Stryker V40 Hip Recall Leads to Patient Lawsuits

Filing a Lawsuit Against Stryker Hip Implants

Dozens of patients have filed lawsuits over a recalled hip implant component that can lead to severe failures and debilitating side effects.

• Stryker LFIT Anatomic V40 Femoral Head
• Class 2 Device Recall (August 29, 2016)

While Stryker’s dangerous hip component is now off the market, thousands of patients may have already suffered serious complications. Our attorneys can help. Learn more about your options with a Hip implant lawsuit.

Over 300,000 Americans undergo hip replacement surgery every year for treatment of pain and discomfort from hip injuries or degenerative joint and bone conditions. Hip replacement devices are intended to last for at least 15 years, but thousands of patients nationwide have found themselves in need of revision surgery within less than 5 years of implantation due to prematurely worn-out, broken, or otherwise malfunctioning hip implants.

Stryker Hip Recall: “Higher Than Expected” Fail Rates

After a series of hip device recalls were issued in 2016 due to patient reports of serious hip replacement complications, outraged victims across the country are now filing lawsuits against device manufacturers such as Stryker Corp., accusing these companies of “faulty” product design and failing to warn doctors and patients of the potential risks of their widely-used hip prosthetics.

LFIT CoCr V40TM Femoral Heads

One of the most recent and controversial hip device recalls was first announced by Stryker on August 29, 2016, regarding its LFIT V40 Cobalt-Chromium Femoral Head, an artificial hip component that’s been frequently employed in hip replacement / revision surgeries worldwide since its release in the early 2000’s.

According to Stryker’s “Urgent Medical Device Recall” notice, over 4,000 lots of the product, all manufactured before 2011, needed to be recalled because of “higher-than-expected” failure rates, based on a high volume of complaints from patients. These complaints revealed that the affected lots pose a number of “potential hazards” that have caused patients to suffer severe complications such as:

• Loss of mobility
• Device breakage
• Uneven leg lengths
• Pain from device loosening
• Joint instability or dislocation
• Adverse local tissue reactions
• Inflammatory immune system reactions
• Need for revision surgery due to intense pain or risk of accident

As later reported by the FDA, Stryker distributed this notice via e-mail to all of its relevant branches / agencies, instructing them to “quarantine” any affected units.

Stryker Hip Recall Attorney: Federal Agencies Issue Stryker Alerts

Shortly after Stryker announced its “voluntary recall” of the  affected LFIT V40 Femoral Head lots, the FDA as well as governmental agencies from other countries issued urgent nationwide alerts to doctors and patients

• Canada. Health Canada actually published its medical device recall alert for Stryker LFIT V40 Femoral Heads on August 24, 2016—several days before Stryker sent out its official internal company notice on August 29. The Health Canada alert was distributed to healthcare professionals as well as the general public.

• Australia. On September 27, 2016, the Australian government’s Department of Health Therapeutic Goods Administration announced Stryker’s recall.

• USA. On November 9, 2016, the FDA released information about the recalled Stryker devices on the official FDA website.

Stryker has been heavily criticized for the lack of information included in its recall notice, especially regarding how no reasons were given for the unexpected failures mentioned in the recall—the possible causes are merely described as still “under investigation.”

Yet a wave of hip failure lawsuits say Stryker did have extensive information about the source of the problem at the time it sent out the 2016 notice. This recall, plaintiffs assert, was instigated not only by the consumer complaints mentioned in the notice, but also by research published in prominent orthopedic journals that Stryker should have been aware of.

Stryker Hips Causing “Catastrophic Failure”

One recent journal article, published by medical researchers at the Thomas Jefferson University Hospital in Pennsylvania, specifically looks at patients suffering from complications of Stryker hip replacements. The authors describe 5 case studies of patients from their hospital, all of whom who received Stryker hip components and experienced “catastrophic implant failure” —complications severe enough to necessitate immediate revision surgery.

The researchers explained that the specific problem encountered by all of these patients was a complication termed “taper lock failure,” which is when the femoral head and hip stem in a replacement hip no longer securely lock together—whether it’s due to loosening, wear, or breakage—and suddenly come apart, often causing intense pain and rendering the patient unable to move.

Though this type of failure is thought to be much rarer than complications such as inflammation and other “adverse local tissue reactions” more commonly associated with modern hip implants, the authors felt their findings indicated that surgeons should be acutely aware of how to diagnose taper lock failure and recognize revision surgery is the necessary treatment for it.

