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>
면책조항: XM Group 회사는 체결 전용 서비스와 온라인 거래 플랫폼에 대한 접근을 제공하여, 개인이 웹사이트에서 또는 웹사이트를 통해 이용 가능한 콘텐츠를 보거나 사용할 수 있도록 허용합니다. 이에 대해 변경하거나 확장할 의도는 없습니다. 이러한 접근 및 사용에는 다음 사항이 항상 적용됩니다: (i) 이용 약관, (ii) 위험 경고, (iii) 완전 면책조항. 따라서, 이러한 콘텐츠는 일반적인 정보에 불과합니다. 특히, 온라인 거래 플랫폼의 콘텐츠는 금융 시장에서의 거래에 대한 권유나 제안이 아닙니다. 금융 시장에서의 거래는 자본에 상당한 위험을 수반합니다.
온라인 거래 플랫폼에 공개된 모든 자료는 교육/정보 목적으로만 제공되며, 금융, 투자세 또는 거래 조언 및 권고, 거래 가격 기록, 금융 상품 또는 원치 않는 금융 프로모션의 거래 제안 또는 권유를 포함하지 않으며, 포함해서도 안됩니다.
이 웹사이트에 포함된 모든 의견, 뉴스, 리서치, 분석, 가격, 기타 정보 또는 제3자 사이트에 대한 링크와 같이 XM이 준비하는 콘텐츠 뿐만 아니라, 제3자 콘텐츠는 일반 시장 논평으로서 "현재" 기준으로 제공되며, 투자 조언으로 여겨지지 않습니다. 모든 콘텐츠가 투자 리서치로 해석되는 경우, 투자 리서치의 독립성을 촉진하기 위해 고안된 법적 요건에 따라 콘텐츠가 의도되지 않았으며, 준비되지 않았다는 점을 인지하고 동의해야 합니다. 따라서, 관련 법률 및 규정에 따른 마케팅 커뮤니케이션이라고 간주됩니다. 여기에서 접근할 수 있는 앞서 언급한 정보에 대한 비독립 투자 리서치 및 위험 경고 알림을 읽고, 이해하시기 바랍니다.
