Dr. Thomas Mustoe, MD

D. N.,
Plaintiff,
vs
Thomas Mustoe, M.D.,
Mark Talamonti, M.D.,
Dr. Miguel Gallegos, Dr. Joseph Daw,...
Northwestern Memorial Hospital,
Ethicon, Inc.,
Johnson & Johnson, Inc.,
and Burrows Company,
Defendants,
and
Thomas Mustoe, M.D. and
Mark Talamonti, M.D.,
Counter-Plaintiffs,
vs
Ethicon, Inc., Johnson & Johnson, Inc.
and Burrows Company,
Defendants/Counter-Defendants.

Here are some of the details giving rise to this plastic surgery malpractice and medical product liability lawsuit, which is actually two suits in one, the Complaint filed by the plaintiff and the Complaint For Contribution filed by Drs. Thomas Mustoe and Mark Talamonti.

Ms. D. N., at the time of surgery, a 27 year-old pharmacist who was 5' 3" and weighed 157 pounds, was experiencing back pain which had been getting worse over the last several years because of her large breasts. They were also not symmetric, as the right was a DD cup and the left a D cup, and finally made the decision to have breast reduction surgery to alleviate these problems.

On November 20, 1996, she underwent surgery at Northwestern Memorial Hospital, recommended and performed by plastic surgeon Dr. Thomas Mustoe who was assisted by Drs. Gallegos and Daw. The internal absorbable Vicryl sutures (stitches) used during the procedure were manufactured by Ethicon, a subsidiary of Johnson & Johnson, which in turn were distributed and/or sold to Northwestern Memorial by Burrows Company.

After surgery, things did not go too well for Ms. N, who was eventually diagnosed with an infection from propionibacterium acne, or P. acne. The following, written by Dr. Mustoe on what appears to be Northwestern Medical Faculty Foundation stationery, or, possibly entered into their database and also into Ms. N's medical file, read like this:

Ms. N. is seen today in follow up. She began to spontaneously drain from her left breast which we cultured. The areas of her right breast are unchanged. We put a needle in each side and pulled off about 4-5 cc of pus from each area of firmness and sent them for culture. We placed her on Augmentin instead of Bactrim. I have asked her to see Dr. Talamonti who suggested we get an ultrasound. We will follow her closely. I have not seen this problem before post breast reduction.

On June 12, 1997, she again underwent surgery, performed by Dr. Mark Talamonti, on both breasts to have them debrided (surgically cleaned) and also had catheters installed to drain what were described as "multiple loculated breast abscesses" for a "severe allergic reaction" to the Vicryl sutures. On an interesting note, after she stopped seeing Drs. Mustoe and Talamonte, she underwent allergy testing at another hospital where it was found that she was not allergic to the Vicryl sutures.

Unfortunately, this was not enough to save her breasts and she subsequently underwent a double mastectomy on February 19, 1998, a procedure normally reserved for breast cancer victims, to save her life, and subsequent breast reconstruction.

In this suit, originally filed on December 30, 1998, Ms. N. claimed, among other things:

Drs. Mustoe, Talamonti, Daw and Gallegos (although it appears that Daw and Gallegos had nothing to do with her treatment after surgery) failed to promptly review and/or respond to her post-surgical complications, failed to obtain an infectious disease consult and treated her with antibiotics even though all cultures were negative, formulated a presumptive diagnosis of Vicryl suture reaction and did not do a proper work-up to rule it in or out, and also failed to remove the Vicryl sutures soon enough.

Against Ethicon she claimed that, among other things:

The Vicryl sutures were contaminated, not capable of maintaining a sterile condition as manufactured, were toxic, could not be re-sterilized and that Ethicon and Burrows Company also failed to warn users of this as there had been a voluntary recall of the sutures in question in September of 1994, which Ethicon claimed this case is not related to.

On another interesting note, Ethicon had agreed to produce product injury reports for a six month time period prior to her injury claiming infection after the reduction surgery but, apparently not before then.

In their Counterclaim For Contribution against Ethicon, Johnson & Johnson and Burrows Company, Drs. Mustoe and Talamonti also re-alleged everything in the second preceding paragraph, among other things, and obviously wanted them to contribute to any settlement reached.

Under Bush's tort/medical reform plan, Ms. N's breasts are only worth $250,000 in non-economic damages. You see, the term "non-economic damages" is a term carefully worded by crafty lawyers which means exactly what it says. In Ms. N's case, her breasts offer no way of contributing to her "economy" because she is a pharmacist. And having or not having breasts makes no difference as to whether she can make money, making the loss of them "non-economic". Whenever you hear or read that smoke-and-mirrors phrase, replace it with what it really means to non-lawyer types. It really means emotional damages and pain and suffering. Do any of our female visitors think that their own breasts are worth only $250,000? Probably none.

