Medical monitoring claims are viable in Florida.

The protection afforded by a court-supervised medical monitoring regime truly is an equitable solution to an enormous problem.

Unfortunately, situations arise where groups of individuals are exposed to dangerous substances. Although these people may not immediately manifest any physical injury, reasonable and prudent physicians often recommend that they be monitored or tested for the early onset of disease related to the exposure. In the landmark decision of Petito v. A.H. Robins Co., Inc., 25 Fla. L. Weekly D19 (Fla. 3d DCA Dec. 22, 1999),(1) Florida's Third District Court of Appeal ruled that, under appropriate circumstances, those exposed are entitled to pursue equitable relief in the form of a court-supervised medical monitoring program from a wrongdoer who caused the exposure.

Existing case law, equity, common sense, and the decisions of courts around the United States persuaded the Petito court to authorize equitable claims for court-supervised medical monitoring programs where viable and necessary to do justice.(2) Accordingly, it is now clear that Florida law allows equitable medical monitoring claims as a viable cause of action. The Petito decision is in line with Florida's long-standing principle that the purpose of injunctive relief is to "prevent an injury from occurring."(3)

What Is Medical Monitoring?

Medical monitoring is a program whereby those exposed to dangerous substances may obtain physical examinations and testing necessary to diagnose or detect the early onset of a disease or injury caused by the exposure to, or ingestion of, dangerous, hazardous, or toxic products. Medical monitoring may include chest X-rays, CT scans, MRIs, blood and urine tests, and other diagnostic examinations. The types of diagnostic testing required and the length of the surveillance should be decided by the court with the assistance from a court-appointed plan administrator and a court-appointed panel of physicians.(4)

When Is Medical Monitoring Appropriate?

The trial court's goal when establishing a medical monitoring program should be to promote the early detection and prevention of disease or injuries to persons exposed to dangerous, hazardous, or toxic products. Thus, medical monitoring should result in the saving of lives and the minimization of injuries.

Medical monitoring is possible whenever a group of persons has been exposed to, or has ingested, a dangerous, toxic, or hazardous product or substance that may later result in the development of a disease or injury. Exposure to or ingestion of products that may cause latent injuries or diseases such as cancer, heart disease, lung disease, birth defects, and other serious conditions are particularly appropriate for medical monitoring. Cases where medical monitoring may be proper include those involving asbestos, chemical spills, radiation leaks, Diethylstilbestrol (DES), fen-phen, defective heart valves, defective pacemakers, and other dangerous pharmaceutical and medical products.

Although not limited to class action cases, medical monitoring claims are best suited for class actions or mass tort situations. The procedures required to establish a medical monitoring program are comprehensive, and it may not make sense for a court to require a defendant to fund a medical monitoring program unless the number of persons adversely affected justifies the creation of such an equitable solution.

Facts and Procedural History of Petito

The Petito case began as a statewide class action for medical monitoring filed in equity against the makers and sellers of fen-phen,(5) a diet drug combination. Fen-phen was suspected of causing heart valve and lung damage at an alarming rate, compelling the Food and Drug Administration and the American College of Cardiologists to recommend medical monitoring and testing for those who used the pharmaceutical products.(6) The defendants in the underlying case filed a motion for judgment on the pleadings, arguing that Florida did not recognize a claim for future medical expenses without the existence of a discernible physical injury. The trial court granted the defendants' motion for judgment on the pleadings. The plaintiffs appealed the trial court's decision to the Third District Court of Appeal. The Third District reversed the trial court and recognized a cause of action in equity for court-supervised medical monitoring, even though the party seeking relief has not yet developed any identifiable physical injury or symptom, provided that certain elements are proven.(7)

Elements of a Claim

In order to succeed in a medical monitoring case, a plaintiff must prove the following:

1) The exposure to a substance at greater than normal background levels;

2) The substance is hazardous, dangerous or toxic;

3) The exposure results from the wrongful conduct of a defendant;

4) There is a significant increased risk of contracting a serious latent disease;

5) There is a monitoring procedure in existence for the early detection of the disease;

6) The monitoring procedure is different from that normally recommended in the absence of exposure to or ingestion of the hazardous or dangerous substance; and

7) The monitoring regime is reasonably necessary according to modern scientific principles.(8)

The above requirements are logical and comport with common sense. The exposure must be greater than what the population encounters in everyday life. The exposure must be to a hazardous substance or, in other words, a substance that can cause disease. The exposure must be caused by some wrongful conduct on the part of defendant. Most importantly, there must be diagnostic tests available that will detect disease--tests doctors recommend as reasonably necessary for those exposed.

