New York Injury Lawyer Blog

The New York Times reports that DePuy Orthopaedics Inc is recalling two hip replacement products -- the ASR Hip Resurfacing System and the ASR XL Aceabular System. Acebabular refers to the bowl-shaped socket on the hip.

The company is a division of Johnson & Johnson. The Wall Street Journal said the company decided to issue the voluntary recall due to an increased risk of follow-up surgeries being required in conjunction with the use of the devices.

New York City medical malpractice claims can result from defective medical devices. Most hip replacement surgeries involve older adults who are at increased risk for complications and who may require significantly longer to heal after a surgical procedure. A second surgery can seriously impact recovery rates and may even result in a reduced quality of life or a premature death.

About 120,000 patients undergo hip replacement surgery each year, according to the National Institute of Arthritis and Musculoskeletal and Skin Diseases. About one-third of adults will have a joint replaced in their lifetime.

The company said this week that a new study showed one 1 of every 8 patients needed a second surgery.

DePuy Orthopaedics said the company is "committed to paying for the cost of doctor visits, tests and procedures associated with the recall." Patients are being told to visit their surgeons to evaluate the performance of the implants.

Symptoms of problem implants include a loosening of the implant from the bone; bone fractures around the implant; and dislocation where the two parts of the implant are not longer aligned.

For more information on the hip replacement recall, you can visit the company website.

The company also warned the Food and Drug Administration this week that it is illegally marketing two other joint replacement products.

Continue reading "New York City patients with defective hip replacements should consult medical malpractice law firm" »

The Food and Drug Administration has issued a warning about Inferior Vena Cava Filters, citing risks associated with their long-term use.

Our New York City medical malpractice attorneys have reported problems associated with pharmaceuticals or medical devices, including Avandia and infusion pumps. Defective medical devices, dangerous pharmaceuticals or the inadequate care of a physician can require the assistance of an experienced attorney to protect a patient's rights.

In this case, the government is concerned that medical filters used to stop clots from reaching the lungs or heart could be causing their own problems.

In the last 5 years, the federal government has received 921 reports of problems with the filters, including device movement or migration (328), detachment of components (146) and filter fractures (56). The government reports some of the risk may be from leaving the filters in place for a long period of time, beyond the point when the risk of pulmonary embolism has subsided.

The FDA is concerned about the devices not being removed in a timely manner and is urging doctors and clinicians to remove the filters as soon as protection from pulmonary embolism is no longer needed.

ABC-4 in Utah reports that filters can become attached to the vein, making them difficult or impossible to remove. At least one Utah patient has filed a medical malpractice lawsuit over the issue.

The FDA's report could trigger a larger product recall and could result in other medical malpractice or product liability claims.

Continue reading "Safety of Inferior Vena Cava Filters called into question; New York medical malpractice claim may result from long-term use" »

A federal review panel has recommended that Avandia, the controversial diabetes medication linked to heart attack risk, either be removed from the market or allowed to remain on the market with severe restrictions, the New York Times reported.

As our New York City medical malpractice attorneys have reported, this drug has had a long and sorted history. Most recently, we reported that the majority of studies that favored the drug had been written by doctors and other experts who were paid by the company. Consumers continue to be at risk from dangerous pharmaceuticals and medical products. Companies spend billions in marketing and developing drugs and devices and the government seems to be paying little attention to the potential dangers until well after the fact.

Nearly a decade after Avandia went on the market -- and three years after a Cleveland Clinic physician raised the alarm -- some government officials concluded Avandia was likely causing about 300 deaths a month and should be pulled from the market. Yet even that recommendation was only made public after the Times obtained the government report.

This week, a federal advisory panel split on what recommendation should be made to the Food and Drug Administration. Twelve members voted to withdraw it from the market; 10 favored increased warning labels and restrictions; 7 voted for increased warning labels only; and 3 said it should continue to be marketed as is.

Meanwhile, information was revealed during the hearings that the company knew of the drug's reported dangers for years and did not reveal the information to regulators or the public.

