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Pharmaceutical and Medical Device Litigation 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. 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 an industry with domestic sales of over $200 billion dollars each year. Prescription drugs, over-the-counter medicines, medical devices and herbal supplements may suffer from several different defects, which may lead to pharmaceutical liability claims. A design defect occurs when the manufacturer or producer fails to design the drug or medical device so that it is safe for its intended use. Typically, the manufacturer could have used a safer alternative design to avoid foreseeable risk. A manufacturing defect occurs during the manufacturing process and has nothing to do with the design. Even if the design was perfect, poor manufacturing can undo proper safety measures. This can occur when a manufacturer uses the wrong materials or fails to use appropriate quality controls. A marketing defect such as the failure to warn of danger or instruct on proper use is a different kind of defect. A product that is safe when the consumer knows how to use it can turn dangerous without the proper warnings. The manufacturer has a duty to warn users of potential side effects that can make the product dangerous. There can be a failure to warn if the manufacturer does not inform consumers about adverse drug interactions. Although the law varies from state to state, claims for injuries arising from the use of prescription drugs, over-the-counter medications, herbal or dietary supplements and medical devices generally may proceed under two legal theories: strict liability or negligence. Under the strict liability theory, the medicine is on trial and the jury will be asked to decide whether the medicine or its manufacturing process is defective. To prove the claim, you must show that the medicine has a defect that makes it unsafe, that the defect injured you and that the injuries caused you monetary damage. For a negligence claim, you must show that the manufacturer owned you a duty of care, that the duty was breached, that the breach caused your injuries and that you were injured. Another thing to consider is whether a claim ought to be pursued against the doctor who prescribed the medication to you or to the pharmacy that filled the prescription or helped you decide what medicine to buy. These claims are distinct from claims against the manufacturer and need to be considered separately. Gianni ♦ Petoyan is a recognized leader in drug litigation. We have been representing clients against drug manufactures for many years and are available to evaluate injuries resulting from drug exposure, including the following medications: Fen-phen/Redux® Fenfluramine (Pondimin®) and Dexfenfluramine (Redux®) were popular weight loss drugs in the mid-1990s. They 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. They have 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. 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. There have been a number of studies that show significantly increased incidences of cardiovascular problems including blood clots, 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 Ortho Evra® 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. Gadolinium Gadolinium is a contrast agent commonly used during MRI scans in kidney patients. Many kidney patients have experienced 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 debilitating and potentially fatal condition, within two days to 18 months after receiving gadodiamide, gadoversetamide or gadopenetate for MRI scans. NSF is a painful 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 commonly used in microwave popcorn to give it a buttery taste. On May 7, 2007, The Washington Post article reported a rising number of cases of lung disease in workers at popcorn flavoring plants. 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 diminished 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. Heparin Heparin is a blood thinner used in surgery, dialysis, and to prevent blood clots in the bedridden. Baxter International manufactures about half of the multi-dose Heparin vials used in the US. In January 2008, Baxter International recalled 9 lots of its 1000/unit ml multi-dose Heparin vials. The Baxter Heparin recall was initiated after the company received 100 reports of serious allergy-type reactions in patients who had been administered Baxter Heparin. Following the recall, Baxter said that it was suspending the manufacture of Heparin until the reason behind the reactions could be determined. In February 2008, the Food & Drug Administration (FDA) issued a Public Health Advisory warning doctors and other health practitioners not to use Baxter Heparin products. According to the FDA, since the beginning of 2008, it has received 350 reports of side effects linked to Baxter Heparin. The FDA also said that four patients had died after being administered the drug. The FDA said nearly all the reported reactions to Baxter Heparin had been in dialysis patients who received high doses of Heparin over a short time. The FDA cautioned that doctors who continued