Medical Monitoring Regime

If the requirements are satisfied, the trial court should use its equitable powers to create and supervise a medical monitoring program. The first step requires the trial court to appoint a qualified plan administrator to manage the plan and assist the trial court in selecting panel members, monitoring physicians, and in establishing the medical monitoring protocol.(9)

With the administrator's help, the trial judge will appoint an advisory panel of qualified and knowledgeable persons to create a plan where those who are affected may participate in the medical monitoring program.(10) The advisory panel determines the regime that will be followed by the examining physicians and establishes the diagnostic tests and procedures to be performed.(11) The panel selects a neutral group of competent examining physicians to perform the tests for both metropolitan and regional areas throughout the state.(12) The panel also establishes a notification procedure to alert affected persons throughout the state.(13) The panel should establish a time frame for those eligible to obtain the monitoring.(14) The length of the medical monitoring program will depend on the latency period for the disease or injury in question. If the latency period extends for many years, the medical monitoring period should cover the latency period.(15) Finally, the panel should implement procedures whereby the monitoring physicians submit their reports and findings, together with the statement of their charges, directly to the plan administrator who will be responsible to pay the claims.(16)

The defendant will be required to periodically fund the medical monitoring program.(17) The plan administrator will be required to provide periodic accounting reports and a final accounting to the court and the parties when the program is completed.(18)

The panel is required to keep all of the records generated by the program. The data gathered from the medical monitoring program may be helpful to the scientific and medical community for the continued research of the health hazards involved. Accordingly, the information obtained in a medical monitoring program will remain public with the exception of the names of the patients.(19)

Supervising Court's Discretion and Duties

The Petito court allowed trial courts great discretion in deciding what guidelines to use in creating and implementing a medical monitoring program. The appellate court found that the specific needs of a case should be left to the trial judge to decide on a case-by-case basis.(20)

The goal of the trial judge should be to insist that the monitoring regime proceeds efficiently and expeditiously. The trial court's duties include appointing those most qualified to serve on the court's advisory panel as well as overseeing the entire process to ensure that it is run in a fair, efficient, cost-effective manner while meeting the health concerns of the persons affected.

In overseeing a medical surveillance program, the supervising court should act in a businesslike manner, as concerns of time and money are of the essence. The program should exist only as long as the court determines is reasonably medically or scientifically necessary.

Petito's Consistency with Florida Law

A cause of action for injunctive relief to prevent future injury was well recognized in Florida before Petito.(21) In Lewis v. Peters, 66 So. 2d 489, 492 (Fla. 1953), the court recognized that "[o]ne of the most valuable phases of injunctions is to prevent an injury from occurring and not be forced to wait until after the damage is done and then attempt to seek redress for the same."

Thus, "plaintiffs need not wait until the injury is accomplished before bringing suit, but may ask, as being timely, injunctive relief to prevent the threatened injury."(22) For example, in Gasparilla Inn, Inc. v. Sunset Realty Corp., 358 So. 2d 234 (Fla. 2d DCA 1978), the plaintiff and defendant were each owners of opposite halves of an island. The defendant constructed a canal which threatened erosion of the plaintiffs portion of the island.(23) Plaintiff, rather than seeking damages for past harm, sought an injunction to prevent future harm. The appellate court affirmed the trial court's reasoning that it is within the court's equitable powers to require the defendant to build a seawall to prevent future damage and that the court could supervise the implementation of this equitable relief.(24)

