Drug Injury Attorney Blog

Several months ago, I wrote about the discovery of an increased risk of cancer for patients who undergo CT scans. As a defective medical device attorney, I am particularly concerned to hear about the discovery of new risks from medical technologies that were thought to be safe. The radiation to which patients are exposed in CT scans -- in many cases unnecessarily, since many patients do not even benefit from them -- turned out to be at a much higher level than previously thought. According to a National Cancer Institute study, the radiation from CT scans performed in 2007 was likely to cause 14,500 fatal cancers.

This is a frightening figure. It becomes even more so in light of a recent St. Louis Post-Dispatch article about the effects of CT scans on children. Children are even more endangered by CT scan radiation than adults are, and about 19,000 children undergo CT scans each day in the U.S. Because their bodies are smaller, their organs are closer together than adults', so a CT scan of particular tissues or organs of the body is more likely to expose other tissues or organs to the radiation as well. Cancer can develop slowly, and since kids have more years of their lives ahead of them than adults do, they have more years during which cancer can grow from damaged cells. And while children's bodies are more sensitive to radiation, they are often scanned at adult levels.

Despite all of this, studies of children arriving in emergency rooms have found that up to a third of CT scans are performed unnecessarily, or even repetitively. Children with head trauma, but with mild symptoms that did not indicate serious injury, were sent for CT scans even though they did not need them. Variation in how CT scans are performed, within and across institutions, also increases the amount of radiation to which patients are exposed, according to a University of California at San Francisco study. Different machines use different doses, and technicians are not always able to understand the machines' manuals or keep up with new technologies. The machines could be programmed incorrectly as well, exposing patients to even higher levels of radiation than planned, as a recent New York Times article about radiation therapy for cancer reports. In fact, a California CT scan facility encountered a problem like this in 2009, when more than 200 patients were exposed to eight times the proper level of radiation, resulting in hair loss and skin problems.

While CT scans are an important diagnostic technology, clearly there is work to be done to ensure patients' safety. Dr. Steven Don, a pediatric radiologist at St. Louis Children's Hospital, advises parents to discuss with their pediatricians why any recommended CT scan is necessary, and to ask the CT scan technician what they are doing to make sure the radiation is at the proper dose.

As a dangerous medical device lawyer, I feel that parents without any special medical knowledge should not bear all of the responsibility for making sure that their children are not injured by unnecessary radiation. A parent whose child is in the emergency room is unlikely to be in a state of mind to have a careful discussion with his or her child's doctors in order to evaluate the risks of CT scan radiation. Rather, the machine's manufacturer has a legal responsibility to ensure that the machine is safe for patients, and that the machine's manual is comprehensible to technicians. (Decision-makers at a hospital may also share some blame.) If the manufacturer fails to ensure that its product is safe, people who have been seriously harmed by the product can sue to recover money for their medical costs and financial losses, as well as compensation for their physical and emotional injuries.

Continue reading "Radiation From CT Scans Poses a Special Cancer Risk to Children" »

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Over the past two years, Baxter International Inc. has received reports of serious injuries and one death linked to its dialysis machines, and as of January 8, 2010, the company initiated a recall of the machines. These automated peritoneal dialysis (PD) systems, marketed as Home Choice and Home Choice PRO, treat both adults and children with severe chronic kidney failure by removing waste products and extra fluid from their blood. The defective machines have put too much of the dialysis solution used for this process into the patients, leading to increased intraperitoneal volume (IIPV), or overfill of the abdominal cavity. Unfortunately, this has led to at least one death, and serious injuries such as heart failure, hernias, and breathing problems. Children and nonverbal patients are at particular risk from these machines because they are unable to clearly communicate when something's wrong. Patients who already suffer from heart or lung problems also face special risk, since the defective machines can further damage these organs.

As a dangerous medical device attorney, I am concerned that Baxter International Inc. has chosen to continue marketing these machines in the face of this Class I Recall. According to the FDA, a Class I Recall is "the most serious type of recall" that involves "situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death." Baxter says that it will add alarms, messages, and software modifications to the device so that patients and caregivers will be able to stop fluid accumulation in time. Patients and caregivers who continue using the machines, as Baxter suggests, should be aware of danger signs such as vomiting, difficulty breathing, or feeling bloated. Children treated with this machine should be monitored as well, and danger signs for them include crying during therapy or reporting a "funny feeling" in the abdomen.

