Drug Injury Lawyer Blog http://www.druginjurylawyerblog.com/ Published by Pogust Braslow & Millrood en Copyright 2010 Fri, 05 Mar 2010 10:25:41 -0500 http://www.sixapart.com/movabletype/?v=3.33 http://blogs.law.harvard.edu/tech/rss INSULIN PUMP PROBLEMS CONTINUE TO PLAGUE DIABETICS 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."

]]> http://www.druginjurylawyerblog.com/2010/03/insulin_pump_problems_continue_1.html http://www.druginjurylawyerblog.com/2010/03/insulin_pump_problems_continue_1.html Medical Devices Fri, 05 Mar 2010 10:25:41 -0500 OFF-LABEL PROMOTION CONTINUES TO MAKE NEWS 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.

]]> http://www.druginjurylawyerblog.com/2010/02/offlabel_promotion_continues_t.html http://www.druginjurylawyerblog.com/2010/02/offlabel_promotion_continues_t.html Product Liability Fri, 26 Feb 2010 16:07:08 -0500 HOSPITAL-ACQUIRED INFECTIONS STILL A HUGE THREAT TO PATIENTS 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.

]]> http://www.druginjurylawyerblog.com/2010/02/hospitalacquired_infections_st.html http://www.druginjurylawyerblog.com/2010/02/hospitalacquired_infections_st.html Consumer Protection Fri, 26 Feb 2010 13:37:50 -0500 Step Therapy – Health Care Cost Effectiveness at What Cost 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.

]]> http://www.druginjurylawyerblog.com/2010/02/step_therapy_health_care_cost_1.html http://www.druginjurylawyerblog.com/2010/02/step_therapy_health_care_cost_1.html Consumer Protection Mon, 22 Feb 2010 12:06:46 -0500 More illegal off-label marketing? Fentora now under investigation 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?

]]> http://www.druginjurylawyerblog.com/2010/02/more_illegal_offlabel_marketin_1.html http://www.druginjurylawyerblog.com/2010/02/more_illegal_offlabel_marketin_1.html Adverse Drug Update Fri, 19 Feb 2010 16:27:08 -0500 Surgeons have an Ethical Duty to Warn of Risks with Shoulder Pain Pumps 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.

]]> http://www.druginjurylawyerblog.com/2010/02/surgeons_have_an_ethical_duty_1.html http://www.druginjurylawyerblog.com/2010/02/surgeons_have_an_ethical_duty_1.html Product Liability Sat, 13 Feb 2010 17:39:52 -0500 Graco Stroller Recall 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.

]]> http://www.druginjurylawyerblog.com/2010/01/graco_stroller_recall_1.html http://www.druginjurylawyerblog.com/2010/01/graco_stroller_recall_1.html Tue, 26 Jan 2010 14:06:48 -0500 Meridia Causing Heart Problems? 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.

]]> http://www.druginjurylawyerblog.com/2010/01/meridia_causing_heart_problems_1.html http://www.druginjurylawyerblog.com/2010/01/meridia_causing_heart_problems_1.html Tue, 26 Jan 2010 13:06:41 -0500 Tylenol Recall by Johnson & Johnson 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.

]]> http://www.druginjurylawyerblog.com/2010/01/tylenol_recall_by_johnson_john.html http://www.druginjurylawyerblog.com/2010/01/tylenol_recall_by_johnson_john.html Tue, 19 Jan 2010 08:28:32 -0500 CT Scan Radiation Causing Cancer 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.

]]> http://www.druginjurylawyerblog.com/2009/12/ct_scan_radiation_causing_canc_1.html http://www.druginjurylawyerblog.com/2009/12/ct_scan_radiation_causing_canc_1.html Medical Devices Wed, 16 Dec 2009 15:32:26 -0500 New Safety Warnings About Diabetes Drug and Kidney Functions 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.

]]> http://www.druginjurylawyerblog.com/2009/11/new_safety_warnings_about_diab_1.html http://www.druginjurylawyerblog.com/2009/11/new_safety_warnings_about_diab_1.html Adverse Drug Update Fri, 06 Nov 2009 14:23:34 -0500 Video and Audio Cables: Are Consumers Paying More than Necessary? 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.”

]]> http://www.druginjurylawyerblog.com/2009/10/video_and_audio_cables_are_con.html http://www.druginjurylawyerblog.com/2009/10/video_and_audio_cables_are_con.html Consumer Protection Wed, 21 Oct 2009 14:08:49 -0500 Even More Dangers of Taking SSRIs When Pregnant Revealed 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.

]]> http://www.druginjurylawyerblog.com/2009/10/even_more_dangers_of_taking_ss_1.html http://www.druginjurylawyerblog.com/2009/10/even_more_dangers_of_taking_ss_1.html Adverse Drug Update Sun, 11 Oct 2009 20:55:20 -0500 Forced to Rent a Cable Box? 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.

]]> http://www.druginjurylawyerblog.com/2009/10/forced_to_rent_a_cable_box.html http://www.druginjurylawyerblog.com/2009/10/forced_to_rent_a_cable_box.html Consumer Protection Fri, 02 Oct 2009 09:46:09 -0500 Another Medtronic Recall For Infusion Pumps 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.

]]> http://www.druginjurylawyerblog.com/2009/09/another_medtronic_recall_for_i_1.html http://www.druginjurylawyerblog.com/2009/09/another_medtronic_recall_for_i_1.html Medical Devices Mon, 21 Sep 2009 13:56:55 -0500