Defense Experts Refute Pelvic Mesh Infection Theory in J&J Death Case

Macrophages at work, Stonybrook Medicine

Early this week, defense attorneys for Johnson & Johnson and its medical device division, Ethicon, questioned two expert witnesses. Both would try and dispel the plaintiffs’ case that Joan Budke died of a septic condition that traveled from her pelvis to her lungs and resulted in her death in August 2009. The source of the pelvic infection was the Prolift mesh implanted in April the year before insisted attorneys for the Budke family in Budke v. Ethicon.

This coverage is brought to you by The Mesh Warrior Foundation for the Injured. Thanks to court watchers for their notes!

The case involves Donald Budke and his product liability, wrongful death action against Johnson & Johnson, Ethicon, Gynecare Worldwide (a division of Ethicon), Becky Simpson, M.D. d/b/a/ Lake Area Women’s Center and Becky Simpson, M.D. (medical malpractice). No. 10CM-CC00085 was filed in the 26th Judicial Circuit Court, Camden Co. Missouri in July 2, 2014.

Jurors in Budke v Ethicon, anonymous artist

The jury appeared attentive, according to a court watcher for Mesh News Desk. (She is mesh injured and wishes to remain anonymous to the public.) Mr. Budke's and his son and both daughters were present in the court room.

So far for the defense, pathologist Dr. Jon Ritter, was called to the stand. He specializes in lung diseases at Washington University. See his background here.

And from the University of Minnesota here.

On Tuesday our observer arrived late afternoon approximately 2:30 pm hearing only the last few questions regarding what would be consistent with Wegner’s Granulomatosis findings. That is the autoimmune disorder the defense claims was the actual cause of death of Ms. Budke though it was never isolated and identified in her.

Wegner’s allegedly also causes inflammation which was present in the plaintiff before she died. See background story on opening arguments for the defense here.

Dr. Donald Fry, expert for the defense

When jury returned after an afternoon break, defense called Dr. Donald Fry to the stand. His special academic interests are in the area of infections and sepsis after surgery.

He is an adjunct professor of surgery at Northwestern University in Chicago. See background here.

Our court watcher reports that Dr. Fry is not board certified in infectious disease. He has never performed a pelvic organ prolapse surgery or any type of female pelvic organ surgery. He has performed abdominal hernia mesh surgeries and rectal prolapse surgeries.

Dan Ball, Bryan Cave Law, St. Louis

Attorney Dan Ball emphasized Dr. Fry was there only to testify about infections and not about the surgical aspects of pelvic floor surgeries or Ethicon documents. The doctor was paid $300 an hour to review Joan Budke’s medical records the jury was told.

Our court watcher took notes to the best of his/her ability and there were no recording devices used to compile these notes. Your editor has chosen to display the notes since she was not there to summarize or compile what was being said.

Defense attorney Ball then had Dr. Fry give definitions slowly, one-by-one to the jury describing a bacteria vs virus vs fungus. Ball then had Dr. Fry confirm that a person may have bacteria, a virus, and a fungus inside their body without an infection.

Ball then moved on to have Dr. Fry define what inflammation was in the body and asked if inflammation was the same as an infection. Dr. Fry replied "NO, they are distinct entities."

At this point, attorney Ball had a large notebook-like pad on a stand brought up closer and faced it towards the jury. Ball began to write out his questions /answer summaries. He began by stating he wanted to approach this chronologically:

Ball stated they would begin by taking it from Joan's surgery on April 28, 2008 for placement surgery until January 5, 2009, her well-woman exam.

Ball: Did Joan have any ongoing infections?

Fry: She did not.

Ball: There were no signs of ongoing bacteria?

Fry: No.

Now, we will stop at January 22, 2009:

Ball: Did she have signs of a systemic infection?......any temperatures, chills, rapid heart rate?

Fry: No.

Ball: Mesh removal was in that time frame and she had cultures?

Fry: Yes.

Ball: Asked for exhibit 10026.43 Gram stain to be brought up.

(These pathology reports were projected on the overhead screen beside/behind the witness stand.)

Ball: Asked Dr. Fry to explain what a Gram stain was…

Fry: A Gram stain is a routine culture where specimen is rubbed on a piece of glass. The glass is stained and the stain examined for bacteria.

Ball: Where there any identifying pathogens on the Gram stain?

Fry: There were no specific identifying pathogens on the Gram stain.

Ball: Asked for exhibit 1002.42 (a culture specimen of the pelvis area…….did it have bacteria?

Fry: Confirmed it did have bacteria………a Bacteroides species.

Ball: Was this Bacteroides species, the species of Bacteroides fragilis?

Fry: It was non-Fragilis Bacteroides species.

Ball: Is vaginitis, beta-lactamase positive in Bacteroides species? (I could not hear complete question)

Fry: Yes.

Ball: Fragilis?

Fry: Yes.

Ball: Does a positive finding mean fragilis?

Fry: A positive finding does not mean fragilis.

Ball: Did medical record reflect signs of UTI infection?

Fry: Yes there were findings of an UTI infection.

Ball: In your expert opinion was the mesh the cause of the infection in January 2009?