This is not the first time Baxter's products have been under scrutiny as dangerous medical devices or dangerous drugs. Most recently, in 2008, Baxter came under fire for failing to make obvious the difference between adult and children's doses of its anticoagulant drug heparin, resulting in overdose and death for a number of babies in several states. This included the newborn twins of actor Dennis Quaid, who eventually sued Baxter. The company did make the adult and children's labels more distinct from one another, but not before these terrible tragedies occurred. And in 2001, Baxter's dialysis machine caused several deaths.

Continue reading "Dialysis Machine Recalled for Potential for Death or Serious Injury" »

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The hot medical news story of this week is one that interests me greatly as a defective medical device attorney. According to a Dec. 14 article from HealthDay News, two studies published this week in the Archives of Internal Medicine say CT scans, the commonly used diagnostic tool, may cause as many as tens of thousands of cancers each year. Doctors have always known that CT scans expose patients to radiation, but the studies found that patients who undergo them are exposed to more radiation than originally though. The authors of the study believe the risk is so serious that they asked doctors to carefully consider whether each CT scan is worthwhile and inform patients of the risk beforehand.

CT scans (formerly called CAT scans) use computer technology and X-rays to create detailed pictures of the inside of patients’ bodies. Dr. Rebecca Smith-Bindman, a lead author on one study, said doctors have lowered their thresholds for using CT scans so much that some patients get no real benefit from them. In fact, her team’s study said the use of the scans has grown dramatically in the past 30 years, from 3 million a year in 1980 to nearly 70 million in 2007. That’s a problem because the dose of radiation a patient receives during an abdominal scan can be as high as 90 millisieverts, which the article said was equivalent to thousands of X-rays. Radiation doses vary according to the type of scan, and tolerance varies across patients. One doctor quoted said that patients could expect to be exposed to that amount of background radiation over 30 years -- but with a CT scan, it comes all at once and focused on the body.

And this, the two studies said, can cause cancers. Smith-Bindman’s team found that one in 270 women and one in 600 men who undergo a coronary angiography CT scan at age 40 will develop cancer. That risk was doubled for 20-year-old patients and halved for 60-year-olds. The other study, headed by Amy Berrington de Gonzalez of the National Cancer Institute, broke down cancer risks according to gender, age and the type of scan. They predicted that CT scans performed in 2007 alone would result in 29,000 cancers, 14,500 of which would be fatal. The highest risks came from chest, head, abdominal and pelvis scans -- all of the most commonly performed. Women bore the greatest risk because they get the scans more often and are more likely to develop breast and abdominal cancers. In addition to warning patients and considering whether CT scans are truly necessary, study authors suggested tracking radiation exposure through a searchable database of medical records.

Radiologists stressed that fear of cancer should not stop patients from getting CT scans that help doctors address other major health issues, like heart disease. But as a dangerous medical device lawyer, I wonder how many patients have already developed life-threatening cancers because they submitted to a scan their doctors recommended. As a rule, patients trust that treatments and diagnostics their doctors recommend are safe and effective, or at least worth the risk. However, the oldest CT equipment, which tends to deliver the highest doses of radiation, is still in use, and patients are unlikely to be told how old the equipment is. That’s true even though the cancer risk from radiation is well understood and has been for decades. Going forward, patients can ask careful questions and give informed consent to CT scans. But for those already exposed, it may be too late to do anything more than assign responsibility after the disease develops.

Continue reading "New Studies Show CT Scans Cause Tens of Thousands of Cancers Each Year" »

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As a St. Louis defective drug attorney, I was disturbed to read about a new Food and Drug Administration warning of potential irreversible cartilage damage from certain anesthetics and medical devices. According to a Nov. 17 article from the Wall Street Journal, the FDA has called for stronger warnings on the labels of pain pumps and certain anesthetics after 35 reports that they caused permanent cartilage damage (chondrolysis) in patients who received continuous infusions after surgery. In more than half the cases, patients needed additional surgery, including joint replacements for otherwise healthy young adults. The FDA required pain pump and anesthetic makers to update their labels within 30 days to include warnings about the destruction of cartilage.

