April 2011 Archives

April 26, 2011

Concerns Grow for DePuy Hip Implant Patients Amid Reports of Potential Effects of Cancer-Causing Metals

When it comes to the science of hip replacement surgery, DePuy Orthopaedics, Inc., a subsidiary of Johnson & Johnson, is a U.S. market leader. DePuy began selling the ASR XL System in the United States beginning in 2005, for use in total hip replacement surgeries. On August 26, 2010, DePuy issued a voluntary recall of the system amid claims that it is a defective product causing serious health issues. Johnson & Johnson claims that the voluntary recall demonstrated its unwavering commitment to patient safety. However, recently released information suggests that DePuy and Johnson & Johnson were aware of the safety issues with the ASR XL System long before it yielded to pressure to recall the product. As a result, unsuspecting surgeons continued to implant the ASR XL System in their patients, only to find - in short order - that those same patients suffered complications from the implant and required hip revision surgery. To date, over 1,000 patients have filed lawsuits in connection with the DePuy ASR XL System. And because 37,000 units have already been implanted in the United States alone, that number is only expected to grow.

ASR XL System: Design Flaws and Patient Injuries

The DePuy ASR XL System is a "metal-on-metal" hip replacement system that uses a cup in the hip joint and a metal ball that connects to the femur. DePuy marketed this product specifically to young women and to those who live an active lifestyle, claiming that the product was tough and durable. Studies and research have discovered otherwise.

Design flaws in the ASR XL System have led to various complications. For example, dislocation of the replacement joint may occur when the hip is rotated at an angle 10 degrees less than competing products. Due to the unique design of the cup, a reported 30% of surgeons have had difficulty inserting the cup at the angle recommended by the manufacturer. This "error rate" is far greater than the industry standard. Additionally, the ASR XL System offers the lowest coverage (meaning the area in which the hip joint can rotate) and the lowest clearance (meaning the distance between the surface of the interior of the cup and the ball rotating within the cup) of any similar product currently on the market. Low clearance results in a minimal fluid-film barrier to protect against friction, leading to increased breakdown of the cup, resulting in joint pain, medical complications, and, ultimately, failure of the product.

The list of medical conditions that may arise is sobering. Among the most serious concerns is the product's release of metal particles into the tissue surrounding the implant, caused by friction between the ball and cup. These metal particles can have numerous harmful effects, including an increase in the levels of chromium and cobalt in the patient's blood stream (which can potentially result in various other serious complications and health risks) and necrosis of otherwise healthy tissue in the area surrounding the implant. With enough exposure to the metal ions, pseudo tumors may develop in the adjacent area, potentially leading to cancer. The list does not end here. Patients can suffer pain, immobilization from dislocation of the joint, bone fractures, and infections. It therefore becomes necessary for a patient implanted with a DePuy ASR XL System to undergo explantation (removal) of the existing system and reimplantation with a replacement system, presenting a new risk of infection and an increased risk of future dislocation.

How Has DePuy Responded?

Prior to the August 2010 recall, DePuy did little to address the issues presented by its ASR XL System. Interestingly, the ASR XL System never underwent the rigorous Food and Drug Administration (FDA) review and testing process to which such products are typically subject. Instead, DePuy was able to legally circumvent the standard FDA approval process by demonstrating that the ASR XL System was "substantially similar" to another metal-on-metal total hip replacement system already on the market.

Clearly, there were many indications that DePuy's product was unsafe well before August 2010. In 2007, a study by the Australian Orthopedic Association's National Joint Replacement Registry provided DePuy with preliminary warnings regarding many of the failures previously outlined, and warned that the internationally-sold equivalent to the ASR XL System was twice as likely to fail as other systems on the market. Nevertheless, DePuy continued to sell the ASR XL system.

Between 2007 and 2009, in the United States alone, the FDA received an increasing number of reports regarding the adverse affects of the DePuy ASR XL System, rising from a reported 87 to as many as 426. These numbers likely understated the actual number of issues with the product, as such reports are entirely voluntary. Yet DePuy and the orthopedic team that developed the device continued to assure patients and doctors that the ASR XL System was safe. In 2007, DePuy faced criminal charges in New Jersey for kickback payments to doctors who used DePuy knee or hip replacement systems with their patients. Investigations revealed that doctors on DePuy's orthopedic team, who continued to maintain that the ASR XL System was safe, were receiving generous compensation from DePuy, including $552,000 to one doctor and $3 million to another between 2009 and 2010. DePuy eventually settled these charges to the tune of $84.7 million.

What Now?

Since this information has come to light, doctors have been increasingly recommending that the DePuy ASR XL Hip Replacement Systems be removed from patients who currently have the device implanted. One reason for the recommendation is patients' ongoing complaints of pain and hip dislocation. Another reason is that patient with the existing ASR XL System are showing dangerously high levels of chromium and cobalt in their bloodstreams. Some studies have shown that the longer the body is exposed to these metal ions, the greater the risk of cancer to the patient. However, these levels can be detected only with a specially ordered blood test. Thus, asymptomatic patients and their physicians may not be aware of the harmful effects the product may be causing while the ASR XL System remains implanted.

