Products Liability Law Daily Design defect and failure to warn claims against field drug testing kit manufacturer unsupported by evidence
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Monday, September 11, 2017

Design defect and failure to warn claims against field drug testing kit manufacturer unsupported by evidence

By Kathleen Bianco, J.D.

An individual who claimed to have been wrongfully arrested and detained in jail for over six months based on an allegedly defective field drug testing kit’s false positive result for methamphetamine failed to present adequate evidence to support her design defect and failure to warn claims against the kit’s manufacturer, a federal district court in California ruled in a tentative order granting the manufacturer’s motions for judgment on the negligence and products liability claims (Michel v. United States of America, September 8, 2017, Curiel, G.).

On June 2, 2014, an individual crossing into the United States at the San Ysidro Port of Entry was detained and eventually arrested after a federal officer discovered a bottle of an unknown substance hidden in her vehicle. Upon discovery of the bottle, the officer conducted a test of the substance using a field drug test kit, which rendered a positive result for methamphetamine. An extensive search of the vehicle uncovered four more bottles of the unknown substance, which also tested positive for methamphetamine. The individual was arrested as a result of the positive drug test.

After the arrest and detention, the substance was sent to a Drug Enforcement Agency (DEA) laboratory for further testing. The DEA lab conducted several different tests on the substance. The first test rendered a positive result; however, a confirmative gas chromatography mass spectrometry test ultimately determined that the substance was not a controlled substance. On December 4, 2014, a motion to drop the charges was filed by the government. The court granted the motion on December 8, 2014, and the individual was released the next day.

In February of 2016, the individual filed suit against the United States government, three individual government employees, and the manufacturer of the field drug testing kit. Pending before the court was the testing kit manufacturer’s motion for summary judgment on the negligence, product liability, and unfair business practice claims against it. The plaintiff’s negligence and product liability claims were based on design defect and failure to warn.

Design defect claims. The plaintiff alleged design defect claims based in both negligence and product liability. The negligence claim contended that the testing kit was not reliable and accurate as marketed, and the product liability claim asserted that the product was defective because it provided a false positive result on the substance found in the plaintiff’s vehicle. To establish a design defect claim, a plaintiff must show that: the product was placed on the market; there was knowledge that it would be used without inspection for defect; the product proved to be defective; and the defect caused injury. The manufacturer challenged the claims, asserting that the plaintiff failed to demonstrate that a defect in the product caused her injury. The plaintiff’s contention that the defect was in the false marketing of the product was unavailing because she failed to provide any legal analysis supporting that argument. As such, the manufacturer tentatively was entitled to judgment on the design defect claims due to the plaintiff failure to establish a required element—a defect—of the claims.

Failure to warn. The plaintiff further alleged that the manufacturer had been negligent in failing to warn users (Custom and Border Patrol officers) that they could not base their probable cause to arrest solely on the positive test result generated by the field testing kit because the product was inaccurate, unreliable, and defective. The manufacturer asserted various defenses to this claim, including: (1) absence of a defect; (2) no causation; (3) the sophisticated user doctrine; and (4) the sophisticated intermediary doctrine. The manufacturer’s argument based on the lack of a defect was rejected because California courts have held that products that are flawlessly designed can still be defective if put in the hands of users without adequate warnings.

As to the claim of no causation, the court agreed, finding that the lack of a warning to the officer on the use of the product did not cause the plaintiff’s injury. The court reasoned that, based on the facts alleged, the plaintiff’s arrest was lawful and not solely based on the false positive test result but on the totality of the circumstances. Thus, the absence of the warning to the CBP officers did not cause her prolonged detention.

The manufacturer also asserted defenses based upon the sophisticated user and the intermediary user doctrines. Under these doctrines, a manufacturer is relieved of its liability for failure to warn where the user of the product already knows, or should know, about the product’s dangers. Because the manufacturer claimed that the CBP was the sophisticated user and not the actual users of the product (i.e., the CBP officers), the sophisticated user doctrine did not apply in this case. However, the sophisticated intermediary defense was applicable and did bar the failure to warn claims because the warnings were provided to the CBP, which in turn dictated the policies and procedures to be followed by officers using the testing kits. Thus, even if the warnings were provided directly to the officers, the officers were still required to follow police and agency procedures, which could not be overridden by the manufacturer. Thus, the failure to provide warnings to the officer did not cause the plaintiff’s injuries.

The case is No. 16CV277-GPC (AGS).

Attorneys: Eugene G. Iredale (Iredale & Yoo, APC) for Doyma Vanessa Michel. Steve B. Chu, U.S. Attorney's Office, for U.S. Customs and Border Protection. David A. Turner (Yukevich Calfo & Cavanaugh) for Safariland, LLC.

Companies: Safariland, LLC

MainStory: TopStory DesignManufacturingNews WarningsNews DefensesLiabilityNews MedicalDevicesNews IndustrialCommercialEquipNews CaliforniaNews

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