Purdue Pharma’s Historical Bad Conduct Started 50 Years Ago: “Crafted By The Sackler Brothers”

 DOCUMENTS SHOW LONG-TERM DRUG INDUSTRY MANIPULATION BY THE SACKLERS

By Mark A. York (January 16, 2019

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) In 2007, Purdue Frederick Co. (not Purdue Pharma) and three company executives pled guilty to misbranding 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 Criminal Plea Agreement US Department of Justice May 10, 2007. This plea deal “a get-out-of-jail free card” was engineered by none other than former New York City Mayor and political/corporate fixer, Rudy Guiliani, by directly leveraging high level US DOJ contacts and other DC insiders to derail the prosecution of Purdue Pharma, and instead offer up Purdue Fredrick Co. as the guilty party and thereby permitting the multi-billion dollar per year Oxycontin assembly line to continue operations.

The Sackler family has always been protected by the company shield, even though their most profitable selling opioid drug Oxycontin, and its boardroom coordinated marketing campaign was the brainchild and a direct result of the Purdue Pharma company founders, the Sackler brothers and their tried and true business model.

That is now changing, as the State of Massachusetts has filed a lawsuit against Purdue Pharma and the Sackler family as well as various Purdue executives over the prescription painkiller OxyContin. Oxycontin is now recognized as the opioid fuse that ignited America’s opioid crisis, and in a positive move forward, the leading executives and members of the multibillionaire Sackler family, now known to be feuding over the opioid crisis have been named in civil litigation.

The Sacklers named in the lawsuits include Theresa and Beverly, widows of Purdue founders, brothers Mortimer and Raymond Sackler and Ilene, Kathe and Mortimer David Alfons Sackler, three of Mortimer’s children; Jonathan and Richard Sackler, Raymond’s two sons; and David Sackler, Raymond’s grandson. The Sackler family is worth conservatively, an estimated$13 billion according to Forbes, which has been generated from sales of OxyContin.  As is normal procedure by the Sackler family and the company itself, the Sackler family feuding members always decline requests for comment on the catastrophic opioid crisis and avoid discussing any Purdue Pharma links to how the crisis came about.

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 over 1,200 cases in state and federal courts.

The entire Sackler brothers’ Oxycontin marketing plan followed their previously proven drug marketing test drive of “Valium” – when Hoffman-LaRoche hired the Sacklers to market their new drug “diazepam” commonly known as Valium and its sister drug Librium.

While running the drug advertising company, Arthur Sackler became a publisher, starting a biweekly newspaper, the Medical Tribune, which eventually reached 600,000 physicians. He scoffed at suggestions that there was a conflict of interest between his roles as the head of a pharmaceutical-advertising company and the publisher of a periodical for doctors. Later it emerged that a company he owned, MD Publications, had paid the chief of the antibiotics division of the FDA, Henry Welch, nearly $300,000 in exchange for Welch’s help in promoting certain drugs. Sometimes, when Welch was giving a speech, he inserted a drug’s advertising slogan into his remarks. After the payments were discovered, Welch was forced to resign from the FDA.

When Purdue Pharma started selling its prescription opioid painkiller OxyContin in 1996, Dr. Richard Sackler asked people gathered for the launch party to envision natural disasters like an earthquake, a hurricane, or a blizzard. The debut of OxyContin, said Sackler — a member of the family that started and controls the company and then a company executive — “will be followed by a blizzard of prescriptions that will bury the competition.”

Five years later, as questions were raised about the risk of addiction and overdoses that came with taking OxyContin and opioid medications, Sackler outlined a strategy that critics have long accused the company of unleashing: divert the blame onto others, particularly the people who became addicted to opioids themselves.

“We have to hammer on the abusers in every way possible,” Sackler wrote in an email in February 2001. “They are the culprits and the problem. They are reckless criminals.”

Sackler’s comments at the party and his email are contained in newly public portions of a lawsuit filed by the state of Massachusetts against Purdue that alleges that the company, the Sackler family, and company executives misled prescribers and patients as they aimed to blanket the country with prescriptions for their addictive medications.

“By their misconduct, the Sacklers have hammered Massachusetts families in every way possible,” the state’s complaint says, noting that since 2007, Purdue has sold more than 70 million doses of opioids in Massachusetts for more than $500 million. “And the stigma they used as a weapon made the crisis worse.”

The new filing also reveals how Purdue aggressively pursued tight relationships with Tufts University’s Health Sciences Campus and Massachusetts General Hospital — two of the state’s premier academic medical centers — to expand prescribing by physicians, generate goodwill toward opioid painkillers among medical students and doctors in training, and combat negative reports about opioid addiction.

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, against pharmaceutical companies that make or distribute prescription opioids, the complaint was filed in New York state court, the 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, then 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, he added, with West Virginia being one of the states to address the issues pro-actively in all areas.

The same drug abuse related issues that are in New York and other major metropolitan areas are now at healthcare crisis levels, with the causation now being seen as 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 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 lawsuit filed by 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.

The Sackler family name graces some of the nation’s most prestigious bastions of culture and learning — the Sackler Center for Arts Education at the Guggenheim Museum, the Sackler Lefcourt Center for Child Development in Manhattan and the Sackler Institute for Developmental Psychobiology at Columbia University, to name a few.

Now for the first time since the opioid crisis came to the attention of America, the Sackler name is front and center in a lawsuit accusing the family and the company they own and run, Purdue Pharma, of helping to fuel the deadly opioid crisis that has killed thousands of Americans.

Lawsuit filed by the state of Massachusetts against Purdue Pharma

Under an agreement with Mass. General, Purdue has paid the hospital $3 million since 2009 and was allowed to propose “areas where education in the field of pain is needed” and “curriculum which might meet such needs,” the court document shows. Tufts made a Purdue employee an adjunct associate professor in 2011, Purdue-written materials were approved for teaching to Tufts students in 2014, and the company sent staff to Tufts as recently as 2017, the complaint says. Purdue’s New England staff was congratulated for “penetrating this account.”

A Tufts spokesman declined to comment, citing the ongoing legal process. Mass. General did not immediately comment.

In a statement Purdue criticized the Massachusetts Attorney General Maura Healey’s office, which is spearheading the lawsuit, and said the complaint was “a rush to vilify” Purdue. It noted that its medications were approved by the Food and Drug Administration and regulated by the government, and that the company promoted the medications “to licensed physicians who have the training and responsibility to ensure that medications are properly prescribed.”

“Massachusetts’ amended complaint irresponsibly and counterproductively casts every prescription of OxyContin as dangerous and illegitimate, substituting its lawyers’ sensational allegations for the expert scientific determinations of the [FDA] and completely ignoring the millions of patients who are prescribed Purdue Pharma’s medicines for the management of their severe chronic pain,” the company said.

It also said the state attorney general’s office omitted information about the steps Purdue has taken in the past decade to promote safe and appropriate use of opioid medicines.

“To distract from these omissions of fact and the other numerous deficiencies of its claims, the Attorney General has cherry-picked from among tens of millions of emails and other business documents produced by Purdue,” the company said. “The complaint is littered with biased and inaccurate characterizations of these documents and individual defendants, often highlighting potential courses of action that were ultimately rejected by the company.”

Healey’s office sued Purdue, current and former executives, and members of the Sackler family in June. In December, it filed an amended complaint that was nearly 200 pages longer than the June filing, with more allegations spelled out against the individual defendants. Many of the details were redacted; a portion of them were made public in an updated document filed Tuesday in state court, though much of the complaint is still blacked out.

The state’s suit focuses on Purdue’s actions since 2007, when the company and three current and former executives pled guilty in federal court to fraudulently marketing OxyContin and the company agreed to pay $600 million in fines. The case is separate from litigation being waged by STAT to obtain sealed Purdue documents in Kentucky, including the only known deposition of Richard Sackler, about the company’s marketing practices in earlier years, which have been blamed for igniting the current opioid addiction crisis.

The Massachusetts complaint sketches an image of the Sacklers, as board members, exercising tight control over the company, overseeing the deployment of a phalanx of sales representatives who were pushed to get Purdue medications into more hands, at higher doses, and for longer periods of time. The Sacklers, the complaint states, reaped “billion of dollars,” even as the company blurred the risks of addiction and overdose that came with the drugs.

Richard Sackler, who was named president of the company in 1999 before becoming co-chairman in 2003, is singled out in the complaint as particularly domineering as he demanded greater sales. In 2011, he decided to shadow sales reps for a week “to make sure his orders were followed,” the complaint states.

Russell Gasdia, then the company’s vice president of sales and marketing, who is also a defendant in the Massachusetts lawsuit, went to Purdue’s chief compliance officer to warn that if Sackler directly promoted opioids, it was “a potential compliance risk.”

“LOL,” the compliance officer replied, according to the complaint. Other staff raised concerns, but they ultimately said that “Richard needs to be mum and anonymous” when he went into the field.

After the visits to doctors, Richard Sackler claimed that Purdue’s drugs shouldn’t need a legally mandated warning. He wrote in an email cited in the complaint that the warning “implies a danger of untoward reactions and hazards that simply aren’t there.”

Secret trove reveals bold ‘crusade’ to make OxyContin a blockbuster

The following year, Sackler’s pressure on the staff grew so intense that Gasdia asked the CEO to intervene: “Anything you can do to reduce the direct contacts of Richard into the organization is appreciated,” Gasdia wrote in an email cited by the complaint.

It apparently didn’t work. The next week, Richard Sackler emailed sales managers to say that U.S. sales were “among the worst” in the world.

Sales managers were badgered on nights, weekends, and holidays, according to the filing. The marketing campaigns focused on high-volume doctors, who were visited repeatedly by salespeople, and pushed doctors to prescribe high doses. The demands on sales managers created such a stressful environment that in 2012, they threatened to fire all sales representatives in the Boston area because of lackluster numbers.

The complaint also accuses Purdue of rarely reporting alleged illegal activity, such as improper prescribing and massive Oxycontin order increases to government officials when it learned about it. In one 2009 case, a Purdue sales manager wrote to a company official that Purdue was promoting opioids to an illegal pill mill.

“I feel very certain this is an organized drug ring,” the employee wrote, adding “Shouldn’t the DEA be contacted about this?” Purdue did nothing for two years, according to the complaint.

In addition to relying on its sales force, Purdue cultivated ties with academic hospitals, which both treat patients and train the next generation of prescribers.

In 2002, the company started the Massachusetts General Hospital Purdue Pharma Pain Program after a Purdue employee reported that access to the hospital’s doctors “is great … they come to us with any questions, and allow us to see them when we need to.” The hospital, the staffer added, “has significant influence through most of New England, simply because they are MGH.”

As part of the program, Purdue gained influence over training programs and organized a symposium in the hospital’s famed “Ether Dome” — the site of the first public surgery with anesthetic.

The Sacklers renewed the deal with Mass. General in 2009 and agreed to contribute $3 million to fund the program, the lawsuit says.

Purdue’s funding, however, didn’t stop researchers at Mass. General from raising concerns about its products. The complaint cites a July 2011 email from Purdue’s then-chief medical officer Craig Landau — who is now the CEO and is a defendant in the lawsuit — flagging a study questioning the use of opioid painkillers for chronic pain that was conducted by Mass. General researchers with Purdue funding. Landau wanted to make sure that any Purdue-funded study supported the use of its medicines.

Purdue’s ties to Tufts date back even further, according to the lawsuit. In 1980, three Sacklers donated funding to launch the Sackler School of Graduate Biomedical Sciences. In 1999, the Sacklers gave money to help start the Tufts Masters of Science in Pain Research, Education, and Policy. Through the program, “Purdue got to control research on the treatment of pain coming out of a prominent and respected institution of learning,” the filing states. Purdue employees even taught a Tufts seminar about opioids, and Tufts and its teaching hospital collaborated with Purdue on a publication for patients called, “Taking Control of Your Pain.”

Purdue also allegedly used Tufts’s ties in Maine as reports about addiction emerged in the state. Tufts ran a residency program in the state, the complaint says, and in 2000 “agreed to help Purdue find doctors to attend an event where Purdue could defend its reputation.”

The bulk of the documents cited in the Massachusetts complaint were filed by Purdue in federal court in Ohio as part of a consolidated case involving hundreds of lawsuits filed by states, cities, counties, and tribes against Purdue, other opioid manufacturers, and others in the pharmaceutical industry.

Purdue says it produced 45 million pages of documents for the federal court case — known as a multidistrict litigation. In a motion filed last month and in an emergency hearing before the federal judge in Ohio overseeing the MDL, Purdue argued that the details in Massachusetts’ amended complaint were largely drawn from about 500 Purdue documents it had filed on a confidential basis in the federal court. The company’s lawyers argued the rules of confidentiality established in the federal court should apply to Massachusetts’ filing in state court, while state officials say the issue of what should be made public should be decided in state court.

Among the records Purdue said last month should remain confidential are those involving the company’s board of directors. Making them public, the company argued, would have a “chilling effect” on corporate governance.

The effort to protect the disclosure of board-related documents serves another purpose not cited by the company: It protects the Sackler family, whose members have long constituted the majority of board members.

In its filing last month, Purdue also said one company official, whom it did not name, was concerned for his safety because his home address was listed in the complaint along with “numerous irrelevant, incendiary, and misleading comments about his career at Purdue.”

Purdue’s attorneys contend the Massachusetts amended complaint is a “concerted effort by the Commonwealth to use confidential documents in an attempt to publicly embarrass Purdue and its officers, directors and employees.” They claim the information selected was “cherry-picked” to “bolster a series of inflammatory and misleading allegations against Purdue.”

In September 2017, Landau, by that time Purdue’s CEO, jotted down a note summarizing some of the roots of the opioid crisis. It reads:

“There are:
Too many Rxs being written
Too high a dose
For too long
For conditions that often don’t require them
By doctors who lack the requisite training in how
to use them appropriately.”

The state’s lawsuit concludes: “The opioid epidemic is not a mystery to the people who started it. The defendants knew what they were doing.”

The Sackler family is the 19th richest in the nation, with an estimated fortune of $13 billion, according to Forbes.

The Sacklers involved with Purdue Pharma are the descendants of brothers Mortimer and Raymond Sackler. Their eldest brother, Arthur, died in 1987, well before Purdue began making and selling OxyContin. Arthur also worked in pharmaceuticals and developed a reputation for cleverly marketing new drugs directly to doctors, convincing them to prescribe medications including tranquilizers to their patients.

Arthur was inducted into the Medical Advertising Hall of Fame after his death, but he has also been criticized for originating “most of the questionable practices that propelled the pharmaceutical industry into the scourge it is today,” as Allen Frances, the former chair of psychiatry at Duke University School of Medicine, told the New Yorker last year.

Arthur’s family has made a point of noting that he was not involved in the sale of OxyContin and would prefer him to be remembered for his philanthropy, including funding the Arthur M. Sackler Gallery of Chinese Stone Sculpture at The Metropolitan Museum in Manhattan and the Arthur M. Sackler Museum at Harvard University.

“None of the charitable donations made by Arthur prior to his death, nor that I made on his behalf after his death, were funded by the production, distribution or sale of OxyContin or other revenue from Purdue Pharma,” his widow, Jillian Sackler, said in a February statement. “Period.”

Seven of the Sacklers named in the suit have been on the Purdue board since the 1990s, according to the suit, while David Sackler, the grandson, has served since 2012.

