Opinion
Nos. 86-2550, 86-2911.
April 18, 1989. Rehearing Denied September 14, 1989.
Appeal from the Circuit Court, Dade County, Jon I. Gordon, J.
Krupnick, Campbell, Malone Rosselli, P.A., Fort Lauderdale, Klein Beranek, P.A., and Julie Pressly and John Beranek, West Palm Beach, for appellants.
Wicker, Smith, Blomqvist, Tutan, O'Hara, McCoy, Graham Lane and Shelly H. Leinicke, Fort Lauderdale, for appellee Kjell Koch, M.D.
Fowler, White, Burnett, Hurley, Banick Strickroot, P.A., and A. Blackwell Stieglitz, Miami, for appellee University of Miami.
Fleming, O'Bryan Fleming and Paul R. Regensdorf, Fort Lauderdale, for appellee Lederle Laboratories.
Before BASKIN, FERGUSON and JORGENSON, JJ.
This appeal follows the entry of summary final judgments in favor of Dr. Kjell Koch, the University of Miami, and Lederle Laboratories following a determination that the statute of limitations precludes appellants from pursuing their claims. We reverse.
In April 1970, Adam Bogorff, three and a half years old, was diagnosed as having leukemia. In June 1970, the Bogorff family moved to Florida. On the recommendation of his treating physicians, Adam became the patient of Dr. Kjell Koch, a member of the medical staff at the University of Miami. At that time, Adam's leukemia was in remission. Dr. Koch treated Adam with doses of orally administered methotrexate, oncovin, and prednisone. Methotrexate is a drug manufactured by Lederle Laboratories. In June 1971, Dr. Koch supplemented Adam's treatment with three doses of methotrexate administered intrathecally (in the spine), in conjunction with cranial and spinal radiation. According to the Bogorffs, Lederle indicated (in the 1971 Physician's Desk Reference) that intrathecal administration of methotrexate was appropriate, although the Federal Drug Administration had not approved such use. After he received the first three injections, Adam experienced as side effects only a slight headache and loss of appetite.
Intrathecal injections of methotrexate, unlike oral doses of methotrexate, cross the blood-brain barrier to act on toxic cells in the nervous system.
In January 1972, Dr. Koch administered another intrathecal injection of methotrexate as a prophylactic measure. Approximately one month later, in February 1972, the Bogorffs noticed that Adam was lethargic and was losing coordination and mental function. He also suffered from headaches, nausea, and vomiting. In April 1972, Adam began experiencing convulsions and became comatose. Although he recovered from the coma in July 1972, Adam was unable to walk or talk. When the Bogorffs consulted Dr. Koch about these alterations in Adam's condition, Dr. Koch informed them that the changes were the result of either the spread of the leukemia to the brain or a viral infection. In an effort to stop the convulsions, the Bogorffs took Adam to a neurosurgeon, who advised them that Adam's condition was caused by the spread of leukemia to the brain.
In the summer of 1972, Mr. Bogorff came across an article in a medical journal linking intrathecal methotrexate treatment of leukemia to encephalopathy (brain damage). Mr. Bogorff showed the article to Dr. Koch, who read it in his presence, threw it in the trash can, and informed Mr. Bogorff that methotrexate treatment had no relationship to Adam's condition. Adam remained Dr. Koch's patient for several more years without experiencing significant improvement in his medical condition.
Mr. Bogorff was employed as a university librarian; in that capacity, he had access to numerous medical journals. As a service to Dr. Koch, Mr. Bogorff would randomly gather articles dealing with leukemia and provide them to Dr. Koch. The article discussing intrathecal methotrexate treatment and encephalopathy was one of many articles he gave Dr. Koch during their relationship. Mr. Bogorff later stated that he did not read the article at that time.
Dr. Koch disputes the statement that he threw the article in the trash can. Because we are reviewing a final summary judgment, we must view the facts in the light most favorable to the losing party. Moore v. Morris, 475 So.2d 666 (Fla. 1985).
When the Bogorffs moved to Florida, Dr. Paul Winick became Adam's pediatrician. In January 1973, Dr. Winick wrote to Dr. Koch, stating that it was difficult to ascertain whether Adam's condition resulted from the methotrexate injections. From 1973 to 1979, the Bogorffs, hoping to improve Adam's condition, took him to a number of other physicians. A radiologist in charge of Adam's radiation therapy sent a letter to Dr. Winick in May 1973, confirming Dr. Winick's belief that some remote connection might exist between the state of Adam's health and the intrathecal methotrexate treatment. In May 1975, Adam was examined by a neurologist who sent copies of his evaluative report to both Dr. Koch and Dr. Winick. In the report, the neurologist agreed that Adam seemed to have some kind of encephalopathy related either to his leukemia, radiation, or methotrexate treatment.
In July 1977, Mrs. Bogorff took Adam to St. Jude's Hospital in Memphis, Tennessee, for a nutritional evaluation because he was not growing at a rate normal for his age. After examining Adam, Dr. Paul Zee, the physician in charge of nutrition at St. Jude's, wrote to Mrs. Bogorff commending her on her excellent care of Adam and informing her that the details of his examination had been sent to Dr. Winick. Dr. Zee's letter to Mrs. Bogorff gave no indication that he had found any cause for Adam's condition other than that postulated by Dr. Koch; however, in a report sent to Dr. Winick at the same time, Dr. Zee stated that his diagnosis of Adam's condition was "encephalopathy with reversible anatomical changes possibly secondary to radiation and intrathecal methotrexate." Dr. Winick concurred with this diagnosis. By 1979, Adam was described as "a total quadriplegic, functioning at an infantile level, with diffuse brain damage, no speech, and little chance of improvement."
With the exception of Dr. Zee's letter to Mrs. Bogorff, the physicians' letters or reports were not shown to or discussed with the Bogorffs. The Bogorffs could not recall any of Adams' treating physicians ever informing them of a possible connection between methotrexate treatment and Adam's condition. Although these reports were placed in Adam's medical files kept by Dr. Koch and Dr. Winick, the Bogorffs maintain they knew nothing of the letters and reports until February 1982; they allege that when they asked Jackson Memorial Hospital for Adam's hospital records, which would have included Dr. Koch's medical file, they were told there were no records.
