Jon Campisi Nov. 20, 2013, 7:08am


A central Pennsylvania woman is suing the makers of an artificial hip over

allegations that the device failed nearly six years after it was implanted into her body.

Martha L. Strunck, who resides in York, Pa., filed suit in U.S. District Court in Philadelphia Nov. 18 against DePuy Orthopedics and Johnson & Johnson over the injuries she claims to have sustained a result of having had the ASR Acetabular system hip replacement device surgically placed in her body back in the summer of 2007.

On June 13 of this year, just about six years after her initial operation, the plaintiff had to undergo a revision surgery to replace the defective device, her lawsuit states.

The woman claims she suffered from metal poisoning and metalosis due to metal debris from the defective product entering her body.

At some point following the initial surgery, Strunck says she received a recall letter that spoke of a small number of DePuy hips being recalled and that she should follow up with her physician.

A subsequent MRI test revealed no problems, however, and the plaintiff was told that because she was having no apparent problems, the recall likely did not affect her, the complaint reads.

This February, however, Strunck began experiencing pain and difficulties with her right leg and follow-up lab work revealed some concerns with respect to elevated chromium and cobalt levels, the lawsuit states.

Three months later, the woman’s blood levels of chromium and cobalt tested much higher, the complaint states, and she was having increasing difficulties with her hip so a revision surgery was scheduled.

“Plaintiff Martha L. Strunck did not become aware that the DePuy hip may be a problem until February 2013 when she began experiencing pain,” the suit states.

The defendant medical device manufacturers had, during the application approval process, asserted that the ASR and ASR XL Acetabular System did not raise any issues with regard to safety or effectiveness, according to the complaint.

“The Defendants advertised the ASR as being superior than the competition in that the ASR was the device of choice for those wanting to be physically active, for those wanting a high performance hip replacement, and that the system had a strong clinical history and was less prone to wear,” the suit states. “Contrary to the Defendants’ representations, the ASR was/is prone to premature failure, unacceptably high failure rates when compared with other metal-on-metal prostheses, and causes severe injuries to patients due to metal debris that is released in the patient.”

The lawsuit claims that the defendants’ device produces a large amount of metallic debris as the metal components wear, with the debris causing damage to muscles, tendons and other soft tissue.

The defects also are said to interfere with intended bone growth and results in high levels of metal in a patient’s bloodstream.

The defendants are accused of failing to adequately test the ASR design before marketing the product to consumers and the medical community.

“The Defendants knew or should have known that the ASR device was defective, unsafe and not suitable for its intended purpose,” the complaint reads.

The complaint goes on to note that reports of problems associated with the hip replacement device rose sharply between the years of 2006 and 2009, and that there was information coming out of Europe and Australia, where the companies had been selling the ASR, that the failure rates were “unacceptably high.”

In the spring of 2010, the defendants issued a warning to surgeons in the U.S. that the device had a higher than expected failure rate.

The letter came three months after the device manufacturers voluntarily withdrew the ASR device from the Australian market, the lawsuit states.

“ … the Defendants had knowledge that the ASR devices had a higher than acceptable failure rate, were not safe and that the ASR was in fact enhancing and causing injuries,” the lawsuit states. “Even so, the Defendants refused to concede the product was defective and delayed recalling the ASR device such that ASR devices continued to be used in hip replacement surgeries.”

The plaintiff seeks damages for lost wages and future lost earning capacity, medical expenses, pain and suffering, scarring, disfigurement, embarrassment, humiliation and loss of life’s enjoyment.

The complaint contains counts of strict liability, negligence, and breach of implied and express warranties.

Strunck is being represented by attorney Jaime D. Jackson of the Lancaster, Pa. law firm Atlee Hall.

 

The federal case number is 2:13-cv-06716-ER.

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