ASR Hip Implant Trial Shows Inadequate Testing and Early Knowledge of Design Flaw
Damaging testimony continues to pile up against Johnson & Johnson in the first A.S.R. related lawsuit to go to trial. More recently released documents seem to indicate that the company’s orthopedic unit had used inadequate or incorrect standards in their risk assessment of the metal-on-metal A.S.R. hip replacement joint that was used in over 90,000 patients.
In Los Angeles Superior Court, the lawsuit against the DePuy Orthopedics division of Johnson & Johnson represents the first of more than 10,000 similar lawsuits that have been filed in the United States. Internal documents from DePuy show that the company had concerns about the A.S.R. joint long before it was recalled in 2010. In addition, while the company knew of abnormally high failure rates with the device, it continued to market it aggressively in the United States.
Testimony from DePuy executives has been equally as damaging. New company head Andrew Ekdahl, was told by consultants to DePuy in 2008 – while he was in charge of marketing the A.S.R. – that the device was faulty, and failing at alarming rates. However a year later when being questioned by the New York Times regarding safety concerns with the device, Ekdahl said that any reports of safety issues with the A.S.R. were “simply untrue.”
The A.S.R. risk assessment was conducted internally by Johnson & Johnson shortly after the company recalled the device in 2010. This report was introduced late in the first week of the trial and shows that the company fell far short of properly assessing the device. Accompanying testimony from Jimmy Smith, a compliance manager at DePuy, indicates that the company had not used appropriate controls to try and anticipate the device’s problems.
The chief problems arose from a design flaw in the A.S.R. Orthopedic surgeons need to be able to implant the cup component of an artificial-hip at a variety of angles to accommodate different surgical techniques and variances in patient’s build.
However, as DePuy engineer Graham Isaac testified, the company only tested the artificial-joints performance on laboratory equipment at one angle of implementation.
The design flaw in the A.S.R. meant that any variance from the single angle that DePuy had tested made it more likely for the cup and ball components for the device to strike each other and release metallic debris inside the patient. Pain and joint dislocations, infections and bone fractures are some of the more common complaints from patients in which the device has failed.
Research done by DePuy prior to the recall found that the device was failing in an alarmingly high 40 percent of patients within five years. The company chose to analyze why it was failing in 2010 shortly after the device was recalled, In an all too common pattern, DePuy chose not to publically release its finding. Rather than make patients aware of potential health risks from having an A.S.R. implant, the company chose to conceal any damaging findings in an attempt to limit its liability.
The A.S.R. represents only a part of the biggest medical device failure in decades. Since its recall in 2010, the Smith & Nephew R3 and the Zimmer Durom Cup have also been recalled. The Stryker Rejuvenate was recalled in 2012 for metal contamination as well but in that case the metal was leaching from the modular neck joint. Metal-on-metal joints still on the market such as the Biomet Magnum, the Encore and the Wright Profemur Converse, Dynasty, and Lineage are also failing at unacceptably high rates.
As the trial progresses, spokespersons for DePuy continue to insist that with regards to the A.S.R., the company has always acted appropriately. But none of the evidence or testimony introduced thus far supports their claim. Instead a pattern is emerging of a corporation who placed profits above the health of their patients, and even when they learned of the dangers chose to place the welfare of the corporation above the people they served.