When Joints Fail, Who is at Fault?

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Product liability lawsuit over failed elbow implant targets manufacturer and surgeon.


If an elbow joint replacement fails in just 8 months, is it the result of a defective product, wear and tear from an active patient in the prime of her life, or a surgeon who put a left-side implant in the right-side elbow? The U.S. Court of Appeals for the 9th Circuit this week cleared the way for a Las Vegas jury to decide who, if anyone, is at fault in such a scenario.

Since 2003, Marylou Primiano of Las Vegas has been suing device maker Howmedica Osteonics Corp., a Stryker subsidiary based in Mahwah, N.J., over the implantation of a Solar elbow joint by orthopedic surgeon Robert J. Tait, MD, of Henderson, Nev. Ms. Primiano is also suing Dr. Tait as part of the product liability claim, but not for medical malpractice, according to court documents.

After a fall in her kitchen in 2000, Ms. Primiano, who was 36 at the time, needed elbow replacement surgery. During the procedure, when Ms. Primiano's arm was open, Dr. Tait opened the package for the Howmedica joint and discovered that it mistakenly had a joint for a left elbow in it. Rather than cancel the surgery, Dr. Tait called the Howmedica rep, Yan Cook, who told Dr. Tait that he could use the left-side implant on the right side if he drilled an anchor hole on the inside of the bone rather than the outside. Then the implant would work fine, said Mr. Cook, according to court documents.

The surgery seemed to be a success until a few months later when Ms. Primiano's elbow began to squeak and eventually make a metal-on-metal noise. Eight months after surgery, Dr. Tait replaced the implant with a larger one, again for the left side since the hole was already in the bone. The second joint failed and another surgeon inserted a different manufacturer's joint. That joint became loose and required surgical repair as well. Ms. Primiano had 5 surgeries before filing her lawsuit.

Three years into the lawsuit, a district court judge did not allow testimony from Ms. Primiano's surgeon expert witness because the judge believed it was inconclusive and would not be helpful to the jury. He then dismissed the case.

Ms. Primiano appealed to the 9th Circuit, which in an amended appeal issued April 27 ruled that expert testimony submitted on behalf of Ms. Primiano could be used, and sent the case back to the district court. The jury "may conclude that Ms. Primiano's level of activity, or error by Dr. Tait in performing the surgery, caused the failure," wrote the judges. "Or it may conclude that the negligence that matters was in the packing and shipping department of Howmedica, when they sent the wrong pieces to the hospital."

"We're looking forward to presenting Marylou's case to a jury," said Ms. Primiano's attorney, Peter Wetherall. "Her injuries have gotten worse since the case was thrown out of court." Since 2006 Ms. Primiano has had more surgeries and can no longer raise or use her arm, says Mr. Wetherall.

Howmedica and Dr. Tait have until June 10 to file an appeal with the U.S. Supreme Court; otherwise, the case goes before a jury. A trial date has not yet been set. An attorney for the company and the surgeon did not respond to requests for comment.

Kent Steinriede

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