April 13, 2022

The District Court of Appeal of the State of Florida (“Florida Appellate Court”) held in its opinion dated January 21, 2022 “we reverse the trial court’s grant of a directed verdict in favor of Holmes Regional and remand for a new trial” in a Florida medical malpractice case against a hospital where the plaintiff alleged that as a result of inadequate pharmaceutical tracking and recall procedures, contaminated heparin remained at the hospital and was administered to him by an anesthesiologist, who had not been informed of the contaminated heparin or its recall.

The Underlying Facts

In January 2008, Baxter Healthcare Corporation (“Baxter”) informed Holmes Regional Medical Center, Inc.(“Holmes Regional”) that certain vials of Baxter-manufactured heparin—a blood thinner—were contaminated, requiring recall. Baxter identified the contaminated vials by lot number. In response, Holmes Regional conducted three “sweeps” of multiple locations within the hospital to remove the drug from circulation: the first in January, the second in February, and the third on May 12, 2008.

On May 2, 2008, Robert Dumigan, then 76 years old, was admitted to Holmes Regional for heart bypass surgery due to a blockage. At the beginning of the procedure, Dr. Fernando Abad, the anesthesiologist, administered heparin to Dumigan. Dr. Abad testified that he had not been notified about the recall of contaminated heparin. For Dumigan’s surgery, he used heparin located in a blue box on his anesthesia cart, delivered by a pharmacy technician. Dr. Abad testified that he did not record in his anesthesiology report the lot numbers of the heparin he administered, as it was not standard practice to do so. Ten minutes after the heparin was administered, Dumigan developed significant hypotension—a drop in blood pressure. Dr. Abad testified that the drop in blood pressure ten minutes after he administered the heparin was the intended result of other medications he had administered for that purpose.

Over the next hour, Brooks Liles, the perfusionist, administered different vials of heparin to Dumigan through the cardiopulmonary bypass pump. Liles recorded the lot numbers of the vials he administered. The hypotension continued throughout the surgery.

Following the surgery, Dumigan was in a coma for 20 days, during which he developed heparin-induced thrombocytopenia (“HIT”), followed by heparin-induced thrombocytopenia with thrombosis (“HITT”). When he
emerged from the coma, Dumigan experienced significant pain in his legs, which were black and blistered. He developed ischemia, a condition in which there is insufficient blood flow to an organ or body part; his legs were not functioning, and he developed gangrene. As a result, his left leg and right foot were amputated.

Dr. Levin, a hematologist and expert medical witness for Dumigan, presented a differential diagnosis opining that Dumigan’s medical complications from the surgery were caused by heparin contaminated by oversulfated chondroitin sulfate. Dr. Levin concluded that Dumigan would not have had an adverse reaction to heparin during the 2008 surgery had it not been contaminated. As to Dumigan’s pre-existing conditions, Dr. Levin testified that it was unlikely that Dumigan’s peripheral vascular disease would cause thrombosis in multiple locations when Dumigan had not experienced any symptoms of the disease previously. While Dr. Levin agreed that lowered blood pressure is an intended and required state during cardiac bypass surgery, he opined that Dumigan’s blood pressure dropped lower than expected and dropped further after Dumigan was removed from the bypass machine.

Improper Stacking Of Inferences Doctrine 

The improper stacking of inferences doctrine states that stacking the inference of the existence of an essential fact to be drawn from circumstantial evidence cannot be made the basis of a further inference of an essential fact, unless it can be said that the initial inference was established to the exclusion of any other reasonable inference.

At the close of Dumigan’s case-in-chief, Holmes Regional moved for a directed verdict, arguing that a jury could only find for Dumigan through impermissible stacking of inferences. Holmes Regional alleged that there was a complete lack of direct evidence and, as a result, Dr. Levin’s opinion was dependent upon inferences drawn purely from circumstantial evidence, just as a jury verdict in favor of Dumigan would be.

In granting a directed verdict, the trial court stated, “So the Jury could infer that as a result of Holmes Regional’s failure to do the things that they spoke of, obtain a certificate, advising end users of the recall, that contaminated Heparin may have remained somewhere in the Hospital, that would be a permissible inference under the law. But to find that the contaminated Heparin ended up in the possession of Dr. Abad and in the operating room on the day of the Plaintiff’s surgery would require another inference to be drawn from an inference already made that contaminated Heparin remained on the property.”

Florida Appellate Court Opinion

The Florida Appellate Court stated that when the improper stacking of inferences rule is applied to expert testimony, even if an expert relies, in part, on an inference in order to render an opinion on causation, that opinion does not constitute impermissible stacking when it is also drawn from direct evidence. To generate an opinion, the expert must rely to some degree on the assumption underlying the hypothetical question. As a result, unless an expert opinion is based purely on speculation, impermissible stacking will not be found in this context.

The Florida Appellate Court held: “Ultimately, when viewed in the light most favorable to Dumigan, doubt exists as to whether contaminated heparin was still circulating and whether it was administered to Dumigan; Holmes Regional cannot conclusively state that it removed all contaminated heparin prior to his surgery when it failed to track lot numbers or obtain a certificate of compliance with the recall. As such, the evidence in this case, while conflicting and susceptible to different reasonable inferences, should have been submitted as a question of fact to be determined by the jury … The trial court erred in making a credibility determination and weight evaluation when
granting a directed verdict.”

Source Dumigan v. Holmes Regional Medical Center, Inc., Case No. 5D21-1087.

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