The drugs in the FDA’s announcement include bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine and ropivacaine, all widely used local anesthetics. The FDA’s announcement noted that these drugs have been used safely for years or decades, but in smaller, short-term doses. They are not approved for continuous use or use in pain pumps, which deliver constant flows of medication over two or three days. In fact, the pain pumps themselves are not approved for use in joint (intra-articular) areas, the uses that generated the cartilage damage reports. Dr. Constance Chu, a cartilage restoration specialist the University of Pittsburgh, told the Wall Street Journal that local anesthetics are toxic to tissues at high doses and not intended for continuous use. The Canadian version of the FDA issued a warning about cartilage damage in January, following studies and reports on the issue.

Almost all (97%) of the surgeries the FDA reviewed were shoulder joint surgeries. Patients reported stiffness, loss of motion and joint pain as soon as the second month after their surgeries. About half needed additional surgeries to relieve the pain and symptoms, including joint replacements (arthroscopy). Cartilage damage and loss is not life-threatening, but it has an immense effect on the patient’s quality of life. Without cartilage, the bones in joints grind against one another, causing pain, swelling, loss of mobility and thus severe restrictions on the patient’s movement. Osteoarthritis, a common complaint among older Americans, is a form of cartilage loss with similar symptoms. A newer treatment called articular cartilage repair can mend some of the damage to cartilage, but this cannot restore cartilage. Expensive joint replacement surgery may be necessary to restore patients’ normal movements.

The Wall Street Journal noted that pain pump manufacturers are already facing hundreds of lawsuits around the United States over post-operative cartilage damage. As a southern Illinois pharmaceutical liability attorney, I expect the FDA’s warning to add to that number. If the FDA is correct, both the pain pumps and the anesthetics are apparently being widely used for off-label, unintended purposes. This report makes it explicit that the FDA does not approve of those uses, and is even taking steps to warn doctors and patients against them. In fact, medical studies turned up these problems as early as 2006, but manufacturers failed to warn patients about them -- and doctors continued to prescribe pain pumps full of anesthesia.

Continue reading "FDA Calls for New Labeling for Anesthetics Used in Post-Surgery Pain Pumps" »

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The U.S. Food and Drug Administration is investigating possible defects in power cords used with medical devices from at least two companies, Reuters reported Oct. 19. Abbott Nutrition, a division of Abbott Laboratories Inc., and Hospira Inc., have reported 122 incidents of fires, sparks or charring from power cords used with their devices, which include infusion pumps and adult feeding tubes. This can expose users and health care professionals to injury or even death from shocks, fires, and failure of the device while in use. The FDA is warning hospitals and home users of devices to keep an eye on wear and tear on power cords, and stop using cords with visible damage. It also asked users to report any incidents of sparking, charring or fires.

All of the incident reports the FDA has received are about cords manufactured by Electri-Cord Manufacturing Corp. All of the implicated cords use a black plastic “bridge” connecting the plug’s prongs. The two medical device manufacturers, Abbott and Hospira, found that the prongs may fail or crack, either outside the cord or just inside the plastic covering of the plug. The cords have been supplied to other manufacturers of medical devices as well, and the FDA is tracing the cords to determine where else they may be. The problem has already sparked a recall from Hospira; the company initiated a voluntary recall in August, the same month it received a letter from the FDA criticizing its response to the power cord problem. A spokesman for Electri-Cord denied that defects are the problem, suggesting that most cords involved in reported incidents showed signs of “significant abuse.”

I don’t doubt that cords involved in fires, sparking or charring might look abused. However, as a defective medical device attorney, I applaud the FDA’s recall effort, which I hope will prevent further incidents that could seriously hurt someone. Defective cords on any device can be very dangerous because they can electrocute their users or start a fire. (In fact, defective wiring is among the most common causes of house fires.) This may be especially true in hospitals, where doctors routinely use highly flammable pure oxygen during surgery. But on a medical device that patients depend on for nutrition, medicine or other essential needs, faulty wiring can also have serious medical consequences unrelated to a fire or shock. If the device fails, temporarily or permanently, the patient can be deprived of its life-saving effects -- which can be at least as deadly as a fire.

