ULORIC EMERGING LITIGATION – A Drug Made By Takeda Pharmaceuticals, Inc.

“Emerging Uloric Litigation”

By Mark A. York (February 21, 2019)

    ULORIC by Takeda Pharmaceuticals. Inc.

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA)  Uloric made by Takeda Pharmaceuticals gained FDA approval subsequent to New Drug Application (NDA: 021856) in February 2009 and is now facing review by the FDA and others as to the risks associated with the drug.

Following an in-depth review of results from a safety clinical trial, the FDA has found that there is an increased risk of heart-related death and death from all causes with Uloric. Besides adding the Boxed Warning, the FDA is limiting the approved use of Uloric only to patients who have failed or do not tolerate another gout medicine Allopurinol.

Feb. 21, 2019 FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)

Excerpt: [2-21-2019] The U.S. Food and Drug Administration (FDA) has concluded there is an increased risk of death with Uloric (febuxostat) compared to another gout medicine, allopurinol. This conclusion is based on our in-depth review of results from a safety clinical trial that found an increased risk of heart-related death and death from all causes with Uloric.

As a result, we are updating the Uloric prescribing information to require a Boxed Warning, our most prominent warning, and a new patient Medication Guide. We are also limiting the approved use of Uloric to certain patients who are not treated effectively or experience severe side effects with allopurinol.

The FDA-mandated study, published in The New England Journal of Medicine in 2018, revealed that the “treatment with Uloric resulted in overall rates of major cardiovascular events that were similar to those associated with Allopurinol treatment among patients with gout who had coexisting cardiovascular disease. However, cardiovascular death and deaths from any cause were more frequent in the Uloric group than in the Allopurinol group”.

Takeda Pharmaceuticals is now under additional scrutiny as well as facing litigation if they withheld, altered or failed to properly disclose risk that that they were aware of, dating as far back to the initial clinical trials in 2009. Takeda is already facing legal problems over Uloric, with multiple Qui Tam lawsuits filed by a former safety consultant for the company.  These suits that the company withheld information about dangerous side effects related to Uloric, including kidney problems, liver damage, bone marrow failure, drug interactions and more.

Gout, a type of arthritis that occurs when uric acid crystals build up in the joints. Gout has been found to be more common in men than in women Gout is believed affects about 8.3 million people, or 4% of the U.S. population.

Uloric was the first new drug approved to treat Gout in 40 years. Unfortunately, this new treatment which promised relief for those who suffer from Gout, appears to have numerous significant and potentially life threatening side effects that Takeda never warned the public about.

Initial clinical trials testing febuxostat prior to FDA approval linked the medication to possible increased risks of serious adverse cardiovascular outcomes, including heart attack, stroke and death. The FDA rejected the medication twice over these safety concerns before approving it in 2009 on the condition that the manufacturer conduct the now-completed large, post-market randomized clinical trial to further evaluate the cardiovascular risks.

Link to FDA Nov 15, 2017 Uloric Drug Safety Communication Re: FDA to evaluate Uloric caused increased risk of heart issues

Excerpt:[ 11-15-2017 ] The U.S. Food and Drug Administration (FDA) is alerting the public that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. We required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when we approved the medicine in 2009. Once we receive the final results from the manufacturer, we will conduct a comprehensive review and will update the public with any new information.

Febuxostat is FDA-approved to treat a type of arthritis called gout in adults. Gout happens when a naturally occurring substance in the body called uric acid builds up and causes sudden attacks of redness, swelling, and pain in one or more joints. Febuxostat works by lowering uric acid levels in the blood.

Link to: January 11, 2019 Testimony Before FDA Risk and Advisory Committee on Uloric Removal

FDA Drug Safety Communication Re: Uloric Boxed Warning Added – Risk of Death

https://www.fda.gov/downloads/Drugs/DrugSafety/UCM631586.pdf

Takeda started post-marketing trials in 2009 and there are glaring issues with the trial results if Takeda had followed normal protocols.

Notably, 57% of the 6,198 enrolled patients left the trial prematurely, often when they encountered gout flares or thought they weren’t being taken good care of, explained lead investigator William White, MD, of UConn Health in Farmingdale, Connecticut, at the meeting. He noted that withdrawal occurred at the same rate in the febuxostat and allopurinol groups.

The CARES population not uncommonly had difficult problems like alcoholism and obesity and would commonly drop out when they felt like it, White said. “They’re ornery. They’re in pain all the time from the disease.” Such a large drop-out rate would have biased results to the null, which makes the observed cardiovascular mortality risk even more striking, according to panelist Bruce Psaty, MD, of the University of Washington in Seattle.

>To Learn More About the Emerging Uloric Litigation: 

The Uloric Litigation will be used as a case study in the March 8-11, 2019 Mass Tort Nexus “Four Days to Mass Tort Success Course” in Fort lauderdale, FL. To register for the course, contact Jenny Levine at jenny@masstortnexus.com or call (954) 520-4494.

