Merck immune from antitrust claim that it misled FDA about mumps vaccine, court rules
By Brendan Pierson
Oct 7 (Reuters) -Merck MRK.N is immune from an antitrust lawsuit accusing it of misleading regulators about the effectiveness of its mumps vaccine in order to ward off competition, a federal appeals court ruled on Monday.
A 2-1 panel of the 3rd U.S. Circuit Court of Appeals found that Merck is protected by a legal doctrine known as Noerr-Pennington immunity, which states that parties cannot face antitrust claims for petitioning the government even if they are advocating for government action that would reduce competition.
Merck and a lawyer for the plaintiffs — a group of doctors and medical practices claiming they overpaid for the vaccine — did not immediately respond to requests for comment.
New Jersey-based Merck made the only mumps vaccine in the U.S. from 1967 until 2022. It is sold as part of a combined vaccine against mumps, measles and rubella, known as MMR-II, and another product called ProQuad that additionally protects against varicella, also known as chickenpox.
In the late 1990s, the U.S. Food and Drug Administration raised concerns that the mumps vaccine lost potency toward the end of its 24-month shelf life, according to the lawsuit, which was filed in 2012 in Philadelphia federal court.
Merck responded by boosting the initial potency of the vaccine in the hope of addressing the problem and submitted a supplemental application to the FDA to continue selling the vaccine without revising its efficacy claims.
However, the plaintiffs said, Merck relied on a flawed clinical trial to show that the measure worked and concealed the problems with the trial from the FDA, leading the agency to approve the supplemental application.
As a result of that deception, competitor GSK GSK.L, which is not part of the lawsuit, decided not to pursue its own mumps vaccine because it believed it would not be able to show that it was as effective as Merck's, the plaintiffs allege. GSK only went ahead with its vaccine after learning about the problems with Merck's trial.
The plaintiffs said that Merck deliberately misled the FDA in order to prevent competition from GSK, violating the federal Sherman Act and state consumer protection laws.
U.S. District Judge Chad Kenney in Philadelphia last year granted Merck summary judgment on the state law claims but let the Sherman Act claim go forward, and Merck appealed.
But the majority of the 3rd Circuit panel, reversing Kenney's ruling, found in Monday's non-precedential opinion that Noerr-Pennington immunity held even if Merck's actions were "unethical."
"The record contains troubling evidence that Merck sought to extend its apparent monopoly by misrepresenting facts about its mumps vaccines on the FDA-approved drug labeling," Circuit Judge Tamika Montgomery-Reeves wrote for the panel. "But those allegedly false claims were the result of Merck's genuine and successful petitioning of the FDA."
That meant that the Noerr-Pennington doctrine, established by the U.S. Supreme Court in a pair of decisions in the 1960s, clearly applied, she wrote.
Montgomery-Reeves was appointed by President Joe Biden, a Democrat. She was joined by Circuit Judge Peter Phipps, who was appointed by his Republican predecessor, Donald Trump.
Circuit Judge Patty Shwartz dissented, writing that the court should recognize an exception to Noerr-Pennington immunity when a company makes deliberate misrepresentations to the government. She was appointed by former President Barack Obama, a Democrat.
The case is In re: Merck Mumps Vaccine Antitrust Litigation, 3rd U.S. Circuit Court of Appeals, No. 23-3089.
For plaintiffs: Deepak Gupta of Gupta Wessler
For Merck: Jessica Ellsworth of Hogan Lovells
Read more:
Judge rules antitrust claim over mumps vaccine against Merck untimely
Merck accused of stonewalling in mumps vaccine antitrust lawsuit
(Reporting By Brendan Pierson in New York)
</body></html>Eng oxirgi yangiliklar
Javobgarlikdan voz kechish: XM Group korxonalari har biri faqat ijro xizmatlarini koʻrsatadi va onlayn savdo platformamizdan foydalanish huquqini beradi, bu odamga veb-saytda yoki veb-sayt orqali mavjud boʻlgan kontentni koʻrish va/yoki undan foydalanishga ruxsat beradi hamda uni oʻzgartirishga moʻljallanmagan va uni oʻzgartirmaydi yoki kengaytirmaydi. Bunday kirish va foydalanish huquqi doimo quyidagilarga boʻysunadi: (i) Shartlar va qoidalar; (ii) Risklar haqida ogohlantirish; va (iii) Javobgarlikni toʻliq rad etish. Shuning uchun bunday kontent umumiy maʼlumot sifatida taqdim etiladi. Xususan, shuni esda tutingki, bizning onlayn savdo platformamiz mazmuni moliyaviy bozorlarda biror bitimni amalga oshirishga oid maslahat yoki taklif emas. Har qanday moliyaviy bozorda savdo qilish sizning kapitalingiz uchun jiddiy risk darajasini oʻz ichiga oladi.
Onlayn savdo platformamizda chop etilgan barcha materiallar faqat taʼlim/axborot maqsadlari uchun moʻljallangan va unda moliyaviy, investitsiya soligʻi yoki savdo maslahatlari va tavsiyalar; yoki bizning savdo narxlarimizning qaydlari; yoki har qanday moliyaviy vositalar bilan bitim tuzish maslahati yoki taklifi; yoki sizga kerak boʻlmagan moliyaviy reklama aksiyalari hisoblanmaydi
Har qanday uchinchi tomon kontenti, shuningdek XM tomonidan tayyorlangan kontent, masalan: fikrlar, yangiliklar, tadqiqotlar, tahlillar, narxlar va boshqa maʼlumotlar yoki bu veb-saytda joylashgan uchinchi tomon saytlariga havolalar umumiy bozor sharhi sifatida "boricha" taqdim etiladi va investitsiya maslahatini tashkil etmaydi. Har qanday kontent investitsiya tadqiqoti sifatida talqin qilinsa, siz bunday kontentni investitsiya tadqiqotlarining mustaqilligini ragʻbatlantirish uchun moʻljallangan qonun talablariga muvofiq moʻljallanmagan va tayyorlanmaganligini eʼtiborga olishingiz va qabul qilishingiz kerak, shuning uchun unga tegishli qonunlar va qoidalarga muvofiq marketing kommunikatsiyasi sifatida qaraladi. Mustaqil boʻlmagan investitsiya tadqiqoti va yuqoridagi maʼlumotlarga oid risk haqida ogohlantirishimizni oʻqib chiqqaningizga va tushunganingizga ishonch hosil qiling, unga bu yerdan kirish mumkin.
