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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.

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.



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