Hip Implant Injury Attorney
In April, 2016, the medical device company Zimmer Biomet released a new field safety notice that warned surgeons of problems with their M2a 38mm metal-on-metal hip implants. The warning noted that ongoing analysis of patient data revealed a “higher than expected revision rate.”
These warnings were issued in Europe, and not the United States, even though there are thousands of patients in the U.S. with medical complications and high revision rates due to the same faulty hip implants.
Last year, Biomet halted all sales of the M2a metal-on-metal hip system in Australia, and issued a “hazard alert” when data from the Australian health authorities noticed higher than expected revision rates.
In 2014, Biomet reached a court settlement to pay at least $56 million in lawsuits relating to the defective metal-on-metal M2a Magnum hip replacements. Hundreds of patients across the nation claimed that the hip device led to injuries.
The court concluded patients who received a failing Biomet M2a 38 or M2a Magnum hip replacement should receive a base award of $200,000. However the court did not cap compensation for cases with extraordinary injuries. For example, individuals who require multiple revision surgeries, or suffered serious complications may have their cases considered individually.
Joe Lyon is a highly-rated Biomet Hip lawyer and Medical Device attorney representing plaintiffs nationwide in a wide variety of civil litigation claims.
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, tracked more than 400,000 patients who underwent primary hip replacement from 2003 to 2011.
The patients who received metal-on-metal implants had a substantially higher overall failure rate. After five years, over 6 percent of metal-on-metal hips had failed, twice the rate of ceramic hips, and three times the rate of metal-on-plastic implants.
The reasons for failure included bone and device fracture, loosening, and excess friction that caused inflammation in surrounding tissues. Implants also dislocated within weeks after hip replacement, which required 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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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 Biomet M2a Magnum metal-on-metal hip joint replacement devices are built with a large metal head, consisting of a CoCrMo (cobalt, chromium, and molybdenum) metal alloy. Because of concerns over the toxicity of all-metal implants, the FDA ordered 21 makers of metal-on-metal hip implants to provide safety studies, including information on metal ion levels.
There may be the potential for a local tissue reaction due to the presence of the foreign material, as well as potential for debris forming over time. It is uncertain how much debris will accumulate over time, or the potential adverse health effects.
Among other studies, the British Medical Journal published results of an investigation of metal implants. Investigators concluded that systemic metal ions can cause cardiovascular problems.
The U.S. Food and Drug Administration (FDA) warns that certain patients, including female patients, are at risk for increased device wear and adverse reactions to metal debris. Depending on patient age and implant head size, the revision rate for all-metal hips is three to four times higher in women.
Surgeons have also been advised to consider additional monitoring for patients treated with metal-on-metal hip replacements with a femoral head diameter equal to or greater than 36mm. These guidelines adhere to all recipients, not just those with symptoms of hip implant failure.
Even the device maker, Zimmer Biomet, admits the hazards of its product and encourages careful follow-up for all patients, particularly those with M2a 38mm Metal-on-Metal Total Hip Systems. Following an injury, contact a Biomet Hip lawyer to investigate.
Patients who receive metal-on-metal hip implants are urged by medical professionals and authorities to be attentive to changes in their general health, including new 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
Because of how lenient the FDA approval process is for new medical devices, each year many defective products injure American consumers. Victims and attorneys are fighting back against medical device companies like Smith and Nephew, Stryker, Depuy, Wright Medical and Zimmer Biomet, forcing the companies to claim responsibility for the products they market and distribute.
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.