Stryker Orthopaedics has announced that it reached a national settlement in the multidistrict litigation focused on the Stryker LFIT V40 femoral head. The LFIT V40 femoral head is one component of Stryker’s artificial hip system. This settlement announcement is a bit surprising, as the MDL was created for the LFIT V40 femoral head in April 2017. As medical device multidistrict litigation goes, this is a very quick path from formation of the MDL to settlement. One reason for the speed is that this MDL is smaller than other artificial hip MDLs based on the number of injured plaintiffs. The LFIT V40 settlement involves approximately 125 cases in the federal court MDL and an additional 140 cases in New Jersey state court.

In any event, for those people hurt by the LFIT V40 femoral head, this is good news. The terms of the settlement have not been released. I will certainly update this website when the settlement agreement is made available. As for now, all discovery and trial preparation have been stayed (or stopped). The first bellwether trial, scheduled for September 2019, will be removed from the trial calendar. The focus now will be on processing individual settlements for plaintiffs.

Remember that each plaintiff in this or any other medical device litigation is not required to accept the settlement. Although it is often reasonable for the plaintiff to accept the terms of settlement, no plaintiff will be compelled to accept any settlement. As with any litigation, it is important for individual plaintiffs and their attorneys to slow down, review all the terms of settlement, and make a careful decision on whether to participate in the settlement.

I have written about the LFIT V40 femoral head product failure several times in the past. Problems with the hip component began several years ago. On August 29, 2016, Stryker announced a recall for the LFIT V40 head. The recall focused solely on the femoral head, which is the “ball” part of the hip replacement. This femoral head fits inside the “cup” and is also attached to the “stem” (which is connected to the femur, or thigh bone).

The recall involved LFIT V40 heads manufactured before 2011 with the following catalog numbers and sizes:

LFIT V40 Femoral Head Is a Metal-on-Polyethylene (MoP) Artificial Hip

Unlike many other artificial hip product failures, the Stryker LFIT V40 not part of a metal-on-metal artificial hip system. The LFIT V40 system is built utilizing a metal acetabular cup, a polyethylene (plastic) liner, the LFIT V40 cobalt-chromium femoral head, and a titanium femoral stem. Unfortunately, soon after being sold and implanted, the Stryker LFIT V40 began to fail, at a high rate. Patients who received the Stryker LFIT V40 suffered similar symptoms as those who received metal-on-metal hips, including metallosis.

LFIT V40 Taper Lock Failure

The failure of the Stryker LFIT V40 involved the junction of the neck of the femoral stem and the femoral head or ball. This connection was intended to be permanently secured through a taper lock system, holding the stem securely to the ball. However, in many cases the LFIT V40 femoral head began to corrode, which means to disintegrate and lose metal. The corrosion occurred at the site of the connection to the neck (the taper lock). This corrosion in the head would progress slowly, but over time the corrosion would cause the taper lock to loosen. Eventually, the neck would corrode as well, and once the neck began to corrode the breakdown of the artificial hip would advance more quickly. One study found that the loosening would cause fretting and micro-motion at the taper lock site, and this friction would cause metals to be released into body. Thus, the Stryker metal-on-polyethylene (MoP) artificial hip resulted in patients suffering from metallosis, just like so many other patients who received metal-on-metal (MoM) artificial hips.

Keep in mind that the corrosion in the LFIT V40 can be slow. This means you may not know the Stryker hip is failing and releasing cobalt and chromium into the body for years. By then, the neck may have begun to corrode, and when that happens the femoral stem may need to be removed and replaced, which can be a very difficult surgery. The femoral stem is implanted down the center of the femur bone, and when it sets it is usually there permanently. Removing the femoral stem is difficult and painful.

Check back here for updates on the Stryker LFIT V40 femoral head settlement. And if you believe you have a failed artificial hip in your body, call me to discuss: (919) 830-5602.

The vast majority of artificial hip failures over the past decade involved metal-on-metal (MoM) hip components. These medical devices were meant to revolutionize the artificial hip market. Specifically, the all-metal hip components were intended to last a long time, and much longer than older generation artificial hips using materials like ceramics and plastics, which had a tendency to wear down and “fail” after twelve or fifteen years. Beyond that, the metal-on-metal artificial hips were touted to withstand the rigors of active, athletic patients. It sounded like a terrific advancement in the development of artificial hips. The problem is, the metal-on-metal design did not work, in many cases because the metal acetabular cup and the metal femoral head would grind together day after day, month after month, releasing harmful metal debris (metallosis) into the patient’s body. Far too many people were forced to get revision surgeries a few years after the implant surgery to remove the metal hips.

It turned out to be a disaster for thousands of patients and for several large medical device manufacturers. Depuy and Zimmer, to name just two companies, faced thousands of lawsuits from people injured by the metal-on-metal artificial hips. Many of those cases are resolved or resolving, but many more await settlement or jury trials.

The LFIT V40 Is a Metal-on-Polyethylene Artificial Hip

The Stryker LFIT V40 Hip is not a metal-on-metal artificial hip. The LFIT V40 system includes a metal acetabular cup, a polyethylene (or plastic) liner, a cobalt-chromium femoral head, and a titanium femoral stem. The exploded-view diagram at top right gives you an idea of how the Stryker LFIT V40 hip is assembled. Stryker avoided the problematic construction of direct metal-on-metal components.

So far so good, right? Well, unfortunately, no. Soon after being released into the market, the Stryker LFIT V40 began to fail, at an unusually high rate. And patients who received the Stryker LFIT V40 were suffering from similar symptoms as those who received metal-on-metal hips. Even, oddly, diagnoses of metallosis. It was an unexpected result. So what happened?

