What Is The HPV Vaccine And Why Is Its Manufacturer Getting Sued?

HPV stands for human papillomavirus, and it is the most common sexually transmitted infection (STI) in the United States. HPV is defined as an STI because it’s transmitted through skin to skin contact, typically through sexual acts like oral sex, anal sex, or vaginal sex. Because HPV can present itself asymptomatically, many men and women may not know that they have it and therefore could unknowingly pass it to their sexual partners.

In 2018, the CDC reported an estimated 43 million HPV infections, with the primary affected age group being adolescents under 20 years of age. Since it’s a virus, HPV cannot be treated with antibiotics like some STIs, making it a potentially challenging condition to have and treat.

Many strands of HPV come with little to no side effects and typically resolve on their own within a year or two. However, if HPV goes unresolved on a longer-term scale, it can cause genital warts similar to herpes (HSV) or even lead to certain types of cancers. Healthcare practitioners have not been able to predict whether a patient suffering from HPV will later develop cancer, but it is suspected that those with autoimmune disorders or weakened immune systems are at an increased risk for cancer development. 

What Is the HPV Vaccine?

Like most immunizations, the HPV vaccine (brand name Gardasil) works by introducing your body to a small amount of the active virus to stimulate an immune response. Once the body senses a foreign body, it will attack and trigger the production of antibodies. This enables a stronger fight response if you’re exposed to the same virus in the future.

Gardasil is the brand name for the only HPV vaccine available in the United States. The immunization is manufactured by pharmaceutical giant Merck and has been FDA-approved for the treatment of HPV since 2006. The vaccine gained approval in 2018 for an expanded age demographic to include not only ages 9 through 26 but also ages 27 through 45.

Not only is the vaccine highly effective at preventing HPV (up to 99%, in fact), but the commonly reported vaccine side effects are few. Some patients report pain, redness, or swelling at the site of injection (as is the case with most injections), as well as occasional dizziness, nausea, headache, or fainting in rarer cases. In 2019, 73% of girls and 70% of boys received at least one dose of the HPV vaccine, and percentages have continued to hover around that region in recent years. 

Gardasil has been banned in Japan, and France and India have removed it from their recommended list of vaccinations.

The Plaintiff Perspective

As early as 2020, Merck began facing lawsuits for its HPV vaccine, as plaintiffs (all of whom are women) claim that Gardasil caused them to develop auto-immune disorders, fertility challenges, and even cancers. Merck was accused of misrepresenting their drug’s safety and efficacy data and is being held accountable because accusers claim that they failed to properly test and cite all side effects before pushing it to the market.

Gardasil has been banned from usage in Japan, and France and India have removed it from their recommended list of vaccinations due to possible safety and efficacy concerns. Lawyers defending the affected patients also claim that the timing of the manufacturing and FDA approval of Gardasil is suspicious because it closely followed the Vioxx scandal in which Merck lost billions of dollars. This leads lawyers to believe that the pharmaceutical giant put profit ahead of public health, but more research needs to be done to support that claim.

Merck’s Defense

In response to public accusations of the manipulation of Gardasil data and its damaging potential side effects, Merck has strongly stated their commitment to accurate data and safe products. In March of this year, Merck spokesperson Bob Stephenson was quoted saying, “The overwhelming body of scientific evidence – which includes more than 20 years of research and development – continues to support the safety and efficacy profile of our HPV vaccines … We will vigorously defend against these cases.”

So far, government agencies like the FDA and CDC have lined up in favor of Gardasil’s manufacturer. On its website, the CDC explicitly states, “HPV vaccines are very safe. Scientific research shows the benefits of HPV vaccination far outweigh the potential risks.” Their reasoning is due to the fact that the vast majority of patients do not experience any adverse effects and that the vaccine is 99% effective at preventing HPV.

In 2017, only 9% of Americans believed that pharma and biotech put patients above profit.

The Case Currently

As of April 2023, a federal court ordered Merck to turn over all Gardasil clinical trial data so that they can investigate its integrity (a standard operating procedure in lawsuits of this kind). The proceedings for this case are expected to begin in the next couple of years. And given the trend of women stepping forward with similar accusations, the lawsuits could continue to stack up against Merck. However, more research will need to be done to conclude whether Merck is at fault in their representation of Gardasil or if the plaintiffs’ arguments hold any validity.

A 2017 poll showed public trust in pharmaceutical companies was at an all-time low, as only 9% of Americans believed that pharma and biotech put patients above profit. It’s highly likely the Covid pandemic and its resulting new vaccine perpetuated the trend of distrust through the early 2020s. This sentiment could be attributed to the fact that pharmaceutical companies have historically failed patients by mismarketing drugs, manipulating clinical trial data, and downplaying harmful side effects to increase the number of prescriptions written. In the past decade alone, there have been countless examples of pharmaceutical companies behaving immorally to suit their business interests.  

Closing Thoughts

While there is currently no evidence supporting the fact that Merck manipulated data or wrongly marketed Gardasil, many affected women are left wondering whether this is going to be another instance where women’s health concerns are disregarded by the healthcare industry. For decades, the gender bias in medicine has unfavorably affected women, meaning that healthcare providers (historically male) have neglected proper care, undermined the female pain experience, and brushed off patients’ concerns as overly dramatic.

Though accusations have been piling up since 2020, this multidistrict lawsuit has just begun. For more information on the lawyers defending the plaintiffs, you can find case updates here. For more information on Merck and its public statements surrounding the Gardasil vaccine, visit https://www.merck.com/media/news/.

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