Merck Hit with Two New Wrongful Death Suits Over Gardasil

 

Isabella Zuggi and Sydney Figueroa, before and after Gardasil

Last week, Wisner Baum's vaccine attorneys initiated two fresh wrongful death litigations. One was filed on behalf of a North Carolina mother, asserting that Merck's Gardasil HPV vaccine led to the demise of her 10-year-old daughter. The other lawsuit, representing a Pennsylvania mother, alleges that Gardasil caused the passing of her 12-year-old daughter. Both cases argue that the HPV vaccine triggered severe autoimmune and neurological complications, culminating in the tragic loss of their daughters.

Monique Alarcon, Bijan Esfandiari, Michael L. Baum, and Stephanie B. Sherman, attorneys specializing in Gardasil lawsuits, are representing Kristine Zuggi. Zuggi's daughter, Isabella, a vibrant fifth-grader, tragically passed away merely ten weeks following her Gardasil vaccination. Additionally, they're representing Lynne Guzman, whose 12-year-old daughter, Sydney Figueroa, became wheelchair-bound post-vaccination and sadly succumbed shortly thereafter.

The lawsuits target Merck & Co., Inc., a pharmaceutical powerhouse based in New Jersey, and its subsidiary, Merck Sharp & Dohme. The allegations are as follows:

1/ Merck consistently jeopardizes lives despite being fully aware of Gardasil's limited effectiveness and significant risks.

2/ Merck knowingly neglects to inform both the public and healthcare providers about the potential for injury or fatality associated with Gardasil.

3/ Merck is accused of perpetuating an aggressive propaganda campaign aimed at instilling fear and guilt in parents to compel them to vaccinate their children with Gardasil.

4/ Merck deliberately introduced a substantial risk of harm to children and patients who received Gardasil injections, thus justifying the awarding of punitive damages.

“The senseless deaths of these two beautiful young girls brings home the seriousness of the allegations against Merck in these cases–that the company has exaggerated the benefits of Gardasil as cancer preventative and ignored the risks, including death–all for the sake of the company’s bottom line” said Wisner Baum attorney, Monique Alarcon.

Isabella Zuggi, a vibrant 10-year-old who adored Harry Potter, received her first and only Gardasil injection on August 26, 2022, with no prior health concerns. Two weeks later, she began experiencing headaches, lethargy, stomach pains, body aches, and intermittent fevers. An infectious disease consult revealed she had MOG antibodies, associated with acute, inflammatory, demyelinating diseases of the central nervous system. The complaint alleges a link between MOG antibody disorders and several vaccines, including Gardasil, which research identifies as a common trigger for central nervous system demyelination. Isabella tragically passed away on November 5, 2022, with her death attributed to Acute Encephalitis Associated with Anti-MOG Antibody Production. Her mother, Kristine, regrets not being informed of Gardasil's potential risks and feels pressured by Merck's marketing tactics into vaccinating her daughter for cervical cancer protection.

Sydney Figueroa, aged 11 at her first Gardasil dose in December 2017 and 12 at the second, was an accomplished student and athlete, active in soccer, track, and band. Post-vaccination, she suffered from a plethora of debilitating symptoms including headaches, fatigue, and neurological issues, eventually leading to her confinement to a wheelchair and full-time care. Diagnosed with POTS, Tourette's Syndrome, and Functional Neurological Disorder, Sydney tragically passed away on June 2, 2021, due to a pulmonary embolism resulting from prolonged immobility caused by autoimmune diseases triggered by Gardasil. The wrongful death complaint contends that Julie Gerberding, then CDC Director, overlooked evidence of Gardasil's unproven efficacy and potential dangers during the regulatory process.

Sydney’s mother, Lynne, said, “Gardasil destroyed my daughter’s life. She fought for as long as she could but the injuries she suffered, ultimately, killed her. If I knew what I know now, I never would have let Sydney get the shots.”

Wrongful death complaints have been lodged in the U.S. District Court for the Middle District of North Carolina (Case No. 3:22-md-03036-KDB). These cases are joining the Gardasil multidistrict litigation (In Re: Gardasil Products Liability Litigation, MDL 3036), which encompasses over 150 related cases awaiting resolution.

The press release can be read, in full, here.

Bob Fiddaman

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Previously on this blog

Baum Hedlund Take a Stand Against Vaccine Maker

Californian Law Firm Lead the Way in Gardasil Litigation

Fifth Gardasil Vaccine Lawsuit Filed

Gardasil Vaccine Can Cause Infertility, New Lawsuit Alleges

Gardasil Lawsuits Continue

Vaccine Manufacturer Used "Spiked" Placebo to Hide Injuries Between Vaccine and Control Groups, Lawsuit Alleges

The Gardasil Vaccine Lawsuits Keep Piling Up

"I don’t want this pain for other kids." ~ Victoria Trevisan, Gardasil Victim

Merck & Co Face Uphill Battle as Gardasil Lawsuits Consolidated

Parents of 13-year-old Boy File Wrongful Death Lawsuit against Vaccine Manufacturers, Merck

Judge Appoints Four Attorneys For Plaintiffs Damaged by Vaccine

Glendale Woman Files Suit Against Gardasil Manufacturer

Merck's Gardasil Adverse Events Databases To Be Released

Woman Develops Cervical Cancer After Gardasil Shots

Merck's Gardasil Adverse Events Databases To Be Released

 

Merck forced to turn over all of its Gardasil adverse event databases.

U.S. District Judge Robert J. Conrad, Jr, recently ordered Merck to turn over all of its Gardasil adverse events databases to plaintiffs suing the pharmaceutical company for injuries allegedly caused by the human papillomavirus (HPV) vaccine.

Regular readers of my blog will know I've been covering the Gardasil litigation for quite a while now (Links at the foot of this post)

The Gardasil adverse events databases have been held under lock and key by Merck and up until Conrad Jr's order they had refused to make the entire Merck Adverse Event Reporting and Review System (MARRS) databases available to the plaintiffs’ attorneys.

In passing down his order, U.S. District Judge Robert J. Conrad, Jr, said, “Plaintiffs’ and their experts should have the same opportunity as Merck to review and analyze the entirety of the data.”

Common sense, plus a strong legal argument from plaintiffs' attorneys Wisner Baum seems to have seen the light of day.

Wisner Baum have have filed dozens lawsuits on behalf of young people injured by Gardasil, alleging Merck knowingly and fraudulently concealed the vaccine’s risks. There are also 80 pending in the federal court system and that number is expected to increase. Senior Partner, Michael Baum said, “Access to this full database of adverse event reports should allow experts to better analyze the full extent of post-Gardasil autoimmune symptom clusters, and demonstrate there is a “statistically significant causal connection between Gardasil and autoimmune conditions.”

Source: Brenda Baletti Ph.D

U.S. District Judges often come under heavy criticism for, seemingly, siding with large corporate companies such as Merck. Robert J. Conrad, Jr's order and subsequent reasoning for placing such an order has to be applauded here.