In the fall of 1999, makers of Avandia secretly studied whether it was safer than a competing pill. Not only did it prove no better, it actually proved that Avandia was riskier to the heart. Instead of publishing the results, it spent the next decade trying to cover them up, according to the New York Times. In most cases, failure to release the results would be a violation of law, the Times reported.

The heart risks of Avandia did not become known until 2007. In ensuing months, executives at the drug's maker, GlaxoSmithKline, were forced to admit they knew of the drug's potential risks since at least 2005.

The documents obtained by the Times suggest that the company knew of the risks since at least 1999 and hid them because of the potential loss of $300 million a year in revenue.

Make no mistake about it: Pharmaceutical sales is big business, perhaps the biggest business. Billions are spent marketing and developing drugs. Millions more are spent compensating well-paid sales people to push the drugs at doctors offices and hospitals. When patient care is lost in the mix, serious injury or death may result. Those harmed should seek experienced, aggressive and knowledgeable legal representation to fight for their rights.

Continue reading "Avandia saga continues to reveal high risk of medical malpractice, complications for New York patients taking prescription medication" »

Washington lawmakers are unveiling new legislation aimed at regulating auto safety in an effort to reduce serious and fatal traffic accidents caused by defective vehicles, the New York Times reported.

The effort comes in the wake of the worldwide recall of more than 9 million Toyotas for a number of defects, including problems associated with sticking gas pedals. The company agreed last month to pay a record $16.375 million fine levied by the National Highway Traffic Safety Administration.

It is the first serious look at auto safety undertaken by Congress since the deadly accidents involving Firestone tires and the Ford Explorer a decade ago. The Senate's version would also restrict ties between auto companies and staff members of the National Highway Traffic Safety Administration; one of the challenges of such safety organizations is those empowered with oversight are frequently former industry executives or are recruited or promised lucrative positions by industry insiders once they conclude their government service. Such cozy relationships have become a concern in other area of governments, including the Environmental Protection Agency.

"Recent Toyota recalls showed an urgent need to update safety standards to reflect modern vehicle technology and give auto safety regulators the stronger tools and resources they need to protect the public," said Sen. John D. Rockefeller IV (D-WV), who introduced the bill. "We can do better by the American people."

The Motor Vehicle Safety Act of 2010 would require automobiles to be able to stop within a certain distance, even with an open throttle. Safety advocates have been lobbying for such a requirement for years. One means of accomplishing that goal would be for automakers to install brake override systems, although the proposed law does not specifically require them. Instead, the measure would require the NHTSA to create a rule requiring a minimum distance between accelerator and brake pedals and the vehicle floor and would require safety standards governing electronic vehicle controls.

The safety agency would also establish standards for keyless ignition standards, which have become increasingly popular. The rules would be aimed at creating uniformed steps for a driver to control a vehicle in the event of an emergency. And automakers would be required to install data records, similar to "black boxes" on airlines, which would record crucial accident data for testing and investigation.

Lastly, the bill would increase the civil penalties for automakers by 500 percent -- from $5,000 a vehicle to $25,000 per vehicle -- and remove the cap on penalties for manufacturers that fail to report vehicle defects or that provide misleading information. The $16 million fine levied against Toyota was the largest allowed by law, despite the fact that the government contends the company intentionally hid the safety defects from regulators and consumers for months before the recalls were announced amid a flurry of serious and fatal accidents.

Continue reading "Lawmakers take aim at auto safety; target car accidents caused by defective vehicles" »

Almost 100 recalls have been issued already this year involving defective children's products.

The U.S. Product Safety Commission has issued a recall of 217,000 Graco drop side cribs made by LaJobi, a Cranbury, New Jersey company.

It is the second major recall issued this year for a Graco product. As our New York City defective product attorneys reported in January, 1.5 million Graco strollers were recalled because they posed a risk of fingertip amputation for small children.