The board met on a weekly — sometimes daily — basis while the company was being investigated by 26 states and the Justice Department from 2001 to 2007, according to the lawsuit. In 2007, the board settled and agreed to pay a $700 million fine after the company’s CEO at the time, Michael Friedman, and two other high-ranking company officials pleaded guilty to misleading doctors and patients about opioids.

KENTUCKY LEGAL FIGHT TO KEEP SACKLER TESTIMONY SEALED

In an example of the past coming back to haunt the present, in 2015 Purdue Pharma agreed to pay $24 million to settle a lawsuit filed by Kentucky, December 22, 2015 Purdue Pharma Settlement With State of Kentucky,  which Purdue thought would end that problem by paying a fine and moving on, which isn’t the case it seems. See Purdue Pharma settles with Kentucky over Oxycontin claim(statnews.com/pharmalot) for information on the claims in Kentucky.

That state court litigation is now subject to an ongoing legal battle in the Kentucky courts where Purdue is fighting to keep the original court records from that settlement sealed, due to the only deposition testimony of one of the Sackler brothers is known to be located. The Purdue court records were unsealed by Pike County Judge Stephen Combs in May 2016, and Purdue immediately appealed with oral arguments taking place June 26, 2017 in front of a three judge panel of the Kentucky Court of Appeals, which as of June 20, 2018 has not issued a ruling on releasing the records. The original Kentucky vs. Purdue docket information is case no. 07-CI-01303, Judge Stephen Combs, Pike County Circuit Court of Kentucky.

OxyContin was hailed as a medical marvel when it debuted in 1995. Pitched as balm for people suffering from moderate to severe pain, it reportedly generated more than $35 billion in revenue for Purdue Pharma.

Oxycontin’s chief ingredient is oxycodone, a cousin of heroin, and prosecutors say Purdue played down the dangers of addiction while getting hundreds of thousands of Americans hooked on opioids.

Purdue has argued that OxyContin is approved by the Food and Drug Administration and accounts for just 2 percent of the opioid prescriptions nationwide.

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FDA STATEMENT ON BAYER ESSURE SAFETY OVERSIGHT AFTER BAYER STOPS U.S. SALES

 

 

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the long-term safety oversight of the Essure device following discontinuation of its U.S. sales

For Immediate Release

December 20, 2018

FDA Statement

When new safety concerns arise for particular devices, we’re committed to taking action to develop post-market information that can help patients and providers make more informed decisions and also support regulatory actions that reduce any potential risks to patients. We’ve taken a series of such steps with respect to Essure, a permanent birth control device. The product has been the focus of several important FDA safety actions. We’re announcing some additional steps today to make sure the FDA continues to evaluate the product’s long-term safety profile past its scheduled discontinuation from the U.S. market following a series of earlier regulatory actions that we took apply significant new requirements on its use. This includes the agency’s decision to take the step of making Essure a restricted device.

In July, citing the declining annual number of implantations, the manufacturer of the device, Bayer, announced that Essure will no longer be sold or distributed in the U.S. after Dec. 31, 2018. At that time, I stressed that, even when Essure is no longer sold, the FDA would remain vigilant in its oversight of the device. This includes requiring that Bayer complete the postmarket surveillance study that we ordered in February 2016. I also affirmed that we’d continue to actively communicate with patients and physicians as new information about the device becomes available or as the FDA takes additional regulatory steps.

Today, I’m providing an update on new steps to revise and strengthen the manufacturer’s postmarket study, to make sure we continue to collect long-term safety information following the discontinuation of the product to better evaluate the safety profile of the device when used in the real world.

As part of the revised protocol for the postmarket surveillance study, the FDA has worked with Bayer to see that the manufacturer implements several approved modifications to the study that we believe will strengthen the evidence collected.

First and foremost, women in the study will be followed for five years, rather than the three years that was initially required. This significant extension follows the FDA’s request that the company go beyond the three-year period provided for by law. This extension will provide us with longer-term information on adverse risks of the device, including issues that may lead women to have the device removed.

Second, we’re requiring additional blood testing of patients enrolled in follow-up visits during the study to learn more about patients’ levels of certain inflammatory markers that can be indicators of increased inflammation. This could help us better evaluate potential immune reactions to the device and whether these findings are associated with symptoms that patients have reported related to Essure.

The FDA is also requiring Bayer to continue to enroll patients who might still opt to receive Essure in advance of its full discontinuation from the U.S. market, and to continue to submit more frequent reports to the FDA on the study’s progress and results. Since FDA’s 2016 decision to order Bayer to conduct the postmarket study and then to add a boxed warning and Patient Decision Checklist to the labeling, sales of Essure declined by 70 percent. Earlier this year, the FDA decided to restrict the sale and distribution of the device to only health care providers and facilities that provide information to patients about the risks and benefits of this device and that give patients the opportunity to sign an acknowledgement of understanding before implantation. In view of this decline in sales and the manufacturer’s decision to discontinue sales and distribution at the end of this year, we recognize that Bayer is having challenges reaching the study’s initial sample size that relied on enrolling patients who were newly implanted with Essure until May 2020. We believe that this new, revised study plan will help provide more long-term information regarding complications that may be experienced by patients who have Essure, despite reduced enrollment.

For the past several years, the FDA has been monitoring the progress of an Essure post-approval study that was mandated to gather long-term data on pregnancies occurring in patients who may have received a transvaginal ultrasound in order to confirm that Essure was properly placed in a woman’s fallopian tubes and could be relied upon to prevent pregnancy. The FDA’s Center for Devices and Radiological Health conducted an  analysis of an ongoing post-approval study data to gain a fuller understanding of device removals over time; they also completed their extensive evaluation into a significant collection of medical device reports submitted in 2017 and the first half of 2018 that mentioned issues involving potential device removal to learn more about why women were choosing to have the device removed, which usually requires a surgical procedure. CDRH also spent the past several months actively evaluating more than 15,000 medical device reports submitted to FDA in 2017 through June 2018 on the Essure device. (The majority of these reports referenced an instance in which the device was removed from a patient, and most came from cases that were made available by plaintiff attorneys as part of litigation against the manufacturer Bayer.) CDRH is providing some important new information about the removals of the Essure device learned from this analysis on our website.

Based on this information, the FDA instructed Bayer to extend the postmarket surveillance study from three years to five years to capture longer term information about device removals. We believe it’s important to continue closely monitoring device removals in the postmarket surveillance study to gain greater knowledge of this issue.

Following Essure’s removal from the market, the FDA is committed to continuing to monitor women who have the device implanted. In addition to the post-market surveillance study, the agency will continue its efforts to monitor Essure’s safety and effectiveness since its approval in 2002 by reviewing the medical literature, clinical trial information, post-approval study data and medical device reports submitted to the agency. This follows previous actions the FDA has taken, including requiring Bayer to add a boxed warning to the labeling of Essure and issue a Patient Decision Checklist to help women considering Essure to be fully informed about potential risks and the sales restriction that FDA placed on the product.

I personally had the opportunity to meet with women who have been adversely affected by Essure to listen and learn about their concerns. Some of the women I spoke with developed significant medical problems that they ascribe to their use of the product. We remain committed to these women and to improving how we monitor the safety of medical devices, including those related to women’s health.

We’re also advancing new ways to solidify our monitoring systems to achieve our new goal to consistently be the first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices.

As we announced when we issued our Medical Device Safety Action Plan in April, we’re working to implement an active surveillance system to help us detect device safety signals faster, including for devices related to women’s health. We’re implementing active surveillance capabilities as part of our National Evaluation System of health Technology, which will leverage a wide range of data systems that could provide real-time information on device safety signals from electronic health information, such as registries and electronic medical records. We’re also continuing our ongoing efforts to strengthen our Coordinated Registry Networks (CRN), which link different real-world data sources to generate clinical evidence about medical devices used by patients.

We’re especially focused on addressing clinical questions for device therapies that address conditions that are unique to women, such as treatment of uterine fibroids, pelvic floor disorders, female sterilization (including the Essure device) and long-acting reversible contraception. To advance these goals, the FDA partnered with the American College of Obstetricians and Gynecologists, the American Urogynecologic Society, the National Library of Medicine and others on this effort, which is known as the Women’s Health Technologies CRN, or WHT-CRN. Once fully implemented, the WHT-CRN can be used to answer crucial questions on medical devices for women’s health to help supplement the evidence we’re gathering from postmarket studies and medical device reports. It could also help us detect safety issues with medical devices faster, enabling us to take actions — like the implementation of special controls — sooner.

We believe women who’ve been using Essure successfully to prevent pregnancy can and should continue to do so. Women who suspect the device may be related to symptoms they are experiencing, such as persistent pain, should talk to their doctor on what steps may be appropriate. Device removal has its own risks. Patients should discuss the benefits and risks of any procedure with their health care providers before deciding on the best option for them. The FDA will continue to collect and review reports of adverse events associated with device removal and is committed to continuing to provide updates on our evaluation of this data as the information is collected and we develop new findings about the device.

____________________________________________________________________________________________________________________

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VALSARTAN U.S. SUPPLIERS IN CHINA AND INDIA ON FDA RECALL RADAR: SEE FDA WARNING LETTER TO ZHEJIANG HUAHAI PHARMACEUTICAL

 

 

 

 

 

 

 

Inspections, Compliance, Enforcement, and Criminal Investigations

Zhejiang Huahai Pharmaceutical 11/29/18

 

 

10903 New Hampshire Avenue
Silver Spring, MD 20993

Via UPS                                                          Warning Letter: 320-19-04

November 29, 2018

Mr. Jun Du

Executive Vice President

Zhejiang Huahai Pharmaceutical Co., Ltd.

Coastal Industrial Zone, Chuannan No. 1 Branch No. 9 

Donghai Fifth Avenue, Linhai, Taizhou Zhejiang 317016

CHINA

Dear Mr. Du:

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Zhejiang Huahai Pharmaceutical Co., Ltd., located at Coastal Industrial Zone, Chuannan No. 1 Branch No. 9, Donghai Fifth Avenue, Linhai, Taizhou Zhejiang, from July 23 to August 3, 2018.

 This warning letter summarizes significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API).

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

We reviewed your August 26, 2018, response in detail and acknowledge receipt of your subsequent correspondence.

During our inspection, our investigators observed specific deviations including, but not limited to, the following.

  1. Failure of your quality unit to ensure that quality-related complaints are investigated and resolved.

Valsartan API

Your firm received a complaint from a customer on June 6, 2018, after an unknown peak was detected during residual solvents testing for valsartan API manufactured at your facility. The unknown peak was identified as the probable human carcinogen N-nitrosodimethylamine (NDMA). Your investigation (DCE-18001) determined that the presence of NDMA was caused by the convergence of three process-related factors, one factor being the use of the solvent (b)(4)). Your investigation concluded that only one valsartan manufacturing process (referred to as the (b)(4) process in your investigation) was impacted by the presence of NDMA.

However, FDA analyses of samples of your API, and finished drug product manufactured with your API, identified NDMA in multiple batches manufactured with a different process, namely the (b)(4) process, which did not use the solvent (b)(4). These data demonstrate that your investigation was inadequate and failed to resolve the control and presence of NDMA in valsartan API distributed to customers. Your investigation also failed:

  • To include other factors that may have contributed to the presence of NDMA. For example, your investigation lacked a comprehensive evaluation of all raw materials used during manufacturing, including (b)(4).
  • To assess factors that could put your API at risk for NDMA cross-contamination, including batch blending, solvent recovery and re-use, shared production lines, and cleaning procedures.
  • To evaluate the potential for other mutagenic impurities to form in your products.

Our investigators also noted other examples of your firm’s inadequate investigation of unknown peaks observed in chromatograms. For example, valsartan intermediates (b)(4) and (b)(4) failed testing for an unknown impurity (specification ≤ (b)(4)%) with results of (b)(4)% for both batches. Your action plan indicated that the impurity would be identified as part of the investigation; however, you failed to do this. In addition, no root cause was determined for the presence of the unknown impurity. You stated that you reprocessed the batches and released them for further production.

Your response states that NDMA was difficult to detect. However, if you had investigated further, you may have found indicators in your residual solvent chromatograms alerting you to the presence of NDMA. For example, you told our investigators you were aware of a peak that eluted after the (b)(4) peak in valsartan API residual solvent chromatograms where the presence of NDMA was suspected to elute. At the time of testing, you considered this unidentified peak to be noise and investigated no further. Additionally, residual solvent chromatograms for valsartan API validation batches manufactured using your (b)(4) process, with (b)(4) in 2012 ((b)(4), and (b)(4)) show at least one unidentified peak eluting after the (b)(4) peak in the area where the presence of NDMA was suspected to elute.

Your response also states that you were not the only firm to identify NDMA in valsartan API. In your case, FDA analyses of samples identified amounts of NDMA in valsartan API manufactured at your firm that were significantly higher than the NDMA levels in valsartan API manufactured by other firms. FDA has grave concerns about the potential presence of mutagenic impurities in all intermediates and API manufactured at your facility, both because of the data indicating the presence of impurities in API manufactured by multiple processes, and because of the significant inadequacies in your investigation.

In response to this letter:

  • Submit risk assessments for all APIs and intermediates manufactured at your facility for the potential presence of mutagenic impurities.
  • Provide an update on investigations and CAPA plans initiated to address the presence of NDMA and other potential mutagenic impurities in all APIs manufactured at your firm.
  • Provide a thorough, independent assessment of your overall system for investigating deviations, discrepancies, out-of-specification (OOS) results, complaints, and other failures. In addition, provide a retrospective review of all distributed batches within expiry to determine if your firm released batches that did not conform to established specifications or appropriate manufacturing standards.
  • Provide test results for all (b)(4)and intermediates for the presence of NDMA, N-Nitrosodiethylamine (NDEA), and other potentially mutagenic impurities.

(b)(4) API

Your firm received a customer complaint on September 13, 2016, concerning (b)(4) API batches ((b)(4) and (b)(4)) that exceeded the specification for (b)(4) (≤ (b)(4)ppm). (b)(4) has been classified as a probable human carcinogen. Your customer’s test results conflicted with your (b)(4) test results, which showed the two batches meeting the specification upon release. Your complaint investigation (CC-16008) identified no clear laboratory error, and no anomalies were detected during the production of the batches. Your investigation failed to evaluate other (b)(4) API batches to determine if the presence of excess (b)(4) was an adverse trend. For example, (b)(4)batches (b)(4), and (b)(4) were OOS for (b)(4) because of production errors; however, they were not discussed in your complaint investigation.

Your response states that (b)(4) API batches (b)(4) and (b)(4) were returned, reprocessed, and released to customers in non-U.S. markets.

Your response also states that in August 2017 you implemented a new (b)(4) test method that uses a (b)(4) LC-MS/MS method, to replace the (b)(4) LC-MS method that was prone to erroneous OOS results. You failed to verify the reliability of the (b)(4) results for all (b)(4) API batches (including (b)(4) batch (b)(4)) originally released using your (b)(4) LC-MS method, which you indicated was inferior to your updated method.

In response to this letter, provide:

  • A risk assessment for all (b)(4) API batches manufactured within expiry.
  • A revised complaint handling procedure and details of any further controls your facility has implemented to ensure that all complaints are adequately documented and thoroughly investigated.
  • Procedures for accepting and reprocessing returned drugs.
  • Results of (b)(4) testing of all (b)(4)API batches released to the U.S. market using your updated (b)(4) LC-MS/MS (b)(4) test method.
  1. Failure to evaluate the potential effect that changes in the manufacturing process may have on the quality of your API.

