Several models of the Smith Nephew Birmingham Resurfacing Hip (BHR) System have been recalled after the company admitted their device leads to a higher-than-normal rate of revision surgery. Smith & Nephew, a UK-based medical device manufacturer, has produced multiple hip resurfacing implant devices that have caused problems for recipients.
The company’s decision for a recall followed a high percentage of dangerous patient problems. Clinical results showed many patients with the BHR implant system needed revision surgery—the percentage was reportedly almost double the safety guideline set by Britain’s National Institute for Health and Clinical Excellence. Hip resurfacing is a newer surgical alternative to total hip replacement. Instead of replacing the entire femur with a prosthetic, a metal cap is fitted over the existing bone along with a matching metal socket. This allows patients to retain more of their original bone structure.
Patients have experienced symptoms including pseudo-tumors, chronic pain, and a local buildup of excessive metal particles. Serious complications may require revision surgery.
The failures of the defective medical devices have resulted in thousands of lawsuits, naming Smith & Nephew as the negligent party. The Lyon Firm is accepting implant cases involving hip replacement systems manufactured by Smith and Nephew, Wright Medical, Depuy, Stryker and Zimmer Biomet.
Joe Lyon is a highly rated product liability lawyer representing plaintiffs nationwide in a wide variety of medical device claims.
In November 2016, Smith & Nephew, Inc. initiated a voluntary recall for the Tandem Bipolar Hip System due to a manufacturing error which affected thousands of their hip replacement devices.
The Smith & Nephew recalls affect implants that were manufactured out-of-specification and could potentially result in one of three functional failures: the device will not assemble, the head is too tight, or the device may appear to assemble but later disassociate post-operatively. Smith & Nephew issued a voluntary market removal of the modular neck, which is a common component in their Modular SMF and Modular REDAPT Revision Femoral Hip Systems.
Smith & Nephew recently reviewed product complaints and clinical study data associated with the modular hip prostheses, and noted a rate of complaints higher than comparable hip implants on the market. Metal-related Adverse Events accounted for the highest category of complaints in both products. The company says the implanted assembly could “potentially disassociate in the patient post-operatively, requiring a revision surgery.”
The adverse events reported to be associated with the Smith & Nephew hip implants were mostly related to high levels of metal in the joint area and in the blood of patients, and with the need for revision surgeries. Patients who have received REDAPT or SMF hips are at risk for developing the symptoms of a hip failure and should be monitored for pain, swelling, limited mobility, and other signs that a revision may be needed.
The company also recommends that patients be tested for levels of cobalt and chromium in the blood; metals from the hip replacements can cause dangerous reactions in soft tissue called metallosis.
Certain groups of patients are more likely to experience complications and require revision surgery after receiving a Birmingham Hip Resurfacing System implant. These groups include females, men aged 65 or older, and patients who require an implant head 48mm or smaller.
The symptoms of a failing hip replacement are potentially dangerous and must be attended to by medical professionals. Some of the warning signs include:
• Severe joint pain
• Bone fracture
• Inability to walk
• Implant dislocation or loosening
• Dead tissue around the implant
• Formation of cysts or pseudo-tumors
• Allergic reaction to metallic debris
• Cobalt or chromium poisoning
• Nerve damage
Thousands of recipients of the Smith & Nephew Birmingham Hip Replacement (BHR) System have reported severe complications and device failure. Perhaps the most serious complication is directly due to its metal-on-metal design.
The BHR components are primarily cobalt and chromium. When these metal components rub against one another, small cobalt and chromium particles are released into the bloodstream and accumulate in soft tissue.
Subsequently, there may be a toxic reaction to the metal debris called metallosis. Metallosis has been linked to chronic pain, dizziness, fatigue, and may lead to the dislocation of the implant, which requires revision surgery.
There are several known risks associated with metal-on-metal resurfacing hip implants. Patients have reported various problems soon after surgery or up to years after their initial implant. Chronic pain is common, as is the issue of metallosis. Some patients with metal-on-metal implants present with various symptoms and unusual tissue masses or pseudo-tumors.
The problems associated with the Smith & Nephew Birmingham Resurfacing Hip Implant and the R3 systems are similar to injuries caused by other metal-on-metal hip devices.
Metal-on-metal resurfacing hip implants were developed and marketed to be more effective than traditional hip implants, but a high rate of failure and potential need for revision surgery sheds a bleak light on the technology and Smith & Nephew’s hip replacement products.
In 2006, the U.S. Food and Drug Administration (FDA) approved Smith & Nephew’s Birmingham Hip Resurfacing System and R3 system for distribution.
The FDA initially approved the R3 to be used as part of the BHR system, and the two devices share a similar mechanism and rate of failure. Smith & Nephew first recalled the R3 in June, 2012 due to high failure rates, and the company withdrew the BHR system three years later under similar circumstances.
In June, 2015, Smith & Nephew announced the voluntary removal of some sizes of the BHR system from the market because of a greater risk of revision surgery than previously believed.
The company issued a field safety notice which warned consumers of the risks associated with their hip implant products. Patients have reported serious problems that include infection, fracture, dislocation, metallosis, and pseudo-tumors.
Many defective, untested devices are approved by the FDA each year because the agency does not require clinical trials for orthopedic implants if the device is deemed similar to an existing medical device already on the market. This results in many recalled products each year and many preventable injuries for American hip implant patients.
Attorneys and victims of failing medical devices are forcing companies like Smith & Nephew to take responsibility for the products they manufacture and distribute.
Any person who is experiencing a failing hip implant may have a claim against the device manufacturer. Patients who are experiencing pain, loss of mobility, inflammation, or instability should contact their implanting surgeon and an experienced attorney for legal assistance.
Patients with a defective hip implant should follow up with a medical professional, particularly if they experience pain, loss of mobility, inflammation, or instability.
In the wake of this voluntary market removal of the Modular SMF and Modular REDAPT Revision Femoral Hip Systems, many patients who have suffered have already filed lawsuits against Smith & Nephew.
Victims and attorneys are filing Smith Nephew lawsuits and forcing medical device companies to take responsibility for the products they manufacture and put to market.
Smith & Nephew is not the only artificial joint manufacturer to face legal problems. Other companies have designed and built artificial hip systems made of metal components that have turned out to be defective.
Medical experts say the problem comes from the fact that when the joint moves, one metal component rubs against another, causing small metal fragments to break away and enter surrounding tissue or blood.
Not every patient reacts poorly to the metal, but some patients experience painful, adverse local tissue reactions. This may lead to a loosening of the joint, pain, and ultimately the need for revision surgery.
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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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.
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 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.