Mass Tort Billionaires

 

Mass Tort Billionaires

What do they know that you don’t?

 

Fact: Mass Torts have made more plaintiff lawyers billionaires (or billionaire adjacent) than any other practice area.

Myth: Most Mass Tort billionaires made their money from the massive trial verdicts we hear about in the news (RoundUp, Talcum Powder etc.).

Fact: The majority of Mass Tort billionaires (or billionaire adjacent) did not reach this lofty status from major trial verdicts, they built their practice over time, accumulating the knowledge and skills required to independently evaluate a mass tort litigation before taking a financial risk.

Most Successful Mass Tort Firms Learned by Trial and Error

There is an easier way!

The Mass Tort Nexus Four Days to Mass Tort Success Course gives you the knowledge, information and skills that current “mass tort insiders” learned the hard way (trial and error).  It is better to learn from the mistakes of others, than to make those same mistakes yourself.

You may not be willing to take the risk required to become a “mass tort billionaire”, however, if you are interested in working smarter vs harder and reaching the financial goals you have set for yourself and your firm, the Four Days to Mass Tort Success Course is the place to start. Click on the image below to get more information about the September Course.

You may also simply call or email Barbara Capasso or Anne Marie Kopek at 954-530-9892, email- barbara@masstortnexus.com or annemarie@masstortnexus.com

How Most Lawyers Get Started in Mass Torts

One Lawyer, we will call him Mr. Mass Tort Big Bucks, gives another lawyer, we will call Mr. Mass Tort Outsider, an inside tip on a great new mass tort in which Mr. Big Bucks is involved. Mr. Outsider takes the tip and runs with it.

One of two things happen:

Scenario A: The litigation does South and Mr. Outsider thinks “Mass Torts is just a big gamble”, I am never doing that again.

Scenario B: The litigation pays off big and Mr. Outsider becomes overly optimistic, thinking, “Wow this Mass Tort thing is great”, I am going to bet on every new case that come along.

Neither Scenario Is Good for Mr. Outsider

In Scenario A, now “mass tort pessimistic” Mr. Outsider is likely to take himself out of the game (mass tort plaintiff law) that has created more plaintiff lawyer billionaires than any other practice area.

In Scenario B, now “mass tort overly optimistic” Mr. Outsider is likely to throw money at every mass tort litigation that comes along and is at risk of eventually losing his shirt.

  1. Big Bucks, who is already sold on a litigation, is not an objective source of information.
  2. Big Bucks can probably afford to lose money that Mr. Outsider may not be able to afford to lose.

Become a Mass Tort Insider!

Instead of relying on tips from other lawyers or the mass tort rumor mill, gain the “insider knowledge“ that will allow you to evaluate mass tort litigation’s objectively. The next time you get a tip from another lawyer, have the information and knowledge that will allow you to do your homework before taking a leap into a mass tort litigation.

The course starts at the most basic level, discussing the difference between Class Actions and Multi-district Litigation and then progresses to providing the tools needed to evaluate the “metrics” relevant to all mass tort litigation’s which need to be considered before taking a financial risk. The basic metrics (below) are explained in detail before the course progresses to how firms can apply these metrics to make decisions and develop strategies that lead to success.

 

On the third day of the course, lead litigators step in and give presentations on various mass torts in which they are currently involved. Course attendees will be armed with the knowledge developed in the first two days of the course, to ask the lead litigators informed questions and use the metrics and other information they have gained thus far in the course to make decisions about which litigation they may be interested in.

The relatively small class size allows course attendees to interact with the lead litigators in the classroom as well as during the outside activities “up close and personal”.

What do past course attendees have to say?

 

 

Visit our YouTube Channel to hear what other past attendees have to say about the course.

https://www.youtube.com/channel/UC8I9zGYo3YC5BhulgxthCOw/videos

 

Read More

FDA – Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma: Who Knew and When?

A Litigation Review by Mass Tort Nexus

July 30, 2019

https://www.fda.gov/medical-devices/safety-communications/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan

By Mark A. York 

(Mass Tort Nexus Media) The  Food and Drug Administration (FDA) has received a total of 573 US and global medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

Since the FDA’s decision, the breast implant business has boomed, now exceeding $1 billion in revenue a year and projected to reach $2 billion by 2025. More than 1.6 million women worldwide received cosmetic breast implants in 2017, including an estimated 345,236 in the U.S., 235,950 in Brazil, 67,478 in Mexico and 54,045 in Italy. As of 2017, breast enlargement was the most common cosmetic surgery in the world.

Link to: FDA criminal-investigations/warning-letters/mentor-worldwide to Alex Gorsky CEO Mentor (J&J) March 18, 2019 -llc-acclarent-573520-03182019

To protect individuals from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), associated with Allergan BIOCELL textured breast implants, the Food and Drug Administration (FDA) requested that Allergan recall its BIOCELL textured breast implants and tissue expanders. Allergan agreed and is removing these products from the global market. The FDA requested that Allergan recall all BIOCELL textured breast implants and tissue expanders marketed in the U.S. based on newly submitted Medical Device Reports (MDRs) reporting worldwide cases of BIA-ALCL and BIA-ALCL-related deaths associated with these devices. Allergan has notified the FDA that it will recall its BIOCELL textured breast implants and tissue expanders from the global market.

What is the connection between textured breast implants and cancer?

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.

While the vast majority of BIA ALCL cases occur in patients with textured implants, the FDA has identified at least 24 in patients with smooth-surfaced implants.

Breast Implants Can Cause Cancer

There is now a link between cancer and breast implants emerging in scientific and medical circles. Just recently in France, their National Cancer Institute released a study that found a “clearly established link” between Anaplastic large cell lymphoma (ALCL) and breast implants. French officials have now recommended that breast implants in their country must carry a “cancer warning.”

There is also more evidence to back this connection now that a study conducted by Cambridge University in the UK found that nearly all cases of ALCL were discovered in women who had breast implants.

When you think about how breast implants are inserted — indeed it is quite gory and gruesome surgery — and about the horrific chemicals they are comprised of, it makes sense that they would, of course, pose a cancer risk. And now we have the data to support this.

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

Allergan, Inc.

Ideal Implant, Inc.

Mentor World Wide, LLC (Johnson & Johnson)

Sientra, Inc.

 

Melissa Shirley vs. Mentor Worldwide (J&J) Complaint USDC ND Georgia (May 15, 2017)

 Silicone Breast Implant Lawsuit Not Preempted, Case to Proceed USDC ND Illinois Ruling

As of July 6, 2019, the Food and Drug Administration (FDA) has received a total of 573 US and global medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This total includes all MDRs the FDA received with any mention of “ALCL” or other spelling variations (for example, “anaplastic lymphoma,” or “anaplastic”) in the event narrative. BIA-ALCL MDRs are counted for those reporting a diagnosis or treatment of ALCL, or confirmed pathology/cytology test, or Anaplastic Lymphoma Kinase (ALK) and CD30 biomarkers.

The tables below summarize unique BIA-ALCL MDR data from the U.S. and worldwide that the FDA has received as of July 6, 2019.

Table 1: Summary of US and Global Deaths Reported in MDRs Received as of July 6th, 2019 (N = 33)

https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma

These data are a tabulation of global deaths reported in MDRs and literature reported as MDRs submitted to the FDA.  We excluded apparent duplicates. The data is stratified by factors that we considered in our analysis.

ALCL Deaths from MDRs and Literature reported as MDRs* Deaths through 7/6/29 (n=33)
n %a
Age at time of diagnosis (years) Median 52
Range 37-83
Not specified (# of reports) 13 39
Time from the last implant to diagnosis (years) Median 9
Range 1-20
Not specified (# of reports) 23 70
Implant Surface Textured 15 48
Smooth* history of textured 1 3
Not specified 17 48
Implant Fill Silicone 14 42
Saline 8 24
Not specified 11 33
Reason for Implant Reconstruction 5 15
Augmentation 17 52
Not specified 11 33
Clinical presentation (breast)b Seroma 6 18
Breast swelling/pain 3 9
Capsular contracture 1 3
Peri-implant mass/lump 13 39
Others 7 21
Not specified 7 21
Anaplastic lymphoma kinase (ALK) Positive 0  0
Negative 12 36
Not specified 21 64
CD30 Statusc Positive 12 36
Negative 0 0
Not specified 21 64
Implant manufacturer Allergan 12 36
Mentor 1 3
Unknown 20 61
Reporter country: US or OUSd US 12 36
OUS 21 64
Not specified 0 0

a Percentage in terms of the total 33 deaths. There are no reports of deaths associated with tissue expanders.
b MDRs sometimes list more than one clinical presentation, e.g. seroma and peri-implant mass/lump, in which two presentations were counted.
c CD30 is a cell membrane protein associated with diagnosis of classic Hodgkin’s Lymphoma and BIA-ALCL.
d US/OUS is counted as the country reported in the narrative or the recorded reporter’s country in the MedWatch form.
* Includes 1 case of B-Cell Lymphoma

Table 2: Summary of US and Global Data as of July 6, 2019 (N=573)

These data are a tabulation of US and global BI-ALCL cases reported to the FDA in MDRs.  We excluded apparent duplicates.  The data is stratified by factors we considered in our analysis.