Patients currently implanted with the DePuy ASR XL System should contact their surgeon to determine whether the implant is a DePuy ASR XL System, and if so, request that the necessary blood tests be ordered to monitor the patient's chromium and cobalt levels. Patients would also be well-advised to discuss revision surgery with his or her surgeon, due to the high risk of product failure and associated complications.

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April 22, 2011

Odds That You'll Encounter Medical Error at a Hospital? One in Three.

According to a new study, one out of every three Americans will suffer injury during a hospital stay. The study, conducted by David Classen from the University of Utah, confirms that healthcare is subject to grossly inaccurate reports of errors and a shocking number of injuries caused by medical treatment.

The study found that older methods used for identifying medical malpractice provided a skewed version of data regarding the prevalence of medical error in hospitals. The study compared three different methods of tracking medical error among a pool of about 800 patients from three top American hospitals. These methods included two older error tracking methods: voluntary reporting in patients' medical records, and voluntary reporting to the Agency for Healthcare Research and Quality's Patient Safety Indicators. The third method is newer. Developed by the Institute for Healthcare Improvement in Cambridge, Massachusetts, the Global Trigger Tool method considers medical errors encompassing a wide variety of issues, ranging from bed sores, to foreign objects left in the body after surgery, to serious and life-threatening complications.

With the use of the Global Trigger Tool, the study identified a striking difference between the number of medical errors actually occurring in hospitals versus those that were ever reported. The two older methods missed over 90% of the injuries caused by medical treatment. Thus, the study found medical errors were ten times more prevalent than reported. This result emphasizes the need for a more accurate and effective reporting system for healthcare professionals to understand and curtail hospital errors that result in preventable injuries to patients.

For more information on this study, please click here to access the Health Affairs article.

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April 20, 2011

When Average Is Not Good Enough

We often hear that the American medical industry is among the best, if not the best, in the world. But for all the cures, medical advances, and lives saved, there still exists a darker side to the medical industry which we hear little about in the media. The understated risk of injury to a patient while in the care of a medical professional is something that is too often swept under the rug or minimized by the medical community. When the rug is lifted though, the reports show that in the United States alone, the number of patient deaths caused by medical error per year range from an estimated 98,000 to 250,000. Other statistics do not paint a much brighter picture. For example, studies suggest that one in seven Medicare patients are injured during medical treatment. Even the average patient will be subject to at least one medication error per day.

So why does the medical industry tolerate such dismal statistics? The answer to this question was recently addressed in an article written by Marshall Allen titled "First Do No Harm." Allen addresses how hospitals and doctors attempt to keep medical error rates within the statistical national average, but do little to achieve a rate below that benchmark. This, Allen believes, creates an even larger problem. While a hospital may appear to have a good safety record, the data really only shows that the hospital has an error rate similar to that established as the national average. Allen argues that the medical industry should strive for an error rate of zero rather than a statistical average, thereby enforcing a zero tolerance policy for medical accidents. Any other goal is untenable for preventable injuries.

Allen also addresses the lack of an accurate reporting system of medical errors within the medical care industry. As the medical industry operates today, it lacks a reliable mechanism to show how safely doctors and hospitals are performing. Often, data concerning reported medical errors is inaccessible to the public. More importantly, the majority of medical mistakes go unreported. Systematically recording errors, Allen argues, would spur improvements in safety in the medical industry, and would drive the accepted standard for error from merely meeting the national average down to zero. The medical industry could police itself through a reporting mechanism, and patients could rely on that system to accurately select the medical professionals with the best reputation for safe practice.

Patients expect to receive safe medical treatment while in the care of medical professionals and do not expect to suffer further injury. No patient should pay escalating costs for injuries that are directly attributable to the hospital or doctor treating him or her. According to Allen, until hospitals strive for zero tolerance, Americans are subject to the possibility of suffering personal injury, or even death, as a result of preventable errors by medical professionals.

For more discussion of these issues, please see Marshall Allen's article, available here.


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April 1, 2011

Child Car Seat Safety Can Avoid Serious Car Accident Injury

The American Academy of Pediatrics and the National Highway Traffic Safety Association recently issued new guidelines regarding child seats in cars. Although the two organizations issued the guidelines separately, both have concluded that a child should ride in a rear-facing child seat until the child reaches two years of age. Studies used to formulate the guidelines showed that a one-year-old child was five times more likely to be injured in a crash in a front facing seat than in a rear-facing seat. The front facing seat enables the child's head to snap forward at impact during a motor vehicle accident, potentially causing serious spinal injury. Young children are more susceptible to this type of injury due to their generally larger head-to-neck size ratio.

The new guidelines also address car seat safety for older children. One such recommendation is that children under the age of thirteen ride only in the back seat. The real trouble, however, could come when parents try to convince their children-even those over the age of twelve, possibly-that they too will be required to ride in a car booster seat. This guideline states that children under the height of 4'9" should ride in a booster seat when using a lap-to-shoulder seatbelt. The underlying rationale is that children at and under that height do not properly fit in lap-to-shoulder belts, often resulting in abdominal and spinal injuries during car accidents. While these remain only guidelines, a battle of resistance between pre-pubescent children and their parents over the use of a booster seat is sure to result.

The guidelines may be found at the National Highway Traffic Safety Association website by clicking here, or the American Academy of Pediatrics website here.

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