Distinguished from Enhanced Risk Cases

In Eagle-Picher Indus., Inc. v. Cox, 481 So. 2d 517 (Fla. 3d DCA 1985), the Third District held that the plaintiff was not entitled to seek damages related to enhanced risk of cancer in an asbestos-related personal injury claim where he had not yet sustained cancer, but had asbestosis.(25) The Eagle-Picher court precluded actions at law for increased risk of cancer but allowed the plaintiff to seek damages for fear of cancer without cancer because plaintiff was exposed to asbestos and had developed a nonmalignant asbestos-related disease.(26) Medical monitoring claims do not seek damages for enhanced risk of injury and are distinguishable from the holding in Eagle-Picher.(27)

The Petito court found that its holding in favor of medical monitoring claims was consistent with its ruling in Eagle-Picher. The court recognized that in medical monitoring cases, only equitable relief--in the form of periodic medical examinations--is needed to detect the on-set of an injury or disease. In comparison, enhanced risk claims seek to recover damages for the anticipated harm itself.(28) In other words, the injury in an enhanced risk claim is the anticipated harm itself. Whereas, in a medical monitoring claim, there is no injury; rather, there is the need for the medical care necessary to detect the disease or injury.(29)

Distinguished from Damages at Law Cases

Similarly, the Petito court rejected the idea that a defendant can be required to pay a plaintiff damages for the cost of medical surveillance.(30) The court, however, found that requiring the defendant to fund the costs of medical surveillance before an injury or disease arises as a matter of equity is appropriate: "It is entirely proper for a court of equity to create and supervise a fund for the purpose of monitoring a condition of Plaintiff when it has been shown that such monitoring is reasonably necessary."(31)

Plaintiffs May Later File Suit for Injury or Disease

In keeping with Eagle-Picher,(32) the Petito court held that "plaintiffs in medical monitoring cases will not be precluded by the rule against splitting causes of action from bringing claims for whatever physical injuries they suffer if and when they arise."(33) Thus, a party who participates in a medical monitoring program, who later develops an injury related to the dangerous product in question, will have the right to bring a separate personal injury lawsuit.(34)

Jurisdictions Recognize Validity of Programs

With the Petito decision, Florida joins numerous jurisdictions throughout the country that have recognized a party's right to medical monitoring absent injury.(35) In the leading case of Ayers v. Township of Jackson, 525 A.2d 287 (N.J. 1987), the Supreme Court of New Jersey addressed what it then considered to be a "new rule" regarding the use of equitable principles to establish a court-supervised medical monitoring program. In Ayers the plaintiffs were exposed to certain groundwater toxins.(36) Although the plaintiffs had not manifested an injury, their doctors recommended medical testing to detect and permit early treatment of disease related to the toxins. The New Jersey high court reasoned that "[t]he use of court-supervised funds to pay medical-surveillance claims as they accrue, rather than lump-sum verdicts, may provide a more efficient mechanism for compensating plaintiffs."(37)

The Ayers court specifically found that the establishment of a medical monitoring fund was a "highly appropriate exercise of the Court's equitable powers."(38) Since the New Jersey Supreme Court's holding in Ayers, many states have followed suit. In Burns v. Jaquays Mining Corp., 752 P. 2d 28 (Ariz. Ct. App. 1987), rev. dism., 781 P. 2d 1373 (1989), the court cited Ayers with approval and held that a court-supervised medical monitoring program was appropriate to test and monitor those exposed to asbestos from the defendant's mill.(39)

Public Policy and Equity Support Claims

There are compelling policy reasons for permitting such relief. In Potter v. Firestone Tire and Rubber Co., 863 P. 2d 795 (Cal. 1993), the Supreme Court of California identified four strong public policy reasons to support medical monitoring:

First, there is an important public health interest in fostering access to medical testing for individuals whose exposure to toxic chemicals creates an enhanced risk of disease, particularly in light of the value of early diagnosis and treatment for many cancer patients.

Second, there is a deterrence value in recognizing medical surveillance claims.