The latest recall involves cribs which can entrap infants when the drop-side detaches, posing a risk of strangulation or suffocation. The government reports children are also at risk of falling out of the cribs when a drop-side detaches. The government reports there have been 99 reported drop-side incidents and six reports of children falling from the cribs.

Click here for a description and affected model numbers.

Several other children's products have been recalled this week:

-Johnson & Johnson is recalling 43 over-the-counter medicines for infants and children, according to the Washington Post.

The medicines, including the liquid versions of Tylenol, Motrin, Zyrtec and Benadryl, are being recalled for undisclosed deficiencies in the company's manufacturing facility, according to federal regulators.

-Gap, Inc., recalled baby swimsuits because of a strangulation hazard caused by halter straps that are too short, causing a plastic ring in the neck of the suit to press against an infant's throat.

The swimsuit is the 48th recall involving children's products issued this year by the federal government. That number does even include toys. Another 44 recalls have been issued involving children's toys.

Continue reading "New York child injury attorneys continue to monitor alarming number of defective children's products" »

The Federal government is moving to increase oversight of medical devices, including a move last week to better regulate automated pumps that deliver intravenous drugs, food and other solutions to patients.

The infusion pumps are among the most problematic medical devices on the market, with more than 10,000 complaints annually and more that 75 product recalls over the last five years; patients who are injured by a defective medical device should contact an experienced New York City medical malpractice attorney to discuss their rights.

The Food and Drug Administration cited the 10,000 complaints in issuing preliminary guidelines that will require manufacturers of infusion pumps to supply the agency with more testing data on the devices before they can be approved for sale. The government said it has received 710 reports of patient deaths in the last five years, although FDA officials say they think the true number may be significantly higher. Causes of death have included problems with the devices, including drug overdoses resulting from human error in loading the pumps or software malfunctions within the pumps, according to the New York Times.

An estimated 2 million pumps are in use in hospitals and clinics and hundreds of thousands are used by patients at home. The devices deliver intravenous food, fluids, pain medication, insulin and cancer treatments.

The new oversight comes as the Obama Administration moves to rehabilitate the agency, which has been criticized in recent years as little more than a rubber stamp for big business. Under particular scrutiny, is the agency's Center for Devices and Radiological Health, which is charged with overseeing critical medical products, including heart implants, imaging equipment and infusion pumps.

Dr. Jeffrey E. Shuren, the center's new director, said the agency has determined that the pumps could be made far safer and that the agency's aggressive new approach could soon extend to other types of medical devices.

While tougher enforcement is certainly welcome from a patient-safety standpoint, it is also another example of the critical need for patients to aggressively protect their own rights when dealing with the medical industry. As we reported earlier this month on our New York Injury Lawyer blog, a report found positive reviews of Avandia, a controversial diabetes medication linked to heart damage, were apparently influenced by payments from pharmaceutical companies.

Continue reading "Defective infusion pumps could be cause of New York medical malpractice; government promises crackdown" »

We are all inundated daily with TV commercials listing the long laundry list of possible symptoms and side effects associated with prescription medications. But a new report in the New England Journal of Medicine argues doctors, researchers and drug makers are not listening closely enough to patient reports of symptoms associated with ingesting prescription medication.

Serious or fatal drug reactions can be a cause for medical malpractice in New York City and elsewhere. Additionally, a doctor or medical professional's failure to listen to a patient's symptoms can lead to misdiagnosis or failure to diagnose a serious medical condition.

Direct reporting from patients is rarely even used during drug approval or clinical trials, according to the report's author, Dr. Ethan Basch, of Memorial Sloan-Kettering Cancer Center in New York.

If patient input is sought at all, it usually comes from doctors or nurses, who write their own impression of how a patient is feeling, according to an article in the New York Times.

Dr. Basch reports that doctors and nurses "systematically downgrade the severity of patients' symptoms" and sometimes miss side effects altogether. "There is a sensibility among some old-school clinicians that they have a better sense of their patients' experience than patients do themselves," he said.

