Drug Injury Lawyer Blog

INSULIN PUMP PROBLEMS CONTINUE TO PLAGUE DIABETICS

2010-03-05T15:25:41Z

According to The Wall Street Journal, the FDA is becoming increasingly concerned about the continuing and increasing number of hardware and software problems associated with insulin pumps, small devices worn by many diabetics to continuously deliver insulin, as an alternative to shots. Incredibly, over the last five years, there have been 18 recalls of insulin pumps, including recalls by manufacturers Johnson & Johnson, Medtronic, Inc., and Roche Holding AG. Tomorrow, the FDA is convening an advisory panel of experts to discuss what needs to be done to “minimize risks associated with the devices in these situations."

]]> These insulin pumps are typically used by diabetics who have Type 1 diabetes who produce little to no insulin naturally. The FDA has reported that the use of these pumps has tripled since 2002.

In the last two years alone, there have been nearly 17,000 adverse event reports filed and 12,000 injuries related to insulin pumps, many resulting in death. In fact, in 41 adverse event reports claiming the device resulted in death, the circumstances surrounding the death involved diabetic coma and incorrect blood sugar measurements.
Moreover, adverse events from medical devices are typically underreported to the FDA so the number of injured patients from these products is substantially greater than 12,000. This is an incredibly high number of adverse events for a device that is so critical to so many diabetics.

Many additional questions need to be asked besides those posed to the FDA advisory committee tomorrow concerning what to advise a patient when their device is recalled. The more significant questions that need to be asked are (1) why wasn’t the FDA calling for expert advisory meetings 10,000 injuries earlier; (2) what is causing these products to continually malfunction; and (3) why are the device manufacturers continuing to produce, sell and market defective products? These devices can obviously increase the quality of life for thousands of diabetics – but no diabetic would trade this benefit for the risk of their device malfunctioning.

If you’ve been injured as a result of defective insulin pump, do not hesitate to contact Pogust, Braslow & Millrood, LLC, so we can evaluate your potential claim.

OFF-LABEL PROMOTION CONTINUES TO MAKE NEWS

2010-02-26T21:07:08Z

Last week, Novartis agreed to settle criminal allegations involving Trileptal, an anti-epilepsy drug, as it deals with similar investigations involving five other Novartis drugs: Diovan, Exforge, Zelnorm, Keturna and Sandostatin. Novartis has agreed to plead guilty to violations of the U.S. Food, Drug, & Cosmetic Act and pay a fine of $185 million. The settlement is pending court approval.

]]> The spate of recent settlements involving illegal off-label promotion of drugs, is encouraging. The question remains, however, whether drug companies view this as the cost of doing business and are deterred from this illegal practice or whether they will continue to market their drugs for any and all potential indications, no matter what the consequences. My guess is that we will see several new qui tam or whistleblower suits in the coming months.

Pogust, Braslow & Millrood represents numerous clients who have developed an irreversible shoulder injury, called PAGCL or chondrolysis following the injection of pain medications directly into the shoulder joint. Recently, the FDA announced that it will require pain pump manufacturers and the manufacturers of the pain medications used in the pain pumps to update their product labels concerning this risk. The FDA stated that it has not cleared any infusion device with an indication for use in intra-articular infusions of local anesthetics. Accordingly, promotion of these products for this purpose is and has been illegal and off-label.

If you are a physician or a sales representative who is personally aware of this off-label marketing for pain pumps, please contact our firm and we will explore what legal options are available.

HOSPITAL-ACQUIRED INFECTIONS STILL A HUGE THREAT TO PATIENTS

2010-02-26T18:37:50Z

Perhaps the most troubling part of a recent study published yesterday in the Archives of Internal Medicine, which estimates that 48,000 people died in 2006 after developing deadly infections while in the hospital, was that many of the deaths involved healthy people who had minor procedures. Sepsis and pneumonia were the two most prevalent infections, accounting for one-third of the 1.7 million that American patients pick up every year while in the hospital, but the figure may be even higher according to the Study. And while certainly many hospital-acquired infections are unavoidable, many of the infections occur because of a lack of proper infection control. This is a serious and growing problem that some hospitals have addressed but many have not.

