Hip replacement surgeries are intended to relieve chronic pain and increase range of movement by fixing or replacing damaged bone or cartilage in the hip joint. Originally hip implants were made of ceramic or a hard plastic. These devices had a large degree of success and are still used as replacements.
Metal-on-metal hip implants emerged in the mid-1990s as the next generation of hip replacement technology. Indeed, thousands of individuals have led happier lives with reduced pain and suffering due to the work of these medical device companies.
Unfortunately, thousands of other individuals have had their conditions made worse by the technology that was designed to fix their problems, which has led to dozens of recalls on numerous models of hip implant and billions of dollars in settlement claims on behalf of patients.
Joe Lyon is a highly-rated recall lawyer and product liability attorney with a broad range of experience on Medical Device Injury, product liability, and class action claims.
For a free consultation on a hip implant defect case, please call (800) 513-2403 to speak with Mr. Lyon.
Hip implants are categorized under the FDA 510K approval process, which is significantly less rigorous than other FDA approval processes. The 510K process allows companies to submit new products without submitting safety and efficacy testing data as long as they can prove that their product is significantly similar to a product already on the market.
This system saves medical device companies money and get products to market more quickly, which has made it the predominant system for medical device approvals.
Unfortunately, once a product is on the market it often takes numerous cases of device failure or severe side effects for companies to address the issues or recall their product.
This is certainly the case for metal-on-metal hip implants. Traditional hip implants had relatively low failure rates, often between 3%-5%. By comparison, some of the more notorious metal-on-metal implants, like the DePuy ASR fail in up to 49% of patients after 6 years according to the British Hip Society.
The British Medical Journal published an article in 2012 that explained that the metal-on-metal failure epidemic was not a small or unforeseen issue. They blamed the process for approving medical devices as “[unable] to prevent a whole class of failing hip implant from being used in hundreds of thousands of people globally”
After seven years, average failure rates are 11.8% for resurfacing and 13.6% for metal-on-metal total hip replacement, although failure rates vary with the brand used. Failure rates for hip implants made of other materials ranges from 3.3%-4.9%. Metal-on-metal devices have been implanted into over a million patients in the US.
Cobalt-chromium implants have been found to release metal ions, which can get into local tissue causing harmful reactions that destroy muscle and bone. These reactions leave some patients with long term disabilities– a condition known as metallosis. The ions can also get into the bloodstream spreading to the lymph nodes, spleen, liver, and kidneys before being excreted in urine.
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There are a number of risks associated with metal-on-metal hip implants. Patients have reported various problems years after their initial surgery. Progressive pain is common, as is the issue of metallosis. The BHR implant, for example, is made of cobalt and chromium, and the levels of these metals in the blood can become dangerously elevated.
Metal-on-metal resurfacing releases large amounts of very small particles and metal ions. The long-term biological consequences of the exposure to Co-Cr particles and ions remain largely unknown, but there may be a toxic reaction to an excess of metal debris or a hypersensitivity reaction to a normal amount of metal debris.
Other patients who receive metal-on-metal resurfacing present with various symptoms and soft-tissue masses or pseudo-tumors. It is estimated that approximately 1 percent of patients who have a metal-on-metal resurfacing develop a pseudo-tumor within five years.
Metal-on-metal hip implants were developed to be more durable than traditional implants. Hip resurfacing techniques were introduced in the 1970s with the aim of minimizing the risk of dislocation, but the method was discarded after showing a high rate of failure. Results have improved over the years, however, there are still a number of reports of serious complications with this type of implant.
In a recent lawsuit, a Texas jury ordered Johnson & Johnson, and its DePuy subsidiary, to pay about $500 million to five plaintiffs who said they were injured by Pinnacle metal-on-metal hip implants. Lawyers argued that the Pinnacle hips were defectively designed, and that the companies failed to warn the public about their risks.
Due to the consistency and severity of complaints to the FDA regarding metal-on-metal implants, the FDA required five producers of all-metal implants to conduct intensive long-term studies on the effects of their implants. The U.S. does not maintain an orthopedic registry that follows patient outcomes, unlike countries such as Britain and Australia.
