(Mass Tort News) Baum Hedlund Aristei & Goldman filed a wrongful death lawsuit today on behalf of a North Carolina couple who allege the Gardasil vaccine killed their 13-year-old son.
Gardasil lawsuit attorneys Bijan Esfandiari, Michael L. Baum, Stephanie B. Sherman, and Monique Alarcon, along with co-counsel Robert F. Kennedy, Jr., filed the complaint for wrongful death in U.S. District Court for the Middle District of North Carolina (Case No. 1:22-cv-810). The attorneys represent plaintiffs Clifton and Kelli Foley, who allege their son, Noah, received the Gardasil human papillomavirus (HPV) vaccine and suffered severe side effects before his untimely death at age 13.
The lawsuit is against Gardasil’s manufacturer, New Jersey-based pharmaceutical giant Merck & Co., Inc. and its subsidiary, Merck Sharp & Dohme. The complaint makes the following allegations (among many others):
- 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.
The Foleys allege that if they had known the truth about Merck’s conduct with Gardasil and its potential to cause serious adverse health effects, they would not have given consent for their son to receive the vaccine.
“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,” said 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.”
“Merck knows that if they disclosed the truth about Gardasil’s potential to cause severe adverse reactions and gruesome diseases, including autoimmune diseases, and death in some recipients, no one would get the vaccine” Sherman adds. “Merck profited billions by giving parents fear instead of facts. It is time for them to take responsibility for the devastating harm they caused the Foley family.”
Noah Tate Foley was a typical young boy when he received his first and only Gardasil injection on May 7, 2018, just two days after his 11th birthday. He enjoyed, hunting and fishing with his dad, playing games with his younger sister, building Legos, and playing his drum set. He loved school and was active in his church. Most of all, Noah loved his family and treasured the times they spent together.
Before Gardasil, 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. Noah’s mother, Kelli S. Foley, agreed to her son receiving the Gardasil injection after having been exposed to marketing by Merck 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. Cancer prevention was something that Mrs. Foley valued because her mother was a breast and ovarian cancer survivor.
Roughly two weeks after the Gardasil shot, Noah began experiencing 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. There was no “cause” found for these fevers, which came and went throughout the summer of 2018.
On October 10, 2018 Mrs. Foley took Noah to the emergency room at Duke University Medical Center in Durham, North Carolina. After examination and blood tests, she was informed that her son’s inflammatory markers were elevated, possibly due to a viral infection. Noah was then referred to the Duke University Infectious Disease department, where blood work revealed that Noah’s white blood cell count had tripled in two weeks.
Several days later, Noah was seen by Dr. Christine Akinboyo at Duke University Infectious Disease, who found a swollen lymph node and ordered an immediate CT scan and biopsy of the lymph node. The Foley family waited for more than a month before doctors confirmed that Noah did not have cancer. “Those were 35 of the longest and most torturous days of my life,” Kelli Foley recalls.
Noah had a follow-up visit at Duke University Medical Center Infectious Disease, eventually being referred to Pediatric Gastroenterology due to weight loss issues and Duke Pediatric Rheumatology to search for any autoimmune disorder responsible for Noah’s continuing physical illness and abnormal blood tests. Nothing definitive was found and Noah’s parents were back to square one.
By May 7, 2019, Noah had an appointment for weight loss where the records state “Over the past year, [Noah] has had a rough year. He was in his usual state of good health per Mother until he went for his 11-year-old vaccine and well child check-up. After that he continues to have fevers and fatigue. He has been seen by multiple specialists over the past 7 months – starting in October 2018. He has had one lymph node removed from his neck as well as CT scan (neck/abdomen) and MRI to evaluate what inflammatory process may be occurring. He has continued to have fatigue and not feel like himself. It has been noted that over the past year he has lost 20lb despite continued good vertical height growth and continued to eat fairly well . . . .”
Noah’s weight was 69 pounds, his BMI was in the 4th percentile at 14.79, and his inflammatory markers remained elevated. At a May 21, 2019 pediatric gastroenterology consultation, the assessment discussed an “autoimmune or inflammatory process.”
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.
According to the complaint, Noah Tate Foley died of encephalitis caused by an autoimmune/autoinflammatory dysregulation process, which was caused-in-fact by the Gardasil vaccination received on May 7, 2018.
