It is the leading theory of the plaintiffs in this pelvic mesh case of Budke v. Ethicon– septic emboli killed Joan Budke, age 77, after her Prolift Pelvic Mesh implant became infected.
Today on the stand was Harvard pathologist, Dr. John Godleski, to confirm that diagnosis.
Before trial, an attorney for the defense, Daniel Ball, was heard telling Judge Hass of Camden Co. Circuit Court, Camdenton, Missouri, he did not want this jury to hear that the bacterial infection originated in the pelvis and traveled to the lung – exactly the theory the doctor would advance.
The pathologist was very thorough in his explanation, which was quite scientific. He stood at board of pink and blue-dotted masses to explain the infectious route.
THANKS TO THE MESH WARRIOR FOUNDATION FOR THE INJURED FOR CONTINUOUS SUPPORT!
Plaintiffs’ attorney Adam Slater explained that medical records are very clear, a massive pelvic infection became an embolism that went through Joan Budke’s leg in through the blood and into her lung, resulting in nodules. It then led to necrotizing pneumonia.
The disease overwhelmed Ms. Budke who died from the infection August 5, 2009.
The defense has advanced she died from Wegner’s Granulomas, which carries a few similarities but is treated with steroids, not antibiotics. In the beginning of this trial, defense attorney Christy Jones admitted no doctor had ever diagnosed Wegner’s, it was a coincidental infection.
See the Mayo Clinic explanation.
Dr. John Godleski, Harvard Pathologist
Dr. Godleski was clearly shown to be an expert as he presented his long list of credentials. His specialty is lung pathology at the largest pathology department in the country. He oversees five other doctors whose sub-specialty is lung pathology alone.
Showing the jury a series of slides of microscopic pictures he created, the doctor explained the colors.
Pink refers to cytoplasm, the portions of the cell that has protein in it and contains the functional part of the cell where contraction takes place. The blue part of the cell is nucleus is where the DNA lives. The blob of blue and pink showed more blue than you would normally expect, indicative that the army of white cells had convened to fight infection from an injury.
There are different kinds of white cells. The Neutrophil (NEUTRO- phil) with its multiple lobes in the nucleus are present to fight acute inflammation. “It takes up the bacteria and kills those bacteria with enzymes within the cytoplasm.” The second is a lymphocyte with a small single nucleus, usually present with chronic inflammation. These cells battle invading organisms and are responsible for immunity. The third type of cell is the Macrophage, it typically has a large, single nucleus, and is a scavenger, what he called a “big eater.”
Science lesson over, the jury of 15 seems riveted to the explanation.
There is evidence of infection where the mesh is present, Dr. Godleski said. Also found were cultures of staphylococcus.
Six biopsies were performed on Ms. Budke’s lungs and the doctors tested the nodules, suspecting cancer. Cancer was never found. What they found was acute inflammation and many neutrophils, indicative of a raging infection, inflammation, and an advancing pneumonia to its eventual final stages.
Slater- “Why is this indicative of pneumonia?”
Dr. Godleski said, “Because of the number of neutrophils. Normally its five to ten percent, when you are responding to an infection its 70, 80, 90 percent and you will see more cells. That’s what you are seeing here.”
Ms. Budke was wasting away unable to eat. By this time a fistula infection connected her vagina to her bladder. Dr. Godleski explained the course of the infection.
“In the specimens from the pelvis we saw acute inflammation, neutrophils and we found a clot. Clots are the basis of emboli and we found a clot in the lung, so we have evidence there were emboli. We have evidence from the abscess in her pelvis, she then developed a lung infection, and in those cases it was the same organism that was cultured from the pelvis.”
Slater- “Did any doctor ever think she had Wegner’s Granuloma (WG)?”
Dr. Godleski – “It does not appear in the clinical record. There were multiple pathologists in the hospital when she was treated. I didn’t think WG was a reasonable diagnosis. The progression is all consistent with infectious pneumonia, originating at the site of the mesh.”
On cross examination Daniel Ball determined Dr. Godleski didn’t normally treat patients. “I’m a pathologist,” he said.
Ball – “So, so far in this case we’ve had a doctor who doesn’t treat patients anymore (Dr. Anne Weber) and a pathologist who doesn’t see patients,” he said rather combatively.