In November 2011 you approved a valsartan API process change (PCRC – 11025) that included the use of the solvent (b)(4). Your intention was to improve the manufacturing process, increase product yield, and lower production costs. However, you failed to adequately assess the potential formation of mutagenic impurities when you implemented the new process. Specifically, you did not consider the potential for mutagenic or other toxic impurities to form from (b)(4) degradants, including the primary (b)(4) degradant, (b)(4). According to your ongoing investigation, (b)(4) is required for the probable human carcinogen NDMA to form during the valsartan API manufacturing process. NDMA was identified in valsartan API manufactured at your facility.

You also failed to evaluate the need for additional analytical methods to ensure that unanticipated impurities were appropriately detected and controlled in your valsartan API before you approved the process change. You are responsible for developing and using suitable methods to detect impurities when developing, and making changes to, your manufacturing processes. If new or higher levels of impurities are detected, you should fully evaluate the impurities and take action to ensure the drug is safe for patients.

Your response states that predicting NDMA formation during the valsartan manufacturing process required an extra dimension over current industry practice, and that that your process development study was adequate. We disagree. We remind you that common industry practice may not always be consistent with CGMP requirements and that you are responsible for the quality of drugs you produce.

Your response does not describe sufficient corrective actions to ensure that your firm has adequate change management procedures in place: (1) to thoroughly evaluate your API manufacturing processes, including changes to those processes; and (2) to detect any unsafe impurities, including potentially mutagenic impurities. For FDA’s current thinking on control of potentially mutagenic impurities, see FDA’s guidance document M7(R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk for approaches that FDA considers appropriate for evaluating mutagenic impurities, at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM347725.pdf.

In response to this letter, provide:

  • Detailed revised change management procedures describing how your firm will assess and control all impurities, including mutagenic impurities, in API and intermediates manufactured at your facility.
  • Detailed procedures describing how your firm establishes impurity profiles for products manufactured at your firm. These procedures should contain instructions for comparing at appropriate intervals against the impurity profile in the regulatory submission, or for comparing against historical data, to detect changes to the API resulting from modifications in raw materials, equipment operating parameters, or the production process.
  • A retrospective analysis of other API and intermediates manufactured at your firm to determine if they were adequately evaluated for anticipated and unanticipated impurities, including potentially mutagenic impurities.
     

CGMP Consultant Recommended

Based upon the nature of the deviations we identified at your firm, we strongly recommend engaging a consultant qualified to evaluate your operations and assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance.

 Quality Systems Guidance

 Your firm’s quality systems are inadequate. For guidance on establishing and following CGMP compliant quality systems, see FDA’s guidances: Q8(R2) Pharmaceutical Development, at https://www.fda.gov/downloads/drugs/guidances/ucm073507.pdfQ9 Quality Risk Management, at https://www.fda.gov/downloads/Drugs/Guidances/ucm073511.pdf; and Q10 Pharmaceutical Quality System, at https://www.fda.gov/downloads/drugs/guidances/ucm073517.pdf.

 Additional API CGMP guidance

FDA considers the expectations outlined in ICH Q7 in determining whether API are manufactured in conformance with CGMP. See FDA’s guidance document Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients for guidance regarding CGMP for the manufacture of API, at https://www.fda.gov/downloads/Drugs/…/Guidances/ucm073497.pdf.

Conclusion

Deviations cited in this letter are not intended as an all-inclusive list. You are responsible for investigating these deviations, for determining the causes, for preventing their recurrence, and for preventing other deviations.

If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(b) and allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.

FDA placed your firm on Import Alert 66-40 on September 28, 2018.

Until you correct all deviations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer.

Failure to correct these deviations may also result in FDA continuing to refuse admission of articles manufactured at Zhejiang Huahai Pharmaceutical Co., Ltd., located at Coastal Industrial Zone, Chuannan No. 1 Branch No. 9, Donghai Fifth Avenue, Linhai, Taizhou Zhejiang, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Under the same authority, articles may be subject to refusal of admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).

After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done since our inspection to correct your deviations and to prevent their recurrence. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.

 Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov or mail your reply to:

Rory K. Geyer

Compliance Officer

U.S. Food and Drug Administration

White Oak Building 51, Room 4235

10903 New Hampshire Avenue

Silver Spring, MD 20993

USA

Please identify your response with FEI 3003885745.

Sincerely,

/S/

Francis Godwin

Acting Director

Office of Manufacturing Quality

Office of Compliance

Center for Drug Evaluation and Research

 

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The Opioid Epidemic and State Courts – Why some aren’t filing into Opiate MDL 2804

Florida, Texas, Nevada, North Carolina, North Dakota, Oklahoma, Tennessee, Massachusetts and others have started  their own Opioid Litigation in state courts across the country

By Mark A. York (December 10, 2018)

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Opioid abuse has been steadily increasing in the United States, and now state courts are becoming the legal venue of choice for filing lawsuits against the “opioid industry” and there may be a need for partnerships with other organizations to confront this epidemic. Lawsuits have already been filed in federal courts and by 22 U.S. states and Puerto Rico against Opiate Big Pharma. 

For a look at the Federal Opiate Litigation MDL 2804 see “OPIOID-CRISIS-BRIEFCASE -MDL-2804-OPIATE-PRESCRIPTION-LITIGATION” where states, counties, cities, indian tribes as well as unions, hospitals and individuals have filed more than 1000 lawsuits against the opioid industry as a whole.

BILLIONS IN PROFITS

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

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

A NEW INFANT NAS MDL 2872

Kevin Thompson of the Opioid Justice Team, has filed a motion for a new prescription opiate related multidistrict litigation, which was heard in front of the JPML panel on November 28, 2018 in New York City, where the panel was requested to designate MDL No. 2872 (INFANTS BORN OPIOID-DEPENDENT PRODUCTS LIABILITY LITIGATION) as a new and separate litigation focused on infants born addicted to opiates and suffering from what’s commonly knows as Neonatal Abstinence Syndrome (NAS) and numerous other long-term medical issues.

The current Opiate MDL 2804 is not moving litigation related to individuals forward in any way. Thompson’s team is requesting that the infant cases be carved out from the sprawling lawsuit in Cleveland and transferred to a federal judge in West Virginia, one of the hardest hit states where roughly 5 percent of all babies are born dependent on opioids. The overall Infant NAS MDL 2872 docket can be viewed here MDL 2872 Infant NAS Re-infants-born-opioid-dependent-products-liability-litigation docket.

The misuse of opioids starting with the flood of prescription pain medicines, which has cast a wide net to now include heroin, fentanyl, morphine, and other drugs both legal and illegal is a serious national problem. In 2015 one in ten Americans reported using an illicit drug in the past 30 days.[1] Marijuana use and the misuse of prescription pain relievers account for the majority of illicit drug use. Of the 21.5 million Americans 12 or older who had a substance-use disorder in 2014, 1.9 million had a substance-use disorder involving prescription pain relievers, and 586,000 had a substance-use disorder involving heroin.[2]

 

Widespread use of opioids has had a devastating impact on many communities. In 2014, more people died from drug overdoses than in any year on record, with 78 Americans dying every day from an opioid overdose. Drug overdose now surpasses motor-vehicle crashes as the leading cause of injury death in the United States. Most opioid-related overdoses involve prescription painkillers, but a growing number are the result of a powerful combination of heroin and fentanyl, a synthetic opioid often packaged and sold as heroin. Some of the largest concentrations of overdose deaths were in Appalachia and the Southwest, according to county-level estimates by the Centers for Disease Control and Prevention.[3]

One contributing factor behind the opioid epidemic is the increase in the use of prescription painkillers nationally. From 1991 to 2011, the number of opioid prescriptions dispensed by U.S. pharmacies tripled from 76 million to 219 million.[4] This increase in the use of opioids is unique to America. The United States represents less than 5 percent of the world’s population but consumes roughly 80 percent of the world’s supply of opioid drugs.[5] There is also wide variation from one state to another in opioid-prescribing rates. In 2012 twelve states had more opioid prescriptions than people: Alabama (142.9 per 100 people), Tennessee (142.8), West Virginia (137.6), Kentucky (128.4), Oklahoma (127.8), Mississippi (120.3), Louisiana (118), Arkansas (115.8), Indiana (109.1), Michigan (107), South Carolina (101.8), and Ohio (100.1).[6]

The impact of the opioid epidemic touches every aspect of our public safety and judicial system. Drug-related arrests involving opioids are skyrocketing. In many communities, court dockets and probation caseloads are filled with individuals with opioid-use disorders. Access to treatment, particularly medication-assisted treatment combined with cognitive behavioral interventions, is limited—particularly in rural communities. This epidemic also comes at a price. In 2015 the Ohio Department of Mental Health and Addiction Services began providing substance-abuse treatment in Ohio’s prisons, spending an estimated $30 million per year on drug treatment in prisons, $4 million on housing for individuals in recovery, and $1 million over two years for naloxone to reverse drug overdoses. The Ohio State Highway Patrol spent over $2 million to expand and improve their crime lab to keep up with substance testing.

In addition to the impact of opioid abuse on the criminal courts, the nation’s family courts and child welfare system are being deeply impacted. A recent report by the Administration for Children and Families shows that after years of decline, the number of children in foster care is rising. Nearly three-quarters of all states reported an increase in the number of children entering foster care from 2014 to 2015. The largest increases occurred in Florida, Indiana, Georgia, Arizona, and Minnesota. From 2012 to 2016, the percentage of removals nationally due to parental substance abuse increased 13 percent to 32.2 percent.

In addition to hundreds of cases consolidated in federal court in Opiate MDL 2804, the defendants face a wave of litigation in state courts as well as civil and criminal investigations by numerous state attorneys general and the federal government. Any settlement would have to protect the defendant companies from future lawsuits over the same issue and that may be difficult to negotiate given all the concurrent litigation in different courts.

The primary federal litigation involving many cities and counties was consolidated by the JPML in December 2017 in a federal court in Cleveland, Ohio, in front of Judge Daniel Polster. The defendants include Purdue, J&J, Teva, Endo, AmerisourceBergen, Cardinal Health and McKesson. The federal litigation is growing daily see, Opiate Prescription MDL 2804, US District Court of Ohio link.

The time has now arrived for Opioid Big Pharma, in all forms to face the facts that for close to 20 years they have flooded the mainstream commerce of America with massive amounts of opiates with little to no oversight, which whether caused by a catastrophic systemic failure on many levels, or simple greed, the time has now come for the opiate industry to face the music of complex litigation in state and federal court venues across the country.

The judiciary can play a critical role in addressing the opioid epidemic. In August 2016, representatives from the Kentucky, Illinois, Indiana, Michigan, Ohio, Pennsylvania, Tennessee, Virginia, and West Virginia courts convened for the first-ever Regional Judicial Opioid (RJOI) Summit. The judicial summit brought together multidisciplinary delegates from each state to develop a regional action plan and consider regional strategies to combat the opioid epidemic. RJOI member states continue to work both within their home states and regionally to share promising practices, as well as to implement the objectives of the regional action plan. Courts are encouraged to work with partners in similar ways to:

  • Invest in local, state, and regional multidisciplinary, system-level strategic planning to identify policies or practice changes that can improve treatment engagement and reduce the risk of overdose death. Judges are particularly effective at using their convening power to bring together a variety of agencies and community stakeholders. The sequential intercept model is an effective approach to identifying gaps and opportunities for diverting criminal-justice-involved people to treatment. Communities are encouraged to not focus singularly on heroin use but to focus on substance-use disorders in general. A recent CDC study found that nearly all people who used heroin also used at least one other drug; most used at least three other drugs.[7]
  • Implement law-enforcement diversion programs, prosecutor diversion programs, or both to deflect or divert individuals with substance-use disorders from the criminal justice system into treatment at the earliest possible point.
  • Expand court diversion and sentencing options that provide substance-abuse treatment as an alternative to incarceration. Problem-solving courts, such as adult drug courts or veterans treatment courts, are the most notable examples of effective approaches.  
  • Incorporate strategic screening questions designed to identify criminal-justice-involved individuals at high-risk for overdose death into all criminal-justice-agency intake forms. Specifically, research suggests that individuals with a history of non-fatal overdoses, individuals with a history of opioids in combination with benzodiazepines like Xanax (alprazolam) and Soma (Carisoprodol), and individuals with an opioid-use disorder recently released from a confined environment (e.g., residential treatment or incarceration) are at particular risk for overdose death. This population should be prioritized for treatment and overdose-prevention services, such as naloxone access.

On January 24, 2017, the Bureau of Justice Assistance released funding for a “Comprehensive Opioid Abuse Program.” Through this solicitation, courts and their partners may implement overdose outreach projects, technology-assisted treatment programs, and diversion and alternatives to incarceration.

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

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

__________________________________________________________________________________________

[1] Center for Behavioral Health Statistics and Quality, “Key Substance Use and Mental Health Indicators in the United States: Results from the 2015 National Survey on Drug Use and Health” (HHS Publication No. SMA 16-4984, NSDUH Series H-51), report prepared for the Substance Abuse and Mental Health Services Administration, Rockville, Maryland, 2016. Retrieved from http://www.samhsa.gov/data/.

[2] Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality, Behavioral Health Trends in the United States: Results from the 2014 National Survey on Drug Use and Health (Rockville, MD: Substance Abuse and Mental Health Services Administration, 2015).

[3] L. M. Rossen, B. Bastian, M. Warner, D. Khan, and Y. Chong, “Drug Poisoning Mortality: United States, 1999–2014,” National Center for Health Statistics, 2016.

[4] National Institute on Drug Abuse, “Prescription Opioids and Heroin,” Research Report Series, Department of Health and Human Services, National Institutes of Health, Washington, D.C., 2015. Retrieved from https://d14rmgtrwzf5a.cloudfront.net/sites/default/files/rx_and_heroin_rrs_layout_final.pdf.

[5] L. Manchikanti and A. Singh, “Therapeutic Opioids: A Ten-Year Perspective on the Complexities and Complications of Escalating Use, Abuse, and Nonmedical Use of Opioids,” Pain Physician 11, 2nd supp. (2008): S63-S88.

[6] L. J. Paulozzi, K. A. Mack, and J. M. Hockenberry, “Vital Signs: Variation Among States in Prescribing Pain Relievers and Benzodiazepines—United States,” Center for Disease Control and Prevention, Atlanta, 2014.

[7] National Survey on Drug Use and Health, 2011-2013.

 

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Why is the US Solicitor General Supporting Merck in Supreme Court Fosamax Preemption Appeal?

WILL BIG PHARMA LOBBYING EFFORTS BE PAYING DIVIDENDS IN 2019?

By Mark A. York (December 7, 2018)

The Supreme Court’s decision involving Merck’s osteoporosis drug Fosamax could have a ripple effect across Big Pharma and Mass Torts.

 

 

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) The U.S. Supreme Court agreed in June to hear Merck & Co.’s appeal in the long running Fosamax liability litigation, (MDL No. 2243, District Judge: Honorable Joel A. Pisano, USDC New Jersey) where plaintiffs are suing Merck & Co over its osteoporosis drug Fosamax, (see Fosamax [Merck] Appeal U.S. Court of Appeals 3rd Circuit).

