Product Liability Lawyer investigating medical device injuries linked to Wright Profemur hip implants on behalf of plaintiffs nationwide
The Wright Medical Profemur Hip Implant system was designed to be a better alternative to previous defective hip implants. Unfortunately, research has shown that Wright Profemur hip implants may fail and lead to revision surgery and chronic pain.
Plaintiffs have filed complaints and lawsuits, alleging the Profemur Z hip implant system fractures, corrodes, frets or causes infection. Wright has produced, marketed, and sold the Profemur hip since 2003. Thousands of patients have been implanted with the device.
It is alleged that Wright Medical failed to adequately assess and test the safety of the device before it was marketed to the public as a safe medical device.
Joe Lyon is a highly-rated Cincinnati, Ohio medical device defect attorney. If you or a loved one have been injured due to complications with a Wright Profemur Hip implant, contact The Lyon Firm for a free case evaluation.
The Journal of Bone and Joint Surgery issued a watch in 2016 for modular hip components due to reports of implant wear and corrosion. Industry experts have showed concern for the Profemur Z hip implants, which may be prone to corrosion, fretting and potentially catastrophic fracture outcomes.
A 2016 review published in The Open Orthopaedics Journal discovered a high failure rate among patients who received Wright hip implants. The study indicated that nearly 1 in every 5 patients who received a Conserve hip between 2005 and 2010 needed revision surgery to correct issued with the devices.
The FDA’s Manufacturer and User Facility Device Experience (MAUDE) has received at least two hundred Profemur fracture reports and other patient complaints. Common complications reported include:
Product liability lawsuits have been filed due to hip implant failures for many years. Settlements are likely to be recovered on behalf of patients who have experienced pain, infection, or needed additional surgeries without the first few years of implantation.
Wright Medical has agreed to settle some injury claims in the past and has resolved over a thousand lawsuits over its hip implants. The majority of lawsuits named Wright’s Conserve and Profemur hip as the cause of injury. Wright’s hip implants were manufactured by their OrthoRecon division. Wright Medical no longer makes hip implants.
Attorneys claim design defects and limited testing led to patient injury and implant failure, and Wright Medical may be liable for adverse outcomes. Potential signs of Wright Profemur hip problems have included:
The Wright Profemur hip system was designed to be modular, and thus could be adjusted for leg length. It was also meant to be more flexible, but that characteristic may have made it more prone to failure. Some consumers who received a Wright hip replacement have reported that the femoral neck broke or fractured, leading to serious pain and revision surgeries.
Metal-on-metal hip implants use alloys made from chromium, cobalt, titanium or other metals in the ball and socket portions. Metal-on-metal hip implants have been largely problematic from the start as the friction between the ball and socket may release a small amount of metal, and patients risk metal poisoning. The buildup of metal ions in the tissue can lead to muscle and bone damage.
After reports of higher failure rate than other hip implants, in 2015, MicroPort Orthopedics, a company that purchased Wright Medical’s hip division, recalled 10,825 of the Profemur hip devices.
Patients implanted with the Wright Profemur implant who have experienced complications such as pain, fracture or loosening of the implant, or infection, may be eligible to file a product liability Wright Profemur hip lawsuit.
Consumer safety lawyers and product liability experts claim that Wright Medical attained FDA approval of the Profemur implant before it properly tested the device. The company pushed their new technology through the FDA’s 510(k) premarket approval procedure, which required no clinical studies because it was “significantly similar” to other implants already on the market.
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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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Recipients of hip implant replacement systems like the Wright Profemur, Wright Dynasty and Wright Lineage models hope to reform their physical health and improve their quality of life.
However, when Wright hip implants allegedly cause injuries like metallosis, infection, tissue and nerve damage and requires painful revision surgery, plaintiffs can contact an experienced medical device lawyer and file product liability lawsuits.
The Lyon Firm takes medical device injury claims seriously and has had success engaging large medical device companies in implant defect claims to recover settlements and compensation to help pay for medical costs, pain and suffering, lost wages, future medical expenses and other damages.
We work with industry experts to hold negligent device companies accountable for defective hip products and to ensure that the consumer is protected in the future.
The Wright Medical Conserve Hip Resurfacing System is a metal-on-metal (cobalt-chromium alloy) hip replacement device, that has concerned safety experts for years. Metal on Metal hip implants can present health issues that other hip systems do not, including the risk of metal poisoning, or metallosis in patients.
The Wright Medical Lineage hip and Wright Dynasty hip replacement devices are also available in metal on metal versions, though not exclusively and they can present their own safety issues.
Implanting surgeons and patients have reported the need for revision surgery after infection, device loosening, fracture, implant ineffectiveness, tissue and nerve damage, and chronic pain. Revision surgeries carry an added risk to patients, and can cause additional long-term pain.
