FDA Fails to Cite Big Pharma for False Marketing and Advertisements

“PROFITS BEFORE PATIENTS REIGNS SUPREME AT FDA”

By Mark A. York (April 22, 2019)

Purdue Pharma and OxyContin Never Warned By FDA

(MASS TORT NEXUS MEDIA)  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. Which 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.

 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 years since the push to increase opioid prescriptions in every way possible became an accepted business model Big Pharma boardrooms across the country.

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

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

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

WHAT IS “OFF-LABEL” MARKETING?

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

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

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

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

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

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

FDA PLEADS NO STAFF

But the agency has long struggled to keep track of the thousands of ads published each year, largely due to lack of staff.

There are approximately 60 FDA staffers responsible for keeping track of at least 75,000 ads and other promotional material published each year. Although in the age of electronic monitoring and hi-tech tracking of data it would seem that monitoring drugs such as Schedule 2 – 4 narcotics or other drugs that are considered high risk for abuse, the FDA could create a quarterly e-review or a flagging system when new campaigns are started by Big Pharma.

“It’s a very, very small unit,” a former high-ranking FDA official said. “It’s historically been underfunded.” Which seems to support the contention that Washington D.C lawmakers are in the pockets of Big Pharma and the hundreds of lobbyists they utilize to ensure a true lack of oversight in the pharmaceutical industry as a whole.

Additionally, many of the ads are submitted to the FDA for review at the same time they begin to run. So by the time the assessment is complete the ad has “already had a significant impact,” the FDA insider said. This policy flies in the face of the creation regulatory oversight based on the fact that when a problem or an issue with a product is discovered, the FDA, EPA or other agency should enforce the law and correct the problem. In the case of the FDA, that is not happening and Big Pharma is and has been aware of the lack of oversight for years.

Critics say the FDA needs to do more to stay on top of an industry with a history of trying to maximize profits by at times misleading consumers, which has recently been described as a policy of “patients before patients” which has resulted in the current Opioid Crisis that’s firmly in place across the United States.

The number of public admonishment letters has been at or close to single digits from 2014 until 2016 during the Obama administration, records show. The FDA sent out 11 of those caution missives in 2016, nine in 2015 and 2014, and 24 in 2013.

A SINGLE FDA WARNING IN 2016

This year, one of the warning letters was sent to Canadian drugmaker Cipher Pharmaceuticals, ordering it stop using deceptive promotional material to hawk its extended-release opioid ConZip.

The ad failed to note “any risk information” highlighting the potentially addictive nature of the powerful painkiller, the FDA letter issued Aug. 24 said. The promotional material was also misleading because it asserted other treatment options “are inadequate,” the oversight agency concluded.

“By omitting…serious and potentially fatal risks, the detail aid…creates a misleading impression about the drug’s safety, a concern heightened by the serious public health impacts of opioid addiction, abuse and misuse,” the FDA said.

The agency demanded that Cipher “immediately cease misbranding” the medication. The drug company responded by yanking the promotional material, the firm’s execs said in a statement issued after the warning letter was made public.

But that was the single caution letter issued to an overhyped painkiller by the FDA this year so far, records show. The other caution letters were sent to Amherst Pharmaceuticals for the insomnia drug Zolpimist, and to Orexigen Therapeutics Inc. for its weight loss drug Contrave.

There are many long term FDA and other senior DC officials who have for whatever reasons, chosen to defer reigning in Big Pharma sales and marketing abuses and now it appears the corrective action has been undertaken in federal courts across the country by mass tort lawyers in litigation which will apparently make the “Tobacco Litigation” of the 1980’s pale in financial comparison.

With the primary lawsuits recently consolidated by in the Multidistrict Litigation titled “National Prescription Opiate Litigation” Case No. MDL 2804, recently assigned to the US District Court, Northern District of Ohio.  With the key case heading including “prescription and opiate” which reflects the federal court recognizing that opiate prescriptions have become such a major issue the federal courts will now determine the penalties assessed against Big Pharma. The focus will be on the long term “sales and marketing campaigns” designed in corporate boardrooms of Fortune 100 companies, to increase corporate profits, while ignoring the known catastrophic increases in addictions and other inter-connected healthcare, economic and social upheavels caused by the flood of opioid drugs in the US market.

The FDA maintains that letters to drug companies are merely one tool the agency uses to keep the pharmaceutical industry in line.

“We have many efforts to encourage compliance by industry, including our work on guidance, by providing advice to companies on draft promotional materials, and outreach to our stakeholders,” FDA spokeswoman Stephanie Caccomo said. “The FDA’s priorities regarding prescription drug promotion are policy and guidance development, labeling reviews, core launch and TV ad reviews, training and communications and enforcement.” The key terms referred to by Ms. Caccamo are “guidance and by providing advice” from the FDA, when direct enforcement actions are required, as Big Pharma see the terms “guidance and advice” as harmless and not applicable to their efforts to increase sales and profits. In-house lawyers at Big Pharma have reviewed FDA enforcement failures and offered opinions to the boardrooms for years about the FDA not willing to enforce anything close to restrictions on opioid drug marketing and sale practices, all the while reaping the profits of the opioid crisis.

U.S. 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.

US CONGRESS IS NOT HELPING

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.

WHITE HOUSE IGNORES BIG PHARMA ABUSE

With the Trump Administration still claiming that no regulatory oversight is needed to monitor the US drug industry, that they can self-regulate, it appears that there will be no letup in the rampant “off-label: and unintended use marketing of pharmaceutical drugs in the United States.  The one way that Big Pharma is held accountable is in the courtroom, although financial damages and penalties against the drug companies amounting to billions of dollars each year being awarded by juries, won’t change FDA policy, it does provide a small amount of official recognition that there are ongoing abuses by the pharmaceutical industry in the USA.

Read More

FDA BANS THE USE OF PELVIC MESH PRODUCTS – How Will This Affect The TVM Litigation?

Will this move by the FDA re-ignite the mass tort engine in TVM litigation or possibly force settlement in Ethicon TVM MDL 2327?

By Mark A. York (April 17, 2019)

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Manufacturers of pelvic synthetic surgical mesh products must stop selling and distributing their products in the United States immediately, the US Food and Drug Administration ordered Tuesday. The surgical mesh is typically used to repair pelvic organ prolapse (POP) and incontinence, but reported side effects have included permanent incontinence, severe discomfort and an inability to have sex.  The key issue with the product for many years is the fact that its made from polypropylene, basically the same material as fishing line.

The FDA said it “has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices.”

The FDA said its April 16, 2019 action to remove surgical mesh products from the market is part of its commitment to ensuring the safety of medical devices. In a November statement, the agency said that it “regulates more than 190,000 different devices, which are manufactured by more than 18,000 firms in more than 21,000 medical device facilities worldwide.”

FDA Release January 4, 2019

FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks

Summary: The U.S. Food and Drug Administration issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina. The FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.

FDA Finally Takes Action

Each year, thousands of women undergo transvaginal surgery to repair pelvic organ prolapse, a condition where weakened muscles and ligaments cause the pelvic organs to drop lower in the pelvis, creating a bulge or prolapse in the vagina. In the 1990s, gynecologists began implanting surgical mesh for the transvaginal repair of the condition and in 2002, the first mesh device specifically for this purpose was cleared for use by the FDA, according to the agency’s statement.

“We couldn’t assure women that these devices were safe and effective long term,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.

For years, medical device companies have stated that the products they are developing and placing into the marketplace are safe and helping patients in the USA and worldwide. That is often not the case and people around the world are suffering.

Medical device makers and compensated doctors have touted FDA approved implants and other devices as the surgical cure for millions of patients suffering from a wide range of pain disorders, making them one of the fastest-growing products in the $400 billion medical device industry. Companies and doctors aggressively push them as a safe antidote to the deadly opioid crisis in the U.S. and as a treatment for an aging population in need of chronic pain relief and many other afflictions.

2017 Pelvic Mesh Study in England Showed High Number of Adverse Events:

Scientific Reports Volume 7, Article number: 12015 (2017) |

Complications following vaginal mesh procedures for stress urinary incontinence: an 8 year study of 92,246 women

Conclusions

Summary: This is the largest study to date of surgical mesh insertions for SUI. It includes all NHS patients in England over an 8-year period. We estimate that 9.8% of patients undergoing surgical mesh insertion for SUI experienced a complication peri-procedurally, within 30-days or within 5 years of the initial mesh insertion procedure. This is likely a lower estimate of the true incidence. Given concerns about the safety of these procedures, this study provides robust data to inform both individual decision-making and national guidance.

Why Device Makers Tout FDA Approvals

  1. “Medtronic receives FDA clearance for two heart devices”
  2. “FDA approves device to help curb cluster headaches”
  3. MRI approved for young infants in intensive care

Manufacturer headlines like these instill consumer confidence that medical devices are safe and effective. After all, they have the FDA’s stamp of approval, right? NO!

The reality is, the FDA seldom requires rigorous evidence that a device works well–and safely–before allowing it onto the market. Medical devices are the diverse array of non-drug products used to diagnosis and treat medical conditions, from bandages to MRI scanners to smartphone apps to artificial hips.

This low standard of evidence applies to even the highest risk devices such as those that are implanted in a person’s body. Surgical mesh, pacemakers and gastric weight loss balloons are just a few examples of devices that have had serious safety problems.

Devices are subject to weaker standards than drugs because they’re regulated under a different law. The Medical Device Amendments of 1976 was intended to encourage innovation while allowing for a range of review standards based on risk, according to legal expert Richard A. Merrill. An array of corporate lobbying has since prompted Congress to ease regulations and make it easier for devices to get the FDA’s approval.

