Clearly, there was insufficient testing conducted before these dangerous devices were approved. We are here today on behalf of these patients to help change a broken system.
Gaithersburg, MD (PRWEB) June 28, 2012
Patricia Lorenz of Whitehall, PA and her lawyer Melissa Hague of the Anapol Schwartz law firm went before the Food and Drug Administration yesterday to testify on behalf of her husband Stephen about the horrendous pain and suffering caused by his defective metal-on-metal hip implants. The devices have transfixed the 51-year-old man with constant pain.
At issue during the meeting is whether or not the FDA should apply stronger standards for metal-on-metal hip implants that have been failing at an alarming rate. Since metal-on-metal implants first began to be introduced in the U.S. around the year 2000, medical device reports of adverse events have risen at an astonishing rate. The baseline total of 10 complaints in 2000 has risen over 120,000 percent to 12,137 for 2011.*
“What makes this situation so dreadful is that the implants were marketed primarily to younger patients,” says Melissa Hague, attorney for Lorenz in the matter Lorenz v. DePuy et al.** “The debilitating pain could conceivably go on for years, and a person can’t undergo an unlimited number of hip transplants.”
One of Lorenz’s biggest problems has been trying to find a surgeon who will take out his defective devices that have poisoned his blood with cobalt and chromium. The metals are considered toxic to the human body and can lead to many systemic problems in addition to routinely damaging a patient’s tissue and bone in the hip area as documented by the National Institutes of Health. Doctors remain reluctant to remove the devices too quickly however, because the risks associated with revision surgery can be worse than the initial procedure. Surgeons also lack fundamental scientific guidelines on which to base the decision to replace the devices.
The metal-on-metal implants were marketed with the promise of a lifespan lasting more than 20 years.*** They seemed an ideal solution for Lorenz who was 48 at the time of his bilateral implant procedure. Since a person can usually only have two or three hip implants during a lifetime due to the amount of bone loss involved in these procedures, Lorenz’s remaining lifespan of 30 years or more at the time of the original procedure is now problematic. There may come a day when nothing can be done.
As the company admitted in their recall notice, DePuy ASR implants were never subjected to clinical trials. The manufacturer made use of the 510(k) regulation that allows fast-track approval for devices that are substantially similar to one already approved. The metal on metal prosthetics create a greater danger to patients because the metal ball at the top of the femur and the metal socket liner create friction that over time shave bits of cobalt and chromium into the bloodstream. Now untold thousands are living with the consequences.
Hague and Tom Anapol, shareholder of the law firm Anapol Schwartz, are both personal injury attorneys with long histories of representing people like Lorenz in mass tort cases. Anapol says the human cost is staggering. “We are talking about thousands of men and women who are facing very uncertain futures. Clearly, there was insufficient testing conducted before these dangerous devices were approved. We are here today on behalf of these patients to help change a broken system.”
Stephen works at Lehigh Cement Company and physical endurance is a job requirement. He hasn’t been sure what’s going to happen to him since the DePuy ASR recall, but he hopes the FDA gets the message that proper clinical trials are needed to safeguard others from the agony he’s experienced.
- Appendix I of an executive summary memorandum prepared by the FDA entitled, Metal-on-Metal Hip Implant Systems.
** Northern District of Ohio Western Division 1:12-dp-21200
About Anapol Schwartz: Founded in 1977, Anapol Schwartz, P.C., is a civil justice law firm with more than 25 attorneys and law offices in Philadelphia, Reading and Harrisburg, Pa., as well as Cherry Hill, N.J., Wheeling, W.Va., and Scottsdale, AZ. The firm has represented individuals in matters ranging from dangerous prescription drugs and defective medical products to medical negligence, burn injuries, spinal cord injuries, and other personal injury matters.