The lack of available data on outcomes puts responsibility on patients and lawyers, to litigate against medical device companies in order to force recalls. Companies who have issued recalls include:
• Smith & Nephew
• Biomet M2a Magnum
• DePuy ASR XL
• Depuy Pinnacle
• Smith & Nephew Birmingham System (BHR)
• Wright Hip Implants
• Stryker Accolade 2
• Stryker Citation
• Stryker LFIT V40
• Stryker Meridian
• Stryker ABG Rejuvenate
• Stryker Trident Hemispherical Cup System
• Zimmer M/L Stem Kinectiv Hip
Hip implants are an increasingly popular means of improving a quality of life for many aging individuals. However, joint replacements, particularly metal-on-metal hip implants, can be defective and cause more harm in patients than good. Metal-on-metal hip implants are manufactured and marketed to relieve the pain and immobility associated with bad hips.
The U.S Food and Drug Administration (FDA) urges patients who receive metal-on-metal hip implants to pay close attention to changes in their general health including new or worsening symptoms outside their hip. The signs of a failing hip replacement are potentially dangerous if left untreated. Some of the warning signs include:
• Severe joint pain
• Bone fracture around the implant
• Inability to walk
• Implant failure, dislocation or loosening
• Dead tissue/bones around the implant
• Formation of cysts or pseudo-tumors
• Allergic reaction to metallic debris
• Cobalt or chromium poisoning
• Nerve damage
In addition, metal particles from implants may cause certain adverse reaction. A 2012 study published in the British Medical Journal warned that the metal-on-metal components of hip replacements could rub against each other and result in metal particles released into the surrounding tissue and blood stream.
The particles could cause metal alkalosis (metallosis). It was not until after the release of this study that the Stryker recall of the Rejuvenate and ABG II systems occurred, citing the need to study the risks of their own products.
More than 20,000 Rejuvenate and ABG II implants were sold before a Stryker recall was issued in July 2012, when it was determined that the modular neck stem components pose a substantial risk of fretting, corroding, and ultimately failing.
In September, 2016, the Australian Therapeutic Goods Administration warned in a hazard alert that the modular components used in Stryker’s Accolade hip replacements have higher-than-expected rates of failures. It has been identified that some LFIT Anatomic CoCr V40 femoral heads manufactured before 2011 have high incidences of taper lock failures.
Australian health officials have identified seven models using the Stryker LFIT hip femoral heads, with head diameters ranging from 36 mm to 44 mm, which may cause issues for patients. An entire line of Stryker’s products with similar specifications has also been included in the hazard alert. The affected Stryker femoral heads are used in various models.
Stryker has settled thousands of cases, however, problems continue to surface. Patients are encouraged to seek possible medical and legal representation.
In response to numerous complaints from orthopedic surgeons and patients, as well as new clinical data showing an increased rate of revision surgery associated with DePuy ASR XL Acetabular hip implant systems, DePuy Orthopedics voluntarily recalled all of its ASR XL Acetabular hip replacement devices, as announced by the company in August 2010.
According to Dr. Joshua J. Jacobs from the Rush University Medical Center, “Most major medical centers have seen issues with this device. [The Depuy recall] does not come as a surprise.”
Since the Depuy ASR recall, other metal on metal hip implants by a variety of manufactures have been implicated in lawsuits due to the defective design, failure to warn, and breach of warranties. Patients at the highest risk are female recipients and those who received ASR head sizes below 50 mm in diameter.
Johnson & Johnson, the parent company for DePuy, officially announced a $4B settlement in the ASR case, which amounted to an average plaintiff settlement of $300,000.
In 2015, Smith & Nephew issued a field safety notice which warned consumers of current risks associated with their metal-on-metal hip resurfacing products. Patients have reported serious problems that include infections, fractures, dislocations, metallosis, and pseudo-tumors in the hips.
The company started selling their hip implants in the United States in 2009, many of which were recalled within the next three years after experiencing a higher-than-normal rate of revision surgery.
