Drug Injury Lawyer Blog http://www.druginjurylawyerblog.com/ Published by Pogust Braslow & Millrood en Copyright 2012 Fri, 27 Jan 2012 12:19:11 -0500 http://www.sixapart.com/movabletype/?v=3.33 http://blogs.law.harvard.edu/tech/rss Knee and Hip Implants: New Not Always Better Than Old? New technology is supposed to be better than the old, but what happens if the new proves not only to be more expensive, but can show no real advancement prior to the older versions? Technology is an advancing arena but, with artificial hip and knee replacements, it is proving to not be the case.

]]> http://www.druginjurylawyerblog.com/2012/01/knee_and_hip_implants_new_not.html http://www.druginjurylawyerblog.com/2012/01/knee_and_hip_implants_new_not.html Medical Devices Fri, 27 Jan 2012 12:19:11 -0500 Possibility of Smith & Nephew Journey Knee Fracture The ability to move around without pain is something most of us don’t think about, so when patients undergo knee replacement surgery they believe their pain will go away. However, if the patients are still experience pain it could be the result of a fracture, if the replacement was a Smith and Nephew-Journey knee.

]]> http://www.druginjurylawyerblog.com/2012/01/possibility_of_smith_nephew_jo.html http://www.druginjurylawyerblog.com/2012/01/possibility_of_smith_nephew_jo.html Medical Devices Thu, 12 Jan 2012 12:56:50 -0500 Ortho Evra Patch – Is it Worth the Risk? The Ortho Evra Patch provides women with a simple solution for their birth control needs. A patch applied to the skin once a month is more convenient than a pill taken every day. As with most medicines today, there are always side effects to go along with the benefits of taking a certain drug. But at what point do the risks start to outweigh the benefits and conveniences of taking it? Most hormone based contraceptives increase your risk for developing blood clots, but the risk is three times greater with the Ortho Evra Patch. This increased risk comes from higher levels of estrogen as well as the constant dosage of estrogen found in the Ortho Evra Patch but not the pill.

]]> http://www.druginjurylawyerblog.com/2012/01/ortho_evra_patch_is_it_worth_t.html http://www.druginjurylawyerblog.com/2012/01/ortho_evra_patch_is_it_worth_t.html Adverse Drug Update Wed, 11 Jan 2012 08:49:43 -0500 FDA ORDERS MORE TRIALS FOR VAGINAL MESH PRODUCTS Stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are not easy subjects for women to talk about. SUI and POP are often the outcomes of weakening muscle tension caused by age or child birth. Stress urinary incontinence is triggered by the weakening of the pelvic muscles, and it can lead an involuntary loss of urine that results from physical activity. Pelvic Organ Prolapse is a condition where a pelvic organ drops and the bulges against the walls of the vagina often protruding outside the vagina.

]]> http://www.druginjurylawyerblog.com/2012/01/fda_orders_more_trials_for_vag.html http://www.druginjurylawyerblog.com/2012/01/fda_orders_more_trials_for_vag.html Medical Devices Tue, 10 Jan 2012 08:43:41 -0500 Appellate Court Reinstates Hormone Therapy Verdicts for Punitive Damages Yet another appellate court has condemned drug-maker Wyeth Pharmaceuticals for its conduct in failing to study and failing to warn about the breast cancer risk associated with its hormone therapy drugs.

]]> http://www.druginjurylawyerblog.com/2012/01/appellate_court_reinstates_hor.html http://www.druginjurylawyerblog.com/2012/01/appellate_court_reinstates_hor.html Adverse Drug Update Wed, 04 Jan 2012 23:52:57 -0500 The Dangers of Proton Pump Inhibitors - It is time for a Black Box Warning Proton Pump Inhibitor Drugs (PPIs) like Nexium and Prilosec are among the most popular drugs in the world but perhaps they may be the most dangerous when taken over the long-term. I have written about the risks of this class of drugs multiple times in prior blogs (see blogs regarding dependency, bone fractures, infections, among others) but I believe it is necessary at this point to support Public Citizen's petition with the FDA to finally put a Black Box warning on these drugs. see www.citizen.org/petition-asking-fda-to-add-warnings-to ppis.

