Judge limits Monsanto Trial Evidence

(Jan. 4, 2019)  A Monsanto Christmas wish was granted this week by a judge in the Roundup cancer litigation.  California Judge Vince Chhabria ruled for Monsanto in its lawyers’ requests that the jury in the next Roundup cancer trial not hear evidence of how Monsanto worked to influence regulators and manipulate public opinion.

Unlike the first trial – in which a jury awarded a $289 million verdict that stated Monsanto’s Roundup caused a California groundskeeper’s cancer – the judge ruled to split the second trial into two parts.  That decision could have far-reaching consequences for the entire Roundup litigation.

New Trial Arrangement favors Monsanto

In the new two-part trial arrangement, the plaintiff’s attorneys will first have to convince the jury that Roundup caused the plaintiff’s non-Hodgkin’s Lymphoma. They will need to do so without any reference to Monsanto’s now well-documented attempts to influence the EPA, other regulators, and the public at large.  Plaintiff’s attorneys will also not be able to show Monsanto’s secret funding of ostensibly “scientific” research projects that established outcomes which virtually always favored the company that funded them.

If – and only if – the plaintiff’s attorneys are able to convince the jury that Roundup caused the plaintiff’s lymphoma, will they then be able to reveal the full scope of Monsanto’s efforts to keep  the public from discovering that Roundup was not as safe as the company advertised.

If Roundup Were Safe

If Roundup were as safe as advertised, why would Monsanto be so concerned with manipulating public opinion?  Why would it spend countless hours and monies to attack or “neutralize” honest researchers like Giles Seralini?  If Roundup were safe, why would Monsanto feel the need to hire academic stooges like Berkeley’s Henry I. Miller to put his name on propaganda penned by Monsanto executives?  If Roundup were safe, why would Monsanto need to cajole and massage EPA employees like Jess Rowland to get them to do the company’s bidding and squelch honest inquiry into Roundup safety?

Scope of Ruling

Judge Chhabria’s Jan. 3 order applies to Edwin Hardeman’s case, which is scheduled for trial on Feb. 25.  The ruling also applies to two other bellwether trials which will help determine the range of damages and define settlement options for the rest of the 620 Roundup cases before Chhabria.

Mr. Hardeman’s lawyers contend that the exluded evidence, including internal Monsanto documents, show the company’s misconduct.  They believe that evidence was critical to an August 2018 California state court jury’s $289 million award in a similar case, though that verdict was later reduced to $78 million and is under appeal.

Under Judge Chhabria’s order, evidence of Monsanto’s alleged misconduct would be allowed only if glyphosate were found by the jury to have caused Mr. Hardeman’s cancer.   If that happens, the trial can proceed to a second phase to determine Monsanto’s (Bayer’s) liability.

Monsanto and Bayer face more than 9,300 U.S. lawsuits over Roundup’s safety in U.S. state and federal courts.

A Bayer statement welcomed the judge’s decision:  “The court’s decision to keep the focus of the trial on the extensive science relevant to human health is encouraging,” the company said.

The attorney for Mr. Hardeman said that even without the evidence of Monsanto’s influence peddling, she feels confident the jury will be able to understand that Roundup caused her client’s lymphoma.

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FDA warns Genetech over Stem Cell Contamination

Liveyon recalls all Genetech Products

(Jan. 2, 2019)  The FDA warned Genetech, Inc. and its president Edwin N. Pinos on Dec. 20, 2018 for marketing stem cell therapies without FDA approval.  The FDA warning letter said the company – based in San Diego, Calif. – also committed “significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including some violations that may have led to microbial contamination, potentially causing serious blood infections in patients.”

The FDA letter said “Genetech processed umbilical cord blood into unapproved human cellular products” distributed by Liveyon, LLC.

Dangerous, Unapproved Stem Cell Products

The FDA warning also put other stem cell providers on notice.  It was pointedly titled:  “FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice.”

In September 2018, Liveyon suspended shipment of all product pending an FDA inquiry into the source of adverse reactions reported last year.  Liveyon also recalled all Genetech products it may have distributed.

E.coli Stem Cell Contamination

The recall came too late for some.  FDA reported on Dec. 20 that at least 12 people have suffered bacterial infections from contaminated stem cell therapy.  FDA said it was aware of a dozen patients who had received Genetech products from Liveyon and subsequently became ill due to blood and other infections caused by a number of bacteria, including Escherichia coli (E. coli).

The FDA and the CDC have both received “numerous reports of safety issues including those involving microbial contamination,” according to the FDA’s Dec. 20 warning letter.

The infections FDA found were described in a Morbidity and Mortality Weekly Report (MMWR) titled “Notes from the Field:  Bloodstream Joint Infections in Patients after Receiving Bacterially Contaminated Umbilical Cord Blood-derived Stem Cell Products for Non-hematopoietic Conditions – United States, 2018.”

