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Ellis, et al. v. De Puy, et al.

Dr. Craig Swenson Details Damage Seen After Hip Implant Surgery, Yielding $8.34M Verdict in Products Liability Case

The Expert: Dr. Craig Swenson, an orthopedic surgeon who testifies concerning his experience with metal hip implants, walking jurors through case studies of issues involving DePuy implants.

By Dr. Gary F. Gansar, MD, FACS
Senior Physician Medical Director, AMFS

Offering testimony for the plaintiff in a 2013 products liability trial out of Los Angeles, Dr. Craig Swenson, a La Jolla orthopedic surgeon, describes his experience with the DePuy metal hip implant. The plaintiff claimed that one of the company’s ASR XL implants caused metal poisoning and pain, requiring removal and replacement. In this video clip, the doctor addresses one of a number of other patient cases he studied that required removal of the implants.

This case involved a 70-year-old male patient that had one hip implant performed in 2006 and the other in 2009. He eventually complained of bilateral hip pain with clicking, grinding, catching and popping of the joint. He was noted to have slightly elevated chromium and cobalt levels. MRIs revealed bilateral fluid collections around both of his implant hips. These implants were revised in 2011 and 2012.

The orthopedist presents visual slides demonstrating the pathology found when one of these hips was explored. The jury can easily see the thick pseudotumor of reactive scar tissue overlying the deep capsule of the hip joint, which when opened appears as “a gray-black, fluid-filled sack.” The normal capsule of the hip “is gone,” as are the external rotating muscles of the hip. This reactive tissue has been generated as a response to the particle debris that is shedding from the hip replacement. The expert states that “I think that this is the signature injury,” of this hip problem. It is the characteristic appearance at surgery of the failure of this prosthesis.

His testimony reaffirms that the findings demonstrated on these slides are typical of the problems leading to failure of this implant, not only in this case, but in general. There is usually bone destruction (osteolysis), the growth of pseudotumor (inflammatory tissue overreaction) over the capsule of the hip joint, and metallosis occurring within the joint. This triad occurs due to wear and tear on the metal interface, resulting in release of the metal ions into the hip joint.

Swenson allows that he has performed 206 hip replacements with this model between 2006 and 2010. Seventy-eight of these have been taken out or are awaiting revision surgery. This represents a 38% failure rate. He testifies that this implant, “fails more than any other device I have ever seen or heard of.”

There was an official recall on this device by De Puy, but the orthopedist does not remove them just because there has been a recall. He was able to identify all of his patients that had this device, and sent them a communication informing them of the recall. He brought each of these patients in to discuss the recall, examine them, perform x-rays, measure serum ion levels, and obtain MRIs on anyone whose ion levels were elevated. If there were no problems revealed, he would not take the implants out until an adverse event was noted, so as not to subject them automatically to a second procedure. Nonetheless, he maintains that if the problems are detected early and revision accomplished early, the soft tissue capsule and external rotator muscles can be preserved. Waiting, delaying or discovering this later can result in loss of function and stability of the subsequent hip replacement.

The jury was convinced by this graphic testimony, awarding $8,338,136 to the plaintiffs.

About the Author Dr. Gary F. Gansar, MD, FACS

Gary Gansar, MD, is residency-trained in general surgery. He served as Chief of Surgery and Staff at Elmwood Medical Center and on the Medical Executive Committee at Touro Infirmary and Mercy Hospital in New Orleans, LA. Dr. Gansar was Board Certified in general surgery while in active practice. He joined AMFS in 2015 as a Physician Medical Director.

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