What Causes “Dangerous” Hip Device Side Effects?

To help better understand what conditions lead to taper lock failure and other severe complications, let’s take a look at the design principles behind modern hip replacement implants.

The Aims Of Hip Replacement

The hip joint is a ball-and-socket joint that allows the legs a wide 3D range of motion. It’s comprised of the rounded top end of the femur (the “ball”), which fits the acetabulum (the “socket”) of the pelvic bone.

In a healthy, well-functioning hip, the acetabulum is lined with cartilage that serves to cushion the femoral head as the joint is articulating. The surface of the cartilage in the hip is also covered with a special lubricant that helps absorb shocks and allows the joint to move smoothly. But over time, the cartilage gets worn down from use, and bone-on-bone friction between the femoral head and the acetabulum causes movement to be increasingly difficult and painful.

In addition to normal wear and tear occurring over a person’s lifetime, loss of cartilage can be accelerated and exacerbated by physical injuries or joint or bone-related conditions such as arthritis and osteoporosis. Patients seeking hip surgery to alleviate discomfort and pain from everyday movement have two main options:

Hip Resurfacing

In hip resurfacing, surgeons shave off the worn-out / damaged surface of the femoral head and fit it with a plastic, ceramic, or metal cap, along with new synthetic lining for the acetabulum to replace the depleted cartilage.

One advantage of opting for hip resurfacing is that it allows patients to get at least several more years of use from portions of their original hip joint while still affording them the possibility of having a total hip replacement in the future.

However, many patients in need of hip replacement cannot have hip resurfacing—this surgery doesn’t replace as much bone as total hip replacement, so the best candidates for this type of hip replacement are patients who are younger and / or still have a considerable amount of healthy bone left.

Hip Replacement Surgery

This option, commonly termed total hip replacement (THR) or total hip arthroplasty (THA), involves completely removing the femoral head, acetabulum, lining, and part of the femur and replacing them with devices made from ceramic or various types of metal or plastic.

The majority of Americans undergoing hip replacement surgery are senior citizens, but the number of younger patients opting for the surgery grows each year, as reported by various news outlets such as the Washington Post.  Researchers believe this is partially due to a trend towards a more active lifestyle, as increased physical activity, while beneficial for overall health, also not surprisingly puts more strain on one’s joints. Also, doctors are advising younger, active patients to undergo hip replacement for preventative measure to ensure their well-being remains optimal.

Successful hip replacement will increase stability and eliminate or minimize pain / discomfort from hip movement. Early hip prosthetics were “monobloc” in nature — that is, the artificial femoral head and the femoral stem were already connected to one another in more or less one piece that would be attached to the femoral stem and designed to fit into the replacement acetabular shell.

This rigid design lacked flexibility and often made it challenging for surgeons to achieve proper fit and leg length / hip balance for a wide range of patients.

Modern Hip Devices

This is why, starting in the 80’s, orthopedic manufacturers began developing “modular” hip systems, in which the femoral head and the hip stem are separate parts that come in various sizes and shapes.

In addition to facilitating a far more individualized fit, modular hip devices were designed to make it easier to do revision surgery by allowing the surgeon to potentially replace only the necessary part of the hip system rather than having to remove and replace the whole thing regardless of wear.

Questionable Modular Design Choices?

Orthopedic researchers and medical professionals were initially excited about the development of modular hip devices and hoped they would resolve troublesome issues of individual fit and long-term wear experienced by many hip arthoplasty patients. Many manufacturers aimed not only to facilitate fit and ease of replacement, but also to reduce overall wear.

But some of the ways manufacturers tried to achieve these aims ended up backfiring, instead potentially predisposing the devices to early failure , according to recent lawsuits and medical research articles.

Increased Corrosion Releases Toxic Metal Ions

Metal debris from modern hip replacement systems builds up and can cause hip implants to corrode, which can lead to pain, instability, and even breakage necessitating revision surgery.

Some corrosion is unavoidable, as the human body is a harsh chemical environment for a metal device, especially one designed to remain in the body for years. But experts believe there are 2 main design features that may particularly facilitate the corrosion process in modern metal-on-metal and metal-on-polyethylene hip replacement devices:

Choices of Metals May Cause Galvanic Corrosion

Metals can vary greatly in how resistant they are to corrosion and oxidation–for example, some metals readily form protective surface films in a liquid environment.  Indeed, Stryker likely opted to use cobalt, chromium, and titanium alloys for various useful characteristics such as tensile strength, malleability, and corrosion-resistance. However, the potential problem lies in how Stryker selected cobalt / chromium for the femoral head and titanium for the hip stem rather than using the same metal or alloy for both parts.