Jackson Memorial Hospital is operated by the Public Health Trust of Dade County. The University of Miami, in its contracts with the trust, staffs and supervises the medical staff at Jackson Memorial Hospital. Because Dr. Koch treated Adam at Jackson Memorial Hospital facilities, Adam's medical files would be maintained at the hospital.
In October 1979, the Bogorffs began to consider the possibility that Adam's medical care may have been negligent. They contacted a law firm to investigate, but were advised that no cause of action existed.
The Bogorffs made no further inquiries until February 1982. At that time, they engaged an attorney to assist them in applying to the Social Security Administration for financial aid for Adam's care. The Bogorffs requested Adam's medical records from Dr. Winick, and upon examining them, discovered Dr. Zee's letter. In December 1982, the Bogorffs filed a multicount complaint against Dr. Koch and the University of Miami, seeking damages for their medical malpractice, and against Lederle Laboratories for damages for products liability arising from the manufacture and dissemination of methotrexate. In response to defense motions raising the bar of statutes of limitations, the trial court entered, vacated, and in 1986, reentered summary judgments in favor of all three defendants.
The Bogorffs contend that their claims were not barred by the statute of limitations. Resolution of the limitations issue depends on when the Bogorffs knew, or through the exercise of reasonable diligence, should have known of the alleged negligence or of the ensuing injury. Nardone v. Reynolds, 333 So.2d 25 (Fla. 1976); Nolen v. Sarasohn, 379 So.2d 161 (Fla. 3d DCA 1980). Substantive questions pertaining to the merits of the asserted claims must await determination of the limitations question.
Section 95.11(4), Florida Statutes (1971) (amended 1974, 1975), governs the limitations question before us. That section prescribes a four-year limitations period with no statute of repose for any actions not specifically provided for in Chapter 95. See Dade County v. Ferro, 384 So.2d 1283 (Fla. 1980); Foley v. Morris, 339 So.2d 215 (Fla. 1976); Hellinger v. Fike, 503 So.2d 905 (Fla. 5th DCA 1986), review denied, 508 So.2d 14 (Fla. 1987). In malpractice lawsuits governed by this section, timeliness of filing is measured from the date a plaintiff has notice of the negligent act giving rise to the cause of action, or notice of the physical injury resulting from the negligent act. Nardone; City of Miami v. Brooks, 70 So.2d 306 (Fla. 1954).
The statute of limitations contained in section 95.11(4)(b), Florida Statutes (1987), provides a two-year limitations period with a four-year statute of repose. If fraud, concealment, or intentional misrepresentation prevent discovery of the injury within the four-year period, the limitations period is extended two years, but may not exceed seven years from the date the incident giving rise to the injury occurred.
A plaintiff who lacks actual knowledge is deemed to have constructive notice of a negligent act disclosed by the contents of obtainable hospital and medical records. Nardone, 333 So.2d at 34. But see Tetstone v. Adams, 373 So.2d 362 (Fla. 1st DCA 1979) (knowledge of medical records not imputed to patient when hospital and medical records contain technical terms that an ordinary lay person could not be expected to understand), cert. denied, 383 So.2d 1189 (Fla. 1980). However, when defendants fraudulently conceal or misrepresent their negligence, the statute of limitations does not begin to run until plaintiff is able to discover the negligence. Nardone; Almengor v. Dade County, 359 So.2d 892 (Fla. 3d DCA 1978); Buck v. Mouradian, 100 So.2d 70 (Fla. 3d DCA), cert. denied, 104 So.2d 592 (Fla. 1958).
Questions of fact pertaining to the statute of limitations exist in the record before us: When did the Bogorffs know that Dr. Koch's conduct was possibly negligent? Did Dr. Koch or the University of Miami conceal information the Bogorffs needed to recognize the existence of a claim? The record discloses that the variation in Adam's condition was not ascertainable immediately upon administration of the intrathecal methotrexate; the deviation did not become apparent until approximately three months after the treatments ended. Thus, no immediate change of condition put the Bogorffs on notice of the connection between the condition and the treatment. See Humber v. Ross, 509 So.2d 356 (Fla. 4th DCA), review denied, 518 So.2d 1275 (Fla. 1987). In fact, when the Bogorffs asked Dr. Koch specifically about the cause of Adam's condition, he told them that Adam was suffering either from some viral infection or from the spread of the leukemia to the brain. When the Bogorffs handed Dr. Koch the 1972 medical journal article attributing encephalopathy to methotrexate treatment, Dr. Koch denied any relationship between the methotrexate and Adam's condition. Furthermore, when Dr. Koch learned of the connection between the methotrexate and Adam's condition, he allegedly failed to inform the Bogorffs. Although a physician is not required to disclose mere conjecture or speculation about a patient's condition, as one who occupies a position of trust with a patient, a doctor has an affirmative duty to disclose facts which the doctor knows or, through efficient diagnosis, should know. The failure to do so constitutes fraudulent concealment sufficient to toll the statute of limitations. Nardone, 333 So.2d at 39.
The dissent utilizes Robert Bogorff's discovery of the medical journal article to demonstrate that the Bogorffs had knowledge of the cause of Adam's condition in 1972. However, as a matter of law, a plaintiff with no medical knowledge beyond that of an ordinary lay person may not be charged with knowledge of technical medical information such as that contained in a medical journal article. Nolen v. Sarasohn, 379 So.2d 161 (Fla. 3d DCA 1980); Tetstone v. Adams, 373 So.2d 362 (Fla. 1st DCA 1979), cert. denied, 383 So.2d 1189 (Fla. 1980).
The dissent finds that the evidence suggests only a tenuous connection between the methotrexate and Adam's condition, and relies upon Nardone in holding that Dr. Koch did not, therefore, have a duty to disclose that information to the Bogorffs. On the contrary, the evidence strongly indicates that Adam's treating physicians found a connection between the methotrexate and Adam's condition from the beginning. Whether Dr. Koch knew with certainty of the relationship between the methotrexate and Adam's condition so as to give rise to a duty to disclose is a question of fact for jury determination.
