Philadelphia Medical Malpractice Lawyer Blog
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Though everyone knows about the danger and irresponsibility of getting behind the wheel after drinking, few people talk about the similar risks associated with drugged driving. It’s about time that changes given the increasing occurrence of medication-related wrecks on Pennsylvania roadways.

PennDOT, Pennsylvania State and local police have all announced that they are part of a national effort to target drivers who are operating vehicles under the influence of drugs. The campaign has been dubbed “Drive Sober or Get Pulled Over” and is intended to raise awareness of the dangers of impaired driving. PennDOT’s spokeswoman Erin Waters said that while the number of alcohol-related crashes has been down the last few years, instances of drugged driving continue to increase.

This includes not only illegal drugs, but also increasingly, prescription medications. One recent example includes Kerry Kennedy, who was charged with driving under the influence after Ambien was found in her system following a crash into a tractor-trailer.

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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 man from Tennessee has filed a lawsuit against Boehringer Ingelheim Pharmaceuticals, Inc., the maker of Pradaxa. The drug company is being sued by the man who claims his father died as a result of side effects he experienced while taking the blood-thinning drug. Melvin Giles, Jr. sued Boehringer Ingelheim in the U.S. District Court for the Middle District of Tennessee.

According to the suit, Giles’ father was prescribed the drug as a blood thinner. The medication is usually used to reduce the chance of blood clots developing and leading to a stroke in patients who present special risks for such problems. Giles’ father was given the medication in February of 2011 and in June of that same year suffered severe internal bleeding and died as a result. His son claims that the bleeding he suffered was the result of Pradaxa.

Giles claims that the drug maker either knew or should have known about the potential for the dug to cause such serious complications. The suit cites as proof the 932 incidents reported to the FDA between October 2010 and March 2011 related to side effects of the medication. Some 120 of these reports involved death from Pradaxa bleeding, and 500 were severe and life-threatening bleeding events related to the medication. These numbers have gone on to spike and according to a new report from the Institute for Safe Medicine Practices (ISMP), the U.S. Food & Drug Administration received 3,781 adverse event reports associated with Pradaxa in 2011, more than were associated with any other drug the agency monitors.

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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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It’s not at all unusual for patients to put tremendous faith in the hands of their doctors. They often assume given their education and level of training that they are in safe hands. One study found that 70% of people totally trust what their doctor says and never even bother asking for a second opinion. Trust is a good thing, blind trust, however, can be dangerous. There are certain warning signs that all patients should be on the watch for to avoid having preventable mistakes happen to them.

The first sign is a sleepy doctor. According to the Journal of the American Medical Association, surgeons who slept for less than six hours the night prior to performing a surgery had twice as many surgical complications as those surgeons who got enough sleep. Many doctors understand the benefits of sleep but often cannot help being stuck at the hospital for terribly long shifts, sometimes even 24 hours. This lack of sleep combined with the stress of the job can result in poor decisions from the overworked docs. These wrong decisions lead to medication errors or misdiagnoses.

Another sign for worry is a doctor’s personal bias. According to a study conducted by The Journal of Law, Medicine & Ethics, some physicians admit to assuming that women exaggerate their symptoms. Due to this unfortunate and unfounded bias, women may not be given the treatment they deserve. Patients should be on the lookout for doctors who seem eager to impose their own views on a patient’s care.

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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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