Not only should Plaintiffs’ and their experts have access to adverse reactions, the general public should too. Hopefully this data will be made public. It's important in light of recent news that a bill has been introduced in Sacramento to require students entering the 8th grade to have the HPV vaccine. Such a bill, if granted without first seeing MARRS databases, can potentially put patients at risk, patients such as those listed in the links below.

Bob Fiddaman

Baum Hedlund Take a Stand Against Vaccine Maker

Californian Law Firm Lead the Way in Gardasil Litigation

Fifth Gardasil Vaccine Lawsuit Filed

Gardasil Vaccine Can Cause Infertility, New Lawsuit Alleges

Gardasil Lawsuits Continue

Vaccine Manufacturer Used "Spiked" Placebo to Hide Injuries Between Vaccine and Control Groups, Lawsuit Alleges

The Gardasil Vaccine Lawsuits Keep Piling Up

"I don’t want this pain for other kids." ~ Victoria Trevisan, Gardasil Victim

Merck & Co Face Uphill Battle as Gardasil Lawsuits Consolidated

Parents of 13-year-old Boy File Wrongful Death Lawsuit against Vaccine Manufacturers, Merck

Judge Appoints Four Attorneys For Plaintiffs Damaged by Vaccine

Glendale Woman Files Suit Against Gardasil Manufacturer

Glendale Woman Files Suit Against Gardasil Manufacturer

 

Catherine Boss of Glendale, California was just 16 years-old when she received her first Gardasil shot, after which she experienced significant fatigue, headache, shortness of breath, hypotension, and abdominal pain. Episodes of syncope (fainting), as well as migraine with visual loss, vomiting, and intermittent panic attacks pursued some months later. Despite this, Catherine received her second dosage of Gardasil in early 2017.

Months later, she was evaluated by a cardiologist who noted frequent episodes of orthostatic light-headedness, panic attacks, fatigue, abdominal pains, and syncope. The physician performed orthostatic vital signs, and his assessment included “frequent dysautonomia symptoms, possibly postural orthostatic tachycardia syndrome.”

Over the next year or so she experienced continued dizziness, difficulty sleeping, decreased appetite, severe menstrual cramps, lethargy, chills, shortness of breath and headache.

One would think these bodily injuries would have raised a red flag for Catherine, her mother, Kathleen, and their treating physician, however, on November 6, 2017, Catherine received her third Gardasil shot.

Now 22, Catherine walks with a cane that doubles as a seat when she can no longer stand. She struggles to overcome all her Gardasil related conditions, which include, but are not limited to:

• POTS

• Dysautonomia

• Gastroparesis

• Migraines

• Syncope

• Pain disorder

• Endometriosis

From the onset of Catherine's first Gardasil shot, both she and her mother were told Gardasil was safe and effective for preventing cervical cancer. Considering the doctor’s recommendations, Catherine’s mother, Kathleen Boss, consented to her daughter being injected with the “cervical cancer vaccine,” Gardasil.

Furthermore, it is alleged Gardasil manufacturers, Merck, actively concealed the fact that Gardasil can cause a constellation of serious adverse reactions and bodily injuries. According to filed complaints, According to the complaints, Gardasil contains numerous hazardous ingredients, including at least one ingredient that Merck failed to disclose to regulators and the public. Studies have shown that one of Gardasil’s ingredients, Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) binds to non-vaccine proteins, triggering autoimmune disorders and other serious conditions.

It is also alleged that Merck designed its clinical trial studies to purposefully conceal evidence of chronic conditions such as autoimmune diseases while exaggerating the vaccine’s purported efficacy.

Baum Hedlund Aristei & Goldman have now filed a lawsuit (Case 2:22-cv-06993) on behalf of Catherine Boss, one of many previously filed (see links below).

To date, Merck, who are headquartered in New Jersey, have been found guilty of numerous violations and fined a total of $10,467,155,581. Those violations include, drug or medical equipment safety violation, safety-related offenses, healthcare-related offenses, off-label or unapproved promotion of medical products, and kickbacks and bribery.

Further information about Catherine's plight and injuries caused by Gardasil can be found here.

Bob Fiddaman

Related

Baum Hedlund Take a Stand Against Vaccine Maker

Californian Law Firm Lead the Way in Gardasil Litigation

Fifth Gardasil Vaccine Lawsuit Filed

Gardasil Vaccine Can Cause Infertility, New Lawsuit Alleges

Gardasil Lawsuits Continue

Vaccine Manufacturer Used "Spiked" Placebo to Hide Injuries Between Vaccine and Control Groups, Lawsuit Alleges

The Gardasil Vaccine Lawsuits Keep Piling Up

"I don’t want this pain for other kids." ~ Victoria Trevisan, Gardasil Victim

Merck & Co Face Uphill Battle as Gardasil Lawsuits Consolidated

Parents of 13-year-old Boy File Wrongful Death Lawsuit against Vaccine Manufacturers, Merck

Judge Appoints Four Attorneys For Plaintiffs Damaged by Vaccine

Judge Appoints Four Attorneys For Plaintiffs Damaged by Vaccine

 

Merck, the manufacturers of the HPV vaccine Gardasil decided to guilt trip parents back in 2016 with the following promotional ad.

Fast forward 6 years and a press release provided today by the hugely successful Los Angeles based law firm, Baum Hedlund Aristei & Goldman.

"A federal judge overseeing the Gardasil MDL (multidistrict litigation) appointed four attorneys to serve on the litigation leadership for plaintiffs who allege the Gardasil HPV vaccine caused them severe side effects."

It's estimated that hundreds of claims will soon be filed in the MDL, none of these injuries were mentioned in the promotional ad above, such as; Autonomic Dysfunction, Premature Ovarian Failure, and Postural Orthostatic Tachycardia Syndrome.

The press release also states: "Merck took steps to mask and downplay these risks; and Merck was also negligent in the way it conducted its clinical trials and post-marketing pharmacovigilance." Furthermore, "Plaintiffs further allege that, in its direct-to-consumer advertising to patients and parents, Merck misrepresented and overemphasized Gardasil's efficacy while concealing Gardasil's serious risks."

To read about some of those risks and who was harmed see the links below.

Vaccine manufacturers and co-conspirators will always be held accountable at some point in history. These Gardasil cases are just the tip of the iceberg. Personally, I hope Merck take a huge hit which will, in turn, upset their shareholders. Remember, Merck's target audience was children.

Litigation is a powerful tool in getting never seen before documents into the public domain, unless, of course, the accused decide to make a settlement. With the evidence stacked against them, I suspect Merck's legal team will try every trick in the book to get these cases overturned...and then, maybe, strike a deal to settle out-of-court.

I, for one, am hoping to see how Merck manipulated the Gardasil clinical trials by spiking the placebo with amorphous aluminium hydroxyphosphate sulfate (AAHS) and the vaccine’s other additives, which resulted in approximately equal numbers of subjects in the vaccine group and the placebo group suffering adverse reactions thus giving the impression that Gardasil was just as safe as taking a placebo.

More about Gardasil side-effects here.