Once a drug is on the market, the Food and Drug Administration's Medwatch system allows doctors and patients to report adverse symptoms. But it is a passive system that awaits reports of problems instead of proactively seeking input from patients.

So the next time you hear the lengthy list of possible side effects of a prescription drug being advertised on television, keep in mind it might reflect little more than the medical profession's opinions regarding a drug's safety. And, just because a side effect is not listed, certainly does not mean you might not be experiencing a serious adverse reaction to a prescribed medication.

Continue reading "Failure to diagnose drug reactions can be case of New York medical malpractice, defective pharmaceuticals" »

Members of the government agency overseeing the health and safety of pharmaceuticals have recommended that Avandia, a diabetes medicine, be removed from the market, saying hundreds of people on the drug are dying of heart attacks and heart failures each month, according to The New York Times.

As reported earlier this month on our New York Injury Lawyer blog, the Food and Drug Administration is also urging stronger warning labels for Meridia, a popular diet drug, after reports of an increased risk of heart attack or stroke.

The recall of Avandia is the latest in a long string of high-profile drug recalls, including Vioxx in 2004 and Fen-Phen, another popular diet drug linked to liver damage. Pharmaceutical companies spend millions developing and promoting drugs. But, when medication touted as life-saving turns out to have deadly consequences, a New York City medical malpractice attorney or New York defective product lawyer should be contacted to protect your rights.

The government reports obtained by The New York Times said if every diabetic now taking Avandia, were instead treated with a similar medication, called Actos, about 500 heart attacks and 300 cases of heart failure could be averted each month. The government contends Avandia damages the heart and was linked to 304 deaths during the third quarter of 2009.

Some government officials within the Food and Drug Administration want Avandia, which is manufactured by GlaxoSmithKline, to be removed from the market; other agency officials contend studies of the drug provide contradictory information and want the drug to remain an option for doctors and patients.

GlaxoSmithKline contends that scientific evidence does not establish that Avandia increases the risk of heart attacks. The debate has been brewing for years but made news again recently after a Senate investigation concluded the drug maker should have warned patients earlier about the drug's potential risks.

Avandia was once one of the world's best-selling drugs. Driven by multi-million-dollar advertising campaigns, the company sold more than $3.2 billion worth of the drug in 2006 alone. Sales began to fall after a Cleveland Clinic study in 2007, which found that the drug harmed the heart. The FDA issued a warning about the drug but voted 8 to 7 to allow it to remain on the market.

The New York Times reports that hundreds of thousands of patients still take the drug.

The Food and Drug Administration is urging a stronger warning label on Meridia, a popular diet drug, in response to reports of an increased risk of heart attacks and strokes, the New York Times reported.

Pharmaceutical companies spend millions developing drugs and millions more promoting them. But the industry has a long history of recalling popular drugs because of dangerous or fatal side effects, including the 2004 Vioxx recall (also because of an increased risk of heart attack and stroke) and Fen-Phen (another popular diet drug recalled because of the potential risk of liver damage).

New York City medical malpractice attorneys are often called upon to help clients who have suffered injury as a result of a drug interaction or other negligence on the part of doctors, hospitals and pharmacies.

In this case, the European Medicines Agency advised doctors and pharmacists to stop prescribing Meridia while the FDA took a less forceful step in response to the study, asking Meridia's maker, Abbott Laboratories, to put a stronger warning on its label.

The new warning will indicate that the drug should not to be used by people who have a history of heart attacks or strokes, or who have uncontrolled high blood pressure.

Abbott said it would comply with the new requirements in the United States and stop selling the drug in Europe. The company said the drug was safe and effective when used in appropriate patients.

"We believe there are many patients who benefit from sibutramine," said Dr. Eugene Sun, vice president for global pharmaceutical research and development at Abbott.

The company's global sales of the class of sibutramine drugs to which Meridia belongs were about $300 million last year.