When two types of metal are in contact with one another in an electrically conductive liquid environment, if one metal is significantly less corrosion-resistant than the other, then it will corrode faster than it would on its own.  Thus a metal hip device composed of dissimilar metals would be expected, based on fundamental principles, to experience increased corrosion in comparison to a single-metal or single-alloy device.

Fretting Corrosion in the Femoral Head – Hip Stem Junction

The other main potential design issue in Stryker hip devices lies in the particular type of interface Stryker chose for connecting the femoral head and the hip stem. The LFIT V40 Femoral Head fits into its hip stem via a trunnion sleeve that rotates. This rotating sleeve was meant to reduce friction between the femoral head and the acetabular cup, which it does–but at the expense of allowing for another, more problematic source of friction: Fretting corrosion in the trunnion sleeve.

Fretting corrosion occurs when two surfaces that are meant to fit snugly against one another without movement end up rubbing against each other due to some unavoidable external force. In the case of hip replacement devices, the femoral head is supposed to lock securely into the femoral neck, but vibration from movement of the hip joint inevitably leads to some friction at the head-neck interface, resulting in fretting corrosion.

The degree of fretting corrosion can vary depending on the taper lock design; the geometry of the head taper seems to be especially important according to published research.

Stryker Hip Replacement Class Action: Hip Implant Side Effects

A worn-down, broken, or otherwise malfunctioning artificial hip device can cause a number of deleterious side effects, including chronic pain, cardiovascular problems,    Common symptoms include:

• Pain around the implant(s)
• Loosening of the implant
• Difficulty walking
• Psychological changes
• Dizziness

However, it’s common for failing hip implants to only exert noticeable symptoms after it’s too late — when the damage is already so extensive that the patient urgently needs revision surgery to alleviate intense pain.

Risk Factors for Hip Replacement Failure

Certain patients may be at a higher risk for hip replacement complications.  These risk factors are mostly related to the amount of wear the hip joint is expected to experience:

• Small / petite frame (puts more pressure / tension on the vulnerable parts of the artificial hip joint)
• Overweight / High BMI (more pressure / tension on joints in general)
• Active lifestyle (increased physical activity leads to increased / more frequent wear)
• Men are at higher risk than women (men tend to be more physically active than women)
• Allergies / sensitivities to the types of metal and plastic used in hip prosthetics

None of the Stryker hip recall notices issued so far mention any of these crucial risk factors.

Patients Take Legal Action Against Stryker

After being forced to undergo early hip revision surgery due to taper lock failure or other possibly design or manufacture-related hip replacement complications, dozens of patients have already filed Stryker hip lawsuits over the recalled LFIT V40 Cobalt-Chromium Femoral Head, and many more are believed to be in the process of filing.

The plaintiffs behind some of these cases, which all request over $75,000 in relief from Stryker to compensate for pain, suffering, and loss allegedly caused by the company’s negligence, believe the growing numbers of similar hip lawsuits will soon be staggering, leading them to request consolidation by Multi-District Litigation. This request will be reviewed on March 30, 2017, by the Judicial Panel on Multi-District Litigation.

If MDL status is granted to these cases, it won’t be first time that Stryker faces a large number of cases in an MDL. After the company recalled its Rejuventate and ABG II hip systems in 2012, thousands of lawsuits, some of them grouped together in MDLs or MCLs (Multi-County Litigations), were filed and eventually resolved in 2014 with a large global Stryker hip settlement.

How An Experienced Medical Device Lawyer Can Help: Stryker Hip Replacement Recall

Fighting a case against a major corporation is notoriously difficult, as such internationally-successful companies can often afford to hire top defense lawyers to plead their case. Furthermore, medical device litigation can be particularly complex and requires many years of relevant experience to navigate, as the victim’s lawyer must convincingly demonstrate to the judge and jury that the plaintiff’s injuries were plausibly caused by the device in question.

To make this argument, it helps for the personal injury lawyer to be:

• highly familiar with legislation surrounding drugs and medical devices
• experienced at succinctly explaining relevant medical research to those without a healthcare background
• well-versed in common defense tactics so that he or she can anticipate any possible objections from the defendant’s’ lawyers.