Bob Fiddaman

Baum Hedlund Take a Stand Against Vaccine Maker

Californian Law Firm Lead the Way in Gardasil Litigation

Fifth Gardasil Vaccine Lawsuit Filed

Gardasil Vaccine Can Cause Infertility, New Lawsuit Alleges

Gardasil Lawsuits Continue

Vaccine Manufacturer Used "Spiked" Placebo to Hide Injuries Between Vaccine and Control Groups, Lawsuit Alleges

The Gardasil Vaccine Lawsuits Keep Piling Up

"I don’t want this pain for other kids." ~ Victoria Trevisan, Gardasil Victim

Merck & Co Face Uphill Battle as Gardasil Lawsuits Consolidated

Parents of 13-year-old Boy File Wrongful Death Lawsuit against Vaccine Manufacturers, Merck

Parents of 13-year-old Boy File Wrongful Death Lawsuit against Vaccine Manufacturers, Merck

 

Photo courtesy of Baum Hedlund Aristei & Goldman

Writing about the death of a child is something I've come accustomed to over the years I've been blogging about drug safety. It still pains me to dive into the why's and how's, particularly when these deaths could have been avoidable if profit wasn't such a pull for drug companies, particularly if we had a robust regulatory system in place who cared more about patients than the funding they receive from said drug/vaccine manufacturers, particularly if health care professionals didn't receive kick-backs to promote products they know very little about, particularly if PR firms didn't ghost-write about products without first seeing actual raw data from clinical trials.

This is the story of Noah Foley who received his first and only Gardasil injection on May 7, 2018, just two days after his 11th birthday.

His parents, Clifton and Kelli Foley, were driven to allow their son to be vaccinated with Gardasil after reading and watching Merck's promotional ad campaigns across the US.

According to a press release, “Around the time Noah received Gardasil, Merck’s advertising intimated that you are a bad parent if you do not vaccinate your child with Gardasil to protect them from getting cancer,” says Baum Hedlund attorney and shareholder, Stephanie Sherman. “What the advertising left out is there isn’t a single study to support Merck’s claim that Gardasil prevents certain types of cancer. On the contrary, studies have found that Gardasil may be more likely to cause cancer than prevent it.”

Prior to Noah's Gardasil injection on May 7, 2018, he was your typical 11-year old boy, hunting and fishing with his dad, playing games with his younger sister, building Legos, and playing his drum set. 

Noah had no autoimmune diseases, and no autonomic issues. He was extremely healthy, having received a clean bill of health at his 11-year medical check-up.

The promotional push by Gardasil manufacturers, Merck, convinced Noah's mother that Gardasil was a safe and effective vaccine for preventing not only neck, mouth, penile, and anus HPV-related cancers, but also prevented cancers that could be widely sexually transmitted.

Approximately two weeks after his shot, Noah experienced fevers, going as high as 102.9 degrees. His symptoms continued and one week later, his blood was checked to rule out Mononucleosis or other causes for the ongoing fevers. This continued throughout 2018.

On October 10, 2018, Noah's mother took him to hospital where it was found that his inflammatory markers were elevated. After a referral, it was found that Noah’s white blood cell count had tripled in two weeks.

Days later, a swollen lymph node was found which turned out not to be cancer.

Months later, (May 7, 2019) still suffering with fevers and fatigue and now weight loss, the past year had seen him lose over 20lb.

More from the press release: 

"On September 29, 2020, at approximately 12:45 p.m., Noah’s left leg went numb. On his way to the emergency room, his face and tongue went numb. By the time he arrived at the ER, Noah vomited, and by 6:00 p.m., Noah was completely non-responsive. He was transported to Duke University Medical Hospital, where his condition rapidly declined.

"On September 30, 2020, Noah was almost completely brain dead. On October 8, 2020, Noah passed away four hours after his breathing tube was removed. He was 13 years old."

The cause of death was recorded as encephalitis caused by an autoimmune/autoinflammatory dysregulation process, which his parents believe was caused by Merck's Gardasil vaccine.

Yesterday, Attorneys from Baum Hedlund Aristei & Goldman filed a wrongful death lawsuit on behalf of Noah's parents.

The lawsuit alleges:

 - Merck regularly risks the lives of patients with full knowledge of Gardasil’s limited efficacy and severely harmful and sometimes fatal dangers.

 

 - Merck has made conscious decisions to not warn or inform the unsuspecting public and medical providers of such risks of injury and sometimes death.

 

 - Merck engaged in a relentless propaganda campaign aimed at frightening and guilting parents who failed to inoculate their children with Gardasil.

 

 - Merck’s conduct, including its false promotion of Gardasil and its failure to issue appropriate warnings concerning the severe risks of Gardasil, created a substantial risk of significant harm to children and patients who were being injected with Gardasil, and therefore warrants an award of punitive damages.

Up until the COVID "vaccine" rollout, Gardasil had more reported adverse events than any other vaccine.

Here's a short video of Noah. I doubt if this will in anyway move any person associated with Merck. Experience tells me that Noah, and others like him, are just part of business for these multi-billion dollar pharmaceutical companies. They are fuelled by greed and lack in morality and compassion. As for their marketing departments, I cannot think of any other superlatives to describe them apart from heinous and callous.

Noah Tate Foley's obit can be read here.

Rest in peace, little guy.

Bob Fiddaman

To learn more about Gardasil and Merck's promotion of it, I highly recommend a deep dive into the Baum Hedlund website here.

You can read about other Gardasil lawsuits here:

Baum Hedlund Take a Stand Against Vaccine Maker

Californian Law Firm Lead the Way in Gardasil Litigation

Fifth Gardasil Vaccine Lawsuit Filed

Gardasil Vaccine Can Cause Infertility, New Lawsuit Alleges

Gardasil Lawsuits Continue

Vaccine Manufacturer Used "Spiked" Placebo to Hide Injuries Between Vaccine and Control Groups, Lawsuit Alleges

The Gardasil Vaccine Lawsuits Keep Piling Up

"I don’t want this pain for other kids." ~ Victoria Trevisan, Gardasil Victim

Merck & Co Face Uphill Battle as Gardasil Lawsuits Consolidated

Merck & Co Face Uphill Battle as Gardasil Lawsuits Consolidated

 

Last Thursday, the United States Judicial Panel on Multidistrict Litigation (JPML) issued an order consolidating Gardasil human papillomavirus (HPV) vaccine lawsuit claims. The order, according to a press release, allows the cases to move into coordinated discovery and pretrial proceedings.

When cases, like these Gardasil lawsuits, are complex, it is requested that they be moved to one district court. That one court can then handle all discovery and pretrial proceedings for the lawsuits. 

Multidistrict Litigation is handled by just one judge during the pretrial and discovery process where it is hoped parties will reach a settlement. If no settlement is reached then cases are sent back to their original courts.

Merck & Co will now have to submit written answers to some very tough questions regarding the number of claims made by plaintiffs.