Course attendees will receive the benefit of a step by step analysis of the emerging Uloric Litigation, using these primary metrics:

For information on the class and to enroll, use this link-“Enroll Here To Attend “Four Days to Mass Tort Success”

The Mass Tort Nexus Course on Emerging Litigation and Ongoing Mass Torts are considered the premier source in the country to learn about the fundamentals of mass torts and how to enhance your firm practice, increase revenues and manage the related business operations effectively.  Don’t wait for the next class or next year, enroll today and learn what others already have, Mass Torts are where your firm can and will grow its practice.

 

 

 

 

 

 

 

 

Read More

RICHARD SACKLER DEPOSITION TRANSCRIPT UNSEALED IN KENTUCKY vs. PURDUE PHARMA

Full Article: statnews.com/2019/02/21/purdue-pharma-richard-sackler-oxycontin-sealed-deposition/Feb 21-2019

By DAVID ARMSTRONG — PROPUBLICA, FEBRUARY 21, 2019

and MOLLY FERGUSON FOR STAT

(This is a partial reprint by MASS TORT NEXUS of a collaboration between STAT and ProPublica contained in the full article link above).

“Purdue’s Sackler embraced plan to conceal OxyContin’s strength from doctors, unsealed Richard Sackler deposition shows” 

 A LINK TO THE FULL RICHARD SACKLER DEPOSITION TRANSCRIPT IS CONTAINED IN ARTICLE BELOW

 

 

 

 

 

 

 

 

 

 

 

 

 

(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.

In the Kentucky vs. Purdue Pharma litigation (Pike County Kentucky Circuit Court) , where in the recently unsealed court documents is the only known deposition testimony of a Sackler family member, with this being the August 28, 2016 deposition of Pudue Pharma family member Richard Sackler, a link to the full deposition transcript is contained within this article, as well as the full ProPublic/StatNews article link, statnews.com/2019/02/21/purdue-pharma-richard-sackler-oxycontin-sealed-deposition/Feb 21-2019.

Who is Richard Sackler, and why was he deposed?

The son of a Purdue co-founder, Sackler began working at the company in 1971 and has been at various times its president and co-chairman of the board. The Sackler family controls Purdue and has received billions of dollars from OxyContin sales.

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 has been the subject of 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 had failed to rule on the argumanets as recently as January 2019

In May 1997, the year after Purdue Pharma launched OxyContin, its head of sales and marketing sought input on a key decision from Dr. Richard Sackler, a member of the billionaire family that founded and controls the company. Michael Friedman told Sackler that he didn’t want to correct the false impression among doctors that OxyContin was weaker than morphine, because the myth was boosting prescriptions — and sales.

“It would be extremely dangerous at this early stage in the life of the product,” Friedman wrote to Sackler, “to make physicians think the drug is stronger or equal to morphine. … We are well aware of the view held by many physicians that oxycodone [the active ingredient in OxyContin] is weaker than morphine. I do not plan to do anything about that.”

“I agree with you,” Sackler responded. “Is there a general agreement, or are there some holdouts?”

Ten years later, Purdue pleaded guilty in federal court to understating the risk of addiction to OxyContin, including failing to alert doctors that it was a stronger painkiller than morphine, and agreed to pay $600 million in fines and penalties. But Sackler’s support of the decision to conceal OxyContin’s strength from doctors — in email exchanges both with Friedman and another company executive — was not made public.

Related: Purdue cemented ties with universities and hospitals to expand opioid sales, documents contend

The email threads were divulged in a sealed court document that ProPublica has obtained: an Aug. 28, 2015, deposition of Richard Sackler. Taken as part of a lawsuit by the state of Kentucky against Purdue, the deposition is believed to be the only time a member of the Sackler family has been questioned under oath about the illegal marketing of OxyContin and what family members knew about it. Purdue has fought a three-year legal battle to keep the deposition and hundreds of other documents secret, in a case brought by STAT; the matter is currently before the Kentucky Supreme Court.

READ THE SACKLER DEPOSITION HERE

Meanwhile, interest in the deposition’s contents has intensified, as hundreds of cities, counties, states and tribes have sued Purdue and other opioid manufacturers and distributors. A House committee requested the documentfrom Purdue last summer as part of an investigation of drug company marketing practices.

In a statement, Purdue stood behind Sackler’s testimony in the deposition. Sackler, it said, “supports that the company accurately disclosed the potency of OxyContin to healthcare providers.” He “takes great care to explain” that the drug’s label “made clear that OxyContin is twice as potent as morphine,” Purdue said.

Still, Purdue acknowledged, it had made a “determination to avoid emphasizing OxyContin as a powerful cancer pain drug,” out of “a concern that non-cancer patients would be reluctant to take a cancer drug.”

The company, which said it was also speaking on behalf of Sackler, deplored what it called the “intentional leak of the deposition” to ProPublica, calling it “a clear violation of the court’s order” and “regrettable.”

Much of the questioning of Sackler in the 337-page deposition focused on Purdue’s marketing of OxyContin, especially in the first five years after the drug’s 1996 launch. Aggressive marketing of OxyContin is blamed by some analysts for fostering a national crisis that has resulted in 200,000 overdose deaths related to prescription opioids since 1999.