Unique ALCL cases1 Cases through 9/30/18
(n=457)
Cases through 7/6/19
(n=573)
n %a n %b
Age at time of diagnosis (years) Median 53 53
Range 27-90 27-90
Not specified (# of reports) 111 24 161 28
Time from the last implant to diagnosis (years) Median 9 8
Range 0-34 0-34
Not specified (# of reports) 110 24 169 29
Implant surface Textured 310 68 385 67
Smooth 24 5 26c 5
Not specified 123 27 162 28
Implant fill Silicone 274 60 343 60
Saline 183 40 197 34
Not specified 0 0 33 6
Reason for implant Reconstruction 108 24 115 20
Augmentation 104 23 111 19
Not specified 245 54 347 61
Clinical presentation (breast)d Seroma 266 58 302 53
Breast swelling/pain 135 30 150 26
Capsular contracture 69 15 73 13
Peri-implant mass/lump 82 18 94 16
Others 43 9 56 10
Not specified 105 23 147 26
Anaplastic lymphoma kinase (ALK) Positive 0  0 0 0
Negative 229 50 255 45
Not specified 228 50 318 55
CD30 statuse Positive 215 47 246 43
Negative 0  0 0 0
Not specified 242 53 327 57
Implant manufacturer Allergan* includes McGhan, Inamed 386 84 481 84
Mentor 36 8 38 7
Sientra 2 0.4 6 1
Other Manufacturerf 5 1 6 1
Unknown Manufacturer 28 6 42 7
Reporter country: US or OUSg US 276 48 320 56
OUS 181 32 253 44
Not specified 0 0 0 0

1Patients with bilateral BIA-ALCL are counted as 2 cases of BIA-ALCL.
a Percentage in terms of the total 457 MDRs.
b Percentage in terms of the total 573 MDRs.
c In the 26 cases of smooth implants, 12 have unknown prior history of implants, 7 have a history of textured implants, and 7 have a history of prior implants with an unknown texture. There are no reports of cases associated with tissue expanders.
d MDRs sometimes list more than one clinical presentation, e.g., seroma and peri-implant mass/lump, in which two presentations were counted.
e CD30 is a cell membrane protein associated with diagnosis of classic Hodgkin’s Lymphoma and BIA-ALCL.
f Other Manufacturers include: Bristol Myers Squib, Nagor, Polytech Silimed, Silimed and Sientra/Silimed
g US/OUS is counted as the recorded reporter’s country in the MedWatch form, or if the event was noted to be from a foreign source in box G3 of the MedWatch form. Please note that the reporter country may not reflect the country where the event occurred or the country where the device is marketed.

History of Adverse Events Has Been Known 

The FDA has  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 updates to the public regarding BIA-ALCL.

According to a complex analysis of FDA adverse event data, the number of suspected breast implant injuries jumped from an average of fewer than 200 a year through 2016, before the FDA’s more rigorous reporting rules, to 4,567 events in 2017 and at least 8,242 in the first half of 2018. More than 10 million women worldwide have received breast implants over the last decade, a remarkable comeback for a medical product that had suffered a crippling safety scandal and a lengthy ban in the United States.

The agency was aware of the true number of reported injuries but did not disclose them until recently. In Europe, some manufacturers have avoided reporting ruptures altogether, Dutch regulators were told. This was discovered during the  International Consortium of Investigative Journalists long term investigation titled, Implant Files investigation , which revealed the ongoing health problems plaguing many thousands of women with breast implants as part of its global research project that was released in November 2018.

Experts worldwide agree that more long-term studies are desperately needed, but neither Allergan nor Johnson & Johnson’s Mentor completed the studies of 40,000 women ordered by the FDA.  After two years, about 40 percent of the participants in the breast augmentation section of the Allergan study had dropped out; after three years, Mentor had lost about 80 percent of its breast augmentation study subjects.

The FDA now says that although it does not have evidence to support a link between breast implants and systemic illness, safety studies “would need to be much larger and longer than those conducted so far” to clearly rule out an association. Allergan and Mentor faced no consequences for failing to complete the mandatory studies.

In September 2018, researchers at the MD Anderson Cancer Center in Houston reported the results of the largest-ever long-term safety study of breast implants. The study found associations between silicone implants and three autoimmune diseases. In the same month, an Israeli study of tens of thousands of women also discovered a link between breast implants and autoimmune diseases. Several smaller studies conducted in recent years in the Netherlands and the U.S., reached similar conclusions.

In March 2017, the FDA issued a breast implant cancer warning, indicating that it was aware of at least 359 medical device reports involving women diagnosed with a rare form of non-Hodgkins lymphoma, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The illness has been linked to at least nine deaths.

The agency indicated at the time that the lymphoma cases appeared to be more common among breast implants with textured surfaces, as opposed to smooth breast implants, but a definitive connection was not able to be made.

Australia’s Therapeutic Goods Administration (TGA) launched an effort monitor the association between breast implants and anaplastic large cell lymphoma, more than doubling the recognized number of cases identified among Australian patients between September 2016 and April 2017.

Researchers from the TGA published a study in May indicating that side effects of textured breast implants may be linked to a 14 times higher risk of ALCL in some cases.

The TGA has estimated that the breast implant lymphoma risk may be between 1-in-1,000 and 1-in-10,000, with most cases occurring between 3 and 14 years after implant, but the median being 8 years and some cases diagnosed as much as 37 years after breast surgery,

Due to the potential lymphoma risk with breast implants, regulators have made efforts to increase awareness among health care providers about cases of the rare cancer linked to textured breast implants, indicating that they should discuss the benefits and side effects of the implants with their patients.

The FDA has also recommended that doctors consider the possibility that a breast implant recipient is suffering from anaplastic large cell lymphoma (ALCL) when they present with late, onset, persistent peri-implant seroma.

Each year in the United States more than 300,000 women and undergo breast augmentation, with the total number of breast implants procedures each year being  anywhere between 5 to 10 million around the world.

Before the operations women are often told by their surgeons that it is a safe procedure with “very little” risk, with the . FDA generally supporting that incorrect statement, by offering that “breast implants are relatively safe” which is now being shown to be very inaccurate.

There is a growing body of evidence, now supported by  thousands of examples of adverse events from women all over the world who have had implants. Facts are emerging that breast implants have been and continue to cause  debilitating autoimmune disorders  as well as emerging evidence of links to certain types of cancer.

No implant on the market today can last a lifetime. Every type is prone to leaking and rupturing, and instance, the saline valve implants, can even become black with mold, causing a systemic fungal problem in a person’s body.

Breast implant lawsuits are underway as of October 2016. In March 2017, the FDA issued a warning confirming that breast implants cause ALCL cancer. Lawsuits for ladies with BIA-ALCL are currently being organized. In April 2017, a bipartisan bill called the Medical Device Safety Act H.R. 2164 was introduced and needs your help in being passed to hold the manufacturers accountable for the harm they have caused. In January 2018, a Mentor MemoryGel Silicone Breast Implant case was able to in part pass preemption.

Background:

In the early 2000s, Allergan and Mentor were approved for premarket Investigational Device Exempt (IDE) studies where a limited number of plastic surgeons were allowed to use silicone breast implants, accordingly they were supposed to inform women of the study and follow up on them. In November 2006, Mentor and Allergan silicone breast implants were conditionally approved and six postmarket studies were to be conducted, see Mentor Approval Order and Allergan (formerly Inamed) Approval Order. The manufacturer premarket and postmarket studies have overall failed to follow up on women and provide real statistics on health problems that arise.