]]> Additionally, the cost of these infections is having an enormous economic impact on our healthcare. Infections typically require patients to spend significant extra time in the hospital and cost $8.1 billion each year to treat, according to the Center for Disease Dynamics, Economics, and Policy at Washington-based Resources for the Future. And the cost of prevention is cheap – follow hospital protocols for hand washing and sanitizing medical supplies. According to the CDC’s Guidelines for Hand-Hygiene in Healthcare Settings, an average of only 40% of healthcare workers adhered to hand hygiene protocols .Although, I would expect this figure to be higher today with the H1N1 fears and more state legislatures becoming involved in requiring hospitals to report these types of infections.

In a recent article published by the University of Calgary, faculty of nursing, healthcare workers often fail to comply with hospital hand washing protocols due to inconvenient access to hand washing utilities or shortage of time. The article recommends alcohol based hand rubs with no-touch dispenser in every patient room, outside elevators, in waiting rooms and outside staff workstations and medical equipment should be cleaned regularly.

Next time you or a family member has to go to the hospital. Please take notice of the hospital’s hand-washing protocols and wash your hands.

Step Therapy – Health Care Cost Effectiveness at What Cost

2010-02-22T17:06:46Z

In an attempt to drive down health care costs, insurance companies are utilizing what is commonly called "Step Therapy". Step Therapy, also called Step Protocol, forces patients to try the least expensive drug for a particular condition first to see if it is effective. If that drug is not effective, then the insurer will approve payment for the next least expensive drug and so on. From allergy and heartburn medications, to blood pressure medications, to medications for pain, New Jersey doctors and patients continue to be denied and denied again when it comes to Step Therapy.

]]> And while maintaining health care costs is a good thing and cheap generic drugs are typically as effective as their expensive brand name counterparts, is it really fair to deny coverage for a drug that your doctor believes is the most effective drug for the treatment of your medical condition? Apparently, the state of New Jersey believes that the Step Therapy protocol is unfair – because New Jersey regulations prescribe this practice of forcing patients and their doctors to take cheaper medications first – especially when the doctor knows this is not the standard of care. Then, the question is, why are New Jersey insurers violating these regulations and requiring New Jersey patients to try cheaper, potentially less effective medications against their doctor’s wishes? The answer is simple. No one has stood up to these insurers and demanded they stop this questionable, and at least in New Jersey, illegal practice.

Ironically, this practice of challenging a doctor’s prescribing habits may ultimately backfire in controlling costs if patients get ill from taking a less effective drug for their condition. These insurers are gambling with patient health. Doctors are in the best position to determine what particular drug best suits a particular patient and his or her condition. When insurers begin making decisions for doctors, patients lose. And, ultimately, the insurers may lose as well.

If you’ve been injured as a result of an insurer denying coverage for a medication prescribed by your doctor or even if you are paying out-of-pocket for a medication denied by your New Jersey insurer, contact us at Pogust, Braslow & Millrood. We are not afraid to stand up to these insurers.

More illegal off-label marketing? Fentora now under investigation

2010-02-19T21:27:08Z

The drug Fentora is Cephalon’s next generation narcotic painkiller which is only approved for cancer patients who are in severe pain and already taking morphine or other painkillers. In other words, this drug should only be used for those cancer patients whose normal pain medications are not providing pain relief. This highly addictive drug is considered a “Class II” opiate, 80 times more powerful than morphine. So why are thousands of patients taking this drug for migraines, back pain and other injuries?

]]> In 2007, after sales data revealed more than 80,000 prescriptions for Fentora, questions arose as to whether Cephalon was illegally marketing Fentora for off-label uses, after it had already been investigated in 2006 for illegally marketing its predecessor drug, Actiq.

