Current Projects


Digitek Digoxin Recall

As of April 25, 2008 there has been a nationwide recall of Digitek (digoxin tablets, USP, all strengths) for oral use. The recall is due to the possibility that tablets with double the appropriate thickness may have ben commercially released. These tablets contain twice the approved level of active ingredient needed. Digitek is used to treat heart failure and abnormal heart rhythms, the existence of double strength tablets poses a risk of digitalis toxicity in patients with renal failure. Digital toxicity can cause Nausea, vomiting, dizziness, low blood pressure, cardiac instability, bradycardia and even death.


NuvaRing

NuvaRing is the trade name for a combined hormonal contraceptive vaginal ring manufactured by Organon. NuvaRing releases a combination of thinyl estradiol and etonogestrel, a progestin, which has been associated with a higher risk of deep venous thrombosis, which can cause blood clots. In two studies 15% of women discontinued use after one year because of adverse side effects. Several possible side effects are strokes, blood clots, hear attacks, and pulmonary embolisms. These severe side effects have been linked to the high dose of etonogestrel released by NuvaRing.


Duragesic Pain Patch

A pain patch which may have a cut in the internal reservoir lining. The result is the possible release of fentanyl gel from the gel reservoir into the pouch in which the patch is packaged, exposing patients or caregivers directly to fentanyl gel. Fentanyl, a drug 100 times stronger than morphine with effects similar to heroin, is supposed to be released in controlled doses into the patient’s bloodstream by absorption through the skin. If the wrong dose is administered, the patient can suffer an overdose that may be fatal.


Stryker Hip Replacement

The defects in two hip implant components have resulted in complications in patients who have had hip replacement surgery which include bone fractures, and possible staph infections. Other problems resulting from the defects include squeaky or noisy hip implants, pain and discomfort, difficulty walking, component breakage and chipping, and uneven component ware. The complications and problems result in some patients requiring revision surgeries and in some cases, secondary hip replacement surgeries.


Gadolinium is a metal that is often in drugs used by Radiologist in performing MRI’s. Gadolinium has been known to cause a condition called nephrogenic systemic fibrosis (NSF). When Diagnosed with NSF systems may include Tightening and swelling of the skin, usually in the extremities, Thickening of the skin around the joints, which restricts movement, Muscle weakness and many more symptoms.


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Advanced Medical Optics Voluntarily Recalls Complete MoisturePlus Contact Lens Solution. The company is taking this action as a precaution because of reports of a rare, but serious, eye infection, Acanthamoeba keratitis, caused by a parasite Acanthamoeba keratitis may lead to vision loss with some patients requiring a corneal transplant. The infection primarily affects otherwise healthy people who wear contact lenses. The symptoms of Acanthamoeba keratitis can be very similar to those of common eye infections and may include eye pain or redness, blurred vision, light sensitivity, sensation of something in the eye or excessive tearing but Acanthamoeba is more difficult to treat.

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Stents are small stainless steel tubes used to prop open and offer support to arteries that would otherwise be collapsing.   The CYPHER® and TAXUS® Stents are drug eluting stents (DES), also known as medicated stents. They are coated in medications intended to prevent restenosis  (re-blocking of the artery).   Medicated stents represent approximately 90% of all stents sold in the U.S. in recent years. Recent studies have linked medicated stents with side effects such as thrombosis (blood clotting) and the need for long-term costly antiplatelet medication therapy in order to prevent thrombosis. The studies also found that the drug-coated stents may result in a higher death rate due to cardiac events such as heart attack when compared to metal stents without a drug coating.

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The Composix Kugel Mesh Patch was removed from the U.S. market on December 22, 2005.  The Composix Kugel Mesh Patch is used for ventral or incisional hernias and is manufactured by Davol, Inc and  was recalled because the “memory recoil ring,” which opens the patch after it has been inserted into the intra-abdominal space, can break causing injury.

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A contact lens solution linked to a serious fungal eye infection resulting in possible blindness.

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A birth control patch associated with life-threatening blood clots, fatal heart attacks, strokes, pulmonary embolisms and others serious medical problems.


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FDA Issues Nationwide Notification of Class I Recall of Certain Guidant and Medtronic Implantable Defibrillators. These devices can develop an internal short circuit without warning, resulting in failure to deliver a shock when needed. Such a delay or non-delivery could result in patient injury or death because patients are not receiving the appropriate therapy in timeThe FDA defines a Class I recall as a situation in which there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.

Tobacco and Second Hand Smoke
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The Alvarez Law firm also represents people injured by tobacco products, including flight attendants with respiratory illnesses resulting from their exposure to secondhand cigarette smoke aboard airline flights.

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Latest Firm News$2.2 Million in Settlement in Last 30 Days
posted on Jun 04, 2007

In a combination of trials, and negotiated settlements, the Alvarez Law Firm successfully recovered $2.2 million in awards...
 
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FDA Med Watch
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