One of the biggest defective medical device stories of 2010 and 2011 was surrounding the DePuy hip replacement. Why was this such a big story? Because Johnson and Johnson (J&J), the parent company of DePuy Industries recalled 93,000 units for faulty wear and tear that resulted in metal shards entering the hip area causing the surrounding tissue to necrotize (die on a cellular level) causing a tremendous amount of pain.
As if this wasn’t bad enough, the recall only came after thousands of people had already had the defective DePuy hip replacements installed in their bodies. They did this because DePuy had convinced medical professionals and the public that “metal on metal,” ball-in-socket construction was sturdier and longer lasting than the standard metal in polyurethane socket. In fact, it turned out to be the opposite.
It was only after an influx of complaints, bad press, and a scandal in Scotland, that the Food and Drug Administration took the issue seriously. J&J on the other hand has done everything it can to avoid taking responsibility. Now it seems, their backhanded tactics have backfired.
FDA Inspection
The FDA inspected DePuy Industries located in Warsaw, Indiana, on May 10, 2011, through June 7, 2011, nearly two years after the complaints started streaming in and a year after a major news story about it. The facility manufactures:
- ASR Acetabular Cup System
- ASR XL Acetabular Cup System
- Pinnacle Acetabular System
- PFC Sigma Knee System
- Agility LP Total Ankle Prosthesis
- Other ankle, knee, hip, shoulder, elbow, and wrist replacement devices.
After a painfully long review period of data, on December 8th of 2011, the FDA issued DePuy warning letter stating what they had discovered. It said inspectors found that many of the devices that were distributed into the market hadn’t been adequately vetted by the agency or in some cases the FDA hadn’t even told of the existence of the medical device on the market at all!
“[The devices] have no premarket clearance or approval, or have been modified in ways that could impact the safety and effectiveness of the devices,” the warning letter said.
The FDA also warned DePuy had failed to establish adequate design procedures to ensure the devices conformed to their intended use. The agency also said the company lacked a proper statistical method for detecting recurring quality problems.
These devices were being sold to the public and installed permanently in people’s bodies. This is exactly one of the tasks that the FDA is there to protect from. It is as if the company was distributing a drug that was not approved and touted benefits that had not be substantiated without determining or revealing any side effects or warnings what so ever.
FDA Action Against J&J and DePuy
Regulators have warned the pharmaceutical giant and it’s sister company against selling joint replacement products without proper approval, prompting the company to stop producing some devices under threat of possible regulatory action, including seizure, injunction and financial penalties. The regulators gave DePuy 15 business days to correct the violations.
A statement released by DePuy on Wednesday said the “company produced the items as custom medical devices for physicians. Custom devices are exempt from the rules the FDA cited in the warning.”
But the agency said the products were too standard in design to qualify for exemption.
“While DePuy believes it had complied with FDA requirements, the company has made the decision at this time not to provide custom devices,” the company statement said. “DePuy has implemented a number of actions to address concerns raised in the inspection, and has responded to all concerns raised in the warning letter.”
Problems With The ASR XL Acetabular System and ASR Hip Resurfacing System?
Perhaps the largest problem is surrounding the metal on metal design, which is different from the usual polyethylene cup design. The design itself has caused some serious discomfort, but there are also serious design flaws due to the metal on metal system. This has highlighted the manufacturing, design, and testing process of J&J and DePuy as a harmful profit over patient approach.
Some problems with the products reported by the customers have been:
Loose Parts – The device is a ball and socket system which is attached to both the pelvic bone and the femur bone. It has been known to become loose in the socket, in the shaft, or loose in other parts of the system causing severe pain and lost mobility.
Dislocation – The ball of the unit can completely detach, leading to severe pain, loss of movement, and requiring immediate emergency medical attention.
Femur or Pelvic Bone Fracture – The unit is attached to the pelvic bone and femur bone. Patients have complained the hard metal, though tough, causes bone fractures in these places.
Infection – Infection after a long hip surgery can lead to serious implications for the patient’s overall health. Some of the implications include the ability to fight disease, ongoing pain and fatigue, and the infection getting into the blood system and affecting other organs in the body. Having another replacement surgery may be fatal to some patients.
Genotoxicity – Ware and tear can cause units have metal loss. Microscopic metal shavings cause the chromosomes of bone marrow or white blood cells to breakdown. Genotoxic effects have been known to result in cancer or even heritable defects if toxicity reaches the reproductive organs and reproductive cells are affected. This is easier than one may think since the hip is very close to that area.
Malalignment – At the time of surgery the technicians or surgeons did not notice that the device was not aligned correctly. After the patient had started using the hip, the malalignment led to severe discomfort and pain. It can also lead to malfunction as the patient struggles with the devices malaligned movement and their natural movement.
DePuy Defective Drug Attorney
Ethical business practices put customer safety first and foremost, with proper and thoughtful design of medical devices and products, adequately extensive testing, and fast recognition of problems once they are realized. If all of these ethical procedures had been practiced, particularly the last one, then 12,000 patient’s wouldn’t be in the painful and crippling situation they are now.
Phillips Law Firm understands the plight of the patient and addresses each individual client’s needs. We are a group of experienced Defective Medical Device Lawyers that will take the time to listen to the patient and their needs in order to seek the proper justice and compensation they deserve. Callt Phillips Law Firm Today for a free consultation.