Presently, in 2018, there are over 50,000 women in breast implant illness Facebook support groups. Similar to the Dow times, the manufacturers have again pushed a campaign marketing the safety and inertness of implants rather than disclosing the truth of lack of real statistics and follow ups, the adjuvant immunologic effects of silicone, and the numerous heavy metals and chemicals used in manufacturing. With the lack of awareness on the matter, there is currently a public health crisis as the medical community at large has failed to help women identify breast implants as playing a role in their symptoms and has led to many misdiagnoses, unnecessary medications and treatments, and body parts being removed (thyroid, gall bladder, uterus, etc.). History is repeating itself and the manufacturers need to be held accountable for the alleged lack of informed consent and toxicity caused by saline and silicone breast implants.

Current Breast Implant Lawsuits:

Silicone

  • Weber v. Allergan (2012)
  • Ebrahimi v. Mentor (2016)
  • Mize v. Mentor Nguyen v. Mentor (Spouse Plaintiff) (2017)
  • Gravitt v. Mentor Gravitt v. Mentor (Spouse Plaintiff) (2017)
  • Skelton v. Allergan – BIA-ALCL (2018)
  • Cashen v. Mentor | Cashen v. Mentor (Spouse Plaintiff) – BIA-ALCL (2018)
  • Rea v. Allergan – BIA-ALCL (2018)
  • Vieira et al v. Mentor Worldwide, LLC et al (2018)
  • Sewell et al v. Mentor (2018)

Saline

  • Laux v. Mentor (2015)
  • Allergan Saline Lawsuits (2016)

Mentor Silicone Breast Implant Lawsuits:

Lawsuit Filed Against Mentor Worldwide Over Mentor MemoryGel Silicone Breast Implants 

(September 28, 2016)

A Seattle woman, Sara Ebrahimi, has filed suit against Mentor Worldwide LLC and its parent company, Johnson & Johnson Services, Inc., alleging the defective manufacturing of Mentor MemoryGel™ Silicone Breast Implants. The lawsuit alleges that Mentor and its parent company, Johnson & Johnson, repeatedly failed to follow the requirements imposed by the Food and Drug Administration (“FDA”) in connection with the approval of Mentor’s premarket approval application. It is further alleged that the companies failed to warn the FDA and women receiving the implants of the devices’ known dangerous propensities. The lawsuit — Ebrahimi v. Mentor Worldwide LLC, et al. (case no. 2:16-cv-07316-DMG) — was filed in the Central District of California in Los Angeles, where Mentor is headquartered.

Mentor develops, manufactures, and markets products for surgical and non-surgical procedures, including Mentor MemoryGel™ Silicone Breast ImplantsThe lawsuit alleges that chemicals Mentor used in the manufacturing process bled through the implants, and into Ms. Ebrahimi’s body, causing her to suffer serious medical problems. It is alleged that Mentor and Johnson & Johnson knew that their devices were defective, yet allowed them to be surgically implanted in Ms. Ebrahimi and other unsuspecting women. It is further alleged that Mentor and Johnson & Johnson failed to warn the FDA of these risks by not providing adequate follow-through studies.

Mentor MemoryGel™ Silicone Breast Implants are regulated medical devices under the Food, Drug and Cosmetic Act that require FDA approval. As a condition of approval, the FDA required that Mentor conduct six post-approval studies to demonstrate, over time, that its silicone implants were safe and effective. The lawsuit alleges that Mentor failed to design effective studies and, as a result, failed to provide the FDA with the longitudinal studies that were required as a condition to the devices’ approval. It is alleged that:

It was Mentor’s obligation to design and execute a study where women were able to access internet forms that are easily understood and provide a working forum to report their experience with implants. Mentor intentionally and systematically failed to make this happen which is a violation of the FDA’s conditions for approval. Data collection was sparse and potential serious side effects and harmful complications were downplayed and under-reported due to inadequate sample size.

This lawsuit influenced a new wave of breast implant litigation. Its research and structure are being used as a model being replicated by the following lawsuits below.

Rexina Mize, et al. v. Mentor Worldwide LLC

(February 2nd, 2017)

The case is Mize v. Mentor Worldwide LLC, No. BC-649083, California Superior Court (Los Angeles). In March 2017, the case was transferred and reassigned to the federal judge handling Ebrahimi v. Mentor and the case number was changed to CV 17-1747 DMG (KSx). In August 2017, the case was remanded back to state court.

Her husband, Spouse Plaintiff Minh Nguyen, is also suing Mentor on loss of consortium.

From the article, Johnson & Johnson Unit Sued Over Leaking Breast Implants:

Catherine Gravitt, et al. v. Mentor Worldwide LLC

(July 25th, 2017)

The case is Gravitt et al v. Mentor Worldwide LLC, No. 1:2017cv05428, Illinois Northern District Court (Chicago). Catherine Gravitt and her husband Travis Gravitt are the plaintiffs who filed against Mentor, see Complaint. She was implanted with textured Mentor MemoryGel Silicone Breast Implants in 2010 and in 2016 she discovered a rupture. Health complications included abnormal thyroid levels, swollen lymph nodes, severe and random skin rashes, blackouts and periods of disorientation, extreme fatigue and weakness, muscle soreness, frequent flu like symptoms, anxiety, depression, and more. Additionally it is alleged she gave birth to a son and daughter who both developed defects related to the toxic materials leaking from her breast implants. See the docket and the news article, “Couple’s lawsuit faults California breast implant maker.

In January 2018, U.S. District Judge Gary Feinerman allowed the case to in part pass federal preemption, see Memorandum Opinion and Order. This is a significant court ruling for all breast implant cases. See the news article, “Mentor Silicone Breast Implant Lawsuit Not Preempted, Cleared To Proceed: Judge.”

Renee Cashen, et. al v. Mentor Worldwide LLC, Ethicon, and Johnson & Johnson 

(April 27th, 2018)

The case is Cashen et al v. Mentor Worldwide LLC, filed in the Superior Court of New Jersey. Renee Cashen and her husband Richard Cashen are plaintiffs. In February 2008, she was implanted with textured Mentor MemoryGel Siltex Round Moderate Gel Breast Implants. After implantation, she was discharged from the post-market study she had been enrolled in. In 2016, she noticed a lump under her right armpit. A month later a biopsy was done and ALCL was discovered but it took several weeks later until her doctors associated it with her Mentor breast implants. In May 2016, Mrs. Cashen had explant surgery and six lymph nodes removed. In July 2017, she began chemotherapy treatments. The Defendants allegedly failed to comply with their post-approval surveillance obligation.

They are represented by Ross Feller Casey, LLP and McEldrew Young, both in Philadelphia, Pennsylvania.

Vieira et al v. Mentor Worldwide, LLC et al

(June 27th, 2018)

Nicole Vieira and Emilia Barozzi filed complaints in Los Angeles County Superior Court, Case No. BC711663. Plaintiffs were implanted with Mentor MemoryGel Silicone Breast Implants and afterwards they “experienced various medical complications, including fatigue, weakness, memory loss, and nausea.” After explantation it was discovered that the implants’ silicone gel had bled. The complaint alleges mistakes in Mentor’s manufacturing of the implants and defects in the silicone used. These resulted in silicone gel to bleed and therefore triggered the medical complications.

In July the case was moved to Federal Court, Case No. 2:18-cv-06502, and in September it was remanded back to Los Angeles Superior Court.

Allergan Silicone Breast Implant Lawsuits:

Nicole Weber v. Allergan No. 13-17017 (9th Circuit 2015)

The case was filed in 2012 and is moving to trial in early 2018.

“Weber appealed the district court’s dismissal of Weber’s diversity action brought against Allergan Inc, asserting strict product liability and negligence, and alleging that Allergan’s Natrelle Style 20 [silicone] breast implants are dangerous.” (Sept 21, 2015). See youtube video on her 9th Circuit court hearing. (The opposing attorney talks at 37:00)

Her amended claim was found to adequately state parallel state law claims (Oct. 23, 2015).

“Weber has identified to the extent possible without discovery, the standards she believes the manufacture of her implants violated, adequately stating parallel state-law claims.” the court said.

