For many years, faulty hip implants have been plaguing thousands of patients in Ohio and across the country. As the incidences of Stryker LFIT adverse effect reports increases, more and more personal injury lawsuits emerge.
Hip replacement systems are gaining in popularity, and can do wonders for a patient’s quality of life. However, too many patients have suffered the consequences of faulty medical devices.
Stryker has a history of personal injury claims against them. As a result, Stryker has recalled two metal hip products in the past—the Rejuvenate and ABG II were recalled over concerns that components could corrode, and cause pain and inflammation in the surrounding tissue. Like the recalled Rejuvenate and ABG II, Stryker’s Accolade V40 has been met with allegations of consumer injury.
Stryker’s metal-on-metal hip implants have caused similar problems to patients with Johnson & Johnson’s recalled DePuy ASR systems and other allegedly dangerous metal-on-metal hip replacements. The most common adverse health problems reported include premature implant failure and metal poisoning, which can lead to numerous secondary issues.
In 2014, Stryker reached a settlement that cost the company an estimated $1 billion, but the medical device company continued to manufacture other alleged failing hip implant products.
The Lyon Firm is accepting hip implant failure cases involving hip replacement systems manufactured by Wright Medical, Depuy, Zimmer Biomet, Smith and Nephew and Stryker.
Joe Lyon is a highly-rated Cincinnati recall lawyer and Ohio product liability attorney representing plaintiffs nationwide in a wide variety of medical device and Stryker LFIT defect claims.
In August, 2016, Stryker issued an Urgent Medical Device Product Field Action Notification for the Accolade and the LFIT V40, noting that they had received “higher-than-expected complaints” of failure. The hip systems are responsible for a number of complications, which cause severe pain, inflammation, loss of mobility, and more serious concerns such as metallosis.
Stryker has indicated in a letter that some models of the V40 femoral heads manufactured prior to 2011 have a higher than expected incidence of taper lock failure. Although there have been no recalls in the United States, the Accolade V40 has been recalled in both Canada and Australia.
There are potentially thousands of affected hip implants around the world as a result of the V40’s design. According to the FDA’s recent notice, over 42,000 potentially defective units have been distributed and implanted across the U.S. market and worldwide.
ABOUT THE LYON FIRM
Joseph Lyon has 17 years of experience representing individuals in complex litigation matters. He has represented individuals in every state against many of the largest companies in the world.
The Firm focuses on single-event civil cases and class actions involving corporate neglect & fraud, toxic exposure, product defects & recalls, medical malpractice, and invasion of privacy.
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The Firm offers contingency fees, advancing all costs of the litigation, and accepting the full financial risk, allowing our clients full access to the legal system while reducing the financial stress while they focus on their healthcare and financial needs.
The Accolade V40, also known as the Stryker LFIT Anatomic CoCr V40, is an alloy femoral head that is used in conjunction with modular hip implants for hip replacement surgery. The Accolade V40 is believed to wear down prematurely due to the friction between the modular neck and stem. The resulting metallic debris can cause deterioration of tissue around the joint, and loosening of the hip replacement.
Stryker officials say potential taper lock failures may jeopardize the connection between the femoral head and femoral stem, causing issues that may include the following:
• Disassociation of femoral head from hip stem
• Excessive metallic debris
• Insufficient range of motion
Stryker’s Anatomic CoCr V40 Femoral Head is the third hip implant product that the company has recalled in the last five years. When a hip replacement fails, the device may lead to serious side effects. Patients implanted with LFIT Anatomic V40 Femoral Heads may suffer from:
• Loss of mobility
• Adverse local tissue reaction
• Joint instability
• Bone Fractures around the components
• Nerve Damage
• Need for revision surgery
Since its release in the U.S. market, there have been over 100 adverse events reported to the FDA associated with the Stryker LFIT model. Pain may develop gradually along with a decrease in range of motion, resulting in a need for revision surgery. Revision surgeries are often more complex than the initial surgeries and may result in longer recovery times and increased risks.
Metal-on-metal hip implants are the subject of many reports of serious complications. In one study in the British Medical Journal, researchers concluded that systemic metal ions may cause cardiovascular problems.