Significant Deviations

The FDA said that during its inspection it documented evidence of “significant deviations” from CGTP and CGMP requirements in the manufacture of the umbilical cord blood-derived products.  Those deviations included:

  • Deficient donor eligibility practices
  • Unvalidated manufacturing processes
  • Uncontrolled environment
  • Lack of control over components used in production
  • A lack of defined areas or a control system to prevent contamination and mix-ups

The FDA requested a response from Genetech within 15 working days of the letter’s release.  (That would be on or around Jan. 4, 2018). The response letter should detail how the deviations noted in the warning letter will be corrected.  FDA said deviations not corrected by companies and owners can lead to enforcement action such as seizure, injunction, or prosecution.

FDA:  Report Adverse Events

The FDA warning letter also said health care professionals and consumers should report any adverse events related to treatments with the Liveyon products, Genetech products, or other stem cell treatments.

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J&J knew Asbestos contaminated Baby Powder

(Dec. 12, 2018) A Reuters story this week shows Johnson & Johnson knew for decades that its baby powder was contaminated with asbestos.  Newly unearthed records show the company typically did not know – and plaintiff’s lawyers in several talc cancer lawsuits have argued the company did not want to know – exactly how much asbestos was contained in each batch.  Nevertheless, this latest Reuters research strongly suggests, and some would say “proves,” what several plaintiffs’ lawyers have argued in the courts – that J&J knew some of its talcum batches were contaminated with carcinogenic asbestos.

Though the company has successfully turned back some talc-cancer lawsuits, it has lost more jury verdicts than it has won. Going forward, the difference now may be that Reuters has turned up the evidence that some juries have found lacking in some of the talc-cancer trials against Johnson & Johnson.  The company has thus far been able to keep  juries from seeing most of this latest uncovered evidence of its internal communications regarding asbestos-tainted talc.

A Potential Game Changer

The internal documents Reuters just unearthed present a potential game changer for talc litigants. The documents which Reuters turned up show that J&J has known of its talc-asbestos contamination problem for at least 60 years.  The documents show J&J has been aware – at least since the late 1950s – of an asbestos-contaminated talcum problem.

In addition, the internal documents show J&J officials knew their talcum powder was sometimes tainted with carcinogenic asbestos, yet they kept that information from regulators and the public.

J&J documents Unavailable to Plaintiff
In one lawsuit directed against J&J for alleged talc-related ovarian cancer, 52-year-old Darlene Coker filed suit against the company.  Ms. Coker believed her mesothelioma was caused by her longtime use of J&J talcum powder.  She hadn’t worked in ship building, mining, manufacturing, or in any other industry which employs people prone to developing the deadly disease.  Ms. Coker ran a massage school in Lumberton, Texas.  How had she been exposed to asbestos?

Darlene Coker sued Johnson & Johnson in 1999, alleging “poisonous talc” in the company’s flagship product gave her mesothelioma, which would eventually kill her at age 63.

J&J denied the claim.  Its attorneys argued that J&J Baby Powder was asbestos-free.  As the case progressed, company attorneys were able to convince the judge not to make them hand over talc test results and other internal company records which the plaintiff demanded. Without that  evidence, Ms. Coker was forced to drop her lawsuit.  Without those documents, her lawyer could not establish the burden of proof placed by law on every plaintiff.

Nearly 20 years later, the evidence Ms. Coker needed is emerging.  J&J has now been compelled to share thousands of pages of company memos, internal reports and other confidential documents with plaintiffs’ lawyers who represent some 11,700 plaintiffs who claim J&J talc caused their cancers. Thousands of those women have ovarian cancer.

J&J Talc Tested Positive for Asbestos

Reuters examination of many of those documents, as well as deposition and trial testimony, show that from at least 1971 to the early 2000s, J&J’s raw talc and finished powders sometimes tested positive for small amounts of asbestos, though the company tested just a tiny portion of its powders.  Meanwhile, J&J executives, mine managers, scientists, doctors, and lawyers fretted over the problem and how to address it.  And all the while they failed to disclose their concerns to regulators or the public.

J&J silenced Regulators

The documents also show J&J’s successful efforts to influence U.S. regulators’ plans to limit asbestos in cosmetic talc products, and limit scientific research on the health effects of talc.

Previous Trials lacked this evidence
Lawyers for plaintiffs in several talc-cancer trials so far have been able to present only a small portion of the documents the Reuters study has unearthed. J&J has been able to keep many documents from public view by court orders that allowed the company to turn over thousands of documents it designated as “confidential.”

They are confidential no more, at least not to the public. Reuters reports much of their contents for the first time. Reuters found that J&J first mentioned talc-asbestos contamination in 1957 and 1958 reports from a consulting lab. Those reports described contaminants in talc from J&J’s Italian supplier as fibrous and “acicular,” or needle-like, tremolite. Tremolite is one of the six minerals classified as asbestos in their naturally occurring fibrous form.
From those late 1950 to the early 2000s, reports by scientists at J&J, outside labs and J&J’s supplier found similar results. Those reports identified contaminants in talc and finished powder products as asbestos or describe them in terms typically applied to asbestos, such as “fiberform” and “rods.”

J&J Fails to Inform FDA of Talc-Asbestos Contamination
In one more bombshell from the documents, when the FDA was weighing limits on asbestos in cosmetic talc products, J&J assured FDA that no asbestos was “detected in any sample” of talc produced from December 1972 to October 1973. J&J failed to tell FDA that at least three tests by three different labs from 1972 to 1975 had found asbestos in its talc – in one case at levels reported as “rather high.”

