Annie E. Casey Foundation. In Texas, Florida, Oregon, and elsewhere, kids have been forced to sleep in state buildings because there were no foster homes available, says advocacy group Children’s Rights. Federal child welfare money has been dwindling for years, leaving state and local funding to fill in the gaps. But Ashtabula County is one of the poorest counties in Ohio, and despite a recent boost in funding, the state contributes the lowest share toward children’s services of any state in the country. 

In the USA, Opioid use by women in rural areas is driving the increasing numbers. Tennessee is part of a cluster of states, including Alabama and Kentucky, experiencing some of the highest rates of NAS births. In East Tennessee the problem is particularly acute: Sullivan County alone reported a rate of 50.5 cases of NAS per 1,000 births, the highest rate in the state for five years running.

Tennessee is currently the only state in the country that equates substance abuse while pregnant with aggravated assault, punishable by a 15-year prison sentence. Eighteen other states consider it to be child abuse, and three say its grounds for civil commitment. Four states require drug testing of mothers and 18 require that healthcare professionals report when drug abuse is suspected. There are also 19 states that have created funding for targeted drug treatment programs for pregnant women.

Opponents of the punishment philosophy claim that punishing addicted pregnant women will not stop them from abusing drugs – instead it will stop them from seeking prenatal care. Many also claim that these policies would unfairly punish mothers for drug use compared to fathers. Organizations, such as the American Civil Liberties Union (ACLU) and the American Congress of Obstetricians and Gynecologists (ACOG), have encouraged a treatment over punishment approach for pregnant mothers with drug addictions

Local efforts are now seen as the primary way to address the opioid crisis in children- the attempt to secure federal intervention and support to help curb the opioid crisis has not been a priority of the Trump Administration..

WHITE HOUSE PROMISED ON OPIOIDS BUT DIDN’T DELIVER

But since he took office, Trump’s plans to tackle the epidemic head-on have fizzled. Republicans’ recent effort to repeal and replace Obamacare would slash funding for Medicaid, which is the country’s largest payer for addiction services—and which covers nearly half of Ohio’s prescriptions for the opioid addiction medication buprenorphine. The bill would enable insurers in some states to get out of the Obamacare requirement to cover substance abuse treatment. A memo leaked in May revealed Trump’s plans to effectively eliminate the White House’s drug policy office, cutting its budget by 95 percent. (The administration has since backpedaled on the plans, following bipartisan criticism.) Trump’s 2018 budget proposes substantial cuts to the Administration for Children and Families, the Substance Abuse and Mental Health Services Administration, and the Temporary Assistance for Needy Families program.

Until the governments at the federal, state and local levels can all agree on a long term viable solution to the opioid crisis and the impact on school age children, infants born addicted and society as a whole, the opiate drug crisis will linger for generations long into the future.

 

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Why Does the FDA Ignore “Off-Label” Drug Marketing?

“BY REMOVING FDA OVERSIGHT BIG PHARMA RUNS AMOK”

By Mark A. York (August 1, 2018)

(MASS TORT NEXUS MEDIA)  In 2017 and continuing into 2018, Big Pharma has been fighting major legal battles related to off-label marketing of drugs for unintended uses. They also engaged in a parallel strategy, where they were influencing the FDA and other policy making agencies behind the scenes in Washington DC. Big Pharma was paying millions to lobbyists, making campaign donations and generally buying influence as they always have. It was a foregone conclusion that with the Trump administration view of , “no regulatory oversight required” that there would be some loosening of the FDA regulatory shackles.

Big Pharma was getting ready for freedom to sell, sell, sell their drugs in any way they could, including off-label marketing of the drugs for unintended use purposes. A corporate policy, that’s technically illegal, yet results in billions of dollars in profits every years for Big Pharma. Then the FDA rolled out an unexpected new proposed rule, in March 2017 cracking down on “off-label’ marketing of drugs. This new rule change wasn’t in Big Pharma’s bests interests, sending the drug industry into a furious lobbying scramble. Bring in the Trump camp and on January 12, 2018 Big Pharma and the army of lobbyists and elected officials that were recruited, seem to have succeeded in stopping the FDA rules change that would have tightened up “off label” marketing of drugs.

Trump stops FDA enforcement rule change: January 12, 2018 Food and Drug Administration Press Release: FDA Delays Change to “Off-Label” Drug Use Enforcement Rules

This seems to be further evidence of the Trump administration permitting private corporations to control what goes on behind the scenes in federal regulatory agencies these days. The same loosening of enforcement rules has been seen in the EPA as well as in Dept. of Energy oversight enforcement authority. Whatever else you might think about the ramped up Trump vs. Obama administration mindset, this rule delay is an example of the new FDA leadership doing what is in the best interests of those they are supposed to be regulating, the drug makers, and not in the interests of the US consumers.