It’s easy to see why having a seasoned attorney with extensive experience in product liability / medical device litigation can help a hip replacement failure victim move much more efficiently and with less stress / worry through the necessary legal processes.

“Faulty” Design Leads To Early Failure, Plaintiffs Say

According to a wave of recent lawsuits, Stryker’s LFIT V40 Cobalt-Chromium Femoral heads, a line of components commonly used in total hip replacement surgery, are prone to premature wear and even breakage due to a complication called “taper-lock failure.”

As described by scientists from the Rothman Institute at Thomas Jefferson University Hospital in Pennsylvania and other leading orthopedic researchers, the main design issues may stem from:

1. The manufacturer’s choice to use cobalt and titanium in the implicated hip implants, as such electrochemically dissimilar metals can cause increased wear and release of potentially-toxic metal ions through a process called “galvanic corrosion,” and
2. The geometry of Stryker’s femoral heads; in particular, the design of the connecting piece between the femoral heads themselves and the hip stem, which is the part that’s attached to the patient’s femur.

But one might wonder, how did these alleged design “flaws” make it past the FDA in the first place?

510(k) Clearance: Is FDA Weak On Medical Devices?

First of all, Stryker was able to avoid the FDA’s rigorous approval process by submitting its application for the device through 510(k) Clearance, in which a Class II medical device (moderate risk requiring “special controls”) is accepted for market release without the need for the usual strict standard for safety testing and clinical trial data. Instead, the application is judged only on the new device’s similarity to a device that’s already on the market. 510(k) Clearance is designed to help expedite the development and introduction of new medical devices, but many critics feel that it can put  public health at risk through the hasty release of potentially dangerous, untested products.

Also, some orthopedics researchers and other medical professionals believe that metal hip implants are not placed in the right regulatory class and should actually be considered a “high risk” Class III device, a class that is always required to obtain FDA approval before being marketed.

Stryker Accused of Violating FDA Regulations

Though taking advantage of 510(k) Clearance may seem questionable considering the potential dangers of hip implants, it’s currently a legal and commonly-accepted way for device manufacturers to speed up their product releases. But hip replacement plaintiffs say they believe that Stryker kept the “dangerous” device on the market by neglecting or willfully failing to adhere to key FDA requirements for Class II devices, such as informing the FDA of:

• Any adverse event reports involving the product
• Recorded product failures
• Unanticipated side effects emerging after product is on the market
• Any increase in incidence of adverse effects / events
• Product corrections / improvements

Also, according to the plaintiffs, Stryker failed to conduct “design validation”–testing or other research performed to confirm that the product in question is meeting patient needs for its intended use(s).

Legal Theories Used Against Stryker

Stryker hip attorneys have generally supported allegations against Stryker and other orthopedic companies accused of releasing “faulty” hip replacement systems with the following legal theories:

Negligence

As an influential part of the healthcare community, medical device manufacturers are responsible for upholding patient safety,  and are thus obligated to exercise a standard level of care in conducting all of the tasks required to design, build / manufacture, test, distribute, and market their products.

If these companies fail to perform their duties with a reasonable level of diligence and attention (judged according to how the average person with experience and education comparable to that of the defendant(s) would behave), then they may be accused of being negligent.

Strict Products Liability

Under this legal theory, manufacturers are liable for any injuries caused by their products when employed for their intended use, regardless of intent or conduct of the manufacturer. That is, even if the manufacturer did everything possible to prevent patients from being injured by a product, as long as the plaintiff’s lawyer is able to demonstrate that the product was plausibly the cause for the plaintiff’s injuries, the manufacturer will be held liable. Though this theory doesn’t necessarily apply to drugs and devices that are judged “unreasonably dangerous” to begin with, hip implants, currently classified as only moderate risk devices, would not likely be thought of as dangerous enough that users should expect such severe adverse effects as loss of mobility, intense pain, heart attack / stroke, or surgical complications from early revision.

Failure to Warn

If a healthcare company becomes aware of potential hazards associated with a new or existing product, it’s typically obligated to inform the public, the FDA and the medical community of these risks as soon as possible.

Stryker hip attorneys claim in recent lawsuits that Stryker should have known that its choice to use a trunnion-interface design and dissimilar metals–cobalt and chromium–in its LFIT V40 Femoral Heads carried risks of high wear rates and release of metal debris due to the effect of galvanic and fretting corrosion.