Vivian Skelton v. Allergan – BIA-ALCL

The case was filed as Skelton v. Allergan, No. BC696400 in Los Angeles County Superior Court. It was transferred to California Central District Court and the case number was changed to 2:18-cv-02617. She was diagnosed with breast implant-associated anaplastic large cell lymphoma, this is an Allergan BIA-ALCL Lawsuit.

Rhea v. Allergan – BIA-ALCL

(May 8th, 2018)

Michele Rea and Carl Rea from Fairfax, Virginia filed in the Superior Court of New Jersey in May 2018, see case here.

From Ross Feller Casey in ‘Another Lawsuit Alleges Breast Implants Cause A Rare Cancer‘:

Rea underwent reconstructive surgery for a partial mastectomy in 2011. About five years later, she was diagnosed with anaplastic large cell lymphoma, which was caused by a Natrelle Style 410 [highly cohesive silicone gel] implant made by Allergan, Inc., the suit alleges.

Allergan Saline Lawsuits:

In Jacksonville, Florida, the law firm of Terrell Hogan is filing hundreds of lawsuits against two local plastic surgeons – Dr. Loren Clayman and Dr. Mark Clayman. There are also allegations of fraud, as well as a lawsuit against Allergan.

“I represent about 150 women,” said Attorney Chris Shakib.

Shakib, the lead attorney in the case, called his findings unbelievable.

For further information, see articles on this here (June 1st, 2016) and here (November 29th, 2016).

Mentor Saline Lawsuits:

Anita Laux v. Mentor Worldwide LLC

(December 29, 2015)

The case is Laux v. Mentor Worldwide LLC, No. 2:16-cv-01026-ODW(AGR), filed in Ventura County Superior Court and moved to federal court. She is represented by Robert A. Zeman (Law Offices of Robert A. Zeman) and Alan C. Milstein (Sherman Silverstein Kohl Rose and Podolsky).

Breast implants are categorized as Class III medical devices (along with hip implants, pacemakers, cardiac stents, etc) and are very difficult to sue due to the 2008 Supreme Court case, Riegel v Medtronic which gave broad federal protection to manufacturers. To sue a manufacturer, one would need a product liability case and these are generally governed by state laws under theories of negligence, strict liability, and breach of warranty. The Supreme Court ruling with Riegel created a precedent for preemption of state laws, essentially citing that Class III medical devices are solely accountable to the regulations and surveillance of the FDA. After Riegel, the only way to sue is to assert parallel state law claims where one must prove the manufacturer deviated from a guideline they were approved by (a violation of a federal requirement, such as a FDA guideline), the violation of an identical state law, and how that violation of that federal requirement caused injury.

BIA-ALCL

Breast implant associated anaplastic large cell lymphoma (BIA-ALCL) is a cancer of the immune system caused by breast implants. It is generally found in fluid collection in between the implant and capsule, in a seroma, or in a nodule in the capsule. Physical signs are effusion, swelling, pain, inflammation, mass, ulceration, and others. The overwhelming symptoms in a majority of patients is a delayed seroma, persistent swelling, and pain. While even more rare some patients may present skin changes, lymphadenopathy, capsular contracture, or a potentially palpable mass.1 CD30 is the diagnostic test being used to distinguish ALCL. It is found to occur at a much higher rate in textured breast implants, however there have been some smooth surfaced breast implant cases as well.

Risks:

“[S]tudies reported in medical literature estimate that the lifetime risk of developing BIA-ALCL for patients with textured breast implants ranges from 1 in 3,817 to 1 in 30,000.” – FDA Update 3/21/18

Medical Device Reports (FDA)

Update: As of July 2017, Dr. Mark Clemens states that worldwide there have been 464 adverse event reports in relation to BIA-ALCL and 12 deaths. See PSEN Breast Implant Associated Anapestic Large Cell Lymphoma.

As of February 2017, the FDA has received a total of 359 medical device reports (MDRs) of breast-implant-associated ALCL, including nine deaths. Out of those 359 total reports, only 64% (231 reports) listed data on the surface at the time of reporting:

  • 87% (203 out of the 231 report) were with textured surfaces
  • 12% (28 out of the 231 reports) were with smooth surfaces

Although it is rare, breast-implant-associated ALCL appears to develop more frequently in women with textured implants than in women with smooth-surfaced implants.

Sample of the FDA Adverse Event Reports on BIA-ALCL:

Note: Parentheses represent redacted information to protect privacy.

  1. Company rep reported right side anaplastic large-cell lymphoma and “subcutaneous nodules and lymph nodes. ” the pt had a bilateral reconstruction seven years ago with style 410 breast implant placed on the left side and a style 115 placed on the right side. The pt had done well until she presented last week with a pathology report from her oncologist stating that she had alcl. The pt stated that she had nodules on the right axilla. A pet scan was carried out that showed metastasis in the lung and bone marrow involvement. No seroma was noted. The oncologist has decided on her treatment plan to exclude radiation. Explant surgery will take place (b)(6) 2013. (Reported in 2013, Allergan silicone) Link.
  2. Anaplastic large cell lymphoma of the breast arising around mammary implant capsule: an (b)(6) report written in aesthetic plastic surgery 2013 reports alcl, seroma, pain. Additional information noted in article anaplastic large cell lymphoma of the breast arising around mammary implant capsule: an italian report written in aesthetic plastic surgery 2013 article notes in regards to the right side, “necrosis and chronic inflammation signs are present” and “skin above the implant became red and painful and the patient had febrile episodes. ” treatment noted for the event of seroma as “a broad-spectrum antibiotic. ” (Reported in 2013, Allergan silicone) Link.
  3. Healthcare professional reports a case of lymphoma and other b-symptoms via mw (b)(4) the mw notes that: “the reporter called on behalf of a pt who was diagnosed with alcl. The pt presented with anaplastic large cell lymphoma, diagnosed in 2013. History of hodgkin’s lymphoma diagnosed in 2011. These two events came about after the pt underwent breast augmentation in 1994. In 2010, pt presented with an abnormal mammogram performed in 2010. Breast pain, skin color change, skin texture change, and inflowing diffusion form the right breast up to right neck and shoulder. The pt was running a fever throughout the entire process. After an mri and subsequent test, the pt was diagnosed with hodgkin’s lymphoma and underwent mantle radiation. In 2012, the pt underwent surgery essentially for a breast mass, but the pt also desired a mastectomy for removal of right and left implants and capsules. The pathology of the operation soon reported that the pt also has alcl; the mass had come from the lymphoma. ” (Reported in 2013, Allergan saline) Link.
  4. Pt is a female who underwent left mastectomy in 1996, for ductal carcinoma in situ with tissue expanders and saline implant reconstruction. She presented in 2010, with a peri-implant hematoma, though possibly post-traumatic. She underwent evacuation of the hematoma and change to a silicone gel implant. All pathology specimens were negative for tumor. She again presented in 2012, with a spontaneous hematoma and at surgery multiple biopsies revealed anaplastic large cell lymphoma (alcl) limited to the periprosthetic capsule and hematoma fluid. After an extensive hematologic and metastatic workup which was negative, she underwent removal of the implant and total periprosthetic capsulectomy. Capsular pathology showed alcl. (Reported in 2012, Mentor silicone) Link.
  5. On (b)(6) 2010, diagnosed with anaplastic large cell lymphoma (alcl) alk-negative. Possibly related or caused by breast implants received in (b)(6) 2002 for augmentation. Experienced complications with left implant diagnosed as capsular contraction. Implant replaced on (b)(6) 2008. Still experiencing capsular contraction after replacement. (b)(6) 2010 – (b)(6) 2011: received 12 doses of chemotherapy, received 20 doses of radiation therapy. Preparing for stem cell transplant scheduled for (b)(6) 2011. (b)(6) 2010: needle biopsy – diagnosis lymphoma. (b)(6) 2010: surgical biopsy – diagnosis alcl. (b)(6) 2010: surgical biopsy – diagnosis alcl. (Reported in 2011, Allergan saline) Link.
  6. The original purchase date of this device was (b)(6)2004. In (b)(6) 2006, the pt was implanted with mentor siltex saline devices during a revision augmentation procedure. In (b)(6) 2008, the devices were replaced with mentor smooth saline devices due to a left device deflation. In (b)(6) 2010, the pt had both implants removed due to recurring fluid accumulation in the right breast. On (b)(6)2010, the pt was diagnosed with alcl (t-cell lymphoma). No further info is available at this time. (Reported in 2010, Mentor saline) Link.
  7. It was reported by a physician that a (b)(6) year old female patient was diagnosed with alcl on (b)(6) 2017. This patient’s medical history includes diagnosis of left breast invasive ductal carcinoma in (b)(6) 2015. She underwent bilateral mastectomy and bilateral tissue expander placement in (b)(6) 2015. The patient had mentor tissue expanders that were implanted from (b)(6) 2015. The patient then had mentor memory shape low high moderate plus profile breast implants (catalog #334-1507, r. Side serial # (b)(4)) implanted in (b)(6) 2015. On (b)(6) 2017, the patient experienced a large right breast effusion that developed over 24-48 hours. The effusion was aspirated and tested using flow cytometry and cd30 ihc and came back positive for bia-alcl on (b)(6) 2017. The time between patient signs/symptoms of peri-implant alcl to definitive diagnosis was 1 week. The patient did not have any complications such as infection, hematoma, or implant rotation during implant course prior to alcl diagnosis. The patient did not experience skin lesions, fevers, night sweats or weight loss. There was no pain, redness, palpable breast mass, or capsular contracture. The lymphoma cells were found in the seroma fluid surrounding the implant. Immunohistochemical and flow cytometry testing showed alk negative and cd30 positive results. This is a pathologically confirmed stage ie primary diagnosis of alcl. Based on histology, there is no capsular involvement. The lymphoma cells were found in the effusion fluid surrounding the implant. The patient underwent bilateral implant removal and capsulectomies with no implant replacement on (b)(6) 2017. The implants were intact and not ruptured upon removal. (Reported in 2017, Mentor Memory Shape Silicone) Link.

