Facts

On April 30, 2004, plaintiff, a registered nurse and mother of three, went to her doctor's office for a routine programming of a Medtronic intrathecal infusion pump which had been previously implanted in her abdomen to deliver pain medication. A medical technician erroneously entered the time duration in the "minutes" field instead of the "hours" field while programming the pump. The pump delivered 20 hours' worth of morphine in approximately 20 minutes.

The screen in which the technician entered the time duration did not have labels on the fields for hours, minutes, and seconds. As a result, the young mother, Randa Stacey Seargeant, suffered an overdose and lapsed into a coma while driving home from her doctor's office. Randa never came out of the coma and died nine days later on Mothers' Day.

Three separate products were at issue: the intrathecal pump itself, the programmer, and the related application software.

PLAINTIFF'S CONTENTIONS:
Randa Seargeant's death was a result of a defective product combined with medical negligence. Had the medical staff been more attentive to the field in which the data was being entered, Ms. Seargeant would still be alive. Had the product manufacturer designed a safer product or provided adequate warnings of the danger, the death could have been avoided. As to the products at issue, as separate products the components are each required to undergo pre-market approval by the FDA with respect to their exclusive use with a particular product (here the pump), otherwise they are not specifically preempted. Preemption defenses by the medical industry are efforts to shed an important source of market discipline - the threat of liability for visiting unjustifiable harm on others. The functions served by tort law should be treated as a complement to - not a substitute for - the functions served by regulation.

Specials in Evidence

$81,688; $30,455; $188,970; Past-Future loss of household services, $18,792; Future loss of health insurance, $6,614; Funeral and burial costs, $7,822.

Result

$250,000 settlement.

Other Information

The application software for the pump's programmer was later recalled. This action was classified by the Food and Drug Administration (FDA) as a Class I Recall. The FDA defines a Class I recall as a situation where there is a reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death. The manufacturer later distributed replacement software which had time labels on the screen to help reduce the risk of these kinds of programming errors. An important legal and public policy issue relating to the class of medical devices concerned here was whether the Medical Device Amendments of 1976 (MDA) to the Food, Drug and Cosmetic Act (FDCA) preempt a state action for products liability against the device manufacturer. The breadth of preemption is still in question by the Ninth Circuit Court of Appeals.