A lawyer for Johnson & Johnson (JNJ)’s DePuy unit, which lost a $8.3 million verdict in the first trial over its recalled hip implant, denied claims in a second trial that the device was defectively designed.
Richard Sarver, a J&J lawyer, countered claims yesterday by Carol Strum, 54, an Illinois nurse, that her ASR hip failed after three years and she needed replacement surgery known as a revision because of the design of the metal-on-metal device. He also denied claims by Strum’s attorney that DePuy failed to warn of the risks of the ASR, which J&J recalled in August 2010.
Strum’s case is the second of 10,750 lawsuits to be tried. On March 8, J&J lost the first trial when a Los Angeles jury ruled that the ASR was defectively designed. Jurors awarded compensatory damages to a Montana man while ruling that J&J adequately warned of the risks. J&J recalled the device when the revision rate in the U.K. hit an unacceptable rate of 13 percent after five years, not because it was defective, Sarver said.
“Many factors contribute to the overall revision rate so a single root cause cannot be defined at this time,” Sarver said yesterday in his opening statement. “We absolutely didn’t say the product is a defective product. We said we don’t know. We need to figure this out.”
To say the recall “is an admission of a defect, it is absolutely absurd,” Sarver said.
Strum’s lawyer, Denman Heard, told jurors that the ASR design flaws caused it to shed chromium and metal debris into surrounding tissue. Surgeons implanted a metal cup in the hip and a metal ball atop the femur that rotated inside the cup. DePuy claimed its design would last longer than other products.
“Before Carol Strum ever had the ASR put into her body, DePuy knew that the design flaws in this defective device could cause it to shed those particles into patients, causing tissue death, causing high blood metal ion levels and the need for the serious and unnecessary second surgery,” Heard said.
He said DePuy discovered the flaws and weighed a redesign of the ASR in 2008 before scrapping the project. DePuy never told doctors such as Strum’s surgeon about the risks, he said.
“If they had done so, we literally would not be here today,” Heard said. “Ms. Strum would not have had a defective implant put into her body because her doctor would have been fully informed about this product.”
Sarver said that DePuy fully researched the ASR, conducting hundreds of tests on machines and cadavers and sharing its data with the U.S. Food and Drug Administration. To “say we were hiding things is just utter rubbish,” Sarver said.
The design of the ASR, which is slightly less than a half hemisphere, was improved along the way, including by strengthening the cup and improving instruments used during surgery, Sarver said.
DePuy consulted “really just the best orthopedic surgeons in the world,” he said. “Only surgeons know what you need, so they tell us what kind of a product do you need, and then every step of the way they are telling us this works, this doesn’t work, this is a good idea, bad idea.”
Sarver said Strum had an “extremely lengthy and significant medical history,” including allergies, migraine headaches, chest and back pains, a family history of Crohn’s disease and apparent autoimmune problems, including skin rashes.
“Some people don’t react well to devices,” Sarver told jurors. “We don’t know why.”
He said three things must work well for a successful surgery: a doctor who does his job; a device working properly; and a patient’s body responding. In Strum’s case, he said, the doctor and the device worked well, while her body did not.
“In this case, that didn’t go well,” he said. “Mrs. Strum’s individual biology and health issues were the cause of the revision, not the device.”
Sarver said the revision rates were low at first. In 2006, patients had 12 revisions of 6,211 hips implanted; the next year, it was 64 of 16,881, or .38 percent, an “incredibly good number,” he said.
An internal DePuy analysis in September 2011 showed 37 percent of ASRs failed within 4.5 years, and Australian national registry data showed in 2012 that 44 percent failed within seven years.
Sarver said Strum was part of a “challenging population” of women under 55. He said 40 percent of all devices for those women fail within 19 years.
Her “optimism about how well this worked is just not the real world,” Sarver said. “In the real world it doesn’t work that way.”
Strum’s first witness was Magnus Flett, who led a DePuy design team and oversaw a group conducting a so-called failure mode and effect analysis, or FMEA, of the ASR. Jurors saw a videotape of Flett, as they did in the Los Angeles trial in which the plaintiff was Loren “Bill” Kransky, a retired prison guard.
Strum also is seeking punitive damages in the case. Jurors in the Kransky trial rejected a request for such damages, indicating “fraud or malice,” of as much as $179 million.
J&J faces more than 10,750 ASR lawsuits. About 500 are in state court in Illinois, according to another Strum attorney, Peter J. Flowers. About three-quarters of the total were consolidated in federal court in Toledo, Ohio. More than 2,000 are in state court in California. Others are in state courts around the U.S. The next trial is scheduled in federal court in Ohio in May.
The case is Strum v. DePuy, 2011-L-9352, Circuit Court of Cook County (Chicago).
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