The study, called the Scout trial, was the first to actually test the long-held presumption that such diet drugs would also help reduce the health risks of obesity, including heart attacks. Some experts said the results actually found an increase in such risks for some high-risk patients, according to the Times.

The results could call into question the safety of other diet drugs and might make it harder for new obesity drugs to win approval. However, others said the issue might be unique to Meridia, which clearly raises blood pressure and heart rate.

Continue reading "Defective medications can increase risk of medical malpractice in New York " »

The recent rash of consumer product recalls offers a stark reminder of the danger posed to consumers by defective products.

The New York City defective product attorneys and the New York defective vehicle lawyers at Queller, Fisher, Washor, Fuchs & Kool represent clients who have been seriously injured or killed by poorly designed or dangerous consumer products.

Companies have an obligation to ensure their products meet safety standards and are free from known defects that could cause harm to customers. But, too often, profits are put before safety. And, when consumers are seriously injured, companies can and should be held responsible for the injuries they cause.

-About 1.5 million Graco strollers have been recalled because they could pose a risk of fingertip amputations and lacerations to children, CNN reported on Jan. 20. The models recalled by Graco Chidren's Products include the Graco Passage, Alano, and Spree Strollers and travel systems, according to the Consumer Product Safety Commission.

- A day earlier, the CPSC issued a statement on Jan. 19 notifying consumers of a recall of more than 600,000 baby cribs by Dorel Asia because of a risk of suffocation and strangulation to infants and toddlers.

-The U.S. Food and Drug Administration has announced a recall of all Tylenol Arthritis Pain Caplet 100 count bottles with the red EZ-OPEN CAP due to consumer reports of a moldy or mildew-like odor associated with nausea, stomach pain, vomiting and diarrhea. The recall has since been broadened to include more than two dozen other over-the-counter products manufactured by McNeil Healthcare, according toThe New York Times.

Continue reading "New York defective products a danger to consumers" »

Most of us bring more new products into our homes during the Holiday Season than at any other time of the year. Consumer advocacy groups continue to publish holiday recall reports and consumers should be mindful of the dangers new products can pose in the home.

Companies have an obligation to ensure their products are safe and can be held responsible when someone is injured or killed by a defective product. The New York City defective product lawyers and the wrongful death attorneys at Queller, Fisher, Washor, Fuchs & Kool urge parents to pay particular attention to the toys given to their children this holiday season.

The 24th Annual "Trouble in Toyland: Survey of Toy Safety," by the U.S. Public Interest Research Groups, reported the government recalled 45 million toys in 2007 and identified the following common toy safety hazards:

Choking: At least 196 children have died from choking or asphyxiating on a toy part since 1990. Some 5.3 million toys and children's products were pulled from shelves in 2009 because of choking hazards; small parts were commonly found on toys for children under 3, despite laws aimed at preventing such choking hazards.

Loud Toys: Almost 15 percent of children ages 6 to 17 show signs of hearing loss; some toys currently on store shelves may not meet noise standards in place to prevent hearing loss.

Lead in Toys: Lead continues to be found in toys, despite strict safety standards. Lead exposure can affect almost every organ in the body, especially the central nervous system, and is especially toxic to the brains of young children.

Last year, 19 children died as a result of toy-related injury and more than 82,000 children under the age of 5 visited emergency rooms, according to the Consumer Product Safety Commission.

And the dangers defective products pose to children is not limited to toys.

Last week, 2.1 million Stork Craft Cribs were recalled. The cribs were manufactured as far back as 1993, including nearly 150,000 with the Fisher-Price logo, according to U.S. News and World Report. Four infant suffocations have been reported in North America, according to the U.S. Consumer Product Safety Commission, which has received 110 reports of drop-sides detaching from the cribs.

Parents with the cribs should stop using them until they receive a free repair kit from Stork Craft Manufacturing. To order the free repair kit, phone Stork Craft 877-274-0277 or go to the company's Web site.

The Consumer Product Safety Commission maintains a list of recalled consumer products.

Continue reading "Defective products a holiday hazard" »