Taken together with a Massachusetts complaint made public last month against Purdue and eight Sacklers, including Richard, the deposition underscores the pivotal role of the Sackler family in developing the business strategy for OxyContin and directing the hiring of an expanded sales force to implement a plan to sell the drug at ever-higher doses. Documents show that Richard Sacklerwas especially involved in the company’s efforts to market the drug, and that he pushed staff to pursue OxyContin’s deregulation in Germany. The son of a Purdue co-founder, he began working at Purdue in 1971 and has been at various times the company’s president and co-chairman of its board.

In a 1996 email introduced during the deposition, Sackler expressed delight at the early success of OxyContin. “Clearly this strategy has outperformed our expectations, market research and fondest dreams,” he wrote. Three years later, he wrote to a Purdue executive, “You won’t believe how committed I am to make OxyContin a huge success. It is almost that I dedicated my life to it. After the initial launch phase, I will have to catch up with my private life again.”

During his deposition, Sackler defended the company’s marketing strategies — including some Purdue had previously acknowledged were improper — and offered benign interpretations of emails that appeared to show Purdue executives or sales representatives minimizing the risks of OxyContin and its euphoric effects. He denied that there was any effort to deceive doctors about the potency of OxyContin and argued that lawyers for Kentucky were misconstruing words such as “stronger” and “weaker” used in email threads.T

The term “stronger” in Friedman’s email, Sackler said, “meant more threatening, more frightening. There is no way that this intended or had the effect of causing physicians to overlook the fact that it was twice as potent.”

Emails introduced in the deposition show Sackler’s hidden role in key aspects of the 2007 federal case in which Purdue pleaded guilty. A 19-page statement of factsthat Purdue admitted to as part of the plea deal, and which prosecutors said contained the “main violations of law revealed by the government’s criminal investigation,” referred to Friedman’s May 1997 email to Sackler about letting the doctors’ misimpression stand. It did not identify either man by name, attributing the statements to “certain Purdue supervisors and employees.”

Friedman, who by then had risen to chief executive officer, was one of three Purdue executives who pleaded guilty to a misdemeanor of “misbranding” OxyContin. No members of the Sackler family were charged or named as part of the plea agreement. The Massachusetts lawsuit alleges that the Sackler-controlled Purdue board voted that the three executives, but no family members, should plead guilty as individuals. After the case concluded, the Sacklers were concerned about maintaining the allegiance of Friedman and another of the executives, according to the Massachusetts lawsuit. To protect the family, Purdue paid the two executives at least $8 million, that lawsuit alleges.

“The Sacklers spent millions to keep the loyalty of people who knew the truth,” the complaint filed by the Massachusetts attorney general alleges.

The Kentucky deposition’s contents will likely fuel the growing protests against the Sacklers, including pressure to strip the family’s name from cultural and educational institutions to which it has donated. The family has been active in philanthropy for decades, giving away hundreds of millions of dollars. But the source of its wealth received little attention until recent years, in part due to a lack of public information about what the family knew about Purdue’s improper marketing of OxyContin and false claims about the drug’s addictive nature.

Although Purdue has been sued hundreds of times over OxyContin’s marketing, the company has settled many of these cases, and almost never gone to trial. As a condition of settlement, Purdue has often required a confidentiality agreement, shielding millions of records from public view.

That is what happened in Kentucky. In December 2015, the state settled its lawsuit against Purdue, alleging that the company created a “public nuisance” by improperly marketing OxyContin, for $24 million. The settlement required the state attorney general to “completely destroy” documents in its possession from Purdue. But that condition did not apply to records sealed in the circuit court where the case was filed.

In March 2016, STAT filed a motion to make those documents public, including Sackler’s deposition. The Kentucky Court of Appeals last year upheld a lower court ruling ordering the deposition and other sealed documents be made public. Purdue asked the state Supreme Court to review the decision, and both sides recently filed briefs. Protesters outside Kentucky’s Capitol last week waved placards urging the court to release the deposition.

Related:  Purdue appeals order to unseal OxyContin records to Kentucky Supreme Court

Sackler family members have long constituted the majority of Purdue’s board, and company profits flow to trusts that benefit the extended family. During his deposition, which took place over 11 hours in a law office in Louisville, Ky., Richard Sackler said “I don’t know” more than 100 times, including when he was asked how much his family had made from OxyContin sales. He acknowledged it was more than $1 billion, but when asked if they had made more than $5 billion, he said, “I don’t know.” Asked if it was more than $10 billion, he replied, “I don’t think so.”

By 2006, OxyContin’s “profit contribution” to Purdue was $4.7 billion, according to a document read at the deposition. From 2007 to 2018, the Sackler family received more than $4 billion in payouts from Purdue, according to the Massachusetts lawsuit.

During the deposition, Sackler was confronted with his email exchanges with company executives about Purdue’s decision not to correct the misperception among many doctors that OxyContin was weaker than morphine. The company viewed this as good news because the softer image of the drug was helping drive sales in the lucrative market for treating conditions like back pain and arthritis, records produced at the deposition show.

Designed to gradually release medicine into the bloodstream, OxyContin allows patients to take fewer pills than they would with other, quicker-acting pain medicines, and its effect lasts longer. But to accomplish these goals, more narcotic is packed into an OxyContin pill than competing products. Abusers quickly figured out how to crush the pills and extract the large amount of narcotic. They would typically snort it or dissolve it into liquid form to inject.

