Medical device maker Stryker is facing thousands of injury claims and Stryker hip lawsuits concerning their ABG II and Rejuvenate hip implant systems. Complaints involving the devices include implant failure, spontaneous dislocation, severe pain, inflammation, loss of mobility, and metallosis.
Attorneys involved in the ongoing litigation say thousands of similar claims are surfacing, noting that tens of thousands of Stryker hip replacement systems may still be implanted in injured patients.
The company has been a target of many personal injury and product liability Stryker hip lawsuits. Stryker metal-on-metal hip components like the Stryker Rejuvenate and ABG II have all been targeted by lawyers and patients who allege the devices have caused major injuries and revision operations.
Several Stryker implant recalls have been issued by the U.S. Food and Drug Administration (FDA), and as more and more adverse effect reports come to light, more personal injury claims are filed.
Hip replacement systems can be wonderful quality-of-life improvements, but many patients have suffered from faulty medical devices.
With these hip systems, there is a risk that components will corrode, and cause pain and inflammation in the surrounding tissue. The implant may fail prematurely and lead to numerous secondary infections and painful conditions.
Joe Lyon is a highly-rated Medical Device Defect Lawyer representing plaintiffs nationwide in Stryker ABG and Rejuvenate hip lawsuits.
Experts say the head and stem connection on some Stryker implants is poor due to an inferior design and material choices that allow the parts to fret and create metal debris. Lawyers and medical experts close to the lawsuits allege Stryker knew for years that some hip system components were defective and dangerous, ad still chose not to report the health risks.
In 2014, Stryker reached a huge settlement with injured patients, but the medical device company continues to manufacture other failing hip implant systems. Stryker is facing allegations of violating various federal regulations and product liability law, including:
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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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Metal-on-metal hip implants have repeatedly been questioned by safety authorities after they cause a myriad of serious complications. A recent study published in The Lancet shows that some metal-on-metal implants are likely to fail much sooner than available alternatives.
The research indicates that patients who receive metal-on-metal implants have a substantially higher overall failure rate—twice the rate of ceramic hips, and three times the rate of metal-on-plastic implants.
The British Medical Journal published a study that concluded systemic metal ions (metallosis) could cause cardiovascular problems. When hip replacements fail, serious side effects are likely. Complicated revision surgeries and infections are relatively common risks for hip replacement patients.
Since its FDA approval and market release, there have been numerous adverse events reported to the FDA. Pain may develop gradually in patients, along with a decrease in range of motion, resulting in a need for revision surgery—additional surgeries are often more complicated and may result in longer recovery times and increased risks. According to the FDA, the signs of a failing hip implant include:
Signs and symptoms of metal toxicity include:
In July, 2012, Stryker Corporation voluntarily recalled its Rejuvenate and ABG II modular-neck stems. The initial press release from Stryker states the decision was based on “potential risks associated with fretting and corrosion at the modular neck junction.”
Stryker’s decision to recall their implants not only halted global distribution and future operations, but recommended that surgeons consider the removal of Stryker Rejuvenate and ABG II modular-neck stems.
More recently, 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.
Stryker advises patients with these particular hip replacement systems to schedule a follow-up evaluation with the surgeon who performed the procedure to discuss possible issues.
Qualified medical professionals will evaluate how the hip systems are functioning and can recommend possible treatment. They may order diagnostic testing, including diagnostic imaging on your hip, including X-rays, MRIs, or Ultrasound.
It may be necessary to adjust current post-operative plans. Surgeons may recommend revision surgeries, which are procedures performed to remove the old implants and replace them with new, safer components. For many patients, hip revision surgery is the only way to resolve pain or reduce serious health risks.
Hip replacement surgery has become a very common procedure that can improve a person’s quality of life dramatically. Many patients have lived with pain for so many years that they don’t remember what it feels like to have a pain-free and mobile life. Hip implants have changed that, but in some cases, patients are implanted with defective products, and the situation deteriorates.
Tens of thousands of patients receive hip implants and other joint replacements each year in the U.S. Chronic pain is relieved in most cases. In other cases, patients are plagued with more pain, infections, toxic exposures, and failing hip replacement systems.
In 2012, the Food and Drug Administration (FDA) issued a warning and a Stryker ABG recall for the defective hip implant that caused a number of complications and injuries. The Stryker ABG II hip replacement system was considered a problematic metal-on-metal hip implant product and could potentially release metal into patients’ bloodstreams.
As a result, Stryker Orthopaedics recalled the Rejuvenate and ABG II modular-neck stems, both of which were integral components of Stryker’s hip implant systems. The ABG II modular-neck stem was used with metal and ceramic hip implants. Complications reportedly included chronic pain, inflammation, tissue damage, nerve damage and metallosis.
In 2014, Stryker announced a settlement of the lawsuits for patients implanted with the Rejuvenate or ABG II hip replacement systems prior to November 2014. The settlement was valued at over $1 billion, but Stryker’s liability is not capped and payments to victims could exceed $1 billion dollars.
Medical device manufacturers are held responsible for the safety of their products. The company has a duty to properly test products before releasing them to the market. Stryker, however, did not conduct proper clinical testing on the safety of ABG II hip systems before selling the devices to the public. Several lawsuits seek compensation for pain and suffering.
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.