In the 2012 recall, Smith & Nephew said the metal liner of the replacement hip was “not performing as well” as the company expected, and stated it may lead to premature failure and potential health issues. Smith & Nephew’s chief medical officer said the company was “not satisfied with the clinical results of this component.”
The decision to withdraw a component of its metal-on-metal artificial hip system, followed a high percentage of patient problems. Clinical results showed that 1.6 percent of patients with the system needed revision surgery each year, almost double the safety guideline set by Britain’s National Institute for Health and Clinical Excellence.
Smith & Nephew is a British multinational corporation that develops metal-on-metal hip implants, and other medical equipment. The company manufactures and sells a variety of hip replacement and resurfacing products, some of which have been recalled, injured patients and stimulated lawsuits in the U.S.
In 2012, the U.S. Securities and Exchange Commission (SEC) investigated Smith & Nephew for allegedly paying doctors employed by foreign governments to use the company’s equipment instead of competitors’ products.
In a settlement, Smith & Nephew paid $22 million in fines. In 2012, a New York woman filed a hip implant defect product liability lawsuit against Smith & Nephew. Her attorneys claimed she had suffered instability consistent with anterior dislocation and severe pain, requiring emergency care.
Current personal injury and product liability lawsuits and settlements can compensate victims implanted with defective Smith and Nephew, Zimmer Biomet and Stryker systems.
Contact a hip implant defect lawyer if you have been implanted with a defective product. Smith & Nephew has said patients who experience symptoms including pseudo-tumors, tissue masses, fluid collections, pain and swelling, buildup of excessive metal particles or metal hypersensitivity, may require revision surgery.
If a patient is fitted with a Birmingham Hip Replacement (BHR) System, or metal liners for its R3 acetabular system, the patient is at a risk of needing revision surgery. Those at greater risk of requiring a revision surgery:
• Males aged 65 or greater
• Patients requiring an implant head size <48mm
Many defective devices are approved by the U.S. Food and Drug Administration (FDA) each year because the safety agency does not always require studies and clinical trials if the hip replacement is deemed similar to an already existing device. This process hastens the sales process and results in recalled faulty products and preventable injuries for hip implant patients.
Attorneys and victims taking legal action to medical device companies force manufacturers to take responsibility for any defective products they produce and distribute.
If you are experiencing persistent pain, a loss of mobility, inflammation, or instability, you should contact your implanting surgeon and an experienced defective hip replacement lawyer. You may have a claim against the device manufacturer.
The Lyon Firm is taking cases involving hip implants manufactured by Wright Medical, Smith and Nephew, Depuy, Zimmer Biomet and Stryker. Medical device litigation is critical in not only reaching settlements for plaintiffs but for improving consumer safety for America in the future.
Defective medical device litigation helps to improve patient safety and holds medical device companies accountable when defective products injure plaintiffs and clients.
Ohio Definition of Defective
Under Ohio law, a medical device is defective if it is unreasonably dangerous for its intended use. A legal cause of action can be based on several types of medical device product defects. Most jurisdictions a version of one or more of these cause of actions.
(1) Manufacturing/ Construction Defect of the medical device:
(2) Defective design and/or formulation of the medical device:
(3) Failure to warn or inadequate warning or instruction associated with the medical device:
(4) Misrepresentation on the Safety or Efficacy of the Medical Device:
(5) Fraud Related to the Safety or Efficacy of the Medical Device
(6) Negligent Distribution or Testing of the Medical Device
Defective design medical device 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 (e.g. the metal on metal design, the porosity and stiffness of transvaginal mesh )
For these claims, the FDA Review process is critical on whether a pre-emption defense exists. For devices that went through the PMA (pre-market approval process), rather than the 510K process, the case must be evaluated very carefully for any parallel claims under state and federal regulations (e.g., failure to warn or failure to disclose adverse events) that can advance the case forward. Without a careful legal analysis, the case may be subject to dismissal even where the medical device design proves to be defective.