Whether this newly released information will find its way into the court rooms in this litigation is uncertain. For now, it is enough to give those litigants hope who believe their ovarian cancer or mesothelioma was caused by exposure to J&J talc products.

Johnson & Johnson Response

Johnson & Johnson, meanwhile, says that releasing these documents shows the care the company takes to ensure its products are asbestos free.  J&J says it will appeal the recent verdicts against it. The company has maintained in public statements that its talc is safe.  It says years of the best tests available show its talc is safe.

J&J has blamed its losses on juror confusion, “junk” science, unfair court rules, plaintiffs’ attorneys.  J&J’s vice president of global media relations, Ernie Knewitz, emailed a response to Reuters’ findings: “Plaintiffs attorneys out for personal financial gain are distorting historical documents and intentionally creating confusion in the courtroom and in the media.  This is all a calculated attempt to distract from the fact that thousands of independent tests prove our talc does not contain asbestos or cause cancer.  Any suggestion that Johnson & Johnson knew or hid information about the safety of talc is false.”

Reuter’s reported that it tried for more than two months to have Johnson & Johnson executives comment further for this latest article.  The executives refused.  J&J did tell Reuters it would have one of its experts contact the news agency, but no J&J expert contacted Reuters for nearly a week. Finaly, one J&J expert said that he would not comment.

Johnson & Johnson referred all inquiries to its outside litigation counsel, Peter Bicks. In responses emailed to Reuters, Mr. Bicks rejected the new agency’s findings as “false and misleading.”

“The scientific consensus is that the talc used in talc-based body powders does not cause cancer, regardless of what is in that talc,” wrote Mr. Bicks.  “This is true even if – and it does not – Johnson & Johnson’s cosmetic talc had ever contained minute, undetectable amounts of asbestos.” Mr. Bicks dismissed tests cited in this article as “outlier” results.

Talc Asbestos Cancer Lawsuits

Nearly 12,000 talc asbestos cancer lawsuits have now been filed across the country.

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Valsartan BPM contains Carcinogen

(Oct. 18, 2018)  The FDA announced in July 2018 that Valsartan blood pressure medicine contains a probable human carcinogen.  The agency has recalled products containing N-nitrosodimethylamine (NDMA).  Since that initial Valsartan recall, the FDA has continued to expand the list to include lots from more and more manufacturing facilities. The FDA recall list for Valsartan continues to expand.   You can find that list here.

Valsartan BPM contains Carcinogen

Valsartan is a commonly-prescribed high blood pressure medication that contains NDMA, a probable human carcinogen. Researchers found tumors in the bodies of mice and rats after they were exposed to NDMA.

Free Legal Consultation

Matthews & Associates is accepting cases in which a person took Valsartan and was then diagnosed with cancer of the digestive tract,  including liver, kidney, colorectal, stomach, pancreatic, and bladder cancer.  Call 713-522-5250 or email us now for a free legal consultation.

FDA Approved Drugs Kill 106,000 People Yearly

The Valsartan debacle is no exception for anyone paying attention to how the FDA works (or doesn’t) in tandem with Big Pharma drug makers.  The agency approves more and more drugs each year despite those drugs killing at least 106,000 Americans each year.

Here’s a fact which should be headline news in every TV news show and newspaper in the country:  More than 105,000 people are killed each year by FDA-approved drugs. (Another 119,000 Americans are killed yearly by errors committed in hospitals.)

These facts have been well known since at least July 26, 2000, when the Journal of the American Medical Association (JAMA) published a review by Dr. Barbara Starfield titled:  “Is US health really the best in the world?”  The answer to that question, easily proven by statistics, was a most emphatic, “No!”

Let’s recap the Dr. Starfield U.S. Health System Review:

  • The US medical system kills 225,000 Americans per year.
  • 106,000 deaths per year come from FDA-approved medical drugs.
  • 119,000 deaths per year come from treatment errors in US hospitals.

Drug Industry pays FDA to Approve its Drugs

In an email interview with No More Fake News writer Jon Rappoport, Dr. Starfield wrote:  “Even though there will always be adverse events that cannot be anticipated, the fact is that more and more unsafe drugs are being approved for use.  Many people attribute that to the fact that the pharmaceutical industry is required to pay the FDA for reviews [of its new drugs], which puts the FDA into an untenable position of working for the industry it is regulating. There is a large literature on this.”

U.S. Healthcare System Broken by Vested Interests

Mr. Rappoport asked Dr. Starfield whether her work was an indictment of the FDA.

Dr. Starfield would not blame the FDA directly.  She said,  “They [the death statistics] are an indictment of the US health care industry: insurance companies, specialty and disease-oriented medical academia, the pharmaceutical and device manufacturing industries, all of which contribute heavily to re-election campaigns of members of Congress. The problem is that we do not have a government that is free of influence of vested interests. Alas, [it] is a general problem of our society — which clearly unbalances democracy.”

Dr. Starfield also noted that the figures she found were accepted by virtually all those who study them, with the lone exception of one  former medical school dean who has received lots of attention for claiming the US health system is the best there is. That lone apologist for the broken system has a vested interest in medical schools and teaching hospitals, so his outlier criticism is highly suspect.

