Exactech Connexion GXL
Hip Replacement Recall Lawyer
Reviewing defective hip implants & alleged Exactech Connexion GXL Hip failure
The Lyon Firm is investigating Exactech hip replacement failures after recent reports that the Exactech Connexion GXL liner may be prone to a high rate of early failure.
Total hip arthroplasty procedures are one of the more popular joint implant surgeries, and while they can drastically improve the quality of life, they can also be very troublesome.
Hip replacement failure includes problems with instability, infection, and component, often leading to early revision surgery. Several implant designs with poor track records have been recalled and some models have unacceptably high failure rates because of acetabular and proximal femoral osteolysis or eccentric liner wear.
A recent study published in the Journal of Arthroplasty describes a “potential correlation between the Exactech Connexion GXL polyethylene liner and massive osteolysis with subsequent revision due to pain or loosening with a relatively short time to failure.”
The manufacturing of the Exactech Connexion GXL polyethylene liner differs with other cross-linked polyethylene liners. The irradiation dose is slightly less than other liners, and the Exactech Connexion GXL liner is the only one that undergoes sterilization via gamma irradiation.
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.
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 device 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 an Exactech Connexion GXL hip implant injury 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.
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.
NO COST UNLESS WE WIN
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.
Due to the consistency and severity of complaints to the FDA regarding hip replacements, the FDA required five producers of hip 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 device recalls include:
Hip implants are an increasingly popular means of improving a quality of life for many aging individuals. However, joint replacements can be defective and cause more harm in patients than good.
The U.S Food and Drug Administration (FDA) urges patients who receive 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
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 Exactech Connexion GXL cases as well as 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.
The Lyon 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 following an Exactech Connexion GXL hip injury.
Experience: Joe Lyon is an experienced Cincinnati Defective Device Lawyer. The Lyon Firm has 19 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.