A first national class action in Nova Scotia

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Ken Taylor broken Profemur Hip Implant System. Credit: David Komm affidavit.
Ken Taylor broken Profemur Hip Implant System. Credit: David Komm affidavit.

When Ken Taylor’s hip implant broke in 2009, he did not think that his injury would one day make history. However, five years later, he is leading the first national class action ever certified in Nova Scotia.

Taylor’s legal battle is taking place at the Supreme Court of Nova Scotia against the Tennessee based company Wright Medical Group (WMG) and its subsidiaries in Canada. The resident of Dartmouth claims that WMG knew that their Profemur Hip Implant Systems had a high risk of failure, but the company sold them anyway. After receiving one in 2007, Taylor had to overcome three surgeries and he is now asking for compensation.

This first national class action could make a precedent and bring hope for better justice access for Nova Scotians. Class action procedures allow the plaintiffs to share the expensive costs of a trial. They also permit the Court to rule one case for many members, instead of having several similar trials backlogging the judiciary system.

“Usually, a national class action is certified in Ontario, as if it’s the only place that it could be done”, explains Michael Dull, from Wagner law firm, who is Taylor’s lawyer. “What this case says is that there are provinces outside of Ontario. We are pleased that the Court of Nova Scotia recognized that and didn’t take a back seat to Ontario.”

However, the battle is not won yet. Judge Michael J. Wood from the Supreme Court of Nova Scotia certified the lawsuit on March 7, but WMG appealed of the decision on July 8. For the American company, each medical case is different. Therefore, the class action should not be allowed, says the Tennessean corporation, that would prefer to manage the situation with each plaintiff separately instead of having them fighting together. Between the two sides, the legal battle in the Halifax Court House could last for years to come.

Taylor’s multiple surgeries

On September 1, 2009, Ken Taylor was plugging an amplifier at the bottom of his TV. “I was trying to get myself up and then I could hear a crunch.” At first, the large build man – Taylor measures 6 feet 1 inch and weights over 200 pounds – thought he just pulled something.

However, a few hours later at the hospital, radiography showed that it was serious: the neck of his hip implant broke. “The doctor told me: ‘You’re not going anywhere. The only thing that is holding your leg right now is the ligament under your skin.’”

Three days later, Ken Taylor had his first revision surgery. He received a new hip implant. Unfortunately, his bone was not growing around the prosthesis and the WMG product was loosening.

Six months later, on February 24, 2010, he underwent a third surgery, this time with a bone graft.

“And because of all that, I had my other hip done too,” says Taylor. “I put so much weight on my good hip for so long. So I had four operations in total: three on my left hip and one hip replacement on the right.”

A faulty product?

The hip implant was supposed to improve the quality of life of Ken Taylor who was suffering of osteoarthritis. This inflammation of the joints affects one in ten Canadian adults. Before receiving the hip implant, the cartilage of Taylor’s left hip eroded with time and became painful.

His doctor, Dr. Gross from Halifax, had good hope with the WMG hip implant, as he wrote it in 2006: “we will be using a ceramic articulating surface which I am hoping will give him twenty/twenty-five years of pain free range of motion without wear.” However, the implant only lasted two years and three months.

To support Ken Taylor’s case, two affidavits from experts were filed. In his testimony, Dr. David Zukor, Chief of the Department of Orthopaedic Surgery at the Jewish General Hospital in Montreal, indicates that the prosthesis Taylor received has been reported “to have a much higher than normal rate of failure at a much earlier time.” Zukor quotes the 2009 report of the Australian Hip Registry indicating that the WMG implant has an expected revision rate of 11.2%, instead of less than 2.5% for conventional hip replacements.

The second expert is David Komm, a mechanical engineer living in Arizona who has over 29 years of experience in examination of product failures and personal injuries. For Komm, it is “well within the balance of probability” that the WMG hip system has manufacturing or design issues. He uses the Manufacturer and User Facility Device Experience Database (MAUDE) from the Food and Drug Administration to make his point. His review suggests that the most common issue with the WMG hip implant is the fracture.

Battle of numbers

Revision rate for Profemur Hip System

Although David Zukor and David Komm’s opinions were damaging for Wright Medical Group, the company did not throw in the towel. Ken Taylor and his lawyer presented their expert opinions in October 2012. WMG presented its version of the situation in February 2013.

WMG’s expert, Byron Deorosan, a biomedical engineer from California, claims that both David Zukor and David Komm are wrong in their analysis. They used the MAUDE database which was an error, says Deorosan, because the FDA does not review the MAUDE reports. Therefore, the information is not a reliable source, he thinks.

In the affidavit of Debby Daurer, the Senior Manager with Wright Medical Technology contradicts the high rates of failure of the Profemur Hip Implant System. Quoting WMG records, she indicates that the worldwide fracture rate is 0.13% for the prosthesis. This number is well below the statistics from the 2009 Australian registry, used by David Zukor and David Komm.

Next step

The class action has been certified but the Supreme Court of Nova Scotia will hear the appeal from WMG this upcoming October. If the appeal is received, it could mean the end of the lawsuit, but if the appeal is rejected, the class action will go on.

“Then it could end in two ways,” explains Michael Dull. “The defendants could settle at any time. Otherwise, we would go on trial. If we win, we win for the benefit of everybody that had a fracture. If we loose, we loose to the detriment of everyone. That could take at least a couple of years.”

Thirty Canadians already joined Taylor’s class action.

Contacted by email, Wright Medical Group refused to give us an interview. However, in its 2013 Annual report, the company indicates that they changed the material of their Profemur implants in 2009 to improve their solidity. It is also specified that management estimates the liability cost of the Profemur prosthesis related claims from $17 million to $26 million in North America.

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