Articles Tagged with Depuy

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I have written extensively about metal-on-metal (MoM) artificial hips. Specifically, I have covered the painful and sordid history of the Depuy ASR metal-on-metal (MoM) artificial hip. In this post I set out a timeline of important dates in the the journey of the Depuy ASR hip: from (quickly) finding its way into the market, then into thousands of patients, followed by thousands of revision surgeries, and ultimately to a massive multidistrict litigation (MDL) in federal court in Ohio involving thousands of injured people. Let’s take a look at the calendar of events of the Depuy ASR product failure.

1995

Doctor reviewing Depuy ASR hip X-ray
In 1995, Dr. Graham Isaac released a short paper discussing the problems with metal-on-metal (MoM) artificial hips. Dr. Isaac explained how metal wear debris created from MoM hip joints was a serious problem because of poor design and manufacturing of the metal components. Dr. Isaac also stated that even with higher quality manufacturing and engineering techniques, the performance of MoM hip implants were as “unpredictable as ever, working well for a period of time before suffering catastrophic breakdown . . . accompanied by a release of a large volume of debris.” This paper and Depuy’s other internal documents suggest that Depuy Orthopaedics most likely knew of the MoM risk factors in 1995, twenty-two years ago, and ten years before the company began selling the Depuy ASR artificial hip. In fact, one doctor noted that Depuy needed “to be cautious of the legal/litigation issues and lawyers, etc…perception of metal debris and metal-ion release.” I wrote more about what Depuy may have known about the serious risks of the ASR hip here.

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“What did they know and when did they know it?” When something goes wrong with a medical device, this eventually becomes the key question. Unfortunately for Depuy Orthopaedics (Depuy), a lot has gone wrong with its metal-on-metal (MoM) hip implants over the past ten years. And to make matters worse, recently released documents* show Depuy knew it would have problems with its MoM hip implants decades ago.

Depuy MoM Hip Implants: An Overview

iStock-587512462-1-300x200Hip implants have been around for a long time. They can be made of various materials. Some older models use a polyethylene cup and a metal ball to create the artificial hip joint. While this combination works well, it’s not perfect. Engineers have looked for other materials to find a hip joint that can last longer with fewer adverse effects.

One attempted solution was to have both the cup and ball made out of metal, hence a metal-on-metal hip joint. However, the performance of these hip implants was even worse than joints that used polyethylene and metal. Problems with MoM hip implants included significant pain, bone loss, hip implant failure and metallosis.

As a result of these problems, thousands of lawsuits have sprung up, not just against Depuy, with its ASR and Pinnacle MoM implants, but other MoM hip implant manufacturers such as Biomet and Stryker. Many of the Depuy lawsuits have been consolidated into multi-district litigation, or MDL. A few initial bellwether trials involving the Depuy Pinnacle have resulted in massive verdicts against Depuy, which I wrote about here.

Basically, things have not been looking good for Depuy. And they just got worse.

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Depuy ASR Settlement Agreement ExtensionWe are getting more clarity on the recent extension of the Settlement Agreement in the Depuy ASR artificial hip litigation. As I wrote about in a previous post, the ASR Settlement has now been extended to cover people implanted with the Depuy ASR hip who received a revision surgery between January 31, 2015 and February 15, 2017. This is an important development because up to this point the Settlement did not include any injured people who had undergone revision surgery after January 31, 2015. And this represented a lot of people.

Last week the Depuy ASR MDL executive committees sent correspondence with more clarification of the extension agreement. To make things easy, I am going to refer to this Depuy ASR extension agreement as the “Third Settlement” (because it follows two prior Settlement Agreements which had clearly defined terms and clearly defined deadlines).

Third Settlement Enrollment Deadlines

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Depuy Pinnacle AppealNow it’s the plaintiffs’ turn. The five victims of the Depuy Pinnacle artificial hip have answered the appeal of Depuy Orthopaedics and Johnson & Johnson in the Fifth Circuit Court of Appeals. And as they did at trial, the plaintiffs have come out fighting.

Recap of Depuy’s Appeal

A few weeks ago I wrote about the appeal brought by Depuy and Johnson & Johnson after a Texas jury awarded $502 million dollars to five plaintiffs. You can read about the Defendants’ appeal here. But to recap, Depuy and J&J argue that they were unfairly prejudiced by the plaintiffs’ team aggressive tactics at trial. They argue that Defendants are entitled to a new trial because the plaintiffs’ team had “a strategy” to “inflame the jury through highly prejudicial evidence and wholly inappropriate argument.”

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Depuy Pinnacle TrialI will not forget my first jury trial. It was many years ago, not long after I graduated from law school, and let’s just say I was in over my head a bit. It was a simple car crash case. I represented a driver who was rear-ended and injured (but not seriously). I walked my client through his direct examination, and I thought it was going well. Then the insurance defense lawyer was given the opportunity to cross-examine my client. He asked simple questions about the severity of the injuries (“were you able to return to work a week later?”) and after eight or ten of these questions, I objected. The judge peered down at me over his reading glasses:

“Counselor?”
“Yes your honor, I object.”
“On what grounds?”
“This line of questioning is prejudicial.”
“Prejudicial?”
“Yes, your honor. I move to strike the testimony as prejudicial.”

The judge sat back in his chair. “Mr. Hodges, wouldn’t every question on cross-examination be prejudicial to your case?” This query reminded me of the complete language of Rule of Evidence 403: The court may “exclude relevant evidence if its value is substantially outweighed by a danger of . . . unfair prejudice.” I had remembered most of the rule, but not the key word: unfair. All evidence presented in any court case is supposed to be prejudicial to the other side’s case. To exclude evidence under Rule 403, the testimony must be unfairly prejudicial.

