Articles Posted in Defective Products

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According a recent article on Dotmed.com, this past year has seen a massive number of medical device recalls. According to ExpertRecall, a company tasked with tracking food, drug and device recalls, a whopping 123 million such devices were recalled in the most recent quarter of the year, representing a nearly two-year high.

ExpertRecall pointed out that the number of device recalls is actually down slightly from the first quarter. However, the number of individual units affected by the recalls passed the 100 million mark for the first time since the third quarter of 2010. An analysis of FDA enforcement reports found that the second quarter of 2012 saw some 242 medical device recalls, a drop of 13% from the 277 recalls seen in the first quarter of this year. Though there was a drop, the most recent numbers still represent an increase of 4% from the same time last year.

The 123 million units recalled last quarter represent an astounding 50% increase on the 82 million units recalled in the first quarter of the year. Though the gap may seem larger, stepping back in time reveals an even difference. In the second quarter of 2011, only 16 million devices were recalled, about 1/8 as many as last quarter.

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A recent study has found a major flaw in the Food and Drug Administration’s process that approves medical devices. At least four dangerously defective medical devices were expedited through FDA’s approval process with minimal testing. The four devices were the DePuy ASR hip implant, transvaginal mesh, heart rings, and defibrillator lead wires. Each of these devises has caused severe injuries and sometimes death. All of these devices were used in patients without any significant testing of their safety. The hip implant released metal fragments into the body and caused the surrounding tissue to decay. The transvaginal mesh broke through the vaginal wall. The heart ring was used in patients without being approved by the FDA at all, and the defibrillator wires short-circuited because they were not properly insulated.

The FDA’s approval process is known as the 510(k) clearance process. The purpose is to allow manufacturers to market medical devices to US consumers. It allows a device that is “substantially equivalent” to another device that is already being marketed to consumers. The FDA defines substantial equivalence as “the new device is at least as safe and effective as the predicate.” It also provides a list of factors that can determine whether the standard of “substantial equivalence” has been met.

“A device is substantially equivalent if, in comparison to the predicate it: has the same intended use as the predicate and has the same technological characteristics as the predicate or has the same intended use as the predicate and has different technological characteristics and the information submitted to the FDA does not raise any new questions of safety or effectiveness and demonstrates that the device is at least as safe and effective as the legally marketed device.”

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The Food and Drug Administration recently announced it would be meeting with a panel of orthopedic experts to more fully explore the growing body of evidence showing that metal-on-metal hip devices have a higher failure rate than other similar devices, typically made of plastic or ceramic.

The FDA’s chief scientist for medical devices, William Maisel, has said, “The FDA has been aware of some of these problems for three years and has made recommendations in the past, but I think what you’ll see coming out of these meetings are more specific recommendations for follow-up care.” Dr. Maisel was quick to say that the agency would not announcing any new recommendations right away, but would instead need time to fully investigate its options.

The problem is a significant one for Americans given that some 285,000 hip replacement surgeries are performed each year. Nearly half a million people in the United States have all metal hip implant devices. The reason the devices were used in the first place is because it was thought that metal-on-metal hip implants lasted longer than those made from other materials. The all-metal devices were given primarily to younger, more active patients. The most recent date from 2006 suggests that a whopping 32% of all hip replacement surgeries involved metal-on-metal devices.

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The FDA made a major announcement recently which will make medical devices a lot like mass-produced consumer devices such as cars and microwaves. The new proposed rule will require that each medical device manufactured be given a unique code which will help with tracking and hopefully assist the agency in catching safety problems earlier.

While similar codes are already found in almost all consumer products, the barcodes have been noticeably absent from such critical devices. The rule says that device makers will begin by placing barcodes on their riskiest devices, like implants or pacemakers. Over-the-counter or incredibly low-risk devices, think bedpans, will not be given a tracking code.

The FDA will then place all the codes in a public database which they hope will allow doctors and regulators to detect problems more quickly and notify affects patients in much less time about any dangers. Companies and hospitals will be able to access the database and quickly pull products that are affected by recalls or other problems. The codes will also benefit the device makers by helping to prevent counterfeit or stolen products from entering the supply chain.

