March 1, 2000

Florida Recognizes a Cause of Action for Medical Monitoring

Holland & Knight Newsletter
Chris N. Kolos

For the first time, a Florida appellate court has recognized a cause of action for medical monitoring where the plaintiff has yet to develop an identifiable physical injury or symptom. In Petito & Stubbs v. A. H. Robbins Company, Inc., 25FKWD19 (Fla. 3d DCA Dec. 22, 1999), the plaintiff filed a statewide class action against the defendant manufacturers of Fenfluramine and Phentermine (Fen-Phen), the much publicized pharmaceutical weight-loss products. Though plaintiffs had no current physical injury as a result of using these drugs, they claimed that ingesting them had placed them at a substantial increased risk of developing serious cardiac and circulatory ailments including heart valve damage. The plaintiffs sought an injunction requiring the defendants to fund a court-supervised medical monitoring program, which would provide for medical testing, monitoring and a study of the plaintiffs and those similarly situated for conditions caused by their use of Fen-Phen. The plaintiffs contended that this monitoring was medically reasonable and necessary. The defendants argued that the case should be dismissed because Florida does not and should not now recognize a pre-injury claim for future expenses of medical diagnosis. The lower court granted their motion to dismiss and the plaintiffs appealed. The Florida Third District Court of Appeals reversed and recognized a cause of action for future expenses for medical diagnosis. The court reasoned that, although it did not believe that plaintiffs should be able to recover lump sum damages in anticipation of future diagnostic expenses, it is proper to create and supervise a fund for the purpose of monitoring the condition of the plaintiffs when it has been shown that such monitoring is reasonably necessary. The court further held that, should plaintiffs develop an injury in the future, they would not be precluded from suing again to recover damages for those injuries. The court held that "the rule against splitting causes of action should not be rigid and inflexible such as to defeat the ends of justice."

To sustain a cause of action for medical monitoring, the plaintiffs must prove the following:

  • exposure to greater than normal background levels
  • exposure to a proven hazardous substance
  • caused by the defendant’s negligence
  • as a proximate result of the exposure, plaintiff has a significantly increased risk of contracting a serious latent disease
  • a monitoring procedure exists that makes the early detection of disease possible
  • the prescribed monitoring regime is different from that normally recommended in the absence of exposure
  • the prescribed monitoring regime is reasonably necessary according to contemporary scientific principles

The court also discussed certain procedures necessary to the court’s supervision of the medical monitoring program. The court held the following steps were appropriate:

  • the appointment of a plan administrator
  • the approval of an advisory panel of persons qualified and knowledgeable in the field to: (a) establish a plan where only persons who consumed the harmful medication or hazardous substance may participate; (b) establish the minimal number and types of diagnostic tests or procedures that will be performed including the extent of duration; (c) select a list of highly knowledgeable, skilled, competent and neutral examining physicians to perform the test
  • establish a notification process sufficient to bring the opportunity for monitoring to the attention of persons who consumed the medication or were exposed to the hazardous substance
  • establish a time frame for those eligible to obtain the monitoring
  • implement procedures whereby the monitoring physicians submit their reports and findings together with a statement of their charges directly to the plan administrator who shall promptly pay the reasonable amount of their claims

The court held that the parties shall have full access to such reports and that the reports will be made public except for the names of the persons examined, who shall remain confidential.

No doubt, many perplexing questions will arise in the administration of such a medical monitoring program. The plan administrator must be supervised closely by the trial court. The trial court must insist on a periodic accounting to assure that the monitoring process is run as efficiently and expeditiously as feasible so that the program can be brought to early closure. The trial judge must be concerned with the time and money involved with such a large scale program since private industry should not be compelled to interminably defray the cost. As the Third District Court of Appeals said, "the monitoring contemplated is not a social justice program." It should be created only to address injury which has not yet manifested and which warrants medical monitoring to reduce social harm.

Related Insights