DePuy ASR | Hip Implant Injury
Medical Device Lawyer investigates defective hip implant systems for injured plaintiffs nationwide
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Depuy ASR Hip Injury
Investigating hip replacement injury cases
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.
DePuy ASR Hip Recall
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.
Depuy ASR Hip Complications
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.
DePuy Hip Recall Lawsuit
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.
Defective Hip Injury
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
• Infection
• Decreased range of motion
• Tissue Damage
• Nerve Damage
• Metallosis
• Revision Surgery
DePuy Pinnacle Lawsuits
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.
Defective Hip Settlements
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:
- Medical costs related to revision surgery
- Medical costs related to a new hip replacement
- Costs associated with lost wages, recovery, rehab, or physical therapy
- Compensation for the loss of a job, or loss of future wages
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Why are these cases important?
Defective medical device litigation helps to improve patient safety and holds medical device companies accountable when defective products injure plaintiffs and clients.
Questions about Defective Medical Device Litigation
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
- Hernia Mesh
- Breast Implants
- Transvaginal Mesh Implants
- Catheters
- Hip Replacements
- Knee Implants
- Shoulder Replacements
- Heater Coolers
- Bone Grafts
- Ventilators
- Defibrillators
- IUD
- IVC Filters
- Da Vinci Robot Surgery System
Medical Device Manufacturers
- Atrium Hernia Mesh
- Bard Hernia Mesh
- Bard IVC Filters
- Covidien Hernia Mesh
- Depuy Hip Implants
- Arthrex knee replacement
- Exactech knee replacement
- CareFusion ventilators
- Essure Birth Control System
- Ethicon hernia mesh
- Infuse Bone Grafts
- LivaNova Heater-Coolers
- Stryker Hip Implants
- Smith & Nephew Hip Systems
- Zimmer Biomet Shoulder Systems
- Wright Medical Hip Implants
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.
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:
- The medical device manufacturer knew, or in the exercise of reasonable care, should have known about a risk
- A reasonable medical device manufacturer would have provided a warning of the risk
- The medical device manufacturer failed to provide the warning
- The patient was injured due to a lack of warning. The same elements apply whether the claim is based on a warning present during the marketing or post-sale warnings.
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”).
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 over 20 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.
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