Virtually every study similar to the one Dr. Starfield published in 2000 has found much higher numbers of deaths caused by legal drugs and deaths by medical mistakes.

We must first identify a problem before we can properly fix it.  The U.S. healthcare system is not the best in the world.  It is badly corrupted by money and the vested interests of interlocked corporations with parallel interests in profits, not people or their health.  The health system’s vice-like grip on our personal finances (forcing us into expensive and restrictive insurance policies) and its monetary control of our health choices (they’ll pay the rotten system for expensive chemo which fails 97% of those it poisons; but they won’t pay for a vitamin B-12 shot or the treatment of your choice) will continue unabated, unless we do something about it.

More than 225,000 deaths per year by legal drugs and medical mistakes is an awfully steep price to pay for a broken system of “healthcare.”

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FDA Gadolinium Warning

(Oct. 15, 2018)  The FDA issued a warning about gadolinium-based contrast agents in December 2017.  The agency’s Drug Safety Communication concerned gadolinium-based contrast agents (GBCAs) used in magnetic resonance imaging (MRI) for diagnostics.  The FDA alerted health care professionals and patients about the dangers of gadolinium retention.   The FDA announced that a new class warning would be required for all GBCAs concerning gadolinium remaining in the body for months or years  following the drug’s injection for an MRI.

Related:  Gadolinium – MRI Dye Lawsuit

FDA Calls for Gado Dye Safety Tests

FDA also announced that GBCA makers must conduct human and animal studies to further assess the safety of gadolinium contrast agents. The agency is also requiring a patient medication guide be given prior to a patient’s receiving any GBCA.  The FDA says gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function, and the agency “has  concluded that the benefit of all approved GBCAs continues to outweigh any potential risks.”

All People at Risk from Gadolinium

ScienceDaily writes:  “Previously gadolinium was thought to accumulate only in patients with impaired kidney function. New evidence now shows that all patients are at risk. The authors call for urgent retrospective and prospective studies to assess the clinical effects on patients who have been exposed to gadolinium-based contrast during MRI scans.”  See:  ScienceDaily.com

Gadolinium Dangers can outweigh Benefits

Despite the FDA’s pronouncement that gadolinium benefits outweigh risks, one might be wise to consider Science Daily’s pronouncement as well as the example of the actor Chuck Norris’ wife.  The FDA warning over gadolinium and nephrogenic systemic fibrosis (NSF) states that only those with diagnosed kidney problems should avoid gadolinium-based contrast agents.  Mr. Norris’ wife had no known kidney problems when she was given GBCA before several MRIs. The couple have charged in several lawsuits against the makers of GBCAs that gadolinium caused Mrs. Norris grievous personal injuries.  And the Norris family is not alone in believing that GBCAs can cause undue harm.

Gadolinium deposition disease is real for many people who were injected with gadolinium prior to an MRI despite their having not been diagnosed with kidney problems beforehand.  Many forums can be found on the web with anecdotal reports from people who say they were injured by gadolinium dye.

Symptoms of gadolinium deposition disease — GDD — can start from within a few minutes to one month after administration of a gadolinium-based contrast agent (GBCA).

Gadolinium Deposition Disease (GDD) Symptoms:

  1. Intense burning of the skin and skin substrate may be felt overall in the entire body, though it may be localized to the trunk area or the distal extremities.
  2. Intense boring pain in bones or joints can arise early after GBCA exposure and affect any bones or joints. Joint pain may be peripheral and also affect large joints such as the knee or hip.  Any bones may feel some severe point pain, but rib pain is distinctive for GDD.
  3. Brain fog or mental confusion can also arise early after GBCA exposure.  Brain fog is also a prominent feature of lead toxicity, another heavy metal malady.
  4. Muscle vibrations (muscle fasciculations) and skin pins and needles/tingling may represent part of the same process that is causing brain fog. Muscle vibrations/twitching and pins and needles skin sensations generally reflect nerve disease or neuropathy.
  5. Head pain or headache, of variable degree, are a very common occurrence.  GDD sufferers describe it as a head pain unlike any head-ache they’ve ever experienced.  Some describe it as a burning pain or an extreme tightness  — like feeling a tight bathing cap on the head.
  6. Distal arm and leg skin/skin substrate thickening, discoloration, pain can arise in the subacute stage at 2 + weeks after GBCA exposure.  This can be similar to the principal features of NSF, but generally less severe.

GadoliniumToxicity.com says, “This symptom complex should be expected.”

Gadolinium Lawsuit

Maybe those symptoms should be expected for gadolinium deposition disease, but the makers of GBCA owe a duty to people to warn them of the real dangers of gadolinium contrast dye.  Our law firm is handling gadolinium lawsuits for people adversely affected by gadolinium dye.  Contact us for a free legal consultation if you or a loved one was injured as a result of being injected with gadolinium prior to an MRI.  You may be entitled to significant compensation for any gadolinium-related injuries.

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Zostavax Shingles Suits set in Philadelphia

(Oct.16, 2018) – Several Zostavax shingles vaccine lawsuits filed against vaccine giant Merck are set up to be tried in the U.S. Judicial Panel on Multidistrict Litigation.  This past summer, a judiciary panel granted Merck & Co.’s request to centralize dozens of shingles vaccine suits which allege Merck’s Zostavax vaccine caused people injuries.  The Eastern District of Pennsylvania was chosen as the setting after a court found that the suits involve common questions of fact.

