The First Depuy ASR Hip Replacement Lawsuit In The USA — shows why you need a personal injury attorney on your side

The first Depuy product liability trial in the USA concluded Friday March 8, 2013 with an $8.3 million dollar verdict for the Plaintiff, Mr. Loren Kransky.

As the five week trial continued and documents were unsealed, and testimony was finally heard, we learned many disturbing new facts about the back story of this recall which has serious repercussions for many of the over 93,000 recipients. So far in the USA there are only about 10,750 pending Depuy ASR trials from these recipients since the recall was issued by Depuy two years ago.

January 22, 2013 New York Times,
"Maker Aware of 40% Failure in Hip Implant"

An internal analysis conducted by Johnson & Johnson in 2011 not long after it recalled a troubled hip implant estimated that the all-metal device would fail within five years in nearly 40 percent of patients who received it, newly disclosed court records show. [...]

The internal Johnson & Johnson analysis is among hundreds of internal company documents expected to become public as the first of over 10,000 lawsuits by patients who got an A.S.R. prepares to go to trial this week. The episode represents one of the biggest medical device failures in recent decades and the forthcoming trial is expected to shed light on what officials of Johnson & Johnson's DePuy Orthopaedics division knew about the device's problem before its recall and the actions they took or did not take. [1]

The trial uncovered a story of Depuy that cared more about the profitability of the Depuy ASR hip replacement device than patient safety, even after early warnings from leading orthopedic surgeons and even these internal memos acknowledging the risk to patients who received the device and the high percentage of patients who would have that device fail early, within five years.

On the blog following Mr. Kransky's trial from one of Mr. Kransky's lawyers, the closing arguments of Mr. Kranksy's lawyers show Depuy as a company cared more about profits than humans.

DePuy's overarching goal as a company to profit, Mr. Panish noted that Randy Kilburn himself described the company by saying "[w]e are a competitive company, and hips and knees are a competitive market. We wanted to be a ruthless competitor." Mr. Panish explained that while a company needs to do business for profit, there was never any talk of patient safety, that once DePuy noticed problems with the ASR and its early failure rates no one stopped to think about the patient. Instead, the employees only considered what was best for the company.

[…] Defendants' proffered experts, highlighting the fact that one such expert is considered the "go-to-guy" in the defense industry, the same expert who in a PG & E case regarding bad groundwater, did everything he could to help the industry despite numerous injuries to individuals. That very expert, Dr. Paustenbach, was paid $5 million to testify in the Kransky case.

[…] As to negligence, DePuy's own employee testified that the performance with respect to design failure modes and effects analyses was inadequate. They were negligent. Mr. Panish explained that the standard for DePuy was to roll out a metal-on-metal device that was at least as good or better than others on the market. The ASR was neither. Mr. Panish reasoned with the jury that when a company like DePuy has these problems, it should stop and go fix the design. The fact that DePuy never did so was negligent. The fact that DePuy encountered numerous red flags with respect to the ASR, but never acted on any of them, constitutes negligence.

Depuy only offered Mr. Kransky and the others $200,000 before trial as settlement offer to the 10,750 people adversely effected with this Depuy ASR and pending trials. For Mr. Kransky this $200,000 settlement offer was far under just his medical bills for his device ordeal of $338,000. However, the Depuy Defense Attorneys paid $5 million to a notable defense expert witness for his expert testimony against Mr. Kransky.

Defective and dangerous medical device products rushed to market

The problem of the Depuy ASR recall is not an isolated incident. In just the last 10 years, a great many medical devices have been recalled, but only after they had been given to patients, often through a surgery, and then only when a significant number of patients experienced health risks, sometimes even early death, the need for another surgery to correct the recalled device, and perhaps lifelong complications from the recalled device.

Experts put blame for the great number of dangerous and defective medical devices being recalled on an FDA 510(k) approval process. that allows an expedited review of a product when it is, "substantially similar," to previous products. About 90% of medical device applications use this expedited review, including the Depuy ASR. Considering that this group of medical devices can also include pacemakers, one can easily see how critical and potentially dangerous these medical devices are to the lives of the patient.

In addition, what was learned with the Depuy recall, was that there was no way of tracking the patients, to see how patients were doing and to monitor signs of trouble as existed with the Depuy ASR. In fact, problems with the whole medical device industry, not just orthopedics: "Gaps in FDA's postmarket surveillance show that unsafe and ineffective devices may continue to be used, despite being recalled." [2]

United States Senators have become concerned about the ability to track medical devices once they have been approved by the FDA, in order to have an earlier ability to identify problems. With a new bill the idea is to get an earlier warning systom, not slow down technological improvements. This was a significant issue with the early warning signs of the Depuy ASR and could have prevented thousands of people from ever receiving the Depuy ASR hip replacement device. The idea is also to try and strengthen the FDA 510(k) process with greater security for patient safety.