The plaintiffs have requested the U.S. Supreme Court uphold a federal appeals court ruling that allowed their cases to move forward, however acting U.S. Solicitor General Jefferey Wall asked for permission to present oral arguments. It would be a plus for Merck, because Wall has been a major supporter of the Big Pharma position on the issue of preemption, which revolves around the question of whether FDA decisions protect pharma companies from state legal challenges.

How the Court answers this question will no doubt shape the drug and device industry for years to come. Levine provided that a drug manufacturer could not be held liable under a failure-to-warn theory if the FDA had previously considered—and rejected—a proposed amendment to the product’s warning label. But Levine did not clearly define when preemption would apply in these circumstances, and as a result, lower courts have struggled to uniformly apply this rule.  With Albrecht, the Court now has an opportunity to clear up the ambiguities left in Levine’s wake.

On December 3, 2018 the Supreme Court agreed to let the Solicitor General’s office participate in the oral arguments, which probably caused the executive suites at Big Pharma to raise a toast to Jeffrey Wall.

The pre-emption question dates back to the original Fosamax case, which was filed by patients who suffered femoral fractures while taking the osteoporosis drug. Merck added language to the product’s label about the risk in 2011, but more than 500 patients claimed that their injuries occurred before then, and Merck should have warned them sooner.

In January 2019, the full Supreme Court will hear arguments in Merck Sharp & Dohme Corp. v. Albrecht, a case arising out of the In Re: Fosamax (Alendronate Sodium) Products Liability Litigation. Fosamax is a drug used to treat osteoporosis, with a cited adverse evenet bieng that it may inhibit bone repair, which could result in an atypical femoral fracture.

The central claim at issue concerns the Fosamax warning label, which initially did not warn of the risk of an atypical femoral fracture. Plaintiffs contend that the label should have included such a warning, while Merck counters that it tried to add language addressing the risk of a “Low-Energy Femoral Shaft Fracture,” but was prevented from doing so by the FDA, who affirmatively told Merck to “hold off” on adding any such language until the FDA could decide on “atypical fracture language, if it is warranted.”  Ultimately, the FDA rejected Merck’s proposed warning label, stating that the justification for such language was “inadequate.” The FDA reversed course the following year, and Merck then added a risk of atypical femoral fracture to Fosamax’s label.

Based on these facts, Merck moved for summary judgment on the plaintiff’s failure-to-warn claims, arguing that such claims were preempted under Wyeth v. Levine because “clear evidence” demonstrated that the FDA would not—and did not—approve of the proposed label change.  The District Court agreed, but the Third Circuit did not, holding instead that: (1) Levine’s reference to “‘clear evidence’ referr[ed] solely to the applicable standard of proof,” which Merck failed to satisfy; and (2) the issue of whether the FDA would have rejected the label change was a fact question for the jury.

Merck said it tried to update the label earlier, but failed because the FDA rejected its proposed wording. Because it was the FDA’s call, pre-emption should apply, Merck claimed and Wall concurred. Now, the Supreme Court will offer 10 minutes for the U.S. to make its case.

“The government has a significant interest in the proper resolution of the case, which concerns the manner in which the scope and effect of an FDA labeling decision is determined in private tort litigation,” asserted Wall in his MOTION OF THE UNITED STATES AS AMICUS CURIAE FOR LEAVE TO PARTICIPATE IN ORAL ARGUMENTS.

At least three court members (Thomas, Gorsuch, and Roberts) appear likely to support preemption under this set of facts, and it would not be unreasonable for Kagan, Ginsburg, and/or Breyer to hold similarly, given that the latter two were both part of the Levine majority, which stated that preemption would apply if there existed “clear evidence that the FDA would not have approved a change[.]” Wyeth v. Levine, 555 U.S. 555, 571 (2009). The odds of a five-justice majority favoring preemption could be buttressed if Kavanaugh is confirmed. Regardless, all one can truly hope for is that the Court avoids a plurality decision, since such an outcome would leave the Third Circuit’s opinion intact and muddy the waters further.

SCOTUS Docket: Merck Sharp & Dohme Corp. v. Albrecht

17-290 3d Cir.  Hearing Date January 7, 2019

Issue: Whether a state-law failure-to-warn claim is pre-empted when the Food and Drug Administration rejected the drug manufacturer’s proposal to warn about the risk after being provided with the relevant scientific data, or whether such a case must go to a jury for conjecture as to why the FDA rejected the proposed warning. CVSG: 05/22/2018.

Date Proceedings and Orders (key to color coding)
Jun 23 2017 Application (16A1264) to extend the time to file a petition for a writ of certiorari from July 23, 2017 to August 22, 2017, submitted to Justice Alito.
Jun 27 2017 Application (16A1264) granted by Justice Alito extending the time to file until August 22, 2017.
Aug 22 2017 Petition for a writ of certiorari filed. (Response due September 25, 2017)
Aug 31 2017 Waiver of right of respondents Affronti, Joanne, et al. to respond filed.
Sep 11 2017 Blanket Consent filed by Petitioner, Merck Sharp & Dohme Corp. on 09/12/2017
Sep 19 2017 Waiver of right of respondents Esther Parker & Pamela Paralikis to respond filed.
Sep 20 2017 Blanket Consent filed by Respondents, Albrecht, Doris, et al. on 09/21/2017
Sep 21 2017 Order extending time to file response to petition to and including October 25, 2017, for all respondents.
Sep 22 2017 Because Justice Alito now realizes that he should have recused himself from consideration of this application, the order of June 27, 2017, is vacated. Pursuant to Rule 22.2, the application (16A1264) to extend the time to file a petition for a writ of certiorari from July 23, 2017 to August 22, 2017, has been submitted to Justice Sotomayor.
Sep 22 2017 Application (16A1264) granted by Justice Sotomayor extending the time to file until August 22, 2017. (Justice Alito is recused)
Sep 25 2017 Brief amicus curiae of Pharmaceutical Research and Manufacturers of America filed.
Sep 25 2017 Brief amici curiae of Product Liability Adisory Council, Inc., et al. filed.
Oct 25 2017 Brief of respondents Doris Albrecht, et al. in opposition filed.
Nov 08 2017 DISTRIBUTED for Conference of 12/1/2017.
Nov 08 2017 Reply of petitioner Merck Sharp & Dohme Corp. filed. (Distributed)
Dec 04 2017 The Solicitor General is invited to file a brief in this case expressing the views of the United States. Justice Alito took no part in the consideration or decision of this petition.
May 22 2018 Brief amicus curiae of United States filed (to be corrected and reprinted).
May 22 2018 Brief amicus curiae of United States filed (Corrected brief received 5/29/18).
Jun 05 2018 DISTRIBUTED for Conference of 6/21/2018.
Jun 05 2018 Supplemental brief of respondents Doris Albrecht, et al. filed. (Distributed)
Jun 07 2018 Supplemental brief of petitioner Merck Sharp & Dohme Corp. filed. (Distributed)
Jun 27 2018 DISTRIBUTED for Conference of 6/27/2018.
Jun 28 2018 Petition GRANTED. Justice Alito took no part in the consideration or decision of this petition.
Jul 27 2018 Motion for an extension of time to file the opening briefs on the merits granted. The time to file the joint appendix and petitioner’s brief on the merits is extended to and including September 13, 2018. The time to file respondents’ brief on the merits is extended to and including November 14, 2018.
Jul 27 2018 Motion for an extension of time to file the opening briefs on the merits filed.
Sep 12 2018 Blanket Consent filed by Respondents, Doris Albrecht, et al..
Sep 13 2018 Brief of petitioner Merck Sharp & Dohme Corp. filed.
Sep 13 2018 Joint appendix (2 volumes) filed. (Statement of costs filed)
Sep 17 2018 Blanket Consent filed by Petitioner, Merck Sharp & Dohme Corp..
Sep 20 2018 Brief amicus curiae of Washington Legal Foundation filed.
Sep 20 2018 Brief amici curiae of Product Liability Adisory Council, Inc., et al. filed.
Sep 20 2018 Brief amici curiae of Pharmaceutical Research and Manufacturers of America, et al. filed.
Sep 20 2018 Brief amicus curiae of United States filed.
Oct 12 2018 Motion of the Acting Solicitor General for leave to participate in oral argument as amicus curiae and for divided argument filed.
Oct 26 2018 Justice Alito is no longer recused in this case.
Nov 14 2018 Brief of respondents Doris Albrecht, et al. filed.
Nov 21 2018 Brief amicus curiae of Public Citizen filed.
Nov 21 2018 Brief amici curiae of Commonwealth of Virginia, et al. filed.
Nov 21 2018 Brief amici curiae of Joseph Lane, M.D., and Vincent Vigorita, M.D. filed.
Nov 21 2018 Brief amici curiae of MedShadow Foundation, et al. filed.
Nov 21 2018 Brief amicus curiae of The Cato Institute filed.
Nov 21 2018 Brief amici curiae of Tort Law Professors John C. P. Goldberg and Benjamin C. Zipursky filed.
Nov 21 2018 Brief amici curiae of Public Law Scholars filed.
Nov 21 2018 Brief amici curiae of Jerome P. Kassirer, M.D., et al. filed.
Nov 21 2018 Brief amicus curiae of American Association for Justice filed.
Nov 28 2018 SET FOR ARGUMENT ON Monday, January 7, 2019
Nov 30 2018 CIRCULATED

The SCOTUS ability to resolve the preemption question could have a ripple effect on the entire pharma industry. The issue generated heated debate a few years back, when a liability case raised questions about whether generics makers can be held responsible for patients’ injuries, given that they must use label language the FDA approved for branded versions of the drugs.

In a close 5-4 decision, the justices ruled that generics makers could not be held liable in those cases.

Initially, it looked as if Merck would prevail in its preemption argument, too, as the  defense had won two bellwether lawsuits filed over alleged Fosamax injuries. Then, in 2014, a federal judge tossed out 5,000 lawsuits from patients who claimed their fractures were caused by Fosamax, followed by a federal appeals court reviving those cases by over-ruling that dismissal.

Lawyers representing the patients in this case have argued that Merck’s preemption argument is faulty because it’s largely based on an internal memo recounting a phone conversation one of its employees had with the FDA.

“Respondents are aware of no other preemption case in which the manufacturer relied on hearsay accounts of informal FDA communications,” the lawyers said in a recent brief.

Merck developed Fosamax to strengthen bones and reduce the risk of fractures from osteoporosis. However, numerous studies have linked the medication to an elevated risk of abnormal femur fractures. Furthermore, plaintiffs in the litigation argue that Merck had an intrinsic obligation to its consumers to provide stronger warnings that users could experience femur fractures from little or no trauma while taking the medication. This includes falling from standing height or less.

Merck introduced Fosamax in 1995, and the company didn’t add a thigh bone fracture risk warning label to the drug until 2011. Plaintiffs claim Merck knew about the risk for years but concealed it to maximize sales and profits.

Fosamax was a blockbuster drug with annual sales of over $3 billion, until the company  lost its exclusive patent rights in 2008, even then the brand name drug still brought in $284 million in sales in 2016.

Both Merck and the Solicitor General contend that if the FDA believed there was scientific reasoning to support a labeling change, the agency would have added the warning, because federal laws require it to do so.

As SCOTUS gets set to hear the case, many individuals and organizations have filed briefs in support, urging the justices to uphold the lower court ruling that would allow those thousands of Fosamax suits to go forward. Consumer watchdog group Public Citizen, for example, filed a brief earlier this month suggesting that Merck’s pre-emption argument is invalid because federal statutes do not support the idea that “the FDA’s rejection of a particular proposed warning constitutes a determination ‘that no new labeling language is warranted.’”

Besides, Public Citizen argued (PDF), SCOTUS should preserve patients’ rights to pursue drug liability claims in state courts, and by siding with Merck, the judges might make it much harder for those suits to be filed.

“Allowing patients to pursue tort claims against pharmaceutical manufacturers for injuries caused by inadequate warnings is important as both an incentive for manufacturers to be vigilant about product safety and a means to provide remedies to patients,” Public Citizen wrote. “For this reason, the case has important implications that go well beyond the interests of the parties.”

How Big Pharma’s cadre of lobbyists and congressional insiders appears to be paying major dividends as we approach 2019 remaons to be seen, but considering the wide-open lack of federal oversight for pharmaceutical and medical device manufacturers by the current administration, it would appear that Big Pharma investments in the FDA and related oversight agencies is apying off very well.

To access the most relevant and real time information on Mass Torts  sign up for:

Mass Tort Nexus “CLE Immersion Course”

March 8-11, 2019 at The Riverside Hotel in Fort Lauderdale , FL

For class attendance information please contact Jenny Levine at 954.520.4494 or Jenny@masstortnexus.com.

       1. For the most up-to-date information on all MDL dockets and related mass torts visit  www.masstortnexus.com and review our mass tort briefcases and professional site MDL briefcases.

      2. To obtain our free newsletters that contains real time mass tort updates, visit www.masstortnexus.com/news and sign up for free access.

 

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Why Did The FDA Approve A Drug 10 Times Stronger Than Fentanyl-When Opiates Are Still Killing Thousands

HAS THE FDA LEARNED ANYTHING FROM THE OPIOID CRISIS THEY HELPED CREATE?

Mark A. York (November 6, 2018)

 

 

 

 

 

 

 

 

 

Just The Opioid Facts

Drugs kill more Americans than guns, cars and AIDS. How we got here.

(Mass Tort Nexus Media) More than 175 Americans will die today of drug overdoses, which equals a 737 crashing and killing all the passengers on board every single day. But it’s not a plane crash. It is America’s opioid epidemic, one that unchecked could claim 1 million lives by 2020.

See also: Briefcases/Drugs/254/OPIOID-National-Prescription-Litigation-MDL-2804-USDC-ND-Ohio-(Eastern-Division) by Mass Tort Nexus

Who’s Minding The FDA?

A new opioid tablet that is 1,000 times more potent than morphine and 10 times stronger than fentanyl was approved by the Food and Drug Administration Friday as a fast-acting alternative to IV painkillers used in hospitals.

The painkiller Dsuvia will be restricted to limited use only in health care settings, such as hospitals, surgery centers and emergency rooms, but critics worry the opioid will fuel an already grim opioid epidemic.

Also on Friday, the Drug Enforcement Administration released a report showing that prescription drugs were responsible for the most overdose deaths of any illicit drugs since 2001.

Democratic Senator Ed Markey of Massachusetts urged the FDA to not approve Dsuvia last month, saying “an opioid that is a thousand times more powerful than morphine is a thousand times more likely to be abused, and a thousand times more likely to kill.”

To that, FDA Commissioner Scott Gottlieb said in a statement that “very tight restrictions” will be placed on Dsuvia. This statement flies in the face of reality as proven by assigned federal agencies to monitor and enforce rules on the already existing opiates that have flooded the US marketplace and killed hundreds of thousands of Americans.

So why should we think that anything is different with a new drug that basically comes under the same oversight umbrella as fentanyl, oxycontin and all the other prescription opiates? The DEA, FDA and anyone else assigned to monitor narcotic drug use, prescribing practices as well as marketing have failed miserably again and again.

FDA Claims Restricted Access

Dsuvia will not be available at retail pharmacies or for any home use, Gottlieb said. The medication, which comes in a single-use package, also should not be used for more than 72 hours. The medicine comes in a tablet that can dissolve under the tongue. Side effects of the potent drug include extreme tiredness, breathing problems, coma and death.