Fry: It is my opinion that the mesh did not cause the infection.

Ball: Was vaginitis or UTI candidates for the infection?

Fry: The tissue infection was very likely caused by the UTI or vaginitis.

Ball: We've discussed the mesh……the January 23, 2009 surgery and culture. Now, let's move to January 30, 2009 surgery by Dr. Simpson. What was that surgery?

Fry: Dr. Simpson went back into area where pelvic mesh was removed, (unclear______) looked for residual infection, cleansed area with irrigation and concluded the surgery.

Ball: On February 2, 2009, when Mrs. Budke was discharged what was her diagnosis and condition?

Fry: (Unclear)_______infection to pelvic area mesh, resolved.

Ball: At followup? February 2009….did tests show any ongoing infection?

Fry: It did not.

Ball: Now, we will go on to March 2009. (But………Before we do that), Ball wanted to point out at this time that Mrs. Budke had been to the Camdenton Hospital and at this point, she is at the University of Missouri Columbia. Did tests show any ongoing infection?

Fry: No.

Ball: April 2009, followup ……any tests showing an ongoing infection?

Fry: It did not.

Ball: April 2009 – There was an infection in urine?

Fry: She had sample tissues of urine and had both types (a few dozen derived) ________ MRSA and Serratia marcescens (subculture in urine not related to mesh but in urine of bladder).

Ball: What is MRSA?

Fry: Methicillin-Resistant Staphylococcus Aureus.

Ball: What was treatment and how did Mrs, Budke do?

Fry: Treatment was antibiotics and resolved.

Ball: Is MRSA and Serratia in relationship to one another?

Fry: Not in relationship.

Ball: Looking back from April 28, 2009 to April 2009 with the exception of surgery in January 2009, any signs of ongoing infection?

Fry: From that timeframe described, there were no signs otherwise of an ongoing infection ……slight pause …..(then added) at the site of original operation.

Ball: Where there EVER at any time any polymicrobial infection in the pelvic?

Fry: No…..not at the site of the original mesh operation.

(NOTE: A small definition of polymicrobial versus mono is given to the jury at this point at judges' inquiry).

Ball: Treatment???

Fry: A lot of antibiotics given. No evidence persisted.

BALL: Now moving from the pelvis to the lungs.

BALL: There was an abnormal nodule incidentally found on CT of the abdomen and pelvis on 01/22/2009. The timeframe is now from January 22, 2009 until August 2009 when Mrs. Budke's death. Where there cultures from the lungs?

Fry: Many, indeed.

Ball: Symptoms from lungs?

Fry: She did not.

Ball: Timeframe May, June, July……symptoms of lungs?

Fry: She did not.

Ball: In this timeframe, we are in the hospital St. John's Mercy in St. Louis (states another in St. Louis???) Did she have many cultures and biopsies?

Fry: Multiple. University of Missouri and 2 at St. John's. Results, (unclear _______)yes, pathological.

Ball: Radiological tests by CT lungs?

Fry: Yes.

Ball: In all that testing, any mention of septic emboli?

Fry: No.

Ball: In your opinion was there an infectious process of infected material from a remote site that goes to the lung?

FRY: Based on evidence and my opinion of lung condition was not caused by septic emboli (unclear __________). I do not believe her medical condition was due to infection of septic emboli to lungs.

Ball: Let's talk about septic emboli to the lungs. What would symptoms be?

Fry: Rapid breathing, cough, systemic fever, chills, severe rapid heart rate due to spread into blood stream.

Ball: Treatment?

Fry: Antibiotics would be treatment for it but…… AFTER …….you take care of primary source where emboli coming from.

Ball: If appropriate treatment given, what would recovery expectations be?

Fry: With arrest of the primary source/site of emboli, would expect complete resolution within several weeks' time.

Ball: Mrs. Budke's treatment?

Fry: She continued with antibiotics; she received triple drug (antibiotic) therapy to cover every potential……..she progressively deteriorated.

Ball: If antibiotics do not make it better….what would that be evidence of?

Fry: Evidence it was not an infection in the lung.

Ball: Talk about cultures……can you still have an infection…..an ongoing infection if on a wide-range of antibiotics with a normal culture?

Fry: No, infection in blood gives those conditions (unclear on complete question _______).

Ball: Now moving to the "talk you've heard" of a pelvic infection moving from blood to the lungs? You've heard some about bacteria in pelvis that moved into the lungs? Did that occur?

Fry: It did not occur.

Ball: It was (attorney stumbled all over the pronunciation of the word)…..Candida pseudomonas……… and

(Then, Dr. Fry, talked over him) Fry: Correcting Ball stating it was really called (new name) Stenotrophomonas maltophilia, a gram-negative bacterium.

Ball: (Date given 06/30/2009)……Is Candida ……then attempted to say Stenotrophomonas maltophilia….(being corrected again) a fungus?

Fry: It is totally unrelated to pelvic infection. It definitely would have had to of been inhaled in a hospital environment. It is an organism not associated with longstanding lung condition.

Ball: At any time during entire hospitalizations of Mrs. Budke, did any doctor diagnose septic emboli before Mrs. Budke's death?