to use Baxter Heparin should use the lowest doses possible and administer it slowly. On February 14, 2008, it was revealed that a Chinese factory that supplied the active ingredient for Baxter Heparin had never been inspected by the FDA. That ingredient is made by the Chinese facility, as well as a US plant, both owned by Wisconsin-based Scientific Protein Laboratories LLC. On February 29, the FDA announced that Baxter would be recalling all of its remaining Heparin products. By this time, Baxter Heparin had been implicated in more than 400 life-threatening reactions and could have been responsible for as many as 21 deaths. On March 5, 2008, both Baxter and the FDA announced that their respective investigations had found a contaminant in the active ingredient used in Baxter Heparin. The company said its findings "suggest that the root cause may be associated with the crude Heparin, sourced from China, or from the subsequent processing of that product before it reaches Baxter." Heparin's side effects involved a variety of symptoms including abdominal pain, decreased blood pressure, burning sensation, chest pain, diarrhea, dizziness, drug ineffectiveness, dyspepsia, dyspnea, erythema, flushing, headache, hyperhidrosis, hypoesthesia, hypotension, loss of consciousness, malaise, nausea, pallor, palpitations, paresthesia, pharyngeal edema, restlessness, vomiting/retching, stomach discomfort, tachycardia, thirst, trismus, and unresponsiveness to stimuli. Digitek In April 2008, Actavis Towtowa recalled all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP, all strengths) for oral use due to a manufacturing defect. The Food & Drug Administration (FDA) said the Digitek defect could expose users to twice the amount of active ingredient, which could cause serious and even fatal reactions. The FDA received several reports of illnesses and injuries in patient taking Digitek. Actavis said it had 11 such reports. Digitek, manufactured by Actavis Towtowa, is sold by Mylan Pharmaceuticals Inc., under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label. Digitek is a form of digitalis, a chemical derived from the foxglove plant that has been used as a heart medicine since the 18th century. The medication is sold generically as digoxin by several companies. Digitalis medicines strengthen the force of the heartbeat by increasing the amount of calcium in the heart's cells. When the medicine reaches the heart muscle, it binds to sodium and potassium receptors. These receptors control the amount of calcium in the heart muscle by stopping the calcium from leaving the cells. As calcium builds up in the cells, it causes a stronger heartbeat. Digitalis toxicity is a complication of digitalis therapy and may be caused by an acute ingestion of digitalis. Digitalis toxicity can occur from a single exposure or chronic overmedication. People with heart failure are commonly given diuretics (medications used to pull excess fluid from the body) along with digoxin. Many diuretics can cause potassium loss. Low levels of potassium in the body increase the risk of digitalis toxicity. Digitalis toxicity may also result from low levels of magnesium in the body. Reduced kidney function will cause digitalis to accumulate in the body rather than being excreted normally through urine. Therefore, any disorders that disrupt kidney functioning (including dehydration) make digitalis toxicity more likely. Trasylol Since 1993, Trasylol, manufactured by Bayer AG, has been used in one third of all open-heart surgeries in the US. However, numerous studies have indicated that Trasylol puts these patients at a higher risk of death. In November 2007, Trasylol was finally removed from the market after a portion of a Canadian clinical trial was halted because Trasylol subjects were dying at a higher rate than others in the study. In November 2007, the Canadian Data Safety Monitoring Board had stopped a Trasylol trial, known as the BART clinical study, after a data analysis indicated that the 30-day mortality risk in the study's Trasylol patients was nearing "statistical significance". Following the revelations over the Canadian Trasylol study, Bayer suspended sales of the drug in the US, Canada and Germany. Evidence suggested that Trasylol could also increase the likelihood of serious kidney damage, congestive heart failure and strokes. In November the FDA asked Bayer to suspend Trasylol sales after learning that the Canadian study had been halted. Even after Trasylol sales were halted, other studies continued to show that the drug put patients at a needlessly high risk of death. A Trasylol study released in February 2008 looked at more than 10,000 patients who had bypass surgeries at Duke University Medical Center from 1996 through 2005. It found that 6.4 percent of patients who were given Trasylol died within 30 days of the surgery, a rate nearly two times higher than patients who got another drug or who received no treatment for excessive bleeding. At one year after surgery, almost 16 percent of Trasylol patients had died - again, roughly 2 times higher than the other two patient groups. Back to Top |
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