Drug companies are not allowed to market the drugs for any reason other than what the Food and Drug Administration has approved. In 2008, an FDA panel denied Cephalon’s request to expand the approved uses of Fentora. One FDA official was concerned that use of Fentora in non-cancer patients could have devastating effects. Of particular concern is the risk of severe injury or death when Fentora is given to an individual who has never been exposed to this type of medication. Obviously, when Fentora or Actiq are prescribed for conditions other than cancer, the risk of opioid intolerance is greatly increased. In fact, Actiq has been linked to 127 deaths and 91 serious injuries from fatal respiratory complications.

In September 2007, following several deaths from Fentora, Cephalon issued a warning letter to physicians advising of serious adverse events and death involving Fentora. This warning, however, has apparently not been enough to stop physicians from prescribing this drug to non-cancer patients. Currently, Cephalon is being investigated for off-label marketing of Fentora.

Off-label marketing of drugs to physicians is illegal and should not be tolerated under any circumstances. This does not mean that physicians shouldn’t be allowed to prescribe drugs for uses that are not approved by the FDA. What it does mean, though, is that drug companies, particularly those who are aware that their drugs are being prescribed in this manner, need to conduct proper studies to confirm whether these off-label uses are safe and effective.

If you have been injured by Fentora or have first-hand knowledge of these off-label marketing practices, please contact us. Until these illegal practices stop, more lives will be needlessly lost to drugs like Fentora, which can help many people – but only if used properly.

Surgeons have an Ethical Duty to Warn of Risks with Shoulder Pain Pumps

2010-02-13T22:39:52Z

Dr. Joseph Carrese, director of the ethics and clinical practice program at John Hopkins Berman Institute of Bio-Ethics, recently stated that he believes surgeons need to inform all of their patients about the risks associated with the use of a pain pump catheter during shoulder surgery. Presently, many arthroscopic shoulder surgeries utilize this tiny catheter, placed directly into the shoulder joint, which infuses pain medication continuously for several days following the procedure. The concern that Dr. Joseph Carrese and many others have, is what happens to patients in the long run, as the result of this device.

]]> Although rare, some patients may develop a condition called Post-Arthroscopic Glenohumeral Chondrolysis, or PAGCL, which occurs when the pain medication deteriorates the bone cartilage between the shoulder joints creating bone on bone contact. This results with patients experiencing extreme pain in the shoulder joint and of a feeling and hearing a popping or clicking when moving their arm. There is no cure or treatment for this debilitating condition, other than a complete shoulder replacement.

Based on growing reports of chondrolysis, Dr. Carrese has laid out several specific directives for physicians to discuss with any individuals who have had a pain pump or are possibly going to get a pain pump following arthroscopic shoulder surgery.

First, physicians should discuss the potential risk and adverse events that are commonly associated with the use of a pain pump, stemming from when anesthetic medication is applied directly into the joint space.

Second, for all patients that develop chondrolysis, physicians must give patients all known information about this condition including the likelihood that their condition is the result of the pain pump and the steps they may take for proper diagnostic and treatment care. Finally, for all patients that develop chondrolysis, physicians should advise the patients of their right to pursue legal action relating to their condition.

If you think that you may be suffering from chondrolysis after having a postoperative pain pump inserted directly into your shoulder following your arthroscopic shoulder surgery, then please contact Pogust Braslow & Millrood for a free consultation.

Graco Stroller Recall

2010-01-26T19:06:48Z

On Wednesday, January 20, 2010, Newell Rubbermaid announced that it is recalling 1.5 million baby strollers after receiving 7 reports of amputations or lacerations to children’s' fingers. The products' canopy hinges are to blame for the injuries, which occurred when children got their fingers stuck in the canopy as it was being opened or closed.