In 2011, an Institute of Medicine panel recommended that the “flawed” system be replaced, because it does not actually establish safety and effectiveness. At the time the FDA said it disagreed with the group’s recommendations.

Defective devices cleared through this system have included hip replacements that failed prematurely, surgical mesh linked to pain and bleeding and a surgical instrument that inadvertently spread uterine cancer.

Bard took the Avaulta implants off the market in 2012 and did the same with the Align inserts in 2016. The company chose to remove the products the day after the U.S. Food and Drug Administration in 2010 ordered Bard and other mesh-manufacturers, including Johnson & Johnson (Ethicon), Boston Scientific and Endo (American Medical S), to review their mesh products, which also resulted in J&J removing four lines of synthetic surgical mesh products from the market. .J&J’s Ethicon subsidiary is facing more than 50 thousand lawsuits regarding its synthetic mesh device in Ethicon (J&J) Pelvic Mesh TVM Litigation MDL-2327.

The Ethicon MDL is in the same West Virginia federal court as the Bard and other mesh manufacturer multidistrict litigation, which are all being heard by Judge Goodwin.  Judge Goodwin has previously expressed his frustration with the parties not engaging in substantive settlements discussions to resolve the thousands of cases, the one option he has is to begin remanding cases back for trial in court venues around the country, possibly forcing both sides to begin earnest settlement talks. Goodwin has held hearings with leadership attorneys from both sides appearing before the court to possibly kickstart settlements. He has gone so far as to warn mesh manufacturers that if they do not settle, U.S. juries appear poised to inflict hundreds of millions, or even billions, of dollars in compensatory and punitive damages on them in thousands of cases that would overload the federal judicial system for years to come.

The FDA forcing mesh manufacturers to stop the use of synthetic mesh is long overdue, and how this action results in renewed interest by mass tort firms across the country, remains to be seen. Regardless, it would seem that Ethicon and the other defendants in the pending TVM litigation that have been unwilling to discuss settlement, may now be forced to deal with the catastrophic consequences of manufacturing and marketing medical devices that have injured untold thousands of patients around the world.

To access the most current TVM case status and other real time information on Mass Torts  sign up for:

Mass Tort Nexus “CLE Immersion Course”

May 31 to June 3, 2019 at The Riverside Hotel in Fort Lauderdale , FL

For class attendance information please contact  Barbara Capasso 954.383.3932 or Barbara@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.

 

 

Read More

Analysis of Proposed Xarelto Settlement Discount Rates – Debunking Defendants Rationale

 

 

Analysis of Proposed Xarelto Settlement Discount Rates

Debunking Defendants Rationale

 This is a follow up to the Mass Tort Nexus article “Xarelto Settlement: Dead on Arrival” – link: Xarelto-Settlement-Dead-on-Arrival? April 15, 2019

 

(MASS TORT NEXUS MEDIA) This article is intended to address the Xarelto defendants’ contentions that certain settlement offer “discounts” are justified for client cases arising in 2015 and 2016 due to changes in the FDA label,  which the defendant contends brought warnings contained in the label into adequacy. This paper will also address defendant’s contention that cases arising under the laws of the States of Texas and Michigan merit a massive discount in settlement value (offers).

We will focus on the Xarelto label change from 11/07/2018, AND an additional label change was made on 01/15/2019 related to Eosinophilia, which could be relevant to many of the Xarelto cases already filed as well as give rise to a Xarelto Litigation II, that could involve more injured individuals than the current Xarelto Litigation. The relevance and significance of the 01/15/2019 “Eosinophilia” label change will be addressed by Mass Tort Nexus in the near future.

Mass Tort Nexus has also received information that there is an ongoing investigation related to Xarelto potentially causing kidney injury, which may or not be related to Eosinophilia. We will continue to provide more information related to this subject in future articles. Given the new Eosinophilia warning and the investigation related to Kidney injury, and the 11/07/2018 label change related to anticoagulation tests (and the possible impact on future Xarelto case trials) Mass Tort Nexus understands why the defendants might be eager to reach a settlement sooner rather than later. Conversely, there is no reason why plaintiffs’ firms should believe the defendants to be in a superior negotiating position, nor be willing to accept subpar settlements for their existing cases.

It is worth nothing that the 11/07/2018 label change (admission) by the defendant that the most commonly used anticoagulation tests are “not recommended” (in reality likely have no diagnostic value) would make it far more difficult for the defendants to prevail in future trials under the Learned Intermediary Doctrine, as doctors would be less likely to testify that, “they would still do everything exactly as they did when originally prescribing Xarelto.” Had the defendant revealed the foregoing before the prior bellwether trials, the outcome of those trials may have been very different.  It is not surprising that the defendants are eager to settled Xarelto cases without having to face another trial post the 11/07/2018 and 01/15/2019 label changes.

Had the defendants revealed the information related to the most common anticoagulation tests used as “not being recommended” prior to the bellwether trials, doctors testifying in support of a defendants “Learned Intermediary Defense” would likely face questions like these:

 Plaintiffs’ Counsel:  So, Dr. Smith, I see that you performed an INR test to make sure that my client was correctly anticoagulated, that their blood was not to thick or too thin, is that right?

Dr. Smith: Yes

Plaintiffs’ Counsel:  Were you aware that as of 11/07/2018 the defendants recommend that this test not be used and in fact, the literature shows that this test provides no diagnostic value when a person is taking Xarelto?

Dr. Smith: It unlikely that Dr. Smith will say he knew the above when he prescribed Xarelto as he would essentially be admitting to medical malpractice.

Plaintiffs’ Counsel:  So, Dr. Smith, would you still today, follow the same protocol when prescribing Xarelto and use an INR test to make sure the dose of Xarelto did not have the patient’s blood to thick (likely to clot) or too thin (likely to bleed).

Dr. Smith: Unlikely that Dr. Smith would say he would still do what the defendant now recommends he not do.

Plaintiffs’ Counsel:  Dr. Smith, just out of curiosity, do you think the words “No Routine Blood Testing Needed” mean the same thing as “The blood test routinely used don’t work”?

The same line of questioning could be used for doctors that treated a Xarelto bleed or clot.

The contention that any label change could render a product adequately warned for all circumstances and facts relevant to every possible client injury scenario is somewhat preposterous; however, we will address and rebut the defendant’s contentions more directly. Although the Xarelto warning label has been changed numerous times since 2016, we only need to review the label change made on 11/07/2018 (see below) to conclude that the label was not adequate in any clients case in which the referenced anticoagulation tests were used in the “dosing” of Xarelto or the treatment of any Xarelto related injury 11/07/2018.

 11/07/2018 Xarelto Label Change

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022406s029lbl.pdf

 5.0 Warnings and Precautions

 5.2 Risk of Bleeding

Reversal of Anticoagulant Effect

Additions and/or revisions underlined:

… anticoagulant activity of rivaroxaban. Use of procoagulant reversal agents, such as prothrombin complex concentrate (PCC), activated prothrombin complex concentrate or recombinant factor VIIa, may be considered but has not been evaluated in clinical efficacy and safety studies. Monitoring for the anticoagulation effect of rivaroxaban using a clotting test (PT, INR or aPTT) or anti-factor Xa (FXa) activity is not recommended.

Mass Tort Nexus Comment: The highlighted language above was added to the Xarelto FDA (U.S) 0n 11/07/2018, indicating that the use of PT, INR, aPTT anti-factor Xa (FXa) is not recommended. A more accurate statement (warning) would be that these tests have no diagnostic value and should not be used when evaluating dosing for individual patients nor treating bleeds and other conditions related to Xarelto, while the patient has Xarelto in their system.

 We will first address the 11/07/2018 label change as it related to the defendants contentions that the Xarelto label “adequately warned”  of the risks associated with label changes made in 2015 and 2016 as well as the justification (or lack thereof) for any discounts to base settlement offers arising therefrom.

Mass Tort Nexus opinion is as follows:

  1. At minimum, no discount is justified in any case arising before 11/07/2018, in which any of the anticoagulation tests now “not recommended” for use, where used by the prescribing physician immediately before and or any time after prescribing Xarelto, for use by the specific client. The doctor nor the patient were adequately warned with regard to these tests providing any diagnostic value that could serve to mitigate the risks associated with the use of Xarelto.  Additionally, for any client that presented at a medical facility (prior to 11/07/2018), with a Xarelto related injury which resulted in the use of the tests in the process of treating that injury, the warning label was not sufficient to mitigate the risks associated with the use of tests which the defendant now recommends not be used.
  2.  Today the warning label remains inadequate and no discount based on a contention that the warning label was brought into adequacy at any point in the past, is warranted. Until the defendants make further changes to the label including, but not limited to, giving the “anticoagulation” test “warning” greater prominence on the label as well as changing the “not recommended” portion of the statement to reflect a more truthful representation, that is less likely to be overlooked or misunderstood by prescribing physicians. An adequate warning would include information as to why the tests are not recommended (they likely have no diagnostic value).
  3.  It would be difficult for the defendants to argue that the fact that the most commonly used anticoagulation tests “are not recommended” for use in dosing Xarelto or treating a Xarelto injury, would not likely have impacted some doctors decision to prescribe the drug had they been previously warned prior to 11/07/2018. In reality, given the lack of prominence of the 11/07/2018 label change and the fact that no additional educational efforts are being made by defendants (that we are aware of), to insure that doctors are now aware that these tests are “not recommended” and in fact, likely have no diagnostic value, it is probable that the 11/07/2018 warning has not significantly decreased the risk posed Xarelto users, related to this new “warning.

