Over the past few decades, hip replacements have become more and more common as many of the baby-boomers begin to retire. However, despite great advances in surgical techniques, materials, and general medicine some of these hip implant devices have been recalled due to defects in their design. One of the more prominent recalls in recent years is the DePuy ASR XL Acetabular Hip System and the ASR Hip Resurfacing System, which was formally recalled, by Johnson and Johnson on August 26, 2010.
Johnson and Johnson recalled these devices because they were found to have a much higher rate of failure compared to other similar products that are currently on the market.
Unfortunately, the DePuy ASR XL Acetabular Hip System and the ASR Hip Resurfacing System were widely used and have caused severe problems for those who had these devices implanted. If you have a hip replacement with the DePuy ASR XL Acetabular Hip System and the ASR Hip Resurfacing System and the products fail you may be faced with another expensive and painful operation within 5 years. Typically, a hip replacement is supposed to last upwards of 15 years. In 2009, DePuy withdrew the ASR from the marketplace citing poor sales. At that time they stated they were not planning to recall the product. They also denied that it was defective. Johnson and Johnson finally decided to issue a recall only after numerous negative reports were issued and over four hundred complaints had been sent to the FDA.
What are the Different Recall Classes?
In order to get a medical device listed on the market, companies have to go through a process known as the 510(k) program. Under this system, manufacturers are entitled to sell their devices on the market provided that they can show that a “substantially equivalent” device is already on the market. However, the 510(K) process does not require the same rigorous safety studies and trials that other devices must undergo, which can, unfortunately, increase the chance that patients who receive these devices that they may be faulty or less effective.
Consumer’s Union found a total of 578 recalls from six major manufacturers between from Nov. 1, 2002, to Jul. 23 2013. These major manufacturers include:
- Smith & Nephew
- Wright and Zimmer
Out of all of these manufacturers, Stryker came in first place with the amount of recalls for their devices coming in with a total of 231. DePuy holds the distinction of having the second-highest amount of recalls with 150. When the FDA issues a recall or manufacturers do voluntary recalls, they are classified into three classes by order of severity of an injury that devices may cause.
- Class I. These recalls are the most urgent because they are the most harmful. According to the FDA, class, I recalls are “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” More than 10 percent of the recalls in this time period were Class I.
- Class II. The FDA classifies these recalls as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” The majority of hip recalls fall into the class II category.
- Class III. These recalls are the least serious and are unlikely to cause harm. The FDA did not classify any hip recalls in this category.
When a product is recalled it is issued a class number, which determines the urgency based on their potential harm. Unfortunately, the DePuy was high on the list.
Why was the DePuy Artificial Hip Recalled?
Whenever a product is recalled from the market people often wonder why was it recalled. In this case, the DePuy ASR XL Acetabular Hip System and the ASR Hip Resurfacing System were never clinically tested before they were inserted into patients. Despite the seriousness of having a recall, not every company seems to be too concerned with their products being recalled from the market. Johnson and Johnson has a history of placing products into the marketplace that required a recall after harming innocent consumers. Just last year, Rolaids Softchews, Children’s Benadryl Allergy Fast Melts, Junior Strength Motrin Caplets, and Acuvue Lenses were also recalled.
Prior to the recall, studies noted various painful and sometimes permanent side effects associated with the DePuy ASR XL Acetabular Hip System and the ASR Hip Resurfacing System, including:
- Loose ASR cup
- Allergic reaction to metallic debris
- Pseudotumors (soft tissue mass that can form as a result of reactions to excess metallic debris)
- Cobalt or chromium poisoning
A published study by the Joint Registry of England and Wales stated that twelve to thirteen percent of all patients who received the DePuy system would require a costly and painful second hip surgery. It is believed the defective DePuy hip implants have been placed in well over ninety-three thousand patients meaning that over eleven thousand patients will need a second surgery. This means that one in eight patients who used the product may be forced to undergo revision surgery which may require a long and complicated recovery and rehabilitation process. Dr. Stephen Graves the director of the Australian Hip Implant Database claims that data has recognized the shortcomings of the DePuy products for many years. In December 2009, DePuy voluntarily withdrew their products from Australia. They should have done the same in the United States. Our experienced Philadelphia product recall attorneys and medical malpractice lawyers are demanding answers why the manufacturer failed to warn of the dangers and defects of this dangerous and defective product.
When medical professionals in the United States and around the world informed DePuy that the devices were failing, the company refused to stop selling the product or issue a warning. Why did Johnson and Johnson wait such a long time to issue the recall and warn patients about a device that had received an exorbitant amount of criticism and was never clinically tested? Were they sacrificing the interests of consumer safety in order to maximize profits?