To put this into perspective, consider the current “Opioid Crisis” gripping the entire country, where “off-label” marketing of opiates for the last 20 years by drug makers, has resulted in thousands of deaths each year, unknown financial losses and the related social impact felt in every state across the country. Another result is the Opiate Prescription Litigation MDL 2804, (see OPIOID CRISIS BRIEFCASE: MDL 2804 OPIATE PRESCRIPTION LITIGATION) where litigation started when hundreds of counties, states and cities and other entities impacted by the catastrophic expense related to combatting the opiate healthcare crisis fought back. The various parties have filed lawsuits against opioid drug makers and distributors, demanding repayment of the billions of dollars spent on addressing the massive costs related to opioid abuse, primarily due to opioid based prescription drugs flooding the country.

When the Obama administration ended on January 9, 2017, the FDA issued a Final Rule on “Clarification of When Products Made or Derived from Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘Intended Uses.’” That “clarification” was meant to enable additional enforcement and control over drug makers rampant “off -label” marketing of drugs for purposes that were never FDA approved. This was an attempt by the FDA to have the ability to punish off-label promotions, where previously the process was a two-step regulatory review, whereby off-label promotions are said to prove an indicated use not included in the label and, thus, not accompanied by adequate directions for use – making the product misbranded. These regulations have been around since the 1950s, but a recent series of court decisions invoking the First Amendment called into question the FDA’s interpretation of “intended use” and its efforts to shut down truthful medical-science communications about potential benefits from off-label use.

In a 2015 proposed rule, the FDA referred to striking the language from regulations permitting the FDA to consider a manufacturer’s mere knowledge of actual use as evidence of intended use, which would have further enabled Big Pharma drug marketing abuses to go unchecked. But then, the FDA’s January 9, 2017 proposal reversed course, stating that retained knowledge of off-label use as evidence of intended use, clarified that any relevant source of evidence, whether circumstantial or direct could demonstrate intended use, and ultimately invoked the dreaded “totality of the evidence” standard. This would have enable the FDA to begin oversight and enforcement of practices such as the blatant and wide open “off-label” marketing of opioid prescription drugs that started in the mid-1990’s and never stopped.

Instead of putting a check on Big Pharma abuses, we have the Trump administration placing a hold on new regulations, and delaying the “intended use” regulation change to March 19, 2018, so that comments could be received and considered, and thereby enabling the Big Pharma “lobby machine” to become fully engaged across all DC circles, ensuring that the FDA changes are effectively put to rest.

The bottom line is that the FDA is now proposing to “delay until further notice” the portions of the final rule amending the FDA’s existing regulations on “off-label” drug use, when describing the types of evidence that may be considered in determining a medical product’s intended uses.  The FDA will receive comments on this proposal through February 5, 2018.

Here is the official FDA publication of January 16, 2018:

The Federal Register:  https://www.federalregister.gov/documents/2018/01/16/2018-00555/clarification-of-when-products-made-or-derived-from-tobacco-are-regulated-as-drugs-devices-or

WHAT IS “OFF-LABEL” MARKETING?

Global health care giant Johnson & Johnson (J&J) and its subsidiaries will pay more than $2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider.  The global resolution is one of the largest health care fraud settlements in U.S. history, including criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion.

“The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” stated Eric Holder, then US Attorney General, “This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health care fraud.  And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people” he added.

The resolution includes criminal fines and forfeiture for violations of the law and civil settlements based on the False Claims Act arising out of multiple investigations of the company and its subsidiaries.

“When companies put profit over patients’ health and misuse taxpayer dollars, we demand accountability,” said Associate Attorney General Tony West.  “In addition to significant monetary sanctions, we will ensure that non-monetary measures are in place to facilitate change in corporate behavior and help ensure the playing field is level for all market participants.”

The Federal Food, Drug, and Cosmetic Act (FDCA) protects the health and safety of the public by ensuring, among other things, that drugs intended for use in humans are safe and effective for their intended uses and that the labeling of such drugs bear true, complete and accurate information.  Under the FDCA, a pharmaceutical company must specify the intended uses of a drug in its new drug application to the FDA.  Before approval, the FDA must determine that the drug is safe and effective for those specified uses.  Once the drug is approved, if the company intends a different use and then introduces the drug into interstate commerce for that new, unapproved use, the drug becomes misbranded.  The unapproved use is also known as an “off-label” use because it is not included in the drug’s FDA-approved labeling.

