Boston Personal Injury Lawyers Blog

Nine months after DePuy Orthopaedics, Inc., a subsidiary of Johnson & Johnson, issued a voluntary recall of its defective product, ASR XL Acetabular Hip Resurfacing System, it is evident that DePuy's reaction to the product's defects may have been a classic example of: "too little, too late."

While much of the controversy surrounding the DePuy ASR XL System, a product designed for patients undergoing total hip replacement, has centered on the adverse health effects of metallic debris that the product deposits in a patient's body, an equally concerning issue exists: the likelihood that the implanted device will fail.

A recent study by the British Orthopaedic Association revealed that patients who have been implanted with a DePuy ASR System will experience a revision rate of between 21% after just four years, to 49% after just six years. This means that after only six years post implantation, as many as half of all implanted patients will need a second surgery to remove and replace the failed DePuy ASR System.

This new study conflicts with the information that originally accompanied the DePuy recall, where DePuy claimed that only about 12% of patients who had received the device would require revision surgery.

This is just one of many questionable representations made by DePuy. For example, DePuy had represented that the DePuy ASR XL System was a safe medical device, substantially similar to devices already approved for use in the United States market, thereby allowing DePuy to speed the product through the FDA regulation process, bypassing the rigorous safety testing generally required of new medical devices. In marketing the device to orthopedic surgeons, DePuy represented that the DePuy ASR XL System was simple to implant, reduced the risk of dislocation, and was ideal for patients will smaller body frames and those who lead a more active lifestyle. When DePuy finally recalled the product, it claimed to have done so promptly after receiving "new" data relating to the DePuy ASR XL System revision rate. However, all of these representations were made with knowledge of substantial evidence to the contrary. In fact, DePuy had been aware of warnings contained in studies and medical literature relating to "metal-on-metal" devices such as the ASR XL System years before the August 2010 recall. Nevertheless, DePuy continued to sell the DePuy ASR XL System for implantation in patients requiring total hip replacement.

Based on the new data, DePuy's sale of an unsafe product will have resulted in up to an estimated 46,500 revision surgeries, representing half of the 93,000 DePuy ASR Systems sold worldwide. To date, approximately 700 lawsuits have been filed in the United States federal courts against DePuy and Johnson & Johnson by patients who have received and been injured by the defective device. Additional lawsuits have been filed in New Jersey and California state courts.

As of January 2011, Johnson & Johnson had arranged a $922 million set-aside for litigation costs and potential settlements associated with the recalled DePuy ASR XL System. However, given the serious injuries caused by the device and the growing number of lawsuits, it is anticipated that the company may end up paying much more to compensate victims.

Continue reading "New Study Confirms DePuy Hip Implant Product Recall Came Too Late" »

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.

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

The Food and Drug Administration (FDA) was granted regulatory power over tobacco companies in 2009. The FDA, sometimes considered incredible, has made tobacco companies and manufactures accountable by law for their products, with the intention of protecting the public and to prevent personal injury cases.

If, for example, a tobacco company wants to change its product, it must disclose intended changes to the FDA.

It's possible that the tobacco industry will be made to reveal all the ingredients in brand-manufactured cigarettes.

Previously, tobacco companies were sued when their negligence for public health was publicized. Often times cases were kept quiet. Now, like other public and private institutions, tobacco companies will have to maintain transparency.

Continue reading "Tobacco Companies' Intentions Made Public" »

Every year, World Against Toys Causing Harm, Inc. (W.A.T.C.H.) comes out with its list of the "10 Worst Toys" for that year. Below is the 2010 list:

The list usually involves seemingly benign toys that the group has determined - or through incidents has confirmed - that there is a propensity for the toys to injure children. Let me first state that I think any group whose mission is to minimize or eliminate injuries to children using harmful toys is worthwhile and bringing the group's concerns to consumers is important given the seemingly benign nature of these toys.

The question then becomes what next? Do we boycott these toys, do we demand a product recall of the toys from store shelves, or do we as parents make an independent decision regarding whether to purchase these toys for our children or not? I believe too often, parents rely on others - be it the school, toy manufacturers, or the government - to weigh in on issues involving our children. When did that happen and because of that, do we as parents feel somewhat protected by our decisions because we are following the advice of others? I hope not. What is appropriate for one 8-year-old girl may not be appropriate for another 8-year-old girl. Who is in the best position to make those determinations? The school? Toy manufacturers? Government? Or are the parents in the best position to make those decisions and then be responsible for the consequences of their decisions. Are we better or worse off having agencies caring about the safety of our children? I believe the answer is "better off," so long as parents do not use these agencies as a substitute for prudent decision making for their children.

If an injury occurs to a child using a toy, and those parents decide to take action against the toy manufacturer, that toy manufacturer will seriously consider whether it makes sense to bring the parents into the case as defendants. Toy manufacturers will argue, among other defenses, that the parents were not supervising their child, they purchased a toy that was inappropriate for their child, or they did not follow the directions included with the toy. Massachusetts law regarding product liability can make these arguments fail, but you can imagine the toll it can take on parents to have blame placed on them as the cause of their child's injury.

While being an informed parent as to the dangers your children may be exposed to is important, it is equally important not to take a backseat to these agencies' decisions or recommendations regarding your own children.