Continue reading "Suspected Defects in Power Cords for Medical Devices Spark FDA Investigation" »

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As a defective medical device attorney, I was alarmed to read a detailed article on medical device recall problems from the Associated Press Oct. 5. In short, the article exposes the federal government’s dangerous lack of a centralized system to track down people using medical devices that have been recalled for safety reasons. When a device is recalled, the FDA and manufacturers send out press releases and may make it into the news -- but only certain devices are registered and tracked so that patients may be personally notified. As a result, health care providers, medical professionals and patients may continue to use the recalled products for months or years before realizing the problem.

The FDA currently requires comprehensive registries for 14 medical devices, including pacemakers and breast implants, and a registry for artificial joints is in the works. However, thousands of devices are excluded from these registries, meaning patients must rely on medical providers to keep track of which devices have been recalled. Most hospitals note the serial number of a device in paper records, which can be time-consuming to sift through; some health insurers and nonprofit medical organizations are building their own databases. A comprehensive national medical device registry is part of the health care legislation that Congress is currently considering, but the medical device industry says it would be too costly and unnecessary. However, a study of 2,200 hospitals by a hospital umbrella group found that even after one device was recalled, doctors continued to implant it in at least 50 patients.

The article focuses on the sad story of married couple Michael and ShellyAnn King of New York. Michael King agreed to donate a kidney to his dialysis-dependent wife, but after the surgery to remove the kidney, a Hem-o-lock brand surgical clip popped off his renal artery. Before the problem was discovered, he bled to death in the hospital at the age of 29. After the incident, the King family discovered that the Hem-o-lock clips had been recalled about two years earlier out of concerns that they could dislodge from the renal artery and cause deadly uncontrolled bleeding -- precisely what happened to Michael King. The family’s dangerous medical device lawyer said the hospital had been notified of the recall but never took action. They are suing the hospital, the medical center and the surgeon involved.

This is disturbing news. Patients rely on medical devices to sustain or save their lives, or help them live normal, healthy lives. If our doctors and regulatory agencies don’t have the information they need to stay up to date on which devices have safety problems, they can’t give us the information and the excellent care that we deserve -- and that they want to provide. As a defective medical device lawyer and a longtime observer of the pharmaceutical and device industries, I know that both the use of medical devices and the number of medical device recalls have grown rapidly; the article notes a 164% increase in medical device recalls since 2000. Millions of patients are using devices in an industry with a spotty safety record. If even 1% of those devices slip through the cracks, that still leaves thousands of patients with potentially life-altering or fatal problems from devices implanted in their own bodies.

Continue reading "FDA System for Tracking and Announcing Medical Device Recalls Faulted as Recalls Soar" »

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Last year’s Supreme Court ruling in Riegel v. Medtronic took away patients’ right to sue makers of defective medical devices that seriously harmed them or their loved ones. The court said in the 2008 ruling that patients may not file these legal claims because they are explicitly preempted by language in federal law. In response, Congress introduced the Medical Device Safety Act of 2009, which would correct that decision with language that explicitly says federal law does not preempt state-court lawsuits against makers of dangerous medical devices. On April 9, the New England Journal of Medicine published an editorial supporting the legislation, on the belief that it would make patients safer.

The editorial noted that thousands of medical device lawsuits have been thrown out of court since Riegel, regardless of how deserving the injured patients might be. In particular, it cited dismissal of more than 1,000 lawsuits filed by victims of the defective Medtronic Sprint Fidelis defibrillator, which is surgically implanted directly into the patient’s chest. The device has a defective wire that’s unreasonably likely to break, causing it to stop working or shock the patient internally at random times until it can be surgically removed. As the New York Times noted April 7, that surgery is very risky and should ideally be performed by a doctor who specializes in removing the wires. Medtronic itself notes that there have been 13 related deaths so far -- but thanks to Riegel, victims and their families have no legal recourse.

The editorial called for the Medical Device Safety Act’s passage for two major reasons, most importantly, patient safety. The decision shielded medical device makers from the potential consequences of not disclosing risks -- and as a defective medical device lawyer, I know all too well that some pharmaceutical companies are willing to hide risks in order to protect their profits. Restoring the right to sue would remove that risk and improve safety. It would also bring the law on dangerous medical devices in line with the law on defective drugs, the editorial said. The Supreme Court recently ruled in Wyeth v. Levine that federal law does not preempt state-court claims that a medication is defective, a decision the writers find inconsistent with Riegel. The proposed bill would level the playing field between drugs and devices, they wrote.