On granting the consolidation of Gardasil human papillomavirus (HPV) vaccine lawsuit claims, the United States Judicial Panel on Multidistrict Litigation said, "These personal injury actions present common questions of fact arising from allegations that plaintiffs, or their minor children, developed postural orthostatic tachycardia syndrome (POTS) and various other injuries as the result of an autoimmune reaction to the Gardasil vaccine…"

Baum Hedlund Aristei & Goldman, are representing young men and women across the country who allege they suffered serious injuries as a result of Gardasi, injuries that include but are not limited to:

Autonomic Dysfunction (Dysautonomia)

Complex Regional Pain Syndrome (CRPS)

Premature Ovarian Failure (POF)

Fibromyalgia

Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS)

Orthostatic Intolerance (OI)

Postural Orthostatic Tachycardia Syndrome (POTS)

By July 28, 2022, 48 cases were pending with at least 100 more to be filed in federal courts nationwide. You can read about some of these cases below:

Baum Hedlund Take a Stand Against Vaccine Maker

Californian Law Firm Lead the Way in Gardasil Litigation

Fifth Gardasil Vaccine Lawsuit Filed

Gardasil Vaccine Can Cause Infertility, New Lawsuit Alleges

Gardasil Lawsuits Continue

Vaccine Manufacturer Used "Spiked" Placebo to Hide Injuries Between Vaccine and Control Groups, Lawsuit Alleges

The Gardasil Vaccine Lawsuits Keep Piling Up

"I don’t want this pain for other kids." ~ Victoria Trevisan, Gardasil Victim

Bob Fiddaman

The Gardasil Vaccine Lawsuits Keep Piling Up

 

Photo Courtesy of Baum Hedlund Aristei & Goldman

Drug company nemesis, Baum Hedlund Aristei & Goldman, lawyers filed a lawsuit yesterday on behalf of a 22-year-old Abigail “Abby” Stratton of Mount Pleasant, South Carolina who developed postural orthostatic tachycardia syndrome (POTS) and other serious health problems after receiving the Gardasil human papillomavirus (HPV) vaccine.

Abby was a healthy and active young woman before receiving a Gardasil jab in November of 2017. Within weeks of this jab, she developed serious and debilitating health conditions. Eventually she was diagnosed with POTS and autonomic dysfunction that her attorneys allege were caused by the Gardasil vaccine.

Lawyers Bijan Esfandiari, Nicole Maldonado, Michael L. Baum, Monique Alarcon, and co-counsel Robert F. Kennedy, Jr. filed the Gardasil lawsuit (Case No. 3:21-av-99999-CIV) in United States District Court, District of South Carolina against Merck & Co., Inc. and subsidiary Merck Sharp & Dohme Corp, both based in New Jersey.

According to John Hopkins Medicine, POTS is is a blood circulation disorder characterized by two factors:

 - A specific group of symptoms that frequently occur when standing upright

 - A heart rate increase from horizontal to standing (or as tested on a tilt table) of at least 30 beats per minute in adults, or at least 40 beats per minute in adolescents, measured during the first 10 minutes of standing.

 - Symptoms include, but are not limited to: light-headedness (occasionally with fainting), difficulty thinking and concentrating (brain fog), fatigue, intolerance of exercise, headache, blurry vision, palpitations, tremor and nausea.

The complaint alleges Merck tested the Gardasil vaccine against a toxic placebo spiked with Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS), a powerful neurotoxin. By adding this harmful ingredient to the control group, Merck could then claim its vaccine was “as safe as a placebo.”

Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) is an additive in Gardasil meant to produce a stronger and longer immune response. Aluminum, however, is known to be neurotoxic if it accumulates in the brain.

Merck are accused of concealing the Gardasil vaccine induces and increases the risk of autoimmune diseases, including POTS and dysautonomia (a group of medical conditions caused by problems with the autonomic nervous system)

Abby was just 19 years old when her doctor recommended the Gardasil HPV vaccine. Her physician stated that Gardasil was a safe and effective vaccine for preventing cervical cancer, with this information, plus Merck’s marketing and advertising messages, she decided to receive the vaccine.

Within weeks she developed a skin condition that caused redness and visible blood vessels in her face. A month or so after receiving the jab she also developed excruciating migraines. The headaches were so bad that she often vomited and visited the hospital to try and relieve the excruciating pain.

As if the skin condition and migraines weren't bad enough, Abby, some months later,  began to experience symptoms of POTS, these became so debilitating that during workouts at her local gym she had to lay down to avoid passing out.

By the summer of 2019, Abby was taken to the hospital by ambulance because she could barely walk. She was told by the hospital treating physician that she was "dehydrated."

Many other incidents later, Abby was again wrongly diagnosed and told she had anxiety and that it was "nothing serious."

Her inability to focus in class because of extreme fatigue and severe migraines led her to seek help from her school to help her with her disabilities with extra services. The school agreed but said she needed a letter from her doctor. Sadly, her doctor refused to sign the forms indicating her medical issues were hindering her studies. Remarkably, he diagnosed her with POTS but then accused her of using the condition as an excuse for her drop in performance. 

“One of the hardest things about life after Gardasil is having people not believe me when I tell them I’m suffering,” Abby says. “The pain is hard enough to deal with; when you also have to suffer the indignity of not being believed about that pain, it’s so much worse. I’m doing this because I want others who are dealing with POTS to know that they aren’t alone.”

Meantime, Merck, the manufacturer of Gardasil, continues to deny any wrong-doing that has resulted in this young woman's horrific ordeal.

It's time to stop taking the words of doctors and drug company marketing on faith.

Way I see it.

How many people buy a used car without first seeing the history log book?

If the salesman told you it's a great runner with no history of mechanical faults would you just take this as the truth?

 Millions of young men and women have rolled up their sleeves  and received Gardasil on this premise.

If lessons are to be learned from Merck's history of malfeasance then one need look no further than the promotion of their blockbuster drug, Vioxx, a drug used treat osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, acute pain conditions, migraine, and dysmenorrhea.  First introduced to the U.S. market in 1999 it became quickly embroiled in scandal and was withdrawn from the market in 2004 after it was found to increase the risk of cardiovascular side effects (heart attacks and stroke). According the Drugwatch, Vioxx may have caused approximately 140,000 heart attacks resulting in an estimated 60,000 deaths. You can read more about Vioxx here.

To date, Merck has paid out over $5 billion in fines which include healthcare-related offenses, safety-related offenses, off-label or unapproved promotion of medical products, and drug or medical equipment safety violations.

You can read more about Abby's plight and other Gardasil victims here. 