The Bogorffs' patient-physician relationship with Dr. Koch permitted them to place great faith in his skills and to rely on his affirmative representations that the methotrexate was not connected to Adam's condition. If Dr. Koch fraudulently concealed the very facts which would have put the Bogorffs on notice of their cause of action, the statute of limitations does not bar their claims. Thus, it is essential that a jury determine such questions as: the extent of Dr. Koch's knowledge of the cause of Adam's condition; when he gained that knowledge; and whether he should have informed the Bogorffs.
The dissenting opinion states that the Bogorffs did not blindly accept Dr. Koch's diagnosis of Adam's condition, but consulted at least two other doctors. The record shows that the Bogorffs consulted other doctors, not because they did not believe Dr. Koch, but because Dr. Koch had stated that he could do nothing more for Adam. The Bogorffs continued to take Adam to Dr. Koch until the doctor left the area in 1978, thereby demonstrating their faith in his judgment.
The University of Miami, as employer of Dr. Koch, may be vicariously responsible for his actions. Jaar v. University of Miami, 474 So.2d 239 (Fla. 3d DCA 1985), review denied, 484 So.2d 10 (Fla. 1986). The record discloses that the University of Miami may have been culpable in its own right for the Bogorffs' inability to discern the truth about Adam's condition: when the Bogorffs requested Adam's medical records from Jackson Memorial Hospital, they were told there were none.
The Bogorffs' lack of sophisticated medical knowledge during a grave medical crisis does not foreclose their right to seek recovery. If, in April 1972, they knew that something was wrong with Adam, it does not necessarily follow that they knew or should have known that Adam's condition was caused by medical negligence. See Florida Patient's Compensation Fund v. Sitomer, 524 So.2d 671, 674 (Fla. 4th DCA 1988) ("knowledge of an injury, without more, does not necessarily put a patient on notice that the injury was caused by the negligence of another"); Schafer v. Lehrer, 476 So.2d 781 (Fla. 4th DCA 1985). Whether the Bogorffs should have been able to distinguish between the severe physical effects of leukemia and those produced by drug-induced encephalopathy is a question for jury determination. See Moore v. Morris, 475 So.2d 666 (Fla. 1985) (parents of infant knew that emergency situation existed at birth of infant, but such knowledge, without more, is insufficient to impute notice of negligence to them); Almengor (infant's condition could have been attributable to congenital defect rather than to medical negligence).
A trial court is not permitted to resolve issues of fact when deciding a motion for summary judgment; its role is to decide whether issues exist for resolution by the trier of fact. Moore. That principle extends to the appellate court which may not anticipate the outcome of matters properly decided by full, rather than summary, consideration. "Summary judgments should be cautiously granted in negligence and malpractice suits." Moore, 475 So.2d at 668. Only in the complete absence of any genuine issue of material fact should summary judgment be granted, Moore; Holl v. Talcott, 191 So.2d 40 (Fla. 1966); see also Howard v. Department of Health Rehabilitation Servs., 541 So.2d 117 (Fla. 3d DCA 1989); otherwise, the trial court should submit the cause to the jury. The court's immediate concern extends only to the statute of limitations and the asserted existence of fraudulent concealment tolling the statute. Moore; Sitomer; Schafer; Phelan v. Hanft, 471 So.2d 648 (Fla. 3d DCA 1985), disapproved on other grounds, Carr v. Broward County, 541 So.2d 92 (Fla. 1989).
We turn next to the summary judgment entered in favor of Lederle Laboratories, the manufacturer of methotrexate. During the period Adam was receiving intrathecal methotrexate injections, products liability actions were governed by a four year statute of limitations. § 95.11(4), Fla. Stat. (1971). In 1975, section 95.031(2), Florida Statutes (1975), established a statute of repose for products liability actions. According to section 95.031(2), the period of limitation in a products liability action commences to run "from the time the facts giving rise to the cause of action were discovered or should have been discovered with the exercise of due diligence, . . . but in any event within 12 years after the date of delivery of the completed product to its original purchaser, regardless of the date the defect in the product . . . was or should have been discovered." The twelve-year bar has been applied to cases in which the incident giving rise to the cause of action occurred before 1975, the year the repose statute became effective, provided the operation of section 95.031(2) does not bar a cause of action before it accrues, thereby denying an injured party access to the courts. See Diamond v. E.R. Squibb Sons, Inc., 397 So.2d 671 (Fla. 1981); Purk v. Federal Press Co., 387 So.2d 354 (Fla. 1980); Bauld v. J.A. Jones Constr. Co., 357 So.2d 401 (Fla. 1978).
The twelve year repose provision for products liability actions was repealed effective July 1, 1986. See Ch. 86-272, Laws of Fla. The repeal, however, has no retroactive application. Melendez v. Dreis Krump Mfg. Co., 515 So.2d 735 (Fla. 1987).
The statute of limitations in a products liability action begins to run only when both the "moment of trauma" and the "moment of realization" have occurred. Steiner v. Ciba-Geigy Corp., 364 So.2d 47, 53 (Fla. 3d DCA 1978), cert. denied, 373 So.2d 461 (Fla. 1979). Trauma is defined as "ill effect, damage or injury;" realization includes the "`known or should have known' element associated with trauma." Steiner, 364 So.2d at 53. Although at times the moment of trauma and the moment of realization may coincide, there are instances in which the trauma is not of a type which would give rise to the realization that it was caused by negligence. Steiner, 364 So.2d at 53. Genuine issues of fact exist as to when the Bogorffs' moment of realization occurred. The injury Adam sustained, which the Bogorffs now link to the intrathecal injection of methotrexate, was not easily distinguishable from the leukemia he suffered.
In examining the record, we find no information indicating precisely when the University of Miami and Dr. Koch received delivery of the methotrexate used to treat Adam. Thus, we cannot determine whether the Bogorffs' cause of action should be barred under the twelve-year limitation provided in section 95.031(2), Florida Statutes (1975). For these reasons, we reverse the final summary judgment in favor of Lederle.