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The Food and Drug Administration just released some surprising news that it found poor software quality is to blame for many of the recalls that have been seen in the medical device industry. The FDA’s research revealed that such glitches were responsible for 24% of all such recalls.

Given this revelation, the FDA’s Office of Science and Engineering Laboratories will now begin dedicating significantly more time testing software quality and security. The goal will be to help reduce the failure rate cited in the most recent annual report released just this week. The agency will increase its efforts to avoid injury or death thanks to poorly designed or written software.

In a statement, the FDA said that it is developing “techniques and laboratory expertise to assist our review staff in identifying potential vulnerabilities and evaluating risk mitigation measures.” The procedures the agency will put into place are in line with those in other regulated industries and are intended to be rigorous. The statement continued saying, “Manufacturers are responsible for identifying risks and hazards associated with medical device software/firmware, including risks related to security, and are responsible for putting appropriate mitigations in place to address patient safety.”

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A few months ago one unfortunate couple made a purchase they’ll likely regret for the rest of their lives: a bag of magnets. They were shopping near their hometown and came across some high-powered magnets that could be used to form various shapes. The couple bought them for a little amusement. When they got home they made sure to put the toys away on an upper shelf. Apparently the shelf was not high enough to keep their young son, 2-year-old Braylon, away. He found the bag of magnets and ended up swallowing eight of them.

Rather than just simply passing the round balls, they magnets fused together and, in the process, wreaked havoc on the digestive tract of the little boy. The high-powered magnets attached to each other and, in doing so, twisted and ultimately perforated the boy’s intestines.

Since the terrible accident the child has been in the hospital. Most of the time was spent in the ICU given the severity of his injuries. Braylon has had six surgeries, developed a blood infection and had to be fully sedated for three weeks. Though he’s scheduled to leave the hospital soon, he’ll have to return for additional surgeries. He’s currently scheduled to get an intestinal transplant due to the amount of tissue that had to be removed in his previous surgeries.

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Who doesn’t love a new gadget? Whether it’s the latest iPhone or a new videogame console, we all love our technology. Sometimes, though, this rush can be to our determent. A good example of the danger of rushing involves the da Vinci Surgical Robot.

According to the manufacturer, Intuitive Surgical, the device makes a surgeon’s job much easier, allowing smaller incisions and increased recovery time. The manufacturer says the da Vinci Robot can be used to treat obesity, endometriosis, throat cancer, prostate removal, kidney cancer, coronary artery disease, and gallbladder removal. The robot has four arms: three for surgical instruments and a fourth with an attached camera. It claims to give doctors an increased range of motion and to provide a less invasive way of achieving many traditional surgeries. Sounds great, right? Unfortunately there’s more to the story.

While the benefits touted by the manufacture may be true to an extent, there have also been reports of serious injuries related to the use of the robot. Part of the problem appears to be a rush to train surgeons who are being put in control of the powerful machines before they are ready. Patients who have been injured by the robots have begun filing lawsuits and recently requested that a panel of federal district court judges consolidate the litigation before a single federal court.

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Traveling carnival rides are regulated by the Consumer Product Safety Commision (“CPSC”), but this federal agency has not required safety improvements from any ride manufacturers during the last eight years. The agency, which is responsible for overseeing the safety of 15,000 products in addition to the safety of amusement rides, has no employees devoted to ride safety. Frequently, CPSC employees don’t even arrive at a carnival where an injury has occurred until after the ride has been taken apart, making the task of determining what went wrong with the ride virtually impossible.

While the regulation of traveling carnival rides is poorly enforced and often subject to voluntary standards set by the amusement industry, fixed theme parks are worse off because they are not subject to any regulations at a national level. Rather, all laws regarding theme park safety are governed by the state in which the park is located.