Bob Fiddaman

Back Stories

Thursday, August 20, 2020 - Baum Hedlund Take a Stand Against Vaccine Maker

Thursday, September 17, 2020 - Californian Law Firm Lead the Way in Gardasil Litigation

Friday, January 22, 2021 - Fifth Gardasil Vaccine Lawsuit Filed

Thursday, February 04, 2021 - Gardasil Vaccine Can Cause Infertility, New Lawsuit Alleges

Friday, April 02, 2021 - Gardasil Lawsuits Continue

Monday, April 19, 2021 - Vaccine Manufacturer Used "Spiked" Placebo to Hide Injuries Between Vaccine and Control Groups, Lawsuit Alleges

Vaccine Manufacturer Used "Spiked" Placebo to Hide Injuries Between Vaccine and Control Groups, Lawsuit Alleges

 

Los Angeles-based attorneys, Baum Hedlund Aristei & Goldman, has filed yet another lawsuit, this time on behalf of a 23-year-old teacher in Reno, Nevada who claims Gardasil, a human papillomavirus (HPV) vaccine, caused her countless injuries, including, but not limited to, chronic migraines, a shortage (deficiency) or impaired function of a hormone called aldosterone, and autonomic nervous system damage

At the age of 14, Savannah Flores received her first dose of Gardasil, shortly after she experienced fatigue, dizziness, and nausea. Her second dose of Gardasil was administered just days after her 15th birthday after which she experienced trembling, shaking, chest pressure, and headaches. It was at this point that her health seriously declined. Severe migraines, vertigo, menstrual irregularities, and more  followed and life as she knew it pretty much ceased. Church camps, swimming, basketball and various other activities became too painful for Savannah.

“I live in fear of the next migraine,” Savannah said regarding her migraines that are so intense she sometimes experiences blindness. “It’s scary not knowing at any given time whether I’ll get a migraine or have another symptom that lays me up for a day or more. I miss normal.”

Baum Hedlund Aristei & Goldman, who represent others in Gardasil injury lawsuits, allege that Gardasil manufacturers, Merck & Co., Inc. and subsidiary Merck Sharp & Dohme Corp:

Utilized a toxic, or spiked, placebo to mask injuries between the vaccinated and control groups and also cut the dose of aluminum in half for the vaccinated group to mask injuries (critics believe aluminum to be the most toxic component of the vaccine)

Further, it is alleged that Merck failed to follow the protocol to report adverse events and falsely told participants that the placebo was a saline solution.

Coming at a time when vaccines seem to be the talk of the town, these claims are deeply worrying. If, as alleged, Merck knowingly hoodwinked participants in their clinical trials then what of other vaccine manufacturers? Is this a standard practice for drug companies to deceive or trick participants in trials, or indeed regulators who grant licences to vaccines?

You can read more about Merck's underhand shenanigans and Savannah's plight here.

Bob Fiddaman

--

Back Stories

Thursday, August 20, 2020 - Baum Hedlund Take a Stand Against Vaccine Maker

Thursday, September 17, 2020 - Californian Law Firm Lead the Way in Gardasil Litigation

Friday, January 22, 2021 - Fifth Gardasil Vaccine Lawsuit Filed

Thursday, February 04, 2021 - Gardasil Vaccine Can Cause Infertility, New Lawsuit Alleges

Friday, April 02, 2021 - Gardasil Lawsuits Continue

Gardasil Lawsuits Continue

 

Baum Hedlund Aristei & Goldman recently filed yet another suit against Merck & Co. Inc. and subsidiary Merck Sharp & Dohme Corp. on behalf of a 22-year-old Higganum, Connecticut woman, Korrine Herlth, who alleges that the Gardasil vaccine caused her to develop postural orthostatic tachycardia syndrome (POTS), complex regional pain syndrome (CRPS), vision loss, and other serious health conditions.

At the age of just 15, Korrine was vaccinated against the human papillomavirus (HPV), a viral infection that commonly causes skin or mucous membrane growths (warts). Korrine's mother, Andrea, gave her consent after reviewing Merck's assurances that the vaccine was a safe preventative measure against HPV and cervical cancer. The vaccine is administered as a three-dose series for 15-year-olds and after her second shot, Korrine started to experience dizziness, shakiness, nausea, faintness, and headaches, as well as an increased heart rate. Because of this, her mother did not give consent for her daughter to receive the third jab.

Korrine's symptoms worsened from this point onwards and she has had to endure daily seizures, convulsions, chronic fatigue, joint pain, anxiety attacks, sleep apnea, hypoxia, and sleep disturbances and tics amongst a multitude of other bodily disturbances.

“My daughter has been assaulted on a systemic level,” her mother said. “Currently, there is no known cure, no offered hope of reversing the damage, just a series of trial treatments that have either failed her or exacerbated symptoms. It is a devastatingly helpless feeling watching my only child decline without hope of better days ahead.”

“Gardasil has made my life a living hell. The things I loved doing were ripped away from me. … I just want my old life back.”, Korrine said.

Baum Hedlund Aristei & Goldman is a national law-firm that regularly goes head-to-head against pharmaceutical corporations that intentionally mislead customers about the safety and efficacy of their products. They, on behalf of Korrine, allege that Merck negligently manufactured the Gardasil human papillomavirus (HPV) vaccine, negligently designed and conducted clinical trials before receiving U.S. Food and Drug Administration (FDA) approval, and failed to warn consumers of the vaccine’s dangerous known side effects.

More can be read about Korrine's case here.

Bob Fiddaman

Gardasil Vaccine Can Cause Infertility, New Lawsuit Alleges

Baum Hedlund Aristei & Goldman has filed their 7th lawsuit against Gardasil manufacturers, Merck.

Plaintiff Kayla Carrillo, 20, alleges Gardasil caused her to develop postural orthostatic tachycardia syndrome (POTS), seizure disorder, and infertility, among many other serious health issues. POTS  is a condition that affects blood flow. and also causes the development of symptoms such as fainting and an uncomfortable, rapid increase in heartbeat.

Kayla was just a 12-year-old when she received her first shot of Gardasil. Within 24 hours she experienced a seizure-like episode. Over the following months other serious health issues developed including irregular menstrual problems.

It was during this time that Kayla received her second Gardasil injection. Two days later, she collapsed at school and was rushed to the Emergency Department of Children’s Hospital of Orange County.

As the months wore on, Kayla suffered severe abdominal pain and an ultra scan showed she had a hemorrhagic cyst in her right ovary along with large Nabothian cysts in her cervix, the cysts were gradually enlarging so Kayla reluctantly decided to have the cyst on her ovary surgically removed. 

Since the age of 15, Kayla has undergone at least one surgery per year on her reproductive organs. Doctors say she will not be able to get pregnant and will not be able to pursue in vitro fertilization (IVF).  

Had Kayla or, indeed, her mother been warned of the risks of these and other adverse events, she never would have consented to receive the Gardasil vaccine. 

According to the lawsuit, Merck failed to disclose to regulators and the public that one of the Gardasil ingredients, Polysorbate 80, is associated with infertility and many other health problems.

“Having to be the one to tell your daughter that she won’t be able to get pregnant is a pain that is beyond words. People need to know that these risks are very real. They need to know exactly what they are getting into with Gardasil,” said Kayla's mother, Marlena 

Quite why Merck failed to tell the American Drug regulator and, more importantly, the public about this is unknown.

Let's hope that this lawsuit can throw some light on Merck's alleged deception.

