Metal-on-metal (MoM) hip implants are a type of hip replacement that uses all-metal components. When these devices were first introduced, manufacturers claimed that they were superior to previous hip replacements. Unfortunately, as many patients have discovered, all-metal hip implants have been shown to have a higher failure rate and can cause complications due to the release of metal ions.
The DePuy ASR hip system, manufactured by Johnson & Johnson’s DePuy unit, is the most well-known of these implants; in 2010, 93,000 ASR hips were recalled around the world when data showed that the implants fail at unacceptably high rates. This hip replacement recall is considered one of the biggest device failures in recent history.
As Johnson & Johnson hip implant complications became more publicized, thousands of patients implanted with the devices sought legal help in obtaining MoM lawsuit settlements and DePuy ASR hip implant settlement amounts. As a result, J&J is now faced with thousands of hip implant lawsuits. To find out more about patient compensation for hip implant failure, contact the experienced defective medical device lawyers at Parker Waichman LLP today.
See below for a comprehensive timeline that includes the history of metal-on-metal (MoM) hip replacements, dates of MoM hip replacement device recalls, and updates on the lawsuits and potential settlements
Metal-on-Metal Hip Implant Timeline
Before 1976: Metal-on-metal hips are marketed in the United States. Concern over metal ion toxicity is documented. At this time, the U.S. Food and Drug Administration (FDA) has no control over medical devices.
1976: The Medical Device Amendments are added to the Food, Drug, and Cosmetic Act. The FDA now has authority over all medical devices, including metal-on-metal hip implants. Since they were marketed prior to this amendment, they are classified as “high-risk” (Class III). However, the implants are regulated through 510(k), the “fast track” approval route.
Late 1980s: Second generation metal-on-metal hip replacements are introduced.
1990: The World Health Organization International Agency for the Research on Cancer lists trivalent chromium ion as a potential carcinogen. Later on, the London Implant Retrieval Centre finds trivalent chromium in patients with metal hip replacements.
1997: In Europe, hip implants are tested and approved using a mere mechanical simulation. Clinical testing is not performed.
1998: The FDA begins to approve larger heads, or femoral components, for metal-on-metal hip replacement. The bigger heads are approved via 510(k), which requires little to no clinical testing.
2004: Metal hip manufacturers modified their design by shortening the taper (also referred to as a trunnion), the end of the stem that connects to the ball, or head. The design change is approved by the FDA via 510(k). Later, studies find that this modification contributed to high rates of failure, metal ion debris and increased wear.
2009: Japanese surgeons contact DePuy Orthopedics (a subsidiary of Johnson & Johnson), expressing concerns over the health risks associated with the Pinnacle Hip System. Apparently, the system’s design flaws “generated metal debris between stem taper and head, and final necrosed tissue” according to an article published in the British Medical Journal on Feb. 28, 2012.
Aug. 2009: Vice President of DePuy Pamela Plouhar writes an email discussing the failures of the ASR implants, which are recalled a year later. The email mentions the fact that the FDA had rejected the device after reviewing company data. The email is not publicly discovered until February 2012.
Aug. 2010: Depuy recalls two products, the ASR XL Acetabular System and ASR Hip Resurfacing System. The recall was based on the devices’ high failure rate. According to the data from the National Joint Registry of England and Wales, the implants failed 12 to 13 percent of patients needed additional surgery, or revision, within the first five years. Typically, artificial hips are expected to last at least 10 to 15 years.
Mar. 2011: At the British Hip Society Annual Conference, The British Orthopedic Association discusses concerns about large diameter metal-on-metal implants. The conference concludes that these implants “should be carefully considered and possibly avoided.”
May 6, 2011: The FDA orders 21 metal-on-metal hip manufacturers to conduct postmarket surveillance studies of the device. The manufacturers are told to analyze metallic debris concentrations and other health concerns.
May 23, 2011: The U.S. Judicial Panel on Multidistrict litigation establishes a multidistrict litigation for the DePuy Pinnacle hip implant. The hip replacement lawsuits filed in federal court will be consolidated and centralized in the U.S. District Court for the Northern District of Texas before Judge James E. Kinkeade.