The pending Massachusetts lawsuit against Purdue accuses Sackler and other company executives of determining that “doctors had the crucial misconception that OxyContin was weaker than morphine, which led them to prescribe OxyContin much more often.” It also says that Sackler “directed Purdue staff not to tell doctors the truth,” for fear of reducing sales. But it doesn’t reveal the contents of the email exchange with Friedman, the link between that conversation and the 2007 plea agreement, and the back-and-forth in the deposition.

STAT Plus:  Exclusive analysis of biotech, pharma, and the life sciences.

A few days after the email exchange with Friedman in 1997, Sackler had an email conversation with another company official, Michael Cullen, according to the deposition. “Since oxycodone is perceived as being a weaker opioid than morphine, it has resulted in OxyContin being used much earlier for non-cancer pain,” Cullen wrote to Sackler. “Physicians are positioning this product where Percocet, hydrocodone and Tylenol with codeine have been traditionally used.” Cullen then added, “It is important that we be careful not to change the perception of physicians toward oxycodone when developing promotional pieces, symposia, review articles, studies, et cetera.”

“I think that you have this issue well in hand,” Sackler responded, while Friedman and Cullen could not be reached for comment.

Asked at his deposition about the exchanges with Friedman and Cullen, Sackler didn’t dispute the authenticity of the emails. He said the company was concerned that OxyContin would be stigmatized like morphine, which he said was viewed only as an “end of life” drug that was frightening to people.

“Within this time it appears that people had fallen into a habit of signifying less frightening, less threatening, more patient acceptable as under the rubric of weaker or more frightening, more — less acceptable and less desirable under the rubric or word ‘stronger,’” Sackler said at his deposition. “But we knew that the word ‘weaker’ did not mean less potent. We knew that the word ‘stronger’ did not mean more potent.” He called the use of those words “very unfortunate.” He said Purdue didn’t want OxyContin “to be polluted by all of the bad associations that patients and healthcare givers had with morphine.”

Related: ‘A blizzard of prescriptions’: Documents reveal new details about Purdue’s marketing of OxyContin

In his deposition, Sackler also defended sales representatives who, according to the statement of facts in the 2007 plea agreement, falsely told doctors during the 1996-2001 period that OxyContin did not cause euphoria or that it was less likely to do so than other opioids. This euphoric effect experienced by some patients is part of what can make OxyContin addictive. Yet, asked about a 1998 note written by a Purdue salesman, who indicated that he “talked of less euphoria” when promoting OxyContin to a doctor, Sackler argued it wasn’t necessarily improper.

“This was 1998, long before there was an Agreed Statement of Facts,” he said.

The lawyer for the state asked Sackler: “What difference does that make? If it’s improper in 2007, wouldn’t it be improper in 1998?”

“Not necessarily,” Sackler replied.

Shown another sales memo, in which a Purdue representative reported telling a doctor that “there may be less euphoria” with OxyContin, Sackler responded, “We really don’t know what was said.” After further questioning, Sackler said the claim that there may be less euphoria “could be true, and I don’t see the harm.”

The same issue came up regarding a note written by a Purdue sales representative about one doctor: “Got to convince him to counsel patients that they won’t get buzzed as they will with short-acting” opioid painkillers. Sackler defended these comments as well. “Well, what it says here is that they won’t get a buzz. And I don’t think that telling a patient ‘I don’t think you’ll get a buzz’ is harmful,” he said.

Sackler added that the comments from the representative to the doctor “actually could be helpful, because many patients won’t get a buzz, and if he would like to know if they do, he might have had a good medical reason for wanting to know that.”

Sackler said he didn’t believe any of the company sales people working in Kentucky engaged in the improper conduct described in the federal plea deal. “I don’t have any facts to inform me otherwise,” he said.

Purdue said that Sackler’s statements in his deposition “fully acknowledge the wrongful actions taken by some of Purdue’s employees prior to 2002,” as laid out in the 2007 plea agreement. Both the company and Sackler “fully agree” with the facts laid out in that case, Purdue said.

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

The deposition also reveals that Sackler pushed company officials to find out if German officials could be persuaded to loosen restrictions on the selling of OxyContin. In most countries, narcotic pain relievers are regulated as “controlled” substances because of the potential for abuse. Sackler and other Purdue executives discussed the possibility of persuading German officials to classify OxyContin as an uncontrolled drug, which would likely allow doctors to prescribe the drug more readily — for instance, without seeing a patient. Fewer rules were expected to translate into more sales, according to company documents disclosed at the deposition.

One Purdue official warned Sackler and others that it was a bad idea. Robert Kaiko, who developed OxyContin for Purdue, wrote to Sackler, “If OxyContin is uncontrolled in Germany, it is highly likely that it will eventually be abused there and then controlled.”

Nevertheless, Sackler asked a Purdue executive in Germany for projections of sales with and without controls. He also wondered whether, if one country in the European Union relaxed controls on the drug, others might do the same. When finally informed that German officials had decided the drug would be controlled like other narcotics, Sackler asked in an email if the company could appeal. Told that wasn’t possible, he wrote back to an executive in Germany, “When we are next together we should talk about how this idea was raised and why it failed to be realized. I thought that it was a good idea if it could be done.”