But the judge was still waiting for my answer. The jury waited too. I tried my best:
“Well, yes, your honor. But this testimony is unfairly prejudicial.” At least I had finally wedged in the key word.
“I don’t think so, counselor, objection overruled.”

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Patient with Artificial Hip Failure
Not all artificial hips fail. Many total hip replacement surgeries are successful. Unfortunately, the metal-on-metal artificial hips have “failed” at a rate much higher than previous artificial hips, whose components typically consisted of a combination of metals, plastics, and ceramics. The metal-on-metal design placed a metal ball or head directly into a metal acetabular cup. By using a metal cup and a metal ball, these artificial hips forced metal to rub against metal with the full weight and pressure of the human body.

In any hip replacement surgery, there is a period of rehabilitation. Even with great surgery results, the patient will suffer some soreness, stiffness, and a period to regain strength, mobility, and comfort. From the dozens of people I have spoken with over the years who have undergone hip replacement surgery, even successful hip replacements do not turn you into a completely pain-free eighteen year old athlete.

For many patients, however, particularly those who received the metal-on-metal hip, there may come a point when they wonder if their artificial hip has failed. But given that all hip surgeries initially come with some discomfort and pain, how do they know if their hip has failed.

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Depuy Pinnacle MDL TexasImagine going to sleep the night after making the decision to strip five hundred million dollars from six families. I imagine it would be unsettling. On Tuesday, Judge Ed Kinkeade, a federal judge in Texas overseeing the Depuy Pinnacle MDL, made the decision to cut $500,000,000.00 from a jury award presented to six families after a grueling ten-week trial last fall. You can read about the trial and the jury’s verdict here. In that post I wrote that the jury’s verdict was “staggering,” and it was. It may be more staggering that a judge, less than a month later, would wipe out half a billion dollars of the jury’s award.

“Single-Digit Multipliers”

On January 3, 2017, Judge Kinkeade issued his post-trial court order reducing the amount of punitive damages awarded to the six families, writing that “constitutional considerations limit the amount a plaintiff may recover in punitive damages.” The relevant portion of the Order states:

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Texas Depuy Pinnacle Hip TrialStaggering. It’s really the only word for it. Yesterday a Texas jury awarded six plaintiffs over one billion dollars for injuries sustained following the failure of the Depuy Pinnacle metal-on-metal artificial hip. And that comes out to more than $170,000,000.00 per plaintiff. The verdict was handed down last night following ten weeks of punishing trial.

This trial was the third “bellwether” case in the Depuy Pinnacle MDL (multidistrict litigation). The first Pinnacle bellwether trial ended in a defense verdict, which means the jury did not find negligence on the part of the defendants, Depuy Orthopaedics and Johnson & Johnson, and therefore the plaintiffs received no compensation. The second bellwether trial resulted in a huge $502 million dollar verdict for five plaintiffs, which I wrote about here. In fact, much of the speculation about this third bellwether trial was whether the plaintiffs’ team could put on the same powerful case that they did in the second bellwether trial, or whether the $500 million verdict in March was simply a bizarre outlier, one of those remarkable unicorn verdicts that come along once and never again.

Today, the $500 million dollar verdict seems modest compared to yesterday’s jury verdict. Plainly, juries are sending a huge message to Depuy and J&J that they hurt many people when they marketed and sold the Depuy Pinnacle Hip.

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Depuy Pinnacle Jury AwardIn March 2016 five people injured by the Depuy Pinnacle metal-on-metal artificial hip scored a huge courtroom victory. In that case a Texas jury awarded five plaintiffs $502,043,908.00 for injuries suffered by the failure of the Depuy Pinnacle hip. That figure was divided in different ways to the five injured people. Of that amount, $360,000,000.00 was awarded by the jury for punitive damages. The jury concluded that the Pinnacle hip sold by Depuy was defective and that Depuy knew about the flaws but did not adequately warn patients and their doctors of the risks. Like I said, this was a huge win. Unfortunately, the punitive damages award did not last long.

Judge Forced to Reduce Punitive Damages Award

Punitive damages are money damages, separate from compensatory damages, which are awarded by a jury and which are intended to punish or deter a bad-acting defendant and others from engaging in similar conduct. Judge Kinkeade, who is the federal judge presiding over the Depuy Pinnacle multi-district litigation (MDL), stated that he was bound by a Texas statute which puts a limit or “cap” on the amount of punitive damages a jury can award. Thus, Judge Kinkeade was required by law to reduce the punitive damages award, which a jury of twelve individuals, after a 42 day trial, thought was appropriate.

Thank You, Tort Reform!

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Depuy Seeks Delays in Pinnacle Hip TrialsA request by Depuy Orthopaedics Inc. to delay more trials concerning its Depuy Pinnacle hip implants is pending in the federal court in charge of thousands of cases against the company. The request came from Depuy on May 24. Depuy asks the Court to hold off on further trials until an appeal of one large case tried in March is resolved. That case, which I wrote about here and here, resulted in a stunning $502 million verdict for five people injured by the defective artificial hip components. So Depuy is plainly motivated to delay, if not overturn, the award. If the request is granted it will take much longer for other plaintiffs to have their cases tried, as complex appeals like this one can take years to resolve. As the saying goes, justice delayed is justice denied. I hope federal judge Ed Kinkeade in Texas denies Depuy’s motion. These remaining cases deserve their day in court.

Depuy and the other defendants claim their planned appeal could have “far-reaching implications” on how future cases are tried. Defendants claim the “grounds for appeal are strong” and that they “acted appropriately and responsibly in the design and testing” of the devices.

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