The U.S. Food and Drug Administration (FDA) has recalled several hip replacement products manufactured by Johnson & Johnson’s DePuy Orthopedics over the last 15 years. The DePuy recalls cover a variety of products, including the Depuy ASR , were recalled due to alleged faulty performance that lead to hundreds of revision surgeries for patients.
Over four million Americans have had a hip implant surgery, typically when diagnosed with serious hip osteoarthritis. Hip replacement systems are an effective way to increase the quality of life in many patients. However, thousands of recipients of defective devices have been injured, and deserve compensation for their pain and suffering.
Medical device companies have a duty to ensure their products are safe to protect consumers. This is not always the case with thousands of revision surgeries performed each year due to faulty hip implants.
Joe Lyon is a highly-rated product liability lawyer representing plaintiffs nationwide in a wide variety of defective medical device and civil litigation claims, including the Depuy hip lawsuit.
In 2010, DePuy recalled a component for the ASR Hip System, intended to provide increased patient mobility and reduced pain. The company recalled the product because of continual patient complaints.
DePuy recalled the ASR Hip Resurfacing System and ASR XL Acetabular System after studies surfaced concluding the Depuy ASR hip implants had high failure rates. Plaintiffs and medical device attorneys have alleged that DePuy delayed the recall, and knew of the product’s limitations long before.
Depuy eventually recalled the hip implants after hundreds of complaints and injury reports. The FDA received many reports of hip implant complications and investigated the matter. As early as 2007, surgeons and medical experts warned DePuy that its hip implant products were failing at a very high rate.
Tens of thousands of patients have been implanted with the Depuy ASR hip replacement system.
The litigation surrounding Depuy hip replacement products, and other metal-on-metal hip implants stems from a medical device design that is allegedly prone to failure. Statistics from the National Joint Registry of England and Wales showed 13 percent of hip implant patients who received Depuy Acetabular implants needed revision surgery within five years, far shorter than the average rate of 15 years for other alternative implants.
In recall statements, DePuy said that it would cover the medical costs related to their hip products, including revision surgeries. However, these claims are complex for each consumer and there may be a necessity to contact a product liability lawyer.
The Lyon Firm is experienced in engaging medical device companies following device injury and failure. Compensation is likely and settlements can help pay for medical costs and other damages.
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.
Metal-on-metal hip replacements, including the Depuy ASR model, have been linked to serious complications. When metal hip components rub against one another after implantation, they may release metal fragments that can lead to metallosis toxicity. The DePuy ASR hip implants have been recalled, and are subject of thousands of lawsuits.
A patient implanted with a DePuy metal-on-metal hip replacement can have up to 100 times the normal levels of chromium and cobalt in their bloodstream. DePuy patients may also experience infection of the tissue, as well as an allergic reaction. Excessive levels of metals in the blood have been linked to heart, kidney, and liver damage.
Metal on metal hip replacement systems have been an area of concern among medical experts and consumer safety attorneys nationwide for many years. Thousands of injuries have been reported, and the products are still on the market for the most part.
The accelerated wear may cause metal debris to shave off and become embedded in the soft tissue within the hip joint. Many defective hip implants have required revision surgery, a good basis for personal injury and product liability lawsuits.
DePuy leads the top six medical device manufacturers of joint implants with over 270 recalls since 2003. Of these recalls, up to 477 different devices or components were recalled.
Four of the recalls were classified as a Class I recall, deemed dangerous enough that that could seriously harm patients. DePuy has recalled components and devices for the following reasons:
• Possible Fracturing—implant components may crack or fracture during normal activities. These require a need for a revision procedure.
• Sizing Issues—screw sizes that came with the implant did not match the size of the other components.
• Mislabeled Components—implanted femur components may have been incorrectly labeled Left or Right.
• Metal Debris—implanted anchors may have had metal debris inside, causing potentially dangerous complications.
• Assembly Difficulties—Device defects made it difficult for surgeons to seat the polyethylene insert, acting like cartilage for the implant.
• Incomplete Seal—incomplete seal may result in loosening of an implant, requiring revision surgery.
Lawsuits have been filed against DePuy in relation to the premature failing of hip implants, and a potential lack of safety oversight by the medical device company. When complications arise, and hip implants fail, revision surgery is common and often very painful.
Revision surgery can be more complicated than the original implanting surgery because of scar tissue build-up, bone or tissue damage, or resulting infection. Revision surgeries raise the risk of further complications for patients. Other patient issues common for recipients of defective hip devices include the following:
• Persistent pain
• Bone Loss or fracture
• Decreased range of motion
• Tissue Damage
• Nerve Damage
• Revision Surgery
In 2019, Johnson & Johnson agreed to pay around $1 billion to resolve the majority of pending metal-on-metal Depuy hip lawsuits. Plaintiffs and victims claimed the company sold a defective product, and may have been aware of the health risks their products presented.
With the agreement, J&J settled hip implant defect cases in which surgeons has to remove or replace Depuy Pinnacle devices due to chronic pain, infection, tissue damage or metallosis.
The total Depuy hip settlement includes an earlier amount of $400 million. However, there are still thousands of other hip implant lawsuits, filed by patients who suffered injuries or required revision surgery.
The FDA recalled metal-on-metal DePuy hip implants in 2010 due to device failures, metallosis, inflammation, infection, pain, and the need for revision surgery. In 2012 DePuy stopped selling Pinnacle hip implants with a defective metal component.
J&J pulled Pinnacle’s metal-on-metal version after the U.S. Food and Drug Administration strengthened regulations covering such devices.
Product liability and personal injury lawsuits have been filed against Johnson & Johnson in relation to failing Depuy Pinnacle hip implants. Plaintiffs have alleged a potential lack of safety oversight and clinical testing by the company.
Johnson & Johnson announced the massive settlement a month after the company agreed to pay $120 million in deceptive marketing claims about Depuy hips implant durability. The company claimed said over 99 percent of the metal-on-metal hips would last three years. European health regulators, in an independent study said the actual rate was about 7 percent.
In a U.S. Securities and Exchange Commission report, before the prior settlements, J&J noted the company still faced a total of 10,500 Depuy Pinnacle lawsuits. The company didn’t specify how much it had already spent litigation costs. Further legal action is likely for injured plaintiffs.
According to court documents, DePuy was aware that its hip implants had safety issues before the official recall. Failure rates in some reported studies were almost 40 percent. But DePuy repeatedly touted the new technology, and sold the products to the public.
Finally, in March 2010, after legal pressure began to mount and investigations questioned the safety of metal-on-metal hip implants, Johnson & Johnson acknowledged that ASR products had an unacceptable failure rate.
If you or a loved one has been implanted with a defective DePuy ASR hip product since 2003, you may be eligible to receive compensation for the following:
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.