Feb. 7-11, 2012: A study presented at the American Academy of Orthopaedic Surgeons 2012 Annual Meeting shows that metal ion levels are higher for those who have metal-on-metal hip replacements. Findings also indicate that this problem is worse for those who have a large diameter metal implant.
updated guidelines for metal-on-metal hip replacements
Feb. 28, 2012: The Medicines and Healthcare products Regulatory Agency (MHRA) issues updated guidelines for metal-on-metal hip replacements. Patients with large diameter heads (>36mm) are to undergo annual monitoring for the life of the implant. This also applies to all types of DePuy ASR hip replacements and symptomatic patients with small diameter heads (<36mm). Patient follow-up recommendations include blood metal ion tests, ultrasound, magnetic resonance imaging (MRI) and Metal Artefact Reduction Sequence (MARS).
Feb. 28, 2012: The British Medical Journal publishes an article by Deborah Cohen, investigations editor. The article provides an in-depth look at the potential dangers associated with metal-on-metal hip implants. Cohen discusses failures on behalf of both manufacturers and regulators, stating that patients have unknowingly joined “a large uncontrolled experiment.”
Mar. 1, 2012: The British Hip Society recommends a ban on large diameter metal-on-metal primary total hip replacements. The organization advises healthcare professionals to follow the MHRA guidelines issued on February 28th.
March 13, 2012: The Lancet publishes a study showing that metal-on-metal hip replacements fail more than other types of hip replacement systems. Metal hip replacements an overall revision rate of 6 percent within five years, as opposed to the 1.7 to 2.3 percent seen in plastic or ceramic implants. Findings also suggest that health risks have a direct relationship to head size, and women tend to have a higher failure rate than men. Analyzing data from the National Joint Registry of England and Wales, researchers studied over 400,000 devices and from different manufacturers, including Johnson & Johnson, Zimmer Holdings Inc and Smith & Nephew Plc.
Apr. 2, 2012: The MHRA issues a medical device alert concerning Finsbury Orthopedics MITCH TRH system used in combination with Stryker’s uncemented Accolade head. According to an analysis based on data from the England and Wales National Joint Registry (NJR), the MITCH system fails at a rate of 10.7 percent when used with uncemented Accolade.
Apr. 16, 2012: Following the data on the MITCH TRH system, a recall is issued overseas. In New Zealand, Stryker contacts the surgeons of 41 patients who have the device; three patients required revision surgery.
May 2, 2012: A study published in The Journal of Bone & Joint Surgery reviewed the cases of four women who experienced spontaneous dissociation of offset, face-changing polyethylene liners from the acetabular shell of their DePuy Pinnacle hip implant. The authors concluded that “The combination of a vertically positioned acetabular component and an offset, face-changing liner resulted in impingement and dissociation of the liner from the shell in four patients. Proper acetabular component positioning, rather than the routine use of uniquely designed polyethylene liners, is critical to maximizing implant stability in total hip arthroplasty.”
May 4, 2012: The Journal of Arthoplasty publishes a study showing that metal-on-metal hip implants have higher corrosion rates than metal-on-polyethylene. Researchers found a relationship between adverse local tissue reaction (ALTR) and corrosion of the head taper junction. The authors noted that “The corrosion score increased with implantation time, and at all time intervals, the corrosion score for the MOM group was greater. Because corrosion worsens with time, we are concerned that MOM ALTR failures will increase with longer follow-up.”
Jun. 2012: The Journal of Bone & Joint Surgery publishes a study where 39% of patients with large diameter metal-on-metal hip replacements developed pseudotumors (mean follow-up of 3.6 years). Researchers found a fourfold increased risk of pseudotumors in patients with serum cobalt levels greater than 5 micrograms per liter.
Jun. 1, 2012: Smith & Nephew withdraws the metal cup liner used in its R3 Acetabular System after clinical data showed that the device failed in 1.6 percent of patients, which is higher than the 1 percent guideline set by Britain’s National Institute for Health and Clinical Excellence.
Jun. 13, 2012: A study published in Chemical Communications finds Co2+ in inflamed tissue from patients with failed metal-on-metal implants. Co2+ is known to be genotoxic, meaning that it destroys a cell’s DNA.