Above is only a sample of six reports to the FDA. As of July 2017, Dr. Mark Clemens states the FDA has received 464 adverse event reports in relation to BIA-ALCL and 12 deaths. Join the Facebook group ALCL in Women with Breast Implants BIA-ALCL to view reports by country.

BIA-ALCL Causation Theories:

The cause is still unknown but is actively being studied. Some researchers have theorized that biofilm contributes to lymphoma and others have thought the chemicals in the implants irritate the immune system. Both theories rely on the presence of persistent inflammation, which means chronic activation of immune cells and particularly the T lymphocytes, which are white blood cells involved with ALCL.

Throughout the body, there are many diverse populations of bacteria that are both beneficial and harmful. In recent years, there has been an increased focus in characterizing bacteria and analyzing patterns of bacteria to understand the possible correlation between normal versus infectious/cancerous scenarios – especially in relation to breast cancer. What has been discovered is that similar to how the gut has its own microbiome of good and bad bacteria, the normal breast tissue and human milk also have their own microbiology that over time is influenced by factors such as dietary and sugar changes. The article “Microbiota of the Human Breast Tissue” delves into the various specific bacteria that were found in human breasts. Since breasts are not sterile, if a foreign object is placed inside the body, it will be colonized and infected.

Biofilm is bacteria that adheres to the surfaces of medical devices. It can result in a low grade chronic bacterial infection, chronic inflammation, and capsular contracture. Some bacteria produce acid as they grow and this reduces the pH of the surrounding environment. In the closed off space between the surface of the implant and the inner capsule surface, the bacteria coating the implant could form an acidic environment that contributes potentially to the breakdown of silicone. Australian researchers found that biofilm from capsular contracture cases was different from the biofilm identified on 26 implants from lymphoma patients. This brings biolfim to light as “a possible infectious contributing cause” for the lymphoma.

The chemicals used in the manufacturing process, which are neurotoxic and carcinogenic, are also believed to be playing a role in the development of lymphoma. The majority of ALCL cases have been found with textured implants, the roughness of the surface is triggering chronic inflammation. Textured implants were designed to keep the implants in place, thus, the capsules embed themselves on and around the textured surface. This creates an intimate, hand in hand connection between the scar tissue and chemically abrasive textured surface. Over time, this can lead to a direct abrasive irritation of the immune system, significantly affecting T cells.

It is interesting to note the connection between polyurethane coated implants and textured implants. Polyurethane coated implants were the first type of breast implant linked to cancer, and textured implants have now become the second type of breast implant linked to cancer – what they both have in common is a chemically abrasive fuzzy surface. Polyurethane implants were in production from about 1980 to when the manufacturer voluntarily withdrew them in 1991 due to significant safety concerns. These implants were the precursors to the textured breast implants since the textured surface was thought to be important in reducing capsular contracture and firmness, but the implant manufacturers could not use polyurethane so instead they created the textured surface currently manufactured today (since the mid-1990’s). This textured surface is also linked to an increased occurrence of forming double capsules (scar tissue surrounding the implants) and seromas, thereby going against its intended purpose.1,2

Protocol: 

In October 2017, a study published in the medical journal JAMA Surgery warned that many breast implant cancer case worldwide were probably not reported, and noted that doctors and patients may not be aware the ACCL risks. As more information becomes public about the breast implant cancer cases, experts have warned that the number of cases reported will likely increase significantly.

BIA-ALCL and Mammograms:

There have been cases reported in the BIA-ALCL FB Support Group where mammograms have triggered breast swelling and led to BIA-ALCL diagnoses.

Resources:

Government Health Agencies and Other Sources

Science and Medical: 

Please see the Scientific Articles page for over 200+ references to breast implant related scientific articles. They are organized into eight categories: 1. General, 2. Researchers, 3. Saline Implants & Mold, 4. Ruptured Silicone Implants, 5. Biofilm & Infections, 6. Breast Feeding with Implants and Effects on Children, 7. Biomaterials, and 8. ALCL (cancer).

Current Experts:

Dr. Pierre Blais (chemist and biocompatibility expert – Canada), Dr. Arthur Brawer (rheumatologist and silicone toxicity expert – Long Branch, NJ), Dr. Yehuda Shoenfeld (physician and autoimmunity researcher – Israel), Dr. Cohen Tervaert (rheumatologist – Edmonton, Canada), Dr. Henry Dijkman (pathologist – Netherlands), Dr. Diana Zuckerman (President of National Center of Health Research), Dr. Sarah Myhill (UK), Dr. Lu-Jean Feng (plastic surgeon – Cleveland, OH), Dr. Victor Urzola (plastic surgeon – Costa Rica), Dr. H. Jae Chun (plastic surgeon – Newport Beach, CA), Dr. Matthew G. Stanwix (plastic surgeon – Henrico, VA), Dr. Susan Kolb (plastic surgeon – Atlanta, GA), Dr. Edward Melmed (plastic surgeon – Dallas, TX), Dr. Rita Kappel (plastic surgeon – Netherlands), Dr. Michael Harbut (environmental medicine specialist – Detroit, MI), Dr. S V Maharaj (silicone breast implants and platinum expert). See here for some of their publications.

Educational Links:

What You Need to Know About Breast Implants (National Center For Health Research)

Breast Implant Illnesses: What’s the Evidence? (National Center For Health Research)

Safety – Junk Science, ‘New’ Cohesive Gel, and Toxicity for Silicone and Saline Implants

Breast Implants and Cancer (BIA-ALCL) and BIAALCL.com

Dr. Myhill –

Silicone Breast Implants and Injections

Chemical Poisoning – Diagnosis

Detoxification

Dr. Urzola –

Breast Implant Illness

“Over the past year and 8 months I have learned and researched a lot about this condition. After explanting over 100 patients and seeing the extraordinary post operative reports with over 85% of patients reporting complete remission of their symptoms or at least an important improvement, we are committed to starting a scientific investigation with the purpose of validating BII as a syndrome and getting the medical community to recognize it as a problem affecting thousands of women around the world.” (2017)

Dr. Feng –

Breast Implant Removal: Basics I

Topic: Linda L. Haas, Feng Clinic CEO, answers basic scheduling questions from patients who have just started researching breast implant removal. Videos: Part I and Part II.

Breast Implant Removal: Basics II

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Note: (Excerpts within this article include other online media sources)

____________________________________________________________________________

Additional Resources On Breast Implant Complications and Adverse Events

Topics: pathology, mold/microorganisms, detoxification, coinfections/diseases, selecting a surgeon, silicone vs. saline, capsule removal, lymph node removal, hormones and symptoms of BII. Videoand Transcript.

Breast Implant Removal: Basics III

Topics: the aesthetics of the breast, muscle repair, mastopexies or breast lifts, fat transfer and who is a candidate. Video and Transcript.

