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WPI 110.02.01 Manufacturer's Duty—Design—Unavoidably Unsafe Products—Negligence—Comment K

6 WAPRAC WPI 110.02.01Washington Practice Series TMWashington Pattern Jury Instructions--Civil

6 Wash. Prac., Wash. Pattern Jury Instr. Civ. WPI 110.02.01 (7th ed.)
Washington Practice Series TM
Washington Pattern Jury Instructions--Civil
April 2022 Update
Washington State Supreme Court Committee on Jury Instructions
Part IX. Particularized Standards of Conduct
Chapter 110. Product Liability
WPI 110.02.01 Manufacturer's Duty—Design—Unavoidably Unsafe Products—Negligence—Comment K
A [pharmaceutical] [medical product] manufacturer has a duty to use reasonable care to design [drugs] [medical products] that are reasonably safe. “Reasonable care” means the care that a reasonably prudent [pharmaceutical] [medical product] manufacturer would exercise in the same or similar circumstances. A failure to use reasonable care is negligence.
The question of whether a manufacturer exercised reasonable care is to be determined by what the manufacturer knew or reasonably should have known at the time the product left its control.
In determining what a manufacturer reasonably should have known in regard to designing its product, you should consider the following:
A [pharmaceutical] [medical product] manufacturer has a duty to use reasonable care to test, analyze, and inspect the products it sells, and is presumed to know what such tests would have revealed.
A [pharmaceutical] [medical product] manufacturer has a duty to use reasonable care to keep abreast of scientific knowledge, discoveries, advances, and research in the field, and is presumed to know what is imparted thereby.
NOTE ON USE
Use this instruction in cases involving prescription drugs and medical devices. In cases of other products that may be considered unavoidably unsafe, such as pesticides, the language should be adapted accordingly.
COMMENT
This instruction was discussed favorably in Payne v. Paugh, 190 Wn.App. 383, 410–11, 360 P.3d 39 (2015). See also Rogers v. Miles Lab'ys, Inc., 116 Wn.2d 195, 802 P.2d 1346 (1991); Transue v. Aesthetech Corp., 341 F.3d 911 (9th Cir. 2003) (applying Washington law while holding that comment k applies as a blanket rule to prescription drugs and medical products).
Restatement (Second) of Torts § 402A, comment k (unavoidably unsafe products). Comment k to Restatement (Second) of Torts § 402A identifies a category of products for which a manufacturer cannot avoid a high risk of possible harmful effects. Vaccines with side effects are examples, along with other drugs where the prescription drug can possibly save a patient's life, but the risks of physical harm from the drug itself are substantial, even when the drug is properly manufactured. Comment k explains: “The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.” Under comment k, these unavoidably unsafe products are excluded from the general rule of strict liability, as long as the products are properly prepared and marketed and proper warnings are given.
Comment k applies to cases under the Washington Product Liability Act (WPLA) despite not being mentioned by the Act. Ruiz-Guzman v. Amvac Chem. Corp., 141 Wn.2d 493, 505–06, 7 P.3d 795 (2000) (pesticide); Est. of LaMontagne v. Bristol-Myers Squibb, 127 Wn.App. 335, 111 P.3d 857 (2005) (prescription drug); Payne, 190 Wn.App 383 (endotracheal tube). In cases where comment k applies, the standard of conduct in a design defect case is negligence, not strict liability. Rogers, 116 Wn.2d 195; Young v. Key Pharm., 130 Wn.2d 160, 922 P.2d 59 (1991); Payne, 190 Wn.App. 383; Transue, 341 F.3d 911. For a more complete discussion of comment k as it relates to the WPLA, refer to the Comment to WPI 110.03 (Manufacturer's Duty to Provide Warnings or Instructions With Product) and the extended discussion in Payne v. Paugh, 190 Wn.App. 383, 409–13, 360 P.3d 39 (2015).
The court in Payne v. Paugh, 190 Wn.App 383, 360 P.3d 39 (2015), held that the trial court did not err by refusing to give a supplemental instruction on the risk utility and consumer expectation tests to define whether a medical device is reasonably safe.
The issue in Payne was whether WPI 110.02.01 needed to be supplemented with a definition of “reasonably safe” as set forth in WPI 110.02 (Manufacturer's Duty—Design) (absent the first sentence). The court held as follows:
Under the WPLA and case law, the risk utility and consumer expectations tests are used to determine whether a manufacturer is strictly liable and do not apply to a negligence design defect claim under comment k. And contrary to the assertion of [plaintiff], the Comment K Negligence Instruction addresses the factors the jury should consider in determining whether a medical device manufacturer used reasonable care to design a medical device that is reasonably safe. Specifically, “[i]n determining what a medical device manufacturer reasonably should have known in regard to designing its device,” the jury must consider:
A medical device manufacturer has a duty to use reasonable care to test, analyze, and inspect the products it sells, and is presumed to know what such tests would have revealed.
A medical device manufacturer has a duty to use reasonable care to keep abreast of scientific knowledge, discoveries, advances, and research in the field, and is presumed to know what is imparted thereby.
The court did not err in refusing to give the supplemental jury instruction. The instruction the court gave to the jury correctly describes the duty of a manufacturer of unavoidably unsafe products in designing reasonably safe medical devices under comment k of the Restatement (Second) of Torts section 402A.
Payne, 190 Wn.App. at 412–13.
The trial court jury instruction discussed in Payne changed the time when a medical product manufacturer is to be judged under WPI 110.02.01 from “at the time of the plaintiff's injury” to “at the time the product left its control.” Payne, 190 Wn.App. at 411. The WPI Committee has made this change to the jury instruction which conforms to the language in WPI 110.21 (Burden of Proof—Design—No Affirmative Defense).
While the standard is negligence for comment k products when a design defect is claimed, the standard is strict liability for comment k cases involving a failure to warn. Taylor v. Intuitive Surgical, Inc., 187 Wn.2d 743, 389 P.3d 517 (2017); see Comment to WPI 110.03 (Manufacturer's Duty to Provide Warnings or Instructions with Product).
[Current as of December 2020.]
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