 Before addressing Texas 82.007 and Michigan 600.2946, it is important to point out that one of the most Signiant claims made by the makers of Xarelto, in their effort to establish their product as being superior to Warfarin was that “no routine blood testing (anticoagulation tests) was needed” for patients using Xarelto. Patients taking Warfarin and other VKA’s (Vitamin K Antagonists) do require routine monitoring to insure their anticoagulation levels remain in a therapeutic range.

The “No Routine Blood Testing Needed” claim of the makers of Xarelto, made to the FDA and the public appears to have been very misleading. Mass Tort Nexus has yet to determine how the makers of Xarelto concluded that No Routine Blood Testing was needed for patients taking Xarelto. The 101,743 adverse event reports filed with the FDA related to Xarelto since 2011, is one indicator that “Routine Blood Testing” is needed to insure Xarelto user’s safety. If no Routine Blood Testing was needed, then why have Xarelto patients experienced such a high volume of bleeding and clotting events? The FDA warning letter sent to the makers of Xarelto (provided at the end of this document), is highly relevant to this topic.

If Xarelto was so well designed that a doctor could just assume that patients would be maintained with a therapeutic range (not too thin and likely to bleed or too thick and likely to clot), then why has the FDA received Xarelto 101,753 adverse event reports since 2011, many involving bleeding or clotting that might have been prevented with “routine testing’?

 

Texas and Michigan Cases

To the best of our knowledge, the defendant has yet to raise a defense under Texas 82.007 and Michigan 600.2946 in any case, much less prevail in arguments arising under these laws.

Neither Texas 82.007 nor Michigan 600.294 provide an absolute defense for drug manufacturers. Both state’s laws have language which provide a plaintiff with means, by which to overcome the presumption that these laws provide immunity for a given defendant. We will refer to the language in both States laws as the “savings clause” in the remainder of this article. We will also address each law separately with regard to the burden plaintiffs would face, in overcoming a defense raised under either Texas 82.007 or Michigan 600.294.

First, We Will review the “savings clause” for both Texas 82.007 and Michigan 600.2946 available to plaintiffs to overcome the presumption of drug manufacturer immunity arising under the two laws. See the relevant savings clauses and links to the entire statutes below:

Texas   82.007

(2)(b)  The claimant may rebut the presumption in Subsection (a) as to each defendant by establishing that:

(1)  the defendant, before or after pre-market approval or licensing of the product, withheld from or misrepresented to the United States Food and Drug Administration required information that was material and relevant to the performance of the product and was causally related to the claimant’s injury;

(3)(A) the defendant recommended, promoted, or advertised the pharmaceutical product for an indication not approved by the United States Food and Drug Administration;

(B)  the product was used as recommended, promoted, or advertised;  

Michigan 600.2946

(5) In a product liability action against a manufacturer or seller, a product that is a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable, if the drug was approved for safety and efficacy by the United States food and drug administration, and the drug and its labeling were in compliance with the United States food and drug administration’s approval at the time the drug left the control of the manufacturer or seller. However, this subsection does not apply to a drug that is sold in the United States after the effective date of an order of the United States food and drug administration to remove the drug from the market or to withdraw its approval. This subsection does not apply if the defendant at any time before the event that allegedly caused the injury does any of the following:

(a) Intentionally withholds from or misrepresents to the United States food and drug administration information concerning the drug that is required to be submitted under the federal food, drug, and cosmetic act, chapter 675, 52 Stat. 1040, 21 U.S.C. 301 to 321, 331 to 343-2, 344 to 346a, 347, 348 to 353, 355 to 360, 360b to 376, and 378 to 395, and the drug would not have been approved, or the United States food and drug administration would have withdrawn approval for the drug if the information were accurately submitted

http://www.legislature.mi.gov/(S(5z3q41uoys1lzoajegixoc5p))/mileg.aspx?page=GetObject&objectname=mcl-600-2946

As a preliminary point, if any discount was justified arising under Texas 82.007or Michigan 600.2946, it should be minimal in light of the fact that the defendant has neither raised a defense in any individual case (to the best of our knowledge), nor prevailed in such a defense. A small discount might be warranted to allow plaintiffs to avoid the cost of litigating any matter raised by defense in the unlikely event that the defendants are willing to incur the cost of litigating the matter themselves.

Secondly, if any discount arising under Texas 82.007 and Michigan 600.2946 was justified, cases arising under Texas 82.007 would warrant a less significant discount than those arising under Michigan 600.2946, for reasons we will address below.

It is worth noting that the defendants must affirmatively raise a defense under Texas 82.007 or Michigan 600.2946 and doing so may expose their clinical trials, communications with the FDA, (including warning letters related to their advertising, one of which we have included at the end of this document), to discovery and scrutiny they may wish to avoid. Mass Tort Nexus would be interested in any internal communications, as well as third party communications the defendants engaged in related to the death of Arnold Palmer (including communications with his family) as we have long held the opinion that Xarelto may have caused or contributed to the death of Xarelto’s most famous spokesperson.

Comment: Texas 82.007, does not require a showing that any information that may have been withheld or misrepresentation made to the FDA was “intentional.” Texas 82.007 does not require a plaintiff to plead nor show that the FDA would, and the drug would not have been approved, or the United States Food and Drug Administration would have withdrawn approval for the drug if the information were accurately submitted. Michigan 600.2946, does require plaintiffs to show and plead that any misrepresentations or withholding of information and the drug would not have been approved, or the United States food and drug administration would have withdrawn approval for the drug if the information were accurately submitted.

Michigan 600.2946 obviously places a far more significant burden on a plaintiff seeking to rebut the presumption of immunity than does Texas 82.007. Pleading that a drug would not have been approved, or the United States food and drug administration would have withdrawn approval for the drug if the information were accurately submitted, can be problematic in light of the SCOTUS decision Buckman v. Plaintiff Legal Committee: https://www.loc.gov/item/usrep531341/

The foregoing should not be interpreted as presenting an impossible burden for plaintiffs to overcome under Michigan 600.2946 as was shown in the Second Circuit decision in DESIANO v. WARNER-LAMBERT & CO. https://caselaw.findlaw.com/us-2nd-circuit/1209786.html. Also see TAYLOR v. SMITHKLINE BEECHAM Michigan Supreme Court decision https://caselaw.findlaw.com/mi-supreme-court/1355001.html. These two well-reasoned rulings and opinions make it clear that 1. Plaintiffs can meet the requirements set forth in Michigan 600.2946 to overcome the presumption of immunity without running afoul of Buckman. 2. Plaintiffs can prevail in overcoming a defense raised under Michigan 600.2946 as they did in DESIANO.

Notwithstanding the foregoing, the burden placed un plaintiffs under Michigan 600.2946 is still far greater than that placed on plaintiffs by Texas 82.007.  It appears that any defendant has a better chance of prevailing in raising a defense under Michigan 600.2946 than one raised under Texas 82.007 however, given the fact that Michigan has a population of 9,996,000,(3.05% percent of the U.S. population) while Texas has a population of 27,700,000 (8.45% percent of the U.S. population), would the defendants be willing to undertake the time and expense (and continued concern from the market) involved in raising a defense under Michigan 600.2946, which would not dispose of a significant number of cases, if they prevail given that there is no reason to believe that a disproportionate number of the total Xarelto cases on file arise under Michigan law. Additionally, would the defendant be likely to undertake the time and expense (and continued concern from the market) involved in raising a defense under Texas 82.007, with a far less likelihood of prevailing than in Michigan.

The plaintiff’s burden with overcoming a defense raised under Texas  82.007 is obviously less arduous that than the burden over overcoming a defense raised under Michigan 600.2946. Due to the foregoing, the defendant’s application of the same discount (if any is justified) to cases arising under Texas law to those arising under Michigan Law, is not justified.

 

Michigan and Texas Law and the 11/07/2018 Label Change

Texas 82.007 and Michigan 600.2946:

Texas 82.007: The defendants’ statements in the 11/07/2018 label change “not recommending” these tests are still arguably misleading given that the test apparently have no diagnostic value when a patient is taking Xarelto and more importantly represent important information previously withheld from the FDA and/or mispresenting to the FDA. A strict interpretation of C would not require a plaintiff to show that that the actions or inactions of the defendant were intentional. Arguably, the 11/07/2018 label change related to these tests could be rebut the presumption that the protection provided from Texas 82.007 is available to the defendant.

Michigan 600.2946: The same reasoning applied to the analysis of Texas  82.007 applies to Michigan 600.2946 in this matter with one exception, Michigan 600.2946 requires a showing that the defendants actions or inactions were intentional and a showing that the FDA would not have approved or would have withdrawn the approval for the product if not for the information withheld or misrepresentations made. MTN provides an analysis below aimed at showing what the defendants knew and when they knew it relevant to the warnings they neglected to add to their label until 11/07/2018.

Analysis

The following analysis is more relevant to Michigan 600.2946 than to Texas 82.007. There is a high degree of confidence that Plaintiffs would prevail in any defense raised under Texas 82.007.

In that overcoming a defense raised under Michigan 600.2946 requires a showing that the defendant intentionally made misrepresentations the FDA or intentionally withheld information from the FDA. Additionally, under Michigan 600.2946   plaintiffs must make a colorable argument that the FDA would not have approved the drug or would have later withdrawn approval, absent the misrepresentations or withheld information. The 11/07/2018 FDA label change related to anticoagulant testing would be an example of evidence plaintiffs might present to meet the requirements of Michigan 600.2946. In that Michigan’s law require plaintiffs show the offending actions or inactions of the defendant were intentional, demonstrating what the defendants knew (relevant to the referenced anticoagulation tests) and when they knew it would be important in overcoming a defense raised under Michigan 600.2946.