“When pharmaceutical companies interfere with the FDA’s mission of ensuring that drugs are safe and effective for the American public, they undermine the doctor-patient relationship and put the health and safety of patients at risk,” said Director of the FDA’s Office of Criminal Investigations John Roth.  “Today’s settlement demonstrates the government’s continued focus on pharmaceutical companies that put profits ahead of the public’s health.  The FDA will continue to devote resources to criminal investigations targeting pharmaceutical companies that disregard the drug approval process and recklessly promote drugs for uses that have not been proven to be safe and effective.”

 J&J RISPERDAL MARKETING ABUSE

In a related civil complaint filed today in the Eastern District of Pennsylvania, the United States alleges that Janssen marketed Risperdal to control the behaviors and conduct of the nation’s most vulnerable patients: elderly nursing home residents, children and individuals with mental disabilities.  The government alleges that J&J and Janssen caused false claims to be submitted to federal health care programs by promoting Risperdal for off-label uses that federal health care programs did not cover, making false and misleading statements about the safety and efficacy of Risperdal and paying kickbacks to physicians to prescribe Risperdal.

“J&J’s promotion of Risperdal for unapproved uses threatened the most vulnerable populations of our society – children, the elderly and those with developmental disabilities,” said U.S. Attorney for the Eastern District of Pennsylvania Zane Memeger.  “This historic settlement sends the message that drug manufacturers who place profits over patient care will face severe criminal and civil penalties.”

In its complaint, the government alleges that the FDA repeatedly advised Janssen that marketing Risperdal as safe and effective for the elderly would be “misleading.”  The FDA cautioned Janssen that behavioral disturbances in elderly dementia patients were not necessarily manifestations of psychotic disorders and might even be “appropriate responses to the deplorable conditions under which some demented patients are housed, thus raising an ethical question regarding the use of an antipsychotic medication for inappropriate behavioral control.”

The complaint further alleges that J&J and Janssen were aware that Risperdal posed serious health risks for the elderly, including an increased risk of strokes, but that the companies downplayed these risks.  For example, when a J&J study of Risperdal showed a significant risk of strokes and other adverse events in elderly dementia patients, the complaint alleges that Janssen combined the study data with other studies to make it appear that there was a lower overall risk of adverse events.  A year after J&J had received the results of a second study confirming the increased safety risk for elderly patients taking Risperdal, but had not published the data, one physician who worked on the study cautioned Janssen that “[a]t this point, so long after [the study] has been completed … we must be concerned that this gives the strong appearance that Janssen is purposely withholding the findings.”

The complaint also alleges that Janssen knew that patients taking Risperdal had an increased risk of developing diabetes, but nonetheless promoted Risperdal as “uncompromised by safety concerns (does not cause diabetes).”  When Janssen received the initial results of studies indicating that Risperdal posed the same diabetes risk as other antipsychotics, the complaint alleges that the company retained outside consultants to re-analyze the study results and ultimately published articles stating that Risperdal was actually associated with a lower risk of developing diabetes.

The complaint alleges that, despite the FDA warnings and increased health risks, from 1999 through 2005, Janssen aggressively marketed Risperdal to control behavioral disturbances in dementia patients through an “ElderCare sales force” designed to target nursing homes and doctors who treated the elderly.  In business plans, Janssen’s goal was to “[m]aximize and grow RISPERDAL’s market leadership in geriatrics and long term care.”  The company touted Risperdal as having “proven efficacy” and “an excellent safety and tolerability profile” in geriatric patients.

In addition to promoting Risperdal for elderly dementia patients, from 1999 through 2005, Janssen allegedly promoted the antipsychotic drug for use in children and individuals with mental disabilities.  The complaint alleges that J&J and Janssen knew that Risperdal posed certain health risks to children, including the risk of elevated levels of prolactin, a hormone that can stimulate breast development and milk production.  Nonetheless, one of Janssen’s Key Base Business Goals was to grow and protect the drug’s market share with child/adolescent patients.  Janssen instructed its sales representatives to call on child psychiatrists, as well as mental health facilities that primarily treated children, and to market Risperdal as safe and effective for symptoms of various childhood disorders, such as attention deficit hyperactivity disorder, oppositional defiant disorder, obsessive-compulsive disorder and autism.  Until late 2006, Risperdal was not approved for use in children for any purpose, and the FDA repeatedly warned the company against promoting it for use in children.

The government’s complaint also contains allegations that Janssen paid speaker fees to doctors to influence them to write prescriptions for Risperdal.  Sales representatives allegedly told these doctors that if they wanted to receive payments for speaking, they needed to increase their Risperdal prescriptions.

