Legal Brief: What Happens if Your Product Delivers a Lawsuit?

Attorney Erica Stump presents a thorough overview of products liability for supplement manufacturers.

Erica Stump, Erica Stump

March 24, 2014

6 Min Read
Legal Brief: What Happens if Your Product Delivers a Lawsuit?

Products liability is the area of the law that governs entities responsible for placing products, e.g., dietary supplements, into the stream of commerce and determines who is liable if the prescribed standard of care is not met. When a “defective” supplement causes injury, the manufacturer of the product, the distributor, the wholesaler and the retailer who sold the supplement may all be liable to the plaintiff.

In the United States, the claims most commonly associated with product liability are negligence, strict liability, breach of warrant, and various consumer protection claims. The majority of product liability laws are determined at the state level and vary widely from state to state. Each type of product liability claim requires different elements to be proven to present a successful claim.

Negligence and strict liability are the most common theories used to recover against a manufacturer. The general rule regarding negligence cases is that if it is reasonably foreseeable that a product will create a risk of death or injury to a plaintiff if the product is not carefully made or supplied, the manufacturer and supplier have a duty to carefully manufacture and supply the product.  

In order to prevail on a negligence claim against a manufacturer, a plaintiff must prove: (1) a duty owed; (2) a breach of that duty; (3) the breach was the cause in fact of the plaintiff's injury (actual cause); (4) the breach proximately caused the plaintiff's injury; and (5) the plaintiff suffered actual quantifiable injury (damages).

Strict liability is the easiest theory to recover because it focuses on the product itself and not on the conduct of the manufacturer. Most states hold manufacturers and suppliers strictly liable for the injuries their defective products cause. Strict liability was established as a matter of public policy because of the danger involved in placing damaged or defective products into the stream of commerce.

There are several rationales for imposing strict liability. First, the manufacturer is in a much better position to avoid a risk of loss than the consumer is. Second, more often than not, negligence is too hard to prove in products liability cases and strict liability represents the only way an injured plaintiff could recover for his injuries and, third, the threat of liability without fault hopefully acts as an incentive for manufacturers to make sure that their products are safe. 

Strict liability does not automatically mean that a plaintiff will recover if injured.  In order for a manufacturer to be found strictly liable, the plaintiff must prove that the product was defective, that the defect was caused by the manufacturer or supplier, and that the defect caused the plaintiff’s injuries.

Thus, under the rule of strict liability, to hold a dietary supplement manufacturer liable, a person injured when taking a supplement product need only show that: (1) the supplement product was defective; (2) it was used as intended; and (3) the defect caused the injury. The care used in the manufacture of the supplement product is irrelevant to the determination of liability.

The only issue in a supplement product liability case is the defectiveness of the supplement product, not the manufacturer’s conduct in somehow allowing the defect to arise. As a result, proof of negligence is not required to recover damages.

So, with that out of the way…

What is a “defective” supplement?

A defective supplement may include a supplement that is contaminated if the contamination caused the injury. A defective supplement may include a supplement that is adulterated under DSHEA if the defect causes injury. Additionally, a defective supplement may include a supplement that contains an ingredient that requires an NDI (new dietary ingredient) notification and does not have one if the ingredient causes the injury.  Similarly, a defective supplement may include a supplement that is not compliant with California’s Proposition 65 if the higher level of non-compliant ingredient cases injury.  

Contamination is fairly obvious –the product contains something that it should not contain.  Violation of California’s Proposition 65 is fairly clear as well – the statutory limits are set forth in the Code. The other concepts are not quite as clear. 

What is an adulterated supplement under DSHEA? 

Dietary supplements are regulated under 21 U.S.C. § 342(f)’s general food regulations. According to 21 U.S.C. § 342(a), as a type of “food,” a dietary supplement is generally “adulterated” within the meaning of § 342 if it “bears or contains any poisonous or deleterious substance which may render it injurious to health[.]” Additionally, § 342(f) states that a supplement is “adulterated” if, among other things, it contains a dietary ingredient that “presents a significant or unreasonable risk of injury” when used as directed or as commonly used or contains a dietary ingredient that is adulterated as defined by the regular definition of adulterated food.

When does an ingredient need a NDI notification pursuant to DHSEA? 

DSHEA provides that “new” dietary ingredients in food supplements must be notified to the FDA at least 75 days before they are offered or marketed in the U.S., unless the NDI and any other dietary ingredients in the dietary supplement “have been present in the food supply as an article used for food in a form in which the food has not been chemically altered.” The chief purpose of the notification is to provide the FDA with the basis for the marketer’s belief that the NDI will be reasonably expected to be safe under the proposed conditions of use. If the FDA is not notified at least 75 days before the NDI is offered or introduced into interstate commerce, the FDA considers both the NDI and the products in which it is used to be unlawfully on the market. 

What can a manufacturer do to avoid or limit its liability? 

It should perform its own investigation of each ingredient that a company asks it to include in a supplement. This may entail a great deal of research as to whether an ingredient is DSHEA complaint, which may be very costly. In lieu of that, a manufacturer could require the company to submit proof of DSHEA compliance from its legal and regulatory attorney. A manufacturer should also include indemnification language in its manufacturing agreement with its customers to ensure that the company be responsible for any liability that the manufacturer may face because of its decision to manufacture a product containing an ingredient that it is not sure whether it may face liability down the road.

About the Author(s)

Erica Stump

Erica Stump

Erica W. Stump  is an intellectual property (IP) and dietary supplement regulatory compliance attorney. Her practice focuses on the legal challenges that face dietary supplement and food companies, including trademark and trade dress infringement, false advertising, counterfeiting, unfair competition and patent infringement.

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