Primary Ovarian Insufficiency

In winning its motion for summary judgment, Merck has knocked out more than 200 lawsuits in the nationwide Gardasil safety communication litigation. In what’s shaping up to be a red-letter week for Gardasil, Merck & Co. has simultaneously opened a massive new manufacturing facility for the human papillomavirus (HPV) shot in the U.S. and put hundreds of lawsuits to bed alleging that the company downplayed the safety risks of its blockbuster vaccine.In a decision signed Monday, North Carolina federal judge Kenneth Bell granted Merck’s motion to dismiss the claims of plaintiffs who argued that Merck failed to warn that Gardasil—first approved in 2006 to prevent cervical and other cancers linked to HPV—could cause recipients to develop certain health conditions.In particular, the plaintiffs contended that Merck should have added safety warnings to its Gardasil label in 2011 and 2013 detailing the risks of recipients developing postural orthostatic tachycardia syndrome (POTS) or primary ovarian insufficiency (POI), respectively.POTS is a condition that leads to multiple symptoms, such as dizziness and fast heart rate when a person moves from lying down to standing up. POI, otherwise known as premature ovarian failure, occurs when the ovaries stop working before age 40, often leading to infertility.Judge Bell specifically ruled that Merck lacked the power to add safety warnings to its Gardasil label under federal law, which pre-empts the plaintiffs’ state-based claims.In winning its motion for summary judgment, Merck has knocked out more than 200 lawsuits in the nationwide safety communication litigation, according to court documents filed this week.Given the lack of solid evidence on a causal relationship between Gardasil and the two conditions, Merck didn’t possess the authority to simply change the vaccine’s label of its own accord, the judge ruled.“As of 2013, when plaintiffs contend that the latest of the warnings should have been given, more than a hundred million doses of Gardasil had been administered worldwide,” the judge said in his decision. “However, by that time, there had been only one published, verified case of POTS and four published case reports of POI.”In turn, Judge Bell argued that “no scientist could reasonably conclude there is a causal association between POTS and POI and Gardasil based on this paucity of evidence, even putting aside the fact that the FDA was made aware of all these cases and studies.” Further, it would have ultimately been up to the U.S. FDA, rather than Merck itself, to approve any label updates for the vaccine. Bell also warned about the inherent risks that come with adding “unwarranted warnings” to potentially life-saving vaccines, arguing that they could sway people to forgo immunizations or “crowd out” legitimate safety risks that should be monitored.In summarizing his position, the judge stressed that “[f]ederal law requires more than speculative inferences prior to adding dire warnings to lifesaving vaccines that discourage their use.”In an emailed statement, a Merck spokesperson said that the company is “extremely pleased” with the court’s decision and stands by the safety of its vaccine.“The evidence that Gardasil does not cause POTS and its associated symptoms or POI is consistent and overwhelming,” the spokesperson said, citing data from clinical trials, real-world epidemiological studies and global regulatory decisions.Gardasil, which is now approaching two decades on the market, remains one of Merck’s top selling products. The shot’s global sales in 2024 dropped 3% overall but still landed at $8.6 billion for the entire year.Meanwhile, despite ongoing struggles in the key Chinese market, Gardasil has notched a number of recent wins in the U.S. Late last month, a California jury trial over Gardasil side effects was put on hold until September, in a move Merck chalked up to its strong body of safety data on the vaccine. One of the lawyers for the plaintiff in that case told Reuters that it was difficult to run the trial alongside Robert F. Kennedy Jr.’s confirmation hearing for HHS secretary. Kennedy—a noted vaccine skeptic who has since been confirmed for the HHS post—previously disclosed in an ethics agreement that he stood to receive a payout for referring successful cases to one of the law firms representing Gardasil plaintiffs.Separately, Merck on Tuesday announced the opening of a new $1 billion, 225,000-square-foot manufacturing facility in Durham, North Carolina, that is slated to crank out bulk drug substance for Gardasil. 