The Lyon Firm feels strongly that taking legal action against medical device companies that market and distribute unsafe and defective products improves the lives of consumers and discourages bad corporate practices. Wright Medical has faced numerous lawsuits regarding a hip implant that has allegedly caused injury and required revision surgery.
In 2015, a recall was issued for the Profemur modular neck devices manufactured from June 15, 2009 to July 22, 2015. Because MicroPort Orthopedics, Inc. did not acquire Wright Medical Group’s OrthoRecon business until 2013, some of these recalled devices were manufactured by Wright, and they faced legal consequences.
The Profemur complications included fracture, fretting, implant loosening, metallosis and pain, all reported to the FDA’s adverse event database by doctors and patients.
In 2013, Wright medical sold its hip and knee manufacturing division for $290 million, which coincided with reported health problems linked to metal-on-metal hip implants like the Conserve, Dynasty and Profemur hips. Plaintiffs have alleged that Wright hip implant defects occur more frequently than other hip implant systems, and cite certain studies and injury reports.
A 2016 study found high, sooner-than-expected failure rates among 108 Wright Conserve metal-on-metal hips. The hips were implanted in 98 patients – some patients having both hips replaced. Usually, only 1 in 10 hip implants will fail within 15 years of being implanted. But the Conserve hips in the study failed in larger numbers and sooner.
While soreness is to be expected for a few weeks after implantation of the Lineage, Dynasty, Profemur or Conserve, chronic discomfort can be a result of Wright hip implant defects.
Defective medical device litigation helps to improve patient safety and holds medical device companies accountable when defective products injure plaintiffs and clients.
When a medical device has the potential to fail and cause injury, companies should voluntarily issue a recall. 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.
A product is defective if it is unreasonably dangerous for its intended use. A legal cause of action can be based on several types of product defects. The following are Cincinnati product liability and strict liability claims available in Ohio and in most jurisdictions nationwide:
(1) Manufacturing/ Construction Defect:
These issues arise where the product is released from the factory in a manner that deviates from the intended design or specifications. The defect can be a result of using the wrong materials, including the wrong or completely foreign materials (e.g., Tylenol contamination, food poisoning, damaged car part from factory installation).
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.
(2) Defective design and/or formulation:
Defective design product liability 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.
Federal regulations set minimum standards for the design of many consumer products, and preemption defenses may preclude liability in some situations if the manufacturer follows and obtains federal approval for a product. Automotive recalls and product liability cases are usually a result of a defective design. Common cases include the Toyota Brake Recall, Chrysler Gen III seat belt buckle, lap belt only cases, Metal on Metal hip implants, transvaginal mesh.)
(3) Failure to warn or inadequate warning or instruction associated with the product:
All consumer products come with necessary and appropriate warnings and instructions for use. If the lack of a warning makes the product and use of the product unsafe, the manufacturer is liable for the failure to place the warning. The most common area of litigation for failure to warn is in pharmaceutical litigation.
Pharmaceutical manufacturers are required to warn of the known or foreseeable side effects and update the warnings in a timely manner. Litigation arises where there is evidence the 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.
The product fails to conform to a representation or warranty. Warranty claims are more common in commercial and economic loss cases than in personal injury cases. In many States, The Product Liability Act does not apply to cases with only economic loss, because the Commercial Code provides recourse for breach of warranty.
The warranty may be written or implied based upon the products intended purpose and merchantability. An example of a breach of warranty cases are cases involving automotive defects.
Risks: The following factors are considered under Ohio law when determining the risks associated with the design of a product: (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.
Benefits: The following factors are considered under Ohio law when determining the benefits associated with product design: (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)
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 is based on a defect that occurred during the manufacturing process. Many auto companies have been involved in this kind of product liability lawsuits in recent years, due to defective airbags, software defects, tire failure, and other dangerous manufacturing errors.
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.
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.
Manufacturing Defect Examples:
In determining whether a product 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”).
Many pharmaceutical companies have been targeted in failure to warn lawsuits for either failing to place warnings on medication guides and packaging or failing to properly test their product before putting it to market.
Design and manufacturing defects result in thousands of product recalls each year in the United States, initiated by federal safety agencies. Following injury and illness, regardless of recall status, victims and plaintiffs may pursue legal action and contact a product liability lawyer to begin the litigation process. Rightful compensation can be sought and help plaintiffs recover medical costs and other related damages.
Product liability law overlaps with regulatory law, which are the systems of legislative rules and administrative agencies, and part of federal and state governments. These agencies regulate the safety of the products sold to the public. Examples include:
The listed government agencies, however, 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.
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 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.
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.