It should be noted that a defense raised under Michigan 600.2946 or Texas 82.007 exposes the defendant to broad discovery, through which plaintiffs would likely discover far more evidence to support their rebuttal arguments than can be discovered in the public domain.  For our instant purpose however, we will focus on determining when the defendant knew or should have known that the anticoagulation tests listed in the 11/07/2018 label change provide no diagnostic value for patients on Xarelto.

Mass Tort Nexus has conducted a review of the publicly available literature in order to establish what the defendant knew or should have know and when, related to anticoagulation testing with commonly used modalities and methods. We will not present a chronological listing (not exhaustive) of information in the public domain relevant to this topic.

 It should be noted that any information or data published in clinical literature must be developed over time (before it is reported). We can safely assume that any information reported in the medical literature in 2012 was known to the defendant at the time they sought the initial FDA approval for Xarelto, granted in July of 2011. If the defendants were to raise a defense under Michigan 600.2946 or Texas 82.007, plaintiffs would likely be allowed broad discovery which would reveal that the defendants possessed or should have possessed the information related to anticoagulation tests that they withheld from the FDA and prescribing physicians until 11/07/2018.

 No Exhaustive Review of the Literature

2012

The data below was taken from a presentation from Ohio Society of Pharmacist Association in 2012. Given the fact that the information below was reliant on clinical observations prior to the presentation of the below, it is likely that the defendant was aware of the issue related to INR testing, prior to seeking U.S. FDA approval (granted July 1, 2011)

Summary
• Dabigatran
– aPTT
• Appears to be a useful measure in hemorrhagic emergency
• Therapeutic ranges have not yet been established
– Ecarin clotting time
• Also useful in hemorrhagic emergency, but not widely available.
• Rivaroxaban and Apixaban
– Prothrombin time, but not INR
• Appears to be useful in hemorrhagic emergency
• Therapeutic ranges have not yet been established
– HepTest, PiCT, and chromagenic assay all appear to be
useful, but not commonly available

https://cdn.ymaws.com/www.ohioshp.org/resource/resmgr/annualmeetinghandouts/effects_of_new_oral_anticoag.pdf

 May 2012

Rivaroxaban: Quantification by anti-FXa assay and influence on coagulation tests: a study in 9 Swiss laboratories.

RXA plasma levels can be quantified accurately and precisely by a chromogenic anti-FXa assay on different coagulometers in different laboratories. Ingestion of 10mg RXA results in significant alterations of both PT- and aPTT-based coagulation assays.

https://www.ncbi.nlm.nih.gov/pubmed/21840043?dopt=Abstract

July 2012 Rivaroxaban: A practical Guide

INR testing should be preformed just before the next intake of Rivaroxaban on the INR measurement

http://www.uclmontgodinne.be/files/RivaroxabanPracticalGuide06072012.pdf

Thrombosis Journal 2013

https://thrombosisjournal.biomedcentral.com/articles/10.1186/1477-9560-11-11

Because rivaroxaban and other target-specific oral anticoagulants have different mechanisms of action from traditional anticoagulant agents, laboratory tests used for these traditional agents (such as PT/international normalized ratio [INR] or activated partial thromboplastin time) are not suitable for target-specific oral anticoagulants

Pub Med   May 2017

https://www.ncbi.nlm.nih.gov/pubmed/28476405

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 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.

See the warning letter sent from the FDA to the makers of Xarelto. Mass Tort Nexus believes more warning letters like this one exist and will continue our efforts to discover all relevant FDA communications. This warning letter is highly relevant to the prior subject matter of this article.

(FDA Link to June 6, 2013 Warning Letter to Johnson & Johnson Re: Xarelto Label is Below)

NDA 202439 XARELTO (rivaroxaban) tablets   

June 6, 2013

Johnson & Johnson International, Inc.

 

 

______________________________________________________________________________________________________

 

 

Food and Drug Administration

Silver Spring, MD 20993

Roxanne McGregor-Beck, Director

Johnson & Johnson International, Inc.

1000 Route 202 South

P.O. Box 300

Raritan, New Jersey 08869-0602

 

RE: NDA #202439

XARELTO (rivaroxaban) tablets

MA #215

Dear Ms. McGregor-Beck:

The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has reviewed a direct-to-consumer (DTC) print advertisement (K02XS121040 AF) (Print Ad) for XARELTO (rivaroxaban) tablets (Xarelto) submitted by Johnson & Johnson International, Inc. (Johnson & Johnson) on behalf of Janssen Pharmaceuticals, Inc. under cover of Form FDA 2253 and observed during routine surveillance in the January/February 2013 issue of WebMD magazine. The Print Ad is false or misleading because it minimizes the risks associated with Xarelto and makes a misleading claim. Thus, the Print Ad misbrands Xarelto in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 352(n) and FDA implementing regulations. 21 CFR 202.1(e)(5)(i); (e)(7)(viii), (ix).

Background:

Below is the indication and summary of the most serious and most common risks associated with the use of Xarelto.1 According to its FDA-approved product labeling (PI), in pertinent part:

Xarelto is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

There are limited data on the relative effectiveness of XARELTO and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well controlled.

 The PI for Xarelto contains Boxed Warnings regarding increased risk of stroke after discontinuation in patients with nonvalvular atrial fibrillation and the risk of spinal/epidural

hematoma. The PI also contains Contraindications regarding active pathological bleeding and severe hypersensitivity reaction to Xarelto, as well as Warnings and Precautions regarding the risk of bleeding, use in patients with renal impairment and hepatic impairment, use with P-gp and strong CYP3A4 inhibitors or inducers, and risk of pregnancy related hemorrhage. The most common adverse reactions with Xarelto were bleeding complications.

Minimization of Risk Information

 Promotional materials are false or misleading if they fail to present risks associated with a drug with a prominence and readability reasonably comparable with the presentation of information relating to the benefits of the drug. Factors impacting prominence and readability include typography, layout, contrast, headlines, paragraphing, white space, and other techniques apt to achieve emphasis. The Print ad prominently presents various efficacy claims for Xarelto, such as, but not limited to, the following, that are presented in large, bolded and/or colorful text and graphics (emphasis original):

• “If you have atrial fibrillation (AFib)”

• “Ready to break your AFib routine?”

• “XARELTO® is the first and only once-a-day prescription blood thinner for patients with AFib not caused by a heart valve problem, that is proven to reduce

the risk of stroke—without routine blood monitoring.”

• “…With XARELTO®, there’s no routine blood monitoring—so you have more time for yourself. There are no dietary restrictions, so you’re free to enjoy the healthy foods you love. And there are no dosage adjustments, which means you can manage your risk with just one pill a day, taken with your evening meal. Learn how XARELTO® can help simplify your AFib-related stroke risk treatment….”

In contrast, the risk information is presented on the preceding adjacent page without any of the emphasis (i.e. color scheme, borders, layout, and graphics) used with the efficacy claims. The result is a presentation which appears unconnected to the efficacy claims and is therefore not likely to draw readers’ attention. This overall presentation misleadingly  minimizes the risks associated with Xarelto because it fails to convey this important risk information with a prominence and readability reasonably comparable to the efficacy claims. We note that the Print Ad contains the statement, “Please see accompanying Medication Guide on the following pages” (emphasis original) at the bottom of the page, and that risk information is presented on an adjacent page, but this is not sufficient to mitigate the overall misleading presentation.

Misleading Claim

 The Print Ad includes the following claim (emphasis original):

• “And there are no dosage adjustments…”

The above claim misleadingly suggests that dosage adjustments are not necessary with Xarelto. However, according to the DOSAGE AND ADMINISTRATION section of the PI, the dose should be lowered to 15 mg once daily for patients with renal impairment who may have a CrCL of 15 to 50 mL/min. In addition, the WARNINGS AND PRECAUTIONS section of the PI states, “…Periodically assess renal function as clinically indicated…and adjust therapy accordingly….” Thus, patients with renal impairment may need to have their dosage adjusted while on Xarelto therapy.

Conclusion and Requested Action

For the reasons discussed above, the Print Ad misbrands Xarelto in violation of the FD&C Act, 21 U.S.C. 352(n) and FDA implementing regulations. 21 CFR 202.1(e)(5)(i); (e)(7)(viii), (ix). OPDP requests that Johnson & Johnson immediately cease the dissemination of violative promotional materials for Xarelto such as those described above. Please submit a written response to this letter on or before June 20, 2013, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) for Xarelto that contain violations such as those described above, and explaining your plan for discontinuing use of such violative materials.

Please direct your response to the undersigned at the Food and Drug Administration,

Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 5901-B Ammendale Road, Beltsville, Maryland 20705-1266 or by facsimile at (301) 847-8444. To ensure timely delivery of your submissions, please use the full address above and include a prominent directional notation (e.g. a sticker) to indicate that the submission is intended for OPDP. Please refer to MA# 215 in addition to the NDA number in all future correspondence relating to this particular matter. OPDP reminds you that only written communications are considered official. The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Xarelto comply with each applicable requirement of the FD&C Act and FDA implementing regulations.

Sincerely,

{See appended electronic signature page}

Zarna Patel, Pharm.D.

Regulatory Review Officer

Office of Prescription Drug Promotion

{See appended electronic signature page}

Amy Toscano, Pharm.D., RAC, CPA

Team Leader

Office of Prescription Drug Promotion

 

Read More

Xarelto Settlement: Dead on Arrival?

April 15, 2019

(Mass Tort Nexus Media) Bayer and Johnson & Johnson both issued press releases on March 25th indicating to the public, as well as stockholders and analysts, that the companies had reached a settlement to resolve approximately 25,000 claims related to Xarelto. This announcement was arguably highly misleading, in that the agreement reached has not actually resulted in the settlement of a single Xarelto lawsuit (to the best of our knowledge) and certainly not 25,000 cases.

