The Fen-Phen Lawsuit Explained

Jun 19, 2023 | Defective Pharmaceuticals

In the 1990s, the fen-phen weight loss drug lawsuit was one of the largest defective pharmaceuticals cases in history. This legal case remains a prominent landmark, possibly rivaled only by opioid settlements. 

American Home Products (currently a division of Pfizer), established in 1926, boasts a long-standing history in the industry. Nevertheless, despite their extensive expertise, the company knowingly engaged in the sale of a hazardous drug purely for financial gain.

For decades, the FDA was an independent watchdog agency. Today, the FDA relies on industry-paid user fees for almost half its budget. This consumer watchdog agency is now an industry rubber stamp agency.

Until fen-phen use caused the death of a consumer in the 1990s, FDA bureaucrats did nothing about this dangerous drug. Some thirty years later, the FDA still only recalls dangerous drugs as a last resort. Additionally, product recalls don’t compensate injury victims. Personal injury cases against massive corporations like Pfizer are extremely complex. Luckily, our experienced and aggressive defective pharmaceutical attorneys can help victims recover. 

The Fen-Phen Lawsuit

Fenfluramine, a serotonin-releasing agent, was a marginally-effective weight-loss drug that hit store shelves in the 1970s. Phentermine, a CNS stimulant, is a much more powerful weight loss drug with very powerful side effects. AHS marketers believed a fenfluramine and phentermine combination would be a blockbuster. More is better, right?

Company officials knew that aminorex, a chemically-similar drug to phentermine, caused severe heart and lung damage in over two dozen people. Based on this evidence, in 1996, an FDA inspector refused to approve fen-phen unless it had a black box pulmonary hypertension warning. A senior FDA evaluator overruled that decision, approved fen-phen, and it was off to the races.

Less than two years later, once again after someone died, the FDA reversed course and pressured Wyeth to stop selling fen-phen. According to the agency, approximately 30 percent of people who had taken the combination for up to 24 months had abnormal echocardiograms, even though they had no other risk factors or symptoms.

As many as 50,000 victims filed legal actions. In 2000, a Philadelphia federal judge approved a $3.75 billion fen-phen settlement. Depending on the specific facts, most of these victims received between $5,000 and $200,000.

Legal Options

Most fen-phen cases used the public nuisance doctrine. A public nuisance is an unreasonable interference with a right the general public shares in common. Everyone has the right to health and safety. A drug with large-scale side effects, like fen-phen, encroaches on that right. Most opioid cases use the same theory for the same reason.

The misconduct standard is lower in public nuisance cases. A Houston personal injury attorney must only show an unreasonable interference, which is not the same thing as an actual injury or even an increased risk of injury.

This doctrine is only available in fen-phen, opioid, and similar dangerous drug cases that affect tens of thousands of people. A few thousand victims won’t do.

Incidentally, many opioid litigation plaintiffs are cities or counties which incurred additional costs because of the epidemic. The individuals who took these drugs often aren’t very sympathetic to jurors. Additionally, drug company lawyers could easily blame these plaintiffs for their own injuries. 

But cities and counties stuck with unexpected bills are sympathetic. Furthermore, these unexpected bills, and not the source of these bills, are the key issue.

Most smaller-scale dangerous drug claims use the failure to warn theory or a product liability theory.

Failure to warn is a negligence theory. Drug companies have a duty to warn consumers about known side effects. Because of Wyeth’s clear failure to warn, the attorneys that handled these cases could have used this theory. But they went with public nuisance instead. Public nuisance doesn’t have as many moving parts.

In addition to duty, these victim/plaintiffs must prove the defendant breaches that duty, which means the company’s behavior fell below the standard of care. Overlooking a safety warning might or might not be a breach of care. 

The other two elements of a negligence case are cause and damages. The failure to warn must have caused injury, not simply increased the risk of injury. Additionally, the victim/plaintiff must have sustained actual damages. Fear and worry usually aren’t actionable.

Companies are strictly liable for injuries their defective products cause. So, there’s no need to prove negligence or unreasonable interference. But, a Houston personal injury lawyer must prove cause.

Causation isn’t easy to prove in defective product claims. “Experts” testify on behalf of drug companies and swear that the most dangerous drug in history is as safe as mother’s milk.

One thing is clear. Victims need and deserve compensation for their serious injuries. Our experienced defective pharmaceutical attorneys at Williams Hart & Boundas LLP have several alternatives. To find out which alternative is right for you and your family, reach out to us now for a free consultation.

Disclaimer: This material is provided for informational purposes only. The provision of this material does not create an attorney-client relationship between the firm and the reader and does not constitute legal advice. Legal advice must be tailored to the specific circumstances of each case, and the contents of this newsletter are not a substitute for legal counsel. Do not take action in reliance on the contents of this material without seeking the advice of counsel.

The information contained in this blog may or may not reflect the most current legal developments. Accordingly, information in this blog is not promised or guaranteed to be correct or complete, and should not be relied upon as such. Readers should conduct their own appropriate legal research.


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