Merck Wishes Granted by Judges
A six-judge panel granted Merck & Co. Inc. and Merck Sharpe & Dohme Corp.’s petition to centralize 57 suits currently filed in nine different districts.  The Merck petition was also supported by McKesson Corp., a co-defendant in 30 suits.

The judges held that the suits hinge on common factual questions which arise from allegations that Merck’s shingles vaccine caused plaintiffs to develop shingles or other injuries caused by live virus contained in Merck’s vaccine.  Plaintiffs charge that Merck failed to sufficiently warn of the shingle’s vaccine’s substantial risks.

Live Shingles Vaccine Virus

The judiciary panel wrote:   “Issues concerning the design, testing, manufacture, regulatory approval, labeling, and marketing of Zostavax are common to all actions.  In this litigation, all plaintiffs allege they were injured by the same product in the same manner — exposure to the live attenuated virus in Zostavax — indicating common factual issues will arise concerning the potential risks associated with the use of the live virus in the vaccine.”

The judges noted that plaintiffs in 15 of the actions supported centralization, but they disagreed on where to send the new MDL.  Plaintiffs in 30 of the actions opposed centralization, but said that if the panel insisted on it, they wanted the MDL sent to the Middle District of Florida or the Eastern District of Wisconsin.

The panel nevertheless backed Merck’s first choice for the new MDL, sending it to the Eastern District of Pennsylvania.  The panel said the suits there were furthest along, and also noted Merck’s facilities were in Pennsylvania and also at its nearby New Jersey headquarters.

Seven Actions
The panel wrote that, “Seven actions are pending in this district, and they are the earliest filed and most advanced actions in this litigation.”  They further backed their choice by saying that many common documents and witnesses would likely be located in the same area.

The panel also noted its awareness of 41 more federal suits related to the litigation since Merck filed its motion.

The panel transferred the new MDL to Philadelphia-based U.S. District Judge Harvey Bartle III, who was nominated for his lifetime position by George Bush I.  The six said he is an experienced transferee judge familiar with the claims and issues in the Zostavax cases.  Judge Bartle is already presiding over the related cases in that district.

The defendants already have some helpful rulings from the Republican nominee Bartle, who stripped fraud claims from 10 Zostavax suits in May 2018.  The judge ruled that the plaintiffs failed to back up allegations that Merck made false representations to doctors and others to hide the shingle’s vaccine’s design flaws.

Zostovax a stronger Chickenpox vaccine
Merck’s Zostavax is a stronger  version of Varivax, the company’s chickenpox vaccine.  Zostavax was one of the flagship results from Merck’s European joint vaccine venture with Sanofi SA.  The two companies disbanded in 2016.

Brain swelling, eye disorders
Plaintiffs from across the U.S. have filed lawsuits alleging Merck failed to warn them that its shingles vaccine could cause brain swelling, eye disorders, and serious other problems.  Plaintiffs’ petitions also question the efficacy of Zostavax, arguing that some groups of people who take the shot are more likely to develop shingles than if they had not taken the shot at all.

At least 12 Zostavax actions involving more than 300 plaintiffs have been filed in California state court.  Those cases have been consolidated for pretrial proceedings, along with 50 Zostavax actions concerning more than 800 plaintiffs in New Jersey state court.  According to the JPML order, two petitions for coordination of the New Jersey actions are pending.

Plaintiffs in the suits being consolidated are represented by Bern & Partners LLP, and other law firms.

Zostavax Shingles Suits set in Philadelphia

The case is IN RE: Zostavax (Zoster Vaccine Live) Products Liability Litigation, MDL No. 2848 before the U.S. Judicial Panel on Multidistrict Litigation.

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Diabetes Drugs raise Cancer Risk, Genital Gangrene

Popular diabetes Invokana Lawsuitdrugs Invokana, Farxiga, and Jardiance can raise kidney and bladder cancer risk, the risk of ketoacidosis, and the risk of genital amputations.

First introduced in 2013, these SGL2 inhibitors are supposed to work by reducing a certain protein and forcing the kidneys to flush glucose out of the body instead of absorbing it.  The problem is that altering the body’s natural processes can cause other problems.

Genital Amputations, other “Side Effects”

Invokana and the other SGL2s can raise the risk of amputations of the genitals or genital amputations.

Fournier’s Gangrene or Necrotizing Fasciitis

The diabetes drugs Invokana, Farxiga, and Jardiance have been linked to causing Fournier’s gangrene of the genitals, or necrotizing fasciitis.  The FDA reported in September 2018 that it had received reports of at least 11 people who suffered Fournier’s gangrene of the genitals from Invokana and other SGL2 drugs. All of the people required painful surgery; one of them died from the condition.

$2.5 Billion in Annual Sales

Though SGL2 inhibitors have proven dangerous or deadly for many people, these drugs account for more than $2.5 billion annually in Big Pharma profits.  Invokana alone brought its maker, Johnson & Johnson, $1 billion in sales in 2018.

