What do politicians, medical device manufactureres and pharmaceutical companies have in common? They are all incapable of learning that a cover-up will inevitably be far costlier than disclosing the truth up front. The latest example comes from DePuy Orthopaedics, a division of Johnson & Johson. A product liability trial commenced last week in Los Angeles in connection with the DePuy Articular Surface Replacement hip implant. The New York Times reports from the trial that:
"Johnson & Johson excecutives knew years before they recalled [the] troubled artificial hip in 2010 that it had a critical design flaw, but the company concealed that information from physicians and patients, according to internal documents disclosed on Friday during a trial related to the device's failure."
The fact that this information is coming out only because a case has gone to trial, illustrates that importance of our constitutional system of trial by jury. But for the Seventh Amendment to the Constitution, which guarantees the right to trial by jury, manufacturers would have every incentive to conceal safety information from physicians and the public. Fortunately, the justice system rarely fails to uncover such duplicity.
In the case of the DePuy Orthopaedics ASR hip implant system, the Times reports that DePuy, a division of Johnson & Johnson, had received complaints from doctors about the device, the Articular Surface Replacement, or A.S.R., even as it started marketing a version of it in the United States in 2005. The A.S.R.’s flaw caused it to shed large quantities of metallic debris after implantation, and the model failed an internal test in 2007 in which engineers compared its performance to that of another of the company’s hip implants, the documents show.
Still, executives in Johnson & Johnson’s DePuy Orthopaedics unit kept selling the A.S.R. even as it was being abandoned by surgeons who worked as consultants to the company. DePuy executives discussed ways of fixing the defect, the records suggest, but they apparently never did so.
The A.S.R. represents one of the biggest medical device failures in recent decades. According to DePuy’s internal estimates, it is projected to fail within five years in about 40 percent of patients who received one. That is eight times the failure rate of most orthopedic implants. DePuy hid these internal estimates from physicians and the public, going so far as to dispute estimates from the British hip registry that the DePuy A.S.R. failure rate would be around 30%. Around the time if its recall, DePuy insisted that the failure rate was closer to 12-13%.
DePuy's cover-up was summarized by the Times as follows:
DePuy sold two versions of the A.S.R., one used in an alternative hip replacement called resurfacing and one used in standard hip replacement. Only the version used in standard replacements was sold in the United States.
In 2003, DePuy began selling the resurfacing version of the A.S.R. outside the United States in an effort to catch up with a competing device known as the Birmingham hip. But by 2005, some doctors had begun telling DePuy that the A.S.R. was failing quickly after implantation, and company consultants soon stopped using it, records show.
The problem, internal DePuy records indicate, was the design of the cup component that fit into a patient’s hip socket. The cup, which was used in both the resurfacing and the standard versions of the A.S.R., had an inside groove against which a surgeon pressed a tool to implant the component.
The design was flawed because the groove limited the surface area inside the cup in which the device’s ball could rotate as a patient moved. As a result, the ball was more likely to strike the cup’s edge, causing wear and generating metallic debris.
In 2007, DePuy engineers tested the A.S.R.’s rate of wear to see if it matched the wear rate of another all-metal hip implant made by the company. It did not.
“The current results for A.S.R. do not meet the set acceptance criteria for this test,” that report stated.
The same year, company officials began discussing ways to fix the problem, like redesigning the cup to eliminate the groove. But at the same time, it was actively marketing the A.S.R. to surgeons in the United States, who were implanting it into tens of thousands of patients.
“We will ultimately need a cup redesign, but the short-term action is manage perceptions,” one top DePuy sales official told a colleague in a 2008 e-mail. A DePuy executive, Andrew Ekdahl, who is now the unit’s president, was also told by a company consultant that the A.S.R. was flawed, according to another document.
In mid-2008, DePuy apparently abandoned the redesign project, an internal document indicates. A company spokeswoman, Mindy Tinsley, declined to comment on the document.
In the fall of 2009, the Food and Drug Administration rejected DePuy’s application to sell the resurfacing version of the A.S.R. in the United States, saying it was concerned about, among other things, “high concentration of metal ions” in the blood of patients who received it.
DePuy executives soon started making financial estimates of when the company should stop selling the A.S.R., based on the time it would take to convert surgeons to another company implant, a document shows.
The 10,000 product liability lawsuits already filed on behalf of DePuy hip implant patients may be the tip of the iceberg. About 90,000 patients received such implants, which are estimated to continue to fail at about a 40% rate over the next several years. I'll bet that DePuy would have saved an awful lot of money by coming clean rather than attempting to cover up.