Articles on Law, Science, and Engineering

Public Policy and the Preemption of State Tort Claims against Medical Device Manufacturers (cont'd)

Why Not Treat Medical Devices the Same as Prescription Drugs?[index]

In many of the cases before the courts, the plaintiffs arguing that there is no preemption for prescription drugs and thus there need not be preemption for medical devices. Plaintiffs assert that products liability actions do not have an adverse effect on the cost and availability of prescription drugs. There is no consensus that this true. Many observers do not believe that forcing prescription drug manufactures to endure both intrusive FDA regulation and unfettered products liability litigation best serves the public interest. A manufacturer may spend 10 years and $300,000,000 to get a drug to market. To then subject that drug to products liability litigation without regard to the significance of the FDA approval process that the drug has undergone raises prices and stifles innovation.

We have seen the impact of this in three areas: contraceptives, drugs for pregnant women, and childhood vaccines. The combined impact of regulation and products liability has nearly eliminated research into new contraceptive agents. There have been no new contraceptive agents brought to the market for more than generation. Even Norplant is just a new packaging for an a decades old agent. (Ironically, Norplant may soon be forced from the market because it is encased in silicone.[4])

Medical problems secondary to pregnancy are one of the major threats to the health of women. Few drugs are developed specifically for these problems, however, and drugs licensed for other purposes are seldom tested for ancillary benefits to diseases of pregnancy. The reason is clear: products liability claims. The Bendectin cases,[5] among others, have demonstrated that however good the scientific evidence for the safety and efficacy of the drug, the courts are unable to deal with the difficult causation issues posed by birth injury cases. Faced with a daunting array of contradictory statistical evidence, they frequently succumb to emotional pleas to compensate the innocent child at the expense of the pharmaceutical manufacturer.

This same difficulties in evaluating statistical causation, combined with the understandable bias toward the injured plaintiff in the courtroom almost destroyed the vaccine industry. Products liability cases drove vaccine prices to unacceptably high levels. The elevated prices still did not make up for the risk of being sued so most manufacturers left the market. Congress was forced to step in and establish a system that preempts most of the traditional products liability claims against vaccine makers.

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