Tens of thousands of patients implanted with defective metal-on-metal hip replacements have experienced months of pain, inconvenience, and rehabilitation therapy. Now data has been released showing that one in eight patients will need to undergo the ordeal all over again because of defects with their ASR Hip Resurfacing System or the ASR XL Acetabular System hip replacement implant device. ASR Hip Resurfacing Systems and ASR XL Acetabular System hip replacements were made by DePuy Orthopaedics, a division of Johnson & Johnson.
When problems first developed with DePuy metal-on-metal hip replacement devices, the company reportedly blamed surgeons for the hip implant device failures in patients, by claiming that the surgeons were implanting the devices improperly. In response to these allegations, some surgeons stated their belief that the hip implants contained design flaws or defects.
Later, evidence came out showing that DePuy likely knew that the problems were related to manufacturing or design deficiencies. Specifically, it came to light that patients and doctors began reporting problems with ASR hips soon after the hip replacements went on the market in Australia and England in 2003. Then, in 2008, DePuy was reportedly warned by a company consultant that the metal-on-metal hip implant might have a design flaw.
In an internal e-mail dated August 2009, Johnson & Johnson executive Pamela Plouhar reported that the FDA had refused to approve the ASR device because the company’s own studies showed it had failed prematurely at a higher rate than other devices, and required repeat surgeries after implantation. Ms. Plouhar notified the executives that the FDA had cited early failure, or “revision,” during clinical trials as the reason for denial.
The email was received by at least three other company executives—including DePuy’s president at the time, David Floyd.
It wasn’t until 2010 that DePuy Orthopaedics confirmed that the metal-on-metal hip replacement implants could be considered defective products. At that time, DePuy issued a warning to patients to be on the lookout for symptoms including, but not limited to:
- Fracture of the bone.
- Hip implant component loosening, dislocation, or hip implant component misalignment.
- Increased metal ion levels in the blood.
- Nerve damage.
- Tissue damage.
- Muscle damage.
By August 2010, it was clear that something else had to be done.
DePuy Hip Replacement Products Taken Off the Market
Three DePuy hip replacement products are no longer on the market. They are:
- The ASR Hip Resurfacing System. This device was never approved by the FDA, but was approved in other countries. The ASR Hip Resurfacing System replaced the ball portion of the hip and had a metal stem that fit into the top of the hip bone, or femur.
- The ASR XL Acetabular System. This device was recalled in 2010. The ASR XL Acetabular System was a concave metal piece used to provide a smooth lining for the acetabulum, the bowl-shaped socket in the pelvis.
- The Pinnacle. This device was not recalled, but was taken off the market in 2013. More than 150,000 Pinnacle hip replacements were reportedly implanted since 2001. When a surgeon implants a DePuy Pinnacle hip, he has the option of using a metal, ceramic, or polyethylene liner inside the outer cup. It is a modular system with an outer shell component. The DePuy Pinnacle metal-on-metal component was designed to last 10 to 15 years or more. Numerous reports in Kentucky and throughout the country are indicating that the hip component might be failing prematurely, some within one or two years.
Patients who suffered complications from these devices were at risk of metallosis, infection, breaks, falls, and other serious dangers.
Lawsuits Have Been Filed
DePuy Hip lawsuits have been filed by patients seeking compensation for their pain, suffering, physical injuries, costs of replacement surgery, and other financial difficulties. The complaints include charges that DePuy concealed that its metal-on-metal hip implants were defective or flawed from patients and physicians.
On September 28, 2010, a class action lawsuit was filed in federal court against DePuy Orthopaedics, Inc., on behalf of all United States citizens who received an implant of the ASR XL Acetabular System. The class action litigation seeks answers and compensation on behalf of plaintiffs, including whether DePuy should have known of the defects in the device prior to its sale and implant in patients, and whether DePuy failed to provide timely and adequate post-market warnings of the health risks associated with the its ASR™ XL Acetabular System.
By October 2010, Johnson & Johnson faced more than ten class actions and individual injury lawsuits in federal courts on behalf of plaintiffs who suffered permanent injuries as a result of the allegedly defective hip replacement implant.
Since then, other cases have been filed. Some have been decided and some are still pending.