Reversed and remanded for further proceedings consistent with this opinion.
FERGUSON, J., concurs.
I respectfully dissent. I would affirm the summary final judgments because the undisputed chronology reveals that the actions are time-barred.
Viewing the record and all attendant inferences in the light most favorable to Bogorff, the party opposing the motions for summary judgment, Holl v. Talcott, 191 So.2d 40 (Fla. 1966), the facts giving rise to these actions may be summarized as follows. Adam Bogorff was born on October 16, 1966. In April, 1970, Adam was diagnosed as having undifferentiated lymphoblastic leukemia by Dr. Edward Morse of the University of Connecticut medical school in Hartford, Connecticut. Adam was treated with the drugs oncovin, mecaptopurine and prednisone in order to induce a remission. In June, 1970, Adam and his parents, Robert and Thelma, moved to Florida. Pursuant to the recommendation of Adam's physicians in Connecticut, the Bogorffs placed Adam under the care of Dr. Kjell Koch, a pediatric hematologist at the University of Miami medical complex. The Bogorffs selected Dr. Paul Winick as Adam's pediatrician. Dr. Winick, who was not affiliated with the University of Miami, cared for Adam before, during, and after his treatment by Dr. Koch.
Because Adam's Connecticut physicians had successfully induced a remission in his leukemia, Dr. Koch placed Adam on a regimen of drug therapy to maintain his remission. Dr. Koch continued Adam on the drugs previously administered in Connecticut with only one change. He substituted methotrexate, a drug manufactured by Lederle, for mercaptopurine. The methotrexate was administered orally. In the spring of 1971, Thelma Bogorff approached Dr. Koch regarding the use of some type of prophylaxis to prevent cancer cells from invading Adam's central nervous system. She specifically inquired into the possibility of treating Adam with cranial radiation in view of the positive results that a Dr. Aur at St. Jude Children's Research Hospital in Memphis, Tennessee, had achieved in child leukemia patients. Dr. Koch refused to commit to such treatment until he had obtained the quarterly report on leukemia therapy from the National Cancer Institute in May, 1971. In June, 1971, Dr. Koch determined that prophylaxis consisting of intrathecal (intraspinal) injections of methotrexate was appropriate. Dr. Koch administered two intrathecal injections of methotrexate. In the summer of 1971, Dr. Koch referred Adam to Dr. Komanduri Charyulu, the chief radiologist at the University of Miami. Dr. Charyulu ordered prophylactic cranial and spinal radiation administered to Adam. During the radiotherapy, Adam experienced several adverse side effects that Dr. Koch had told the Bogorffs could result from the combined treatment of intrathecal methotrexate and radiation, e.g., loss of hair and appetite, headaches, and nausea. In September, 1971, the Bogorffs reported to Dr. Koch that Adam had slept for an entire day and had subsequently appeared lethargic. These symptoms abated in the fall of 1971 when the radiation ceased. Adam received a third intrathecal injection of methotrexate in January, 1972, again accompanied by radiation. The following month the Bogorffs perceived distinct, alarming changes in Adam's condition, including lethargy, headaches, seizures, jerking movements, slurred speech, and impaired motor skills. Three months later, in April, 1972, Adam suffered convulsions and lapsed into a coma. Dr. Koch discontinued the intrathecal injections of methotrexate. Dr. Robert F. Cullen, a pediatric neurologist at the University of Miami, was called in to assess Adam's condition. Dr. Cullen attributed Adam's decline to a subdural implant indicating the presence of leukemia cells in the brain. He prescribed additional radiation followed by chemotherapy which included the oral administration of methotrexate. Although Dr. Cullen's treatment succeeded in rousing Adam from his comatose condition, Adam never regained his former state of health and never recovered his speech or motor skills.
Treatment of acute leukemia in the child involves two phases: induction of remission and maintenance of remission. . . . For maintenance, it has been found that the intramuscular or oral administration of methotrexate twice weekly is superior to daily oral dose of methotrexate or mercaptopurine or to courses of methotrexate alternated with courses of mercaptopurine. . . . Methotrexate, given in the spinal canal, produces improvement in 80 percent of patients with meningeal leukemia.
3B L. Frumer M. Friedman, Products Liability § 50.01[26] (Supp. 1986).
By July, 1972, Adam had become paralyzed and unresponsive. At this time, the Bogorffs consulted Dr. Gary Giesecke, a neurologist who was not affiliated with the University of Miami. Pursuant to the Bogorffs' request that Adam's physicians maintain communications, Dr. Giesecke conveyed his findings by way of a letter to Dr. Koch wherein he noted that the Bogorffs had provided all of Adam's medical records to assist him in evaluating Adam. Dr. Giesecke agreed that Adam had suffered brain damage and offered three possibilities as to the type of damage: localized leukemic implant, multifocal leuko-encephalopathy, or subcortical demyelination. Dr. Giesecke concluded his letter with the following observation: "I think the parents do realize that this child is quite ill and the prognosis is grave. They, of course are looking for help from any source, and this in itself has led to some confusion on their part. I encouraged them to continue with their care at the University of Miami and discouraged them from seeking information or help from outside sources, since I do not think it would be of any further significant benefit to this child."
The Bogorffs returned to Dr. Koch, who had ascribed Adam's brain damage to either leukemia cells invading the brain or a viral infection. Robert Bogorff, in his capacity as a university librarian, had discovered an article in a British medical journal which suggested a possible connection between methotrexate therapy in leukemia patients and encephalopathy or brain damage. The article detailed "encephalopathy in seven patients who were receiving prolonged methotrexate therapy, in part by intrathecal injection." The abstract theorized that the brain damage did not conform to the type of brain damage caused by viral encephalitis. The abstract further explained that because the brain damage improved somewhat with the administration of folic acid, "the condition appears to be due to methotrexate." Finally, the abstract characterized the relationship between methotrexate and encephalopathy as "a condition not previously described." Bogorff shared the article with Dr. Koch and inquired as to its relevance to Adam. According to Bogorff, Dr. Koch read the article in his presence, dismissed it as inapplicable to Adam, and discarded it in the trash. Dr. Koch maintained his position that Adam's brain damage was the consequence of either a virus or proliferating cancer cells. In an attempt to secure a more definitive diagnosis of Adam's condition, Dr. Koch contacted Dr. Aur at St. Jude Children's Research Hospital. Dr. Aur was unable to provide any additional insight. After 1973, Adam received no treatment for his leukemia, which remained in remission; instead, Dr. Koch simply monitored Adam's leukemia by taking blood samples. When Dr. Koch left Miami in 1978, he did not take Adam's medical records with him.