A traditional hip replacement will last approximately fifteen years. Patients who have received a hip replacement manufactured by DePuy have complained of pain and swelling in as little as only one year. Orthopedic specialists have stated that the problem with the ASR systems is the replacement cup. The DePuy cup is shallower than ones found in other competing systems. This leads to problems with implementation and alignment. Even the co-creator of the ASR Dr. Thomas P. Schmalzried stated “The window for the component position that is consistent with good, long-term clinical function is smaller for the DePuy ASR implant,” than other cups. This means that the product is much harder to align correctly. Problems with the cup have led to swelling, pain, and even difficulty in performing common movements such as walking. Another problem with the DePuy hip implant system is that excess friction between the ball and the cup creates metallic particles. These metallic particles and shavings are then released into the blood stream. Metallic particles in the human blood stream can lead to deafness, dementia, and even life-threatening complications such as heart failure.
The ASR hip system created by DePuy was originally touted as a medical and scientific breakthrough that would last longer and provide greater natural movement to patients. This could not be further from the truth. DePuy is one of the largest manufacturers of replacement hips in the world with sales close to 5.4 Billion Dollars. We believe that DePuy exploited a loophole in the FDA regulations that allowed this product to reach the consumer without a single clinical test being performed. Dr. Sydney Wolfe, the director of the Public Citizens Health Research Group has stated that DePuy “are basically testing these devices in an uncontrolled way on a large number of people”. DePuy has agreed to pay for medical expenses, monitoring, and revision surgery if necessary. This is a poor attempt to cover up the corporate wrongdoings of a company that profited off dangerous devices that were never tested. If you or anyone in your family has received a hip replacement after 2003 we strongly encourage you to call the surgeon who performed the operation and ask if the DePuy ASR was implanted. Please call a doctor immediately if you experience swelling, pain and difficulty walking. An x-ray can reveal how the implant is performing and a blood test can determine if there are any metallic particles in your system. Do not contact DePuy, Johnson, and Johnson, or sign any documents without first contacting a law firm with the experience needed to handle your case. Please fill out the questionnaire or contact us if you or anyone you know may be affected by this harmful product. It is important to contact an experienced medical equipment failure lawyer as soon as possible if you wish to protect your legal rights and remedies.
What types of Compensation Can I Receive for DePuy Hip Injuries?
If you successfully file and win a DePuy hip implant lawsuit, you may be eligible for compensation for your injuries through either a trial verdict or a settlement. Since the recall was instituted, more than 12,000 people have filed lawsuits against Johnson & Johnson and the DePuy unit in almost every U.S. state and federal courts. Most of these suits have alleged that they were injured by the metal-on-metal components of the hip device.
As mentioned above, some people who have brought a claim for damages have gone to trial, and some of them have settled out of court. However, it is important to note that just because you might be able to go to trial and receive a larger compensation from a jury, this is not always a guarantee. In fact, if you go to trial you may lose your case and not be able to recover any money for any injuries from a hip implant. It is important, however, to remember that a lawsuit victory is never guaranteed. Each lawsuit has different facts and injuries, and each person is different, as well as each jury is comprised of different people who may not decide in your favor.
Before you decide to file a suit you should consider if you would be willing to settle. This is a good conversation to have with an experienced attorney who can look at all of the facts of your case and advise you. Generally, if a patient has suffered debilitating injuries as a result of one of these hip implants that has drastically reduced their quality of life they will be able to recover damages in the form of compensation for past and future medical expenses, pain and suffering, lost wages and other damages.
If you have Suffered from the After-effects of a DePuy Artifical Hip, our Philadelphia Personal Injury Attorneys can Help
The Pennsylvania defective product and DePuy hip implant defect lawyers of Reiff & Bily have successfully represented the rights of injured consumers against some of the world’s largest corporations. Many of the clients that we are speaking to are angry, frustrated, and do not know what to do. Not surprisingly, many of the physicians who installed these devices are also concerned and not sure how to proceed. Our lawyers have gathered a group of leading physicians to review and investigate these cases to determine eligibility at no cost to our client for their ability to prosecute a claim against DePuy for resulting damages. It is important to contact a DePuy hip implant lawyer now as thousands have already begun the process by submitting information necessary for investigative review. Time may be of the essence.
If you or a loved one has sustained an injury and resulting damages as a result of a DePuy ASR hip implant, please contact us online or toll-free at (215) 274-0072.