]]> The recall by Graco Children's Products, Inc., an Atlanta-based division of Newell Rubbermaid, Inc., includes certain model numbers of Passage, Alano, and Spree Strollers and Travel Systems, which have been on the market for five years. The company claims it moved quickly to create a protective hinge cover, available free to any consumers who have purchased a recalled product. A complete list of the recalled products is available on Graco's website. To identify a stroller’s model number and manufacturing date, look on the sticker located on the lower, inside portion of the rear frame, above the rear wheels.

The New York Times and the Atlanta Business Chronicle have reported that the strollers were made in China and sold to major United States retailers, such as Wal-Mart, Target, Babies R Us and Toys R us, K-mart, Sears, and others from October 2004 to December 2009.

The Consumer Product Safety Commission is turning new attention to the entire product line, according to spokesman Scott Wolfson, as this is he second large-scale stroller recall that has occurred recently. The Times noted that /Maclaren strollers were recalled after similar reports of the amputation of children's fingertips due to a hinge mechanism.

Meridia Causing Heart Problems?

2010-01-26T18:06:41Z

Last week, the Food and Drug Administration (FDA) requested that drug manufacturer Abbott Laboratories strengthen the product labeling for its weight-loss drug Meridia (sibutramine) to disclose an increased risk of heart attack and stroke in patients with a history of cardiovascular disease.

]]> The FDA’s request comes on the heels of its review of additional data from the SCOUT (Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event) trial, which was a six year study including approximately 10,000 overweight and obese patients with a history of heart disease, diabetes, or both. According to the FDA's safety alert, the study was intended to investigate whether treatment with Meridia was more effective than placebo in reducing the risk of cardiovascular events.

Early results from the SCOUT trial, released in November 2009 and reviewed by the FDA at the time, showed that Meridia actually increased the risk of heart events, and last week’s update confirmed that this increased risk was specific to patients in the study with a history of cardiovascular disease.

Interestingly, the FDA’s European counterpart, the European Medicines Agency (EMA), took a different tack. The EMA advised physicians to stop prescribing Meridia altogether.

If you or a family member has a cardiovascular event while taking Meridia, you can contact our firm to help you determine whether you have a legal claim. Call us at (610) 941-4204 or reach us on the web at www.pbmattorneys.com. We are here to listen to your story, and we’ll help you protect your legal rights.

Tylenol Recall by Johnson & Johnson

2010-01-19T13:28:32Z

Last week, drug manufacturer Johnson & Johnson announced an expansive recall of a variety of products, including Tylenol, Motrin, and Benadryl, after complaints of an “unusual moldy, musty or mildew-like” odor accompanying the products.

]]> Apparently, J&J has dragged its feet in dealing with the odor issue, as it was receiving complaints from consumers as far back as 2008. According to the FDA, J&J did not notice the issue until September 2008 and did not notify the FDA until November 2009, when the company recalled certain lots of its Tylenol Arthritis Pain product. On December 18, 2009, J&J expanded that recall to all lots of that product. On January 15, 2010, the company expanded the recall yet again, this time to include a variety of other products that were affected by the odor. The FDA has sent a warning letter to J&J giving the company 15 days to report back to the agency and outline its progress in handling the problem and preventing similar problems in the future.

According to J&J, the odor was caused by a chemical used to treat wooden pallets on which packaging materials for certain products were shipped, and the contamination has resulted in consumer complaints of nausea, vomiting, stomach pain, and diarrhea. The company would not comment on whether or not the chemical contamination altered the makeup of any of the drug products at issue.

If you need to know whether a product you purchased is subject to the recall, you can visit http://www.mcneilproductrecall.com.

And if you or a family member has been injured by a product covered by the recent recall, you can contact our firm to help you determine whether you have a legal claim. Call us at (610) 941-4204 or reach us on the web at http://www.pbmattorneys.com. We are here to listen to your story, and we’ll help you protect your legal rights.

CT Scan Radiation Causing Cancer

2009-12-16T20:32:26Z

In October, we alerted readers that the FDA became aware of numerous radiation overexposures during CT scans at a particular facility, with patients receiving radiation doses that were approximately eight times the expected level. The article noted that this situation may reflect more widespread problems with CT quality assurance programs and may not be isolated to this particular facility - putting patients at increased risk for long-term radiation effects.