Asked at the deposition about that comment, Sackler responded, “That’s what I said, but I didn’t mean it. I just wanted to be encouraging.” He said he really “was not in favor of” loosening OxyContin regulation and was simply being “polite” and “solicitous” of his own employee.

Near the end of the deposition — after showing Sackler dozens of emails, memos and other records regarding the marketing of OxyContin — a lawyer for Kentucky posed a fundamental question.

“Sitting here today, after all you’ve come to learn as a witness, do you believe Purdue’s conduct in marketing and promoting OxyContin in Kentucky caused any of the prescription drug addiction problems now plaguing the Commonwealth?” he asked.

Sackler replied, “I don’t believe so.”

THIS IS A PARTIAL REPOSTING OF A STATNEWS and PROPUBLICA ARTICLE COLLABORATION (February 21, 2019)

 

 

 

Read More

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.

 

 

Read More

INDIVIDUAL CLAIMS = INFANT “NAS”, RICO, WRONGFUL DEATH, NEGLIGENCE AND MORE…

Individual Opioid Injury Claim Types

 

A MASS TORT NEXUS OVERVIEW:

by John Ray

A great deal of media attention has focused on lawsuits filed by States, Counties and Cities against the manufacturers of opioids, yet less attention has been given to viable individual opioid patient claims against these same companies. This article is the second in a series published by Mass Tort Nexus to have you gain a better understanding of the vast number of opioid claims, which may be filed on behalf of individual victims of the opioid crisis. Please also read the first article in the series (link to the first article).

This article is intended to cover the major categories or types of potential opioid individual claims based on injury or adverse event type.

  1. Overdose resulting in death

  2. Overdose without death

  3. Opioid Addiction

  4. Neonatal Abstinence Syndrome

  5. Birth Defects

  6. Heart attack

Attend the July 20-22, 2018 Mass Tort Nexus Opioid Crisis Summit to learn more about what your firm can do to help individual victims of the opioid epidemic.

In addition to providing information related to the types of claims that may be brought against the opioid defendants on behalf of individual plaintiffs, you will also receive information related to marketing to obtain these clients, as well as vital information related to the complex issues related to qualifying clients for each category of opioid injury.

To register for the Opioid Summit contact Jenny Levine at 954-530-9892 or email at jenny@masstortnexus.com. You may also register online at  https://www.opioidcrisissummit.com

Opioid Litigation Individual Claims

Given the publicity surrounding the opioid crisis gripping our nation, most of the country is aware that opioid addiction and overdose risk is far greater than the opioid litigation defendants, their Key Opinion Leaders and Front Groups led us to believe.

The researchers at Mass Tort Nexus estimate that there are approximately 250,000 individuals and families with viable claims against the opioid litigation defendants; however, yet few firms have engaged in an effort to retain these clients and provide the legal representation they desperately need and deserve. This fact is somewhat astounding given that many of these potential plaintiffs have been represented by your personal injury firm in the past.

Overdose Resulting in Death

  When an individual, often a juvenile, dies from an opioid overdose, family members are left behind to suffer the pain and costs.

Significant evidence exists to demonstrate that the opioid manufacturers negligently and wantonly deceived doctors and the public about the risks associated with opioids. They continued to do so, even after it was apparent that their deceptions were resulting in loss of life and other severe injuries caused by their products.

The potential number of wrongful death claims which could be brought against the opioid defendants, could exceed the total number of wrongful death claims brought for any other reason over the next decade.

 Overdose Deaths Soared as Big Pharma Reaped the Profits

According to the National Institute for Drug Abuse revised report from March 2018, despite the efforts to stem the opioid crisis, 115 people in the United States die from an Opioid overdose every day.

Overdose deaths, once rare, are now the leading cause of accidental death in the U.S., surpassing peak annual deaths caused by motor vehicle accidents, guns and HIV infection.

More Americans died from drug overdoses in 2016 than the number of American lives lost in the entirety of the Vietnam War, which totaled 58,200.

 

 

 

 

 

 

 

 

 

 

Prescription opioid deaths account for the majority of the increase in overdose deaths since 1999. It is no coincidence that the astounding increase in drug over dose statics beginning in 1999 coincides with the opioid manufactures campaign (beginning in the late 1990s) to convince doctors, based on false information, that past concerns related to opioids were unwarranted.

The opioid manufacturers are accused of using big tobacco style techniques to increase the consumption (and their profits) from increased sales of opioids. The manufacturers are accused of taking a page from the big tobacco play book, using front groups and key opinion leaders in the health field to promote the narrative that the risk associated with opioids was not significant.  The false narrative promoted by the opioid manufacturers has been unveiled at the cost of an enormous loss of human life and suffering.

The link between the success of the opioid manufacturers deceptions, and the devasting effects caused by their fraudulent acts can be seen in a single chart. As the opioid manufacturers made billions of dollars, individual patients relying on these companies paid the price.

 

 

 

 

 

 

 

Overdose Without Death

Opioid overdose deaths are devasting to the family of the victim. Opioid overdoses that do not result in death can be equally or even more devasting.

Victims of opioid overdoses often suffer brain damage, heart damage and other adverse events that will impact their lives and their families permanently.