This was the headline in Reuters:  Bayer, J&J settle U.S. Xarelto litigation for $775 million,see Reuters.com/article/us-bayer-xarelto/bayer-jj-settle-us-xarelto-litigation-for-$775-million

At the time of press release, in which Bayer and Johnson & Johnson led the public and the market to believe they had resolved (settled) 25,000 pending Xarelto lawsuits, the overwhelming majority of firms representing those 25,000 clients had yet to receive significant details related to the proposed settlement, and of course had yet to present any offer to their individual clients, who would have to accept any offer made before a case could actually be settled.

Law Firms attending the Mass Torts Made Perfect conference in Las Vegas last week received more details related to the defendants proposed settlement and the reaction was not positive.

Large Scale Rejection of Proposed Settlement?

Mass Tort Nexus has spoken with a great a number of firms who were in attendance at MTMP, as well as numerous others since that time, and the clear indication that we have received would lead us to the conclusion that it is highly unlikely that the defendants proposed settlement will be accepted by enough firms (or rather their clients), to make going forward with the current proposed settlement anything other than a waste of time.

Law Firms that have been in contact with Mass Tort Nexus have indicated that they will fulfill their duty to present any offer made by defendants for their cases to the individual clients; however, they will not likely recommend that clients accept the offers made under the proposed settlement scheme. Many of the firms made colorful comments that we will not publish; however, there was a common theme among the comments:

“I would feel like I was selling out my clients if I recommend they accept the current offer the defendants have made.”

Others went as far as to say:

“I think it would be malpractice to recommend that clients accept the final amounts likely to be offered in this settlement scheme”

Dilemma for Bayer and Johnson & Johnson

The premature and arguably misleading public announcement, which would likely be considered official stock holder guidance, may create additional problems for the corporations already plagued by legal woes, which pose risks to their respective stock prices and stock holder value. If the proposed Xarelto settlement does fall through, as it appears will likely be the case, the companies will be faced with having to walk back previous positive news  “We have resolved the risk associated with the Xarelto litigation” to “not only have we not resolved the risk associated with the Xarelto litigation, but that risk may now be more significant than it was before we proposed a settlement, and many plaintiffs firms see it as more of an insult than an offer.”

If the proposed settlement was even close to something plaintiffs might except in significant numbers, Bayer and J&J might have been in a position to “tweak the settlement” and avoid having to deliver bad news to their stockholders and the public. Unfortunately for Bayer and J&J, the proposed settlement seems to be so far from “acceptable” that their only option may be to scrap the current proposed settlement and come back with another proposal, that will not be received with such strong resistance. If the two corporate giants have any hope of salvaging their messaging to the market, they will need to act quickly.

Proposed Settlement Appears to be a “Non-Starter” 

      

For now, it appears that there is no amount of lipstick that would make the proposed Xarelto settlement scheme attractive.  Most of the firms Mass Tort Nexus has spoken to have indicated that the defendants offer is not even a starting point.

 

 

 

 

MTN will provide more information in future articles about the proposed settlement, as well as the reasons a large number of firms do not feel the settlement is fair and just to their clients. At this point in time; however, it seems likely that the proposed Xarelto settlement is:

The Industry Comment

       XARELTO SETTLEMENT

Read More

TEXTURED BREAST IMPLANTS – “An Emerging Mass Tort”

 

France and Canada look to banning sale of textured implants-what’s the next move in the USA?

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Recent studies have shown that patients with textured implants face a higher risk of a rare form of cancer called breast implant associated anaplastic large cell lymphoma (BIA ALCL). BIA ALCL is not a breast cancer but a cancer of the immune system. Plastic surgeons have identified at least 688 cases of BIA ALCL worldwide, as of February 2019. The FDA estimates the risk of BIA ALCL among patients with textured implants as between 1 in 3,817 and 1 in 30,000, but newer data from Australia has placed the risk as high as 1 in 1,000.

Nine deaths from a rare form of cancer have been linked to breast implants, the Food and Drug Administration announced as far back as 2017, the US oversight has not taken the warning seriously, however the international oversight apparently has. Countires around the globe are starting to ban the sale of “textured breast implants” based on the emerging clinical linbks to these implants and cancer. .

Red flags were raised as far back as  2011 regarding the safety of breast implants and their possible link to a type of lymphoma, but the FDA has only now updated information on the risk to women with both silicone and saline breast implants.

As of February 1, 2017, the FDA had received a total of 359 reports related to breast implant-associated anaplastic large cell lymphoma — a rare cancer of the immune system — including nine deaths, the agency said in a statement. ALCL is not a form of breast cancer, but it grows in the breast in implant patients.

The FDA says the exact number of cases of the disease remains difficult to determine due limitations in the reporting of breast implant sales data. Estimates of the frequency of the disease range from 1 in 3,000 women to 1 in 30,000, according to the Associated Press. The cancer is treatable with the removal of implants, though nearly a dozen deaths have occurred.

Additionally, thousands of women have blamed breast implants for a range of other health ailments, including rheumatoid arthritis, pain and chronic fatigue. In documents released before the meeting, the FDA contends “at the present time, there is not sufficient evidence to show an association between breast implants and rheumatologic or connective tissue disease diagnoses.”

A recent study published in JAMA Oncology concluded that  found that silicone breast implants with a textured surface are 400-times more likely to cause a rare type of cancer compared to silicone breast implants with a smooth surface.

Approximately 1 out of every 26 women in the United States have breast implants.

The primary makers of breast implants approved for use in the United States include:

Allergan, Inc.

Ideal Implant, Inc.

Mentor World Wide, LLC

Sientra, Inc.

Breast augmentation remains the most common cosmetic surgical procedure in the U.S. with more than 300,000 performed each year, according to the American Society of Plastic Surgeons.

The meeting comes a week after the FDA sent warning letters to two breast implant manufacturers for their failure to comply with requirements to conduct long-term studies assessing the safety of silicone gel-filled implants.

International Review

The International Consortium of Investigative Journalists revealed the ongoing health problems plaguing women with breast implants as part of its global Implant Files investigation in November 2018, and has covered breast implant safety extensively in the aftermath. In the wake of the investigation, health authorities from France to Brazil to the United States recently announced initiatives to better protect patient health.

Health Canada is advising a manufacturer of breast implants that it could soon ban the sale of its product in Canada because of a possible link to a

The Biocell implants, manufactured by Allergan, have a slightly textured surface, designed to adhere better to the surrounding tissue. Health Canada intends to remove them from the market as a precautionary measure, to “protect Canadians from the rare but serious risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)” the department wrote in a news releaseThursday.

Of 28 confirmed cases of BIA-ALCL reported to Health Canada, 24 involved that particular implant, the department said.

 Quebec contacting women with textured breast implants to warn of cancer risk

BIA-ALCL is not a cancer of the breast tissue, but rather a rare type of non-Hodgkin lymphoma that can develop months or years after the implants were put in. It usually leads to an accumulation of fluid inside the breast. It’s generally treated by carefully removing the implant and fluid containing the cancerous cells. In some cases, it can spread throughout the body, warranting chemotherapy treatment, according to the World Health Organization.

WATCH: Winnipeg woman says breast implants ruined her life and her health

 

 

 

 

 

 

Health Canada will allow Allergan 15 days to present medical evidence about the implants’ safety. If the evidence isn’t “satisfactory,” Health Canada intends to suspend their medical license, meaning the product would no longer be permitted for sale in Canada.

France also announced that it intends to ban textured breast implants earlier this week.

 Breast implant safety under review by U.S. authorities

Health Canada is currently reviewing breast implant safety and BIA-ALCL and plans to present its entire report by the end of April. A second report looking at other symptoms reported among recipients of breast implants will be released this summer, according to the press release.

 Bowmanville woman wants Health Canada to push awareness of ‘breast implant illness’

If you have breast implants, Health Canada recommends that you speak with your surgeon to find out what type of implant you have received. If you experience any unusual changes to your breasts, you should contact a health-care professional and discuss any decisions about implant removal with them too.

Nearly all the lymphoma cases have occurred in women who had implants with a textured surface, rather than a smooth one. Textured implants made by Allergan, a major manufacturer, were taken off the market in Europe in December. Smooth implants are used more often than textured ones in the United States.

 FDA NOTICE ON TEXTURED IMPLANTS

 

 

 

 

 

 

March 20, 2019

FDA News Release March 20, 2019

FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements

For Immediate Release

Today, the U.S. Food and Drug Administration issued warning letters to two breast implant manufacturers for failure to comply with their requirements, under their premarket approval orders, to conduct post-approval studies to assess the long-term safety and risks of their silicone gel-filled breast implants.

The FDA issued warning letters to Mentor Worldwide LLC of Irvine, California, and Sientra, Inc. of Santa Barbara, California.  Every manufacturer of approved silicone gel-filled breast implants is required to conduct post-approval studies to further evaluate safety and effectiveness of the products and to answer additional scientific questions about the long-term safety and potential risks of breast implants that their premarket clinical trials were not designed to answer.

“Post-approval requirements are critical to ensuring the safety and effectiveness of the medical products we regulate and we’ll continue to hold manufacturers accountable when they fail to fulfill these obligations,” said FDA Commissioner Scott Gottlieb, M.D. “We’re issuing these warning letters based on the manufacturers’ low recruitment, poor data, and low follow-up rates in their required post-approval studies. We expect these manufacturers to meet the pre-specified study requirements in order to ensure the collection of long-term data that can be used to inform long-term patient safety.  Post-approval studies, along with other surveillance tools such as adverse event reports, registries, and scientific literature, allow the FDA to help ensure the safety of medical devices and protect patients.”