I strongly agree, and not just because this issue affects my practice as a defective drug and medical device attorney. Medical device safety, effectiveness and disclosure are literally life-or-death situations for many patients. The high-profile cases of drugs like Vioxx and Seroquel make it clear that not all manufacturers are putting safety ahead of profits, and mistakes or lax regulation by the FDA show that we can’t rely on that agency as our only safeguard. Allowing litigation in the cases that slip through the regulatory cracks would give medical device companies the accountability that American patients deserve. As the editorial said, “lawsuits by injured patients... have been an important part of the regulatory framework and very effective in keeping medical devices safe.”

Based in St. Louis, the Lowe Law Firm represents clients throughout the United States who have been seriously harmed or lost a loved one because of a defective prescription drug or medical device. If you or a loved one was hurt after taking a drug, and you believe the manufacturer failed to disclose important safety information about it, our Missouri defective pharmaceutical lawyers can help. To speak to us about your situation and your legal rights, please contact us online as soon as possible or call toll-free from anywhere in America at 1-877-678-3400.

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Political lobbying may have trumped FDA scientists’ opinions during the approval process for the medical device Menaflex, the Wall Street Journal reported March 6. According to the newspaper, internal documents and emails show that FDA scientists twice rejected an application for controversial “fast-track” approval by Menaflex maker ReGenBiologics Inc. before the agency later approved the device. Agency emails show that officials later removed language from a draft letter because it documented special treatment for ReGen.

Menaflex is an implant used to treat tears to the meniscus, the most commonly injured part of the knee. Millions of people undergo surgery to correct a torn meniscus every year, and some need to repeat the surgery later. This device is unique, according to Dr. Jay Mabrey, an orthopedic surgeon who chaired the FDA advisory committee that considered Menaflex. For that reason, Mabrey told the Wall Street Journal, he believes it should not have been fast-tracked. Mabrey said he now suspects that the FDA packed the committee with friendly members to secure approval for Menaflex.

The ordinary approval process was not working out well for Menaflex. According to the article, ReGen started a clinical trial required under the conventional approval process, only to be rebuked by the FDA for recordkeeping violations and a conflict of interests on its independent oversight panel. ReGen then applies fast-track approval process -- which doesn’t require a clinical trial -- even though devices must be substantially similar to an approved device to qualify. After the FDA rejected its request twice, ReGen enlisted lobbying help from elected officials and sent letters pressuring the FDA to remove officials who had rejected their requests before. The agency did what ReGen asked, even after FDA scientists disputed ReGen’s favorable analysis of the results in its clinical trial.

The agency is already under fire for its handling of medical device approvals. An anonymous group of FDA staffers wrote to the Obama transition team in January calling for the removal of top medical device officials, saying the process was “corrupted and distorted by current FDA managers.” Also in January, the watchdog General Accountability Office said the FDA was too quick to allow fast-track approval. If all of these allegations are true, they point to severe corruption of the regulatory process -- and the science behind that regulation. And that would put patients who use and trust Menaflex in potential danger from an untested, unproven device.

As a defective medical device lawyer practicing in Missouri and around the nation, I have seen multiple cases of medical devices with serious flaws that cause real harm to patients. If improper pressure from ReGen contributes to another, victims could have a strong case against the company for knowingly bypassing safety regulations and selling an untested, unproven product. In a dangerous medical device claim, patients can win back all of the costs related to the injury, plus compensation for physical pain, emotional suffering and any permanent disability. The Lowe Law Firm handles these claims throughout the United States for a variety of unsafe medical devices, along with defective prescription drugs.

If you or someone you love has been hurt by Menaflex or any other flawed medical device and you’d like to learn more about your legal options, please contact the Lowe Law Firm online or call us at 1-877-678-3400.

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Federal legislators are introducing new bills that would allow patients to once again file lawsuits over injuries from flawed or unsafe medical devices, the New York Times reported Feb. 19. The bills are necessary because of a February 2008 Supreme Court decision in Riegel v. Medtronic Inc. (PDF), which found that defective medical device lawsuits based on state claims are preempted by explicit language in federal law. The decision barred most, if not all, medical device claims, leaving patients at the mercy of a flawed FDA approval process.