Kay, Encephalopathy in Acute Leukaemia Associated with Methotrexate Therapy, 47 Archives of Diseases in Childhood 344 (1972).
Dr. Koch acknowledged in his deposition that he had summarily told the Bogorffs that the article did not pertain to Adam's case. Dr. Koch pointed out several significant differences between the seven patients chronicled in the article and Adam, the most dramatic being the much larger doses of methotrexate the seven patients had received. Dr. Koch further stated that he did not dispose of the article in the trash.
Dr. Cullen left the University of Miami to become director of pediatric neurology at Variety Children's Hospital in Miami, but he continued to treat Adam for his neurological damage. Although Adam initially reacted favorably to a course of weekly intravenous B-12 and folic acid, the treatment proved unsuccessful and was abandoned in 1973 or 1974. Despite Dr. Cullen's program of various antiseizure medications, he was unable to alter Adam's cognitive functions. Regrettably, as Dr. Cullen noted in his neurology consultation of May, 1975, Adam remained "at a 10% level when one takes 100% as being normal." In 1975, either Dr. Winick or Dr. Cullen referred Adam to Shands Teaching Hospital in Gainesville, Florida, for a complete metabolic evaluation during which an EEG was performed. No additional knowledge was obtained by these studies. Neither did Dr. Cullen change his treatment of Adam as a result of the Shands consultation.
In 1977, Adam was evaluated by Dr. Paul Zee and Dr. Billmeier at St. Jude Children's Research Hospital. Concerned by Adam's stunted growth, the Bogorffs hoped that Dr. Zee, as chief of nutrition and metabolism, could provide recommendations for improving Adam's stature. Dr. Billmeier conducted a physical examination of Adam which included a CAT scan. Again the physicians were unable to recommend any protocol for Adam's improvement. At Thelma Bogorff's request, Dr. Zee communicated his findings to Dr. Winick in a letter dated July 18, 1977. Dr. Zee summarized his diagnosis: "Encephalopathy with irreversible anatomical changes possibly secondary to radiation and intrathecal methotrexate." In a separate letter to Thelma Bogorff dated July 19, 1977, Dr. Zee commended her on her care of Adam and advised her that the results of all of Adam's tests at St. Jude's had been sent to Dr. Winick.
In 1979, the Bogorffs applied for supplemental social security on Adam's behalf but submitted no supporting documentation. The application was rejected. Also in 1979, the Bogorffs consulted counsel regarding the existence of a medical malpractice or products liability claim for Adam's injury. They were advised that no cause of action existed. In 1982, the Bogorffs reapplied to the Social Security Administration for financial aid for Adam. To support their second application, they obtained Adam's complete medical records from Dr. Winick. For the first time, the Bogorffs read the correspondence among the various physicians who had treated or evaluated Adam. The letters acknowledged the possibility that methotrexate could have been a cause of Adam's brain damage. The Bogorffs consulted another attorney to investigate the viability of a lawsuit.
The Bogorffs subsequently filed a legal malpractice complaint against the attorney they had consulted in 1979. The basis of their claim is that the attorney failed to apprise them of the statute of limitations restrictions.
In December, 1982, the Bogorffs filed a complaint against Dr. Koch and the University of Miami for medical malpractice and against Lederle for negligence and products liability. The subsequently amended complaint alleged, in relevant part, that Dr. Koch and the University were negligent in their treatment of Adam as evidenced by the failure to recognize methotrexate as the cause of Adam's brain damage and to take prompt action to reverse the damage; the failure to seek the assistance of neurologists in reversing the damage; the failure to make full and fair disclosure of the fact that prophylactic intrathecal methotrexate was an experimental procedure; and the failure to inform the Bogorffs that intrathecal administration of methotrexate had not been approved by the Food and Drug Administration [FDA] at the time of Adam's treatment. The amended complaint against Lederle alleged that Lederle was negligent (1) in not providing, through package inserts or other information, adequate warnings to physicians of the adverse side effects, reactions, and contraindications of methotrexate; (2) in not providing full disclosure of necessary information so as to allow the physician to determine the ratio of risk to benefit for the patient; (3) in not warning the medical community that intrathecal doses of methotrexate could lead to meningitis and central nervous system deterioration in children; and (4) in not following applicable federal rules and regulations for labelling, testing, and marketing methotrexate.
Dr. Koch, the University, and Lederle answered the complaint and raised as an affirmative defense the expiration of the relevant statute of limitations. They subsequently moved for summary final judgment based upon the expiration of the statute of limitations. In opposition to the motions for summary judgment, the Bogorffs argued that the statute of limitations had been tolled by Dr. Koch's fraudulent concealment and misrepresentations as to the connection between Adam's brain damage and methotrexate. The Bogorffs also contended that Lederle's fraud and concealment tolled the statute of limitations. The Bogorffs specifically alleged that Lederle had intentionally misrepresented the adverse side effects of methotrexate through its annotation in the 1970 Physician's Desk Reference which stated that the FDA had approved methotrexate for intrathecal use.
The motions for summary judgment cited section 95.11(6), Florida Statutes (1973), or section 95.11(4)(b), Florida Statutes (1975), as the controlling statute of limitations. The Bogorffs contended that section 95.11(4), Florida Statutes (1971), was applicable. Although the trial court's orders granting summary final judgment for Dr. Koch, the University, and Lederle do not cite to a specific statute, it is clear that the parties and the trial court were working with a four-year-limitation period. My analysis is predicated on the statute of limitations advocated by the Bogorffs, section 95.11(4), Florida Statutes (1971).