In many cases, the financial and other damages caused by an overdose not resulting in death will exceed those of overdose cases resulting in death.

Opioid Addiction

Despite the opioid litigation defendants attempts to blame the victims and their doctors, the blame for the meteoric rise in opioid addiction coincided with the opioid manufacturers fraudulent practices designed to deceive doctors and the public about the risk of opioid use.

According to the CDC, by 2016 2.1 million Americans suffered from opioid addiction (opioid use disorder) and 2.1 million more Americans received their first opioid prescription in the same year, guaranteeing the continuation of the Country’s opioid addiction epidemic.

 

Not every opioid addict will have a viable claim for damages against the opioid manufacturers.

Qualifying opioid addiction clients is complex. Attend the Mass Tort Nexus July 20 -22

Opioid Crisis Summit to learn more about qualifying clients with viable opioid addiction claims.

Neonatal Abstinence Syndrome

 By 2012, the National Institute for Health had recognized a dramatic increase in Neonatal Abstinence Syndrome (NAS) and the number of babies born with NAS has continued to increase since that time.

 

 

 

 

 

 

 

 

 

NAS occurs when a mother ingests opioids during pregnancy. Despite the risks associated with NAS and opioids, the opioid manufacturers are accused of aggressively promoting the use of opioids for pain commonly associated with pregnancy.

In addition to damage to the fetus before birth, opioid consumption during pregnancy often results in the infant being born addicted to opioids. The long term impact of NAS, often results in consequences that will plague the infant for the remainder of their lives.

Impaired cognitive abilities, severe behavioral issues, as well as an increased susceptibility to opioid use and addiction later in life are among a long list of complications associated with NAS.

Babies born with NAS and opioid related birth defects will often suffer from the day they are born until the day they die. The opioid defendant’s actions leading to the harm of infants should be a great source of shame for the opioid defendants; however, at this point, it appears that the opioid defendants have no shame.  They continue to blame others for what is clearly their fault.

Birth Defects

There is significant support in the medical literature demonstrating opioids cause numerous severe birth defects.

One of the types of birth defects potentially caused by maternal opioid use is Tetralogy of Fallot.

 

 

 

 

 

 

 

Tetraolgy of Fallot is a heart defect that presents with some or all of the following defects in the infants heart: Overriding Aorta, Pulmonary Stenosis, Ventricular Septal Defect and Right Ventrial Hypertrophy.

Any of the defects associated with Tetraolgy of Fallot can result in infant death or the need for multiple cardiac surgeries and a permeant decrease in quality of life.

Neural Tube Defects may also be caused by maternal opioid use. Neural Tube Defects include Spina Bifida, Anencephaly and Encephalocele. Any of these birth defects can result in infant death, the need for multiple corrective surgeries over numerous years, as well as a permanent decrease in quality of life.

 

 

 

 

 

 

 

The above is only a partial list of birth defects which are associated with maternal opioid use. Given the increase in clinical interest and study surrounding opioid use, we expect to see additions to the medical literature demonstrating a large number of opioid associated birth defects, in the near future.

HEART ATTACK

      There is overwhelming support in the medical literature demonstrating an increased incident of heart attack and other coronary issues associated with opioid use.

Cardiac damage and heart attack are common secondary issues related to opioid overdose; however, these adverse events appear to occur at a high rate in all opioid users without regard to the occurrence of an overdose.  The increased risk appears to exist for patients that are predisposed to cardiac problems, as well as those who are not.

The conditions and adverse events associated with opioid use covered in this article do not include all the medical issues associated with opioid use.

Attend the July Mass Tort Nexus Opioid summit for a more through understanding of the medical conditions which may give rise to viable individual claims against the opioid defendants.

To register for the Opioid Summit contact Jenny Levine at 954-530-9892 or by email at jenny@masstortnexus.com.

You can also register online at https://www.opioidcrisissummit.com

Read More

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

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

 

 

 

 

 

 

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

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

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

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

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

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

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

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

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

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

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

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

BILLIONS IN PROFITS

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

THE SACKLERS AND PURDUE

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

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

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

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

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

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

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

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

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

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

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

PURDUE-OXYCONTIN HISTORY

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

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

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

US DEPT OF JUSTICE INDICTMENTS

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

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

FORMER PRESIDENT BILL CLINTON SPEAKS TO THE OPIATE CRISIS ISSUES”

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

RURAL vs. BIG CITY OPIATES

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

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

FDA Failed to Cite Opioid Big Pharma

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

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

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

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

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

 

Read More

Zinbryta Emerging Litigation

Emerging Zinbryta Litigation

 

 

 

 

 

 

 

 

Zinbryta (daclizumab) is made and marketed by Biogen and AbbVie. Zinbryta first received FDA approval pursuant to Biologic License Application (BLA: 761029) in May of 2016.  Zinbryta is a humanized monoclonal antibody that is self-administered as an injection for the treatment of Multiple Sclerosis.

In March of 2018 Biogen published a letter directed towards physicians and surgeons giving notice that Zinbryta would be withdrawn from the market and would no longer be available as of April 30, 2018.