Third, [t]he availability of a substantial remedy before consequences of the plaintiffs' exposure are manifest may also have the beneficial effect of preventing or mitigating serious future illness and thus reduce the overall costs to the responsible parties.

Finally, societal notions of fairness and elementary justice are better served by allowing recovery of medical monitoring costs. That is, it would be inequitable for an individual wrongfully exposed to dangerous toxins, but unable to prove that cancer or disease is likely, to have to pay the expense of medical monitoring when such intervention is clearly reasonable and necessary.(40)

Thus, when a:

[D]efendant's tortious act causes someone bodily harm and that person is made to incur medical expenses as a result, the law clearly affords the recovery of these expenses. The reason these expenses are recoverable, however, is because defendant's fault caused plaintiff to incur them. This reasoning applies as persuasively to plaintiffs who have suffered physical injury as it does to those who have not.(41)

Accordingly, the Petito court also rejected the concept that a plaintiff must wait until after incurring the expense of medical surveillance to have standing to bring a claim.

One can hardly dispute that an individual has just as great an interest in avoiding expensive diagnostic examinations as in avoiding physical injury. Having plaintiffs wait until an injury arises to recover the expense of monitoring would foreclose countless economically disadvantaged individuals from obtaining the supervision they need, and regardless of financial need, simply force the victims rather than the wrongdoers to initially bear these great expenses. Such a result is untenable in a court of equity.(42)

In the authors' opinion, it is completely reasonable to place the financial burden of medical monitoring expenses to detect and prevent injuries and death on the party responsible for placing the public in danger. This is especially true because the culpable party is typically engaged in a commercial business endeavor. Moreover, the funding party will also benefit from the surveillance program by mitigating damages, thereby effectively reducing its liability and financial exposure.

Arguments Against Medical Monitoring

Critics of medical monitoring argue that it will create a litigation explosion of speculative lawsuits. This criticism is illogical because medical monitoring funds do not require, or for that matter, promote, individual lawsuits. Once the fund is established, users of the dangerous product are required to comply with the court order directing the manner in which they obtain medical monitoring.(43) Moreover, since Ayers v. Township of Jackson, 525 A.2d 287 (N.J. 1987), and its progeny, there has been no such flood of litigation.

Critics also argue that court-supervised medical monitoring programs will consume enormous resources that could be used for better causes. Nevertheless, what better usage of funds exists than those designated for the prevention of injuries and disease? In addition, this concern is subsumed within the requirement that the monitoring be reasonably necessary.

Finally, critics argue that a law authorizing medical monitoring should be left to the legislature to enact; however, the court-driven common law, and not the legislature, historically has shaped the rights of consumers.(44) Moreover, as discussed in this article, equitable relief is well within the provence of the courts.

Conclusion

The Petito decision is a landmark case that undoubtedly will be discussed in academic, legal, and medical circles for many years. The case's practical effect will result in the saving of countless lives and the prevention of injuries and diseases. Court-supervised medical monitoring programs not only will benefit consumers, but also will protect the long-term interests of manufacturers and sellers of known dangerous products, who will mitigate damages in a significant manner by paying relatively modest amounts for the detection and prevention of injuries, rather than paying substantial compensatory verdicts. The protection afforded by a court-supervised medical monitoring regime truly is an equitable solution to an enormous problem that involves two major concerns: health and money.

(1) Note that the authors serve as lead counsel for the plaintiffs in the Petito lawsuit and appeal.

(2) Petito, 25 Fla. L. Weekly at D20.

(3) Lewis v. Peters, 66 So. 2d 489, 492 (Fla. 1953).

(4) Petito, 25 Fla. L. Weekly at D19.

(5) The popularly used pharmaceutical combination of fenfluramine and phentermine used in the 1990s was prescribed by physicians to patients desiring to lose weight.

(6) On July 8, 1997, the F.D.A. alerted the public of the hazards of fen-phen stating that it caused heart valve damage as well as primary pulmonary hypertension, a serious lung disease. The manufacturers of fenfluramine and dexfenfluramine voluntarily recalled the products on September 15, 1997.

(7) Petito, 25 Fla. L. Weekly D19.

