Drug and device cases regularly involve plaintiffs who have suffered serious injuries, the type that engender sympathy, even from defense attorneys. It’s understandable that a plaintiff who suffered such trauma would turn to the courts for redress. But bad experiences do not make a viable drug or device claim. Drugs and devices have inherent risks, so the law requires more than injury due to those risks for a viable products liability claim. Generally, the injury must result from a defect of some sort, such as a design, manufacturing or warning defect. If a plaintiff doesn’t allege such a defect, the court must dismiss the claim, no matter how traumatic the plaintiff’s injury.

Smith v. Pride Mobility Products Corp., 2016 U.S. Dist. LEXIS 149955 (N.D. Cal. Oct. 28, 2016), illustrates this. The plaintiff was wheelchair-bound and claimed that, while attending a Renaissance Fair, the power to her wheelchair gave out as she was trying to climb a steep hill. Ultimately, the wheelchair went into a free-wheel fall at a sharp angle down the hill, throwing plaintiff from the wheelchair to the ground. Plaintiff claimed serious injury to her neck and knee, permanent disability to one of her toes, whiplash and serious psychological and emotional distress resulting from the event and her injuries.

These allegations no doubt suggest great trauma for the plaintiff. But do they state a claim? The initial consideration for a court is not the severity of the injuries or the trauma that led to them but whether the plaintiff’s allegations are sufficient to state a viable products liability claim. Here, the Smith court did its job. It reviewed plaintiff’s allegations dispassionately and determined that plaintiff had not made the type of allegations necessary to state a manufacturing defect claim:

In order to allege a strict products liability claim under a manufacturing-defect theory, a plaintiff “must identify/explain how the [product] either deviated from [the company’s] intended result/design or how the [product] deviated from other seemingly identical” models of the product.

Here, Plaintiff states that the wheelchair started “freewheeling down [a] hill” after Plaintiff placed the wheelchair in reverse on a hill and that the wheelchair “was either defective or . . . deliberately designed to” freewheel in such a manner. The complaint does not state how the wheelchair that Plaintiff purchased is different from the design of the wheelchair that Defendant intended or from other identical models of the wheelchair. Rather, “Plaintiff[] make[s] only conclusory allegations” that the product is defective, which is insufficient to allege a manufacturing defect claim.

Id. at *25-26 (citations omitted).

As to design defect, the court found that, not only had plaintiff failed to elect the particular design defect theory under which she was proceeding—that is, either the “consumer expectations test” or the “risk-benefit test”—but she had not alleged facts that could support either:

Count Six of Plaintiff’s complaint does not “identify” whether Plaintiff intends to proceed under the consumer-expectations test or the risk-utility test. As discussed above, Plaintiff states that the wheel-chair “was either defective or . . . deliberately designed to freewheel when pushed vigorously back-wards.” Plaintiff alleges that although “such a design might be useful in a nursing home, it should not have been installed in a wheelchair called Go Go Elite Traveler Plus.” This does not identify which theory of design defect Plaintiff intends to assert.

Moreover, in addition to identifying the test that Plaintiff intends to use, Plaintiff’s complaint must “allege facts to support” the test that Plaintiff identifies in order to adequately state a claim for strict products liability.

Id. at 27-28 (citations omitted). The court dismissed this claim as well. Plaintiff’s complaint contained a series of other legal claims, all of which the court dismissed as improperly pleaded, including an attempt to privately enforce FDA regulations.

Reviewing and evaluating a drug and device law claim isn’t always comfortable business for a court. But under TwIqbal and the law it has a well-defined job to do. Smith is an example of a court doing its job.