Biogen Withdrawal Letter link: Biogen – AbbVie Notice of Withdrawal of Zinbryta in USA – March 12, 2018

Additional media related to withdrawal of Zinbryta:

https://www.zinbryta.com/content/dam/commercial/multiple-sclerosis/zinbryta/pat/en_us/pdfs/zinbryta-withdrawal-patient-letter.pdf

Adverse events potentially associated with Zinbryta include:

Serious Liver Damage

Inflammatory Brain Disease

Encephalitis

Onset of Seizures secondary to adverse reactions.

Death secondary to adverse reactions.

To Learn More About the Emerging Zinbryta Litigation:

The emerging Zinbryta Litigation will be used as a case study in the May 18th to 21st 2018 Mass Tort Nexus, “Four Days to Mass Tort Success Course” To register for the May Course, contact Jenny Levine at jenny@masstortnexus.com or call (954) 520-4494.

 

 

For information on the class and to enroll, use this link-“Enroll Here To Attend “Four Days to Mass Tort Success”

Course attendees will receive the benefit of a step by step analysis of the emerging Zinbryta Litigaton, using these primary metrics:

Mass Tort Nexus Metrics

 

 

 

 

 

 

 

 

 

 

Some of the top mass tort trial lawyers in the country have endorsed the Mass Tort Nexus Immersion Course, including James Onder, of The Onder Firm in St. Louis, MO>

 

 

The Mass Tort Nexus Classes on Emerging Litigation and Ongoing Mass Torts are considered the premier source in the country to learn about the fundamentals of mass torts and how to enhance your firm practice, increase revenues and manage the related business operations effectively.  Don’t wait for the next class or next year, enroll today and learn what others already have, Mass Torts are where your firm can and will grow its practice.

Read More

Ocaliva Emerging Litigation

Emerging Ocaliva Litigation

Ocaliva: An Emerging Litigation

 

 

 

 

 

 

 

 

 

 

Ocaliva (obeticholic acid) made by Intercept Pharmaceuticals, Inc. was first approved by the FDA subsequent to New Drug Application (NDA: 207999) in May 2016.

Ocaliva is “indicated for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA.

Recent FDA Communications Excerpts:

September 21, 2017, The FDA is notifying you, under Section 505(o)(4) of the FDCA, of new safety information that we believe should be included in the labeling for OCALIVA (obeticholic acid). This information pertains to the risk of liver injury, liver decompensation, liver failure and death in primary biliary cholangitis (PBC) patients withmoderate to severe hepatic impairment.

Additionally, we refer to our letter dated October 26, and December 7, 2017, notifying you, under Section 505(o)(4) of the FDCA, extension of discussion period warranted for new safety information that we believe should be included in the labeling for OCALIVA (obeticholic acid) Tablets. This information pertains to the risks liver injury, liver decompensation, liver failure and possibly death in primary biliary cholangitis (PBC) patients with moderate to severe hepatic impairment.

FDA warns about serious liver injury with Ocaliva (obeticholic acid) for rare chronic liver disease:  (see link below)

FDA Warning of September 21, 2017:   https://www.fda.gov/Drugs/DrugSafety/ucm576656.htm

  >To Learn More About the Emerging Ocaliva Litigation:

The emerging Ocaliva Litigation will be used as a case study in the May 18th to 21st 2018 Mass Tort Nexus, “Four Days to Mass Tort Success Course” To register for the May Couse, contact Jenny Levine at jenny@masstortnexus.com or call (954) 520-4494.

 

 

For information on the class and to enroll, use this link-“Enroll Here To Attend “Four Days to Mass Tort Success”

Course attendees will receive the benefit of a step by step analysis of the emerging Ocaliva Litigaton, using these primary metrics:

 

Mass Tort Nexus Metrics

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Some of the top mass tort trial lawyers in the country have endorsed the Mass Tort Nexus Immersion Course, including Jerry Parker, Founder of the Parker-Waichman Firm>

 

 

 

The Mass Tort Nexus Classes on Emerging Litigation and Ongoing Mass Torts are considered the premier source in the country to learn about the fundamentals of mass torts and how to enhance your firm practice, increase revenues and manage the related business operations effectively.  Don’t wait for the next class or next year, enroll today and learn what others already have, Mass Torts are where your firm can and will grow its practice.

 

 

Read More

Viberzi Emerging Litigation   

 Emerging Viberzi Litigation  

Viberzi Litigation

   

 

 

 

 

 

 

 

 

 

Viberzi made by Allergan received FDA approval subsequent to New Drug Application (NDA:206940) in May of 2015.

Since its approval the makers of Viberzi have flooded the media with advertisements, primarily directed toward women, featuring a now familiar female character wearing a jumpsuit featuring print depicting a portion of the human gastro-intestinal system.

 

FDA Communication Excerpt on Viberzi:

“FDA is warning that Viberzi (eluxadoline), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder. An FDA review found these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death. Pancreatitis may be caused by spasm of a certain digestive system muscle in the small intestine. As a result, FDA is working with the Viberzi manufacturer, Allergan, to address these safety concerns.