The FDA’s warning letter to Mentor Worldwide LLC (Mentor) noted several serious deficiencies in the manufacturer’s post-approval study for its MemoryShape breast implant, first approved in 2013, including that the manufacturer had failed to enroll the required number of patients in the study. The action also notes Mentor had poor follow-up rates with patients in the study. Finally, the FDA notified Mentor that there were significant data inconsistencies in the study, including poor patient accounting and missing race and ethnicity data. While the FDA had concluded after reviewing several interim study reports submitted by Mentor that progress on the post-approval study appeared adequate at that time, the agency advised Mentor of concerns about patient enrollment, follow-up rates and data inconsistencies.

Mentor’s failure to address these concerns and comply with its post-approval study requirements is a violation of the firm’s pre-market approval order.

The FDA’s warning letter to Sientra, Inc. (Sientra) noted a serious deficiency in the manufacturer’s post-approval study for its Silicone Gel Breast Implants, first approved in 2013. The manufacturer had poor follow-up rates with patients. Currently, the manufacturer reported a follow-up rate of 61 percent, which is below the target follow-up rate. In the response to the manufacturer’s most recent interim study report, the FDA notified the manufacturer that the study progress was inadequate because of low follow-up rates. Sientra’s failure to address these concerns and comply with its post-approval study requirements is a violation of the firm’s pre-market approval order.

The FDA requested responses from both manufacturers within 15 working days of the issuance of the warning letters, with details about how the noted violations will be corrected. The FDA may take action for a failure to comply with post-approval orders, including pursuing applicable criminal and civil penalties, where appropriate.

The FDA’s actions today are part of the agency’s ongoing commitment to its public health mission of ensuring patient access to safe and effective medical devices. As part of the Medical Device Safety Action Plan, the FDA committed to streamlining and modernizing how the agency implements postmarket actions to address device safety issues to make responses to risks more timely and effective, including taking actions against manufacturers when their postmarket studies are non-compliant with any study requirements. The FDA has issued several warning letters in recent years to manufacturers who did not adequately fulfill certain postmarket study requirements, reflecting the agency’s commitment to take more aggressive actions against manufacturers who fail to comply.

In addition to the required post-approval studies, the FDA has taken additional steps to ensure the agency is monitoring the safety and risks of breast implants. For instance, FDA staff have coordinated with the American Society of Plastic Surgeons and the Plastic Surgeons Foundation to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (BIA-ALCL) Etiology and Epidemiology (PROFILE), which collects real world data regarding patients who have a confirmed diagnosis of BIA-ALCL. The data collected from this registry, have contributed to a better understanding of BIA-ALCL and FDA communication updatesto the public regarding BIA-ALCL.

Additionally, the FDA has worked with multiple stakeholders to facilitate the development of the National Breast Implant Registry (NBIR) to provide a platform for collecting additional real world data on the safety and performance of breast implants. This newly launched registry will greatly add to the information we collect in our own post-approval studies about the long-term safety of breast implants, and potentially enhance our understanding of the long term safety and risks associated with breast implants.

The FDA remains committed to thoughtful, scientific, transparent, public dialogue concerning breast implant safety and effectiveness. The FDA welcomes public dialogue about breast implant safety and risk at the upcoming public meeting of the General and Plastic Surgery Devices Panel at the FDA’s headquarters in Silver Spring, Maryland on March 25-26, 2019, which will also be available via webcast.

Health care professionals and consumers should report any adverse events related to breast implants to the FDA’s MedWatch Adverse Event Reporting program.  The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace.

End of FDA Release

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

Mass Tort Nexus “CLE Immersion Course”

May 31 – June 3, 2019 at The Riverside Hotel in Fort Lauderdale , FL

For class attendance information please contact Barbara Capasso at 954.530.9892 or Barbara@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 com/news and sign up for free access.

 

 

 

 

Read More

FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering

fda-logo

 

 

 

 

 

 

 

FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering

Safety Announcement

[4-9-2019] The U.S. Food and Drug Administration (FDA) has received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased. These include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide.

While we continue to track this safety concern as part of our ongoing monitoring of risks associated with opioid pain medicines, we are requiring changes to the prescribing information for these medicines that are intended for use in the outpatient setting. These changes will provide expanded guidance to health care professionals on how to safely decrease the dose in patients who are physically dependent on opioid pain medicines when the dose is to be decreased or the medicine is to be discontinued.

Rapid discontinuation can result in uncontrolled pain or withdrawal symptoms. In turn, these symptoms can lead patients to seek other sources of opioid pain medicines, which may be confused with drug-seeking for abuse. Patients may attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances.

Opioids are a class of powerful prescription medicines that are used to manage pain when other treatments and medicines cannot be taken or are not able to provide enough pain relief. They have serious risks, including abuse, addiction, overdose, and death. Examples of common opioids include codeine, fentanyl, hydrocodone, hydromorphone, morphine, oxycodone, and oxymorphone.

Health care professionals should not abruptly discontinue opioids in a patient who is physically dependent. When you and your patient have agreed to taper the dose of opioid analgesic, consider a variety of factors, including the dose of the drug, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient. No standard opioid tapering schedule exists that is suitable for all patients. Create a patient-specific plan to gradually taper the dose of the opioid and ensure ongoing monitoring and support, as needed, to avoid serious withdrawal symptoms, worsening of the patient’s pain, or psychological distress (For tapering and additional recommendations, see Additional Information for Health Care Professionals).

Patients taking opioid pain medicines long-term should not suddenly stop taking your medicine without first discussing with your health care professional a plan for how to slowly decrease the dose of the opioid and continue to manage your pain. Even when the opioid dose is decreased gradually, you may experience symptoms of withdrawal (See Additional Information for Patients). Contact your health care professional if you experience increased pain, withdrawal symptoms, changes in your mood, or thoughts of suicide.

We are continuing to monitor this safety concern and will update the public if we have new information. Because we are constantly monitoring the safety of opioid pain medicines, we are also including new prescribing information on other side effects including central sleep apnea and drug interactions. We are also updating information on proper storage and disposal of these medicines that is currently available on our
Disposal of Unused Medicines webpage.

To help FDA track safety issues with medicines, we urge patients and health care professionals to report side effects involving opioids or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

Read More

Insys Therapeutics “Fentanyl Spray Criminal Trial” In Jury Deliberations

“Fentanyl Spray Federal Criminal Trial” Now In US District Court of Massachusetts Jury Deliberations

By Mark A. York (April 8, 2019)

Subsys: a highly addictive fentanyl spray.

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

To compound further harsh scrutiny for Insys, it’s new CEO Saeed Motahari, moved over from Purdue Pharmaceuticals, the Oxycontin maker, who’s also a major target of criminal and civil investigations across the country by various agencies. Purdue is being investigated for false marketing, off-label use and ignoring Oxycontin’s highly addictive dangers for years, while bringing in literally billions of dollars in profits.

PRIOR DOCTOR INDICTMENTS

Doctors who’ve written massive numbers of Subsys prescription, under the “fee to speak” program have been indicted and they include pain clinics, medical centers and other healthcare facilities who now face federal criminal charges for fraudulent prescription writing, submitting false claims to insurance companies and numerous other federal charges and all face a minimum of 20 to 50 years in federal prison. Two of the busiest “Subsys” prescription writers in the country were Alabama doctors, John Couch and Xiulu Ruan, who earned over $40 million from Insys, and were charged with running a pill mill between 2013 and 2015, have been convicted and sentenced to 20 years each in federal prison.

The top “Subsys” prescriber of all, Dr. Gavin Awerbach, of Saginaw, MI pled guilty to defrauding Medicare and Blue Cross out of $3.1 million in improper Subsys prescriptions, his criminal sentence is pending. To show the far reach of Insys and its corporate plans to saturate the US market with opioids, in Anchorage, Alaska Dr. Mahmood Ahmad, was charged with a massive Subsys prescribing operation, which he denies, but immediately surrendered his Alaska medical license which caused the revocation of his license Arkansas.

THE OFF LABEL CAMPAIGN

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

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

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

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

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

Prosecutors also said that two former Insys employees who were first charged in 2016 in connection with the scheme, Jonathan Roper and Fernando Serrano, had secretly pleaded guilty and become cooperating witnesses. The five doctors were arrested last Friday morning and face charges including that they violated the federal anti-kickback law and conspired to commit fraud.

INSYS RX ABUSES WERE BLATANT

The case is the latest in a series of medical practitioners and former Insys executives and employees facing criminal charges related to Subsys, the company’s potentially addictive fentanyl-based spray.

Federal prosecutors in Boston are moving forward aggressively against the seven former Insys executives and managers as well billionaire founder John Kapoor, all accused of actively designing and participating in the scheme to bribe doctors to prescribe Subsys and to defraud insurers into paying for it. Insys has said it may need to pay at least $150 million towards part of a settlement with the U.S. Justice Department as well as numerous other state investigations around the country, not to mention the civil complaints filed against the company in the Opiate Prescription MDL 2804, see OPIOID-CRISIS-BRIEFCASE-INCLUDING-MDL-2804-OPIATE-PRESCRIPTION-LITIGATION, where the Insys sales and marketing tactics are listed as prime examples of boardroom designed “profits over patients” policies are cited.

Insys is joined in the massive Federal Opioid MDL 2804, by other Big Pharma defendants including Purdue Pharmaceuticals, Endo Health, J&J’s Janssen Pharmaceutical and other opioid manufacturers who were allowed to place profits over patients for more than 15 years, while earning billions in profits.