Ball asked, “Wenger’s can cause pneumonia can’t it?”
“Wegner’s doesn’t cause pneumonia per se. It causes a mass that can be seen on an x-ray,” said the doctor.
Mr. Ball indicated Ms. Budke was being treated with antibiotics and still didn’t get well, indicating she should have if it was a bacterial infection. She had a very resistant methicillin-resistant staphylococcus, the doctor explained.
Ms. Budke was never treated with steroids, the treatment for Wegner’s, Mr. Ball established.
Wegner’s also presents with acute inflammation, doesn’t it, he asked. By May doctors now in the St. Louis hospital where she had been transferred, had still not ruled out a malignancy.
Ball – “Was the same bacteria found in the pelvis ever found in the lungs?”
Dr. – “It was not mentioned in the lungs and pelvis, except there were reports in the pelvis where it said poly-microbial organisms, that means there were so many they didn’t identify each one.”
After April there were no further cultures of any infection in the pelvis.
Ball said that was his point, no one ever reached the final diagnosis of septic emboli that originated from the pelvis? And the test for Wegner’s was never done either.
Under cross-examination, Adam Slater established that pneumonia, rather than clearing out everything in the airway, went into an organizing process and that became permanent part of the fibrous tissue of the lung that led to respiratory failure.
Slater read off several reports from hospitals discharges, one from Mercy Hospital, “complicated respiratory infection consistent with septic emboli;” from St. Johns, “Progressive pulmonary nodule with septic emboli.”
Did that happen in Joan Budke’s case?
“Yes that was the direction it was going.”
Ball came back one more time, in a pathologist’s role, septic embolism is rarely diagnosed, he asked. That’s correct said the doctor.
Radiologist Dr. William Matouzzi
Next on the stand for the plaintiffs was diagnostic radiologist Dr. William Matouzzi from New Jersey. He was highly credentialed, had a neat beard and a nice suit. His days are spent reading a broad spectrum of diagnostic medical images including CT scans, mammograms, x-rays. He read Joan Budke’s scan. A nodule in the left lung, it said. Looking at cross sections of her body under the CT scan taken in February 2009, he pointed out to the jurors her pulmonary arteries were abnormal, on the right side there was a pulmonary embolism, “which can be life threatening.”
“Mrs. Budke presented with a mesh infection in her pelvis and had a pelvic infection abscess in the pelvis, a collection of pus. When it goes to the lungs it has to come from somewhere, typically the veins in the lower portion of the body or in the pelvis itself. In her case, when there is an active infection in the pelvis from the mesh, a clot breaks off, travels to the lungs and gets seeded out to the lungs. It will go into smaller vessels to seed or spread out into the lung tissue. That’s important because it’s a mode of disseminating infection.”
Ms. Budke had multiple nodular areas in her lungs by March 2009 he said showing the CT scan. Why is this significant?
When she came in with a pelvic infection, mesh had eroded in the vagina and shortly after she had another scan it showed a blood clot had traveled to her lung from the lower body.
“It’s the highway infected material goes up through the pelvis into the lungs and spreads through arteries into the lung tissue and creates nodules of pneumonia.”
He called it, organizing bacterial pneumonia or septic emboli. Septic means infected pulmonary emboli.
Again Slater asked about the defense argument of Wegner’s Granuloma. Dr. Matuzzi said it missed three of the four signals of the disease, she had none of those things. “She only had one of the four, you have to have two to fit into the diagnosis,” he said.
Dr. Matuzzi’s final call was “Infection to the lungs starts pneumonia and progresses over months so severe she is overwhelmed by this; she’s debilitated; she’s succumbing to progressive pneumonia and this kills her. Respiratory failure with overwhelming necrotizing pneumonia.”
Defense attorney Ball asked Dr. Matuzzi how much he charges.
He said $3,000 for a half day, but for this trip he would have to calculate in travel which he rarely does. Ball suggested it’s the job of a pulmonologist to culture blood, work up clinical symptoms, radiology and pathology, not a radiologist. “They do both,” he said.
Were you aware the plaintiffs’ had a theory that mesh particles in the lungs were the cause of death for months?
No, answered the radiologist. #