Dumigan v. Holmes Reg'l Med. Ctr.

Decision Date21 January 2022
Docket Number5D21-1087
CourtFlorida District Court of Appeals


Appeal from the Circuit Court for Brevard County LT Case No 05-2012-CA-038662-X Michelle L. Naberhaus, Judge.

Stephen Joseph Biggie, of Arcadier, Biggie, and Wood, PLLC W. Melbourne, for Appellant.

Andrew S. Bolin, of Bolin Law Group, Tampa, for Appellee.


Robert Dumigan ("Dumigan"), individually and as executor of the estate of Edith Dumigan, appeals the trial court's directed verdict entered in favor of Holmes Regional Medical Center, Inc. ("Holmes Regional"). This case finds itself before this Court for the third time.[1] Because the evidence presented did not warrant a directed verdict, we reverse.

In January 2008, Baxter Healthcare Corporation ("Baxter") informed 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.

On May 2, 2008, 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 but did not record the lot numbers of the vials he used. Ten minutes after the heparin was administered, Dumigan developed significant hypotension-a drop in blood pressure. 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.

Four years later, Dumigan filed a complaint against Holmes Regional, alleging that as a result of inadequate pharmaceutical tracking and recall procedures, contaminated heparin remained at the hospital and was administered to him by Dr. Abad, who had not been informed of the contaminated heparin or its recall. Holmes Regional initially moved to dismiss Dumigan's suit, claiming that he had failed to comply with the pre-suit procedures required by Florida law in medical malpractice cases. After the trial court denied that motion, Holmes Regional petitioned this Court for a writ of certiorari. Dumigan I, 151 So.3d at 1283. That petition was denied, finding that the case sounded in negligence rather than medical malpractice. Id. at 1288. After discovery, Holmes Regional successfully moved for summary judgment based primarily on impermissible inference stacking.[2]That judgment was reversed on appeal. Dumigan II, 325 So.3d at 113.

At trial, the evidence reflected that Jill Walling, the pharmacy buyer responsible for executing recalls, received the Baxter recall notice and supervised the three subsequent "sweeps" to retrieve the medication. She testified that, per hospital procedure, once heparin entered Holmes Regional's pharmacy, lot numbers were not tracked; and the vials were subsequently distributed to multiple locations throughout the hospital, including Pyxis machines, [3] the satellite pharmacy, the operating room pharmacy, and heart boxes. Walling explained that, after a physician ordered heparin from the pharmacy for a surgery, it was delivered to the operating room and placed "somewhere in the [operating room] suite" but she was not "exactly sure where" within those suites.

In response to the January recall notice, Walling instructed technicians to visually inspect heparin vials located in Pyxis machines and "all other areas" to remove contaminated heparin by lot number. Walling stated she did not know that contaminated heparin could have been stored in medication and anesthesia carts and did not instruct staff to search those locations specifically; she also was not aware of the "blue boxes" used by anesthesiologists for medication storage. Due to another recall notice received in February, Walling instructed staff to conduct a second search, this time pulling all Baxter heparin, regardless of lot number. She noted that no documentation was created or maintained for either sweep reflecting which areas were searched or which vials had been removed.

Walling testified that ten days after Dumigan's surgery, her supervisor ordered her to conduct a third sweep due to an urgent recall reminder from Baxter indicating reports of noncompliance at some hospitals. Specifically, the notice stated that some hospitals had failed to retrieve Baxter heparin from ancillary locations such as anesthesia carts. As a result, she was instructed to search those areas. When shown a pharmacy receipt documenting a hospital return of Baxter heparin in June, Walling stated that the receipt reflected a delayed credit for vials returned several months prior. Walling acknowledged that Holmes Regional's recall policy handbook required notification of a recall to all end users of the medicine.

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 stated 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. He added 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.

Liles testified that he also administered heparin to Dumigan later in the surgery, using different vials than Dr. Abad. Liles stated that he had been informed of the recall and was instructed to inspect and record the lot numbers of the heparin he used. He recorded those lot numbers in his perfusionist report.[4]

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. His diagnosis noted the dramatic drop in blood pressure to unsafe levels; swelling indicative of an anaphylactic reaction; the emergence of the heparin antibody; and the rapid onset of significant, progressive thrombocytopenia. Dr. Levin also noted that Dumigan had not had an allergic reaction to heparin when he was treated with it during another procedure in 2010. As a result, 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.

On cross-examination, Dr. Levin agreed that HITT is a known risk and complication of heparin use, which is noted on the drug's package insert. He counsels his patients of the risks, including amputation, although he adds that it is a rare occurrence. 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. As to the heparin antibody discovered in Dumigan's blood after surgery, Dr. Levin agreed that the timing was consistent with when the antibody would have developed from uncontaminated heparin in a patient having an atypical reaction to the drug. He acknowledged that thrombocytopenia is an expected result of heparin but opined that the way it manifested in Dumigan was atypical and consistent with contaminated heparin use.

Timothy Hawkins, a hospital administration expert, described two mechanisms for properly conducting a recall: the first requires a hospital to record lot numbers upon receipt and track them throughout distribution-a procedure that is rarely practiced. The second option is to retrieve all the product, regardless of lot number. For either method, Hawkins testified that the national standard for medication recalls requires notifying all end users; he added that doing so is problematic without meeting with department managers to identify the end users and the locations where they store the recalled drug. Specifically, Hawkins explained that after a medication is delivered to a satellite pharmacy for use in the operating room, the drug is further distributed to multiple end users, including nurses, technicians, and anesthesiologists. Those end users store the medication in multiple locations, including in operating rooms, anesthesia machines and carts, and "even in lab coat pockets." According to Hawkins, the medication "wind[s] up everywhere," and without the necessary meetings "the product is still out there."

After reviewing Holmes Regional's records of the recall Hawkins opined that...

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