Merck convinced a federal judge to toss claims alleging that it failed to properly warn patients of potential risks related to its Gardasil HPV vaccine. District Judge Kenneth Bell in North Carolina concluded that the plaintiffs’ claims are preempted by federal law because Merck was not permitted to add the warnings to Gardasil’s label without prior approval from the FDA. Plaintiffs in the multidistrict litigation before the US District Court for the Western District of North Carolina allege that Gardasil caused them to suffer one of two conditions called POTS or POI. As of December, more than 225 Gardasil cases were pending against Merck in either federal or state court. It’s unclear how many of those cases remain. “The evidence that Gardasil does not cause POTS and its associated symptoms or POI is consistent and overwhelming,” a Merck spokesperson told Endpoints News on Tuesday. POTS, or postural orthostatic tachycardia syndrome, causes the heart to beat faster than normal when standing up, while POI refers to premature ovarian failure. Plaintiffs in the multidistrict cases argued that Merck should have added warnings to Gardasil’s label for POTS and POI in 2011 and 2013, respectively. While prior approval from the FDA is typically required to make label changes, the plaintiffs said Merck could have made the changes without the FDA’s clearance based on “newly acquired” evidence. However, Merck argued that there is no evidence Gardasil causes either condition. Bell sided with the pharma company on Tuesday, concluding that the evidence “falls far short” of establishing that Merck had newly acquired information indicating a link between Gardasil and POTS or POI. He pointed out that plaintiffs cited just one published case of POTS and fewer than 20 unverified reports of POTS among the tens of millions of people who have received Gardasil. Thus, the company “did not have the authority under federal law” to add the requested warnings to the label, Bell wrote. The plaintiffs “ignore the real harm that is risked by adding unwarranted warnings to a vaccine,” he added. “First, of course, anyone unnecessarily discouraged from taking a potentially lifesaving vaccine could suffer dire consequences,” Bell wrote. “Also, adding ‘warnings’ for every diagnosed malady that befalls a vaccine recipient within months or years after vaccination will crowd out the impact of those warnings that truly need to be given.” Bell had previously dismissed several claims brought by a group of initial “bellwether” plaintiffs, including manufacturing and design defect claims. Bell’s Tuesday order dismisses the remaining claims brought by bellwether plaintiffs. The order states that the decision “shall be applied to Plaintiffs in the MDL other than the Bellwether Plaintiffs in accordance with the prior orders of the Court and/or the agreement of the Parties.” The Merck spokesperson said the company is “extremely pleased” with the verdict and “will seek to have this applied more broadly.” Editor’s Note: This story has been updated to include comment from Merck.

MONDAY, Dec. 16, 2024 -- In an evidence-based guideline issued by the Centre for Research Excellence in Women's Health in Reproductive Life and published online Dec. 8 in Climacteric , updated recommendations are presented for the diagnosis and management of premature/primary ovarian insufficiency (POI). Nick Panay, M.D., from Queen Charlotte's and Chelsea Hospital at Imperial College London, and colleagues developed guidelines relating to diagnosis and management of POI based on evidence collected from literature searches and assessment. In general, the recommendations were informed by women with lived experience of POI. The authors note that the prevalence of POI is 3.5 percent, which is higher than previously thought. The updated guidelines included 145 recommendations. The list of clinical questions addressed in this guideline was expanded, including in relation to the role of anti-Müllerian hormone (AMH) in the diagnosis of POI and fertility preservation. The topic of complementary treatments was extended, focusing on nonhormone treatments and lifestyle management. Significant changes from the previous guideline include the recommendation that only follicle stimulating hormone (FSH) >25 IU is required for POI diagnosis and guidance that AMH testing, repeat FSH measurement, and/or AMH may be necessary in cases of diagnostic uncertainty. Recommendations relating to genetic testing, estrogen doses and regimens, use of the combined oral contraceptive, and testosterone therapy were also updated. "The guideline group concluded that there is still an urgent need for more research on the most appropriate diagnostic and treatment options, but also to further elaborate the impact of estrogen deficiency on the health and life expectancy of the women diagnosed with POI," the authors write. Several authors disclosed ties to the pharmaceutical industry. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.