Interview with Jerry Avorn on the role of litigation in addressing product-related damage to health.

Listen to the full interview on New England Journal of Medicine

Dr. Jerry Avorn argues that when Congress and federal regulators fail to act on clear evidence that a widely used product harms health, litigation has repeatedly stepped in as a last resort to force accountability. He anchors this argument in three parallel cases: the 1990s tobacco litigation, in which 46 state attorneys general sued the four largest cigarette manufacturers; the early-2000s litigation against Merck over Vioxx (rofecoxib), which more than doubled patients' risk of myocardial infarction and stroke; and recent 2026 judgments against Meta and YouTube (9 million dollars) and against Meta alone (375 million dollars) for social media products alleged to cause psychological harm. In each case, he writes, internal company research had documented the same risks the companies later denied, government officials including multiple U.S. surgeons general had raised warnings, and yet no effective legislative or regulatory response followed until litigation intervened. Dr. Avorn, who served as a pro bono expert witness in the Vioxx litigation, describes watching plaintiffs' attorneys lay out causal evidence more effectively than Congress or federal agencies had over many years. He also acknowledges litigation's limits and risks, citing meritless lawsuits linking acetaminophen to autism and the withdrawal of the safe anti-nausea drug Bendectin due to litigation costs.

BACKGROUND

The article opens by framing a recurring pattern: a profitable corporation sells a product that poses a documented health risk, government fails to act, and victims -- represented by state attorneys general or private lawyers -- eventually use litigation to force change. Dr. Avorn states this pattern now applies to the March 2026 verdicts against Meta and YouTube, which he links directly to the earlier Vioxx and tobacco cases.

KEY FINDINGS

THE THREE PARALLEL CASES

Dr. Avorn traces common features across the Meta/YouTube, Merck/Vioxx, and tobacco cases: widespread observational evidence of harm, internal corporate research confirming the same concerns, corporate denial of that evidence's relevance, and years of legislative and regulatory inaction despite warnings, including from U.S. surgeons general "more than a half-century apart" regarding tobacco and then social media.

QUESTIONS RAISED BY THESE CASES

Dr. Avorn poses several unresolved questions he sees as common to all three cases: what role government should play in detecting and acting on product-related health risks; whether harm resides in a product itself or in how it is used; how causality can be established for widely used products absent randomized controlled trials; how much responsibility a "warned" user bears; and when regulation (labeling, age restrictions) versus an outright ban (as with Vioxx) best protects public health.

OUTCOMES AND REFORMS

He states the 1998 tobacco Master Settlement Agreement extracted more than 200 billion dollars from tobacco companies and forced them to limit marketing and stop denying health risks, though he notes much of that settlement money "was eventually diverted from its intended uses." He states the Vioxx litigation, involving thousands of plaintiffs and costing Merck nearly 5 billion dollars in settlements, led Congress to force the FDA to create a nationwide drug-safety surveillance system by 2007. He notes the social media cases are still subject to appeal, and it is not yet known whether they will produce comparable reforms.

RISKS OF LITIGATION AS A TOOL

Dr. Avorn cautions that courts "can occasionally advance problematic causes," citing plaintiff lawsuits linking acetaminophen to autism and the market withdrawal of Bendectin (doxylamine and pyridoxine), which he states was "proven to be safe" despite litigation over alleged birth defects. He writes that lay juries "can occasionally err in assigning blame in difficult questions of causal inference."

IMPLICATIONS

Dr. Avorn states his preference would be for the country to "proactively create thoughtful, timely, unbiased, effective, and evidence-based laws and policies," but when that process fails, "the courts may provide a last-resort layer of protection to limit product-related damage to peoples' health." He concludes that litigation "may not be the most elegant or efficient way to accomplish that goal, but sometimes it works." He also directly attributes government inaction in part to Congress and the executive branch being "influenced by antiregulatory ideology and generous campaign support from those corporations."