Health care professionals should not prescribe Viberzi in patients who do not have a gallbladder and should consider alternative treatment options in these patients. Hospitalizations and deaths due to pancreatitis have been reported with Viberzi use in patients who do not have a gallbladder. Symptoms of pancreatitis have occurred with just one or two doses of Viberzi at the recommended dosage for patients who do not have a gallbladder (75 mg), and who do not consume alcohol.”

Viberzi Emerging Litigation

Gallstone disease is one of the most common of all digestive diseases. The U.S. Centers for Disease Control and Prevention estimates that 6.3 million men and 14.2 million women in the United States have gallbladder disease. There is marked variation in the prevalence between ethnic groups

Approximately 700,000 individuals in the U.S.  have their gallbladder removed each year.

How to Learn More About the Emerging Viberzi Litigation

The emerging Viberzi Litigation will be used as a case study in the May 18 – 21, 2018 Mass Tort Nexus, “Four Days to Mass Tort Success Course” to register for the May Course, contact Jenny Levine at jenny@masstortnexus.com or call (954) 520-4494.

For information on the class and to enroll, use this link-“Enroll Here To Attend “Four Days to Mass Tort Success”

 

Course attendees will receive the benefit of a step by step analysis of the emerging Viberzi

Litigation, using these primary metrics:

 

Mass Tort Nexus Metrics

 

 

 

 

 

 

 

 

 

 

 

 

 

See endorsements below of some of the top mass tort trial lawyers in the country who’ve attended the Mass Tort Nexus Immersion Course>

 

 

The Mass Tort Nexus Classes on Emerging Litigation and Ongoing Mass Torts are considered the premier source in the country to learn about the fundamentals of mass torts and how to enhance your firm practice, increase revenues and manage the related business operations effectively.  Don’t wait for the next class or next year, enroll today and learn what others already have, Mass Torts are where your firm can and will grow its practice.

 

Read More

Varubi Emerging Litigation

 Emerging  Varubi Litigation

 

 

 

 

 

 

 

 

 

 

 

VARUBI®(rolapitant) was originally developed by Schering-Plough Corp. and after the merger with Merck & Company they began marketing in November 2009. Tesaro Inc. has since licensed Varubi.

January 2018 FDA Communication Excerpt: 

“Anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported in the postmarketing setting, some requiring hospitalization. These reactions have occurred during or soon after the infusion of Varubi (rolapitant) injectable emulsion. Most reactions have occurred within the first few minutes of administration. Symptoms of anaphylaxis can include wheezing or difficulty breathing; swelling of the face or throat; hives or flushing; itching; abdominal cramping, abdominal pain or vomiting; back pain or chest pain; hypotension or shock. Anaphylaxis or anaphylactic shock are serious medical conditions which if not promptly treated can result in death”

Where to Learn More About the Emerging Varubi Litigation

The emerging Varubi Litigation will be used as a case study in the May 18 – 21, 2018 Mass Tort Nexus, “Four Days to Mass Tort Success Course” To register for the May Couse, contact Jenny Levine at jenny@masstortnexus.com or call (954) 520-4494.

For information on the class and to enroll, use this link-“Enroll Here To Attend “Four Days to Mass Tort Success”

 

Course attendees will receive the benefit of a step by step analysis of the emerging Varubi Litigation using these primary metrics:

 


Mass Tort Nexus Metrics

 

 

 

 

 

 

 

 

 

 

 

 

 

Some of the top mass tort trial lawyers in the country have endorsed the Mass Tort Nexus Immersion Course>

 

 

 

The Mass Tort Nexus Classes on Emerging Litigation and Ongoing Mass Torts are considered the premier source in the country to learn about the fundamentals of mass torts and how to enhance your firm practice, increase revenues and manage the related business operations effectively.  Don’t wait for the next class or next year, enroll today and learn what others already have, Mass Torts are where your firm can and will grow its practice.

Read More

Defective Airbag Maker Takata Files for Bankruptcy

Flying shrapnel from Takata airbag explosion.
Flying shrapnel from Takata airbag explosion.

Update: Plaintiff lawyers told a U.S. bankruptcy court judge that  Takata Corp.’s restructuring plan is being skewed to benefit automakers over the victims of exploding air bags.

Japanese air bag maker Takata Corp. has filed for bankruptcy protection in Tokyo and the U.S., overwhelmed by lawsuits and recall costs of its faulty airbag inflators that are connected to the death of at least 16 people, according to the Associated Press.

Takata said that rival Key Safety Systems of suburban Detroit will buy its assets for $1.6 billion.

In addition to the fatalities, the defective airbags caused at least 180 injuries and touched off the largest automotive recall in U.S. history.

The solid chemical propellant used in Takata airbags deteriorates over time, particularly under high humidity. This builds up excessive pressure in the metal inflator housing, causing it to rupture. When the air bag deploys, metal shrapnel launches through the bag and at the occupants in the vehicle, according to lawyer Kim Adams.

Nearly eight million vehicles by 10 different manufacturers may be affected, according to Consumer Reports. They include vehicles made by:

  • Acura
  • BMW
  • Chrysler
  • Dodge
  • Ford
  • General Motors
    • Buick
    • Cadillac
    • Chevrolet
    • GMC
    • Pontiac
  • Honda
  • Infiniti
  • Lexus
  • Mazda
  • Nissan
  • Subaru
  • Toyota

Read More