Yet before releasing its “voluntary recall” of the device, Stryker issued no warnings whatsoever about the possibility of taper lock failure or other related complications, even though the company admitted in the recall that it had been receiving high numbers of patient complaints. Furthermore, readily-available orthopedic research studies had been already discussing concerns over potential design flaws in modular hip implants for years before the Stryker recalls.

Loss Of Consortium

The pain, suffering, and loss experienced by patients who fall victim to severe medical device complications not only affects them personally but naturally often also impacts the quality of life of their spouse / life partner. When someone files a hip implant lawsuit on behalf of their spouse (or files jointly with their spouse), they may be able to invoke loss of consortium, where defendants are held liable for causing the plaintiff to miss out on the expected benefits of partnership, such as companionship and emotional and financial support.

Witt Vs. Stryker Lawsuit

One of the more recent examples of a Stryker hip replacement lawsuit was filed in district court of Alaska on January 12, 2017, by couple Patton and Annie Witt. The Witts filed their case against Howmedica Osteonics Corporation, the subsidiary of Stryker that manufactures the LFIT V40 Cobalt-Chromium Femoral Head.

Patton Witt’s Hip Device Complications

According to the lawsuit, Patton underwent total hip replacement of his left hip in March 2008 to help alleviate effects of arthritis (the arthritis in his right hip was judged too severe for hip replacement surgery). The hip system he received included both Stryker’s LFIT (low friction ion treatment) V40 Cobalt-Chromium Femoral Head and its Accolade TMZF (titanium-molybdenum-zinc-iron) femoral stem.

Sometime after the surgery, Patton suffered from unexplained severe pain in the hip area. He went back to his surgeon for diagnostic tests. His doctor found that he had higher-than-normal cobalt serum levels (3.9 ng/mL) and ordered an MRI, which revealed a “large soft tissue mass.” Judging from these results, the surgeon suspected that Patton was suffering from “adverse local tissue reactions” from corrosion in the junction between the Stryker hip stem and the femoral head, and advised Patton to undergo revision surgery.

The revision, performed in January 2015, caused Patton even more pain and suffering, as well as extensive medical costs from the surgery itself, the post-surgical rehabilitation, and continued pharmaceutical needs.

Reportedly, after the allegedly failed hip implant was removed from Patton, the operating surgeon took it apart and closely inspected it, reporting that the he could “clearly see extensive corrosion” in the connector piece between hip stem and femoral head.

Financial Relief For The Witts

Patton was forced to have revision surgery within only 7 years after his initial hip replacement–much earlier than suggested by the standard 10-15 years that hip devices are supposed to last.

The Witts claim that due to the “defective design” and “manufacturing defects” in the Stryker femoral head, as well as Stryker’s alleged negligence and failure to warn, Patton developed complications and sustained injuries that he would not have otherwise suffered, if the product was safely designed and manufactured. Also, if Stryker had only properly warned doctors and the general public about the potential risks, Patton says, he would never had chosen that particular hip implant. Because of these alleged wrongdoings, the Witts hold Stryker accountable for their hardships, asking for more than $75,000 in compensation for their pain, suffering, reduced quality of life, and financial difficulties due to past, current, and future medical expenses.

Lawyers Representing Stryker Hip Victims: Will Plaintiffs Receive Much-Needed Compensation?

Growing numbers of hip replacement patients are now filing legal claims similar to the Witts’ lawsuit. But does it look like plaintiffs have a hope of winning compensation to help them recover from their injuries, suffering, and loss? Judging by fairly recent litigation involving previous Stryker hip device product lines, one might say yes.

In 2014, Stryker settled thousands of legal complaints from patients who needed early revision surgery after implantation with Stryker’s Rejuvenate and ABG II Hip systems. This settlement was among the largest in hip litigation history–Stryker offered a base amount of $300,000 per hip, which could be augmented with “enhancements” according to the number of additional injuries suffered by the claimant. And though this initial settlement was limited to patients who had undergone revision surgery prior to November 3, 2014, Stryker recently extended the settlement agreement to include plaintiffs who received revision before December 19, 2016.

This settlement, along with hip litigation trial developments and settlements issues by other hip device manufacturers, suggests a promising legal environment is emerging for hip replacement plaintiffs hoping to secure compensation for unnecessary hardships and injuries.

Continue Reading: DePuy Pinnacle Hip Replacement Lawsuit Commercial