(8) Id. at D20.

(9) Id.

(10) Id. at D20.

(11) Id.

(12) Id.

(13) Id.

(14) Id.

(15) Id.

(16) Id.

(17) Id.

(18) Id.

(19) Id.

(20) Id.

(21) The following elements are necessary to sustain a cause of action for injunctive relief in Florida: 1) lack of an adequate remedy at law; 2) a reasonable threat of irreparable harm; and 3) equity supports the injunction. Lewis v. Peters, 66 So. 2d 489 (Fla. 1953).

(22) Id. at 493 (citation omitted).

(23) Gasparilla Inn, 358 So. 2d at 235.

(24) Id. at 237.

(25) Asbestosis is the scarring of the lungs caused by exposure to asbestos. McClure v. Owens Corning Fiberglass Corp., 720 N.E. 2d 242, 247 (Ill. 1999). It is not a form of cancer. The two diseases, although attributable to asbestos, are not medically linked. In other words, cancer does not result from asbestosis. Eagle-Picher, 481 So. 2d at 522.

(26) Eagle-Picher, 481 So. 2d at 528-29.

(27) Although never addressed directly before, medical monitoring is not a novel concept in Florida. The Eagle-Picher court discussed medical monitoring favorably in its 1985 decision: "In the toxic waste case of Ayers v. Jackson Township, 198 N.J. Super. 561, 461 A.2d 184 (Law Div. 1983), vacated on other grounds, 202 N.J. Super. 106, 493 A.2d 1314 (A.D. 1985), the lower court held that the plaintiff could not recover for enhanced risk of cancer, but could recover medical monitoring costs. The court wrote that "[p]ublic policy thus supports a conclusion that if such illness could be prevented by surveillance, then the tort-feasor should bear the costs. Is it reasonable to compel a plaintiff to suffer the consequence of a serious if not fatal illness before the defendant's tortious conduct is actionable, when reasonable surveillance might prevent the sickness?" Id. at 573, 461 A.2d at 190. Although, as noted, the appellate division, acknowledging its reluctance to subject public entities to "novel causes of action," 202 N.J. Super. at 123, 493 A.2d at 1323, vacated the lower court decision on the ground that the probability that the plaintiff would develop cancer was insufficient to justify imposing a lifetime financial burden of medical surveillance on the defendant township, it did nothing to disturb the viability of recovery for medical monitoring costs. See also Friends For All Children v. Lockheed Aircraft Corp., 746 F.2d 816 (D.C. Cir. 1984) (medical surveillance damages awarded to Vietnamese orphans for possible injuries sustained during depressurization when plane crashed). Eagle-Picher, 481 So. 2d at 524, n.9.

(28) Petito, 25 Fla. L. Weekly D19, D20. In distinguishing medical monitoring claims from enhanced risk cases, the Petito court cited Redland Soccer Club, Inc. v. Dep't. of the Army, 548 Pa. 178, 696 A.2d 137 (Pa. 1997). The Third District also found support in Friends For All Children, Inc. v. Lockheed Aircraft Corp., 746 F.2d 816, 825 (D.C. Cir. 1984).

(29) Petito, 25 Fla. L. Weekly at D20.

(30) Id. at D19 ("plaintiff should not be able to recover lump sum damages in anticipation of future diagnostic expenses.").

(31) Id. ("it is entirely proper for a court of equity to create and supervise a fund for the purpose of monitoring the condition of plaintiff when it has been shown that such monitoring is reasonably necessary.")

(32) The Eagle-Picher court allowed a plaintiff in an asbestos-related personal injury suit to pursue damages for asbestosis in one suit, and bring an entirely new and separate suit if the plaintiff later developed cancer. 481 So. 2d at 520.

(33) Petito, 25 Fla. L. Weekly at D20.

(34) Id.

