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Premises Liability

The History of the ASR Recall

By Personal Injury Lawyer on October 29, 2010

DePuy Orthopaedics ASR XL hip device implant is one of the most complicated hip recalls in recent history. The case includes alleged deception, unreleased reports of failure and not one, but two devices. So can you understand the recall? The key is understanding its history.

DePuy Orthopaedics, Inc., the orthopedic branch of Johnson & Johnson, manufactured two hip implant products that were recalled in 2010: the ASR XL Acetabular System, a hip socket and the ASR Hip Resurfacing System, designed for “partial” replacements. (Only the ASR XL Acetabular System was used in the United States.)

In March 2010, DePuy issued an “advisory,” on some of its devises, indicating they were exhibiting early failure. The devices, however, stayed on the market.

In July 2010, a New York Times exposé exposed various reports of early failures with the DePuy device, prompting the implants to be finally recalled. The U.S. Food and Drug Administration also reported they knew about the early failure rates of the DePuy ASR XL hip implants since 2008, two years before the recall. They have received nearly 400 complaints of early failure rates, requiring patients to undergo difficult and dangerous revision surgery.

DePuy acknowledged the hip implant was experiencing decreased sales after its August recall, and later admitted to the higher than average failure rate.

As a North Charleston personal injury lawyer, I sort through the complicated DePuy case to get you the claim you deserve.


Top Hip Implant Recalls

By Personal Injury Lawyer on October 28, 2010

DePuy Orthopaedics has been in the news lately for its ASR XL Acetabular System hip implant that was recalled because of early failure rates and chances of metallosis poisoning, but there have been other recalls in recent years you should also pay attention to.

As a North Charleston personal injury lawyer, I’ve dealt with some of the major hip implant recalls and while they were recalled for different things, there were some similarities.

In January 2008, Stryker Corporation recalled the Trident PSL and Hemispherical Acetabular hip replacement cups. The recall was due to poor sterilization procedures at the company manufacturing facility in Cork, Ireland. Hip recall patients with Styker cups reported pain, trouble walking, squeaking noises, the implant breaking and uneven wear of the hip’s components.

In July 2008, Zimmer Holdings halted sales of the Durom Cup artificial hip due to a high failure rate from the device loosening. The company, however, consistently blamed surgeons for failing to have the required precision to implant the cup.

DePuy Orthopaedics also blamed initial failure reports on physicians who inserted their implants. The FDA has received more than 400 complaints about early failure of the device and the ASR has also been linked to metal poisoning.

As a DePuy hip recall lawyer I’ve seen many patients with the implants who now face difficult revision surgery and pain they shouldn’t have encountered because a recalled prothesis. If you or a loved one has experienced negative results from a DePuy hip prosthesis, contact a South Carolina hip recall lawyer.


FDA Rules on Medical Device Recalls

By Personal Injury Lawyer on October 26, 2010

The U.S. Food and Drug Administration doesn’t just advise recalls on food and medicine, but also medical devices. Any medical device found violating FDA law due to defect, health risk or both, could be recalled by the FDA.

When a medical device is recalled, it could mean any of the following:

  • The device in question requires an alteration, adjustment, or repair
  • An inspection of the device is in order
  • Use of the device should be discontinued
  • The patient with the device will require regular medical monitoring

While the FDA rules on medical device recalls, it can’t make companies issue the recall. It can only oversee the recall to ensure the manufacturer takes adequate steps to protect the public and to achieve legal compliance and precautions to prevent the occurrence of similar problems in the future

As a North Charleston personal injury attorney, I have seen this relationship cause some problems. In July 2010, DePuy Orthopaedics recalled its ASR hip implants because of reports the device had an early failure rate of 12-13 percent, but the FDA knew about the reports two years before the recall. If you or a loved one have been affected by a medical device because the recall was too late, contact a North Charleston personal injury lawyer.


Preventing Dangerous Conditions on Business Properties

I recently read about a case that made me think about some of the basic elements of a civil suit. In this case, a woman sustained horrendous injuries when she was shopping in a retail store and a stack of countertops fell on her. American Association for Justice, “Heavy merchandise falls on store patron” TRIAL magazine, January 2010, p.16. The countertops were stacked on their “side”, so that they extended all the way up the wall, but took up only a few feet of floor space – if you can picture that. The jury found in the woman’s favor, that the store had been negligent in not displaying the countertops in a more stable position that would be less likely to fall over.

This is a good decision, and here’s why: the legal system should encourage stores to avoid creating dangerous or hazardous conditions, especially when there is an easy, no-cost alternative to the dangerous condition while still achieving the same result. In this case, the desired “result” was to display and eventually sell the countertops. Presumably, if store managers around the country are aware of decisions like this, then they will make many small decisions that result in safer stores and less customer injuries in the future. This is how tort cases benefit everyone, not just the person who is injured.

This case illustrates another important point for anyone who is injured on someone else’s property: you probably must prove “fault”. Under the legal concept of “negligence”, you can only sue someone when they have done something or failed to do something that caused your injuries. In the case described in the article, the store displayed the countertops in an unstable position, where it easily could have stored them on their longer side or stored them flat. That was their negligent act.

If you or someone you know is injured on somebody else’s property, ask yourself: Did the property owner do something to create the danger? Even if they did not create the danger, did they know about the danger but fail to take reasonable steps to correct or properly warn of the dangerous condition? If you end up needing medical treatment and have reason to believe that someone could have prevented it, then be prepared to answer those questions.

“The information relayed in this blog is for educational purposes only and is not legal advice. The cases referenced and explained by the blog’s author(s) are for informational purposes only and are not intended to imply that certain, or similar, results may be achieved in each client’s case.”


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