Gottlieb said military use of the drug was “carefully considered in this case” as the FDA wants to “make sure our soldiers have access to treatments that meet the unique needs of the battlefield.”

Combined with the increase in overdoses, the fact that opioids are less effective than presumed creates a substantial public health problem. We are throwing large sums of public and private money at treating opioid addiction and related issues caused by a problem that could have been completely avoided by using more effective (and less habit-forming) medications.

In the midst of a national opioid crisis, the federal agency that monitors drug ads has issued a record low number of warning letters to pharmaceutical companies caught lying about their products.

The Food and Drug Administration has sent just three notice letters to drug makers busted for false marketing their medications to unknowing consumers, the lowest ever since the FDA historic decision to ease strict rules for drug ads in 1997. “It certainly raises questions,” said Dr. David Kessler, head of the FDA from late 1990 through 1996, who’s industry credentials would add weight to the issue of why the FDA is not doing more to monitor false marketing campaigns by Big Pharma and Opioid Drug makers in particular.

The FDA’s Office of Prescription Drug Promotion monitors all ads drug companies issue to make sure patients aren’t being scammed by false assertions or misleading marketing campaigns. This now seems to be the norm, based on the hundreds of lawsuits filed against Opioid Drug Makers in the last 3 months, and recently consolidated into Opiate Prescription MDL 2804 see Opioid Crisis Briefcase-Mass Tort Nexus, where Big Pharma is being sued by states, cities and counties across the country. The primary claim in almost every suit is long-term boardroom coordinated false marketing campaigns designed to push opioid drug prescriptions at any cost.

 FDA Told Not to Approve Dsuvia

https://www.cdc.gov/drug-overdose-data-death counts through Oct 2018

Drug overdose deaths hit the highest level ever recorded in the United States last year, with an estimated 200 people dying per day, according to a report by the U.S. Drug Enforcement Administration. Most of that was the result of a record number of opioid-related deaths.

 

How Big Pharma got into opiates: In 1898, Bayer released heroin to treat coughs and other health woes. Soon, people became addicted to heroin, a narcotic and precursor to the current Opioid Crisis.

 Preliminary figures show more than 72,000 people died in 2017 from drug overdoses across the country. About a week ago, U.S. Health and Human Services Secretary Alex Azar said overdose deaths, while still slowly rising, were beginning to level off, citing figures from late last year and early this year.

The DEA’s National Drug Threat Assessment, which was recently released, shows that heroin, fentanyl and other opioids continue to be the highest drug threat in the nation. But federal officials are concerned that methamphetamine and cocaine are being seen at much higher levels in areas that haven’t historically been hotspots for those drugs. The DEA is also worried that people are exploiting marijuana legalization to traffic cannabis into the illicit market or to states that don’t have medicinal or recreational-use marijuana laws, according to the report.

The preliminary data also showed 49,060 people died from opioid-related overdose deaths, a rise from the reported 42,249 opioid overdose deaths in 2016.

Fatal heroin overdoses rose nationwide between 2015 and 2016, with a nearly 25 percent increase in the Northeast and more than 22 percent in the South. Most of the heroin sold in the U.S. is being trafficked from Mexico, and U.S. Customs and Border Protection officers seize the most amount of heroin along the Mexico border, near San Diego, California, the report said.

Fentanyl and other related opioids, which tend to be cheaper and much more potent than heroin, remain one of the biggest concerns for federal drug agents.

The DEA has said China is a main source of fentanyl and other synthetic opioids that have been flooding the U.S. market. China has pushed back against the characterization, and U.S. officials have stressed they work closely with their Chinese counterparts as they try to stem the flow of drugs.

Legislation that Trump signed last week will add treatment options and force the U.S. Postal Service to screen overseas packages for fentanyl.

Azar said in a speech last week that toward the end of 2017 and through the beginning of this year, the number of drug overdose deaths “has begun to plateau.” However, he was not indicating that deaths were going down, but that they appear to be rising at a slower rate than previously seen.

Pot Vs. Pills for Pain Relief

Last month, the Centers for Disease Control and Prevention released preliminary figures that appear to show a slowdown in overdose deaths from December to March. In that period, the figures show that the pace of the increase over the previous 12 months has slowed from 10 percent to 3 percent, according to the preliminary CDC figures.

Even if a slowdown is underway, no one is questioning the fact that the nation is dealing with the deadliest drug overdose epidemic in its history. While prescription opioid and heroin deaths appear to be leveling off, deaths involving fentanyl, cocaine and methamphetamines are on the rise, according to CDC data.

The DEA’s report also noted that methamphetamine is making its way into communities where the drug normally wasn’t heavily used, the report said. Chronic use of meth, a highly addictive stimulant, can cause paranoia, visual and auditory hallucinations and delusions, studies have shown.

As the government enacted laws that limited access to cold medicines containing pseudoephedrine — the ingredient used to cook meth with other household chemicals — or required the medications to be placed behind pharmacy counters, officials discovered the number of meth labs began to drop.

But the DEA has found the gap is being filled by Mexican and Latin American drug cartels that had primarily dabbled in heroin and cocaine trafficking. A saturated market on the West Coast is now driving the cartels to peddle methamphetamine into the Northeast, using the same routes they use for heroin and other drugs.

Officials also warn that because of more cocaine production in South American countries including Colombia, they expect to see larger shipments at the Mexican border.

Who Said “Pain Was The Fifth Vital Sign?”

“Pain as the fifth vital sign” became policy at VA clinics as well as VA hospitals across the U.S.

It seemed odd to equate pain with something like breathing, but doctors were advised by Purdue Pharma and other opiate makers to understand the need to “dignify” and take care of pain.

Across the country doctors seemed too willing to prescribe these opioid pills for chronic pain, patients seemed too willing to take them, and insurers seemed too willing to pay.

The Joint Commission began requiring hospitals to assess all patients for pain on a scale of 1 to 10, which some claimed caused more doctors to prescribe opioids.

Purdue gave the commission a grant to produce a pain assessment and management manual.

Officials from the commission and Purdue denied the company had anything to do with the content of the manual, co-written by Dr. June Dahl, who served on the speakers bureau for Purdue.

The manual told health care facilities the side effects of opioids had been exaggerated and that physical dependence had been wrongly confused with addiction. “There is no evidence that addiction is a significant issue when persons are given opioids for pain control,” the manual said.

Paid Endorsements In Studies

Purdue officials explained that studies on opioid addiction depended on many factors, including mental health. They cited a 2008 article by Dr. David Fishbain of the University of Miami, who analyzed 79 published studies, saying he concluded the prevalence of abuse or addiction was 3.27 percent, or 0.19 percent for those with no past addiction.

Fishbain responded that his study was misinterpreted and that addiction could be anywhere between 3.27 and 20.4 percent.

Commission officials denied its new standards encouraged doctors to prescribe more opioids, blaming drug trafficking as well as diversion and abuse by individuals.

At that time, the “evidence was broadly supported by experts across the spectrum that pain was undertreated and a serious problem leading to poor clinical outcomes,” the commission said.

The commission concluded that “millions of people in the United States suffer from pain, and failure to treat their pain is inhumane.”

The Painkiller Market

Since 1987, Purdue Pharma had been selling a timed-release drug named MS Contin, the company’s version of morphine. Seven years later, annual sales topped $88 million — the best performing painkiller Purdue officials had — but they faced problems.

Doctors knew how addictive morphine could be, and most were reluctant to prescribe MS Contin to patients suffering from chronic pain.

The even bigger problem? MS Contin’s patent would expire soon.

That meant generic drug manufacturers could make their own versions of MS Contin and eat into Purdue’s share of the painkiller market.

A generation earlier, Arthur Sackler, the brother of Purdue’s owners, had marketed Valium and other tranquilizers to women experiencing anxiety, tension or countless other symptoms. The drug broke all sales records, turning many women into addicts and Sackler into a multimillionaire.

The Sackler family planned to repeat that success with a timed-release version of OxyContin, the company’s version of oxycodone.

In internal Purdue documents obtained by the USA TODAY NETWORK, company officials gushed that OxyContin could become a hit in “the $462 million Class II opioid marketplace.”

These documents detail their strategy: They would first market OxyContin strictly for cancer pain, where doctors were familiar with oxycodone.

Then the company would pivot to the lucrative market of chronic pain, which afflicted at least 25 million Americans.

Purdue’s plan included targeting primary care physicians, surgeons, obstetricians and dentists. The company even targeted home care and hospice care nurses who would “rate the patients’ pain and make a recommendation on the type of opioid and dosage for pain control.”

The plan also included targeting patients and caregivers through Purdue’s “Partners Against Pain” program. “You are the pain authority,” the website reassured patients. “You are the expert on your own pain.”

The website declared that “there are 75 million Americans living with pain, although pain management experts say they don’t have to,” reassuring patients that doctors could control their pain “through the relatively simple means of pain medications” and that the risk of addiction to opioids “very rarely occurs when under medical supervision to relieve pain.”

To ensure that OxyContin became a hit, Purdue sponsored more than 20,000 educational programs to encourage health care providers to prescribe the new drug and sent videos to 15,000 doctors.

The company also hosted dozens of all-expenses-paid national pain management conferences, where more than 5,000 physicians, pharmacists and nurses were trained for the company’s national speakers bureau.

By 2001, Purdue was spending $200 million on marketing and promotion and had doubled its sales force to 671. Before the year ended, sales bonuses reached $40 million.

No Addiction Knowledge 

Dr. Fannin, who practices in West Virginia remembers sales reps from Purdue flooding doctors’ offices in Appalachia, where poverty and pain are constant realities.

The reps gave away fishing hats, stuffed toys and music CDs titled “Get in the Swing with OxyContin.”

“Every time you turned around, you saw their faces,” Fannin said. “We had a population of doctors with very little grounding in pain, and I think Purdue took advantage of that.”

Many doctors knew about oxycodone from Percocet, which combined a small dosage of the potent opioid with 325 mg of acetaminophen.

What many of those doctors didn’t realize was that oxycodone was nearly twice as powerful as morphine, delivering a powerful high to those who use the drug.

“It’s more like heroin,” explained Dr. Andrew Kolodny, co-director of the Opioid Policy Research Collaborative at Brandeis University. “It crosses the blood-brain barrier more quickly.”

But the sales reps never mentioned that. Instead, they said OxyContin didn’t create highs like other opioids and was less likely to get people addicted.

Fannin recalled sales reps calling OxyContin “a revolution in pain care” and “much more effective” than the old drugs.

They also talked of studies, citing one that found only four of 11,882 patients — less than 1 percent — became addicted after using opioids. Portenoy and others repeatedly cited this research, with some calling it a “landmark study.”

The truth is it wasn’t even a study. It was a five-sentence letter to the editor that a doctor wrote the New England Journal of Medicine.

For the most part, Fannin believed what the sales reps were telling him, and so did other doctors in the region.

“Our knowledge about addiction,” he said, “was about zip.”

So they spread the opioid with their prescription pads, and it settled into the Appalachian mountains like the ever-present morning fog.

OxyContin, which some hailed as a “miracle drug,” became the blockbuster in 2001 that Purdue officials dreamed of, with more than 7 million prescriptions written and nearly $3 billion in revenue.

By 2015, the Sackler family, who owned Purdue, had made $14 billion, joining Forbes’ 2015 list of America’s richest families, edging out the Rockefellers.

MIDWEST AMERICA WAS TARGETED

According to sources at all levels from police and fire first responders to emergency room physicians across the country and analysts at the CDC, there’s been no slowdown in opiate based medical emergencies in the US over the last 2 years. Emergency response and ER visits for opioid overdoses went way up, with a 30 percent increase in the single year period of June of 2016 to June of 2017, according to the Centers for Disease Control and Prevention.

The increased emergency room visits also include more young children aged 3 to 14 years old, which truly reflects on the unknown number of who have access to still available opiates. These young children being able to readily find opiates at that age,  shows that anyone who has an interest in getting opiates can find them.  This often results in the inadvertent and tragic risks associated with younger victims who somehow are exposed and now being swept up in the opioid crisis.

Center for Disease Control’s Acting Director Dr. Anne Schuchat said overall the most dramatic increases were in the Midwest, where emergency visits went up 70 percent in all ages over 25. This is a figure that’s is comparative to prior medical emergency spikes during pandemic healthcare

Recently two important medical reports on opiate abuse have emerged indicating that the opioid crisis may be at its worst point ever.

The first study comes from the Centers for Disease Control and Prevention (CDC), a federal agency tasked with studying – and stopping – the spread of diseases, including everything from viral infections like the flu to mental health issues including drug addiction. Published in the agency’s monthly Vital Signs report, the study demonstrates that the number of opioid overdoses increased by 30% in a little more than one year from July 2016 to September 2017.

The second study comes from a group of VA medical personnel and public health researchers publishing in the Journal of the American Medical Association (JAMA), who wanted to learn how effective opioid prescription drugs were at managing long-term and chronic pain. As it turns out, opioid drugs showed less efficacy than non-opioid pain medications over a 12-month period – and in fact, over time opioids became worse for patients who had to deal with side effects that patients taking non-opioid medications did not have to deal with. Taken together, these two studies show that current opioid drug policies, procedures, prescription practices and standards of patient care clearly need to be rethought.

For Information on Opiate Litigation and other mass torts:

Kevin Thompson will speak on the Opiate NAS Addicted Infant MDL 2872 litigation as well as the status of opioid litigation and related issues at the upcoming Mass Tort Nexus “CLE Immersion Course”

November 9-12, 2018 at The Riverside Hotel in Fort Lauderdale , FL.

For class attendance information please contact Jenny Levine at 954.520.4494 or Jenny@masstortnexus.com.

       1. For the most up-to-date information on all MDL dockets and related mass torts visit  www.masstortnexus.com and review our             mass tort briefcases and professional site MDL briefcases.

      2. To obtain our free newsletters that contain real time mass tort updates, visit www.masstortnexus.com/news and sign up for                free access.

 

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XARELTO RECENT LABEL CHANGE: Is Rat Poison Safer?

A WHITE PAPER REPORT BY MASS TORT NEXUS

(The following information and conclusions are based on opinions formed after a review of relevant facts and data by John Ray and edited by Lisa Powell, Mass Tort Nexus www.masstortnexus.com)

XARELTO LABEL CHANGE AND CLINICAL TRIAL BACKGROUND

On October 11, 2018, Janssen Pharmaceuticals, Inc. (a division of Johnson & Johnson) changed its Xarelto® drug safety label as follows:

Monitoring for the anticoagulation effect of rivaroxaban using a clotting test (PT, INR or aPTT) for anti-factor XA (FXa) activity is not recommended.

Rivaroxaban is an anticoagulant medication. Anticoagulants thin blood. Rivaroxaban is sold under its trade name, Xarelto®. Xarelto® is used to prevent and/or treat blood clots that could result in strokes in patients with non-valvular atrial fibrillation, in patients undergoing knee and hip reconstruction or replacement surgery, and for secondary prevention in patients who have had an Acute coronary syndrome event.

Prior to FDA approval in 2011, clinical trials were conducted to test the safety and efficacy of Xarelto® and to compare it to other anticoagulants. Trial administrators measured both the medication’s effectiveness in thinning the blood and how long it took to be within the therapeutic range. A blood test is used to measure the international randomized ratio (INR). The INR was used to determine the appropriate dose and dosage (i.e., amount and rate of administration) specific to each patient; or, in this case, each trial participant.