Diabetes Drugs linked to Kidney or Bladder Cancer

Several studies have linked Invokana, Farxiga and Jardiance to kidney and bladder cancer:

  • December 2017:  An EMPA-REG clinical trial showed that patients taking Jardiance may have twice the risk of bladder cancer.
  • October 2017:  A joint U.S / Chinese study found a higher risk for bladder cancer with SGLT2 inhibitors.
  • June 2015:  A University of Colorado study showed that patients taking Farxiga had nearly a six-fold increased risk of suffering bladder cancer.
  • February 2015:  A study by Endocrinology Network predicted  higher risk of UTIs from SGLT2 Inhibitors; UTIs can increase risk of bladder cancer.
  • November 2014:  Invokana was linked to kidney cancer in animal studies.
  • August 2014:  A University of Taiwan study found Jardiance patients showed a five (5) times greater risk of bladder cancer.  Animals given Invokana suffered higher rates of kidney cancer.

Compensation for those Diagnosed with Kidney, Bladder Cancer

Patients who have been diagnosed with bladder or kidney cancer after taking Invokana, Jardiance or Farxiga may be entitled to compensation for medical costs, pain, suffering, and other losses.

The manufacturers of these medications may be liable for damages if the makers can be shown to have known about the drugs’ dangers but failed to properly warn doctors and patients.

Cancer risks from SGLT2 diabetes drugs first appeared before 2012 in early clinical trials.  The FDA granted approval for these drugs only on the condition that their makers would conduct more safety testing in the form of post-marketing studies.  Notably, none of these drugs’ makers have added warnings about cancer in the years since, despite several studies suggesting a raised risk.

Kidney and Bladder Cancer

The good news about kidney and bladder cancer is that these types of cancer usually have high rates of treatment success.

Bladder cancer is the 6th most commonly diagnosed type of cancer among Americans.  It usually affects males 65-85.  The three types of bladder cancer are 1.) transitional cell carcinoma, 2.) squamous cell carcinoma, 3.) adenocarcinom.

Bladder Cancer Symptoms include blood in the urine, pain in the side or back, pain during urination, and frequent urination.

Treatment of bladder cancer may include chemotherapy, radiation therapy, surgery, or immunotherapy.  The survival rate with these treatments can be as high as 77%.

Kidney cancer is the 7th most common form of cancer in the U.S.  It can affect men and women of any age. The two most common kidney cancer types are renal cell carcinoma (RCC) and transitional cell carcinoma (TCC).

Common symptoms of kidney cancer include blood in the urine, a mass in the abdomen, persistent sweating, abdomen pain, weight loss.

The most common treatment for kidney cancer is surgical removal of the affected kidney or part of it.  The survival rate for kidney cancer is around 73%, though it can be as high as 92%.

Free Legal Consultation

If you or a loved one developed bladder or kidney cancer after taking an SGL2 inhibitor drug – such as Invokana, Jardiance, or Farxiga – contact us for a free legal consultation regarding a potential lawsuit against that drug’s maker.  We work on a contingency fee basis; we don’t get paid unless we achieve financial compensation for our clients.  We look forward to speaking with you.

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Invokana Flesh-Eating Infection Warning

(August 30, 2018)   Invokana and other diabetes drugs like Farxiga and Jardiance can cause a flesh-eating bacterial infection in the genitals.  The U.S. FDA warned doctors and patients yesterday about the risk of infection from these popular diabetes’ drugs.  

The FDA announced that it found the flesh-eating genital infection risk linked with drugs from Johnson & Johnson, AstraZeneca, and Eli Lilly.  The agency found the “side effect” had occurred in at least 12 patients, one of whom died.

Known as Fournier’s gangrene, the condition developed in a dozen patients shortly after they began taking the medicines between March 2013 and May 2018.  The FDA reported that seven men and five women who suffered the infection were all hospitalized.  They all underwent surgery for the condition, including the patient who died.

An FDA statement said that more cases might be uncovered once the risk is better understood.

FDA’s Diabetes Drug Warning over Genital Infections

The warning covered these drugs:  Johnson & Johnson’s Invokana, AstraZeneca Plc’s Farxiga, and Eli Lilly & Co.’s Jardiance — SGLT2 inhibitors that were approved in 2013, 2013, and 2016.  They are designed to help the body lower blood-sugar levels through the kidneys, by helping excrete excess sugar through the urine.  One known side effect of these drugs is urinary tract infections. Another is that they raise the risk of amputations.

The FDA found just six reported cases of the flesh-eating bacterial condition in a review of all other diabetes drug classes for the past three decades; but one has to wonder how many cases went unreported.   How many people had the diabetes drug “side effect” of a flesh-eating genital infection without relating it to their diabetes drug?

These SGLT2 diabetes drugs are expected to generate as much as $7.1 billion in sales by 2020, says Bloomberg Intelligence.  The FDA estimates that some 1.7 million patients filled a prescription for one of these meds from a retail pharmacy in 2017.

All of the drugs in the SGLT2 class except Merck & Co.’s Steglujan have been linked to the flesh-eating infection condition.  The FDA warning demands that the drug makers add information about the risk to the prescribing information and medicine guides given to patients.  AstraZeneca said it is working with the FDA on updating its label.

