Medical Device Injury Lawyer
investigating NuVasive MAGEC injury & complications
Some NuVasive MAGEC devices, which brace the spines of children with scoliosis, have been recalled since 2020. NuVasive reportedly fixed the previous mechanical problems but the FDA has still received complaints about other injury risks associated with NuVasive MAGEC devices. The most recent FDA warning isn’t a mandatory recall, though it suggests the issues with MAGEC devices may result in serious injury.
The Lyon Firm litigates medical device injury cases nationwide on behalf of plaintiffs. Following any safety issues with a NuVasive MAGEC device, call for a free case review.
The NuVasive MAGEC System is a device implanted into a patient to brace the spine during growth. The device is meant to minimize the progression of scoliosis, and treat early-onset scoliosis in children under age 10 when nonoperative treatment has failed.
The NuVasive MAGEC system works by implanting adjustable growth rods into a patient. Magnets and a remote control the rods, which helps straighten the spine as a patient grows. The implants, however, may loosen, fracture, corrode, migrate, or cause serious pain.
As stated in the reason the FDA recall, 0.5% of NuVasive MAGEC devices have experienced a separation of the rod’s actuator end cap components. This separation may lead to the degeneration of its internal components.
In February 2020, NuVasive issued an Urgent Field Safety Notice thereby recalling MAGEC System Model X rods. The safety notice recommended that healthcare providers examine their inventory, quarantine affected products, and cease implantation of Model X rods. For patients who had already undergone NuVasive MAGEC Model X implantation, the company recommended that patients follow appropriate postoperative procedures. Patients should also assess the device via X-ray imaging every six months.
In December 2020, NuVasive issued an updated Field Safety Notice indicating the MAGEC System could experience “locking pin breakage, O-ring seal failure, generation of metal wear debris, and failure of the rod to distract.” Physicians and patients were encouraged to consider the use of the NuVasive MAGEC system in the European Union only.
In April 2021, NuVasive notified healthcare providers of “biocompatibility concerns” of its components. The FDA received complaints of local tissue reactions possibly related to MAGEC endcap separation.
In July 2021, the FDA issued a warning concerning potential NuVasive MAGEC mechanical failures and tissue incompatibility that can occur upon exposure to these components. The warning covered several NuVasive MAGEC system products and MAGEC System Model X devices, including:
Defective medical devices can pose a significant safety hazard to patients. Besides adverse reactions related to component exposure, the long-term efficacy of the NuVasive MAGEC device remains unknown. Any defect could lead to the potential need for additional surgeries.
Technological advancements in medical science have delivered hundreds of new medical devices in recent years. When they are necessary for ailing patients, health care providers and patients rely on the judgment, honesty, and skill of medical device manufactures to offer safe products. However, not all of these medical devices have been tested, and many have proved defective, injuring thousands of patients who trusted the companies who marketed the so-called safe products.
Because many of the medical devices on the market may be inadequately tested and rushed to the consumer to make a profit, victims and attorneys have filed many claims against the responsible companies. When manufactures are negligent and injure patients with defective medical devices, litigation is often necessary to restore the financial and human loss that is endured.
Although the U.S. Food and Drug Administration (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.
Defective medical device litigation provides answers when medical device companies are unwilling to be honest with consumers and their physicians about the risks and dangers of their products.
Many medical device companies have been involved in medical device litigation for defective produce designs and failure to adequately warn claims. The litigation often precedes a voluntary recall. Many critics have argued that the lenient FDA 510K process is partly to blame for the increase in medical device defects and injuries reported.
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.
Companies should voluntarily issue a recall when a medical device has an unacceptable high rate of failure or complication. According to plaintiffs and attorneys, defective medical devices may only be recalled after they are known to cause serious health problems or targeted by lawsuits. Last year, millions of medical device units were recalled by the U.S. Food and Drug Administration (FDA).
There are two types of processes where a manufacturer can gain access to the U.S market to sell medical devices: Premarket Approval Process (PMA); and a 510 (k) process. It is important to understand the difference between these approval processes, as the types of testing done for each process is vastly different.
Many device models are put to market under the more lenient 510K pre-approval process and not properly tested, putting American consumers and recipients at risk of serious injury.
Many defective, untested devices are approved by the U.S. Food and Drug Administration (FDA) each year because in some cases the agency does not require clinical trials 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 and deaths for American patients. There are two ways in which the FDA can approve a medical device for marketing and sale in the United States:
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.
Defective Medical Device litigation involves complex science, and requires both legal and medical experts to effectively build a case on a personal or class action scale. In widespread device failures, there is often coordination amongst counsel around the country to correctly assess and distribute liability.
If you or a loved one suffered an injury due to a defective medical device and have questions about the legal remedies available to improve quality of life and medical care, contact The Lyon Firm. You will speak directly with Mr. Lyon, and he will help you answer these critical questions.
When defective medical devices injure patients, product liability litigation helps to inform physicians of the true risk of the product, improves patient safety through recalls and design changes, and provides compensation to those injured.
The design defect and failure to warn claims often focus on the company’s lack of testing prior to putting the medical device on the market market. Failure to warn claims typically arise from the medical device company failing to adequately warn about the failure or complication rate in the instruction for use that is provided to the physician.
Many doctors are not fully informed of the risks of the products by corporate sales representatives. Therefore, Medical Device Litigation also informs treating physicians about what the companies knew and tested for regarding the risks of the products.
When the implanting surgeons are deposed, they are shown corporate documents and studies containing safety information that was never disclosed to them prior to recommending the product to the patient. Often this data includes critical information related to efficacy and higher complication rates with the device.
Surgeons frequently testify that had they known the adverse safety data, they would not have recommended the device for the patient.
Many medical device cases have had a positive impact on public health and safety, and resulted in product design changes, recalls, and enhanced warnings as a result of litigation. In other words, defective medical device lawsuits make products safer so more families do not suffer the same adverse events.
Medical device lawsuits also provide for a sense of justice to the families with compensation and financial security for future medical care and lost income
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.
Please see THE LYON FIRM CASE RESULTS for more information.
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 on behalf of clients that did not participate in the national settlement.