A recent study shows that some metal-on-metal implants are likely to fail much sooner than available alternatives.
The research, published in 2012 in The Lancet, shows patients who received metal-on-metal implants had a substantially higher overall failure rate—twice the rate of ceramic hips, and three times the rate of metal-on-plastic implants.
Hip replacement patients should monitor for symptoms of metal poisoning. According to the FDA, the signs of metal toxicity include:
• Impaired kidney function
• Thyroid problems
• Cognitive impairment
• Skin rashes
• Hearing or vision impairments
• Cardiomyopathy—a condition that weakens the heart
After an initial settlement of around $1 billion was reached in 2014, Stryker expanded their hip replacement settlement to include patients who received the Stryker ABG II Modular Neck Hip Stem and the Rejuvenate Modular Neck Hip Stem models and had revision surgery between 2014 and December, 2016. The original settlement offered a $300,000 base award to injured patients.
Stryker now faces claims concerning the Accolade and LFIT V40 femoral head. Among concerns about the LFIT femoral head are a risk of spontaneous dislocation.
Product liability attorneys contend that the litigation has potential to include thousands of similar claims, pointing out that more than 100,000 LFIT V40 components may have been implanted in patients.
Defective hip implants may result in the release of toxic metals into the body, leading to metal poisoning known as metallosis. The metal debris may initially cause inflammation, and lead to fluid buildup known as a pseudo-tumor around the implant.
Some Stryker hips are made of cobalt and chromium, and the levels of these metals in the blood can become dangerously elevated. Metal-on-metal contact releases large amounts of particles and metal ions. The long-term consequences of the exposure to Co-Cr particles and ions remain unknown, but there may be a toxic reaction to an excess of metal debris.
Excess cobalt in the blood has been reported to cause thyroiditis and high blood levels of cobalt or chromium may be toxic to both cranial and peripheral sensory nerves. Patients with elevated blood concentrations of metals due to metal prostheses (metallosis) have been reported to be associated with a systemic immune response.
Metal-on-metal hip implants were developed to be more durable than traditional implants, but there are still many reports of serious complications with this type of implant. In one study on metal implants, researchers writing for the British Medical Journal concluded that systemic metal ions can cause cardiovascular problems.
A recent study shows that some metal-on-metal implants are likely to fail much sooner than available alternatives. The research, published online in 2012 in The Lancet, shows patients who received metal-on-metal implants had a substantially higher overall failure rate—twice the rate of ceramic hips, and three times the rate of metal-on-plastic implants.
The most recent hip device recall is similar to the Rejuvenate and ABGII recall that occurred in June 2012. Several lawsuits have been filed in U.S. courts on behalf of patients that have experienced Stryker femoral head failures. Lawyers allege that the components are defectively designed and manufactured.
Device recalls may be initiated by the Food and Drug Administration (FDA) or by a device manufacturer such as Stryker. However, many injuries have usually occurred by the time a manufacturer or the FDA removes a dangerous device from the market.
Although the FDA is responsible for making sure that medical devices are adequately tested, device recalls have become increasingly common. Device manufacturers are often slow to respond to consumer complaints and must be held responsible for injuries caused.
According to Stryker defect lawsuits filed in 2016, the company did not ask for the affected femoral heads to be returned and did not direct doctors to notify patients of the potential defect. The complaints claim that Stryker knew for years that the LFIT V40 femoral heads were defective and dangerous, but chose not to report the risks of using the components.
The most recent Stryker recall is similar to the Rejuvenate and ABGII recall that occurred in June 2012. Several hip implant lawsuits have been filed in U.S. courts on behalf of patients that have experienced Stryker femoral head failures.
Compensation may be available to individuals who allegedly suffered pain, disability, and other complications resulting from the taper lock failure of a Stryker Accolade or LFIT Anatomic CoCr V40 Femoral Head.
Defective medical device litigation helps to improve patient safety and holds medical device companies accountable when defective products injure plaintiffs and clients.
When a medical device has the potential to fail and cause injury, companies should voluntarily issue a recall. When a company injures patients with defective medical devices, a medical device lawyer may help you recover financial losses, medical expenses and other damages incurred through litigation.