Officials at J&J and Eli Lilly didn’t return phone calls and emails from Reuters News requesting comment.

FDA Recommendation

The FDA said that diabetics using these drugs should seek immediate medical help if they develop tenderness, redness or swelling of the genitals, or if they experience even a slight fever of 100.4 degrees Fahrenheit.

The symptoms can worsen quickly, the agency said; so it’s important to get help right away.

Invokana Lawsuits

Invokana may also increase the risk of ketoacidosis, which is potentially fatal kidney failure.  The U.S. FDA confirmed on May 16, 2017 that the Invokana label needed to include a black-box warning.

Invokana Flesh-Eating Infection Warning – Lawsuit Consultation

If you or someone you love suffered a flesh-eating genital infection following the use of Invokana, Invokamet, Farxiga, or Jardiance, contact our law firm for a free legal consultation regarding a potential diabetes drug lawsuit against the drug’s maker.

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Parkinson’s Drug Nuplazid showed early Red Flags

The Parkinson’s drug Nuplazid showed early red flags. It’s approval by the FDA came with significant reservations from many of the reviewers who voted 12-2 to recommend FDA approve it for sale. A March 28, 2016 StatNews.com story came out just as Nuplazid gained FDA approval. It was titled “Parkinson’s Drug Nuplazid could reduce hallucinations, but at what cost?” It was a fair question then, and it looks prescient now. The real cost of Nuplazid seems clearer by the day. A reported 500 deaths have now been linked with the drug, though ultimate causation questions remain.

MSNBC reported that Nuplazid’s maker, Acadia, saw its stock plunge 22% in April 2018 when the FDA announced that it was reexamining drug.  An FDA spokeswoman told MSNBC the agency is conducting an evaluation of Nuplazid.

An Acadia spokesman, however, said the FDA review does not mean the agency has determined Nuplazid has a new risk, and that FDA has not suggested doctors stop prescribing the drug or that patients stop taking it.

Nuplazid was a hopeful drug for some people with Parkinson’s Disease who experience hallucinations. Parkinson’s can, for some, come with debilitating psychosis. Half of the million or so Americans diagnosed with Parkinson’s can experience hallucinations, illusions, and delusions. Symptoms are usually benign, but they can sometimes be very destructive.

Psychiatric disturbances often result from standard Parkinson’s drugs. That can leave patients choosing between physical and emotional stability. In desperation, some might try meds not designed for their condition.

In 2016, an advisory panel to the FDA voted 12-2 in favor of approving Acadia Pharmaceuticals’ Nuplazid, which was specifically designed for Parkinson’s psychosis. The FDA does not have to follow the panel’s advice, but it usually does, and it did in this case.

Nuplazid costs far more than existing antipsychotics, which are mostly used to treat schizophrenia and are available as generics. StatNews reported that in the votal trial behind Acadia’s marketing application, Nuplazid showed only modest improvements over placebo. It was also tested in a way that makes it difficult to compare against other treatments. (One might ask: Why?)

Nevertheless, physicians involved in the trial, some of who had financial ties to Acadia, stood by Nuplazid.

A neurologist at the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, Dr. Jeffrey Cummings, said he was struck by some of the patients’ “dramatic” responses, but he also acknowledged “families will also respond to placebos, and that’s why we don’t approve drugs based on anecdotal reports.” Dr. Cummings has taken consulting fees from Acadia. He called it “a pretty impressive study.”

Dr. Joseph Friedman, chief of the Butler Hospital Movement Disorders Program, also received consulting fees from Acadia in the past. Dr. Friedman also participated in the Nuplazid study. He noted that fear drives many Parkinson’s patients. He said patients can “start to worry about losing their mind.”

A smaller subset of patients suffers from paranoid delusions, most typically involving the fear that the person’s spouse is cheating on them. Studies have shown that psychosis, more than any other reason, causes Parkinson’s patients to move to nursing homes.

In an effort to help Parkinson’s patients with drugs, doctors often try to lower dosages of conventional Parkinson’s medications. These work to control tremors and other movement problems by targeting the same neurotransmitters in the brain that can also trigger psychosis.

The most common alternative is to give antipsychotic medications that are FDA-approved for treating schizophrenia or bipolar disorder but not Parkinson’s. Some doctors believe antipsychotics like Seroquel or Clozaril have some effect on Parkinson’s psychosis. Some doctors think they can also help ease anxiety and sleeplessness. But clinical studies have not shown any effect on Parkinson’s psychosis.

Nuplazid (also known as pimavanserin) was approved by the FDA in the middle of this already-dicey situation. Hope for Nuprazid rested mostly on a single Phase 3 trial lasting just six weeks.

Nuplazid Maker sponsored own studies
That trial was paid for by Acadia. It focused on 199 Parkinson’s patients. Half were given placebo, the other half Nuplazid. The Lancet reported that Nuplazid treatment showed a 37 percent improvement on a nine-point clinical scale, compared to a 14 percent improvement for those on placebo. It’s very hard to translate those numbers into any real concrete notion of the drug’s safety and effectiveness.