(35) Ayers v. Township of Jackson, 525 A.2d 287 (N.J. 1987); Bourgeois v. A.P. Green Indus., Inc., 716 So. 2d 355 (La. 1998); Burns v. Jaquays Mining Corp., 752 P. 2d 28 (Ariz. Ct. App. 1987); Earthman v. American Home Prod. Corp., No. 97-10-03790 (District Ct. Montgomery Co. Tex., Order entered Oct. 14, 1998); Hansen v. Mountain Fuel Supply Co., 858 P. 2d 970 (Utah 1993); Potter v. Firestone Tire and Rubber Co., 863 P. 2d 795 (Cal. 1993); Redland Soccer v. Dept. of Army, 696 A.2d 137 (Pa. 1997); Rhyne v. American Home Prod. Corp., No. 98-CH04099 (Cir. Ct. Cook Co. Ill., Order entered Jan. 26, 1999); St. John v. American Home Prod. Corp., No. 97-2-06368-4 (Spokane Co. Sup. Ct. Wash., Ordered entered Dec. 14, 1998); and Vadino v. American Home Prod. Corp., No. MID-L-425-98 (N.J. Superior Court) (unpublished Opinion decided Jan. 25, 1999).

(36) Ayers, 525 A.2d at 291.

(37) Id. at 313.

(38) Id. at 314.

(39) Federal courts applying injunctive relief standards have also held that this type of relief is injunctive in nature where the plaintiffs are not seeking to recover damages. See In Re: NLO, Inc., 5 F.3d 154 (6th Cir. 1993) (no abuse of discretion in finding medical monitoring program is injunctive in nature); German v. Federal Home Loan Mortgage Corp., 885 F. Supp. 537, 559-60 (S.D.N.Y. 1995) (request for court-supervised monitoring program is injunctive in nature); Yslava v. Hughes Aircraft Co., 845 F. Supp. 705, 713 (D. Ariz. 1993) (court-supervised medical monitoring program is not simply an action for damages). Other courts have also concluded that plaintiffs may recover medical monitoring costs. See Bourgeois v. A.P. Green Indus., Inc., 716 So. 2d 355 (La. 1998) (claim for establishment of a court supervised medical monitoring claim was cognizable); Gibbs v. E.I. Dupont De Nemours & Co., Inc., 876 F. Supp. 475 (W.D.N.Y. 1995) (reasoning that New York courts would recognize claims for medical monitoring); Stead v. F.E. Myers Co., 785 F. Supp. 56 (D. Vt. 1990) (evidence regarding necessity of medical monitoring admissible); Hansen v. Mountain Fuel Supply Co., 858 P. 2d 970 (Utah 1993) (medical monitoring recoverable); Redland Soccer v. Dept. of Army, 696 A.2d 137, 145 (Pa. 1997) (citing Hansen with approval). One court has surveyed the law in this area. See In Re: Teletronics Pacing Systems, Inc., 169 F.R.D. 203, 215-217 (S.D. Ohio 1996) (most states permit medical monitoring in some form).

(40) Potter, 863 P. 2d at 824.

(41) Bourgeois v. A.P. Green Indus., Inc., 716 So. 2d 355, 359 (La. 1998) (citation omitted).

(42) Petito, 25 Fla. L. Weekly at D19.

(43) Id.

(44) For an excellent discussion of the common law development of warranty law and strict liability in Florida, see generally West v. Caterpillar Tractor Co., Inc., 336 So. 2d 80 (Fla. 1976).

Ervin A. Gonzalez is a member of Robles & Gonzalez, P.A., Miami. He is board certified in civil trial law by The Florida Bar and The National Board of Trial Advocacy, and in business litigation law by The Florida Bar. Mr. Gonzalez is an adjunct professor at the University of Miami School of Law for the trial skills civil litigation program. He received his J.D. from that University.

Raymond W. Valori is a trial attorney with Robles & Gonzalez, P.A., Miami. He concentrates his practice in the areas of complex litigation and products liability. Mr. Valori received his bachelor's degree in architectural engineering from Pennsylvania State University and his J.D., magna cum laude, from the University of Miami School of Law in 1994.

This article is submitted on behalf of the Trial Lawyers Section, David W. Bianchi, chair, and D. Keith Wickenden, editor.