In 2013, Johnson & Johnson said it would pay $2.5 billion to settle the thousands of defective hip implant lawsuits currently pending in federal courts. Some news accounts have estimated the company will pay roughly $4 billion dollars to settle the lawsuits, which would equate to roughly $250,000 per average settlement. This would make the settlement one of the largest defective medical device payouts in history. There are currently over 8,000 cases against DePuy concerning defective hip implants. The proposed settlement covers patients who had a DePuy hip implant installed or removed before September 1, 2013 and who have undergone a second hip replacement to remove the flawed device.
Additionally, the company created a separate pool of funds totaling $475 million to compensate the most severely injured patients, such as those who had ASR devices implanted in both hips or whose joints were irrevocably damaged by the device. Attorneys familiar with this area of the law estimate that at least 10 percent of claimants would be eligible for these additional payments.
By January 2014, several victims had come forward to object to the terms of the settlement and the amount of fees recovered by attorneys in the case. Although the deal offers an average of $250,000 to patients who underwent revision surgeries, awards are set to be lowered for patients based on the length of time they had the implant and demographic factors such as age, weight, and smoking habits. Combined with attorney fees, many plaintiffs’ awards may be so drastically reduced as to barely cover past medical expenses.
The settlement option was again open in the spring of 2015 for patients who had revision surgery between August 31, 2013 and January 31, 2015.
If victims reject the settlement, they may continue to seek compensation through individual claims. Patients who have not yet had surgeries to replace their ASR devices will have to seek compensation in court for their medical bills and ongoing health costs.
When Did All of This Happen? The Timeline
Here’s a look at the important dates in the DePuy metal-on-metal hip story:
- 2003: Johnson & Johnson begins selling the DePuy ASR hip replacement in Australia and England, where patients and doctors begin to report problems almost immediately.
- 2005: The FDA approved DePuy’s ASR XL Acetabular System. While the ASR Hip Resurfacing System was never approved by the FDA, doctors were allowed to use it as an off-label use.
- 2005–2010: Thousands of patients receive DePuy’s ASR XL Acetabular System or ASR Hip Resurfacing System.
- 2008–2010: The FDA receives hundreds of complaints about DePuy’s ASR XL Acetabular System and ASR Hip Resurfacing System.
- March 2010: DePuy Orthopaedics issued a Field Safety Notice after receiving new data from the UK that demonstrated the ASR System had a higher-than-expected revision rate at eight to nine percent at three years when used with smaller head sizes (less than 50 mm diameter).
- May 2010: An alert was issued urging patients implanted with ASR Acetabular cups to get follow-up medical care for at least five years…and possibly longer.
- June 2010: The first lawsuit is filed claiming DePuy’s ASR hip replacement device had a design defect, that DePuy knew of the problems, and that DePuy allowed manufacturing and sales to continue.
- August 2010: DePuy’s ASR XL Acetabular System was recalled. The recall came after data from the National Joint Registry of England and Wales was released showing that the revision rates for these products were approximately 12–13 percent over five years.
- September 2010: A class action lawsuit was filed in federal court against DePuy Orthopaedics, Inc., a unit of Johnson & Johnson, on behalf of all United States citizens who received an implant of the hip replacement device, the ASR XL Acetabular System.
- 2011: The Pinnacle Complete Acetabular System received FDA approval.
- 2013: Pinnacle is taken off the market because of concerns similar to those associated with the ASR XL Acetabular System and ASR Hip Resurfacing System.
- 2013: DePuy make a historic settlement offer.
- 2015: A second round of settlement offers is submitted; however, some litigation continues.
Despite the bewildering range of settlement offers and lawsuits, the matter has not yet been resolved for some patients.
Gray and White Lawsuit Against DePuy
Gray & White Law has handled cases for defective DePuy hip systems since 2003. In 2010, Gray & White filed the first of many lawsuits against DePuy in Kentucky federal court.
By 2010, we had already actively litigated against DePuy for defective hip implants, and obtained confidential settlements on behalf of five patients.
Our commitment to Kentucky patients with defective hip replacements continues. If you’ve been hurt, then please start a live chat with us today to learn more about how we may be able to help you.