It's becoming increasingly difficult to speak out about vaccine injury, especially with the current promotional push for the Covid-19 'vaccine'. Mention any negativity surrounding vaccines on Facebook and the Facebook police will either flag your post or ban you for a lengthy period. These Gardasil injuries, however, are real and have ruined lives. Don't allow Facebook or name-callers to silence you, or others, who wish to create awareness about the dangers and underhand activities of Merck.

Merck, it appears, have a habit of hiding information from the public. Yesterday, Reuters reported that "Newly unsealed court documents and other records show that Merck & Co and U.S. regulators knew about reports of suicidal behavior in men taking the company’s anti-baldness treatment Propecia when they decided not to warn consumers of those potential risks in a 2011 update of the popular drug’s label."

For more details on Kayla Carrillo's injuries and the lawsuit filed visit the Baum website here.

Bob Fiddaman

Californian Law Firm Lead the Way in Gardasil Litigation

 

In 2009 an FDA advisory committee voted to recommend approval of the vaccine Gardasil for males ages 9 to 26 to prevent genital warts.

So, it must be safe then because the FDA granted it a licence, right?

Well, there's been much debate regarding the safety of HPV vaccines over the years. Those that have questioned the safety have often been labelled 'anti-vaxxers'. This is standard protocol for drug companies who often fund pro-vaccine movements who viciously target vaccine safety advocates.

Not many people know that Gardasil has been approved for boys, most think the vaccine was for girls. 

On recommending its approval in 2009, the FDA said, "No serious side effects were seen."

Gardasil allegedly protects boys against the HPV infections that can cause cancers of the anus, penis, and mouth/throat, at least that's the way it was driven to market in various television ads.

One such person who saw these marketing ads was Jennifer Otto whose son, Zach, was just 16 at the time.

She relied on the information in the ads and various online print. She was convinced by the vaccine-maker, Merck, that all was above board.

Zach received his first shot of Gardasil in 2012 and his second some two years later in 2014, shortly after which he started experiencing body pains, headaches, cold-like symptoms, unexplained rashes, joint pains, ear pain, and enhanced lymph nodes in his neck.

In 2015, he received his third Gardasil shot and things went rapidly downhill. Here's a snapshot of the conditions Zach, now a wheelchair bound 24-year-old, is having to deal with:

Fiber Neuropathy (SNF), chronic fatigue syndrome (CFS), mast cell activation syndrome, autoimmune disease, and fibromyalgia

Dysautonomia - a condition in which the autonomic nervous system (ANS) does not work properly. This may affect the functioning of the heart, bladder, intestines, sweat glands, pupils, and blood vessels.

Postural Orthostatic Tachycardia Syndrome - a blood circulation disorder

Orthostatic Intolerance - a disorder of the autonomic nervous system occurring when an individual stands up

Small Fiber Neuropathy - a type of peripheral neuropathy that affects the small nerve fibers in the skin.

Chronic Fatigue Syndrome -  a complicated disorder characterized by extreme fatigue that lasts for at least six months and that can't be fully explained by an underlying medical condition

Mast Cell Activation Syndrome - a condition in which the patient experiences repeated episodes of the symptoms of anaphylaxis – allergic symptoms such as hives, swelling, low blood pressure, difficulty breathing and severe diarrhea

Autoimmune Disease - a condition in which your immune system mistakenly attacks your body

Fibromyalgia - a disorder characterized by widespread musculoskeletal pain accompanied by fatigue, sleep, memory and mood issues

Zach is now represented by Attorneys from the national law firm of Baum Hedlund Aristei & Goldman who, on his behalf, have filed a lawsuit against Gardasil manufacturers, Merck, claiming, amongst other things that:

 - Merck allegedly presented misleading data to the FDA suggesting that human papillomavirus (HPV) infections and some abnormal cervical tissue—cervical interepithelial neoplasia (CIN) lesions inexorably result in cancer

- Merck failed to disclose to regulators and consumers that Gardasil contained host of hazardous ingredients

- In the Gardasil clinical trials, Merck did not use a true placebo, the complaint alleges. Instead, the company “spiked” the placebo with AAHS and the vaccine’s other additives, which resulted in approximately equal numbers of subjects in the vaccine group and the placebo group suffering adverse reactions.

This should be concerning to us all given the current climate and the rush to find a vaccine for Covid-19. If a drug company can hide host of hazardous ingredients from those who approve vaccines then this seriously puts the general public in danger.

Moreover, vaccine-makers have been given indemnity regarding any Covid-19 vaccines that come to market.

Fortunately, for Zach Otto at least, Merck were not afforded that indemnity when they launched Gardasil on an unsuspecting public.

You can read more about Zach's plight on the Baum Hedlund website here.

Bob Fiddaman

Baum Hedlund Take a Stand Against Vaccine Maker

 

Los Angeles based law firm, Baum Hedlund Aristei & Goldman filed a Gardasil lawsuit against Merck yesterday on behalf of Julia Balasco, a 19-year-old, who suffered severe and permanent physical injuries after receiving multiple injections of the human papillomavirus (HPV) Gardasil vaccine.

Merck, the makers of the controversial vaccine, are accused of failing to properly test Gardasil before the HPV vaccine was fast-tracked and administered to millions of young girls and boys throughout the United States and the world. It is also alleged that "Merck knew or had reason to know that its vaccine was defective and ineffective, but instead of warning the medical community and the public, the company wrongfully concealed information and further made false statements concerning the safety and efficacy of Gardasil."

Furthermore, it is claimed that Merck manipulated the Gardasil clinical trials by spiking the placebo with AAHS and the vaccine’s other additives, which resulted in approximately equal numbers of subjects in the vaccine group and the placebo group suffering adverse reactions thus giving the impression that Gardasil was just as safe as taking a placebo.

Julia Balasco was just a 13-year-old when she was administered Gardasil. Her mother, Michaela, the lawsuit claims, was persuaded by the various Merck ads for Gardasil that claimed it was 'very safe' and 'prevented cancer'. Little did she know that her daughter would later develop serious and debilitating autoimmune disease, including POTS, a disorder that affects a branch of the nervous system that regulates functions we do not consciously control, including blood pressure, heart rate, perspiration, and body temperature.

Merck are no strangers to controversy. The New Jersey drug company have been fined over $3 billion dollars since 2000, some of which include health and safety-related offences (see below)

You can read more about the case of Julia Balasco here

Bob Fiddaman

Supreme Court Analyzes Merck's Ambiguous Wording

I'll admit it: I'm a legalese geek. But unlike certain companies peddling certain products, if I was too self-conscious to admit such, my failure to do so wouldn't hurt anyone.

Lately, I've been keeping a close eye on the court proceedings regarding Merck's Fosamax. Fosamax is a drug used in the treatment and prevention of postmenopausal osteoporosis. Ironically, Fosamax has been causing bone fractures in some consumers just as SSRIs can and do cause "depression," anxiety and akathisia in some consumers. But many Fosamax lawsuits haven't been heard by juries because Merck claims the company informed the FDA regarding bone fractures and the FDA failed to act by changing, or agreeing to change, the labeling.