The Physician's Desk Reference, published annually, consists of monographs summarizing FDA-approved package inserts.
The controversy at the hearings on the motions for summary judgment centered on whether the four-year statute of limitations had run prior to the commencement of the Bogorffs' actions in December, 1982. In support of their motion in opposition to summary judgment, the Bogorffs submitted their affidavits and the letters from Adam's medical records. According to their pleadings, only Dr. Zee's 1977 letter to Dr. Winick afforded the Bogorffs notice of the irreversible nature of Adam's injury and possible nexus to intrathecal methotrexate. The Bogorffs contended that the statute of limitations did not commence to run until 1982 when they first read Dr. Zee's crucial letter. Dr. Koch, the University, and Lederle argued that the Bogorffs had access to Adam's medical records at all times and that Robert Bogorff's awareness of the 1972 journal article belied his position of ignorance for a decade thereafter. Following the hearings, the trial court entered summary final judgments in favor of Dr. Koch, the University, and Lederle.
The trial court had previously entered summary judgments in favor of Dr. Koch, the University, and Lederle but had vacated them, pursuant to Bogorff's motion, on the authority of Ash v. Stella, 457 So.2d 1377 (Fla. 1984). The orders under review on these appeals were entered on the renewed motions for summary final judgment filed by Dr. Koch, the University, and Lederle.
I would affirm the summary final judgments in favor of Dr. Koch and the University. The record is devoid of evidence that Dr. Koch had fraudulently concealed the cause of Adam's injury. In the absence of such concealment, the statute of limitations is not tolled. Nardone v. Reynolds, 333 So.2d 25, 39 (Fla. 1976), clearly establishes that a physician has a duty to disclose only "known facts and not conjecture and speculation as to possibilities." See Almengor v. Dade County, 359 So.2d 892, 894 (Fla. 3d DCA 1978). The Bogorffs' claim, that Dr. Koch's denial of the possibility that Adam's brain damage was caused by the intrathecal administration of methotrexate constituted "concealment," is unsupported by the record or the law. There is no showing that, in the exercise of reasonable medical diligence, Dr. Koch should have known that the methotrexate was the cause of Adam's brain damage. Dr. Koch's rejection of the medical journal article linking methotrexate treatment of leukemia patients to encephalopathy and his alternative medical opinion that the damage was the consequence of either a virus or cancer cells invading the brain do not amount to "a fraudulent withholding of the facts, sufficient to toll the running of the statute." Nardone, 333 So.2d at 39.
According to the medical consensus in the record, methotrexate was merely one possibility in a lengthy catalogue of suspected causes. A survey of the various medical opinions regarding Adam's condition demonstrates the lack of any fraudulent concealment by Dr. Koch. Dr. Winick had opined in a 1973 letter to Dr. Koch: "Whether this whole business is secondary to Methotrexate is difficult to ascertain." In a 1977 letter, Dr. Winick speculated: "He [Adam] [s]eems to have some type of encephalopathy, which is related to either his leukemia or more likely to radiation or perhaps related to a folic acid deficiency." In his 1975 neurological evaluation of Adam, Dr. Cullen stated: "He seems to have some type of peculiar encephalopathy, either related to his leukemia, radiation, or perhaps related to a folic acid deficiency accompanying use of Methotrexate." Dr. Zee had thought the encephalopathy was "possibly secondary to radiation and intrathecal methotrexate." The radiologist, Dr. Charyulu, posited "that there may be some distant or remote connection with Methotrexate toxicity." The inability of all the medical specialists to identify the precise cause of Adam's brain damage is best exemplified by Dr. Winick's terse observation to Dr. Koch in 1973: "[T]he only way I think we will be able to make a definitive diagnosis, is a post." To conclude that fraudulent concealment exists where the uncontroverted evidence suggests only a tenuous connection between methotrexate and Adam's brain damage is to require of Adam's treating physician twenty-twenty foresight.
"Admittedly the science of medicine is not an exact science." Bourgeois v. Dade County, 99 So.2d 575, 577 (Fla. 1956). At best, the evidence in this case suggests only that in Dr. Koch's medical judgment methotrexate could be rejected as the cause of Adam's brain damage although other experts might not have eliminated methotrexate from consideration. A divergence of expert views cannot form the basis for fraudulent concealment. Fraudulent concealment exists (1) where a physician (or his employee, agent, or servant) engages in conduct to prevent inquiry or elude investigation as to the cause of action or (2) fails to reveal to the plaintiff facts (not possibilities or conjecture) relating to the nature or cause of the plaintiff's condition. Almengor, 359 So.2d at 894. Here, the record shows that the Bogorffs did not blindly accept Dr. Koch's diagnosis of a virus or spreading cancer cells but instead promptly consulted at least two neurologists, Dr. Cullen and Dr. Giesecke, who were similarly unable to isolate the etiological agent. Significantly, Dr. Koch did not mislead the Bogorffs as to the severity of Adam's injury or encourage them as to his prospect for recovery. See Swagel v. Goldman, 393 So.2d 65 (Fla. 3d DCA 1981) (where plaintiff was incontinent after operation performed by defendant but defendant assured him that condition was only temporary, genuine issue of material fact existed as to whether plaintiff discovered or should have discovered injury prior to the time when defendant finally told him that incontinence was permanent). Neither were the Bogorffs discouraged or otherwise hindered in obtaining Adam's medical records from Dr. Winick, Dr. Koch, Dr. Cullen, or any of the consulting physicians. The Bogorffs were obviously cognizant of the important data located in Adam's records as demonstrated by their furnishing the record for Dr. Giesecke's scrutiny in 1972. The Bogorffs admitted in their depositions that they enjoyed open communications with all of Adam's treating physicians, including Dr. Koch. The Bogorffs had specifically directed the various physicians to keep one another informed of their findings, thereby indicating their awareness that Adam's file contained valuable material.
