Articles Posted in Artificial Hip

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Last week I wrote a timeline on the key events surrounding the failure of the Depuy ASR artificial hip. Today I want to take a similar look at the Depuy Pinnacle artificial hip. The Pinnacle was supposed to be the ASR’s more active and athletic brother. But it didn’t turn out that way.

1995: Study on Metal-on-Metal Hips Released

Study on Metal on Metal Artificial Hips
For all metal-on-metal artificial hips, we have to start with the central question: what did the manufacturer know, and when did the manufacturer know it? In 1995, Dr. Graham Isaac released a short paper discussing the problems with metal-on-metal (MoM) artificial hips. Dr. Isaac explained that the performance of MoM hip implants was “unpredictable,” that the hips may work well for some 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 should have known about the metal-on-metal risk factors in 1995. 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.” That’s not good.

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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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Artificial hip removed as part of revision surgery

If you have been the victim of a failed medical device like a metal-on-metal artificial hip, you may not ever think about preserving evidence. But it is essential to your product liability case. In this post I want to give you some tips about preserving medical device components that have been removed (“explanted”) from your body in a revision surgery. This information is important for all those undergoing revision surgery, but especially those of you who hope to pursue a product liability case without a lawyer.

Here is a quick illustration: You undergo hip replacement surgery in October 2009. In August 2010, you receive a letter from the manufacturer of the artificial hip stating that a recall has been issued on the medical device implanted in your body. Since the device is implanted in your body, you can’t easily turn it back in for a refund. So you monitor the situation. Ten months later, you begin to feel discomfort, and then outright pain. After a few more months you and your orthopedic surgeon decide to have the device removed in a revision surgery. In this operation, the surgeon will remove the defective parts of the artificial hip and replace them with new, non-defective parts. Those removed parts will sit on a surgical tray, and after the surgery they will end up . . . somewhere. They could be thrown out; they could be placed in a Ziploc bag and abandoned in a storage room; they could be handed over to the medical device manufacturer’s representative, who is often in the room during your surgery.

But they need to go to you.

Quite simply, before the revision surgery, the patient should take steps to ensure that he or she will be given the explanted medical device components. This usually involves careful conversations with the surgeon and the surgeon’s nurse or other staff. Unfortunately, most patients have no idea that need to take this step.

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Stryker LFIT V40 Artificial Hip MDL
We’ve previously blogged about Stryker LFIT V40 artificial hip problems, discussing a recall made back in August 2016 and how to tell if you have an artificial hip that’s part of that recall. Since those posts a lot has been going on in courthouses across the country, with dozens of lawsuits popping up from individuals who received affected artificial hips made by Striker Orthopaedics and its subsidiary, Howmedica Osteonics Corporation (HOC).

Just recently, approximately 33 pending lawsuits against HOC were consolidated into a multi-district litigation (MDL). In a way, you can think of this consolidation as a “things just got real” moment for HOC. But what’s the big deal about the Stryker LFIT V40 litigation now being in MDL status? Let’s begin by discussing the underlying lawsuits.

Why Are the Plaintiffs Suing?

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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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Depuy ASR Settlement Agreement
Some late-breaking news: The Depuy ASR Settlement Agreement has been extended to cover injured people who received a revision surgery after January 31, 2015. The extension was announced yesterday. Here’s how it works: if you received a Depuy ASR artificial hip, and then had revision surgery to remove the component between January 31, 2015 and February 15, 2017, you now may qualify to participate in the Settlement Agreement negotiated between plaintiffs and the defendants.

Let’s back up.

Before Yesterday, Where Were We? 

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Metal-on-metal artificial hip
I recently blogged about artificial hip failures. Fortunately, these hip failures are not common when you look at the total number of patients receiving hip implants every year. However, when there is a failure, it can be extremely unpleasant, to put it lightly.

And it’s not just one medical device manufacturer with implants that are causing problems. Stryker, DePuy, Zimmer, and Wright are just some of the companies who have had issues with their artificial hip implants. If you’re curious, you can read more about some of them in my other blog post.

One such company that’s been in the news lately is Smith & Nephew. Over the course of the past few years, Smith & Nephew has instituted a string of recalls and is now at the beginning of a potentially expensive legal fight, with even more lawsuits expected.  So what exactly is going on with Smith & Nephew’s artificial hip implants?

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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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Orthopedic Surgeon with X-Ray of Stryker LFIT V40 Femoral Head

I imagine it can seem overwhelming. Let’s say you had artificial hip surgery in 2011. By 2016 you begin to feel some unusual, new pain. So you Google artificial hip implants and you discover an ocean of words on the many failed artificial hip components that have been sold and implanted (and then failed) over the past decade. Then you run across an article on an urgent recall of  the Stryker LFIT Anatomic CoCr V40 Femoral Head (let’s call it the V40 Head). You have a vague recollection that you were implanted with a Stryker artificial hip back in 2011, but you certainly don’t know if the V40 Head was implanted. So the question for a person like you would be: How do I know if I have the Stryker LFIT Head implanted in my body?

It’s a great question. In fact, you should not be expected to know what precise artificial hip components have been implanted in your body. I had cataract surgery last year, and I don’t have any idea what exact artificial lenses were implanted in my eyes. I hope I don’t ever have to figure out what product they actually are. But back to you. Here is a simple procedure you should follow if you need to find out if a medical device like the V40 Head is currently implanted in your body:

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