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Quitman woman loses hip implant case heard in Marshall

By Robin Y. Richardson
May 7, 2017 at 4 a.m.


A federal jury in Marshall ruled against a Quitman woman Friday, determining that Zimmer, a multibillion-dollar medical device manufacturer, did not give her a defective hip implant in March 2011 that was unreasonably unsafe.

The product liability case kicked off this week in Marshall's federal court with U.S. District Judge Rodney Gilstrap presiding.

The plaintiff, 72-year-old Martha Hardy, sued Zimmer, one of the world's largest medical device makers, in March 2016, alleging that Zimmer's Trilogy Acetabular Cup severely injured and crippled her.

Lawyers in the case argued that because of the incorrect porosity and pore size of the defendants' hip replacement hardware, the bone in the patient did not and could not reasonably grow into or bond with the hip replacement system, resulting in failures, which allegedly resulted in substantial injury. The surgery was conducted on March 15, 2011, when the plaintiff underwent a right hip replacement at 65 years old.

"What this case is really about … it's about a broken promise," attorney Todd Tefteller, representing the plaintiff, argued.

"The almost $10 billion company made a promise it didn't' keep," he said.

Tefteller argued that the company did not build the implant in accordance with Food and Drug Administration regulations and in accordance with the design it told the FDA it needed to have in order to function properly. The one his client received in 2011 "amounted to a ticking time bomb," he said.

Tefteller said prior to the hip replacement in 2011, Hardy was a typical 65-year-old, enjoying life with her husband, their adult children and their grandchildren.

Tefteller said it all changed because of the company's alleged deceptive practices that occurred over the course of 20 years at its manufacturing plant in Puerto Rico. He argued that the company's alleged negligent manufacturing practices and failure to control, test and/or validate its products resulted in improper pore size and porosity, which prevented necessary bone ingrowth.

Tefteller said the implants cost about $10,000 apiece.

"They're an almost $10 billion company, who has almost for 20 years been engaging in deceptive conduct, cover-ups and lies to the FDA about its practices," Tefteller alleged.

The pain his client endured was 100 percent worse than childbirth, he described. Besides a dislocated hip, Tefteller said his client suffered from the alleged "metal piece of junk grinding away at her pelvis" for months at a time until she received the help she needed during another surgery in June 2016 to remove and replace the implant.

"That company chose to ignore its own home core values and has not done the right thing," Tefteller said. "That's how we ended up in here in federal court (in East Texas)…with a 72-year-old woman taking on a company like Zimmer."

Tefteller said the possibility of Zimmer ever doing anything wrong was always an absurdity to the defendant until they came to court in front of the jury and made an admission of missing some key issues over the years that led up to Hardy's implant.

"They told the FDA they were going to build it with a 45 percent porosity," Tefteller said.

Instead, the implant was nearly 28.7 percent - almost less than half the porosity they told the FDA they needed in order to work properly.

"It was a piece of junk. That's what it was and that's how it failed," Tefteller said, noting that the implant was completely detached from Hardy's hip and floated around in her body.

Defendant

Attorney Mike Kanute, co-counsel for the defendant, said Hardy's Trilogy shell, which is the cup, tells the story of what actually happened in this case.

"We tested the cup for porosity," he said. Unlike what the plaintiff's counsel claims, "Each way, it came in above 30 percent."

Kanute said because of that porosity, because of that testing, they no longer have to guess how the validation procedure affected the plaintiff's cup.

"All of these validation questions that were raised have nothing to do with her cup," he said.

"Mrs. Hardy's shell fell within the range set forth by this federal regulation," he said, noting federal regulations say that the porosity for Porous-coated hips has to be between 30 and 70 percent.

"Forty-five percent is not a design specification," attorney Jon Skidmore, also representing Zimmer, said, echoing Kanute's sentiments.

Kanute said to prove their point, they brought in Holly Rhodes, the FDA regulator that came up with the regulation.

"The question is is the implant that went into Mrs. Hardy safe," said Kanute.

"It's not a defect. It's not unsafe and porosity at that level does not make it unsafe," he said. "The fact of the matter is it is safe."

He said the plaintiff's pain was caused by the impact of a fall and a disintegrating bone graft.

"Mrs. Hardy's bone graft disintegrated. The shell loosened and it had nothing to do with porosity or pore sizing," Kanute argued.

Skidmore, representing the defendant, argued that the plaintiff's counsel ignored the medical facts of the case, which, to them, proves that Zimmer wasn't liable for Hardy's suffering.

"Why did her implant surgeon implant 300-plus Trilogies in patients all over East Texas and never had any (problems) or loosening problems?" Skidmore questioned.

"(It's) because Trilogy works," he said.

Skidmore also blamed Hardy's agony on a fall she had in 2011. Two X-rays were done as a result, showing a diminishing bone graft.

Skidmore said the plaintiff's acetabulum had been destroyed. The bone and ball of the hip also had to be replaced.

"The bone graft was supported by the screws up against that cut (that) was in her body," Skidmore said. "The washer is already becoming loose and the bone graft is already disappearing by the summer.

"By the summer 2011, that bone graft was disappearing and that was the area with the most pressure of our cut," Skidmore said. "There is no doubt this cup was moving because that graft was dissolving."

He said if there is micro motion and no growth, what one is going to get is fibrous tissue.

"That structure was the absolute key to stability and it disappeared," he said, urging jurors to look at the medical records. "Read about the fall that may have had some impact on this.

"We don't know, but we (do) know that at the end of the day, the bone disappeared," he said.

The jury also determined that the company did not engage in any false, misleading or deceptive act or practice that the plaintiff's surgeon relied on to her detriment and that was a producing cause of damages to Hardy.

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