For almost 100 years, the FDA has sought to protect an unsuspecting public from dangerous and ineffective drugs, medicines and medical devices. The law requires that pharmaceutical companies intending to sell a drug to the public establish that a drug is both safe and effective.
Drug companies initially test a new drug in animals for toxicity. Companies then propose human testing in the form of an investigational New Drug Application. Human testing involves three phases. Phase I clinical trials are designed to evaluate human safety, and usually involve less than 100 subjects; Phase II clinical trials explore drug effectiveness and common short-term side effects, and typically involve a few hundred subjects; and Phase III clinical trials involve several thousand subjects, and are designed to evaluate drug efficacy.
Over the past decade, changes in the FDA approval process have resulted in the expedited approval of many drugs that were later removed from the market because they were found to have dangerous and often life-threatening side effects. All too often, the evaluation of drug safety by pharmaceutical companies has been incomplete and inadequate. These dangerous drugs have left a wake of death and suffering. Present estimates suggest 200,000 people die each year due to drug reactions, with many thousands more injured. These tragedies occur in a industry with domestic sales of over $200 billion dollars each year.
The attorneys at GIANNI • PETOYAN have been involved in representing clients against drug manufactures for many years. Our attorneys have been at the vanguard of drug litigation, extensively involved in the review and analysis of clinical trials and company documents as well as deposing drug company doctors and scientists. We are available to evaluate injuries resulting from drug exposure, including the following medications:
Fen-phen/Redux®: These drugs were popular weight loss drugs in the mid-1990's. Fenfluramine (Pondimin®) and Dexfenfluramine (Redux®) were taken off the market in 1997. An FDA investigation supported by a Mayo Clinic Study suggested that one-third of users of the medication developed serious heart valve damage often requiring cardiac surgery. It has also been associated with pulmonary hypertension, a life threatening disease involving the progressive narrowing of blood vessels in the lungs. It is characterized by progressive shortness of breath, and is incurable.
PPA (Phenylpropanolamine): PPA was the main ingredient in many popular over the counter cough and cold remedies and diet pills, including Dexatrim®, Acutrim®, Robitussion®, Contac®, Triaminic® and Tavist D®. This drug has been linked to serious side effects including hemorrhagic strokes or bleeding into the brain, which can result in serious neurologic injury or death. In November 2000, the FDA removed PPA from the market due to concerns regarding its safety.
Vioxx®: Vioxx® was voluntarily withdrawn from the market on September 30, 2004, by Merck after one of its own studies, showed an increase in cardiovascular events in people taking Vioxx®. This medication, similar to Celebrex®, is a popular pain reliever and arthritis drug that has been associated with an increased risk of blood clots, heart attacks, and strokes. There have been a number of studies that show significantly increased incidences of cardiovascular problems including heart attack, stroke, and sudden death associated with this drug.
Ortho Evra®: The Ortho Evra® birth control patch has been associated with increased risk of developing blood clots that can potentially result in heart attack, stroke, deep vein thrombosis (DVT), and pulmonary emboli. The consequence of these complications can be fatal. The manufacturer of this produce recently changed its product warnings, suggesting the patch delivers 60% more estrogen than the birth control pill. Increased estrogen can significantly increase the risk of these injuries.
Guidant Pacemakers and Defibrillators: Guidant Corporation issued 5 separate product recalls during the later half of 2005, affecting various models of its pacemakers and defibrillators. The product defects resulting in the recalls can cause life threatening failure of the products.
Gadolinium: Gadolinium is a contrast agent commonly used during MRI scans in kidney patients. Many kidney patients have experineced nephrogenic systemic fibrosis or NSF from exposure to gadolinium during MRI scans. On 12/22/06 the FDA issued an alert regarding patients with moderate to end stage renal failure who developed NSF, a ddbilitating and potentially fatal condition, within two days to 18 months after receiving gadodiamide, gadoversetamide or gadopenetate for MRI scans. NSF is a painful skin disease characterized by thickening of the skin, which can restrict joints and cause significant limitation of motion within weeks to months of exposure.
Diacetyl: Diacetyl is a food flavoring commnly used in microwave popcorn to give it a buttery taste. The washington post reported in May 7, 2007, about the rising number of cases of diacetyl relataed lung disease in popcorn-flavoring plant workers. Bronchiolitis obliterans, also known as 'popcorn workers lung' is a potentially fatal obstructive lung disease that causes victims to slowly suffocate, with progressive symptoms of shortness of breath and dimished lung capacity. The Occupational Safety and Health Administration and the EPA are investigating the chemical properties of diacetly after workers filed a lawsuit alleging injury caused by the chemical.
LYRICA HAS BEEN LINKED TO SUICIDES. LYRICA has been used by over one million people around the world primarily to manage the nerve pain in arms, hands, fingers, legs, feet or toes that can occur with diabetes; this disease is called Diabetic PeripheralNeuropathy, or DPN. LYRICA is also prescribed to help patients control epilepsy disorders as well as the pain associated with Shingles, and recently became approved for treatment of a muscle pain condition called Fibromyalgia.
The FDA is presently investigating whether there is a connection between use of LYRICA and cases of attempted suicide or suicide. Evidence of a causal effect for taking one's own life can provide support for obtaining compensation from the manufacturer of LYRICA by families of deceased victims or survivors of suicide attempts.
QUININE The Food and Drug Administration on 12/22/06 ordered firms to stop marketing unapproved drug products containing quinine, a drug used to treat malaria, citing serious safety concerns, including deaths, associated with quinine products. There are multiple unapproved products containing quinine currently marketed to consumers for off-label use commonly prescribed to treat leg cramps and similar conditions. The FDA believes it should not be used to prevent or treat leg cramps. Many unapproved quinine drug products are marketed without labeling cautioning against use of the product for treatment of leg cramps.
The FDA-approved labeling for the product provides extensive warnings regarding serious adverse events associated with use of quinine, potentially serious interactions with other drugs, and conditions under which quinine should not be used. Quinine is a drug with a narrow margin
between an effective dose and a toxic dose. Since 1969, FDA has received 665 reports of adverse events with serious outcomes associated with quinine use, including 93 deaths. Quinine drugs are associated with serious side effects, such as cardiac arrhythmias, thrombocytopenia (a decrease in blood platelets that can cause hemorrhage or clotting problems), and severe hypersensitivity reactions. There is also the potential for serious interactions between quinine drugs and other drugs,
and there are conditions under which quinine should not be used.