The safety label update made last week by the drug maker, Janssen Pharmaceuticals, Inc. (a division of Johnson & Johnson) in effect states that the INR test used to gain FDA approval—and that doctors continue to use to dose and monitor the effects of Xarelto® in their patients—is arguably defective. Not only would this render the clinical trial results invalid but also bolster plaintiffs’ new and existing claims that the drug maker(s) failed to adequately inform doctors that there was no means by which to determine the correct dose and dosage for any given patient. Essentially a doctor would have to wait until the patient bleeds out or throws a clot before determining that the patient may not be on the right dose and/or dosage. In other words, the INR test likely has no diagnostic value and is no more effective than a shot in the dark.

Summary of Facts and Subsequent Findings

  • On October 11, 2018, the Xarelto® drug safety label was changed to “not” recommend INR testing to monitor the effects Xarelto® on patients
  • INR testing was used in clinical trials to establish the safety and efficacy of Xarelto® and to compare it to other anticoagulants prior to FDA approval and market release in 2011
  • Title 21 of the U.S. Code of Federal Regulation requires that drug labels include a summary of essential scientific information including a statement of the recommended or usual dosage
  • Results from Xarelto® clinical trials using INR testing are at best, questionable, and at worst, invalid
  • A change to the Xarelto® drug safety label likely indicates that the drug makers failed to adequately warn that there was no means by which to determine correct dosage for any given patient
  • A pharmaceutical product for which correct dose and dosage cannot be established for a given patient is arguably defective in a significant way
  • Physicians that rely on INR testing without knowing that it may render inaccurate results could lead them to incorrectly dose Xarelto® potentially causing significant harm to their patients

Methodology Flaws in the Xarelto Clinical Trials

INR testing was used in the original Xarelto® clinical trials known as the ROCKET-AF and EINSTEIN DVT/PE trials. These trials were paid for by the drug makers—Bayer Healthcare and Janssen Pharmaceuticals, Inc. (a division of Johnson & Johnson). These trials were conducted to establish the safety and efficacy of Xarelto® and to compare it to other anticoagulants.

The following is an excerpt from the EINSTEIN DVT/PE clinical trial results:

EINSTEIN DVT/PE trial design: Randomized, phase 3, multicenter, open-label, parallel group,

active-controlled, event-driven noninferiority studies (EINSTEIN DVT and EINSTEIN PE) with patients receiving XARELTO® at an initial dose of 15 mg twice daily with food for the first 3 weeks, followed by XARELTO® 20 mg once daily with food or enoxaparin 1 mg/kg twice daily for at least 5 days with VKA, then VKA only after target INR (2.0-3.0) was reached. Patients were treated for 3, 6, or 12 months at HCP discretion.

In other words, Xarelto® was administered to trial participants and after a target INR was reached, they received a different anticoagulant—a VKA (i.e., vitamin K antagonist).

Given the drug safety update added to the Xarelto® label by Janssen on October 11, 2018:

Monitoring for the anticoagulation effect of rivaroxaban using a clotting test (PT, INR or aPTT) for anti-factor Xa (FXa) activity is not recommended.

Results from Xarelto® clinical trials using INR testing are at best, questionable, and at worst, invalid.

Thank You for Sharing. Not!

In May 2017—17 months before Janssen changed the Xarelto® label—Clinical Therapeutics, an international peer-reviewed journal, published an article entitled, “International Normalized Ratio Is Significantly Elevated with Rivaroxaban and Apixaban Drug Therapies: A Retrospective Study Published.” An excerpt from the article follows (emphasis added):

Purpose

Direct factor Xa inhibitors such as rivaroxaban or apixaban may prolong prothrombin time (PT) and elevate international normalized ratio (INR). However, these tests are not reliable for assessing the anticoagulation effects of these agents. PT assay sensitivity is relatively weak at therapeutic drug concentrations and is subjected to significant variations depending on the reagent used. Conversion of PT to INR may even increase the variability. We conducted a retrospective cross-sectional study aiming to assess the prevalence and extent of INR elevation in hospitalized patients receiving rivaroxaban or apixaban as part of their home medications and to find out whether other existing factors could elevate INR apart from the drug entity itself. [Emphasis added.]

Methods

The data collected from 218 hospitalized patients׳ charts included PT and INR taken on admission, patients׳ characteristics, laboratory results, other medications regularly used, and coexisting clinical conditions.

Findings

No statistically significant association between INR elevation and the parameters examined was found in our study. INR was significantly elevated in both drug groups (P < 0.001), with 84.2% of rivaroxaban patients and 78.3% of apixaban patients presenting with INR levels above the higher limit of the normal range. Furthermore, INR was significantly higher in the rivaroxaban group than in the apixaban group (P < 0.001).

Implications

Both of the reviewed drugs significantly elevated INR. Moreover, rivaroxaban elevates INR significantly more than apixaban, and there are apparently no other factors affecting INR but the drugs themselves. Larger prospective studies are needed to confirm and clarify the clinical significance of these results.

In that the common tests used to determine the correct administration of Xarelto® are not recommended by the drug maker, how are doctors to determine what dose and dosage of Xarelto® is correct vs. what dose and dosage may render a patient over anticoagulated and more likely to experience severe bleeding, or under anticoagulated, leaving patients more likely to suffer the adverse events Xarelto® is intended to treat?

In other words, doctors have relied on—and may continue to rely on—the test that the makers of Xarelto® now say is not recommended to determine the blood-thinning effects of the drug without knowing that these tests were likely rendering inaccurate results which could lead to their treating patients in a manner likely to cause them significant harm.

If the means to determine the correct dosage to administer to a given patient does not exist, the product is arguably defective. In addition, it would be impossible for a drug maker to comply with the requirements of Title 21, as follows:

21 CFR § 201.56 (a)(1): The labeling must contain a summary of the essential scientific information needed for the safe and effective use of the drug.

21 CFR § 201.100(b)(2): Requires labels for prescription drugs bear a statement of the recommended or usual dosage.

Janssen’s Misleading Advertising Campaign

There are three types of anticoagulants used in the United States. Xarelto® is a direct factor Xa inhibitor type. Benefits claimed by its U.S. manufacturer, Janssen Pharmaceuticals, Inc., include once daily administration of an oral pill, no dietary restrictions, and less testing requirements resulting in fewer blood draws. Warfarin, another type of anticoagulant, is a vitamin K inhibitor.  If a patient’s blood becomes too thin after taking warfarin, vitamin K is administered to reverse its blood-thinning effects (i.e., an antidote or reversal agent). While the INR measurement is an effective test to dose and monitor warfarin in patients, Janssen’s advertising campaign touting less testing requirements for Xarelto® as a benefit is laughable given that the INR test used repeatedly to demonstrate the safety and efficacy of Xarelto® “is not recommended.” Until early 2018—approximately seven years after its market release–Xarelto® did not have a reversal agent, and to date, there is not a “recommended” test for doctors to accurately dose and monitor the effects of Xarelto® in their patients.

In 2014, the FDA required Janssen to add new language to its official warnings and precautions including an update to its “black box” because the test equipment used to measure the INR during clinical trials was deemed faulty. The black box is the strongest and most urgent FDA warning added to an official drug label. The update notifies patients and caregivers about certain risks and potentially dangerous side effects from Xarelto®. A year earlier, the FDA cited Johnson & Johnson for its misleading advertising campaign in contradiction to U.S. laws and regulations.

According to Recall Center, a consumer protection organization:

Since the drug’s release, there have been multiple updates to the label warning users of possible risks. In 2013, the FDA issued a determination letter to Johnson & Johnson advising them that their print advertising published in WebMD magazine earlier that year was misleading. They cited the following deficiencies:

  • Effects of the drug to potential patients were downplayed
  • Efficacy claims appeared to be disassociated from the potential risks
  • Assertions that Xarelto has “no dosage adjustments,” which the FDA noted is inaccurate according to the product information’s section on warnings and precautions, as well as its section on dosage and administration.

Because of these allegations, the FDA declared Johnson & Johnson to be in violation of U.S. laws and regulations that oversee drug marketing. [U.S. Food & Drug Administration. “Letter to Roxanne McGregor-Beck, RE: NDA #202439.” (June 6, 2013) FDA.gov. Accessed Oct. 27, 2014]

According to a 2017 PR Newswire press release published by Business Insider (emphasis added):

Johnson & Johnson (NYSE: JNJ), Janssen Pharmaceuticals and Bayer Healthcare (OTC: BAYRY) are accused of downplaying the risks of taking Xarelto and aggressively marketing the drug as an alternative for warfarin in patients needing blood thinners to reduce the risk of dangerous clots. The companies positioned the drug as more convenient, calling for a once-a-day dose and eliminating the need for regular monitoring of a patient’s blood. However, the lawsuits charge that doctors and patients were not fully informed of the risks.

While Janssen’s Xarelto® advertising campaign claims:

And with XARELTO® you can

  • Spend your time how you want to spend it, with no regular blood monitoring

MISLEADING. A more accurate statement would arguably be:

Regular blood monitoring would be useless because it will not identify whether a patient is under anti-coagulated [i.e. clotting too much] or over anti-coagulated [i.e., bleeding too much].

  • Enjoy a full variety of healthy foods with no known dietary restrictions

TRUE.

  • Know it’s working, with no frequent dosage adjustments

MISLEADING. A more accurate statement would arguably be:

There is no means by which to determine if a dosage adjustment is needed in that the common tests to make such a determination are inaccurate in patients who have been administered Xarelto®.

It bears repeating:

A pharmaceutical product for which correct dosage cannot be established or determined for any given patient is arguably defective in a significant way.

With Testing, Rat Poison Can Be Correctly Dosed for Benefit

There may be no better example of why correctly dosing an anticoagulant is important than warfarin. Warfarin first came into commercial use as a rat poison in 1948. Correctly dosed, warfarin is an effective anticoagulant for humans; incorrectly dosed, warfarin is poison.

Unlike Xarelto®, INR testing is reliable for dosing warfarin. To optimize the therapeutic effect without risking dangerous side effects such as bleeding, close monitoring of the degree of anticoagulation is required. During the initial stage of treatment, the INR is checked daily. Intervals between tests can be lengthened if the patient manages stable therapeutic INR levels on an unchanged warfarin dose. Newer point-of-care testing is available and has increased the ease of INR testing in the outpatient setting. Instead of a blood draw, the new INR point-of-care test involves a simple finger prick.

Therefore, an anticoagulant that cannot be accurately dosed is arguably not as safe as rat poison.

———-

The foregoing is an observation of statistics and data related to Xarelto®. The conclusions contained herein are based on opinions formed by the author after a review of the relevant data. We acknowledge that others could draw differing conclusions and opinions based on the same observations.

 References:

https://www.clinicaltherapeutics.com/article/S0149-2918(17)30242-4/pdf

https://www.recallcenter.com/xarelto/fda-news/

https://markets.businessinsider.com/news/stocks/report-more-than-15-000-adverse-events-linked-to-xarelto-in-2016-1002203317

https://www.xareltohcp.com/dvt-pe/clinical-trials

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XARELTO INITIAL ROCKET & EINSTEIN CLINICAL TRIALS NOW SEEN AS FLAWED: ADD THE MAY 2018 FAILURE OF TWO LATEST BAYER/JANSSEN STUDIES = BAD SCIENCE

Xarelto Study Red Flags Ignored: Why were medical research professionals ignored when red flags were raised over the viability of the Xarelto Rocket AF and Einstein DVT study results? Now the clinical trials for both are considered flawed, and the two most recent studies, the “Commander HF” and “Mariner,” failed to produce clear evidence that Xarelto is able to reduce the rate of blood clots in certain high-risk patients or after an acute decline in their condition.

By Mark A. York (October 23, 2018)

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Xarelto (rivaroxaban) is a prescription blood thinner created by Bayer and Janssen Pharmaceuticals that was approved by the Food and Drug Administration (FDA) in 2011. This drug is an anticoagulant for preventing blood from clotting, often used to treat deep vein thrombosis, atrial fibrillation, pulmonary embolism, stroke, and other conditions.

More than one study has shown Xarelto can cause a higher rate of internal bleeding, than other anticoagulant drugs and until very recently, there was 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.

What The Medical Studies Say About Xarelto?

The FDA has received thousands of adverse event reports regarding Xarelto and medical studies have examined the safety of this drug:

  • New England Journal of Medicine (2011): Published the ROCKET-AF study, which compared Xarelto to Warfarin in patients suffering from atrial fibrillation. This was the biggest clinical trial of this medication and it compared the effects of Xarelto to the effects of a similar drug known as Warfarin in over 14,000 patients. The study concluded that “there was not significant between-group difference in the risk of major bleeding.”
  • Archives of Internal Medicine (2012): The study discussed the risk of uncontrollable bleeding outweighing the benefits for several different blood thinners including Xarelto. The researchers in this study found that there was a tripled risk of bleeding among the patients, who were given the drug, and no improvement in overall survival rates.
  • Institute for Safe Medication Practices (2012): Issued a report based on FDA data from the first quarter of 2012. During this period, the FDA received 356 adverse event reports of Xarelto side effects including “serious, disabling, or fatal injury.” Additionally, 158 reports indicated blood clots were the serious side effect.
  • New England Journal of Medicine (2013): Published the results of the ROCKET study, which found that Xarelto may carry an increased risk of bleeding.
  • Medscape (2013): Xarelto is associated with a higher risk of bleeding in certain patients. It caused a nearly 3-fold increase of the risk of bleeding in “acutely ill patients” and 4-fold increased risk of major bleeding in patients that had “Acute Coronary Syndrome” (ACS).

Drug Makers Failed To Disclose Faulty Device In Xarelto Trials

 Rivaroxaban and the ROCKET AF trial issue chronicles: A closer look at benefit risk profile of the drug.

  • BMJ2016354 doi: https://doi.org/10.1136/bmj.i5131 (Published 28 September 2016)Cite this as: BMJ 2016;354:i5131
  • Study Analysis: There has been a lot of hue and cry over the recent question raised about the ROCKET AF[1] trial for rivaroxaban which was the only trial used by the company for drug approval from USFDA. This is indeed a very important concern as it directly impacts the well-being of the patients who are at the receiving end of this very highly prescribed anticoagulant drug in 2014.[2] The main concern with this whole confusion surrounding the ROCKET AF trial is that the device used for measuring the INR in trial arm of warfarin patient was faulty and gave lower INR values than it should have, leading to over dosing of warfarin and thereby increasing bleeding problems with the same, compared to the trial arm of rivaroxaban. However, there has been a reanalysis done by the ROCKET AF researchers, which again reinforced the prior result database of the trial and which was accepted by FDA as well[3]. In the reanalysis, the US FDA clearly mentioned that the effect of the faulty device results in causing bleeding episodes, both minor and major, was minimal.[4]
  • However, following this reanalysis, not everyone who raised the question in the first place was convinced and there was a demand that the data of the complete ROCKET AF trial should be made public for everyone to assess and understand the risks. But since the trial was done and results released before the principles on responsible clinical trial data sharing came into effect, the parent pharmaceutical company for rivaroxaban refused to share the patient level details, citing concerns on privacy and transparency policy [5].
  • In spite of everything said and written for and against this issue, a simple question arises, regarding the amount of belief, honesty and hard work that goes without questioning when you bring a new chemical entity to the research stage, get it approved and then bring it to market. For this to happen, there have to be maintained a very fine balance between pharmaceutical companies, drug regulatory authorities and marketing people. In this case, after initial suspicions, the drug regulatory authorities have cleared and supported the approval of rivaroxaban after reanalysis and that should have a say, in case we want to continue trust with this process of drug entry into the market.
  • Rivaroxaban has shown its efficacy and safety both in patients who required adequate anticoagulation e.g. those who had atrial fibrillation and underwent cardioversion. There are few other trials where rivaroxaban has performed better or equally good than warfarin in terms of both efficacy and safety [6]. These results lead us to believe that all was not wrong with the ROCKET AF trial results. All these, combined with personal experiences of those physicians who had been using the drug rivaroxaban for the last couple of years with a hugely favorable result clearly imply that the drug rivaroxaban is holding its side strongly in the midst of all the controversies surrounding its approval and efficacy and it is here to stay. Adding a last word to all this discussion is that rivaroxaban will always hold an upper hand compared to warfarin when prescribed because of its very favorable and easy to use once daily dosing. We cannot discard all the positive reports and positive experiences associated with this drug, based on real time data, only because of the question raised by some, and considering the fact that the question had been satisficatorily answered with a re analysis with no change in the result.

