PERSONAL INJURY I PRODUCT LIABILITY I CASE STUDY: Bleeding Implant Sets the Precedent for Strict Product Liability


February 18, 2021

A strict product liability claim is based on an allegation that a consumer product was defectively designed.  Whether a product is unreasonable dangerous and otherwise defective is a question of fact for a jury to decide in a product liability jury trial or a judge while presiding over a product liability bench trial.

Strict product liability is defined as a matter of law as negligence per se. In order for an injured consumer to prevail in bringing a strict product liability claim the plaintiff must show:

(1) that the defective consumer product was unreasonable dangerous due to a defective condition;

(2) that the defect existed at the time the consumer product left the defendant’s control; and

(3) the defective consumer product was the cause of the plaintiff’s injuries.

Strict Product Liability, How is it Alleged in Product Liability Cases?

One of the precedent cases defining “strict product liability” is Barrow v. Bristol-Myers Squibb Co., Case No: 96-689-CIV-ORL-19B; 1998 U.S. Dist. LEXIS 23187, (M.D. Fla. Oct. 29, 1998). In the Barrow case, the injured consumer was a recipient of defective silicone gel breast implants. The injured consumer filed an action against the manufacturer and designer of the breast implant alleging among other things strict product liability. In her allegation the injured consumer alleged that the silicone implants caused systemic disease and local injuries due to a silicone gel bleed. While the recipient of the bleeding breast implants was unable to prove all her damages to a “reasonable medical probability”; she was able to prove to a reasonable medical certainty that the defective silicone gel implants caused a foreseeable chronic foreign body reaction. In their holding where they found for the recipient, the court concluded: “that (1) under either a consumer expectation standard or a risk-benefit/utility standard, the design of the implant was defective, establishing strict liability, (2) the failure to warn physicians of the silicone gel bleed rendered the implants defective in both strict liability and negligence, (3) the recipient could not recover on a breach of warranty claim due to a lack of privity with the manufacturer, (4) the manufacturer was liable in fraud for purposefully concealing the silicone gel bleed, and (5) the implanting physician was not a learned intermediary because he had no knowledge of the silicone gel bleed.” Barrow v. Bristol-Myers Squibb Co., CASE NO. 96-689-CIV-ORL-19B, 1998 U.S. Dist. LEXIS 23187 (M.D. Fla. Oct. 29, 1998)

In this instance the manufacturer and designer of the breast implant was held to be strictly liable on two grounds: (1) for failure to warn physicians of the silicone gel bleed and (2) for creating a defective consumer product in which the risk outweighs the benefit. Consumers injured by a manufacturing defect, design defect and/or a failure to warn have apersonal injury claim. More specifically consumers injured by a product may have a viable product liability lawsuit if there were inadequate product warnings. California product liability law recognizes that even a flawlessly designed and produced product may nevertheless possess such risks to the user when the warning is either inadequate or absent. Even a flawless product without a suitable warning becomes “defective” simply by the absence of a warning.  Thus, manufacturers have a duty to adequately warn consumers about the hazards inherent in their products.

For more articles discussing product liability cases and strict 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:

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 product liability attorneys and California personal injury lawyers.

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