The article starts with the story of the Turnidge family, which lost father Mark Turnidge in January. Turnidge, 33, had an internal defibrillator implanted into his heart, which was intended to regulate his heartbeat. Because of a break in the device that could have caused random, repeated electric shocks to his heart, Turnidge decided to have it surgically removed -- but the surgery went wrong. Turnidge died, leaving wife Wendy and two young boys behind. Wendy Turnidge is considering a medical malpractice lawsuit as well as a dangerous medical device lawsuit against Medtronic, the maker of the flawed defibrillator that made the surgery necessary. But thanks to the Riegel decision, a Medtronic lawsuit would almost certainly be dismissed unless Congress takes action.

Preemption is a legal doctrine that says federal law trumps the laws of states and local governments. If a federal law preempts a state law, following that federal law should protect individuals and businesses from criminal or civil liability for not following state laws on the same subject, including state negligence claims. The Riegel decision found that language in the Medical Devices Amendments of 1976 explicitly preempted state claims. (This makes it distinct from the court’s more recent decision in Wyeth v. Levine, in which the pharmaceutical company argued that the law implied, but did not outright specify, preemption.)

As the Times reported, this decision left medical device patients to rely wholly on FDA regulators to prevent serious injuries or even deaths from medical device defects. That would be more reassuring if so many medications and medical devices had not been recalled in recent years due to serious safety flaws, and if we had not seen so many reports of political and industry influence trumping science at the agency. As a pharmaceutical liability attorney, I have seen patients killed, disabled or diagnosed with lifelong serious health conditions because of injuries from FDA-approved medicines and devices. I do not believe FDA approval is enough to ensure safety, at least at the moment.

Based in St. Louis, The Lowe Law Firm represents clients in Missouri and throughout the nation in defective medical device litigation and dangerous prescription drug claims. If you or someone you love has been hurt by a pharmaceutical product and you’d like to talk with us about legal action, please contact us online or call us toll-free at 1-877-678-3400.

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A federal judge has dismissed with prejudice lawsuits filed over lead wires to an implantable defibrillator made by Medtronic, the Associated Press reports.

The court concluded that the Food and Drug Administration’s approval of the device protected Medtronic from lawsuits under the legal doctrine of preemption. The lawsuit involved the Sprint Fidelis defibrillator wires. In 2007, the wires were pulled off the market after it was discovered that broken wires may have played a role in several patient deaths.

Last year, the U.S. Supreme Court ruled that Medtronic was protected from a similar lawsuit involving FDA approval of a balloon catheter that could burst during angioplasty.

With the democrats controlling the United States House, Senate and Presidency, this protection of medical device manufactures under the guise of preemption may be overturned legislatively.

If you believe you have been injured by a defective medical product, we can help. Contact The Lowe Law Firm headquartered in St. Louis, Missouri to discuss your case.

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The Minneapolis Star-Tribune reported that a doctor from the Minneapolis Heart Institute Foundation expressed grave doubts this week about the safety standards for a new breed of defibrillators. In the Dec. 11 edition of the New England Journal of Medicine, Dr. Robert Hauser (writing with Dr. Adrian Almquist of the Heart Institute) warned that FDA regulations for the medical devices must be strict -- or patients could suffer lethal consequences.

The defibrillators at issue are an improved version of existing implanted defibrillators (ICDs), which are implanted directly into patents’ chests. The devices work by monitoring patients’ heartbeats and sending electric shocks to the heart if they detect missing or irregular heartbeats. Unfortunately, some existing models of ICDs had to be recalled after a lead -- the wire that leads from the device to the patient’s heart -- turned out to be likely to break. This has caused at least five deaths and sent other patients to emergency rooms with uncontrolled and random electric shocks.

Dr. Hauser was among the first to blow the whistle on past ICDs; he and a colleague went public with concerns in 2005 after a patient died due to a defective implanted defibrillator. His current concern, according to the Star-Tribune, stems from the fact that new devices can be approved by the FDA with little testing or review if they’re similar to existing devices. He writes that the new design, which features more leads attached to the patient’s heart, is different enough to require new studies before the FDA can safely approve it. A representative from the FDA wrote that no final decision has been made.