"Under Florida's discovery standard, the cause of action does not accrue, for limitations purposes, until the injured party discovers or has a `duty to discover the act constituting an invasion of his legal rights'." Celotex Corp. v. Meehan, 523 So.2d 141, 145 (Fla. 1988) (quoting Creviston v. General Motors Corp., 225 So.2d 331, 334 (Fla. 1969)). The trial court correctly found that, as a matter of law, the Bogorffs knew or should have known of the existence of their cause of action more than four years prior to the filing of their complaint in 1982, notwithstanding Dr. Koch's opinion that methotrexate was not the cause of Adam's injury. See Nardone (limitations period commences when plaintiffs have knowledge of change in physical condition even where they do not know of causal connection of defendant's act); Carr v. Broward County, 505 So.2d 568 (Fla. 4th DCA 1987) (seven-year statute of repose barred medical malpractice action brought ten years after child's birth where any injury to child from medical malpractice was completed fact on or before time of birth), aff'd, 541 So.2d 92 (Fla. 1989); Carlton v. Ridings, 422 So.2d 1067 (Fla. 1st DCA 1982) (medical malpractice claim time-barred where injury resulting from alleged negligent administration of radiation was discovered within four years from date of injury but suit was not filed before expiration of four-year statute of limitations); Robinson v. Sparer, 365 So.2d 438 (Fla. 3d DCA 1978) (malpractice action barred by statute of limitations where plaintiff was aware of and claimed damage from treatment by physician more than two years prior to filing complaint). See also Moore v. Morris, 475 So.2d 666 (Fla. 1985) (summary judgment precluded where material issue of fact existed as to when parents of brain-damaged child should have discovered cause of injury); Florida Patient's Compensation Fund v. Sitomer, 524 So.2d 671 (Fla. 4th DCA 1988) (statute of limitations issue properly submitted to jury where there was substantial question of fact regarding extent and timing of notice to plaintiff of injury and its cause); Schafer v. Lehrer, 476 So.2d 781 (Fla. 4th DCA 1985) (knowledge of physical injury alone, without knowledge that injury resulted from negligent act, does not trigger limitations).
Even accepting the Bogorffs' argument that Dr. Zee's 1977 letter to Dr. Winick was the only document which could have alerted them to intrathecal methotrexate as the etiological agent, the Bogorffs had both actual and constructive notice of the letter prior to 1978, the latest date of discovery in order to sustain an action filed in 1982. Dr. Zee had informed Mrs. Bogorff in 1977 that his medical findings had been sent under separate cover to Dr. Winick, thereby giving her actual notice of the letter's existence. Nardone teaches that absent fraudulent concealment knowledge of the contents of a patient's medical records will be imputed. Thus, the Bogorffs clearly had constructive notice of the information in Adam's medical file. Even permitting the Bogorffs the latitude of a 1977 discovery date with Dr. Zee's letter triggering the running of the statute of limitations, their action was time-barred by 1982 when their complaint was filed. Because the action against the University of Miami was based upon a theory of vicarious liability, I would affirm summary judgment in favor of the university as well.
I also agree with the trial court that summary judgment for Lederle is required as a matter of law because the sequence of events culminating in Adam's brain damage is undisputed. Adam was treated with intrathecal methotrexate in 1971 and January, 1972. The Bogorffs perceived a deterioration in Adam's condition by the spring of 1972. According to the timetable, both the alleged negligent act (the intrathecal injection of methotrexate) and the alleged injury (Adam's irreversible brain damage) occurred, at the latest, in 1972 or 1973. Section 95.11(4), Florida Statutes (1971), provides a four-year statute of limitations for products liability actions. The Bogorffs' complaint against Lederle was filed on December 1, 1982, well beyond the four-year limit, and was unequivocally time-barred.
95.11 Limitations upon actions other than for the recovery of real property. — Actions other than those for the recovery of real property can only be commenced as follows:
* * * * * *
(4) WITHIN FOUR YEARS. — Any action for relief not specifically provided for in this chapter.
§ 95.11(4), Florida Statutes (1971).
Steiner v. Ciba-Geigy Corp., 364 So.2d 47 (Fla. 3d DCA 1978), cert. denied, 373 So.2d 461 (Fla. 1979), is remarkably similar to the facts of this case. In Steiner, this court affirmed a summary final judgment for a defendant-drug manufacturer on the ground that the action was barred by the four-year statute of limitations. The plaintiff had suffered a loss of vision allegedly due to his ingestion of a prescription drug manufactured by the defendant. Both the drug ingestion and the vision loss had occurred in 1972. The plaintiff filed his action against the drug manufacturer in 1977. This court affirmed the summary judgment for the drug manufacturer upon a finding that "the facts known to the plaintiff were sufficient as a matter of law to begin the running of the statute of limitations." Id. at 52. This court further observed that the "statute of limitations will begin to run only when the `moment of trauma' and the `moment of realization' have both occurred. By `trauma,' we simply mean the ill effect, damage or injury; and by `realization,' we mean the `known or should have known' element associated with the trauma." Id. at 53. This case falls within the Steiner paradigm since both the "moment of trauma" and the "moment of realization" transpired in 1972. The Bogorffs were on notice at that time as demonstrated by their proffer of the journal article to Dr. Koch and their ensuing consultations with other specialists in 1972 in search of a more definitive diagnosis and possible remedy. See generally Annotation, Statute of Limitations: When Cause of Action Arises on Action Against Manufacturer or Seller of Product Causing Injury or Death, 4 A.L.R.3d 821 (1965).
