Medical Injury Lawyer Blog : Houston Medical Injury Lawyer & Attorney : Arnold & Itkin Law Firm : Pharmaceutical Injuries, Medical Devices : Texas, Dallas, Fort Worth, San Antonio

As the Bush administration prepared to vacate office, the Food and Drug Administration (FDA) issued new guidelines that ease restrictions on promotion of off-label drug use by pharmaceutical companies. The rule has been severely criticized because it may lead to more dangers when pharmaceutical drugs are used in ways not approved by the FDA.

It is illegal for pharmaceutical companies to promote off-label use of their drugs, although physicians are allowed to prescribe drugs for purposes not approved by the FDA. Doctors are allowed and often do rely on published medical research to prescribe drugs for unapproved uses to their patients. In its new rule, the FDA allows pharmaceutical companies to cite medical journal research supporting off-label uses of a drug. The biggest problem with relying on medical journal articles is that such research does not go through a strict screening process. It is hardly meant to be used as a substitute for the rigorous approval procedures conducted by the FDA.  Plus, there is also the risk that pharmaceutical companies may pay medical researchers and scientists for articles that recommend promotion of the drug for off-label use, which clearly would not be genuine, in-depth research articles.

The new guideline has been criticized from both within and outside the Bush administration. The Department of Veterans Affairs, patient advocacy groups, state prosecutors and medical injury lawyers around the country stand adamant that the new guidelines will weaken an already unstable FDA and expose patients to the omnipresent dangers of off-label drug use.

Off-label drug use continues to be a major danger to patients at risk of side effects from such drugs. Recently, Eli Lilly and Company agreed to a mammoth settlement over civil and criminal lawsuits arising from off-label drug use promotion. Also, Medtronic currently faces a lawsuit arising from the same unethical practices related to its Infuse Bone Graft. The threat of massive civil and criminal liability is the only thing preventing mass off-label promotion by drug manufacturers.  In the absence of rules completely prohibiting such promotion, drug manufacturers will have the freedom to place patients at risk in order to multiply their profits.

Promotion of off-label drug use by pharmaceutical companies can expose patients to unknown side effects simply because off-label uses are not researched as extensively as approved uses and, therefore, have little research to provide help in the case of adverse effects. In such cases, patients who have been injured can file a medical injury lawsuit against the company with the help of a medical injury lawyer.

If you have been injured by the use of a defective pharmaceutical drug, contact a medical injury lawyer at Arnold & Itkin LLP for a free consultation.

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Pharmaceutical giant Eli Lilly & Company has agreed to a $1.42 billion settlement in a civil and criminal suit involving injuries resulting from the company's promotion of off-label use of its anti-psychotic drug Zyprexa. This settlement includes a $30 million award to Texas.

The U.S. Department of Justice has been investigating the manner in which Eli Lilly & Company engaged in improper marketing of Zyprexa for uses not approved by the FDA. Zyprexa is an anti-psychotic drug approved for treatment of patients with schizophrenia and bipolar disorder. However, the company, beginning in 1999, commenced promotion of Zyprexa use for patients suffering from dementia, depression and other conditions. Eli Lilly representatives were sent to nursing homes to market the drug for elderly residents. The FDA does not prohibit doctors from prescribing medicines for purposes other than those approved, but pharmaceutical companies are not allowed to promote such off-label use of a drug. Eli Lilly was, therefore, acting in blatant violation of FDA regulations by promoting the off-label use of Zyprexa.

Reports of injury, including infections and heart attacks, began to surface, but the company chose to overlook them and continue to promote Zyprexa for use in elderly dementia patients. In 2006, the FDA asked Eli Lilly to include strong warning labels on Zyprexa cautioning patients of the increased risk when used by the elderly. The company has since had close to 32,000 medical injury lawsuits failed against them and has been forced to pay approximately $1.2 billion in settlements.

Eli Lilly’s violation of FDA rules and complete disregard for patient safety has shocked patients' safety advocates, concerned citizens and medical injury lawyers since the scandal first made headlines. Unfortunately, greed often takes precedence over ethical promotion practices at many of the country's most reputed pharmaceutical companies. When the FDA gives approval to a particular drug, it does so to reassure patients that they can feel safe using the drug for a specified condition. When companies like Eli Lilly greedily promote their products for unapproved purposes, they place consumers at risk for serious injury and even death.

Pursuing Pharmaceutical Drug Injury Cases

Pursuing claims against a major pharmaceutical company can be a long, complex procedure, involving expert witnesses and medical researchers, who can help build a winning case. At Arnold & Itkin LLP, we have pursued injury lawsuits against some of the country's biggest companies to recover compensation for our clients. 

If you have been harmed by a defective drug, contact a medical injury lawyer at Arnold & Itkin LLP for a free evaluation of your case.

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