January 29th Morning session:
Plaintiff’s counsel continued their case by playing a video deposition excerpt of Dr. Thomas Vail, a member of the surgeon design team who helped to design the ASR and also received royalties from the sale of the device. Dr. Vail admitted that DePuy did not notify him beforehand that they were recalling the product. When pressed on the issue of whether he believed the ASR to be defective, Dr. Vail would not answer the question but only state repeatedly “I’ve not used the term ‘defective’ to describe the ASR product.”
Next, Plaintiff’s counsel called to the stand Dr. Craig Swenson, an orthopedic surgeon, to testify about his experience with the ASR XL. Our own John Gomez performed the direct examination. Dr. Swenson took the jury through a “Hips 101,” explaining to them how that area of the body functions, when a hip replacement surgery is needed, how it is performed, possible consequences, and what can cause a need for a revision. He then went into detail about his experience with the ASR XL, the revisions he has performed on his own patients, and his beliefs regarding the efficacy and safety of the device. He described that he has a very high failure rate among his ASR patients and that in his opinion, the angle of implantation (one defense DePuy argued early on) did not matter with regards to the failure rate.
Dr. Swenson explained that some of his patients experienced pseudotumors and other soft tissue masses. He further explained, “It’s a soft tissue mass which goes down and communicates with the joint. The body has tried to – the movement of the parts of this hip, I believe, is generating metal particles, and the body’s responding to these metal particles by trying to contain them. Since the particles keep coming, the body responds by making fluid, and you develop this cystic getting bigger and bigger…But as the mass gets bigger, it displaces the normal tissue. The hip capsule gets destroyed by the mass. The muscles around the hip – in his case, the external rotators got destroyed by the mass, but in other patients the abductors have been destroyed by the mass, and in other cases, the bone and other muscles have been destroyed by the mass.”
Dr. Swenson went on to describe various ways the ASR has failed, including “bone removing injury” and very high metal ion levels in the blood due to the prosthesis wearing and grinding away. He also described the numerous symptoms his patients with the ASR experienced, including limping, grating, grinding, popping, and squeaking. To date, Dr. Swenson has put in 206 ASR hip implants. He has revised 70 patients, knows of 4 patients that have been revised by other surgeons, and has another 4 scheduled to perform a revision. His next ASR revision is this upcoming Monday.
Mr. Gomez then presented Dr. Swenson with a picture of a brochure by Johnson & Johnson and DePuy, which claimed a success rate of 99.2 percent at three years. Dr. Swenson recalled seeing such a brochure. When Mr. Gomez asked him if that was his experience with the device he answered “[n]ot at all.”
Dr. Swenson also testified as to what information he was told by DePuy while he was using and implanting the ASR in his patients. He was not told of the concerns about edge/rim loading, that in 2007 DePuy’s testing indicated the ASR would produce 16 times as much metal wear as compared to other hip implants Dr. Swenson was already using, that an DePuy engineer named Chris Hunt identified a number of these design flaws and suggested a redesign, or that Project ALPHA was a code name for a redesign project that was ultimately abandoned.
Trial ended in the afternoon, with Dr. Swenson’s direct examination to continue tomorrow.