]]> http://www.druginjurylawyerblog.com/2011/12/the_dangers_of_proton_pump_inh.html http://www.druginjurylawyerblog.com/2011/12/the_dangers_of_proton_pump_inh.html Adverse Drug Update Thu, 01 Dec 2011 12:23:26 -0500 Ironically – the Osteoporosis drug Fosamax causes Femur Fractures Doctors have been prescribing Fosamax for years to prevent bone loss. And last year, for the first time, the FDA required manufacturers of bisphosphonates, including Fosamax, to warn about the fact these drugs can cause a serious bone fracture. Ironically, the drug causes the very indication that the drug was supposed to prevent. This isn’t the first time we’ve seen drugs cause the very problems that they were prescribed to protect against. We had seen this before with antidepressant drugs that were supposed to prevent suicide but actually caused it.
The FDA’s action was apparently prompted by a study of more than 300 women who had suffered leg fractures while taking these drugs. And earlier this year, the FDA mandated that manufacturers of bisphosphonates include language in their labels stating that the optimal duration for patient use has not yet been determined.

]]> http://www.druginjurylawyerblog.com/2011/11/ironically_the_osteoporosis_dr.html http://www.druginjurylawyerblog.com/2011/11/ironically_the_osteoporosis_dr.html Adverse Drug Update Wed, 30 Nov 2011 15:07:34 -0500 More Warnings for Levaquin - May exacerbate muscle weakness in patients with Myasthenia Gravis Last December, Ortho McNeil-Janssen Pharmacetuicals added new labeling to its blockbuster antibiotic Levaquin. This updated black box warning, states that "Fluoroquinolones, including Levaquin, may exacerbate muscle weakness in persons with myasthenia gravis," a neuromuscular disorder. Levaquin and other fluoroquinolones have neuromuscular blocking activity and have been linked to serious adverse events in patients with myasthenia gravis, including ventilatory support and deaths. This warning is in addition to the July 2008 Black Box warning concerning the increased risk of tendonitis and tendon rupture.

]]> http://www.druginjurylawyerblog.com/2011/08/more_warnings_for_levaquin_may_1.html http://www.druginjurylawyerblog.com/2011/08/more_warnings_for_levaquin_may_1.html Adverse Drug Update Tue, 23 Aug 2011 11:09:15 -0500 FDA ISSUES SECOND WARNING ABOUT COMPLICATIONS ASSOCIATED WITH TRANSVAGINAL MESH DEVICES As women age, they sometimes suffer from a condition called pelvic organ prolapse ("POP"). Some doctors have treated this condition with a medical device called a surgical mesh. These surgical mesh devices - made from the same material as Rubbermaid storage containers - have never been tested on patients. Unfortunately, these untested devices have been found to erode patients' insides, which can result in constant pain and additional operations.

]]> http://www.druginjurylawyerblog.com/2011/07/fda_issues_second_warning_abou.html http://www.druginjurylawyerblog.com/2011/07/fda_issues_second_warning_abou.html Medical Devices Tue, 26 Jul 2011 14:45:39 -0500 Paid Researchers Covered Up Serious Risks of Medtronic Infuse Bone Grafts In two reviews, two studies and an editorial appearing in a special issue of The Spine Journal today, a group of spinal specialists directly rebuke the research of other spinal surgeons that has supported the widespread use of a Medtronic bone growth product called Infuse. More specifically, the specialists chastise those researchers who received millions of dollars from Medtronic and allegedly failed to report serious complications and side effects that affected patients receiving the Medtronic Infuse bone graft product during clinical trials. Ultimately, the specialists have found the clinical research to be both misleading and biased. Early access to these reports spurred the U.S. Senate Finance Committee to announce last week that it was conducting a formal investigation into whether doctors with financial ties to the Medtronic were aware of but didn't report potentially serious complications including male sterility, infection, bone loss and unwanted bone growth.

]]> http://www.druginjurylawyerblog.com/2011/06/paid_researchers_covered_up_se_1.html http://www.druginjurylawyerblog.com/2011/06/paid_researchers_covered_up_se_1.html Medical Devices Wed, 29 Jun 2011 15:27:31 -0500 FDA Warns Not to Use SimplyThick in Milk/Formula with Premature Babies The FDA recently announced in late May that 15 infants who had been given the product SimplyThick developed a life-threatening intestinal condition known as necrotizing enterocolitis (NEC), and that two have died. This has led the FDA to warn all parents, caregivers, and health care providers NOT to use SimplyThick to help with swallowing problems in babies who were born prematurely. Nearly all of the 15 infants who developed the condition had been born prematurely (before 37 weeks) but had been released by the hospital with a diet regimen that included SimplyThick to be mixed with their milk or formula in order to thicken it so that the babies would be able to keep their liquids down.