The Merck case which was heard yesterday by the Supreme Court bears striking similarities to the GSK vs Dolin case. GSK also argued that it informed the FDA about the suicide links related to its Paxil product. (Paxil is an SSRI "brain pellet" that wreaks havoc among users while reaping billions in GSK profits. GSK claims it did everything to warn the public and doctors about Paxil-induced suicide risks. However, just as in the Fosamax case, GSK claims the FDA failed to agree to update the label.

Reading yesterday's Supreme Court transcript is fascinating and I highly recommend you download the 50-page transcript which is linked at the foot of this post. It provides an up-close look at how drug companies use the FDA's impotence to their advantage. Not only does the FDA fail to protect consumers, it proactively protects drug makers by serving as a revolving-door employment agency between pharma, the FDA and back again. Drug companies and the FDA create ambiguity and seem to enjoy a mutual understanding that this ambiguity will later be used to avoid lawsuits, protect shareholders and keep consumers in the dark regarding adverse drug effects.

Déjà vu: Dolin vs GSK

Wendy Dolin filed suit after her husband, Stewart, died when he jumped in front of a Chicago train. Stewart was taking a generic version of Paxil made by Mylan Pharmaceuticals, but GSK, the original manufacturers of Paxil, was responsible for the labeling and any subsequent label updates.

GSK tried to weasel its way out of a trial by citing the circumstances that Merck is now using as a defense in the Fosamax trials. GSK failed and the Dolin trial was heard by a jury who found for Dolin. Not only did the jury find that GSK was responsible for failing to warn consumers of the increased suicide risks created by Paxil, the jury also recognized that Paxil caused Stewart to suffer from akathisia, an adverse drug effect, prior to his death. Dolin was awarded compensation for both Stewart's Paxil-induced death and for Stewart's Paxil-induced suffering prior to his prescribed demise.

The Dolin trial, which lasted six weeks, ended with the jury awarding Wendy Dolin $3 million. But GSK appealed and the jury's decision was later overturned by the Seventh Circuit Court of Appeals. The overturned ruling didn't relate to the jury's finding that Paxil caused Stewart's death. Rather, it related to whether the label and failure to update the label, was the responsibility of GSK or the FDA. Dolin appealed but the Seventh Circuit refused to reconsider its decision to overturn the verdict. Dolin has taken her case to the Supreme Court where attorneys representing victims of Fosamax were yesterday.

A bit confusing, perhaps, but in short: Dolin won and GSK appealed. GSK won and the Dolin case is now in the hands of the Supreme Court.

Dolin's attorneys, Baum Hedlund, likely kept tabs on yesterday's proceedings given Merck's defense is similar to GSK's. The pharmafia conveniently blames its buddies at the FDA because partners in crime don't squeal on each other. Their silent pact sometimes helps both legally avoid responsibility for harming and killing unsuspecting consumers.

Like GSK, Merck is attempting to blame the FDA. Both companies try to adeptly muddy the legal waters so much so that jurors-even those who find the product causes adverse effects-become confused about who, exactly, should be accountable for faulty labeling and related tragic outcomes.

In cases such as Dolin vs GSK, it seems the amount awarded to plaintiffs is sometimes reduced not because the jury doesn't believe the product causes harms, but because the jury is effectively confused by pharma's legal strategy to "blame" its FDA pals. At the end of the day, pharma execs and FDA regulators likely slap each other on the back over dinner and drinks and cryptic "atta boy" correspondence. The end result is that consumers harmed by pharmaceutical products are further harmed by these cozy corporate/FDA ties.

Stress Fractures vs Emotional Lability

Merck is claiming that the FDA denied Fosamax label updates after it was learned a large number of atypical femoral fractures occurred among Fosamax users. Merck claims it proposed a change to the label but the FDA told them the wording in Merck's new proposal was inadequate. The FDA's complete response letter, in essence, said it didn't believe Merck had done a decent job with their proposal to change the label. Therefore, the FDA covers itself by responding to pharmaceutical companies and pharmaceutical companies understand they are essentially off the hook given the FDA won't follow up regarding proposed label updates and pharma won't either.

Merck did indeed inform the FDA about Fosamax related fractures but Merck labeled them stress fractures and not atypical femoral fractures. Thus, when the FDA read Merck's proposal for a label change they may have assumed these stress fractures were a relatively minor adverse drug effect. The FDA tends not to include extensive risk info in patient information leaflets because doing so might prevent consumers from seeking drugs as "treatment."

GSK used the same Merck tactic with its Paxil product after it was forced to acknowledge the number of suicides related to Paxil that occurred during Paxil clinical trials. GSK didn't tell the FDA that Paxil can cause adults to end their lives when suffering from a terrifying Paxil-induced condition called akathisia. Instead, GSK labeled suicidality as "emotional lability" just as Merck labeled atypical femoral fractures as simply "stress fractures."

Tossing the Egg

Imagine the CEO of an egg factory learns that many eggs contain bacteria that can cause serious harm and/or death to consumers. The CEO contacts a government regulator and says they have a problem. The government regulator doesn't think it's a severe problem and simply tells the egg factory to monitor the situation. But the egg CEO only told the regulator part of the story, stating that many eggs were cracked. The CEO didn't mention the bacteria inside the eggs that had grown as a result of said cracks.

It's a win-win for the egg factory. They can continue to sell eggs that are cracked, further, if a wrongful death lawsuit is brought against them, they can deny liability by stating, "We warned the government regulator but they decided not to do anything about the problem."

Both GSK and Merck had secrets hidden in their cracked eggs. The eggs were never fully opened by either company and the FDA only took a sneak peek through the cracks. GSK and Merck don't believe a jury should decide whether the FDA would have approved a label update had either company submitted an updated label change after receiving a first response from the FDA. Both companies claim the FDA wouldn't have sanctioned a second proposed label change. These companies are making assumptions, assumptions they aren't entitled to make despite that the CEO's likely have learned what to expect from their FDA friends.

Why nobody has thought to subpoena the current FDA Commissioner, Dr. Scott Gottlieb, is beyond me. Put Gottlieb on the stand, make him take an oath and ask him the very same questions the judges and legal teams are fighting over. Then again, Gottlieb would probably side with the drug companies given the FDA's incestuous relationship with pharma.

GSK, Merck and the FDA enjoy having their cake and eating it, too. But I doubt they use cracked eggs when together they cook up their half-baked legal excuses.

Bob Fiddaman



Merck Supreme Court Transcript

Wendy Dolin Petition to Supreme Court

Shionogi to Co-Promote Paroxetine Use in Menopausal Women

Back in June last year I wrote about how the FDA had approved a rebadged version of Paxil for women who suffered hot flushes.

The unsuspecting public [women] will now be greeted with a perfect pink package with the brand name Brisdelle emblazoned on it.

So, how can a pharmaceutical company possibly promote paroxetine given it's horrendous side effect profile?

Simple...hire another pharmaceutical company to co-promote it for you.