In addition to allegations relating to Risperdal, today’s settlement also resolves allegations relating to Invega, a newer antipsychotic drug also sold by Janssen.  Although Invega was approved only for the treatment of schizophrenia and schizoaffective disorder, the government alleges that, from 2006 through 2009, J&J and Janssen marketed the drug for off-label indications and made false and misleading statements about its safety and efficacy.

As part of the global resolution, J&J and Janssen have agreed to pay a total of $1.391 billion to resolve the false claims allegedly resulting from their off-label marketing and kickbacks for Risperdal and Invega.  This total includes $1.273 billion to be paid as part of the resolution announced today, as well as $118 million that J&J and Janssen paid to the state of Texas in March 2012 to resolve similar allegations relating to Risperdal.  Because Medicaid is a joint federal-state program, J&J’s conduct caused losses to both the federal and state governments.  The additional payment made by J&J as part of today’s settlement will be shared between the federal and state governments, with the federal government recovering $749 million, and the states recovering $524 million.  The federal government and Texas each received $59 million from the Texas settlement.

NURSING HOME PATIENT ABUSES BY J&J

The civil settlement also resolves allegations that, in furtherance of their efforts to target elderly dementia patients in nursing homes, J&J and Janssen paid kickbacks to Omnicare Inc., the nation’s largest pharmacy specializing in dispensing drugs to nursing home patients.  In a complaint filed in the District of Massachusetts in January 2010, the United States alleged that J&J paid millions of dollars in kickbacks to Omnicare under the guise of market share rebate payments, data-purchase agreements, “grants” and “educational funding.”  These kickbacks were intended to induce Omnicare and its hundreds of consultant pharmacists to engage in “active intervention programs” to promote the use of Risperdal and other J&J drugs in nursing homes.  Omnicare’s consultant pharmacists regularly reviewed nursing home patients’ medical charts and made recommendations to physicians on what drugs should be prescribed for those patients.  Although consultant pharmacists purported to provide “independent” recommendations based on their clinical judgment, J&J viewed the pharmacists as an “extension of [J&J’s] sales force.”

J&J and Janssen have agreed to pay $149 million to resolve the government’s contention that these kickbacks caused Omnicare to submit false claims to federal health care programs.  The federal share of this settlement is $132 million, and the five participating states’ total share is $17 million.  In 2009, Omnicare paid $98 million to resolve its civil liability for claims that it accepted kickbacks from J&J and Janssen, along with certain other conduct.

“Consultant pharmacists can play an important role in protecting nursing home residents from the use of antipsychotic drugs as chemical restraints,” said U.S. Attorney for the District of Massachusetts Carmen Ortiz.  “This settlement is a reminder that the recommendations of consultant pharmacists should be based on their independent clinical judgment and should not be the product of money paid by drug companies.”

OFF-LABEL USE OF HEART DRUG NATRECOR

The civil settlement announced today also resolves allegations that J&J and another of its subsidiaries, Scios Inc., caused false and fraudulent claims to be submitted to federal health care programs for the heart failure drug Natrecor.  In August 2001, the FDA approved Natrecor to treat patients with acutely decompensated congestive heart failure who have shortness of breath at rest or with minimal activity.  This approval was based on a study involving hospitalized patients experiencing severe heart failure who received infusions of Natrecor over an average 36-hour period.

In a civil complaint filed in 2009 in the Northern District of California, the government alleged that, shortly after Natrecor was approved, Scios launched an aggressive campaign to market the drug for scheduled, serial outpatient infusions for patients with less severe heart failure – a use not included in the FDA-approved label and not covered by federal health care programs.  These infusions generally involved visits to an outpatient clinic or doctor’s office for four- to six-hour infusions one or two times per week for several weeks or months.

The government’s complaint alleged that Scios had no sound scientific evidence supporting the medical necessity of these outpatient infusions and misleadingly used a small pilot study to encourage the serial outpatient use of the drug.  Among other things, Scios sponsored an extensive speaker program through which doctors were paid to tout the purported benefits of serial outpatient use of Natrecor.  Scios also urged doctors and hospitals to set up outpatient clinics specifically to administer the serial outpatient infusions, in some cases providing funds to defray the costs of setting up the clinics, and supplied providers with extensive resources and support for billing Medicare for the outpatient infusions.

As part of today’s resolution, J&J and Scios have agreed to pay the federal government $184 million to resolve their civil liability for the alleged false claims to federal health care programs resulting from their off-label marketing of Natrecor.  In October 2011, Scios pleaded guilty to a misdemeanor FDCA violation and paid a criminal fine of $85 million for introducing Natrecor into interstate commerce for an off-label use.