Continue reading "Have we delegated our parental responsibilies to others?" »

According to a Boston Globe The Boston Globe: One dead in I-495 crash">article, John H. Kempster Jr., a 62-year-old man from Taunton was killed when his 2004 Honda SUV flipped over on I-495 in Mansfield. Kempster was ejected from the vehicle after it rolled over a number of times. Police arrived at 10 p.m., and Kempster was transported to the hospital where he was pronounced dead. The car accident is still being investigated.

It is not uncommon for SUV rollovers to occur as a result of some defect in design or manufacture. When that is the case, the manufacturer or another person could be liable for your injuries. Approximately 37 percent of fatal SUV accidents involve rollovers. SUVs are four times more likely to roll over than passenger cars, according to the National Highway Traffic Safety Administration.

The Boston Globe: One dead in I-495 crash

Continue reading "Taunton Man Dies in SUV Rollover on I-495 " »

As Halloween draws near, government safety officials are advising parents to make sure their children's costumes are flame resistant and without large sleeves, capes or skirts that could easily catch fire from candles, Jack-O-Lanterns and other ornaments, resulting in a serious burn or injury.

Indeed, most of us forget about the dangers of flammable clothing. Devastating injuries caused from flammable children's clothing in the 1940s prompted the 1953 enactment of the Flammable Fabrics Act (FFA). The Consumer Product Safety Commission is now responsible for administering the law, and it still struggles to minimize the risks of flammable clothes, sometimes leading to product recalls.

The Boston Globe: Safety officials advising flame-resistant costumes

Continue reading "Parents Advised of Importance of Flame-Resistant Children's Costumes" »

It was recently announced that Toyota Motor Corp. and the family of a California police officer settled a lawsuit arising from a car accident in which the officer and his wife, daughter and brother-in-law were killed.

The tragic accident drew international attention to the issue of unintended acceleration. On August 28, 2009, while the family was driving along Route 125 in East County, California, their 2009 Lexus ES350 accelerated out of control, reaching a speed of 120 mph, and crashed into a riverbed. Earlier this year, relatives of the victims filed the lawsuit, alleging products liability and negligence.

The details of the settlement are confidential, but representatives for both parties told the San Diego Union Tribune that they were pleased with the outcome. The settlement doesn't free the dealership that loaned the car to the officer from an accusation that it installed an improper floor mat that held the accelerator in the open position. There have been many manufacturing defect lawsuits against Toyota in recent years. One lawyer involved in such a suit told the Tribune that the settlement gives him the sense that Toyota is setting up the dealership as a scapegoat.

The experienced attorneys at Parker Scheer LLP have successfully represented clients injured and killed as a result of a wide range of defective products.

San Diego Union Tribune: Saylor family settles suit with Toyota

Continue reading "Settlement between Toyota and Relatives of California Family Killed in Crash" »

LAS VEGAS. A southern Nevada medical clinic, operating as the Endoscopy Center of Southern Nevada, had reportedly been re-using syringes on multiple patients for several years, possibly as far back as March of 2004. Patients who received injections using second hand syringes may have been exposed to dangerous and highly contagious viruses including Hepatitis B and C as well as HIV, the virus which causes AIDS.

According State health officials, as many as 40,000 people may have been patients of the clinic during the subject time period and should be tested for all three viruses as soon as possible in order to best safeguard their own health and the health of those to whom they may have inadvertently transmitted these viruses.According to Parker Scheer Attorney, Andre Lagomarsino, a leading Las Vegas trial lawyer with significant experience in medical malpractice litigation, "the practice of using the same syringe on multiple patients, while rare, constitutes an extreme example of medical negligence, and may give rise to significant malpractice claims by those who contracted viral infection or other harm as a result of the clinic's negligence".

Persons who were patients of the clinic between March 1, 2004 and the present, who feel they may have suffered infection as a result of the negligence of the Endoscopy Center of Southern Nevada, are encouraged to contact the firm's Las Vegas office, toll free, seven days a week, at 866-414-0400 or complete a confidential on-line request for assistance. All inquiries will be maintained in strict confidence.

To find out if you have a case, contact our lawyers for a free confidential case review and receive a response within hours, or call toll free 866-414-0400. If you need a lawyer outside of Nevada, contact us for a referral.

Recently, the National Highway Traffic Safety Administration reviewed 1,446 fatal accidents, and it found that in 255 cases the air bags had not been replaced after a previous accident. A common scheme used by unscrupulous auto repair shops is to bill insurance companies to replace old air bags, but instead stuff old airbags, rags, clothing, beer cans, paper, or even packing peanuts into air bag compartments.

The state of Massachusetts, the federal government, and the insurance industry do not track car accident injuries or fatalities caused by air bag fraud. Massachusetts does not regulate air bag replacement, even after an air bag has been deployed in an accident. Massachusetts has no criminal penalty for fraudulent replacement of air bags.

Typically, a car’s air bag light comes on for a few seconds when a car is started. If the light remains on, flashes, or never comes on, this is a clear warning that there is an air bag malfunction. A qualified mechanic should check the air bag. Not only will a car fail a Massachusetts inspection if the air bag light is on, but the air bag may not deploy in an accident.

Prior to purchasing a used car, it is advisable to check a vehicle’s accident history. Even where an air bag has not deployed, such as in a flood, an air bag’s effectiveness can still be inhibited.

If you or someone you know has been injured by a faulty air bag or an air bag malfunction, you may be entitled to compensation. To speak with a highly experienced air bag malfunction lawyer, or a faulty air bag car accident lawyer, phone Parker Scheer LLP seven days a week, toll free at 866-414-0400. There is no fee charged to discuss your case, and all information furnished, will be kept strictly confidential.