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Product Liability for Defective Design, Part 2

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Product Liability for Defective Design – Part 2

            In the first part of this presentation, we introduced the concept of product liability for defective design, differentiated it from other forms of product liability and looked at the risk-utility test for determining whether a design is defective.

An alternative approach to design defect is called the consumer expectation test. Under this test, a manufacturer may be liable if a product fails to perform as safely as an ordinary consumer would expect when used in a reasonably foreseeable manner.[1]

However, in many cases, the questions of how a device should function and what design would make it safe are ones that most people are not in a position to answer. So, the consumer expectation test has been limited to cases in which the design defect is obvious and apparent to most average users.[2]

Sometimes products, however, are simply unavoidably unsafe. These are cases in which the products are unsafe even if used exactly as intended. There are no reasonable alternative designs which would make the product safe. Guns, cigarettes and many prescription drugs are examples of unavoidably unsafe products. Holding these products to the same standards as other products would always make the manufacturers liable for injuries caused by these products.

Therefore, these products cannot be considered defective merely because they are unsafe. Instead, the question is whether they have been made as safe as reasonably possible even while conceding that they are inherently dangerous products. Factors relevant to this decision include the usefulness of the product, how efficiently safety mechanisms can be built into the product, the availability of safer products that achieve similar goals, the possibility of decreasing the danger during the manufacturing process and the awareness of the standard user of the danger. If the product is properly prepared and accompanied by proper directions and warnings, it will not be considered defective.  [3]

Prescription Drugs

One special area of design defects law is liability for defective prescription drugs and medical devices.

The law recognizes that the area of medicine presents a unique set of risks and benefits. In medicine, what may be helpful for some can be harmful for others. Holding drug manufactures liable when a customer is negatively impacted by their product can reduce the supply of a drug which may be effective for others in different circumstances. For this reason, the standard for establishing liability in these cases is different than for non-medical products.[4]

The standard is that as long as a prescription drug or medical device has usefulness to any class of patients, it is not considered to have a design defect even if it is harmful to other patients.[5] To succeed in a case for design defect, it must be shown that the foreseeable risks so far outweigh the benefits that reasonable health care providers would not prescribe the drug or device to any class of patients.[6]

While this high standard does limit liability for design defect, there are other means of preventing unreasonably dangerous drugs and medical devices from reaching consumers. Prescription drugs and medical devices are regulated the by the Food and Drug Administration. One reason that courts are hesitant to find liability in cases where some class of patients benefits from a medical product is that the legal system tends to defer to the FDA to determine the risks and potential harms of a product.[7]

In this vein, some jurisdictions have passed legislation that recognizes a regulatory compliance defense to claims of design defect. This legislation absolves drug companies of fault for defective medical products if the drug in question has been approved for use by the FDA.[8]

Still, even if the drug or device is not inherently defective, the law imposes an obligation to warn health care providers and/or patients of foreseeable risks associated with the medication or medical device.[9] The duty to warn is primarily a duty to inform a physician or other health care provider of the risks associated with the product, but can also apply to the end user if it’s possible and practical to warn the patient. In fact, most product liability cases for prescription drugs are decided based on the adequacy of the warning (or lack thereof).

Note, however, that failure to warn will only create grounds for liability if the warning would have impacted a physician’s decision to prescribe a drug.

 In one case, the widow of depressed patient who committed suicide after taking an anti-depressant sued the drug manufacturer for failing to warn the prescribing physician of the suicidal tendencies associated with the drug. The court dismissed the action, relying on the fact that the physician in question was familiar with the risks of the drug when he prescribed it. Thus, there was no evidence that the physician would have behaved differently if a warning had been provided.[10]


An important manifestation of the way in which prescription drugs are treated is the National Childhood Vaccine Injury Act of 1986. That act eliminated manufacturer liability for unavoidable adverse side effects of vaccines and created a no-fault compensation program for victims of vaccine side effects, severely limiting the potential liability of vaccine manufacturers.[11] In 2011, the Supreme Court ruled that this law not only prevents most federal product liability lawsuits against vaccine manufacturers, it also preempts state causes of action, meaning that vaccine manufacturers cannot be sued in federal or state court except in accordance with the 1986 federal Act. This rule was passed to stabilize the vaccine market, which had been adversely affected by vaccine related mass tort litigation.[12]


When facing a claim for design defect, courts will be guided by the legal principles we have presented here, with the risk-utility test as the prevalent standard. However, design defects is the area of products liability law in which industry standards plays a central role. The questions before a court dealing with a design defect claim will often be as much technological and economic as legal.

Legal professionals who regularly deal with products liability, and design defects , should endeavor to keep up with industry developments, and pay close attention to the latest medical trends as well as legal decisions, to be up to date in this fast-changing field.


[1] Barker v. Lull Engineering Co., 573 P.2d 443, 20 Cal. 3d 413, 143 Cal. Rptr. 225 (1978).

[2] Pruitt v. General Motors Corp., 86 Cal. Rptr. 2d 4, 72 Cal. App. 4th 1480 (Ct. App. 1999).

[3] Restatement (2nd) of Torts: §412A, comment k

[4] Restatement (3rd) of Torts: Prods Liab., §6, comment b.

[5] Restatement (3rd) of Torts: Prods Liab., §6, comment b.

[6] Restatement (3rd) of Torts: Prods Liab., §6(c).

[7] Restatement (3rd) of Torts: Prods Liab., §6, comment b.

[8] See N.J. Code §2A:58C-4.

[9] Restatement (3rd) of Torts: Prods Liab., §6(d)(1)-(2).

[10] Motus v. Pfizer Inc. (Roerig Div.), 358 F.3d 659 (9th Cir. 2004).

[11] 42 U. S. C. §300aa–22(b)(1)

[12] Brueseqitz v. Wyeth, LLC, 562 U.S. 223 (2011)