by Spencer Aronfeld | Feb 21, 2013 | Defective Drugs
Artificial replacement hip implants made with a metal on metal ball and socket component can corrode, rust and fail. Traditionally, these types of devices are made with a one piece neck and stem that is inserted into the patient’s femur bone. Frequently, patients who have received these kinds of implants often have difficulty walking, feel intense pain and have to undergo revision surgeries. Stryker Orthopedics is one of the largest medical technology companies in the world. It sells over 57,000 products over $8 billion a year in sales. Stryker saw how other metal on metal hip implant manufacturers like Johnson and Johnson’s De Puy were being sued across the country by patients and rushed out a new product called the Rejuvenate. Stryker and its medical device sales representatives told orthopedic surgeons and the FDA that the Rejuvenate was the latest and greatest device. First, it has a ceramic ball and socket that would eliminate metal rubbing on metal. Secondly, Rejuvenate system uses a modular design giving surgeons a variety of components sizes to better fit a particular patient’s anatomy. The Rejuvenate system came with six stems and 16 necks. Sales reps told surgeons that this would make Stryker’s hips the preferred company for younger patients who still had a more active lifestyle. In 2008 Stryker successfully applied for FDA approval for the Rejuvenate under the FDA’s 510(k) Clearances Program. The FDA’s 510 program allows medical devices that are “substantially similar” to an already approved product to bypass the typical testing clinical testing protocol. The FDA allowed Stryker to do “post-market surveillance” rather than testing the devices to make sure...
by Spencer Aronfeld | Dec 24, 2012 | Defective Drugs
Patients who have artificial heart valves should not take Pradaxa (dabigatran etexilate mesylate). Pradaxa is an anticoagulant drug that many hoped would replace Coumadin. Unfortunately, compared to Coumadin, it is more dangerous and deadly. This week, the FDA issued another Pradaxa warning, this time for patients with artificial heart valves. According to Beth Carr,of the U.S. Public Health Service, a European clinical trial of Pradaxa had to be cancelled early, because patients were experiencing serious health issues while taking the drug. ARVE Error: id and provider shortcodes attributes are mandatory for old shortcodes. It is recommended to switch to new shortcodes that need only urlbr /> The FDA warns that Pradaxa should not be used to prevent stroke or blood clots in patients with artificial heart valves due to an increased risk of stroke, heart attack and death. In addition, patients who take Pradaxa are more likely to have bleeding injuries after surgery. The FDA has now officially made Pradaxa “contraindicated” for patients with mechanical heart valves. Any doctor who has patients on Pradaxa with a mechanical heart valve should immediately begin transitioning them to a safer medication. If you are a patient with a mechanical heart valve and take Pradaxa, contact your doctor immediately. Do not hesitate. If you cannot reach your physician contact your nearest emergency room and advise them that you are on a medication that the FDA has just found to cause heart attacks and strokes. It is important to not suddenly stop taking Pradaxa, or any anticoagulant medication, without medical supervision. For additional information on Pradaxa and its new contraindications, you can listen to...
by Spencer Aronfeld | Nov 15, 2012 | Defective Drugs
As a Miami drug lawyer, I am often asked, “Do I have a Pradaxa claim?” In order to answer that, we have to first obtain and analyze medical, pharmacy and autopsy records. Our office utilizes skilled pharmacology and pathology experts to help prove the association between taking Pradaxa and bleeding injuries. Boehringer Ingelheim, one of the largest pharmaceutical companies in the world, makes Pradaxa. They market Pradaxa as a better alternative to Coumodin because it requires less frequent blood testing and does not interact with other medications. In its first year of sales, Pradaxa captured 28% of the market. ARVE Error: id and provider shortcodes attributes are mandatory for old shortcodes. It is recommended to switch to new shortcodes that need only urlbr /> The FDA approved Pradaxa for use by patients with Atrial fibrillation to prevent strokes. The approval was expedited via the FDA’s Fast Track Program. The FDA’s Fast Track Program approves medications before clinical testing is completed. This process is supposed to be used only when a potential new medication fulfills a compelling medical need. Fast Tracking approval for a drug can save lives, but can also be very dangerous. There have been over 3,781 reported adverse reactions, including 542 deaths and 2,367 bleeding injuries associated with Pradaxa. Patients over 80 are at the highest risk for injury and death because Pradaxa, unlike Coumodin, has no known antidote to stop a patient from bleeding. Our Pradaxa compensation claims lawyers are currently investigating a number of claims by people who have taken Pradaxa and suffered bleeding injuries and death. Due to the number of Pradaxa claims already...