A representative from the medical device industry also told the newspaper that the manufacturers themselves test the devices thoroughly before they reach market. Unfortunately, this is cold comfort for victims of defective medical devices and unsafe prescription drugs. As a Missouri medical device defect lawyer, I have seen many situations in which pharmaceutical companies know all about problems with a device or medication, but intentionally do not disclose them to the public in an effort to keep profits high.

When this irresponsible behavior kills or seriously hurts patients, victims and their families have the right to sue the manufacturer over their physical, financial and emotional injuries. My law firm represents victims of several defective medical devices, including the defective Guidant defibrillator Dr. Hauser warned of in 2005. If you believe you’ve been hurt by a defective implanted defibrillator and you’d like to learn more about defending your rights, please contact the Lowe Law Firm for a free initial consultation.

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Thoratec Corp. last month issued a worldwide recall of the HeartMate II Left Ventricular Assist Systems device.

According to the company’s press release, wear and fatigue of the percutaneous lead can cause the pump to stop working. At least five people have died while using the device and the company has received 27 reports of wear and fatigue to the electrical wire.

The mishaps occurred over the past five years with 1,972 implants. The pumps were distributed to 153 hospitals in throughout the U.S., Canada, Europe and other countries.

The recall affects devices with catalog numbers 1355 and 102139. The Lowe Law firm has experience with with defective medical devices and in particular the Thoratec Heartmate LVAD's. We are currently representing the family of a man who died due to the failure of the Thoratec Heartmate II.

If your life has been affected by a defective medical product, we can help. Contact The Lowe Law Firm in St. Louis, Missouri to discuss your case.

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Transvaginal mesh has resulted in over 1,000 Reports of Complications in 3 Years. That number should be multiplied because epidemiologist in the medical field acknowledge that adverse events are under reported usually by a factor of ten. Consequently there may have been an additional 9,000 complications which were not reported.

FDA has issued a public health notification concerning serious complications associated with transvaginal placement of surgical mesh used in the repair of pelvic organ prolapse (POP) and urinary Stress Urinary Incontinence.

Over the past 3 years, FDA has received more than 1,000 reports from 9 surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. These mesh devices are usually placed transvaginally utilizing tools for minimally invasive placement.

The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.

Treatment of the various types of complications included additional surgical procedures (some of them to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.

My law firm currently is handling cases for the defective Kugel Mesh and we are investigating cases involving other defective mesh products. The lawyers of The Lowe Law Firm are experienced in helping people injured by Defective Mesh Products. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages.

We offer a free initial consultation for victims harmed medical products. If you cannot make it to our office, we will come to you where ever you are.

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Medtronic and the Food and Drug Administration (FDA) issued a Class I Recall of the Medtronic Neuromodulation INDURA IP. The recall of the Medtronic device was prompted by potential for life-threatening blockages.

A Class I Recall is the most serious of type of product recall issued by the FDA, and involves situations in which there is a reasonable probability that use of the product will cause serious injury or death.

The pain pumps are often used in patients who have spasticity related to cystic fibrosis, traumatic brain injury, multiple sclerosis and chronic pain. About 25,000 devices have been sold since May 2007.

This recall was prompted by potential misconnections of the Medtronic sutureless connector ("SC") catheters from the catheter port on the pump. These misconnections have resulted in a blockage between the sutureless pump connector and the catheter port on the pump and disconnection from the pump connector.

The Medtronic Neuromodulation INDURA IP consists of 2 models of intrathecal catheter, the sutureless pump, and the intrathecal catheter pump segment revision kit.

The intrathecal catheter or intrathecal catheter revision kits use a sutureless connector for the final connection to the implanted Medtronic SyncroMed II, SynchroMed EL, and IsoMed infusion pumps. The catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space.

The product models included in the recall are: Intrathecal Catheter, Model 8709SC; Intrathecal Catheter, Model 8731SC; Sutureless Pump; Connector Revision Kit, Model 8678; and Intrathecal Catheter Pump Segment Revision Kit, Model 8596SC.

My law firm currently represents numerous victims and their families in lawsuits against Medtronic. The lawyers of The Lowe Law Firm are experienced in helping people injured by Medtronic. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages. We also represent family members in wrongful death cases.

We offer a free initial consultation for victims harmed pharmaceutical products. If you cannot make it to our office, we will come to you.

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