Victims Still Seeking Product Liability Damages for Dangerous Drug

A painful public memory was reawakened late last week when the Gruenenthal Group, which introduced the drug thalidomide in the 1950s, issued an apology to thousands worldwide who suffered severe birth defects after their mothers took thalidomide during pregnancy. The gesture brought no closure for thalidomide victims who have yet to be appropriately compensated for their injuries and disabilities, because the apology came with a reminder by Gruenenthal’s chief executive that the company has no intention of compensating victims for losses caused by the drug.

Thalidomide: Dangerous Drug
Prescribed until 1961 as a panacea for morning sickness, thalidomide interfered with fetal development, leaving its victims with shortened or completely absent limbs, and with other disabling, and often fatal, abnormalities of the heart, genitalia, eyes, and ears. The approximately 12,000 known victims of thalidomide were concentrated throughout Europe (including the U.K.), Australia, Japan, and Canada, where the drug had been approved for use during pregnancy. Even in the U.S., where thalidomide was distributed only on an ‘investigational’ basis, at least 17 children were born with the drug’s characteristic adverse effects. The accommodations those surviving thalidomide victims ended up needing simply in order to get through life turned out to be extensive and costly.

Despite Gruenenthal’s steadfast denial, over the years, of any obligation to compensate thalidomide victims for their injuries, advocates for compensation have never given up their fight, even as the population of thalidomide victims has aged. In the U.S., Gruenenthal, along with British firm GlaxoSmithKline and multinational pharmaceutical developer Sanofi-Aventis, have been named in lawsuits that seek damages based on these companies’ connections with the business entities that originally made thalidomide available to pregnant women in the U.S.

Dangerous Drug Claims
Thalidomide, which is used relatively safely, today, to treat a variety of conditions in non-pregnant patients, worked its notorious fetal harms through undetected or undisclosed side-effects. Also, many claims involve marketing practices that deprived thalidomide prescribers and users of clinical testing information that could have provided notice of serious risks.

Undisclosed dangerous side-effects, failures to limit drug use to safe contexts, and improper marketing are, in fact, often the bases for dangerous-drug damage claims against drug manufacturers and distributors. Manufacturing defects and drug tainting (which may occur during bottling and shipping) are yet another basis for liability recognized under drug product liability law.

Liability Principles

The manner in which a dangerous drug ultimately harmed a patient is likely to influence the legal principles that will form the basis for that patient’s claims for compensation. Where manufacture, bottling, or shipping practices produced a defect in, or tainting of, a drug, competent product liability attorneys may be inclined to assert the principle of ‘strict liability,’ under which solid proof of the mere presence of a harmful defect to which a patient’s injuries may be traced will carry the day.

Where undisclosed side-effects, or misleading or careless marketing practices, led to use of a drug that later caused injuries, counsel may, instead, opt to base claims on negligence theory. This requires a showing that the parties sued owed the injured party a legal duty to warn of risks or use restrictions and these parties failed to fulfill that duty and ultimately causing harm.

Fortunately, Florida legislation makes a variety of legal strategies available to individuals injured by any dangerous product, and the available strategies include both strict liability and negligence. Only after a thoughtful analysis of the facts in any given case, against the backdrop of relevant medical documentation and literature, will a Florida product liability attorney make the important decision of how to proceed.

If you suspect that you or a loved one may have been harmed in this way, contact Miami dangerous drug attorneys at Gerson & Schwartz P.A. We are available for free consultations and can be reached at (305)371-6000 or

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