To understand the dangers caused by this lack of regulation, one can look to the popular ride known as “The Sizzler.” In the last decade, there have been at least 5 deaths from the Sizzler and dozens of injuries. In July, 2007, a 6 year old boy was thrown from a Sizzler in Kentucky and hit in the head by the moving equipment of the ride. This prompted the manufacturer of the ride to recommend to operators that seat belts be added, but because this was not a requirement, it is unknown haw many rides of the approximately 200 Sizzlers in use in the U.S. actually have seatbelts (which are now common on grocery carts throughout the country). The July incident was not the first incident of a child being thrown from the ride. In 2005, a 9 year old girl died in Texas after she slipped under the lap bar and was thrown to the machine’s platform, where her head was crushed by a metal arm. The similarities between these 2 accidents and many others led a group of state ride inspection chiefs from approximately 25 states to call for the Sizzler manufacturer to take action to reduce “an unacceptable level of ejection risk,” but the only action was the recommendation that operators voluntarily install seatbelts.

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A 51 year old construction worker using a Stanley Works nail gun, which was sold to him by Home Depot, suffered seizures and paralysis after a nail from the gun ended up embedded in his brain. The manufacturer said that the nail gun, known as a Model N79 or “contact trip gun,” met industry standards and is very popular with customers. The jury found the man 55% responsible for his injury because he had been using the gun to put nails into metal, rather than wood as was intended, but held the manufacturer 45% responsible for his injuries. The accident occurred when the a 3″ nail the gun fired bounced back at the man and entered his brain after going through his cheek. The jury ordered the manufacturer, Stanley Works, to pay $3.4 million to the man in damages to compensate for their responsibility in causing the injury.

Testimony showed that the man, who was married and the father of four, had worked for 20 years as a construction worker before his injury. At the time of the accident, he was working in a church and was standing 25 feet in the air on a lift putting nails into metal. He had 6 hours of surgery after the accident, but was still paralyzed on his left side and would never be able to work or drive a car again. The jury considered the case for 8 hours before reaching its verdict.

Evidence at trial showed that 129 injuries had been reported from the use of the gun since the 1970’s and that 26 of these resulted in brain injuries. According to the man’s attorneys, newer models of the gun are safer.

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A July 2006 verdict awarding the parents of a one-year who allegedly died from liver failure caused by an overdose of Infant Tylenol was upheld by a Philadelphia appeals Court this month. At trial, the parents alleged that their son died after an overdose of acetaminophen resulted in liver failure. The parents argued that the warnings on the medicine were defective in not stating that liver damage or death could result from the medicine. In response, the manufacturer had argued that the child’s death was not due to an overdose of the medicine; that the parents had not followed the instructions and warnings on the medicine; and that if the child did suffer from an overdose of acetaminophen, it was because the parents combined the Infant Tylenol with other cold medicines that contianed acetaminophen. In upholding the verdict, the appeal’s judge held that the manufacturer’s appeal of 29 different legal rulings was excessive and not consistent with a litigant’s obligation to act in good faith and fair dealing with the court.

The verdict and unsuccessful appeal in the Philadephia case may be a sign of things to come as more of these cases are filed around the Nation, not only against the manufacturers, but also against the drug stores that sell the medicines. In mid-November, a Chicago mother filed suit against the manufacturer of Tylenol and also Walgreens, alleging that the death of her 4 month-old son was caused by the combination of Infant Tylenol Cold Decongestant Plus Cough and Walgreen’s Pediatric Drops-Cough Plus Cold. She argues that the defendants should have known the dangers of the key ingredient of the drugs and warned purchasers of the dangers. In response to allegations that she misused the medications, the mother asserts that she gave her son the two medications back-to-back and in the indicated doses over the course of 4 days and denied that she gave the child both drugs at the same time. An autopsy showed that the infant died of an overdose of dextromethorphan, which built up in his body over the 4 days of use. The mother argues that the defendants were aware of the dangers of dextromethorphan for years, but had not warned purchasers prior to the October, 2007 FDA hearings that resulted in manufacturers removing the products from stores.

Claims against pharmaceutical companies (drug manufacturers) are becoming more common. Also in the news recently, drug manufacturuer Merck has agreed to settle over 30,000 claims concerning the durg Vioxx for $4.85 billion. There have been similar claims concerning many other types and brands of defective medications. If you believe that you have been seriously injured as a result of a defective drug, you should immediately consult with a skilled trial lawyer concerning your rights.