CHAPTER § 9.02 Common Defenses

JurisdictionUnited States

§ 9.02 Common Defenses

[1] The Restatements

Section 402A of the Second Restatement provides that a manufacturer is strictly liable in tort for injuries caused by its defective products.1 Comment k to Section 402A and Section 6 of the Third Restatement carve out exceptions to strict liability for prescription drug and medical-device manufacturers. However, these exceptions to liability are not themselves without limitation. Most courts to consider the issue have rejected manufacturers' arguments that fhese two provisions provide blanket immunity to strict liability for a design defect.

[a] Restatement (Second) of Torts, Section 402A, Comment k

Restatement (Second ) of Torts, Section 402A, comment k (hereinafter "comment k") provides an exception from strict liability for manufacturers of "unavoidably unsafe" products. Comment k recognizes that "[t]here are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs."2 The vaccine for the treatment of rabies, for example, leads to "very serious and damaging consequences when it is injected."3 Since the disease the vaccine seeks to treat "invariably leads to a dreadful death," marketing and use of the vaccine are "fully justified, notwithstanding the unavoidable high degree of risk which they involve."4 Accordingly, "[s]uch a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous."5

The majority of jurisdictions that have considered the matter have adopted comment k.6 Nevertheless, even among jurisdictions adopting comment k, different courts have applied the doctrine differently. A minority of jurisdictions, including California, Pennsylvania, Utah, and Washington, have concluded that comment k provides pharmaceutical manufacturers a blanket immunity from a strict-liability design-defect claim.7 The majority treat comment k as an affirmative defense and utilize the risk-utility test to determine whether it applies.8

[i] Interpreting Comment k as a Blanket Immunity

A minority of jurisdictions have adopted comment k as barring a plaintiff from prevailing on a design defect claim against a seller of a prescription drug when the drug was sold with adequate warnings of the health risks posed by the drug's use of which the seller knew or should have known at the time of the sale.9 The California Supreme Court, for example, adopted this interpretation and concluded that the public interest would best be served by requiring plaintiffs to proceed on theories of manufacturing defect, negligence, warranty, misrepresentation, or failure to warn, rather than strict liability. As explained by the court:

If drug manufacturers were subject to strict liability, they might be reluctant to undertake research programs to develop some pharmaceuticals that would prove beneficial . . . because of the fear of large adverse monetary judgments. Further, the additional expense of insuring against such liability . . . and of research programs to reveal possible dangers not detectable by available scientific methods could place the cost of medication beyond the reach of those who need it most.10

[ii] Risk-Utility Analysis Under Comment k

Most jurisdictions applying comment k do so on a case-by-case basis, believing that societal interests in ensuring the marketing and development of prescription drugs will be adequately served without the need to resort to blanket immunity. These jurisdictions treat comment k as an affirmative defense to strict liability and use a risk-utility test to determine whether the defense applies.11 The burden of proving the various risk-utility factors rests with the defendant.12 Accordingly, courts in these jurisdictions interpret comment k as excepting prescription drugs "from strict liability when it is shown that: (1) the product is properly manufactured and contains adequate warnings, (2) its benefits justify its risks, and (3) the product was at the time of manufacture and distribution incapable of being made more safe."13 As explained by the Florida Court of Appeals:

a more selective application [of comment k] will encourage, rather than discourage, improvements in prescription products Comment K was designed in part to protect new and experimental drugs. . . . Comment k states: "There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use." Obviously, for this to be true, the design must be as safe as the best available testing and research permits. . . . Thus, a product which is as safe as current testing and research permits should be protected. The reverse is also true; a product which is not as safe as current technology can make it should not be protected.14

In making this risk-utility determination, courts rely on several factors, including the usefulness and desirability of the drug, the probability and magnitude of potential injury, the availability of substitutes, a manufacturer's ability to eliminate the unsafe characteristics of the drug, the user's ability to avoid danger, the user's awareness of the danger, and the manufacturer's ability to spread the loss.15 The availability of a reasonable alternative design is often considered.16

[iii] Negligent-Design Claims in Prescription-Medication Cases

Given comment k's general bar on strict liability claims for design defect against prescription drug manufacturers, some courts have held that the plaintiff may proceed against a prescription drug manufacturer with a claim for negligent design.17 A "negligent design" claim, however, is arguably inconsistent with comment k which recognizes that prescription medications are unavoidably unsafe, i.e., there are no alternative designs for prescription drugs that would render them entirely safe.18 Underlying comment k is the notion that there are no available alternative designs for most prescription drugs, because to modify the design of a prescription drug, one must modify the drug's composition, formula, or ingredients, which essentially results in changing the drug into an entirely new, different compound or drug.19 It is also important to consider that a manufacturer lacks any authority under the existing FDA regulatory framework to change its drug's design, formula, or composition without first obtaining FDA approval.20 Thus, it remains to be seen whether additional courts will permit plaintiffs to proceed with negligent-design claims against prescription drug manufacturers.

[b] Restatement (Third) of Torts: Products Liability, Section 6

In an attempt to resolve the split of authority in interpreting comment k, the Restatement (Third) of Torts: Products Liability, Section 6(c) provides:

A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients.21

The Third Restatement advocates:

that prescribing health-care providers, when adequately informed by drug manufacturers, are able to assure that the right drugs and medical devices reach the right patients; and second, that governmental regulatory agencies adequately review new prescription drugs and devices, keeping unreasonably dangerous designs off the market.22

Accordingly, "a drug is defectively designed only when it provides no net benefit to any class of patients."23 This standard is satisfied not merely through evidence that some providers prescribe the defendant's product, but:

whether, objectively viewed, reasonable providers, knowing of the foreseeable risks and benefits of the drug or medical device, would prescribe it for any class of patients. Given this very demanding objective standard, liability is likely to be imposed only under unusual circumstances.24

Courts have treated the Restatement (Third) with skepticism. For example, persuaded by several scholarly criticisms of Section 6(c), the Nebraska Supreme Court concluded that it was "too strict of a rule, under which recovery would be nearly impossible."25 The court was persuaded by the argument that the "reasonable-physician" standard is artificial and difficult to apply, as it asks a jury to presume that physicians have more knowledge about prescription drugs than the manufacturer, while ignoring the fact that physicians tend to prescribe drugs with which they are familiar, even when studies indicate better alternatives.26 Additionally, the court was concerned that a manufacturer could too easily retain an expert to testify that the drug at issue has some benefit to a single class of people, thereby shielding pharmaceutical companies from liability they would otherwise incur under comment k.27

At least one court, however, has applied Section 6(c).28 A federal district court in Arizona rejected the plaintiff's claim that the defendant's medical device was defectively designed on the ground that the plaintiff "failed to demonstrate that a reasonable health-care provider would not prescribe the [device] for any class of patients and thus that the [device] was defectively designed."29

[2] Statutes of Limitations and Repose

In defense of a product liability lawsuit, pharmaceutical drug and medical device manufacturers may, depending on the factual circumstances, assert that the plaintiff's lawsuit should be dismissed because he failed to file it within the time prescribed by the applicable statute of limitations and/or statute of repose.

[a] Statutes of Limitations

Statutes of limitations, which vary by jurisdiction, require a tort claimant to file his lawsuit within a certain period of time following either the...

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