Fry: No. They were looking at other causes for her lung condition.

Adam Slater

##

Attorney Ball finishes his line of questioning and Judge indicates Attorney Slater's turn for the floor.

Slater: Now you stated you were paid $300 per hour by Ethicon. (Slater does a calculation outloud, but I could not hear it clearly)

Fry: Yes.

Slater: You were a general surgeon. You did general surgery, bariatric type….You stopped in September 2005?

Fry: Yes, bariatric and trauma surgeon.

Slater: You are NOT an expert on prolapse surgery……you have NEVER done that type of surgery…right?

Fry: No …..I have never done a female pelvic floor surgery for prolapse.

Slater: You do not practice Infectious Disease either…..correct?

Fry: No, I do not practice Infectious Disease.

Slater: You do have a lot of experience in hernia mesh surgeries?

Fry: Yes.

Slater: We talked before….you have seen hernia mesh infections?

Fry: Yes, a bacteria as a result of soft tissue infection.

Slater: Let us be clear here…….you are NOT board certified in Infectious Disease?

Fry: No….I am not board certified. Actually only internal medicine physicians can take the board for that but I have seen many infections through my years as a general surgeon.

Slater: Now, you have a consulting contract with Johnson and Johnson? We've talked before. You have done over 300 cases for them……150 depositions for Johnson and Johnson?

Fry: (interrupts)………yes, but over the past 35 years (unclear ________)

Slater: Now, you said you last worked at University of New Mexico….Chairman of Department of Surgery, but you were removed?

Fry: (quickly stating) resigned………(then sort of clarifies)…….well, I resigned but with the understanding I would be removed if I did not resign. There was a conflict with the dean, but I knew if I did not resign, I would be terminated. It was clear to me.

Slater: Now you are also with the Healthcare Consulting in Chicago? It is like a "Think Tank" ?

Fry: Yes……________________study outcomes of care whether it is acceptable or unacceptable (NOTE: I could not hear his full answer)

Slater: You design payment modules…..right?

Fry: Yes that is it.

Slater: What would you say the majority of your time is spent doing?

Fry: The majority would definitely be payment modules for healthcare....

(I missed a few questions here)

Slater: You mentioned in reviewing the documents, there was a hospital-acquired infection. If Mrs. Budke was NOT in the hospital, then there would be no infection?

(Both went back and forth on this question a few times but Dr. Fry did admit to that conclusion by Slater)

Slater: Can you have a potentiating (unclear _______) lung infection without a fever?

Fry: Yes, you can have an infection without a fever.

Slater: The tests showed bacteroides in the pelvic cultures……..bacteroides does not belong in the pelvis.

Fry: Correct.

Slater: It was on the test result.

Fry: It was.

Slater: The Gram stain showed gram-positive cocci.

Fry: Showed additional……showed something didn't (unclear____________) test gram-positive cocci.

Slater: The Prolift was exposed through the vaginal wall into the vagina?

Fry: Yes.

Slater: The mesh was potentiating infection with bacteria adherent to mesh ultimately colonizing an infection.

Fry: Infection of soft tissue (unclear________) may become adherent to part of process potentiating infection.

Slater: So it is clear mesh does NOT resist infection but rather potentiates infection…..correct?

Fry: Correct.

Slater: So bacteria on the mesh……bacteria attaches to foreign body…….mesh becomes infected.

Fry: I agree _________ (not clear what was said).

Slater: So would you agree:

1) Patients can have an infection, be on systemic antibiotics and have negative cultures?

(asked to rephrase question) Questions was rephrased and Dr. Fry agreed.

2) Is it possible to have septic emboli from pelvic to the lungs.

Fry: Possible……..anything is possible but unlikely.

***(reiterated bacteria and fungus Candida) (did not get whole interaction)***

Slater finished questioning Dr. Fry.

ATTY BALL JUMPED UP WITH ARMS WIDE OPEN, STATING…… ANYTHING IS POSSIBLE? But then asked based on your reasonable medical expert opinion, did Mrs Budke have septic emboli traveling from pelvis to lung?

Fry: She did not.

Ball: Do patients with normal cultures 8 months duration?

Fry: Based on my reasonable medical opinion of the probability, no.

BALL: What is your opinion?

Fry: It was in the soft tissue not in the mesh.

BALL: When in New Mexico, you had a differing opinion with the dean but, since that time, they have named part of school and emeritus of Society in your name….. Endowment chairman? (I was unable to hear all this information clearly).

BALL: After this, Attorney Ball added, would (septic emboli) be seen in the blood stream culture to which Dr. Fry confirmed.

BALL also asked Dr. Fry to reaffirm from March or so, the blood cultures showed no positive cultures. There was a positive urine tract culture and airway 2 bronchial washings but zero positive blood cultures. On June 30, showed Candida fungus and Stenotrophomonas Maltophilia. To which Dr. Fry stated Stenotrophomonas Maltophilia was very dangerous and hard to eradicate.

This ended the day. Defense stated they had 1 more witness to take the stand tomorrow (Wed). Then, they would tie up any loose ends and felt would be ready to give closing on Thursday. ##