What Did Or Didn’t The FDA Do About Xarelto?

  • In July, 2011, the U.S Food and Drug Administration (FDA) initially approved the medicine for sale on the market for a limited group of people. This included people who had knee or hip replacement surgery because they were considered to be at a higher risk of blood clotting. Read the FDA News Release here.
  • In November, 2011, Xarelto was approved for a larger group of people, including people with an abnormal heart rhythm, and was used to prevent stroke. Read further.
  • In June, 2012, an FDA advisory panel voted against approving this medicine for the treatment of acute coronary syndrome.
  • In November, 2012, Xarelto was later approved for general treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) after a fast track regulatory review by the FDA. Read more.
  • October 22, 2014, the FDA issued a recall for approximately 13,500 bottles of Xarelto after receiving a customer complaint about contamination in a sales sample.
  • January 12, 2015 – An antidote may have been discovered by Portola Pharmaceuticals for Xarelto. A late-stage clinical trial of the intravenous medication, andexanet alfa, met its goal of “immediately and significantly” reversing Xarelto.

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.

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.

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).

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.

Xarelto Clinical Trial Red Flags

Controversy Surrounding ROCKET-AF: A Call for Transparency, But Should We Be Changing Practice?

Jason D Matos1 and Peter J Zimetbaum1,,2

Arrhythm Electrophysiol Rev. 2016 May; 5(1): 12–13.

doi:  [10.15420/aer.2016.24.2]

Prior to the emergence of novel oral anticoagulants (NOACS), nearly all patients were prescribed vitamin K antagonists for thromboembolic prophylaxis in non-valvular atrial fibrillation (AF). Rivaroxaban (Xarelto, Bayer/Johnson & Johnson), an oral factor Xa inhibitor, is now one of the most frequently prescribed NOACs used for this indication.1,2

ROCKET-AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation), published in the New England Journal of Medicine in 2011, demonstrated the non-inferiority of rivaroxaban compared with warfarin for the primary prevention of stroke or systemic embolism in patients with AF. This double-blinded randomised trial, which included 14,264 patients across 45 countries, also showed no significant difference in the risk of major bleeding between these two groups.3

Rivaroxaban use in AF has become widespread since the publication of this trial and US Food and Drug Administration (FDA) approval. Two additional Factor Xa inhibitors, apixaban and edoxaban, have also been evaluated in similar randomised trials and have demonstrated non-inferiority to warfarin for stroke or systemic embolism prophylaxis in patients with non-valvular AF with no significant difference in major bleeding.4,5

In recent months, the results of ROCKET-AF have come into question after the FDA issued a recall notice for the device used to obtain International Normalised Ratio (INR) measurements in the warfarin control group. The FDA found that lower INR values were seen with the ‘point-of-care’ INRatio Monitor System (Alere) compared with a plasma-based laboratory in patients with certain medical conditions.2 These conditions included abnormal haemoglobin levels, abnormal bleeding and abnormal fibrinogen levels.6Since the FDA recall of this device, there has been widespread concern that falsely low INR readings in ROCKET-AF may have led to warfarin overdosing. Inappropriately high warfarin dosing could have increased bleeding rates in the control group and therefore made the rivaroxaban arm appear falsely favourable.7 This point-of-care device recall also highlighted a lack of transparency of the specifics of devices used in large clinical trials.

In response, the authors from ROCKET-AF released a correspondence in February 2016, citing the FDA recall. They also provided a post hoc analysis of patients who may have been affected by the recall. They found that major bleeding was greater in patients with conditions affected by the recall, but, reassuringly, the bleeding risk was greater in those who were on rivaroxaban and not warfarin.6

Despite this post hoc analysis, concern has arisen regarding the generalisability of ROCKET-AF given the faulty point-of-care INR readings. There has been a call for complete transparency of the data from this trial and a better explanation of the mechanism of the incorrect INR measurements.7

Once published, the data supporting an FDA-approved treatment should be available for independent analysis. One issue is that rivaroxaban was approved in the US prior to 1 January 2014, before a new transparency policy on clinical trial data sharing was approved by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA).2 Drug companies are refusing to share any data on pharmaceuticals approved before 2014.

A device malfunction in a large clinical trial also should raise concern, especially when that trial has altered clinical practice for millions of patients. On review of Patel et al’s correspondence regarding the point-of-care malfunction, there is inadequate explanation of the mechanism of these faulty readings. Why are they only seen only in patients with abnormal haemoglobin and fibrinogen levels? How inaccurate could the readings be – within 0.1 or 1.0 of a gold standard value? Most alarming is the revelation that the manufacturer had evidence of faulty readings in similar models dating back to 2002.2

Despite legitimate concerns regarding the absence of data transparency and the faulty point-of-care device, rivaroxaban need not be removed from clinical practice for AF patients. In ROCKET-AF, the drug demonstrated non-inferiority to warfarin in preventing thromboembolic events. In addition, data has shown that patients potentially affected by the faulty point-of-care device actually bled more on rivaroxaban than warfarin.6 Therefore, the original risk–benefit ratio presented in ROCKET-AF remains true.

There are other, albeit smaller, randomised trials with shorter follow-up times that compare rivaroxaban and warfarin for thromboembolic prophylaxis.8,9 For example, Cappato et al in 2014, randomised 1,504 patients to show that oral rivaroxaban was non-inferior to warfarin in preventing a composite endpoint of stroke, transient ischaemic attack, peripheral embolism, myocardial infarction and cardiovascular death in patients with AF undergoing cardioversion. Major bleeding rates in the rivaroxaban and warfarin arms were similar (0.6 % versus 0.8 % respectively).8

The prospective observational trial XANTUS (Xarelto for Prevention of Stroke in Patients with Atrial Fibrillation) followed 6.784 patients on rivaroxaban for AF during a mean time of 329 days at 311 different hospitals. Major bleeding occurred in 128 patients (2.1 events/100 patient years) and 43 patients (0.7 events/100 patient years) suffered a stroke. These numbers are more reassuring than those seen in ROCKET-AF, though the patient population had a lower risk profile, with an average CHADS2 score of 2.0 compared with 3.5 in ROCKET-AF.10

To further mitigate concern regarding inaccuracies of bleeding rates in the ROCKET-AF control group, it is helpful to compare bleeding rates in the warfarin arms of the other major NOAC trials. The RE-LY (Randomised Evaluation of Long-Term Anticoagulation Therapy) trial, had a warfarin-arm major bleeding rate of 3.4%/year.11 The ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) trial, had a warfarin-arm major bleeding rate of 3.1%/year.4 The ENGAGE AF-TIMI 48 (Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) trial, had a warfarin-arm major bleeding rate of 3.4 %/year.5The warfarin arm of ROCKET-AF had a 3.4 %/year major bleeding rate, comparable to the other studies. Furthermore, the ROCKET-AF patients are known to be at higher risk for stroke and bleeding; their average CHADS2 score was highest among these studies (3.5 compared with 2.1–2.8).3 In addition, ROCKET-AF had a very high percentage of patients with a HAS-BLED score ≥3 (62 %) compared with the other studies (23 % in ARISTOTLE and 51 % in ENGAGE AF-TIMI 48).1214

Several large randomised trials have compared the safety and efficacy of rivaroxaban versus warfarin for venous thromboembolic disease. The warfarin arm of the EINSTEIN-PE trial (Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients with Acute Symptomatic Pulmonary Embolism), which randomised patients with pulmonary embolism to warfarin or rivaroxaban, had a major bleeding rate of 2.2 %. The bleeding rate was lower in the rivaroxaban arm (1.1 %) and notably patients received a higher loading dose of rivaroxaban for the first 3 weeks (15 mg twice daily) compared with the daily 20 mg daily in ROCKET-AF.15

The recent uncertainties surrounding ROCKET-AF demonstrate the need for widespread data transparency for major trials with the capability of so greatly affecting patients’ lives. These are complicated issues both for the companies’ manufacturing products and the clinical trial organisations who carry out these studies and analyse the data. Ultimately the goal of full transparency to allow increased confidence in trial results should be sought. In this instance there is no compelling evidence of imminent danger of excessive bleeding with rivaroxaban. We should take notice of the recent findings, but there is no need to change practice.

What Are Xarelto Side Effects?

The most dangerous Xarelto side effect is uncontrollable bleeding. Blood thinning drugs have also been associated with bleeding complications. Other side effects include:

  • Blood clots
  • Gastrointestinal bleeding
  • Spinal bleeding
  • Intracranial bleeding
  • Epidural bleeding
  • Cerebral bleeding
  • Stroke
  • Difficulty breathing

For Information on Xarelto and other mass torts see:

Michael Brady Lunch will speak on the Xarelto litigation as well as the status of Pradaxa litigation and related issues at the upcoming Mass Tort Nexus “CLE Immersion Course”

November 9 -12, 2018 at The Riverside Hotel in Fort Lauderdale , FL.

For class attendance information please contact Jenny Levine at 954.520.4494 or Jenny@masstortnexus.com.

  • For the most up to date information on all MDL dockets and related mass torts visit  masstortnexus.com and review our mass tort briefcases and professional site MDL briefcases.
  • To obtain our free newsletters that contain real time mass tort updates, visit masstortnexus.com/news and sign up for free access.
  • WWW.MASSTORTNEXUS.COM

REFERNCES CITED IN STUDIES SHOWN ABOVE

 Rivaroxaban and the ROCKET AF trial issue chronicles: A closer look at benefit risk profile of the drug. References:
BMJ 2016354 doi: https://doi.org/10.1136/bmj.i5131 (Published 28 September 2016)Cite this as: BMJ 2016;354:i5131
  1. Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011; 365:883-891. Article
    2. Top 50 pharmaceutical products by global sales. PMLiVE, Available here.
    3. FDA analyses conclude that Xarelto clinical trial results were not affected by faulty monitoring device.https://www.fda.gov/Drugs/DrugSafety/ucm524678.htm
    4. ROCKET AF Reanalysis Reviews.http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202439Orig1s000Ro…
    5. Joint EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing Become Effective.http://www.efpia.eu/mediaroom/132/43/Joint-EFPIA-PhRMA-Principles-for-Re…
    6. Cappato R, Ezekowitz MD, Klein AL, et al. Rivaroxaban vs vitamin K antagonists for cardioversion in atrial fibrillation. Eur Heart J 2014; 35:3346-3355.

_________________________________________________________

Controversy Surrounding ROCKET-AF: A Call for Transparency, But Should We Be Changing Practice? References
Jason D Matos1 and Peter J Zimetbaum1,,2 Arrhythm Electrophysiol Rev. 2016 May; 5(1): 12–13.; doi:  [10.15420/aer.2016.24.2]
  1. Kubitza D, Becka M, Wensing G, et al. Safety, pharmacodynamics, and pharmacokinetics of BAY 59-7939 – an oral, direct Factor Xa inhibitor – after multiple dosing in healthy male subjects. Eur J Clin Pharmacol. 2005;61:873–80. PMID: 16328318. [PubMed]
  2. Cohen D. Rivaroxaban: can we trust the evidence? BMJ. 2016;352:i575. DOI: 10.1136/bmj.i575; PMID: 26843102. [PubMed]
  3. Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365:883–91. DOI: 10.1056/NEJMoa1009638; PMID: 21830957. [PubMed]
  4. Granger CB, Alexander JH, McMurray JJ, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365:981–92. DOI: 10.1056/NEJMoa1107039; PMID: 21870978.[PubMed]
  5. Giugliano RP, Ruff CT, Braunwald E, et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013;369:2093–104. DOI: 10.1056/NEJMoa1310907; PMID: 24251359. [PubMed]
  6. Patel MR, Hellkamp AS, Fox KA, et al. Point-of-care warfarin monitoring in the ROCKET AF Trial. N Engl J Med. 2016;374:785–8. DOI: 10.1056/NEJMc1515842; PMID: 26839968. [PubMed]
  7. Mandrola J. Rivaroxaban: It’s not time to cut the rope, yet. Medscape. 9 February 2016. Available at: www.medscape.com/viewarticle/858648. (accessed 6 May 2016.
  8. Cappato R, Ezekowitz MD, Klein AL, et al. Rivaroxaban vs. vitamin K antagonists for cardioversion in atrial fibrillation. Eur Heart J. 2014;35:3346–55. DOI: 10.1093/eurheartj/ehu367; PMID: 25182247.[PubMed]
  9. Cappato R, Marchlinski FE, Hohnloser SH, et al. Uninterrupted rivaroxaban vs. uninterrupted vitamin K antagonists for catheter ablation in non-valvular atrial fibrillation. Eur Heart J. 2015;36:1805–11. DOI: 10.1093/eurheartj/ehv177; PMID: 25975659. [PMC free article] [PubMed]
  10. Camm AJ, Amarenco P, Haas S, et al. XANTUS: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation. Eur Heart J. 2016;37:1145–53.DOI: 10.1093/eurheartj/ehv466; PMID: 26330425. [PMC free article] [PubMed]
  11. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139–51. DOI: 10.1056/NEJMoa0905561; PMID: 19717844.[PubMed]
  12. Sherwood MW, Nessel CC, Hellkamp AS, et al. Gastrointestinal bleeding in patients with atrial fibrillation treated With rivaroxaban or warfarin: ROCKET AF trial. J Am Coll Cardiol. 2015;66:2271–81.DOI: 10.1016/j.jacc.2015.09.024; PMID: 26610874. [PubMed]
  13. Lopes RD, Al-Khatib SM, Wallentin L, et al. Efficacy and safety of apixaban compared with warfarin according to patient risk of stroke and of bleeding in atrial fibrillation: a secondary analysis of a randomised controlled trial. Lancet. 2012;380:1749–58. DOI: 10.1016/S0140-6736(12)60986-6; PMID: 23036896. [PubMed]
  14. Eisen A, Giugliano RP, Ruff CT, et al. Edoxaban vs warfarin in patients with nonvalvular atrial fibrillation in the US Food and Drug Administration approval population: An analysis from the Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48 (ENGAGE AF-TIMI 48) trial. Am Heart J. 2016;172:144–51. DOI: 10.1016/j.ahj.2015.11.004; PMID: 26856226. [PubMed]
  15. EINSTEIN-PE Investigators, Buller HR, Prins MH, et al. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012;366:1287–97. DOI: 10.1056/ NEJMoa1113572. PMID: 22449293. [PubMed]

 

 

 

 

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Pradaxa Federal Court Trial Win: $1.25 million verdict-with punitives of $1 million in death case

Betty Erelene Knight (Deceased), Claude R. Knight   vs. Boehringer Ingelheim Pharmaceuticals, Inc.  Docket No. 3:15-cv-06424; Judge Robert C. Chambers (United States District Court-Southern District of West Virginia)

(MASS TORT NEXUS MEDIA) A federal jury has awarded the family of a deceased West Virginia woman $1.25 million after finding that Boehringer Ingelheim failed to warn of risks associated with its blood thinner Pradaxa, causing her to suffer gastrointestinal bleeding.