]]> Last week, we posted an article that the FDA had identified at least 50 additional patients who were exposed to excess radiation of up to eight times the expected level during their CT scans and that these cases involve more than one manufacturer of CT scanners. Some of these patients reported hair loss or skin redness following their scans.

Now, over the past week, two new studies have been published that indicate the risk of cancer associated with common CT scans is much greater than previously thought - even when the scans are working appropriately. According to the Archives of Internal Medicine, a bi-weekly medical journal published by the American Medical Association, while CT scans have undoubtedly escalated the ease and accuracy of internal medicine diagnosis, the levels of radiation exposure could actually be deadly to many patients.

CT scans carry a wide range of radiation, depending on their diagnostic purpose. According to numerous news reports, in a single procedure, a patient can receive the equivalent of 100 to 440 times the radiation in a conventional X-ray. Dr. Rita Redberg's article in the Archives of Internal Medicine relates that a single coronary angiogram, on average, delivers the equivalent of 309 chest radiographs. This is essentially four times the amount of radiation estimated in earlier studies. The data found by scientists estimates that the risk for developing cancer from the procedure, taking into consideration age, sex, and study type, was one in every 270 forty-year-old women and one in 600 for men. While the risk may be small for any single patient, because 70 million CT scans are given every year in the United States, these scans would cause an estimated 29,000 additional cases of cancer, and 15,000 additional cancer-related deaths.

That is why it is so important that CT scans are not administered unless the alleged benefits of the scans clearly outweigh the risks. The LA Times(12/15) reports that many of these scans are often unnecessary procedures. "Whole body scans of healthy patients are becoming very common, although they rarely find anything wrong...many emergency rooms send patients to the CT scanner before they ever see a doctor." Dr. Rita Redberg confirms this claim, stating that "a pilot study found that only 66% of nuclear scans were appropriate, using American College of Cardiology criteria-the remainder were inappropriate or uncertain."

Bloomberg News (12/15) states that the National Cancer Institute has completed a study predicting lung cancer to be the most common radiation-related cancer. It believes colon cancer and leukemia will follow close behind. The Wall Street Journal reports that one study analyzed data from several databases and that the greatest cancer risk is for young patients. It states that a female who received an abdominal scan at age 3 had a one in 500 chance of developing cancer from it's radiation. The figure drops to one in 1,000 by age 30, and one in 3, 333 at age 70.

Also reported in Bloomberg News, though patients can do little about the doses of radiation they receive during a CT scan, Dr. Rosaleen Parsons, chair of the department of diagnostic imaging at Fox Chase Cancer Center in Philadelphia, says that they should be their own advocates. She encourages patients to keep records of the number of scans they have received, and discuss other types of imaging with their doctors, such as magnetic resonance imaging (MRI), to minimize radiation exposure.

If you feel that you have been unnecessarily exposed to high doses of radiation as the result of CT scans, contact the law firm of Pogust, Braslow, & Millrood, LLC.

New Safety Warnings About Diabetes Drug and Kidney Functions

2009-11-06T19:23:34Z

Recently, the safety warnings were strengthened for the diabetes drug Byetta relating to the risks of pancreatitis and the medicine’s use by patients with severe kidney disease. Specifically, the US Food and Drug Administration ("FDA") notified healthcare professionals of revisions to the prescribing information for Byetta (exenatide) to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency.

]]> The increased warnings come after six patients taking Byetta died in August 2008 from pancreatitis, an inflamed pancreas. Furthermore, from April 2005 through October 2008, the FDA received 78 cases of altered kidney function (62 cases of acute renal failure and 16 cases of renal insufficiency), in patients using Byetta. Overall, 91 percent of patients were hospitalized, 18 required dialysis, two had kidney transplants, and four died. Eighty percent stopped taking Byetta, and half of those patients had an improvement in kidney function after stopping the drug.