Drs. Daw and Gallegos were voluntarily dismissed on May 1, 2003 and NMH made a settlement of $100,000 on May 8, 2003. On August 6, 2003, Ethicon/Johnson & Johnson made a confidential good faith settlement, and on December 23, 2003 an amended complaint was filed replacing Northwestern Medical Faculty as a defendant in lieu of Drs. Mustoe and Talamonti, and this case was then settled on the following December 30, 2003, also in a confidential amount.

The following is a partially transcribed report from Ms. N's medical expert:

There are a substantial number of published reports and ample evidence from the peer-reviewed, medical/scientific literature of the past 15-20 years in the fields of infectious disease, hospital infection, orthopedic surgery, and plastic surgery, of anaerobic infections resulting in the formation of chronic abscesses, including abscesses of the breasts. From these abscesses certain pathogenic bacteria have been cultured, stained, and identified, resulting in targeted pre and post-operative treatments to minimize or eliminate the risks posed by their presence within the tissues of the body. Such treatments include prepping the patient with certain bactericidal solutions, use of certain antibiotics in the irrigating fluids used during the course of the surgery, and the administration of intravenous antibiotics during the course of surgery, and the administration of intravenous antibiotics post-operatively against pathogens whose susceptibility to such antibiotics has been established.

The normal flora of the breast skin and hair follicles are also found within the breast tissue. This flora contains bacteria that exhibit pathogenic activity following surgery. An important, recognized pathogen, in this regard, is the anaerobic bacterium Propionibacterium acne (P. acne) about which many articles have been published by surgical teams, including plastic and reconstructive surgeons.

Before Ms. D N's initial breast surgery for reduction mammaplasty at the Northwestern Memorial Hospital in November 1996, it was commonly understood from the peer-reviewed, published literature that P. acnes exhibited pathogenic properties, i.e., caused abscesses post-operatively, frequently in a delayed manner, and chronically as well. Special precautions were therefore advised in the literature as to how to deal with this anaerobic, non-spore forming, gram-positive, abscess associated microorganism. As noted in Sections I and II of this report, and as evidenced by a Pathology Report from the Northwestern Memorial Hospital dated 06-19-97 reproduced in Section V, Propionibacterium acne was cultured from breast fluid aspirated from D N's left and right breasts by Dr. Thomas Mustoe, her plastic surgeon.

On the basis of the readily available knowledge within the medical community regarding pathogens of the human breast, with specific reference to Propionibacterium acnes; and, on the basis of the availability of infectious disease specialists within the medical/scientific community of Chicago, Illinois; and, on the basis of the storehouse of information immediately accessible via computer search databases on infectious disease; and, on the basis of a pathology report from the Northwestern Memorial Hospital's Pathology Laboratories identifying the culture of P. acne from aspirated fluid taken from D N's breast abscesses, my opinions are:

Neither Dr. Thomas A. Mustoe nor Dr. Mark S. Talamonti sought out information that would have 'demystified' the occurrence of chronic abscesses occurring in the breasts of their patient.
Neither Dr. Thomas A. Mustoe nor Dr. Mark S. Talamonti consulted an infectious disease, immunology, or internal medicine specialist within their own hospital when confronted with the occurrence of chronic abscesses in their patient.
Dr. Thomas A. Mustoe either ignored or didn't understand the vital information provided to him and his colleague, Dr. Talamonti, by Pathology Laboratories of the Northwestern Memorial Hospital as noted in Section V of my report.
Had Dr's. Mustoe and Talamonti utilized the knowledge available to them and instituted appropriate treatments to Ms. D N during their care of her, she probably would not have taken the downward course she experienced in 1997, the consequences of which was bilateral, simple mastectomy followed by reconstructive surgery. And,
Dr. Mark S. Talamonti did not correctly consider, nor did he document the laboratory findings that the laboratory sample cultured positive for Propionibacterium acnes. He did not properly notify Ms. N or the other care providers of the positive laboratory finding.
Drs. Mustoe and Talamonti claimed that they met the standard of care in all ways concerning their treatment of Ms. N, and that their own expert witnesses were expected to testify at trial if necessary, among other things, that Ms. N's symptoms were inconsistent with any pattern of post-surgical problems or complication; that recurrent abscesses can occur even in the absence of any negligence on the part of a treating physician; that a non-healing wound is not necessarily indicative of an infection; that Ms. N's abscesses did not have an infectious nor immunologic etiology, and that the standard of care did not require that Ms. N be referred for either an immunological or infectious disease consultation.

There was no documentation in this file directly blaming P. acne as the culprit contaminating the Vicryl sutures used during Ms. N's surgery. If anyone out there has heard or seen anything about a connection between the two, please give us a jingle.

Click here for an informative site about the Ethicon suture recall.

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