by Spencer Aronfeld | Oct 29, 2012 | Defective Drugs
Our Florida Pradaxa claims law firm is continuing to investigate claims on behalf of patients who have developed irreversible. Pradaxa has been prescribed to many Americans who suffer from atrial fibrillation or AFib. AFib is an irregular heart rate that affects blood flow. Symptoms include heart palpitations, shortness of breath and weakness. For many, AFib episodes come and go. For other the symptoms are chronic. Treatment for AFib includes medications and interventions using cardiac catheter radio-frequency. ARVE Error: id and provider shortcodes attributes are mandatory for old shortcodes. It is recommended to switch to new shortcodes that need only urlbr /> AFib is associated with an increased risk for both ischemic and hemorrhagic strokes. In fact, of the 700,000 Americans who suffered a stroke last year, 15% had AFib. For many years the blood thinning medication Coumadin has been used to reduce the risk of strokes of those with AFib. Coumodin, like every medication, has a risk to benefit and requires frequent blood test to adjust the dosage and cannot be taken with certain foods. In October 2010 the FDA speedily approved a new medication called Dabigatran or Pradaxa for use by AFib patients to prevent strokes. Its manufacturer, Boehringer Ingelheim, spent millions to market Paradaxa as a safer and more efficient alternative to Coumadin. They claimed that Pradaxa did not require the same monitoring as Coumadin and would have fewer food interactions. It all sounded good. Unfortunately, Pradaxa is proving to be defective and more dangerous than Coumadin. In its first weeks on the market, there were more than 300 adverse reactions reported to the FDA. By December...
by Spencer Aronfeld | Oct 17, 2012 | Defective Drugs
More and more patients who have undergone hip replacement surgery with Stryker Rejuvneante are being forced to deal with heavy metal poisoning and its symptoms. Approximately 800 people in South Florida alone have received the implant. Our hip implant injury lawyers are currently investigating claims against Stryker for implant patients across the country. Stryker is a multinational medical device manufacturing company based in Michigan. Stryker’s Rejuvante model is different than the typical metal on metal design because it provides surgeons with an option to modify the implant based upon a patient’s unique anatomic and biomechanic profile. ARVE Error: id and provider shortcodes attributes are mandatory for old shortcodes. It is recommended to switch to new shortcodes that need only urlbr /> Shortly after it came onto the market, the Rejuvenate implant was recalled because patients began reporting extremely high cobalt levels. When Styker’s implant components rub together it causes the metal to fray shooting cobalt and chromium particles into the soft tissue of the body. Symptoms of metal poisoning include fatigue, rashes, swelling, vision loss, tumor-like formation, and other health related issues. Removing the recalled implant is very complicated. Our hip recall injury lawyers best advice is to contact your surgeon and request a copy of your medical records and implant identification information card immediately. Many of our clients do not know what kind of implant they have or whether or not it is subject to the recall. If you have received a recalled hip implant you need to proceed very carefully. Many orthopedic surgeons are skilled at implanting artificial hips, but have little or no experience in removing...
by Spencer Aronfeld | Oct 17, 2012 | Defective Drugs
As a Florida lawyer who sues kidney dialysis centers, I want you to know about the recent investigation into Fresenius Medical Care and their dialysis products GranuFlo and NaturaLyte. Dialysis is a medical procedure that takes the place of the kidneys in clearing waste from the blood. The process includes adding bicarbonate to the system to neutralize acid blood buildup. Fresenius is a German company that provides dialysis care to hundreds of thousands of Americans at its clinics. It also manufactures and distributes dialysis machines and bicarbonate products to other independent clinics. GranuFlo is a bicarbonate dialysis product made by Fresenius. Unfortunately, GranuFlo contains more of bicarbonate than its competitors and has now been linked to an increase in patient injury and death. Patients using GranuFlo have six times the risk of cardiac arrest than those with normal levels of bicarbonate. Last year, amidst an increase in reported deaths related to GranuFlo, Fresenius sent out an internal memo to warn its company doctors about the extra bicarbonate. The Fresenius internal memo revealed that 941 patients had suffered cardiac arrests while receiving dialysis at Fresinius clinics. Shockingly, Fresenius chose not to warn non-company-owned facilities. As a result, more than 125,000 patients continued to use GranuFlo. The FDA recently issued an Official Alert and Class I Recall notice to health care providers. The FDA aslo recommends that doctors immediately review their patient’s bicarbonate levels. The FDA also found that GranuFlo may cause serious adverse health consequences and even death. If you have had any adverse problems, complications or side effect due to the use of GranuFlo or Naturalyte, contact a lawyers...