The federal trial in Huntington, WV, (US District Court Southern District of West Virginia) awarded $250,000 in compensatory damages to the estate of Betty Erelene Knight and her husband Claude R. Knight, and added $1,000,000 more in punitive damages. The jury added the large punitive award after plaintiff counsel showed that Boehringer Ingelheim engaged in wanton and willful acts in handling of its blockbuster drug Pradaxa, primarily in failing to warn of the risks.

The October 17th plaintiffs’ verdict was the first trial win in the country against Boehringer Ingelheim the German drugmaker, showing that the blockbuster drug is dangerous. The Pradaxa defense team had won three earlier trials for the company, and this verdict on behalf of  the estate of Erelene Knight and her surviving spouse Claude, shows that juries can be convinced of the dangers including fatal risks related to Pradaxa. Mrs. Knight, who was in her 80’s passed away while taking Pradaxa.

She suffered from an irregular heartbeat, a condition that often leads to the development of blood clots, which can travel into the brain and cause a stroke. The plaintiff’s doctor stated that she was at “high risk of stroke.”

Prior to being prescribed Pradaxa, her doctors initially prescribed Coumadin, another prescription blood thinner. Because of the risk of uncontrolled bleeding with this particular drug, the victim required “frequent monitoring” which is what the Pradaxa marketing teams focused on, when meeting with doctors while marketing Pradaxa as a “safer alternative to Coumadin.”  Eventually, the victim grew weary of the inconvenience of such monitoring and learned about Pradaxa, which performs a similar function to Coumadin, from a television commercial.

Her doctor agreed to switch her to Pradaxa, and after about 18 months on the drug, she started to suffer from severe, uncontrolled internal bleeding. At one point she required surgery, which significantly weakened her and set into motion a decline in her health. Within several months of the surgery Erelene Knight passed away. Defense vigorously attempted to point the finger at other health conditions and place blame on anything besides Pradaxa, which failed as the punitive damage award of $1 million showed that the jury clearly saw that Boehringer Ingelheim knew the risks of Pradaxa, yet continued offering the drug without sufficient warnings.

The winning plaintiff trial team consisted of the Childers, Schlueter & Smith Firm and partner  Andy Childers, Neal Moskow of Ury & Moskow, LLC and Yvette Ferrer of Ferrer Poirot & Wansbrough. Congratulations to everyone, as the mass tort world looks forward to additional plaintiff verdicts in the many other Pradaxa cases pending in dockets around the country.

WHAT IS PRADAXA?

·        Pradaxa is an anticoagulant medication used to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation (AF), the most common type of heart rhythm abnormality.

·        The safety and efficacy of Pradaxa were studied in a clinical trial comparing Pradaxa with the anticoagulant warfarin. In the trial, patients taking Pradaxa had fewer strokes than those who took warfarin.1

·        From approval in October 2010 through August 2012, a total of approximately 3.7 million Pradaxa prescriptions were dispensed, and approximately 725,000 patients received a dispensed prescription for Pradaxa from U.S. outpatient retail pharmacies.2

Rulings Prior to Trial

The estate’s lawsuit against Boehringer Ingelheim, focused on Pradaxa’s label, asserting claims that the company knew that “certain blood plasma concentrations of Pradaxa increased the risk of a major bleed without contributing any additional stroke prevention benefit.” This risk was actually disclosed on labels for Pradaxa in Europe, but not the United States at the time of the victim’s care. Boehringer also knew that patients should not take Pradaxa if they also use P-gp inhibitor drugs, which Erelene Knight did. And while the company later altered its label to include this information, it did not directly inform doctors of the risk.

Based on all this, the judge presiding over the case ruled the estate presented sufficient evidence to submit the question of liability for “failure to warn” to the jury. Defense protested that at the relevant time, Pradaxa contained a general warning that the drug “can cause serious and, sometimes, fatal bleeding.” But whether or not this was an “adequate” warning given what BI allegedly knew, but failed to disclose on the original U.S. label, will be for the jury to decide.

How the favorable verdict predicts future trial outcomes in not only Pradaxa cases currently pending around the country, but in the more than 25,000 Xarelto blood thinner cases that are filed in the Xarelto MDL 2592 litigation, see Mass Tort Nexus Briefcase XARELTO-(rivaroxaban)-MDL-2592-USDC-ED-Louisiana (Judge Eldon Fallon), and in the Philadelphia Court of Common Pleas, see XARELTO-Case-No-2349-in-Philadephia-Court-of-Common-Pleas–Complex-Litigation-(PA-State-Court). There are several bellwether trials set for the Philadelphia Xarelto cases in 2019, where Laura Feldman and Rosemary Pinto of the Philadelphi firm of Feldman & Pinto, will be co-lead counsel for the trial team.

Michael Brady Lunch will speak on the Pradaxa litigation as well as the status of Xarelto and related issues at the upcoming Mass Tort Nexus “CLE Immersion Course”

November 9 -12, 2018 at The Riverside Hotel in Fort Lauderdale , FL.

For class attendance information please contact Jenny Levine at 954.520.4494 or Jenny@masstortnexus.com.

For the most up to date information on all MDL dockets and related mass torts visit  www.masstortnexus.com and review our mass tort briefcases and professional site MDL briefcases.

To obtain our free newsletters that contain real time mass tort updates, visit www.masstortnexus.com/news and sign up for free access.

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WHY THE ZOSTAVAX MDL 2848 IS NOT SUBJECT TO THE “VACCINE COURT” and the “VACCINE ACT”

There would be no MDL 2848 if this was a Vaccine Court case…

By Mark A. York (October 11, 2018)

See: Vaccine Rules – Court of Federal Claims

 

 

 

 

(MASS TORT NEXUS MEDIA) The National Vaccine Injury Compensation Program (VICP or NVICP) was established by the 1986 National Childhood Vaccine Injury Act (NCVIA), passed by the United States Congress in response to a threat to the vaccine supply due to a 1980s scare over the DPT vaccine. Despite the belief of most public health officials that claims of side effects were unfounded, large jury awards had been given to some plaintiffs, most DPT vaccine makers had ceased production, and officials feared the loss of herd immunity.[1]

The official standing of the “Vaccine Court” was confirmed February 22, 2011 by the US Supreme Court in Bruesewitz v. Wyeth, LLC et al, in https://www.supremecourt.gov/opinions/10pdf/09-152.pdf

The Office of Special Masters of the U.S. Court of Federal Claims, popularly known as “vaccine court“, administers a no-fault system for litigating vaccine injury claims. These claims against vaccine manufacturers cannot normally be filed in state or federal civil courts, but instead must be heard in the U.S. Court of Federal Claims, sitting without a jury.

“In the vaccine court, the burden is on a plaintiff to show a biological theory of harm, demonstrate a logical sequence of events connecting the vaccine to the injury, and establish an appropriate time frame in which injury occurred. The petitioner must also show that there is not another biologically plausible explanation for the injury.[13]

A 2005 United States Court of Appeals for the Federal Circuit ruling[14] held that an award should be granted if a petitioner either establishes a “Table Injury” or proves “causation in fact” by proving the following three prongs:

  1. a medical theory causally connecting the vaccination and the injury;
  2. a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and
  3. showing of a proximate temporal relationship between vaccination and injury.

Pursuant to §11(c)(1)(A) of the Vaccine Act, the Vaccine Court has jurisdiction to only hear cases listed on the Vaccine Injury Table see 42 CFR 100.3 Vaccine Injury Table (Drug List).

  1. The ZOSTAVAX vaccine is not a vaccine listed in the Vaccine Injury Table
  2. The National Childhood Vaccine Injury Act of 1986 (“Vaccine Act”), 42 U.S.C. §§ 300aa-1 et seq. does not preempt a Plaintiff from filing a civil complaint in federal court.

 No Special Tax Was Paid By Zostavax

Merck & Co. did not pay the 75 cent tax per dose to the vaccine court, to have Zostavax included on the “Vaccine Injury Table” see 42 CFR 100.3 Vaccine Injury Table, that lists which drugs are under the “Vaccine Court” jurisdiction and not the normal courts of civil procedure in the United states.

Merck & Co. have taken the position that there is no overriding public interest in Zostavax being available, as there is with vaccines for contagious viruses that could potentially cause a public health epidemic.

The 75 cent excise tax on each vaccine administered to children and others, routinely gets routed to the Vaccine Injury Compensation Trust Fund, which is collected by the U.S. Department of the Treasury.

CDC Shingles Vaccine Warning of Feb. 12, 2018

Women should avoid getting pregnant for at least 1 month after getting a shingles vaccine. Have a weakened immune system due to disease (such as cancer or AIDS) or medical treatments (such as radiation, immunotherapy, high-dose steroids, or chemotherapy).Feb 12, 2018

For additional CDC information on vaccines see: https://www.cdc.gov/vaccines/index.html

Why is Varicella Vaccine on the Vaccine Court List?

Some confusion may exist due to the fact that Varicella vaccines are listed on the Vaccine Court list, this reference however does not refer to Zostavax. The Varicella Vaccines subject to vaccine court are related to the Chickenpox vaccines and not the Shingles vaccine.

Only vaccines that have been determined to be in the public interest despite being unavoidably unsafe are on the vaccine court list. No Vaccine Act preemption arguments arise from the Vaccine Act. for Zostavax.  Zostavax was not permitted to be unsafe as drugs listed on the Vaccine Injury Table are classified.

The U.S. Department of Health and Human Services set up the National Vaccine Injury Compensation Program (VICP) in 1988 to compensate individuals and families of individuals injured by covered childhood vaccines.[4] The VICP was adopted in response to concerns over the pertussis portion of the DPT vaccine.[1] The VICP uses a no-fault system for resolving vaccine injury claims. Compensation covers medical and legal expenses, loss of future earning capacity, and up to $250,000 for pain and suffering; a death benefit of up to $250,000 is available. If certain minimal requirements are met, legal expenses are compensated even for unsuccessful claims.[5]

Since 1988, the program has been funded by an excise tax of 75 cents on every purchased dose of covered vaccine. To win an award, a claimant must have experienced an injury that is named as a vaccine injury in a table included in the law within the required time period or show a causal connection. The burden of proof is the civil law preponderance-of-the-evidence standard, in other words a showing that causation was more likely than not. Denied claims can be pursued in civil courts, though this is rare.[1]

John Ray and other speakers will cover the Zostavax MDL 2848 case criteria and related issues at the upcoming Mass Tort Nexus “CLE Immersion Course”
November 9 -12, 2018 at The Riverside Hotel in Fort Lauderdale , FL.
For class attendance information please contact Jenny Levine at 954.520.4494 or Jenny@masstortnexus.com.
For the most up to date information on all MDL dockets and related mass torts visitwww.masstortnexus.com and review our mass tort briefcases and professional site MDL briefcases.
To obtain our free newsletters that contain real time mass tort updates, visitwww.masstortnexus.com/news and sign up for free access.

 

“VACCINE COURT” Related References

  1. Sugarman SD (2007). “Cases in vaccine court—legal battles over vaccines and autism”. N Engl J Med. 357 (13): 1275–7. doi:1056/NEJMp078168PMID 17898095.
  2. Doja A, Roberts W (2006). “Immunizations and autism: a review of the literature”. Can J Neurol Sci. 33 (4): 341–6. doi:1017/s031716710000528xPMID 17168158.
  3.  Maugh TH II, Zajac A (2010-03-13). “‘Vaccines court’ rejects mercury–autism link in 3 test cases”. Los Angeles Times.
  4. Edlich RF; Olson DM; Olson BM; et al. (2007). “Update on the National Vaccine Injury Compensation Program”. J Emerg Med. 33(2): 199–211. doi:1016/j.jemermed.2007.01.001PMID 17692778.
  5. “Filing a claim with the VICP”. Health Resources and Services Administration. Retrieved 2013-08-19.
  6.  “Vaccine Injury Table”. Health Resources and Services Administration. 2007. Retrieved 2008-01-22.
  7. “National Vaccine Injury Compensation Program statistics reports”. Health Resources and Services Administration. 2008-01-08. Retrieved 2008-01-22.
  8. Balbier TE Jr (1999-09-28). “Statement on National Vaccine Injury Compensation Program”. U.S. Department of Health and Human Services. Retrieved 2008-01-22.
  9.  “Who Can File”. www.hrsa.gov. Last Reviewed: February 2016: U.S. Department of Health and Human Services Health Resources and Services Administration. Retrieved 12 October 2016.
  10. Holder v. Abbott Laboratories, 444 F.3d 383
  11. Davis WN (2006). “No longer immune”. ABA Journal. 92 (7): 19, 43.
  12. Pear R (2002-12-14). “Threats and responses: legal risks; for victims of vaccine, winning case will be hard”. New York Times. Retrieved 2008-01-22.
  13. Keelan, J; Wilson, K (November 2011). “Balancing vaccine science and national policy objectives: lessons from the National Vaccine Injury Compensation Program Omnibus Autism Proceedings”. American Journal of Public Health. 101 (11): 2016–21. doi:2105/ajph.2011.300198PMC 3222385PMID 21940934.
  14. Althen v. Secretary of Health and Human Services (Fed. Cir. July 29, 2005). Text This decision, which is binding upon the United States Court of Federal Claims, clarified the standing for proving “causation in fact” absent a “Table Injury” under 42 U.S.C. 300aa-11(c)(1)(C)
  15. Offit PA (2008). “Vaccines and autism revisited—the Hannah Poling case”. N Engl J Med. 358 (20): 2089–91. doi:1056/NEJMp0802904PMID 18480200.
  16. Rovner J (2008-03-07). “Case stokes debate about autism, vaccines”. NPR. Retrieved 2008-03-07.
  17.  Holtzman D (2008). “Autistic spectrum disorders and mitochondrial encephalopathies”. Acta Paediatr. 97 (7): 859–60. doi:1111/j.1651-2227.2008.00883.xPMID 18532934.
  18.  Honey K (2008). “Attention focuses on autism”. J Clin Invest. 118 (5): 1586–7. doi:1172/JCI35821PMC 2336894PMID 18451989.
  19. Kirkland, A. (13 March 2012). “Credibility battles in the autism litigation”. Social Studies of Science. 42 (2): 237–261. doi:1177/0306312711435832PMID 22848999.
  20. Omnibus Autism Proceeding, US Court of Federal Claims, http://www.uscfc.uscourts.gov/omnibus-autism-proceeding, visited October 12, 2016.
  21. Bridges A (2007-06-12). “Children with autism get day in court”. USA Today. Retrieved 2007-10-14.
  22. Freking K, Neergaard L (2009-02-12). “Court says vaccine not to blame for autism”. Associated Press. Retrieved 2009-02-12.

 

 

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