Breast Implant Removal IV: Detoxification

Topic: An in-depth discussion of detoxification before and after breast implant removal. Video.

Will I recover from breast implant illness without lymph node removal? (Video)

Is There A Connection Between Lyme Disease and Breast Implant Illness? (Video)

MTHFR and breast implants (Video)

Dr. Feng Webinars I-IV and YouTube Channel

Research articles and studies

Dr. Chun –

“Many patients suffer from BII(Breast Implant Illness) from their saline or silicone breast implants.” – Dr. Chun’s Breast Implant Removal Page

YouTube Channel – with videos on explantation, ruptured implants, difficulty associated with detecting ruptured silicone, and an en bloc capsulectomy explant (graphic).

Instagram where you can see Dr. Chun’s meticulous skill and expertise in doing perfect en bloc explants.

FDA Testimony

Dr. Kolb –

If something is of use to women affected by breast implant illness, it will be provided on this website regardless of politics.

Doctors, are you listening?

Immune Protocol

Silicone Immune Treatment Protocol

Inositol for Silicone Detoxification Provided by Dr. Douglas Shanklin

Videos: Dr. Susan Kolb discusses silicone breast implants and saline breast implants

Book: The Naked Truth About Breast Implants: From Harm to Healing

Note: There are currently four pending medical malpractice lawsuits filed against this plastic surgeon.

Dr. Blais –

Breast Feeding

Truth on ‘Cohesive’ Gel Implant

Technology and composition of silicone breast implants

How do implants rupture and cause injury

Testimony to the FDA (2000) 

All articles on breast implants by Dr. Pierre Blais, click here. Topics include: rupture, cancer, breast feeding, polyurethane, saline implants, cohesive gel, explant problems etc.

Dr. Blais is a chemist and expert in the biocompatibility of implant materials. He has been analyzing breast implants and conducting breast implant failure analyses for over 40+ years. There is currently a backlog due to the high demand and he is not accepting any new breast implants. Dr. Blais is a significant resource, he is a wealth of information on most breast implant matters.

Dr. Brawer –

Case Report: Silicone is not fun in the sun (2018)

ASIA vs. the mechanisms of silicone toxicity (2017)

Vague Syndromes (2017)

Mechanisms of Breast Implant Toxicity (2017)

Autoinflammatory Syndrome Induced by Adjuvants (ASIA) Syndrome is Misguided (2017)

Destiny rides again: the reappearance of silicone gel-filled breast implant toxicity (2017)

Breast Implant Toxicity (2016)

Bones, Groans, and Silicone (2012)

Amelioration of Systemic Disease after Removal of Silicone Gel-filled Breast Implants (2000)

Silicon and matrix macromolecules: new research opportunities for old diseases from analysis of potential mechanisms of breast implant toxicity (1998)

Chronology of systemic disease development in 300 symptomatic recipients of silicone gel-filled breast implants (1996)

Clinical features of local breast phenomena in 300 symptomatic recipients of silicone gel-filled breast implants (1996)

Dr. Schoenfeld

Silicone breast implants and the risk of autoimmune/rheumatic disorders: a real-world analysis (2018)

The ASIA syndrome: basic concepts (2017)

Autoimmune/Inflammatory syndrome induced by adjuvants (ASIA) and thyroid autoimmunity (2017)

Sjörgen’s Syndrome and Environmental Factors (2016)

Silicone and Autoimmune/Inflammatory Syndrome Induced by Adjuvants (ASIA). (2015)

Silicone implant incompatibility syndrome (SIIS). A frequent cause of ASIA (Schoenfeld’s syndrome). (2013)

Autoimmune/inflammatory syndrome induced by adjuvants (Shoenfeld’s syndrome): clinical and immunological spectrum (2013)

The spectrum of ASIA: ‘Autoimmune (Auto-inflammatory) Syndrome induced by Adjuvants’ (2012)

’ASIA’ – Autoimmune/inflammatory syndrome induced by adjuvants (2010)

Fibrosarcoma after silicone breast augmentation: is there a connection? (1998)

Light and electron microscopic study of an invasive cribriform carcinoma with extensive microcalcification developing in a breast with silicone augmentation (1994)

Breast carcinoma occurring in association with silicone augmentation (1993)

Doctors Speak Out –

Dr. Bernard PattenDr. Al LevinDr. Robert Goldwyn,

Dr. Frank Vasey (the “Dark” side of silicone breast implants)

Dr. Stephen Edelson (goes into symptom mechanisms)

Dr. Britta Ostermeyer (on dangers of silicone implants)

Other Educational Videos –

Breast Implant Illness – Dr. Faria

Integrative en-block treatment – Dr. Hovsepian

Capsular contracture – ruptured breast implants – Dr. Cassileth

Silicone Toxicity and Detoxification – Dr. Jennings

Immune Response to Silicone (skip to 5:38 for the effects on children)

Dr. Urzola’s Live Feed on Breast Implant Illness (2017)

Other links:

National Birth Defect Registry

  • Did you have breast implants while pregnant?
  • Did you breastfeed with breast implants?
  • Was your child born with a birth defect? Was your child born with a birth defect?

The National Birth Defect Registry might be able to help us research any possible link between breast implants and birth defects. If you’d like to help, please go to their website and register. Click here for more info.

***Search here if a doctor is receiving payments from a manufacturer and here (such as fees in research, consulting, speaker, sponsor, etc).

Petitions –

Breast Implant Petition

Request FDA Hearing

Medical Device Safety Act H.R. 2164

Surveys –

Dr. Victor Urzola’s Breast Implant Illness Data Collection Database

Dr. Yehuda Shoenfeld’s ASIA survey

PIP Implants Survey – if you have or had PIP, please fill out this survey

Concerns for estrogenicy of silicone breast implants

Allergan manufacturing patent

Method of making textured surface implants patent (Mentor)

UK MHRA PIP Implant Ingredient Analyses

Dr. Harbut response to FDA on platinum toxicity

Dr. Maharaj and Dr. Lykissa responses to FDA on platinum toxicity

Facebook Support Groups:

US: Breast Implant Illness – The Ticking Time Bomb

Breast Implant Illness and Breast Cancer Survivors Home

Canada: Breast Implant Failure and Illness – Canada

Australia: Breast Implant Illness – (Australia & New Zealand) Healing and Support

UK: UK Breast Implant Illness and Healing Support Group

ALCL: ALCL in Women with Breast Implants (BIA-ALCL)

For all medical devices: Medical Device Problems

Mothers: Breast Implants and Children

There are over 160+ breast implant illness support groups and awareness pages on Facebook where women share their experiences.

Personal Stories and Videos:

The Naked Truth // My Life with Breast Implants

Personal stories

Alex Chafen – Breast Implants, a Husband’s Perspective

Andrea Conti Cowder (Video and BII Story)

Pursuing Explantation – My path to health after breast implant illness

Beth Maturevich – Breast Implant Illness (Saline) Video

Raylene Hollrah – Diagnosed with ALCL, story

Implant Illness Awareness – Breast implants are not safe. We are the proof.

Mybreastimplantillness WordPress 

nothappywithmentor.blogspot.com

The faces of breast implant illness – Video

Jamee Cook –

Pursuing Explantation – My path to health after breast implant illness

YouTube channel on breast implant illness

Advocacy Groups:

US:

Canada:

Australia:

Netherlands:

UK:

Scotland:

Ireland FB Group: PIP Ireland

France:

Italy FB Page: Protesi PIP and Blog

Sweden:

Switzerland: Informationen zu Brustimplantaten

Venezuela FB Group: Protesis Mamarias PIP

Brasil: Breast Implants Illness (Doença Prótese Mamária) Brasil

Singapore FB Page: Implant Illness and Detox Singapore

South Africa: Breast Implant Illness – South Africa

Breast Implant Illness Websites:

Breast Implant Victim Advocacy (BIVA)

Breast Implant Failure

BIA-ALCL

BIA-ALCL Awareness –  Just Call Me Ray Foundation  (Non-Profit)

Breast Implant Info (Non-Profit)

No Grit No Pearls.org (Non-Profit)

Toxic Discovery (Non-Profit)

Life Since Explant Club

Reversing Breast Implant Illness

Healing Breast Implant Illness

Discover Breast Implant Illness

Miss Diagnosed

BII Aware

Prothese Mammaire Danger

Fake Breasts Real Women

Breast implant illness websites and forums have been around since the late 90s and early 2000s:

Silicone Poison Report

Silicone Holocaust

Implant Information Network (founded in 2004)

Breast Implant Awareness – Humantics Foundation (founded in 2001)

Silicone Implants Survivors (forum since around 1999) and PS List

Silicone Hypersensitivity (owner passed away)

In addition, there were Yahoo support groups and breastimplantsupport.org was another popular forum but now is no longer running.

