For thousands of Americans suffering from knee and hip arthritis, joint replacement helps restore mobility, relieve pain and improve quality of life. The past decade has seen a substantial increase in orthopedic implants, but also substantial failure rates and even some product recalls, particularly involving metal-on-metal hip and knee replacements. In response to severe complications reported by certain recipients, litigation has been filed against medical device manufacturers like DePuy, Zimmer and Wright Medical. Plaintiffs contend that various models of commonly used knee and hip replacement prosthetics are defective, giving rise to premature failure and serious injuries.
Knee & hip replacement failure sparks lawsuits
Showard Law Firm has a long track record of winning defective medical device claims. Our hip & knee replacement injury lawyers are experienced litigators in federal mass torts. Learn more about pursuing a hip replacement lawsuit following implant failure, revision surgery or medical complications.
Reach out to Showard Law Firm to discuss your eligibility for filing a hip or knee replacement lawsuit. Thousands of complaints are still pending against defendants including:
- DePuy Synthes – a subsidiary of Johnson & Johnson
- Stryker Orthopedics
- Zimmer
- Smith & Nephew
- Biomet
- Wright Medical
Plaintiffs are seeking monetary damages for their medical expenses, home health care costs, loss of wages, rehabilitation therapy, pain and emotional suffering and, in some cases, permanent disability.
Metallosis & metal poisoning
Nearly 800,000 Americans have had damaged or diseased joints replaced with metal-on-metal (MoM) hip implants, with the impression that these artificial devices would alleviate chronic pain and allow them to perform physical activity comfortably. Once touted as technologically advanced, all-metal hips have their own set of unique risks, according to the FDA. When a recipient walks or runs, the metal components slide against one another, releasing microscopic particles that irritate surrounding tissue. Metal can also be released from other parts of the implant where two implant components connect. Some of these particles can enter the bloodstream, causing metal poisoning known as metallosis.
MoM hip replacements are manufactured with various types of metal, including titanium, cobalt, chromium, nickel and molybdenum. When toxic levels of these metals accumulate in the body, metallosis can cause irreparable damage to bones and soft tissue.
Recipients of all-metal hip replacements are encouraged to be mindful of metallosis symptoms and complications, such as:
- Implant loosening
- Pain around the implant site
- Decreased mobility
- Swelling
- Unusual sounds such as clicking and popping during movement
- Thyroid dysfunction leading to fatigue and weight gain
- Kidney problems
- Infection
- Skin rashes
- Numbness and nerve problems
- Cardiomyopathy
- Vertigo
- Visual disturbances
- Loss of hearing
- Cognitive impairment
The FDA recommends that patients implanted with metal hip systems have routine screenings for signs of adverse local tissue reaction to reduce likelihood of muscle, tissue and bone damage requiring revision surgery.
The following metal hip devices have been at the center of litigation:
- DePuy ASR XL
- DePuy Pinnacle Ultamet
- Stryker Rejuvenate and ABG II
- Wright Conserve hip implant
Our attorneys are committed to holding manufacturers responsible when their products endanger the health and safety of consumers. If you are experiencing complications from a hip implant with metal components, Showard Law Firm is here to help.
Revision surgery
Knee and hip replacements are designed to last upwards of 15 years. However, research published in the Bone & Joint Journal has stated that all-metal hip replacements are associated with abnormally high revision rates due to premature failure. While blood tests, MRIs and X-rays can determine whether revision surgery is required to replace a defective or failing implant, most patients develop a number of tell-tale complications that worsen with time. Excruciating pain, implant dislocation, implant fracture and tissue inflammation from elevated metal levels are common complaints among patients whose joint replacements have failed.
When a prosthetic knee or hip fails because of defective design, wear and tear or extreme complications, revision surgery must be performed. This secondary operation is more invasive and carries a much higher risk of infection, blood clots, poor healing, and nerve damage. Revision hip and knee surgery entails a much lengthier recovery period. Revision surgery rates for knee and hip replacements have skyrocketed in recent years, leaving patients worse for wear and seeking justice through the courts.
Alleged critical defects in the manufacturing and design of prosthetic joints have been blamed for the uptick in revision surgery rates across the country. Many men and women who got artificial implants to relieve stiffness and improve mobility are suing manufacturers like DePuy and Zimmer under theories of strict liability and failure to warn.
FDA recalls, warnings and regulations
Legal complaints consistently allege that several prosthetic implants for knees and hips on the U.S. market were cleared by the FDA without the benefit of clinical trials. The FDA greenlights hundreds of medical devices every year through a fast-track process known as the Premarket Notification 510(k). The 510(k) pathway allows medical device manufacturers to bypass testing phases if the device is deemed substantially similar to another product already in commercial distribution. Unlike the FDA’s Premarket Approval, which mandates rigorous testing for safety and efficacy, the 510(k) holds Class II devices, such as hip and knee replacements, to much lower standards.