It is now advised that patients with “severe kidney problems” should not take Byetta and that any treatment with Byetta should be done “with caution” in people who have had a kidney transplant.

Byetta, manufactured by Amylin Pharmaceuticals and Eli Lilly, is approved for use as a supplement to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Byetta is administered via twice-daily injection and has been sold since April 2005 for patients also taking other diabetes medications. Doctors wrote almost 7 million Byetta prescriptions between 2005 and 2008 with a main consideration being that it's easier to inject than insulin and can promote weight loss in some people.

If you have any questions related to this information, please contact us at Pogust Braslow & Millrood. Additionally, as with any medication, side-effects related to this drug should be reported to the FDA.

Video and Audio Cables: Are Consumers Paying More than Necessary?

2009-10-21T19:08:49Z

Consumers have paid upwards of $100 for cables whose performance is equal to a standard $10 six-foot HDMI cable. Many electronic stores and manufacturers have made claims that these “premium” cables outperform standard cables. However, many well respected third party reviewers, such as cnet.com contend that this isn’t necessarily the case. “Do you really need to spend that much money on a single HDMI cable? Absolutely not – those cables are a rip-off” says CNET. “And despite what salesman and manufacturers might tell you, there’s no meaningful difference between the $10 cable and the $50 cable.”

]]> Cases where consumers have been mislead about the quality of the cables, and extreme up-selling has also been happening more frequently than not. According to engadgethd.com “Upon further inspection, he realized that the difference in picture quality wasn't due to the gold-plating or fancy braiding, but rather the use of composite cables on the non-Monster TV.” And according to gizmodo.com “While Monster cables are of good quality and engineering, when it comes to digital signals, specifically HDMI cables, we know that its a better idea to buy a $5 dollar HDMI cable today, and then when bandwidth requirements go up in future specs of HDMI, just buy another $5 cable then. It's a lot cheaper than $100 HDMI cables from Monster.”
If you have experienced any of these practices, contact us immediately. Practices such as these are misleading to consumers and are leaving them with no choice but to pay premium prices for unnecessary high-end cables.

Even More Dangers of Taking SSRIs When Pregnant Revealed

2009-10-12T01:55:20Z

According to a recently released Danish study, pregnant women taking an SSRI were twice as likely to have pre-term delivery as other women, and their babies were also more likely to be admitted to an intensive care unit after delivery. Specifically, women taking an SSRI delivered their baby an average of five days earlier and babies exposed to antidepressants during pregnancy were far more likely to have a five-minute Apgar score -- a measure of a newborn's health scored between 0 and 10 -- of seven or below. Any score below seven is generally regarded as low.

Additionally, the study found that women who take more than one SSRI quadrupled the risk of their babies experiencing a septal heart defect, which is a defect in the wall that divides the heart’s left and right sides. For those women taking only one SSRI, the study revealed that use of Celexa and Zoloft early in pregnancy doubled and tripled the risk for the heart defect, respectively. While the association between SSRIs and birth defects has been reported for several years, this is the first study to specifically highlight the increased risk with Celexa and Zoloft.

]]> In September 2005, information emerged that revealed an association between Paxil and birth defects, including cardiac (heart), pulmonary (lung), neural-tube defects (brain and spinal cord), craniosynostosis (abnormally shaped skull) infant omphalocele (abdominal wall defects), club foot (one or both feet turn downward and inward), and anal atresia (complete or partial closure of the anus). In a recently concluded Philadelphia trial, which was the first of 600 filed cases to go to trial, evidence was presented that GlaxoSmithKline, the manufacturer of Paxil, knew of the possible risk of birth defects since 1997 yet failed to disclose the information and, in fact, intended to bury any negative studies. Furthermore, documents showed that Glaxo had gotten a report of a birth defect in 2001 and was "almost certain" that the defect was related to the mother's use of Paxil.