UNETHICAL SALES TACTICS

According to the most recent and prior doctor indictments, the physicians have participated in Insys’ speaker programs, which were in reality social gatherings at high-end restaurants. They earned kickbacks ranging from $68,000 and $308,000 and were among the top 20 prescribers of Subsys nationwide at some point during the marketing campaign. A few doctors indicted as far back as late 2016 have already been sentenced to federal prison terms up to 20 years and forfeit of millions of dollars in assets. The Insys marketing tactics included trips with doctors to strip clubs with Insys sales managers; and often with Insys executives, where they covered lap dances and drinks which on one trip ran up a tab of over $4,100 which was apparently enough to convince physicians to write massive numbers of off-label fentanyl prescriptions.

The Criminal Trial Status

A cooperating witness testified by calling the payments bribes, a former vice president of Insys Therapeutics stood by a giant spreadsheet in court Tuesday and described how the drug company funneled phony “speaking fees” to doctors in exchange for prescribing its highly addictive opioid painkiller.

Alec Burlakoff, who has pleaded guilty to racketeering charges and is testifying in US District Court in Boston against Insys founder John N. Kapoor and four former colleagues, said Kapoor encouraged the program in late 2012 to spur doctors to prescribe Subsys, an under-the-tongue fentanyl spray.

But Kapoor insisted that each practitioner generate at least twice as much revenue for Insys by writing Subsys prescriptions than he or she received from the company.

Burlakoff stood next to an enlarged spreadsheet that executives prepared in December 2012. One column showed what each “speaker” received every time he or she supposedly met with other doctors to promote Subsys. The amounts ranged from $1,000 to $1,600 to $2,400 depending on whether Insys designated them local, regional, or national experts.

In truth, he said, the designation “national expert” was ludicrous and some doctors had only sordid reputations for running “pill mills.”

Another column showed how many prescriptions the practitioners wrote for Subsys, while another displayed how many they wrote for competing fentanyl products.

Assistant US Attorney Fred Wyshak Jr. asked Burlakoff what another column listing sums of money represented.

“That’s the amount of money we paid in bribes to date,” said Burlakoff, the former vice president of sales, prompting one of the defense lawyers for the five defendants to object.

Kapoor and four other former executives of the Chandler, Ariz.-based company are on trial for allegedly conspiring to violate the federal criminal Racketeer Influenced and Corrupt Organizations Act, or RICO, by paying bribes and kickbacks to practitioners. Prosecutors typically use RICO to go after alleged mobsters.

It is the first criminal trial of pharmaceutical executives who marketed an opioid painkiller since the nation’s deadly opioid epidemic began.

Burlakoff, whom jurors first saw last month dressed as a bottle of Subsys spray in a jaw-dropping in-house rap video, said that at least one executive strenuously objected to the company tracking how many Subsys prescriptions participants in the speakers program wrote.

Matthew Napoletano, Insys’s former head of marketing, who has already testified under immunity for the government, rose from his chair at a meeting with Kapoor, Burlakoff, and other executives, Burlakoff said. Napoletano said such a spreadsheet could be viewed as evidence of a crime.

But the company went forward with the payment program.

The payments were hardly the only way Insys prodded doctors to write Subsys prescriptions, Burlakoff said. Leaders of the sales team, including Joseph Rowan, a former regional sales director who is among the defendants, would buy coolers full of steaks for doctors, according to Burlakoff.

In other cases, he said, Insys executives would put staffers in the offices of big Subsys prescribers on the payroll of the drug company; those staffers were often spending considerable time on the phone with insurers trying to get them to approve Subsys prescriptions, and “now doctors would no longer be complaining” about the expense of paying those employees to do that.

Burlakoff, who became vice president of sales in 2012 after spending years at Cephalon, Eli Lilly and Company, and other drug makers, said Insys didn’t only provide incentives to physicians; the company also gave incentives to members of the sales team.

Sales representatives at Insys, he said, had a starting salary of $40,000 a year, less than half of what such employees typically made at other drug companies. But they received an extraordinary commission of 10 percent on the sales they made each quarter, and it wasn’t capped.

Several sales representatives, he said, made $110,000 in a quarter based just on the commission.

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

SALES REP NATALIE REED PERHAC

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

Perhac Plea Excerpts:

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

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

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

How the results of the trail against the Insys Therapeutics boardroom plays out in the overall “Opioid Crisis” battle remains to be seen. There is always the question of why the Sackler family (Purdue Pharma) and the billions they’ve earned off improper marketing of Oxycontin and their scorched earth sales tactics, have not resulted in criminal indictments yet? Perhaps the Sackler family habit of donating billions to charities and having hospital wings named in their honor was a very strategic and forward looking business model that is now paying great dividends.

Read More

THE DEALFLOW LITIGATION FUNDING FORUM

LITIGATION FUNDING FORUM

Why You Should Attend

April 4, 2019 in New York City

MASS TORT NEXUS: A Media Sponsor Of This Event

By Mark A. York

(MASS TORT NEXUS MEDIA) Whether you’re active in litigation funding or a firm exploring outside capital sources to fund your practice, the Litigation Funding Forum April 4th in New York City is where you should be.

Mass Tort Nexus has been invited by DealFlow to meet and discuss the most current issues as well as the forecast for litigation funding in law firm business models. We will be meeting with key members of the industry and asking how the funding world may impact mass torts and other practice areas at law firms.

This includes looking at parties who demand oversight and disclosures to the court when outside capital is used to fund a docket, [not needed from a personal perspective] but there are also those that are demanding more open disclosure. Certain courts including Federal Judge Dan Polster in the Opiate Prescription Litigation MDL 2804, now require firms in that litigation to file disclosures when they are using outside capital to fund their litigation, and this view is being pushed by more defense firms who claim this is needed to show outside interests are involved in ongoing litigation.

This may be a unique trend that goes away once all involved see that securing capital investment in any type of ongoing business is often required for any number of reasons from infrastructure development to business expansion – and why a law firm securing funding from a third party should be viewed any differently seems to be not only intrusive but as interfering with a private business matter. This is an evolving area that may or may not become more open to discussion or it may simply become a non-issue as the parties realize that litigation funding is a regular part of the legal world these days.

The Event

Litigation funding is an increasingly popular way to finance the high cost of a legal action, whether as plaintiff or defendant. Lawyers at the highest ranks of the legal profession are updating their toolkits to perform work in litigation funding, while financiers raise hundreds of millions of dollars to fuel demand.

In an uncertain and complex regulatory environment, The Litigation Funding Forum 2019 is your single greatest resource for getting up-to-the-moment information from the brightest minds in the business.

Groups attending this event include:

  • Specialty Litigation Investment Funds
  • Law Firms
  • Accounting and Financial Advisory Firms
  • Corporate Counsels
  • Brokerage Firms
  • Hedge Funds
  • Private Equity Firms
  • Pension Funds and Endowments

Why Funding May be Needed

Litigation funding offers significant benefits in terms of financial reporting and operations. Funding solutions can create immediate improvements in cash flow, bring greater certainty over forecasts of legal expenditure and divert valuable resources into revenue-generating areas of the business. Critically, third-party funding can enable a law firm to pursue cases that it would not otherwise pursue due to budget constraints, at zero risk and at zero cost.

Generally, these are the financial concerns when expanding a practice, the last three often require outside capital.

  • Executive Summary
  • Company Description
  • Market Research
  • Service/Product Description
  • Management & Operational Infrastructure
  • Marketing & Sales Strategy
  • Financials (Bottom Line)

Seeking a reliable source for capital investment makes sense if there’s a viable model and a plan to enter into a mass tort program or other specialty practice area.  Law firms that use outside funding lee experience increases in their chance of success based on the ability to move faster and develop a timely docket, once capital funding is in place. Often banks and certain investors will keep their wallets closed unless they can see a well-planned and structured method of attack and a stellar credit rating as they are not in the business of working with law firms entering or expanding in to a new practice area. That’s why a fund or capital group that focuses on the legal is now an accepted source of expansion capital or to support and existing firm’s practice.

How Firms Use New Capital:

  • Marketing Campaigns
  • Website launch
  • Social media activity
  • Lead list building
  • Customer retention efforts
  • Potential consumer loyalty programs
  • Intake and verification
  • Securing your docket
  • Managing case docket once filed

What the Defense is Saying:

  • Outside funding views from the defense bar and the U.S. Chamber of Commerce, have called for a nationwide disclosure rule that would lift the veil on the details of litigation finance agreements and reveal the identities of the funders. But the effort has been unsuccessful so far.
  • Lisa Rickard, president of the U.S. Chamber Institute for Legal Reform, wrote in a June 2017 letter that not having a disclosure rule lets funders “continue to operate in the shadows, concealing from the court and other parties in each case the identity of what is effectively a real party in interest that may be steering a plaintiff’s litigation strategy and settlement decisions.”

For more information on the Litigation Funding Forum in New York City this week contact:

Charlie— Charlie@dealflow.com     516 876 8006 ex 20

 TKP CONFERENCE CENTER

APRIL 4, 2019

For this event, DealFlow has contracted to rent the entire 2nd floor to accommodate attendees. The TKP Conference Center is conveniently located within walking distance of Grand Central Terminal, the Port Authority Bus Terminal, and Penn Station.

Web LINK TO LITIGATION FUNDING FORUM EVENT

Location

109 West 39th Street,
New York, NY 10018

 

 

Read More

MDL 2885 – “3M Combat Arms Earplug” JPML Hearing Was Today in Washington D.C.