Step forward Shionogi, a U.S.-based group company of Shionogi & Co., Ltd., a leading Japanese pharmaceutical company. Their global mission? "Shionogi strives constantly to supply the best possible medicine to protect the health and wellbeing of the patients we serve." 

Shionogi's women's health sales force will now promote Brisdelle in the US to a range of healthcare providers, including some primary care doctors.

Wouldn't you just love to be a fly on the wall for this particular promotion?

No doubt Shionogi's managers will train their sales force well. You know, questions to avoid, how to use clinical information spin, how to avoid potential lawsuits, how to play down the side effect profile of paroxetine...etc. Maybe they could ask GlaxoSmithKline how they promoted Paroxetine use in kids and pregnant mothers before they were caught out by the authorities?

I'm going to cut and paste the post I did back in June last year. It pretty much sums up how Brisdelle could be promoted... and probably will be.

Saturday, June 29, 2013

FDA Approve Re-badged Paxil for Hot Flashes - By Bob Fiddaman

Those 'wise' folk over at the FDA in the US have gave the thumbs up for a new drug that's hit the market.

Brisdelle, marketed by Noven Therapeutics, LLC, is in fact a low dose of Paxil [Known as Seroxat in the UK and Aropax in the southern hemisphere].

The drug, which apparently treats moderate to severe vasomotor symptoms [that's hot flashes and night sweats to you and me] will be available in US pharmacies by November 2013.

Ah, the good old FDA approving Paxil yet again for conditions that will no doubt increase the risk of suicide and/or homicide in this patient population.

Brisdelle is a low dose treatment of Paxil, trust me, there ain't no such thing, any dose of Paxil is too much.

Noven Therapeutics claim that "At the unique low dose of 7.5mg of paroxetine as a mesylate salt, Brisdelle was specifically developed for and studied in women who experience hot flashes and night sweats associated with menopause." They add, "Brisdelle contains a lower dose of paroxetine than is indicated for any other condition."

Indications mean nothing, we all know that. This approval basically means Brisdelle will be prescribed for a whole host of conditions. It's perfect for pediatrics out there to prescribe off-label. Only 7.5mg you see, much safer, they will have parents believe, than a single 10mg tablet [currently the lowest single tablet dose]

Hooray, finally a treatment for something that is perfectly natural. I'm not scoffing at this problem, obviously I'm just a guy and, thankfully, I'll never have to experience something like menopause.... wait a minute...

Let's go back in time, just so I can show you how pharmaceutical companies work.

The website andropause.com was launched in 1999. Here's what they were saying about male menopause. [1]

The existence of Andropause is now recognized by the medical world - including the Canadian Andropause Society - and by Canadians alike.

In fact, a recent Angus Reid survey found that 70% of the general public share the belief that men experience a mid-life stage similar to women's menopause. Andropause (also called "male menopause") is a normal part of aging; although, for some men it is accompanied by a gradual and undesired decline in their sexuality, mood and overall energy. Sometimes it can even expose men to more serious health risks.

As with women, Andropause begins at a time when life often offers some of its greatest rewards.

There was even an "Andropause Quiz" for males to take. [2]

So, what is Andropause?

Well, here's what the website told us back in 1999: [3]

By the time men are between the ages of 40 and 55, they can experience a phenomenon similar to the female menopause, called Andropause. Unlike women, men do not have a clear-cut external signpost such as the cessation of menstruation to mark this transition.

Unlike menopause, which generally occurs in women during their mid-forties to mid-fifties, men's "transition" may be much more gradual and expand over many decades.

Although with age, a decline in testosterone levels will occur in virtually all men, there is no way of predicting who will experience Andropausal symptoms of sufficient severity to seek medical help.

Medical help?

The website made claims that "Andropause was first described in medical literature in the 1940's. So it's not really new. But, our ability to diagnose it properly is."

By March 2002 the website changed in appearance and, in addition to explaining what Andropause was, they now had a treatment for it.

Andriol.

Hey, and if you wanted to know more about this treatment there was even a special website for you to read about it, andriol.com.

Here's how andropause.com looked in 2002. [Fig 1]

Fig 1

Both andropause.com and andriol.com carried the copyright symbol of NV Organon.

By 2006 that symbol was clickable. You'd never guess in a million years where it led to? [Fig 2]

Fig 2

In fact, click on both links today and see where you are redirected to. Try them

andropause.com 

andriol.com

Just cut and paste them into your browser. I won't hyperlink them because you need to do this for yourselves folks.

So, having covered the marketing of a drug to treat [ahem] andropause lets now turn our attention back to the 7.5mg Paxil pill, to be marketed as Brisdelle.

What you won't hear in the huge marketing campaign that will no doubt ensue are the side-effects to this drug.

This from the Brisdelle webpage:

Suicidal thoughts or actions:  

BRISDELLE, and related antidepressant medicines, may increase suicidal thoughts or actions within the first few months of treatment.

The website then goes on to tell us, "Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions."

But wait, Brisdelle isn't for depression or other serious mental illnesses is it?

They also warn you to call your healthcare provider right away if you have any of the following symptoms:

Serotonin Syndrome: Nervousness, hallucinations, coma, or other changes in mental status; coordination problems or small movements of the muscles that you cannot control; racing heartbeat, high or low blood pressure; sweating or fever; nausea, vomiting, or diarrhea; muscle rigidity; dizziness; flushing; tremors; seizures.

Bone Fractures: Women who take BRISDELLE may have a higher risk of bone fractures.

Manic Episodes: Greatly increased energy; severe trouble sleeping; racing thoughts; reckless behavior; unusually grand ideas; excessive happiness or irritability; talking more or faster than usual.

Restlessness: Women who take BRISDELLE may feel an inner restlessness, nervousness, or be unable to sit still or stand still especially when they start taking BRISDELLE.

The restlessness they refer to is more commonly known as akathisia.

Akathisia has been studied as the mechanism by which SSRI-induced suicidality occurs and can be reduced by withdrawing or decreasing the dose of the causative agent.

In other words, if you take Brisdelle it may induce your own suicide.

Most strikingly the makers of Brisdelle have gone out on a limb. It's a refreshing move. They write the following:

Do not take BRISDELLE if you:

Are pregnant. BRISDELLE is not for pregnant women. Paroxetine can harm your unborn baby.

Nice job Noven Therapeutics!

I've screen captured the above line for prosperity [Fig 3]

Fig 3

I'm unsure what clowns at the FDA granted license to this particular brand of Paxil. I can, however, be reasonably sure that more and more women are going to become addicted to this very powerful drug. But hey, don't worry about your addiction, that's easy enough to cure - just wrap a rope around your neck, pop a hose in a car, aim that gun at your head - Bang - addiction over.

Brisdelle [7.5mg of Paxil] is the new kid on the block.

I'm guessing that Noven Therapeutics pharmaceutical reps will have those cheque books ready to dine and dash those pediatric quacks and ask them to prescribe off-label. They may as well, every other pharmaceutical company who have manufactured SSRis have done it.

Bob Fiddaman

[1] andropause.com [1999]
[2] Andropause Quiz [1999]
[3] What is Andropause? [1999]