Risks: The following factors are considered under Ohio law when determining the risks associated with the design of a medical device: (1) the magnitude of the risk of injury; (2) ordinary consumer awareness of the risk for injury; (3) the likelihood of causing injury; (4) the violation of a private or public standard; and (5) the consumer’s expectation of the performance of the product and level of danger. Ohio Revised Code 2307.5 (B) Product Defective in Design or Formulation. These factors are considered in most other jurisdictions.
Benefits: The following factors are considered under Ohio law when determining the benefits associated with a medical device: (1) the utility of the product; (2) availability of an alternative design; (3) the magnitude of risks associated with an alternative design. Ohio Revised Code 2307.5 (c) These factors are considered in most other jurisdictions.
Defenses for Defective Design: (1) a pharmaceutical drug or medical device is not defective by design if it contains an adequate warning of an unavoidably unsafe aspect of the pharmaceutical or medical device; (2) the dangerous aspect is inherent to the product, recognizable, and cannot be eliminated without compromising the product’s usefulness; (3) a lack of a feasible alternative design. 2307.75 (d)(e)(f).
A manufacturing defect claim arises where the medical device is released from the factory in a manner that deviates from the intended design or specifications.
Most manufacturing defect cases are based on a products deviation from the intended specification, formula, performance standards, or design model. In such cases, it may be easy to determine the product did not comply with the intended design. In defective medical device cases, the manufacturing defect is often related to performance standards (e.g., the metal does not meet the strength specification or has microscopic fractures–these defects require an examination by a qualified metallurgist who can examine the medical device).
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.
The product may be recalled as a specific lot is identified as being non-compliant and defective. A product may be defective in manufacture or construction, materials and assembly, and a manufacturer or distributor may be subject to strict liability, even though it exercised all possible care. Ohio Revised Code 2307.74.
All medical device products come with warnings and instructions for use that are provided to the physician. If the company does not provide the physician with all the relevant safety data so that the physician adequately understand the risks and benefits of the product, then the medical device is defective.
The physician must be in a position to pass the appropriate safety data onto the patient, so the patient can make an informed decision on whether they wish to have the medical device implanted. Patient informed consent is critical because many devices are designed to be permanent.
Litigation arises where there is evidence the medical device 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.
In determining whether a medical device is defective due to inadequate warning or instruction, evidence must be presented to prove:
Defenses to Failure to Warn Claims: (1) the risk was open and obvious or a matter of common knowledge; and (2) in cases of a pharmaceutical drug or medical device, the warning was provided to the prescribing physician (“Learned Intermediary Doctrine”).
Design and manufacturing defects result in medical device product recalls each year in the United States, initiated by federal safety agencies.
The foregoing listed government agencies may initiate recalls of dangerous products but do not provide remedies or compensation for damages where an individual is injured due to the defective product. Only litigation can utilized to compensate patients injured by a defective medical device.
Our Firm will help you find the answers. The Firm has the experience, resources and dedication to take on difficult and emotional cases and help our clients obtain the justice for the wrong they have suffered.
Experience: Joe Lyon is an experienced Cincinnati Defective Device Lawyer. The Lyon Firm has 17 years of experience and success representing individuals and plaintiffs in all fifty states, and in a variety of complex civil litigation matters. Defective device lawsuits can be complex and require industry experts to determine the root cause of an accident or injury. Mr. Lyon has worked with experts nationwide to assist individuals understand why an injury occurred and what can be done to improve their lives in the future. Some cases may go to a jury trial, though many others can be settled out of court.
Resources/Dedication: Mr. Lyon has worked with experts in the fields of accident reconstruction, biomechanics, epidemiology, metallurgy, pharmacology, toxicology, human factors, workplace safety, life care planning, economics, and virtually every medical discipline in successfully representing Plaintiffs across numerous areas of law. The Lyon Firm is dedicated to building the strongest cases possible for clients and their critical interests.
Results: Mr. Lyon has obtained numerous seven and six figure results in medical device cases. He has litigated cases successfully against some of the largest companies in the world including: Johnson & Johnson, Biomet, Ethicon, Stryker, Coloplast, Smith & Nephew, American Medical Systems, Boston Scientific, Medtronic, Guidant, Bard, & Bayer.
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.