Miracle Drugs, Missing Warnings and Pharma’s Coming Reckoning -By Fransiscus Nanga Roka

Novo Nordisk and Eli Lilly have each made billions thanks to diabetes and obesity treatments, especially Ozempic, Wegovy, Mounjaro and Zepbound. Yet their unprecedented success now faces an equally unprecedented challenge in court: whether manufacturers provided sufficient warnings to patients prior to large-scale use revealing uncommon but devastating injury.

Before US District Judge Karen Spencer Marston in Pennsylvania are thousands of individual claims. That is not class action: each claimant must demonstrate the use of a specific drug, an inadequately warned about risk in its labelling, medical causation and damage to person. Major defendants deny the allegations, argue that their labels properly reflect regulatory evidence and assert that there are advantages from major-weight loss to cardiovascular and renal protection.

The first battlefield for the litigation is all about gastroparesis, ileus, intestinal blockage and related GI injuries. Plaintiffs claim from the outset that manufacturers were aware or should of known, these medicines could prompt slow digestive motility which was pathological and, at times, ongoing but downplayed such risk as mere nausea or vomiting.

That distinction is decisive. Gastroparesis which may precipitate recurrent vomiting, dehydration and malnutrition leading to hospitalisation or dependency on nutritional-support is part of the mechanism of action of incretin medicines in appetite inhibition by means of delayed gastric emptying. No therapeutic mechanism affords a manufacturer immunity from its severity when it purportedly crosses the line of expected effect into permanent injury.

In December 2025, a second MDL (MDL 3163) was established for claims relating to non arteritic anterior ischemic optic neuropathy or NAION: rapid optic nerve ischemia leading to permanent vision loss ability. The August 2026 statistics of the federal judiciary show both MDLs continuing to grow, with thousands of cases in the gastrointestinal proceeding and hundreds of actions already in the vision litigation.

The scientific case remains unsettled. A retrospective, single center investigation that was published in 2024 JAMA Ophthalmology showed significantly higher relative risks for NAION in semaglutide users but could not demonstrate causality. Later, much larger studies found more modest associations. In all, one 2026 veterans study found the relative risk for amputation to be about twice that with SGLT2 inhibitors but with very low absolute cumulative risks of 0.29% versus 0.13%. Association Is Caution, Not Judgment.

Thus, upcoming proceedings under Rule 702 are far more significant than boastful headlines or wildly inventive multibillion-dollar settlement estimates. He must also consider whether experts reliably disentangled the effects of drugs from those of diabetes, obesity, vascular disease and other major confounders. Causation dressed up in the theatre of statistics should not be allowed to go before any bellwether jury.

But a corporate blank cheque is not regulatory approval. The labeling may also adapt as additional evidence develops in the postmarketing period. Manufacturers with safety databases much richer than those of patients must always seek to detect signals, disclose them rapidly and communicate severity rather than bury evidence of emerging harm beneath the language of technical compliance.

How to respond on both strategic and tactical levels? There is no room for compromise. The FDA must mandate uniform registries connecting prescriptions, delivery, dose and duration, gastrointestinal diagnoses, ophthalmic imaging and outcomes. It requires labels to quantify absolute risks wherever possible and provide specific instructions for patients regarding persistent vomiting, preoperative withholding, obstruction symptoms & sudden loss of vision. Auditing of pharmacovigilance data should be performed by independent experts, funded not by the companies but by an external independent body.

Against this backdrop, courts should coordinate neutral expert panels, retain drug-specific causation analysis and reject settlement grids that harmonize semaglutide, liraglutide and dual GIP/GLP-1 drugs like tirzepatide. Novo Nordisk and Lilly should provide timelines for signal induced actions and analyses of adverse events.

Because of the fear that litigation creates they should not just stop an effective treatment. However, it turns out blockbuster perks will not buy hush. As such, the real scandal would not be that these harms rarely emerged, it would be evidence that corporations were seeing them emerge and then alerting the market far too late.

Fransiscus Nanga Roka

Faculty of Law University 17 August 1945 Surabaya and Managing Partner Law Firm Victorious Indonesia