Here at Showard Law Firm, we believe the 510(k) pathway for medical devices has been to the detriment of thousands of patients, who received substandard implants that were dangerous and defective.
Medical device manufacturers are obligated to warn the healthcare community and consumers about potential risks. When it is later discovered that a prosthetic device is flawed, posing risk of injury, premature failure or other complications, companies issue a voluntary recall or pull the product off the market under FDA orders.
In the last 10 years, nearly 80 knee replacement systems or components have been voluntarily recalled or temporarily withdrawn from the market due to safety concerns.
Notable knee implant recalls cited in lawsuits
- Zimmer NexGen Complete Knee Solution LPS Femoral Component
- Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component
- Zimmer Persona Trabecular Metal Tibial Plate Knee implants
- Zimmer Biomet polyethylene joint components
- Smith & Nephew Oxinium Genesis II and Oxinium Profix II knee implants
- DePuy SIGMA HP PFJ Cemented Trochlear Implants
Lawsuits concerning recalled hip replacements have cost manufacturers billions of dollars. Settlements have resolved most of the metal-on-metal hip litigation, while other cases are still pending.
Hip implant recalls involved in litigation
- DePuy ASR XL Acetabular System and ASR Hip Resurfacing System
- Stryker Trident Acetabular PSL and Hemispherical Acetabular Cup
- Stryker Rejuvenate and ABG II Hip
- Stryker LFIT V40 femoral heads
- Zimmer Durom Acetabular Component
- Wright Profemur Z Hip Stem and Conserve Plus
FDA requires PMA process for MoM implants
Since 2011, the FDA has been investigating post-market performance of MoM hip implants and reasons for premature failure. In 2016, the agency issued a proposal that would require manufacturers to submit a premarket approval application for two kinds of all-metal hip replacement devices: the hip joint metal/metal semi-constrained with a cemented acetabular component and the hip joint metal/metal semi-constrained with an uncemented acetabular component. The PMA regulation pathway is much more stringent and intended to decrease the chances of a faulty product reaching the marketplace.
Depuy hip implant lawsuits
Litigation involving DePuy hip replacements has amassed nearly 20,000 lawsuits, all relating to the company’s ASR and Pinnacle devices. DePuy, owned by Johnson & Johnson, recalled the ASR XL Acetabular System and ASR Hip Resurfacing System in 2010. The Pinnacle hip replacement, which is alleged to have high failure rates, remains on the market.
ASR hip replacement litigation status
- 2010 – DePuy ASR lawsuits consolidated as multidistrict litigation (MDL) in Ohio
- 2013 — DePuy resolves 8,000 complaints with $4 billion settlement
- 2015 – DePuy pays another $420 million to settle an additional 1,800 ASR case
Pinnacle Lawsuit Status
- 2011 – Pinnacle hip lawsuits centralized in Texas federal court (9,605 cases pending)
- 2016 – 5 plaintiffs awarded $151 million in Pinnacle hip lawsuit
- 2016 – $1 billion verdict awarded to six plaintiffs (state laws capped this at $543 million)
- 2017 –J&J ordered to pay 5 plaintiffs $247 million judgement
Plaintiffs in DePuy hip replacement lawsuits contend that defendants were aware of defects, were negligent in the design and manufacture of the devices, but placed profits over safety. Litigation is still pending in federal court and it is not too late to explore your legal options with Showard Law Firm.
Stryker hip replacement lawsuit
Stryker Corporation has been sued by some 4,600 people based on allegations of serious defects in its Rejuvenate and ABG II hip replacement systems. Many of the plaintiffs were forced to undergo painful revision surgery after their artificial hip failed. Stryker hip lawsuits argue that flaws in the implants’ designs caused an increased risk of infection, loosening and metallosis. Stryker ultimately settled Rejuvenate and ABG II claims to the tune of $2 billion, with monies to be paid out to plaintiffs by the end of 2017. There are currently more than 1,200 Rejuvenate and ABG II cases still pending in Minnesota federal court.
Products named in Stryker hip litigation:
- Rejuvenate/ ABG II Modular Neck Hip Stems – withdrawn from global market in June 2012 after it was found that metal components were prone to fretting and corrosion
- Accolade TMZF – recalled in 2009 due to increased likelihood of blood metal poisoning
- LFIT Anatomic V40 femoral head – recalled in 2016 due to higher than average reports of taper lock failure
Stryker LFIT V40 hip implant complaints are still in the early stages of litigation, with some lawsuits being managed in MDL proceedings in Massachusetts (In RE: Stryker Orthopaedics LFIT V40 Femoral Head Product Liability Litigation, MDL NO. 2768), and others consolidated in NJ state court (Case No. 624).
If you are experiencing problems with your LFIT V40 femoral head, you may be entitled to compensation for your pain, suffering, medical bills and lost wages.