"[O]nce there is notice of the negligent act, the statute of limitations begins to run even if the full consequences are not known." Byington v. A.H. Robins Co., Inc., 580 F. Supp. 1513, 1517 (S.D. Fla. 1984). The Bogorffs' argument, that they did not realize that Adam's brain damage was permanent until they read Dr. Zee's letter, is unavailing. By any meter, the Bogorffs knew or should have known of the irreversible nature of the injury in 1973 when Dr. Cullen abandoned all attempts at palliation. Byington is instructive on the question of when the Bogorffs knew or should have known of methotrexate as the possible catalyst. In Byington, the district court, applying Florida law, granted summary judgment in favor of the manufacturer of an intrauterine device on the ground that the action was barred by the four-year statute of limitations. Relying on Steiner, the court found that the plaintiff's "persistent pelvic pain, coupled with her doctor's verbalized suspicions and Defendant's public disclosure of the possible dangers of the Dalkon Shield in 1974, should have put her on notice that her cause of action had accrued." Id. at 1515-16. The court reasoned that "[a]lthough she did not `know for a fact' that the IUD was the cause of her discomfit, Mrs. Byington certainly had available to her adequate facts . . . to point in a single direction in search for the responsible party o[r] parties." Id. at 1517 (quoting Steiner, 364 So.2d at 52). Rejecting Byington's contention that the manufacturer's fraudulent concealment of the dangers of the Dalkon Shield tolled the statute of limitations, the court observed that "the failure of a possibly responsible party to ascertain and publish the fact of its responsibility is hardly sufficient to constitute fraudulent concealment." Id. at 1518. Under Byington, there exists no genuine issue of material fact that the Bogorffs' cause of action accrued more than four years prior to the filing of the complaint.
The questions of whether Lederle fulfilled its duty to warn the medical community of the potential dangers of intrathecal use of methotrexate and whether Dr. Koch met his concomitant duty as learned intermediary to disclose to the Bogorffs the side effects of methotrexate are not genuine issues of material fact sufficient to preclude summary judgment. While the record is less than clear regarding the adequacy of the warnings given by Lederle and the reasonableness of the disclosure made by Dr. Koch, these considerations are rendered moot by the statute of limitations. A cause of action is not deemed to accrue when the wrong has been done or the duty has been breached but when the resulting damage is sustained and is capable of ascertainment. See Steiner; Krug v. Sterling Drug, Inc., 416 S.W.2d 143, 148-50 (Mo. 1967). "A statute of limitation runs from the date the cause of action arises; that is, the date on which the final element (ordinarily, damages, but it may also be knowledge or notice) essential to the existence of a cause of action occurs." Carr, 505 So.2d at 570. There is no merit in, and no record support for, Bogorff's contention that Lederle's failure to warn and Dr. Koch's failure to obtain informed consent constituted a continuing wrong against which the limitations period may only begin to run from the time of cessation of the wrong. Accordingly, I would affirm the summary final judgments in favor of Dr. Koch, the University, and Lederle.
As the manufacturer of a prescription drug, Lederle had a duty to warn the medical community of potential side effects resulting from the use of its product. Davis v. Wyeth Laboratories, Inc., 399 F.2d 121 (9th Cir. 1968); Felix v. Hoffmann-LaRoche, Inc., 513 So.2d 1319 (Fla. 3d DCA 1987), rev. granted, No. 71,633 (Fla. Mar. 18, 1988); Ricci v. Parke-Davis Co., 491 So.2d 1182 (Fla. 4th DCA), rev. denied, 501 So.2d 1283 (Fla. 1986); Buckner v. Allergan Pharmaceuticals, Inc., 400 So.2d 820 (Fla. 5th DCA), rev. denied, 407 So.2d 1102 (Fla. 1981); McEwen v. Ortho Pharmaceutical Corp., 270 Or. 375, 528 P.2d 522 (1974); Terhune v. A.H. Robins Co., 90 Wn.2d 9, 577 P.2d 975 (1978). See generally Comment, The Drug Manufacturer's Duty to Warn — To Whom Does It Extend?, 13 Fla.St.U.L. Rev. 135 (1985); Annotation, Liability of Manufacturer or Seller for Injury or Death Allegedly Caused by Failure to Warn Regarding Danger in Use of Vaccine or Prescription Drug, 94 A.L.R.3d 748 (1979), and cases cited therein.
Where a product is available only on prescription or through the services of a physician, the physician acts as a "learned intermediary" between the manufacturer or seller and the patient. It is his duty to inform himself of the qualities and characteristics of those products which he prescribes for or administers to or uses on his patients, and to exercise an independent judgment, taking into account his knowledge of the patient as well as the product. The patient is expected to and, it can be presumed, does place primary reliance upon that judgment.
Buckner, 400 So.2d at 823 (quoting Terhune, 577 P.2d at 978). A doctor's duty is to disclose to the patient the necessary information to enable him to balance the risks against the benefits. Buckner, 400 So.2d at 823 (quoting Ze-Barth v. Swedish Hosp. Medical Center, 81 Wn.2d 12, 499 P.2d 1, 11 (1972)). The relevant standard for assessing the extent of the information which may be required is "whether a reasonable medical practitioner in the community would make the pertinent disclosures under the same or similar circumstances." Ritz v. Florida Patient's Compensation Fund, 436 So.2d 987, 991 (Fla. 5th DCA 1983), rev. denied, 450 So.2d 488 (Fla. 1984); Thomas v. Berrios, 348 So.2d 905, 908 (Fla. 2d DCA 1977); Ditlow v. Kaplan, 181 So.2d 226, 228 (Fla. 3d DCA 1965).
The record contains the package inserts for methotrexate as well as the FDA applications and supporting documents and PDR annotations for 1970, 1971, and 1972. However, the record contains no evidence of the state of expert knowledge regarding the connection between intrathecal use of methotrexate and brain damage during the relevant time frame of 1971 to 1972. Drug manufacturers are held to the level of knowledge of an expert in the field. The duty to warn of a risk does not arise until the manufacturer knows or should know of the risk. Reyes v. Wyeth Laboratories, Inc., 498 F.2d 1264 (5th Cir.), cert. denied, 419 U.S. 1096, 95 S.Ct. 687, 42 L.Ed.2d 688 (1974); Davis v. Wyeth Laboratories, Inc., 399 F.2d 121 (9th Cir. 1968); Ortho Pharmaceutical Corp. v. Chapman, 180 Ind. App. 33, 388 N.E.2d 541 (1979); McEwen v. Ortho Pharmaceutical Corp., 270 Or. 375, 528 P.2d 522 (1974). "[T]here is no duty to warn of unknown or unforeseeable risks. Dates are thus vitally important, since the duty to warn depends on when the risk became apparent." Basko v. Sterling Drug, Inc., 416 F.2d 417, 426 (2d Cir. 1969).