]]> http://www.druginjurylawyerblog.com/2011/06/fda_warns_not_to_use_simplythi.html http://www.druginjurylawyerblog.com/2011/06/fda_warns_not_to_use_simplythi.html Adverse Drug Update Fri, 03 Jun 2011 11:22:17 -0500 Fraudulent Over-the-Counter STD Drugs The FDA has an announced a joint initiative with the Federal Trade Commission (FTC) to combat fraudulent over-the-counter products that claim to be treatments for sexually-transmitted diseases.

]]> http://www.druginjurylawyerblog.com/2011/05/fraudulent_over-the-counter_std_drugs.html http://www.druginjurylawyerblog.com/2011/05/fraudulent_over-the-counter_std_drugs.html Adverse Drug Update Tue, 03 May 2011 16:20:05 -0500 Stryker Cormet Hip and DePuy Pinnacle Hip Systems may also cause metal toxicity Although not yet part of a product-wide recall like the DePuy Orthopedic's metal-on-metal ASR XL Acetabular System and ASR Hip Resurfacing System, Stryker's Cormet metal-on-metal hip system and DePuy's metal-on-metal Pinnacle hip may also cause metalosis, a potentially dangerous and serious condition caused by the metal components of these products grinding up against each other - causing microscopic metal ions (cobalt and chromium) to break off into the surrounding tissues and bloodstream. These hip devices have been implanted in hundreds of thousands of patients over the past several years and their early high failure rates seem like only part of the problem. Perhaps the bigger concern should be this risk of blood toxicity and chromium and cobalt poisoning - the potential adverse effects of which are still being investigated but include soft tissue damage, bone loss and inflammatory reactions. In addition, studies have shown that elevated level may potentially have harmful effects on immunity, reproduction, kidney function, the nervous system and carcinogenisis.

]]> http://www.druginjurylawyerblog.com/2011/04/stryker_cormet_hip_and_depuy_p.html http://www.druginjurylawyerblog.com/2011/04/stryker_cormet_hip_and_depuy_p.html Medical Devices Fri, 08 Apr 2011 16:43:52 -0500 Why is Roche's Accu-CHEK Glucose Meter still on the Market? Between 1997 and 2009, the FDA received 13 reports of death associated with GDH-PQQ (glucose dehydrogenase pyrroloquinoline quinone) glucose test strips in which there was interference from maltose or other non-glucose sugars. Some of the reports indicated that hypoglycemia, confusion, neurologic deterioration, brain damage and coma occurred prior to death. The medical community sometimes refers to this as fatal iatrogenic hypoglycemia, and its reasonable to suspect that there are significantly more cases of hypoglycemia that go unreported or unidentified.

]]> http://www.druginjurylawyerblog.com/2011/03/why_is_roches_accuchek_glucose.html http://www.druginjurylawyerblog.com/2011/03/why_is_roches_accuchek_glucose.html Adverse Drug Update Tue, 22 Mar 2011 14:21:36 -0500 Hair Loss Drugs (Propecia, Avodart) Linked to Sexual Dysfunction and Depression In an article published in the March 2011 issue of The Journal of Sexual Medicine, researchers from the Boston University School of Medicine seem to have confirmed what recent lawsuits have already alleged, namely that there is a link between the use of dutasteride (Avodart) and finasteride (Proscar and Propecia) and temporary and sometimes permanent sexual dysfunction including erectile dysfunction and loss of labido. Notably, more than double the percentage of men reported erectile dysfunction while on one of the drugs (8%) compared to placebo (4%). Further, a loss of sex drive was reported more than twice as frequently among those taking one of the drugs (4%) compared to placebo (1.8%). Other reported side effects of Avodart, Proscar and Propecia included depression, reduced semen production and growth of male breast tissue.

The most devastating information presented, however, relates to symptoms of the side-effects persisting even after the medication was discontinued. In fact, in a second study reported within the same volume of The Journal of Sexual Medicine, Dr. Michael S. Irwig interviewed 71 otherwise healthy men who reported sexual side effects after taking finasteride and determined the mean duration of the negative sexual impact to be 40 months after stopping the drug. Despite the absence of any such information on the drugs' labeling in the United States, these prolonged side-effects do appear on the updated labeling for these drugs in European nations such as Great Britain, Sweden and Italy.

]]> http://www.druginjurylawyerblog.com/2011/03/hair_loss_drugs_propecia_avoda_1.html http://www.druginjurylawyerblog.com/2011/03/hair_loss_drugs_propecia_avoda_1.html Adverse Drug Update Mon, 21 Mar 2011 13:56:27 -0500