Zimmer knee & hip implant lawsuits
Zimmer recalled thousands of NexGen knee replacement components in 2010 and 2014, citing risk of premature loosening, bone loss, infection and other issues requiring early revision surgery. Close to 1,800 NexGen implant recipients sued the manufacturer and cases were consolidated under MDL 2272 in the U.S. District Court for the Northern District of Illinois. In early 2018, Zimmer Biomet agreed to settle the NexGen knee replacement lawsuits, with no admission of liability. The details of the NexGen knee settlement are confidential, and according to the court records will resolve close to 300 lawsuits.
Durom Cup hip replacement litigation
Zimmer also faces litigation concerning its Durom Acetabular Cup hip replacement, which was temporarily pulled off the market in 2008 over concerns of premature failure. Thousands filed complaints against the device manufacturer, claiming the Durom Cup was not properly tested and had a defective fixation surface that led to implant loosening.
- 2010 – Durom Cup MDL established in New Jersey federal court
- 2015 — Zimmer loses Durom Cup lawsuit and ordered to pay $9.2 million (later lowered to $828,000 on appeal)
- 2016 — Zimmer settlement program is proposed to resolve all Durom Cup lawsuits
Claimants may be eligible for the Base Award Program that provides $175,000, subject to increase or decrease depending on certain criteria. Other plaintiffs may be eligible for the Fixed Award settlement that is capped at $25,000.
Biomet hip replacement
Biomet manufactures reconstructive joints for orthopedic surgery, including its M2a Magnum line of metal hip replacement systems. The company, acquired by Zimmer in 2014, has been embroiled in product liability litigation over its M2a 38 and M2a Magnum hip replacements, which are both linked to complications common to MoM implants. Patients implanted with the metal-on-metal systems claim that they developed metallosis, pseudotumors, tissue necrosis and other serious complications associated with metal contamination.
In a 2012 study that examined 108 patients implanted with the Biomet M2a Magnum hip replacement, 39 percent developed pseudotumors within 4 years of their surgery. In 2012, MDL #2391 was established in Indiana federal court to streamline the growing number of Biomet M2a Magnum cases in which plaintiffs alleged chronic pain and early failure requiring revision surgery.
In 2015, Biomet set aside $56 million to settle 1,000 lawsuits involved in multidistrict litigation. The terms of the accord would entitle each plaintiff to a base award of $200,000. If you experienced complications or had revision surgery to replace a failed Biomet hip replacement, speak to one of our lawyers to discuss your eligibility for legal compensation.
Wright Medical
Thousands have sued Wright Medical over complications and premature failures of its Conserve and Profemur hip replacement systems. Claimants argued that the implants released toxic metal particles, causing inflammation, tissue death, extreme pain, and implant loosening. By 2012 multidistrict litigation and Judicial Council Coordination Proceedings were created to boost legal efficiencies for similar Wright hip implant lawsuits.
Wright Medical hip replacement verdicts and settlements
- 2013—Wright settles first Profemur case for undisclosed amount
- 2015 – Plaintiff wins $4.5 million judgement in Profemur lawsuit tried in California
- 2015 — Wright loses Conserve hip implant case, ordered to pay $11 million (later dropped to $2.1M)
- 2016 — $240 million settlement resolves 1,292 Wright Medical hip cases in the MDL and state proceedings
- 2017 – Wright offers $90 million to resolve remaining 600 claims concerning its metal-on-metal hip systems
Showard Law Firm: hip & knee replacement injury attorneys
If you suffered harm because of a substandard knee or hip replacement, take immediate steps to protect your legal rights by contacting Showard Law Firm. When manufacturers negligently misrepresent the safety of their products, they need to be held accountable. We represent clients nationwide and are 100 percent committed to your success. Call today to learn more about filing a hip or knee replacement lawsuit and to schedule a free case review.
Additional resources on hip & knee implant lawsuits:
- Consumer Reports, What the J&J Hip-Replacement Lawsuit Means for You https://www.consumerreports.org/hip-replacement/j-and-j-hip-replacement-lawsuit/
- FDA, Concerns about Metal-on-Metal Hip Implants https://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/metalonmetalhipimplants/ucm241604.htm
- National Institute of Health, Joint Replacement Surgery https://www.niams.nih.gov/health-topics/joint-replacement-surgery#tab-overview
- Prevention, Joint Replacements Gone Wrong https://www.prevention.com/health/a20488085/joint-replacements-gone-wrong/
- DePuy Synthes, DePuy ASR™ Hip Recall Guide https://www.depuysynthes.com/asrrecall/
- LexisLegalNews, Settlement Agreement Reached In Zimmer NexGen Knee MDL, Lead Counsel Tell Judge https://www.lexislegalnews.com/articles/24180/settlement-agreement-reached-in-zimmer-nexgen-knee-mdl-lead-counsel-tell-judge
- Reuter, Biomet reaches $56 million settlement over faulty hip replacements https://www.reuters.com/article/us-biomet-settlement/biomet-reaches-56-million-settlement-over-faulty-hip-replacements-idUSBREA1305Y20140204
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