Jun. 25, 2012: The MHRA issues update guidelines for all metal-on-metal hip replacements. The agency advises patient follow-up on an annual basis for the life of the implant in symptomatic patients, as opposed to the five-year minimum advised in February.
Jun 25, 2012: The MHRA addresses the increased revision rates on metal hip implants when the recalled metal liner is used with Smith & Nephew’s R3 acetabular system. The agency recommends annual patient follow-up for the lift of the implant, regardless of whether the patient is symptomatic or not.
Jun. 27-28, 2012: The FDA’s Orthopaedic and Rehabilitation Devices Panel meets to discuss the safety issues with metal-on-metal hip implants.
Jul. 2012: Orthopedics journal publishes a study analyzing patients with failed metal-on-metal hip. Overall, 78% had revisions with two years and 92.5% within three years. Aseptic acetabular loosening, which was identified in 56.25% of patients, was the most common cause of revision.
Jul. 5, 2012: Stryker Orthopaedics voluntarily recalls their Rejuvenate Modular and ABG II modular-neck hip stems due to concerns of “corrosion at the modular neck junction which may lead to adverse local tissue reactions.”
Aug. 2012: Johnson & Johnson agrees to settle three DePuy ASR hip replacement lawsuits for about $600,000, or $200,000 settlement amount per case. Attorneys note that this is at the low end of what should be expected in the litigation. According to University of Michigan professor Eric Gordon “J&J should have expected to pay in the $200,000-to-$500,000 range of compensation per case.”
Sept. 2012: Smith & Nephew issues a warning over its Birmingham Hip Modular Heads after data from the National Joint Registry of England and Wales and the Australian Orthopaedic Association’s National Joint Replacement showed that the metal-on-metal implant failed more frequently than the 1% benchmark established by the UK’s National Institute for Health and Clinical Excellence (NICE).
Oct. 2, 2012: The Lancet publishes a study suggesting poor revision rates among patients who underwent hip resurfacing. The authors found an “unacceptably high” rate of revision among women and men of smaller stature, and “recommend that resurfacing is not undertaken in women and that preoperative measurement is used to assess suitability in men.”
Nov. 2012: Zimmer pulls the Durom Acetabular Component from the Australian market due to high revision rates. According to the Australian National Joint Replacement Registry, Durom components were associated with a revision rate of 9.6 % at 7 years in hip resurfacing and 6.8 % at 5 years when used in total hip replacement
Nov. 2012: According to a filing by Johnson & Johnson, the company has spent $800 million on the DePuy ASR hip implant recall. J&J did not estimate product liability costs.
Jan. 2013: There are over 3,000 hip replacement lawsuits pending in the DePuy Pinnacle MDL, centralized in the U.S. District Court for the Northern District of Texas.
Jan. 8, 2013: Juror selection begins for the first DePuy ASR hip implant trial.
Jan. 17, 2013: The FDA issues new guidelines for patients with metal-on-metal hip implants. The agency warned that the metal ions released from the implants can lead to adverse local tissue reaction, causing damage to the bone and soft tissue surrounding the implant. For the first time, the agency advised metal ion testing for patients experiencing symptoms. Yearly physicals, routine radiographs and diagnostic imaging was also recommended.
January 18, 2013: The FDA proposes new regulations that would require metal hip manufacturers to conduct clinical tests for safety and efficacy before obtaining approval for the devices. In their entire time on the market, metal-on-metal hip implants were never tested due to the 510(k) approval route, which was supposed to only be a temporary route for metal hip implants. The FDA proposed that the hips go through the premarket approval application (PMA), a stricter route meant for high-risk devices.
Jan. 23, 2013: The first trial over the DePuy ASR hip implant begins in the Superior Court of the state of California, Los Angeles. The case is Kransky v. DePuy, BC456086, Superior Court of the State of California (Los Angeles).
The DePuy ASR recall has significantly impacted Johnson & Johnson’s reputation, and caused consumers to mistrust claims made by the pharmaceutical giant. The recall’s effects are reflected in the company’s finances. In January 2013, Bloomberg reported that fourth-quarter earnings for 2012 were up from the previous year, when the J&J was negatively affected by hip recalls and legal settlements.