Since the initial health advisory related to Paxil in 2005, the FDA issued an alert in July 2006 warning about the increased risk of Neonatal Persistent Pulmonary Hypertension (PPHN) to babies born to mothers taking SSRI antidepressants including Celexa, Fluvoxamine, Lexapro, Paxil, Prozac, Symbyax and Zoloft. The recent Danish study provides further evidence that the risk of birth defects is associated with all SSRIs, not only Paxil.

If you ingested one of these antidepressant drugs while pregnant and there were complications with your pregnancy as described above, then you should immediately contact Pogust Braslow & Millrood for a free consultation with attorneys who continuously battle the pharmaceutical industry fighting for their clients' rights.

Forced to Rent a Cable Box?

2009-10-02T14:46:09Z

Have you looked at your cable bill and found that you are paying $5, $6, and even $10 a month to rent a cable box from your service provider? Ever wonder why you cannot simply purchase your cable box or rent a cheaper box from another company? Many consumers are limited in subscribing to certain cable companies; however, numerous cable companies take advantage of consumers by charging $60 or more EACH year to rent a set-top box that should cost no more than a DVD player to buy.

]]> Years ago, many people were similarly frustrated and asking these same questions about their telephones because telephone companies only allowed their customers to lease their telephones directly from the company. Eventually this practice was deemed illegal and anti-competitive (read the decision), which is why we are now able to purchase or lease our telephones from a variety of companies, thereby ensuring competition. Currently, however, cable customers throughout the country have been dealing with the same situation and have begun to challenge these unfair practices.

Specifically, Time Warner and Comcast are currently under fire in large multi-district class actions in which their customers are alleging that the practice of requiring cable customers to lease a set-top cable box from them - without providing the option to either purchase the box or rent from another company - violates the antitrust laws of the United States as well as the consumer protection laws of their home states.

While these companies are being challenged, there are many other cable providers who are not. Therefore, if you have been forced to rent a cable box from your cable company, then please contact us so that we can make sure that your rights and those of many other cable subscribers are protected.

Another Medtronic Recall For Infusion Pumps

2009-09-21T18:56:55Z

In August 2009, Medtronic began informing physicians for the first time that, contrary to the labeling, its Sutureless Connector (SC) intrathecal catheters were incompatible with IsoMed Infusion Pump Model 8472, a drug delivery system for which the catheters were not designed. On September 14, 2009, the US Food and Drug Administration ("FDA") notified Medtronic that it considers the notification a Class I medical device recall, the strongest notice that the FDA can issue, because accidental use of the catheters with the wrong pump may lead to disruptions of therapy and revision surgery, which pose a risk of serious injury or death. This incompatibility is a design defect and not a result of how the pump is implanted. In fact, it may appear to be connected and secured, but a physical interference between the catheter and the infusion pump may lead to fluids leaking into surrounding tissues and the proper dose of drugs not being delivered.

]]> Medtronic has received ten reports worldwide related to improper connection of the SC intrathecal catheter and Revision Kit - Models 8709SC, 8731SC, 8578, and 8596SCr - to an IsoMed Pump Model 8472. In all ten reports, medical intervention was required to correct the condition. The ten reported events included reports of underlying symptoms, withdrawal symptoms and fluid collection in the pump pocket. In one case, it was reported that a patient death occurred two days following device revision.

This is the second recall of infusions pumps that Medtronic has issued this summer. On July 10, 2009, Medtronic recalled about 3 million disposable infusion sets designed for use with its MiniMed Paradigm insulin pumps. An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient, and is typically replaced by the patient every three days. The affected infusion sets may not allow the insulin pump to vent air pressure properly. This could potentially result in the device delivering too much or too little insulin and may lead to serious injury or death. In July, Medtronic estimated that about 2% of the sets from a lot number starting with “8″ may be defective.

If you have been affected by either of these recalls or would like more information about these products, please contact Pogust Braslow & Millrood for a free consultation.