Breast Implant Manufacturer FDA Information:

Recalls

Allergan Natrelle Silicone & Allergan Silicone Timeline 

Allergan Natrelle 410 Cohesive Anatomical Silicone & Allergan Silicone Timeline

Mentor MemoryGel Silicone & Mentor Silicone Timeline

Mentor MemoryShape Silicone & Mentor Silicone Timeline

Sientra Silicone & FDA Timeline

Allergan Natrelle Saline & Saline Timeline

Mentor Saline & Saline Timeline

Ideal Saline & Saline Timeline

For more information on breast implant FDA links and how to do more FDA research, click here.

Books:

The Naked Truth About Breast Implants: From Harm to Healing by Dr. Susan Kolb

The D.I.R.T. Committee by Gail Hamilton

  • Must read, especially if you had Dow
  • D.I.R.T = Document Investigation & Review Team

The Boobie Trap: Silicone, Scandals, and Survival by Barbara Stanistreet

Informed Consent by John A. Byrne

Dr. Andrew Hall Cutler:

Dr. Cutler has a PhD in chemistry from Princeton University and has extensive study in biochemistry and medicine. He himself got mercury poisoning from amalgam fillings and created these books to provide guidance for detoxification.

Movies: Two Small VoicesBreast Men, Absolutely Safe

Press Articles & News:

Crystal Hefner Removes Breast Implants, Says They ‘Slowly Poisoned’ Her

Mother feels she is dying after her 32E breast implants ‘poisoned’ her

Dr. Britta Ostermeyer testifies to FDA in 2000 on the dangers of silicone breast implants.

Safety of breast implants under review in South Korea after silicone gel found in breast milk

FDA panels put silicone breast implants back under microscope (2011)

The silicone implant scandal (2012)

Breast Implants: America’s Silent Epidemic

Breast Implant Illness by Maya

Sara-Jane Fitness Cover Story

The Troubled History of PIP’s Implant Man in America **Implant manufacturers all operate in relatively similar ways and this article provides a glimpse of the dirty and corrupt business.

The “Dark” Side of Silicone Breast Implants

Toxic Moldy Breast Implants

Breast Implant Toxicity – on the radio with Danielle Delaney & Alex Charfen

The Ill Effects of Breast Implants

Why are celebrities removing their breast implants?

Explant Breast Surgery: Why women are getting their breast implants removed

Devoted mother-of-four dies from heart failure after implants trigger dormant TB

46 cases of ALCL diagnosed in Australia & New Zealand

Australia’s health regulator has confirmed that women with breast implants have a much higher risk of cancer (7 News Sydney – Video)

Patients accuse breast implant manufacturer of fraud (2016 – Allergan)

Breast implant illness conference – Texas (7/16/16)

News Segment on a lady with breast implant illness & saline implants

Monsters Inside of Me – Discovery Channel on saline implants with mold

Mold and Breast Implant Illness – The Doctors (TV show)

2017 – Important Year for Breast Implant News –

Breast implant illness gains nationwide coverage and becomes a movement:

French court says German firm must compensate for faulty breast implants

Woman who beat breast cancer once says breast implants caused cancer again

Johnson & Johnson Unit Sued Over Leaking Breast Implants

Johnson & Johnson, Mentor Worldwide LLC Senior staff target Support Groups

Former Playboy Models Get Their Breast Implants Removed Believing They Caused Illness

Mother-of-two is left with ROTTING breasts after silicone implants leaked into her blood stream – as cosmetic procedures fall to a ten-year low in the UK 

Can implants kill you?

Phoenix Valley women speak out on breast implant illness: ‘I just had to get them out’

Doctor’s Breast Implant Illness Denial Elicits Strong Response

Breast Implants Cause Rare Form of Cancer, FDA says

9 deaths linked to rare cancer form breast implants

In the News: Breast Implants Linked to Rare Cancer (Diana Zuckerman)

Former Women’s IFBB Pro Jackie Paisley dies after long battle with illness (silicone toxicity)

Breast Implant Survey Suggests Doctors Divided on Safety

Nicola Robinson’s Deepest Regret (silicone breast implants)

Breast Implant Illness + 6 Other Breast Implant Dangers (Dr. Axe)

Playboy Models Claim Implants Caused Health Problems (The Doctors, show)

Former Playmate of the Year on removing breast implants: ‘I literally thought I was dying’ (AZ Family News)

Women complain that their breast implants made them sick (West Palm Beach – WPTV News)

Her Hidden Dangers (Illinois – 23WIFR News)

Breast implant patient’s life ‘could have been saved’ – Hairdresser Kandi du Cros died after breast implant operation flared up rare existing disease (BBC News)

2 Massachusetts Women, Thousands Nationwide Say Breast Implants Made Them Sick (CBS Boston News)

Women concerned about implants after learning they may be linked to rare cancer (Fox 59 Indianapolis News)

Caldwell woman diagnosed with cancer from her breast implants, insurance won’t pay to remove them (KIVI 6 On Your Side – ABC Idaho)

A Shocking Diagnosis: Breast Implants ‘Gave Me Cancer’ (NY Times)

DeLauro Statement on Breast Implants Connected to Lymphoma (United States Representative Rosa DeLauro)

Swedish breast implant illness news story: Johanna, 31, varnar andra: “Implantaten gjorde mig jättesjuk”

Danish: Johanna fik opereret brysterne større – aldrig har hun fortrudt noget så meget

Woman reveals danger of implants, horror of lawsuits – silicone poisoning brings on 20 year suit with Dow Chemicals (UB Media Biz)

Conflict of Interest: The FDA & Big Pharma – Does the FDA Work for Big Pharma? (Drug Watch)

Breast prostheses: For a national registry of complications (Dr. José Budo)

Colorado women claim breast implants made them sick (Denver 7 News)

Did breast implants make Valley woman sick? (ABC15 Arizona)

9 Investigates health concerns with silicone breast implants (WFTV9 Orlando, FL)

Brit Boob Implant Cancer Bombshell – Two breast surgery patients die from a ‘bombshell’ cancer linked to implants

Rare cancer reignites debate over breast implants’ safety

Silicone Breast Implants are back – This Time the Issue is Cancer

Sydney mother’s dire warning after breast implants almost ruined her life. (Australia News)

Dr. Robert Whitfield MD, FACS describes breast implant-related illness (The Plastic Surgery Channel)

The Explant Phenomenon (Huffington News)

Former ‘Playboy’ playmates have ‘toxic’ breast implants removed after they make them sick (Inside Edition)

Women say breast implants caused unexplained illness for years (WSB-TV Atlanta, GA)

Why scores of women are having their implants removed (Tucson News, AZ)

More Canadian women having their breast implants removed, surgeons say (CTV News)

2018

Women battling illness after breast implants urge awareness, education (CBS Miami)

The breast implants that may be linked to blood cancer: Linzy was baffled by her symptoms but doctors solved the mystery in time for her to make a full recovery (Daily Mail UK)

South Florida Woman: Breast implants ruined my life (West Palm Beach – WPTV News)

CBS 5 Investigates: Chemist claims breast implants make some women sick (CBS Arizona)

Why Kiwi women are getting their breast implants removed (New Zealand)

I spent the last five years managing my health so my body could cope with these toxic bags’: Why more women are having their breast implants REMOVED following debilitating complications (Daily Mail Australia)

Facing unexplainable symptoms, metro women argue silicone breast implants made them sick (Fox 4 Kansas)

Arkansas women want doctors, FDA to recognize seriousness of ‘Breast Implant Illness’ (THV11 Arkansas)

My breast implants were killing me – how I took my life back (Elephant Journal)

Calls to ban textured breast implants after two die and 23 develop same type of cancer (My Vue News – UK)

Kiwi woman says seven-year illness caused by breast implants (Stuff – New Zealand)

Perth mum Ricci Jess reveals painful truth behind fake boobs (Perth Now – Australia) 