U.S. regulators would gain greater authority to track the use of devices, such as hip implants from Johnson & Johnson (JNJ) and vaginal meshes made by Boston Scientific Corp., that have sparked thousands of patient lawsuits, under a bill introduced in the Senate. [...] In July, the Institute of Medicine, a U.S. advisory group, urged the FDA to replace 510(k), saying it didn't ensure safety.

"Faulty medical devices, especially those implanted in the body, can have disastrous health impacts on patients," said U.S. Senator Herb Kohl, one of the bill's three sponsors, in a statement. "This legislation will help ensure that FDA can act quickly and decisively when there's a problem and that the drive toward getting new technologies to market won't come at the risk of patient safety." [3]

The sponsoring Senators have sent requests to five companies with recalled medical devices asking them for information on how they monitor and track post-market surveillance. Unfortunately, the FDA itself is not allowed the power for further oversite into post-market products, even those approved under the 510(k) process and of course, the industry itself does not want to give the FDA any additional powers to monitor the post-market nor slow down the entry process under the 510(k) process.

According to figures from the Institute of Medicine (IOM), 1.5 percent of all devices approved through the 510(k) process are recalled. [2]

But the experts have widely different figures on these devices and the percentages of recalls for those fast tracked FDA approval. The experts don't even necessarily agree with what most people would consider classifies as an "injury" when they classify these medical devices.

Consider that pacemakers fall into this category of "medical devices" and even recalled medical devices; a pacemaker would require another open heart surgery to replace a faulty pacemaker provided the problem with the device didnt kill the individual first, or through the second unnecessary surgery. With hip and knee implants; it is not just the pain and suffering of an additional surgery, usually it will mean a serious lack of mobility, earlier in life, reduced mobility. Individuals who experience these medical device recalls may have shortened lives, loss of quality of life, cancer, blood poisoning, the list goes on and on.

But, other experts arrive at different numbers and percentages.

Diana Zuckerman, president of the National Research Center for Women and Families, found that in 2010 more than 437 million devices were recalled out of fear that they might kill or permanently harm patients. [4]

But a recent review by Dr. Steven Nissen of the Cleveland Clinic suggests recalls often involve devices approved through the 510(k) process. In Nissen's review of 113 urgent recalls from 2005 to 2009, more than 70 percent of the recalled devices were found to have been cleared via the 510(k) program — compared with 19 percent approved through the FDA's more rigorous premarket approval (PMA) system. Diana Zuckerman, PhD, president of the National Research Center for Women and Families and one of the co-authors of Nissen's study, said the figures vary so much because the IOM figure doesn't include recalls for devices whose malfunction poses just a "moderate" risk of injury. [2]

For instance, recipients of the Depuy ASR recalled hip implant, even though suffering blood poisoning of heavy metals cobalt and chromium at 1000% higher, and having to under go a second revision surgery, unknown long term consequences from damages of the heavy metal poisoning not to mention the potential future early loss of mobility because of the need in a short time for the second hip revision surgery, are considered under these disputed criteria, to only consitute a moderate risk of injury. Clearly, individuals who received these Depuy ASR hip implants might argue otherwise.

Until late summer, officials at the Johnson & Johnson unit, DePuy Orthopaedics, the largest maker of replacement hips worldwide, maintained that the A.S.R. was performing on a par with competing devices. But interviews with doctors indicate that DePuy received repeated warnings that the implant was failing and that surgeons were abandoning it.

[...] DePuy officials cannot say how many patients in this country received an A.S.R. because the company, like other orthopedic makers, does not track such implants. [...] The director of Australia’s orthopedic database said he believed that DePuy had been less than forthright about the A.S.R. Data in that country, he said, showed that in 2008 the A.S.R. was failing early at a rate higher than some competing devices. “When it is clear to the orthopedic community that a company has not been honest, that is a problem,” said Australia’s registry’s director, Dr. Stephen Graves. “I think that J.& J. has a major issue with DePuy.” [5]

Update:

June 3, 2013 - Calif. Trial Judge Denies JNOV, Upholds $8.26 Million Judgment in DePuy ASR Hip Case

June 24, 2013 - Portland personal injury lawyer reviews the events of the first Depuy ASR trials still unfolding

SOURCES

1. January 22, 2013 New York Times,
"Maker Aware of 40% Failure in Hip Implant"

2. April 14, 2011 ABC News
FDA's Fast-Track Medical Device Approval Process Under Fire

3. December 15, 2011 Bloomberg News
Medical Devices Need Greater Follow Up After U.S. Approval, Senators Say

4. July 29, 2011 ABC News
Experts Say FDA Should Abandon Approval Process

5. December 16, 2010 New York Times
"The Implants Loophole"