 (MASS TORT NEXUS MEDIA) 3M Combat Arms earplugs were issued by the U.S. military between 2003 and 2015 and now litigation has begun asserting that 3M designed and distributed defective earplugs designed for use in combat and elevated noise situations, were defective and left hundreds of thousands of soldiers and veterans injured and suffering from hearing loss.

The March 28, 2019 JPML Initial Hearing on 3M Company Combat Arms Earplug MDL 2885 took place in Washington D.C. this morning. One of the lead counsel for plaintiffs, Mark Lanier, of The Lanier Law Firm, PC offered the following statement on MDL 2885, “This is one of the most important litigations in our generation.  It concerns real damage done to our soldiers by American industry, not enemy combatants.  We trust the MDL will go to a court that will prioritize the swift delivery of justice in a complicated and important litigation.”

Primary claims of the military personnel assert that the company defectively designed its earplugs such that they did not provide sufficient levels of hearing protection. The lawsuits also claim 3M misrepresented the effectiveness of the hearing protection devices to the military during the proposal process when as well as after they obtained the government contract as the exclusive earplug provider to the military and thereafter. As a result, service members who used the earplugs allege incurring noise-induced tinnitus and hearing loss.

Shelly Sanford of Watts Guerra LLP, in Austin, Texas, who spoke at today’s hearing offered this statement “We are keenly focused on the veterans who were sent into combat with these earplugs and came home with hearing loss. The vast majority of these Veterans reside in Texas, and that is just one of the reasons I am requesting that the MDL be assigned there.”

Ms. Sanford also added  “As Judge Charles Breyer, an esteemed former member of the JPML, pointed out in the opioid litigation MDL 2804 hearing, the only issue is ‘what did they know and when did they know it?” With 3M, that question is central to both the claims and potential defenses. I think the core issue is where will the JPML send the MDL.”

OVERVIEW OF EARPLUG PROBLEMS

Combat Arms Earplugs, Version 2 (CAEv2) have been issued by the U.S. Military for each deployed soldier between 2003 and late 2015.

The dual-end or reversible earplugs were used during training and on the battlefield to provide ear protection during service. However, design defects may cause the earplug to imperceptibly loosen in the ear canal, rendering the earplugs useless or less effective.

Aearo Technologies first developed and tested the Combat Arms Earplugs in 2000, and began selling them to the U.S. Defense Logistics Agency in late 2003, at which time they became standard issue.

3M Company acquired Aearo in 2008, and continued to sell the earplugs to the military until at least 2015.

COMBAT ARMS EARPLUGS QUI TAM SETTLEMENT

In July 2018, the U.S. Department of Justice reached a $9.1 million settlement with 3M Company over the Combat Arms earplugs, resolving claims that the manufacturer committed fraud by knowingly selling defective earplugs to the government.

According to allegations raised in a 3M earplug lawsuit that led to the settlement:

  • CAEv2 design defects cause the earplug to imperceptibly loosen in users ears over time, which was not disclosed to the U.S. government or end users;
  • 3M Company provided false and inaccurate noise reduction ratings (NRR) for the earplugs, which employed testing methods that did not comply with required or accepted standards;
  • Combat Arms noise reduction ratings listed on the packaging materials and instructions failed to accurately reflect the true characteristics of the earplugs.

The Justice Department found that the earplugs were too short to fit in many ears and imperceptibly would move out of place, making them ineffective. In addition, critics say neither 3M nor Aearo provided proper use instructions to soldiers, which should have told the wearers to fold back the flanges on the open end of the plug before inserting the closed end into their ears so that they properly fit.

  • Listening to television and radio at high volumes
  • Trouble understanding speech, particularly in noisy environments
  • Often asking people to repeat themselves
  • Needing a hearing aid

Following the announcement of the Qui Tam settlement, veterans started looking at the conduct of 3M and as the bad faith of 3M came to light, lawyers across the country became involved. Litigation against 3M was started by various law firms in late 2018 representing veterans who used the Combat Arms™ earplugs, as instructed and suffered noise-induced hearing loss. As of March 2019, there were over 200 lawsuits in various state and federal courts, which resulted in the JPML Motion for Consolidation. Resulting in the hearing earlier today in the 3M Company Combat Earplug Litigation MDL 2885 in Washington D.C., in front of the JPML Panel, who usually take between 7 and 14 days to issue a ruling.

Where MDL 2885 is finally assigned remains to be seen, as there were several venues presented by the parties and each has viable claims and reasoning. Locations include Texas for the military presence and judicial interest, Minnesota for 3M convenience and home court advantage, Washington D.C. where the military operations are at home or Indianapolis where there’s MDL judicial experience. Perhaps the 3M litigation will open the door for holding those responsible for Department of Defense contracting abuses and similar bad conduct being held accountable for their actions on a regular basis.

 

Read More

Xarelto Litigation Settles for $775 million Bayer and Johnson & Johnson Split Bill  

 

March 25, 2019 Global Xarelto Blood Thinner Settlement Announced 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Bayer AG and J&J’s subsidiary Janssen Pharmaceuticals Inc. have now formalized a $775 million settlement of more than 25,000 lawsuits over their blood-thinning drug Xarelto. The cases are pending in both federal and state courts and this may be seen as a run up to Bayer’s next settlement, in their now seen as a bad-for-earnings purchase of Monsanto and its Federal Roundup MDL 2471 docket, as well as cases filed in state courts.

Plaintiffs alleged the drug caused uncontrollable bleeding, and said that Bayer and Janssen failed to adequately warn of that risk as well as manipulated data related to clinical trial and published studies. To date, plaintiffs have not done well in bellwether trials, having lost three in a row in the Xarelto MDL 2592 litigation in from of Judge Eldon Fallon in the US District Court of Louisiana. In those cases the defense asserted an “learned intermediary” defense which was very successful. The same defense was used in the state court trials in the Philadelphia Court of Common Pleas cases and proved a winning defense in the first two plaintiff bellwether losses there.

The upcoming third Philadelphia court bellwether trial was set for May 2019, and may have had an impact on the settlement timing, or Bayer may have been trying to get a major legal headache off the table in anticipation of the ever-expanding Monsanto Roundup litigation.

Judge Michael Erdos, Philadelphia County Court of Common Pleas, was the judge set to hear the upcoming May trial and also the judge who presided over the Hartmann 2018 verdict reversal, which was the first defense trial loss in litigation over the Xarelto blood thinner, and also the first trial outside the Xarelto MDL 2592. The prior losses  at trial were  heard in the  XARELTO MDL 2592 US District Court ED Louisiana litigation in front of Judge Eldon Fallon, US District Court of Louisiana.

Links to the settlement orders entered March 25, 2019 in the Xarelto MDL 2592 docket:

Xarelto MDL 2592 Settlement CMO No. 9 March 25, 2019 Stay on Litigation

 

Xarelto MDL 2592 Settlement CMO No. 10 March 25, 2019 Case Registration Protocol

 

Xarelto MDL 2592 Settlement CMO No. 11 March, 25, 2019 Docket Control Order

For complete docket information on the Xarelto Multidistrict and Philadelphia, PA state court docket see the Mass Tort Nexus briefcases below:

https://www.masstortnexus.com/Briefcases/4/XARELTO-(rivaroxaban)-MDL-2592-USDC-ED-Louisiana

https://www.masstortnexus.com/Briefcases/33/XARELTO-Case-No-2349-in-Philadephia-Court-of-Common-Pleas–Complex-Litigation-(PA-State-Court)

More than five years after the Xarelto™ litigation began, and with Bayer and Janssen Pharmaceuticals prevailing in all six cases that went to trial, the companies have reached an agreement in principle to settle in the amount of 775 million U.S. dollars.

The settlement amount will be shared equally between the two companies. It is expected that Bayer’s share will be partially offset by product liability insurance.

The settlement is global and is designed to resolve all of the approximately 25,000 Xarelto™ claims in the US, based in the specific terms of the still confidential settlement agreement. The companies have reserved the right to withdraw from the settlement if certain participation rates of those who are eligible to participate are not satisfied.

Bayer continues to believe these claims are without merit and there is no admission of liability under the agreement. However, this favorable settlement allows the company to avoid the distraction and significant cost of continued litigation.

Both Bayer and Janssen have faced harsh and ever growing scrutiny related to the recent disclosures that the Rocket AF study and Einstein study data may not have been as favorable towards Xarelto’s push as a “miracle blood-thinner drug” as once viewed in the medical world.

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

Janssen and Bayer market Xarelto as a one-size-fits-all anticoagulant. Patients take one 20-milligram dose of Xarelto once a day and do not need to undergo routine monitoring. The plaintiffs contend that, because each person processes and metabolizes Xarelto at a highly-individualized rate, each patient’s reaction to the drug is decidedly variable, causing some patients to experience major bleeding events.

The plaintiffs acknowledge that the FDA approved Xarelto’s dosing and monitoring scheme. However, they claim that, given the high inter-patient variability, Xarelto is unreasonably dangerous in design because:

  1. Defendants should have designed, but failed to design, a Xarelto-specific Anti-Factor Xa assay so doctors could monitor Xarelto’s anticoagulation effect on each patient and could, along with the patient, weigh the risks and decide whether to continue taking Xarelto.
  2. Defendants have not designed and marketed an antidote to counteract a major bleeding event.
  3. In the absence of a Xarelto-specific Anti-Factor Xa assay, Xarelto’s label should have warned doctors about the availability of the Neoplastin PT test to measure patient’s anticoagulation.

“Because Defendants did not take any of the above three actions, Plaintiffs claim Xarelto is unreasonably dangerous under the LPLA,” the judge said.

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

Mass Tort Nexus “CLE Immersion Course”

May 31 to June 3, 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 com/news and sign up for free access.

 

Read More