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Metallic Ion Levels from DePuy ASR Hip Implant Eight-Times the Safe Limit, Professor tells Jurors

Feb 4, 2013

The levels of toxic metallic ions generated by the DePuy ASR metal-on-metal hip implant were eight-times the limit considered safe by California health regulators in one patient and likely thousands more.

That’s the testimony of one witness called during the sixth day of a trial involving a Montana man who claims the recalled ASR metal-on-metal hip implant is defective and caused dangerous levels of metallic ions to accumulate in his body while also forcing him to endure severe pain until the hip implant was removed long before it was advertised to last.

Loren Kransky, 65, claims he received his ASR hip implant and just a few months after the procedure began suffering complications mirrored by thousands more recipients of this device in a short amount of time after having it implanted. Kransky is the first person in the U.S. to have his claim against DePuy Orthopaedics, a division of Johnson & Johnson, to reach a jury trial. Attorneys representing him are aimed to prove that executives at DePuy were aware of the problems associated with the ASR and ASR XL metal-on-metal hip implants while they marketed them as safe and effective until the day they were recalled in August 2010.

DePuy still maintains that its ASR line of metal-on-metal hip implants are not toxic and that recipients who’ve experienced complications caused by the devices, like Kransky, have prior medical conditions that led to them suffering problems after they received their hip implants. There are more than 10,000 claims against DePuy and its ASR line of metal-on-metal hip implants. That includes more than 7,000 consolidated in a federal Multidistrict Litigation.

During testimony in the ongoing trial delivered on Feb. 1, a professor of medicine at University of California-San Francisco told jurors that DePuy failed to account for the problems caused by increased metallic ions in a person’s body after they received an ASR metal-on-metal hip implant. One of the hallmark complications of a metal-on-metal hip implant is their ability to disperse metallic ions into a recipient’s bloodstream, leading to metal poisoning, or metallosis, by the toxins cobalt and chromium.

According to a Bloomberg report, Robert Harrison, the professor, said DePuy should have but did not account for the problems caused by increased metallic ion levels caused by the ASR hip implants. Based on his knowledge of Kransky’s health, he said that the plaintiff had metallic ion levels of 53.6 micrograms per liter, 8-times the safe limit in California of 7. When Kransky had the ASR hip implant removed in February of last year, his level dropped to 5.

The increased metallic ion levels in Kransky’s blood led to him suffering severe tissue and organ damage, especially at the site of the implant. In previous testimony, one surgeon told jurors that the elevated metallic ion levels caused a “black hole” of dead tissue to form around the metal-on-metal hip implant.

Bloomberg also reports that jurors heard the resumed testimony of Graham Isaac, an engineer at DePuy, who spoke about the emails he and other executives at the company received from two European surgeons who had reported problems among patients they had fitted with the ASR metal-on-metal hip implant.

Both surgeons told Isaac, specifically, that they had stopped using the ASR hip implant altogether after fitting hundreds of patients with it. Isaac said the company did nothing with this information when it was received and continued to market it as safe and effective.

Kransky’s trial is expected to continue this week in Los Angeles Superior Court.

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