PERSONAL INJURY I PRODUCT LIABILITY I CASE STUDY: Manufacturers have a Heightened Duty to Warn of Known Vaccine Harms – Marketing and Warning Defects

VACCINE DEFECTS I VACCINE WARNINGS I VACCINE FAILURES I PERSONAL INJURY I PRODUCT LIABILITY I CASE STUDY: Manufacturers have a Heightened Duty to Warn of Known Vaccine Harms – Marketing and Warning Defects

March 05, 2021

As discussed in our previous strict product liability articles, strict product liability can be established when a consumer shows that the manufacturer of a consumer product breached its duty to warn. The consumer’s burden of proof can be established by showing either: (a) that the manufacturer did not warn of a known danger; or (b) the manufacturer of a consumer product gave inadequate warnings. Basko v. Sterling Drugs, Inc. 416 F.2d 417

Vaccine Defects Give Rise to Product Liability Claim

In the precedent case; Reyes v. Wyeth Labs., 498 F.2d 1264 (5th Cir. 1974), the court looked at vaccine warnings in a product liability case.  In Reyes, the court evaluated the scope of drug manufacturer’s duty to warn consumers of the inherent dangers of the vaccine. The precedent case looks to vaccine warnings and the adequacy of such warnings to determine whether or not a vaccine is deemed defective for product liability purposes.

In Reyes v. Wyeth Labs., 498 F.2d 1264, an eight-month baby was diagnosed as having paralytic poliomyelitis two weeks after she received a dose of the defendant drug manufacturer’s polio vaccine. In response, the baby’s parents sued the vaccine manufacturer alleging that the live polio virus in the vaccine caused the baby’s polo and the manufacturer is liable because they failed to warn of this known danger. Following a prolonged jury trial, a verdict was entered in favor of the injured baby and the vaccine manufacturer was held liable for its failure to warn. Specifically, the jury found that the manufacturer had a duty to market and inform potential customers of the dangers of the vaccine.  Further this duty was heightened since the drug manufacturer had knowledge of the vaccine’s harmful possibilities.

In this instance the vaccine manufacturer knew of potentially life-threatening dangers associated with their product.  Despite this knowledge they failed to disclose the potential side effects of the vaccine. The vaccine in this instance was not inherently defective or unreasonably dangerous because it contained a living virus; rather, it was the lack of adequate warnings that made the vaccine “unreasonably dangerous as marketed”.

Vaccine Defective Due to A Lack of Adequate Warning

The vaccine discussed in the precedent case is a product which the law considers an “unavoidably unsafe product” which may be marketed with adequate warnings and proper directions. An unavoidably unsafe product may be sold to the public without being considered defective or unreasonably dangerous, assuming it is accompanied with adequate warnings and proper directions for use.  It is the failure to give these adequate warnings or proper use directions which make the product defective and unreasonable dangerous as marketed.


A product liability claim based on failure to warn requires the consumer to establish the following: (1) that the manufacturer or seller owed a duty to warn the consumer; (2) the manufacturer or seller breached that duty; (3) the failure to warn or the inadequate warning was the proximate cause of the consumers injuries; and (4) the consumer suffered damages as a result of the warming defect. Dreyer v. Exel Indus., S.A., 326 Fed. Appx. 353.

When focusing on the breach of duty, the injured consumer must establish that at the time the defective product left the control of the manufacturer or seller, the  manufacturer or seller knew or had constructive knowledge of the danger that caused the consumer’s injuries and that the ordinary user of the product would not have realized its dangerous condition. Jowers v. Lincoln Elc. Co., 617 F.3d 346.

For more articles discussing product liability please see the links below:

There are two types of product liability claims.  The distinction between strict product liability claims versus negligent product liability claims are discussed in the articles linked below:

Additional articles discussing compensatory damages in personal injury actions, including negligence, premises liability and product liability cases are linked below:

To better understand what types of damages are recoverable in product liability cases and other personal injury cases, links are included below:

Product Liability Lawyer

If you or someone you know has been injured by a defective product or sustained an injury while using a product, call us today at 619-432-5145 for a free consultation with one of our experienced La Jolla product liability attorney and San Diego personal injury lawyer.

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