Another study participant with financial ties to Acadia, Dr. William Ondo, admitted that it is impossible to say whether that result shows Nuplazid is better than other kinds of antipsychotics. Director of movement disorders at the Houston Methodist Neurological Institute, Dr. Ondo has sat on Acadia’s scientific advisory board.

Nuplazid had failed to demonstrate a benefit in two previous Phase 3 trials. Both included international as well as US patients, which, according to Dr. Cummings, skewed the results. He claimed that people in other cultures carry different definitions of hallucinations.

The previous trials also evaluated the drug using the so-called Scale for the Assessment of Positive Symptoms, or SAPS, a traditional measure to gauge the extent of schizophrenia symptoms.

Acadia adapted that scale to better gauge the effectiveness in combating Parkinson’s psychosis specifically. Acadia adapted that scale to measure the sorts of hallucinations and delusions people experience with the neurodegenerative disease. The modified scale allegedly helped Acadia show Nuplazid was better than placebo at controlling symptoms in Parkinson’s patients. But since the Parkinson’s version of the scale hasn’t been used to test other drugs, some question the tool’s clinical validity.

Nuplazid uses a novel molecular approach. Other antipsychotic medications target both the dopamine and serotonin pathways in the brain; so they can interact with drugs that help regulate movement disorders Parkinson’s patients can suffer. By contrast, Nuplazid targets only the brain’s serotonin receptors. That may be why it was not found to worsen motor symptoms.

Nuplazid Side Effects
Since Nuplazid hit the market, many people have reported significant Nuplazid side effects. In all the Phase 3 trials of Nuplazid, 8.1 percent of patients on the drug experienced severe side effects, while only 4.8 percent who received placebo reported side effects. Symptoms included irregular heart rhythms, muscle injury, weight loss.

FDA: One adverse event for every two who benefit
The FDA noted in its own documents that for every two patients expected to achieve “much improved” status from taking Nuplazid, one patient experiences a serious adverse event.

Parkinson’s patients with psychosis can suffer abominably, as can their families and caregivers. But any answer for terrible suffering must not come with a price tag so high that it may be worse than the suffering itself. At this moment in time, it appears that Nuplazid may cause more problems than it solves.

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Firms request Shingles Vaccine Case Consolidation

(June 22, 2018)  Law firms representing people who have filed shingles vaccine cases have requested they be consolidated in New Jersey.  Law360 reported last month that the firms represent hundreds of people who allegedly suffered serious injuries after using Merck & Co. Inc.’s shingles vaccine.  A bar notice said the attorneys have asked the New Jersey Supreme Court to give the Zostovax cases a multicounty litigation designation (MLC).

Related:  Shingles Vaccine?  Really?

Plaintiffs in some 37 filed cases filed in one petition hail from all across the country. Their lawsuits all claim Merck failed to warn them that its shingles vaccine could cause maladies such as brain swelling, eye injuries, and other physical disorders.

One attorney representing 285 plaintiffs said that the people filing complaints claim similar injuries, so coordinating discovery for the suits “would be advantageous (and) promote convenience and fairness to all parties to these cases.”

Middlesex County is the best place for the cases, said the plaintiffs’ firms. According to Bern & Partners, Bergen and Atlantic counties are already handling 13 other mass torts between them, and two out of the seven mass torts now running in Middlesex are nearly finished; so Middlesex would be a good destination for the shingles lawsuit cases.

Bern & Partners argued that despite nearly identical issues of fact and law presented to the various judges now assigned to the cases, the rulings have not all been consistent. The Bern firm wants the Zostovax cases to go before Superior Court Judge James Hyland, who is overseeing mass torts for Middlesex County.

Bern & Partners attorney Thomas Joyce, who represents 569 plaintiffs, said, “We anticipate and presume that inconsistent rulings on substantively identical issues of law and/or fact will continue to occur. (Thus), MCL designation will be beneficial to preserve consistency throughout these similar cases, and will be fair and convenient for all parties and the court.”

The judiciary welcomed comments and objections to the applications through June 8, 2018.

Shingles Vaccine Lawsuits
Shingles vaccine lawsuits have been filed over Merck’s Zostavax vaccine.  Zostavax causes problems, according to plaintiffs, because it contains a live virus that can cause nerve-damaging inflammation throughout the body. Plaintiffs represented by Sadaka Associates claim that inflammation caused by Zostavax can lead to facial paralysis, encephalitis, meningitis and loss of dexterity.

Bern & Partners allege additional Zostavax shingles-related injuries that include post-herpetic neuralgia, retinol necrosis, keratitis (eye/vision injury) and acute myelitis.  Bern & Partners’ plaintiffs allege that the makers, marketers, distributors and sellers of Zostavax knew or should have known about its “dangerous propensity,” yet concealed the information to boost Merck’s shingles vaccine sales.

Judge Hyland Chosen
Merck also wants the cases to be heard by Judge Hyland, whom Merck recognizes as familiar with the company, according to a September 2017 letter from the drug and vaccine giant’s legal counsel, Fox Rothschild LLP.  That letter was included in the bar notice.

Plaintiffs’ lawyer Mark Sadaka told Law360 that he was hopeful the New Jersey consolidation would work hand-in-hand with the federal MDL.

The Zostavax shingles vaccine cases are in the Superior Court of New Jersey.

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