A product is defective if it is unreasonably dangerous for its intended use. A legal cause of action can be based on several types of product defects. The following are Cincinnati product liability and strict liability claims available in Ohio and in most jurisdictions nationwide:
(1) Manufacturing/ Construction Defect:
These issues arise where the product is released from the factory in a manner that deviates from the intended design or specifications. The defect can be a result of using the wrong materials, including the wrong or completely foreign materials (e.g., Tylenol contamination, food poisoning, damaged car part from factory installation).
As a result of the deviation, the product enters the market in an unreasonably dangerous condition and the consumer is exposed to or purchases a product that is defective. Any personal injuries or economic loss that arise from the the defect are compensable under Ohio product liability law.
(2) Defective design and/or formulation:
Defective design product liability cases arise not because a mistake was made during the manufacturing process, but rather the original design of the product is unreasonably dangerous. A “risk benefit analysis” is used to determine whether safer/less expensive alternative designs were available to the manufacturer.
Federal regulations set minimum standards for the design of many consumer products, and preemption defenses may preclude liability in some situations if the manufacturer follows and obtains federal approval for a product. Automotive recalls and product liability cases are usually a result of a defective design. Common cases include the Toyota Brake Recall, Chrysler Gen III seat belt buckle, lap belt only cases, Metal on Metal hip implants, transvaginal mesh.)
(3) Failure to warn or inadequate warning or instruction associated with the product:
All consumer products come with necessary and appropriate warnings and instructions for use. If the lack of a warning makes the product and use of the product unsafe, the manufacturer is liable for the failure to place the warning. The most common area of litigation for failure to warn is in pharmaceutical litigation.
Pharmaceutical manufacturers are required to warn of the known or foreseeable side effects and update the warnings in a timely manner. Litigation arises where there is evidence the manufacturer failed to timely update a warning in light of new data or simply ignored the risk and failed to conduct sufficient research to identify and then disclose the risk.
The product fails to conform to a representation or warranty. Warranty claims are more common in commercial and economic loss cases than in personal injury cases. In many States, The Product Liability Act does not apply to cases with only economic loss, because the Commercial Code provides recourse for breach of warranty.
The warranty may be written or implied based upon the products intended purpose and merchantability. An example of a breach of warranty cases are cases involving automotive defects.
The normal lifespan for a hip replacement is about 15 to 20 years, but defective products may fail much earlier than expected.
There are several models on the market, some made of plastic, and some metal on metal hips that have been known to cause problems.
Yes, any foreign material implanted into the human body may not be tolerated, but this is rare.
Pain, inflammation, infection, immobility and a sense of instability are all good signs there may be a problem with your hip implant.
Defective products on the market present safety and health hazards for adults and children. Cheap and defective products may pose fire and burn risks; electrocution, strangulation and choking risks; and severe health risks. The manufacturers of consumer products have a duty to foresee potential injury and properly design and test products before they are released.
Companies must also properly warn consumers of any risks associated with their products. Any failure to protect consumers that results in accidents and injury can lead to lawsuits filed by plaintiffs and their Cincinnati product liability lawyer
The Lyon Firm aggressively, professionally, and passionately advocates for injured individuals and families against companies due to a defective product or recalled product to obtain just compensation under the law.
Nationwide Consolidation in U.S. District Court, Northern District of Ohio. The Depuy ASR Hip design was plagued with problems related to premature loosening and metallosis, caused by chromium and cobalt entering the blood stream. The resulting injuries were a result of the metal-on-metal friction inherent with the design of the product. Depuy recalled the ASR and entered into a global settlement valued at $2.5 Billion to cover an estimated 8,000 patients. The Lyon Firm represented several clients in the original settlement and continues to be active in this litigation. The settlement funds provided compensation for the revision surgeries, including compensating for medical costs, lost wages, and pain and suffering.
Nationwide Consolidation in U.S District Court, Northern District of Indiana. Similar to the Depuy ASR, the Biomet metal-on-metal hip design allegedly contributed to premature hip failures and metallosis due to the metal friction. Biomet entered into a global settlement valued at $56 million to cover a few thousand claims. The Lyon Firm represented several plaintiffs in the original settlement and continues to be active in this litigation.