“Our faith is very strong, which is why I know that despite the pain our family continues to feel in Noah’s absence, we won’t let his death be in vain. We will fight for him in getting justice against Merck for what they did to him.” Kelli Foley says.
“I lost my fishing and hunting buddy, and my daughter lost her best friend,” says Cliff Foley. “They say time heals all wounds, but losing your son is something you never really heal from. Every day, we feel the loss, and it doesn’t get any easier.”
“We have several reasons for pursuing this action against Merck,” the Foleys say. “First and foremost, we want justice for our son, who suffered mightily because Merck never told us that serious adverse effects were possible. We want accountability and acknowledgment that what they’ve done is wrong. We hope that our case will raise awareness and provide other families the opportunity to make more informed choices about the risks associated with Gardasil. Lastly, we want some form of closure, which is something that we’ve never had.”
HPV Vaccine Lawsuit Allegations Against Merck
Lawsuits against Merck include the following causes of action:
- Gross Negligence
- Failure to Warn
- Manufacturing Defect
- Breach of Warranty
- Common Law Fraud
- Wrongful Death and Survival
Merck has a long history of bringing controversial products to market, including Fosamax (a purported bone density drug that caused bone fractures) and Nuvaring (a birth control device associated with life-threatening blood clots and death).
Merck’s most infamous drug is Vioxx, a pain medication the company had to pull from the market due to cardiovascular risks. Tens of thousands of patients filed lawsuits against Merck alleging they suffered heart attacks and other cardiovascular injuries as a result of ingesting the medication.
The litigation revealed that Merck knew early on that Vioxx was linked to fatal cardiovascular adverse events but intentionally chose to conceal the risks from the public and medical community. Lawsuits accused Merck of orchestrating a scheme to downplay the severity of the risks, misrepresenting the results of its clinical trials, failing to undertake the clinical trials that would reveal risks, and blacklisting medical professionals who dared to publicly criticize the safety of Vioxx.
Merck paid nearly $5 billion to settle the tens of thousands of Vioxx personal injury actions and an additional $1 billion to settle a securities class action. The company was also forced to pay $950 million in civil and criminal fines to the Department of Justice and other governmental entities as a result of various criminal activities Merck had engaged in with respect to Vioxx.
Attorneys in the Gardasil litigation allege Merck has engaged in similar corporate malfeasance with its HPV vaccine.
According to Merck’s marketing, Gardasil provides lifetime immunity to cervical and other HPV-associated cancers. Plaintiffs in the Gardasil litigation, however, say Merck’s marketing claim that Gardasil prevents cancer (not to mention lifetime immunity), is unproven. The allegations state that Gardasil may actually be more likely to cause cancer in those previously exposed to HPV than prevent it.
Lawsuits allege that Merck knows and actively conceals the fact that Gardasil can cause a constellation of serious adverse reactions and side effects. 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.
Plaintiffs say Merck, in designing and conducting its clinical trials for Gardasil, concealed the risks to falsely enhance the vaccine’s safety profile, just as the company did years prior with Vioxx. In order to obtain its Gardasil license, Merck designed its clinical trial studies to purposefully conceal evidence of chronic conditions such as autoimmune diseases while exaggerating the vaccine’s purported efficacy, the lawsuits allege. This “wholesale fraud” and dishonesty in the clinical tests led many physicians to recommend the vaccination under false assumptions, attorneys say.
Until 2021, Gardasil had more reported adverse events than any other vaccine. The U.S. Food and Drug Administration’s (FDA) Vaccine Adverse Event Reporting System (VAERS) had received more than 64,000 HPV vaccine adverse event reports by December 2019. It’s not surprising then that the Vaccine Injury Compensation Program (VICP) has paid out millions of dollars in damages for injuries and deaths.
“As a result of Merck’s fraud, Gardasil is wreaking havoc on a substantial swath of an entire generation of children and young adults on a worldwide scale,” the Gardasil lawsuits allege.
Statement from Baum Hedlund Aristei & Goldman:
“Baum Hedlund wishes to stress that the firm is not against vaccines. Vaccines have the potential to eradicate disease and save millions of lives. The firm is, however, against intentional efforts to mislead consumers about the safety and effectiveness of a drug or vaccine. Baum Hedlund attorneys have always fought—and will continue to fight—for the rights of consumers to be fully and honestly informed about risks associated with any drug, vaccine, or medical device. The firm will work tirelessly to ensure those rights are defended and victims of injustice are compensated for their injuries.”