“This case is an example of a drug company encouraging doctors to use a drug in a way that was unsupported by valid scientific evidence,” said First Assistant U.S. Attorney for the Northern District of California Brian Stretch.  “We are committed to ensuring that federal health care programs do not pay for such inappropriate uses, and that pharmaceutical companies market their drugs only for uses that have been proven safe and effective.”

Non-Monetary Provisions of the Global Resolution and Corporate Integrity Agreement

In addition to the criminal and civil resolutions, J&J executed a five-year Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General (HHS-OIG).  The CIA includes provisions requiring J&J to implement major changes to the way its pharmaceutical affiliates do business.  Among other things, the CIA requires J&J to change its executive compensation program to permit the company to recoup annual bonuses and other long-term incentives from covered executives if they, or their subordinates, engage in significant misconduct.  J&J may recoup monies from executives who are current employees and from those who have left the company.  The CIA also requires J&J’s pharmaceutical businesses to implement and maintain transparency regarding their research practices, publication policies and payments to physicians.  On an annual basis, management employees, including senior executives and certain members of J&J’s independent board of directors, must certify compliance with provisions of the CIA.  J&J must submit detailed annual reports to HHS-OIG about its compliance program and its business operations.

“OIG will work aggressively with our law enforcement partners to hold companies accountable for marketing and promotion that violate laws intended to protect the public,” said Inspector General of the U.S. Department of Health and Human Services Daniel R. Levinson.  “Our compliance agreement with Johnson & Johnson increases individual accountability for board members, sales representatives, company executives and management.  The agreement also contains strong monitoring and reporting provisions to help ensure that the public is protected from future unlawful and potentially harmful off-label marketing.”

FEDERAL AND STATE JOINT CRIMINAL INVESTIGATIONS

This resolution marks the culmination of an extensive, coordinated investigation by federal and state law enforcement partners that is the hallmark of the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which fosters government collaborations to fight fraud.  Announced in May 2009 by Attorney General Eric Holder and Health and Human Services Secretary Kathleen Sebelius, the HEAT initiative has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation.

The criminal cases against Janssen and Scios were handled by the U.S. Attorney’s Offices for the Eastern District of Pennsylvania and the Northern District of California and the Civil Division’s Consumer Protection Branch.  The civil settlements were handled by the U.S. Attorney’s Offices for the Eastern District of Pennsylvania, the Northern District of California and the District of Massachusetts and the Civil Division’s Commercial Litigation Branch.  Assistance was provided by the HHS Office of Counsel to the Inspector General, Office of the General Counsel-CMS Division, the FDA’s Office of Chief Counsel and the National Association of Medicaid Fraud Control Units.

This matter was investigated by HHS-OIG, the Department of Defense’s Defense Criminal Investigative Service, the FDA’s Office of Criminal Investigations, the Office of Personnel Management’s Office of Inspector General, the Department of Veterans Affairs, the Department of Labor, TRICARE Program Integrity, the U.S. Postal Inspection Service’s Office of the Inspector General and the FBI.

One of the most powerful tools in the fight against Medicare and Medicaid financial fraud is the False Claims Act.  Since January 2009, the Justice Department has recovered a total of more than $16.7 billion through False Claims Act cases, with more than $11.9 billion of that amount recovered in cases involving fraud against federal health care programs.

The department enforces the FDCA by prosecuting those who illegally distribute unapproved, misbranded and adulterated drugs and medical devices in violation of the Act.  Since 2009, fines, penalties and forfeitures that have been imposed in connection with such FDCA violations have totaled more than $6 billion.

The civil settlements described above resolve multiple lawsuits filed under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the government and to share in any recovery.  From the federal government’s share of the civil settlements announced today, the whistleblowers in the Eastern District of Pennsylvania will receive $112 million, the whistleblowers in the District of Massachusetts will receive $27.7 million and the whistleblower in the Northern District of California will receive $28 million.  Except to the extent that J&J subsidiaries have pleaded guilty or agreed to plead guilty to the criminal charges discussed above, the claims settled by the civil settlements are allegations only, and there has been no determination of liability

With the Trump Administration still claiming that no regulatory oversight is needed to monitor the US drug industry, that they can self-regulate, it appears that there will be no letup in the rampant “off-label: and unintended use marketing of pharmaceutical drugs in the United States.  The one way that Big Pharma is held accountable is in the courtroom, although financial damages and penalties against the drug companies amounting to billions of dollars each year being awarded by juries, wont change FDA policy, it does provide a small amount of official recognition that there are ongoing abuses by the pharmaceutical industry in the USA.

 

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