Explants: breast implants removal surgery grows among Perth women (Perth Now – Australia)

My breast implants nearly destroyed my life: how S Club 7’s Hannah Spearritt was left in agony following the boob job she craved (Daily Mail UK)

After 17 years with breast implants, Princeton woman leads calls for more education, safety (WFAA 8 ABC – North Texas)

Mount Pleasant woman says breast implants caused serious health problems (4News – Mount Pleasant, South Carolina)

Breast Implant Illness: What we don’t know can hurt us (Swaay)

Glamour model who got a boob job at 18 shares her plastic surgery nightmare that destroyed her kidneys and has left her on dialysis (Daily Mail Australia)

Facing health issues, Georgia woman has breast implants removed (Fox5 – Atlanta, Georgia)

Breast Implant Illness: Two metro women say implants caused years of complications (13 WHOtv – Iowa)

Breast Implant Illness: Woman claims implants made her sick (7 WJHG – Panama City Beach, Florida)

Former local 4 reporter says breast implants caused years of chronic fatigue, depression, hair loss (Click On Detroit – Michigan)

Auckland woman ‘s painful lesson about the dangers of breast implants (News Hub – NZ) 

What this yoga teacher learned from her mistake with breast implants (Charlotte Five)

Biocell textured breast implants under scrutiny as women complain of pain (CBC – Canada)

Breast implants reveal problems in tracking device safety (AP News) 

Breast Implant Injuries Kept Hidden As New Health Threats Surface (ICIJ)

Under the skin of ICIJ’s Implant Files (ICIJ)

Breast implants study reveals serious safety concerns (The Guardian)

The Implant Files reveal how breast implants linked to rare cancer set off alarm bells (ABC – Australia)

The Implant Files: Faulty breast implants leave women in limbo (Financial Review – Australia) 

Bare dager etter at hun opererte inn silikon i brystet, merket Karin Wenke Osthaug at noe var galt (Aftenpolten – Norway)

Cancer lié aux prothèses mammaires (LAGC) : l’inertie des autorités sanitaires (France Culture)

Temor, burocracia y dolor: hablan tres argentinas damnificadas por implantes mamarios (Perfil – Argentina)

British women are hit by new breast implant cancer scare seven years after PIP scandal as concerns grow over most commonly-used implant banned in France but still allowed in UK (Daily Mail – UK)

Rare form of Blood Cancer Linked to Certain Type of Breast Implants Used by Thousands of Women (People)

Breast Implants May Increase Your Risk of A Rare Type Of Cancer (Women’s Health)

Some medical devices deemed unsafe in other nations still sold in U.S. (NBC News)

Breast-implant-related complications, including cancer, kept secret thanks to broken reporting system (The Star)

My Breast Implants Made Me Sick – and Nobody Believed Me (Cosmopolitan)

Hidden dangers: patients, doctors not informed of defective implants (ICIJ)

Many Women Getting Breast Implants Removed In Light Of Health Concerns (CBS Philly)

Mother, 34, who was left ‘slowly dying’ by her ‘toxic’ C-cup breast implants has them removed after four years of agony (Daily Mail and The Sun)

Richmond woman warns of breast implant illness (K12 – Virginia)

As the Allergan breast implants disaster explodes, isn’t it time women say enough is enough? (Huffington Post – UK)

Allergan’s textured breast implants recalled by French authorities (NBC News)

 

 

 

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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

 

 

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

“Emerging Uloric Litigation”

By Mark A. York (February 21, 2019)

    ULORIC by Takeda Pharmaceuticals. Inc.

 

 

 

 

 

 

 

 

 

 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

>To Learn More About the Emerging Uloric Litigation: 

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

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

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

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

 

 

 

 

 

 

 

 

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RICHARD SACKLER DEPOSITION TRANSCRIPT UNSEALED IN KENTUCKY vs. PURDUE PHARMA

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

By DAVID ARMSTRONG — PROPUBLICA, FEBRUARY 21, 2019

and MOLLY FERGUSON FOR STAT

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

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

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

 

 

 

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) In 2007, Purdue Frederick Co. (not Purdue Pharma) and three company executives pled guilty to misbranding OxyContin and agreed to pay $634.5 million to resolve a U.S. Department of Justice investigation, in the US District Court of Virginia, see Purdue Criminal Plea Agreement US Department of Justice May 10, 2007. This plea deal “a get-out-of-jail free card” was engineered by none other than former New York City Mayor and political/corporate fixer, Rudy Guiliani, by directly leveraging high level US DOJ contacts and other DC insiders to derail the prosecution of Purdue Pharma, and instead offer up Purdue Fredrick Co. as the guilty party and thereby permitting the multi-billion dollar per year Oxycontin assembly line to continue operations.

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

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

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

Who is Richard Sackler, and why was he deposed?

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

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

That state court litigation has been the subject of an ongoing legal battle in the Kentucky courts where Purdue is fighting to keep the original court records from that settlement sealed, due to the only deposition testimony of one of the Sackler brothers is known to be located. The Purdue court records were unsealed by Pike County Judge Stephen Combs in May 2016, and Purdue immediately appealed with oral arguments taking place June 26, 2017 in front of a three judge panel of the Kentucky Court of Appeals, which had failed to rule on the argumanets as recently as January 2019

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

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

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

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

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

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

READ THE SACKLER DEPOSITION HERE

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

“Not necessarily,” Sackler replied.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 

 

 

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

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

By Mark A. York (October 11, 2018)

See: Vaccine Rules – Court of Federal Claims

 

 

 

 

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

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

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

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

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

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

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

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

 No Special Tax Was Paid By Zostavax

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

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

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

CDC Shingles Vaccine Warning of Feb. 12, 2018

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

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

Why is Varicella Vaccine on the Vaccine Court List?

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

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

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

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

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

 

“VACCINE COURT” Related References

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

 

 

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

Individual Opioid Injury Claim Types

 

A MASS TORT NEXUS OVERVIEW:

by John Ray

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

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

  1. Overdose resulting in death

  2. Overdose without death

  3. Opioid Addiction

  4. Neonatal Abstinence Syndrome

  5. Birth Defects

  6. Heart attack

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

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

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

Opioid Litigation Individual Claims

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

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

Overdose Resulting in Death

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

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

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

 Overdose Deaths Soared as Big Pharma Reaped the Profits

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

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

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

 

 

 

 

 

 

 

 

 

 

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

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

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

 

 

 

 

 

 

 

Overdose Without Death

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

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

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

Opioid Addiction

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

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

 

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

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

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

Neonatal Abstinence Syndrome

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

 

 

 

 

 

 

 

 

 

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

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

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

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

Birth Defects

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

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

 

 

 

 

 

 

 

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

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

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

 

 

 

 

 

 

 

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

HEART ATTACK

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

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

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

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

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

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

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

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

 

 

 

 

 

 

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

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

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

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

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

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

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

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

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

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

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

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

BILLIONS IN PROFITS

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

THE SACKLERS AND PURDUE

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

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

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

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

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

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

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

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

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

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

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

PURDUE-OXYCONTIN HISTORY

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

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

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

US DEPT OF JUSTICE INDICTMENTS

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

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

FORMER PRESIDENT BILL CLINTON SPEAKS TO THE OPIATE CRISIS ISSUES”

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

RURAL vs. BIG CITY OPIATES

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

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

FDA Failed to Cite Opioid Big Pharma

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

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

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

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

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

 

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Zinbryta Emerging Litigation

Emerging Zinbryta Litigation

 

 

 

 

 

 

 

 

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

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

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

Additional media related to withdrawal of Zinbryta:

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

Adverse events potentially associated with Zinbryta include:

Serious Liver Damage

Inflammatory Brain Disease

Encephalitis

Onset of Seizures secondary to adverse reactions.

Death secondary to adverse reactions.

To Learn More About the Emerging Zinbryta Litigation:

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

 

 

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

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

Mass Tort Nexus Metrics

 

 

 

 

 

 

 

 

 

 

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

 

 

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

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Ocaliva Emerging Litigation

Emerging Ocaliva Litigation

Ocaliva: An Emerging Litigation

 

 

 

 

 

 

 

 

 

 

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

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

Recent FDA Communications Excerpts:

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

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

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

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

  >To Learn More About the Emerging Ocaliva Litigation:

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

 

 

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

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

 

Mass Tort Nexus Metrics

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

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

 

 

Read More