Something called a taper lock failure. Let’s take a closer look:

The LFIT V40 Taper Lock Failure

The failure of the Stryker LFIT V40 concerns the junction of the neck of the femoral stem and the femoral head or ball. In the illustration above, the neck is that small metal rod that extends out from the femoral stem. The neck connects and attaches to the femoral head (the ball), thus connecting the leg bone to the hip bone. This connection was intended to be permanently secured through a taper lock system, holding the stem securely to the ball.

But as it turned out, in many cases once in the body the V40 femoral head began to corrode, which means to slowly disintegrate and lose metal. The corrosion occurred at the site of the connection to the neck (the taper lock). This corrosion in the head would progress slowly, but over time the corrosion would cause the taper lock to become compromised and loosen. Eventually, the neck would corrode as well, and once the neck began to corrode the breakdown of the artificial hip would advance more quickly. According to one study from 2016, the loosening would cause fretting and micromotion at the taper lock site, and this movement or friction would cause metals to be released into body. Thus, the Stryker metal-on-polyethylene (MoP) artificial hip resulted in patients suffering from metallosis, just like so many other patients who received metal-on-metal artificial hips.

The corrosion in the LFIT V40 can be slow. This means that the average patient may not know the Stryker hip is failing and releasing cobalt and chromium into the body. It can take years for the loosening to cause problems that are recognizable to the patient. At that point, the neck may have begun to corrode, and when that happens the femoral stem may need to be removed and replaced. This can be a very difficult surgery. The femoral stem is implanted down the center of the femur bone, and when it sets it is usually there permanently. Removing the femoral stem is invasive and problematic and painful.

So How Can You Salvage the Femoral Stem?

You must remove the failing V40 femoral head as soon as possible. This means artificial hip revision surgery. If you remove the head at the beginning of the period of corrosion, and the femoral neck is not corroding, you should be able to revise your artificial hip without the difficult work of removing the femoral stem. But either way, you will have to undergo revision surgery, which is no fun at all. My thought would be: check with your surgeon and confirm the exact components you have in your body. If the doctor reports that you have the Stryker LFIT V40, you need to have a lengthy discussion about removing the v40 femoral head, even if you are not currently having symptoms.

I wrote more about the Stryker LFIT V40 artificial hip here. If you would like to read more on the study identifying failures of the Stryker LFIT V40 taper lock, google Trunnion Corrosion Causing Filure in Metal-on-Polyethylene Total Hip Arthroplasty with Monolithic Femoral Components in Reconstructive Review (April 2016).

Note: I am not a doctor, and this is not medical advice. The diagram at the top is for illustrative purposes only and is not intended to depict the specific Stryker LFIT V40 artificial hip.

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?

Patients who received the Stryker LFIT V40 femoral head suffered from a variety of problems with their artificial hip, including extreme pain, cobalt/chromium poisoning, inflammation, joint instability, loss of movement and joint dislocation. These symptoms were the result of a taper lock failure.

The major claim made by plaintiffs is that the taper lock failure was caused by corrosion at the taper junction, which is the part of the hip implant where the LFIT V40 femoral head attaches to the hip stem. Plaintiffs also argue that not only were the LFIT V40 femoral heads defective, but Stryker and HOC knew of these problems and failed to properly warn the doctors who performed surgeries to implant these artificial hips.

Over time, the taper lock failure resulted in metallosis, a serious condition where metal debris builds up in soft tissue, as well as the LFIT V40 femoral head completely separating from the hip stem.

Why Did the Plaintiffs Want Their Lawsuits to Be Consolidated in One Court?

There are several possible reasons why the Stryker LFIT V40 plaintiffs wanted their cases consolidated.

First, it allows plaintiffs to pool their resources and coordinate their legal strategies. This means they can litigate more efficiently and save money.

Second, litigation can occur faster. This is usually good for the plaintiffs, because they can obtain compensation sooner. It also prevents defendants from dragging out a case.

Third, cases consolidated into an MDL get a lot of attention (even, I suppose, this article). The extra media attention can bring in even more plaintiffs. With more money at stake, plaintiffs have more leverage during settlement talks.

In this case, HOC was concerned about extra negative attention. As a result, HOC argued that the name “Stryker” should be removed from the MDL case name in the hopes that it would avoid some of the bad publicity for its parent company. HOC’s argument was not accepted by the Court and the Stryker name stayed in the MDL case name. It is now, “In re: Stryker LFIT V40 Femoral Head Products Liability Litigation.”

The Decision to Consolidate

The decision to transfer was made by the United States Judicial Panel on Multi-District Litigation (JPML). Plaintiffs argued that since all the cases involved one or more common questions of fact, consolidation into an MDL would promote judicial efficiency and be more convenient for the litigating parties.

HOC disagreed, arguing that there were only a “few” cases, so consolidation wasn’t necessary. HOC also argued that even though all the cases involved the same LFIT V40 femoral head, because there were a wide variety of hip stems used by different patients, it didn’t make sense to consolidate the cases. The JPML disagreed with HOC and consolidated all 33 cases into an MDL.

Next Steps

The 33 Stryker LFIT V40 lawsuits from 17 total federal districts will be transferred to the District of Massachusetts, and handled by Judge Indira Talwani, who is already hearing several Stryker LFIT V40 cases. However, Judge Talwani has never handled an MDL and has only been a federal judge since May 2014.

The cases will now advance to pre-trial matters, primarily discovery. In the meantime, additional cases may also be added to the MDL.

Once discovery is complete the cases will be transferred back to their original federal districts for trial. Before that happens, the Court will try to get the parties to settle the cases. One way to promote settlement is to have bellwether trials.

Bellwether trials are cases that represent the whole group. Bellwether cases will go to trial and be tried by a jury. How these cases turn out will provide insight to the parties as to whether a settlement is possible and if so, what the settlement terms should be.