Pharmaceutical Liability

Prescription medications and over the counter pharmaceutical preparations are relied upon by most of us to treat disease and enhance our quality of life. From pain medications, to cancer fighting agents,, these substances and the pharmaceutical manufacturers which create and distribute them, have significantly changed the way in which we manage our lives.—often for the better. We trust that the drugs our doctor prescribes or that we buy off the drugstore shelf will help make us well. We also trust that the companies who sell these drugs ensure that they are safe before they are ever sold to the public.

Yet by some estimates, over 200,000 Americans suffer serious - sometimes fatal - side effects each year from prescription drugs. Indeed, some believe that more Americans die from taking prescription drugs than from using illegal drugs. These estimates do not include the thousands of Americans who suffer adverse reactions to over-the-counter medications and even "natural supplements" which are seldom reported.

Although medication can be life saving, medications often create severe health risks—and unfortunately, the cure is sometimes more health adverse than the ailment for which the drug or medication has been prescribed.

Healthcare providers and patients deserve to be properly informed of these risks when making health care choices. When pharmaceutical companies fail to conduct proper studies, or fail to properly analyze and report the results of the studies which they do conduct, both before and after marketing, it is the public which ultimately suffers. These manufacturers, we would all agree, must continue to be held to a duty to properly study their products before these are brought to market, and before they are submitted to the Untied States Food and Drug Administration for the agency’s approval; and must continue to monitor, report and/or analyze adverse events. Most importantly, they must properly educate healthcare providers and patients about benefits and risks of these products. Their failure to do so, results in a legal finding of negligence. Proving such negligence requires experience, creativity and adequate resources. But the end result can change the way the industry practices and most importantly can save lives

“Pharmaceutical liability" is a term used to describe the legal consequences a manufacturer of drugs may face if its products injure people. The manufacturer may be found liable for making and selling a defective product (a claim of strict liability), or it may be found liable for not taking reasonable care to keep its products from causing injury (a claim of negligence). The law treats these two approaches to liability as distinct theories, and depending on the particular facts of the case, a person might recover damages on one theory but not the other. In some states, however, a statute creates single claim for product injuries, which may combine aspects of the two. Accordingly, if you believe you may have a claim against a drug manufacturer, you should not hesitate to seek legal advice from a lawyer with experience in this area.

If You Suspect You Have Been Injured By a Pharmaceutical

Immediate consultation with your physician is essential to insure that ingestion of the offending drug is discontinued, that proper medical intervention is started, and that your medical condition is stabilized.

If you believe that your injuries are significant and wish to investigate a legal claim, there are important steps which must be followed to guarantee that your legal rights are protected. Save the container the medicine came in as well as any information you received with it, such as a patient brochure or the packaging. And do not delay in speaking with any attorney immediately to discuss your legal choices. Every state requires that these claims be brought within a certain time frame- sometimes as early as one year, depending on the state where you live or where the mediation was prescribed and ingested. Investigating your case and bringing it in a timely fashion is key to the success of your claim.

SSRI’s ( Celexa Paxil and Prozac) linked to congenital heart defects

Paxil, the popular anti depressant manufactured by GlaxoSmithKline Kline has been associated with increased risks of congenital malformations in babies exposed in utero by their mother’s use in early pregnancy. Recognizing that many women of child bearing age use this serotonin reuptake inhibitor (SSRIO), the FDA issued warnings to health care professionals to avoid prescribing this drug to women during the first three months of pregnancy. In a series of three FDA advisories the agency first warned in December 2005 ( after Glaxo’s own studies suggested ) that in utero exposure doubled the risk of certain congenital malformations including heart defects. In March and April 2006, FDA data was updated warning doctors to avoid Paxil prescriptions during the early pregnancy, In July, 2006 a third FDA alert warned that studies had found a sixfold increases risk of persistent pulmonary hypertension in newborns born to women who had ingested the antidepressant after the 20th week of pregnancy.

Persistent pulmonary hypertension ( PPHN ) is a rare respiratory and circulatory complication resulting in severe respiratory failure shortly after delivery. As estimated one to two infants per 1,000 born will develop this serious and life threatening condition and even with proper medical treatment, ten to twenty percent of affected infants will die. The disease causes arteries to the lungs to remain constricted after birth resulting in abnormal blood flow through the heart and lungs and insufficient oxygenation throughout the body.

All SSRI’s have now been implicated in the development of this life threatening disorder, including Forest Pharmaceutical’s Celexa, and the widely prescribe anti depressant Prozac. In fact researchers have found that maternal use of Prozac during the third trimester may drastically increase the risk of delivering a child with PPHN. In the Slone Epidemiology Center Birth Defects Study researchers set out to specifically determine the effects of third trimester Prozac exposure on newborns, with regards to PPHN. The results, following an evaluation of 377 cases of PPHN, found that 14 of the children whose mothers had taken Prozac during the third trimester developed PPHN, while only six children whose mothers did not take this SSRI developed PPHN. This means that third trimester Prozac use more than doubles the risk that a child will be born with PPHN.

The United States Food & Drug Administration

Although drug companies hoping to sell their products in the United States must comply with regulations and procedures mandated by the Food & Drug Administration (FDA), the FDA does not guarantee drug safety. Once the FDA approves a drug for a particular use, patients who are injured by the drug-whether it is used for its approved purpose or for some other reason (known as "off-label" use), must look to the manufacturer for redress. Understanding how the FDA approval process works and where its weaknesses are can be an important part of a successful case against a drug manufacturer. A lawyer experienced with pharmaceutical-liability matters understands the complex process of FDA approval and can explain to the jury what effect it should have on your case.

Legal Claims Against Drug Manufacturers

Claims against drug manufacturers usually take two forms: strict liability and negligence. In a strict liability case, the focus is on the product and the question is whether it has a defect that makes it unreasonably unsafe. In a negligence case, the question is whether the manufacturer has acted with reasonable care. In both cases, manufacturers may assert that medications have reasonable risks or that another party (such as a doctor) is responsible for the patient's injuries. Accordingly, if you believe you may have a claim against a drug manufacturer, you should not hesitate to seek legal advice from a lawyer with experience in this area.

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Ashkin Law Firm
Roberta Ashkin, Esq.
475 Park Avenue South, 17th Floor
New York, N.Y. 10016
Telephone: (212) 702 3322
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