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 Justice Department charged Forest Laboratories Inc. in February with illegal marketing of its antidepressants Celexa and Lexapro, the U.S. Food and Drug Administration (FDA) approved the use of Lexapro for use in children.

Forest Laboratories Inc. marketed the drugs for use in children and adolescents even though it had no FDA approval for such use. The civil complaint filed against the company alleges that:

• Executives at Forest promoted favorable results from one clinical trial to purport that the drugs were effective in children. The trial, conveniently enough, was financed by the company. Another study, that did not result in such favorable findings, was concealed and the company failed to share the results of that study.
• The company awarded pediatricians who prescribed the drugs. There were ski vacations, gift certificates, fishing trips, and spa visits dangled before doctors to coax them into prescribing Celexa and Lexapro.
• Forest conducted trials that were simply marketing campaigns in the guise of studies. Doctors are not prohibited from prescribing drugs for unapproved uses; drug makers, however, are not allowed to promote off label or unapproved uses of drugs. In recent weeks, Eli Lilly settled an off label use promotion suit and Medtronic had a medical injury lawsuit filed against them for off label promotion of its Infuse bone growth product.

The allegations that Forest Laboratories Inc. concealed studies showing unfavorable results for Lexapro and Celexa seem to have received no attention by the FDA. On March 20th, the agency approved the use of Lexapro for use in adolescents. Lexapro is only the second antidepressant approved for use in younger patients.

Medical Injury Attorneys

Often, pharmaceutical companies indulge in unethical and illegal marketing of products that have not been approved for certain uses. Forest Laboratories' illegal marketing of Lexapro and Celexa for use in younger patients even before they were approved for such use, could have placed children and adolescents at risk of antidepressant abuse. Antidepressant medications, when not used as they are prescribed, can cause suicidal fantasies or worsen symptoms of depression. Unfortunately, we often see pharmaceutical companies ignoring health risks posed by unapproved uses of drugs to increase profits without thought of the risks of medical injuries.

Patients injured by unapproved use of a drug can consult a medical injury lawyer to file a lawsuit against the company, if it was engaged in promoting such off label use.

If you or a loved one has been injured by the use of Celexa or Lexapro, contact a medical injury lawyer at Arnold & Itkin LLP to learn about your options for compensation.

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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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Medtronic Inc. is facing a lawsuit over the death of a California woman after a surgery during which the company's Infuse bone growth medical product was inserted into the neck. The lawsuit is the first for the company stemming from allegations that Medtronic indulges in promotion of off-label use of its bone growth product, a liquid protein sealed in a casing and inserted between the vertebrae.

The lawsuit is unusual in that it doesn't blame the doctor for the complications that resulted after 74-year-old Shirley Nesbit underwent the surgery to insert the bestselling bone growth protein in her neck. The FDA had recently warned doctors against use of the product in the neck, because of the possibility of respiratory difficulties. Nesbit underwent the surgery in August, a few weeks after the FDA's warning. She developed serious respiratory problems because of the pressure on her neck and throat.   Attempts to insert a breathing tube lost precious minutes for Nesbit, and she slipped into a coma, dying 9 days later.

Her family alleges in the lawsuit that Medtronic's representative who was present during the surgery, pressured the doctor to use Infuse in her neck, although the FDA approves it for use only in the lower back, and for certain dental applications. Doctors are not prohibited from using any medical product for applications that are not approved by the FDA, but companies are not allowed to push for off label use of the product, which is what Medtronic is accused of doing. Both Medtronic and the surgeon in question, deny any pressure to use Infuse. The company, no stranger to medical injury lawsuits because of its earlier problems with its defective Medtronic defibrillator devices, claims that representatives are sometimes present at procedures for support and advice to the surgeon. Making things worse for Medtronic are two whistleblower lawsuits by former employees that charge the company with paying doctors to use Infuse in ways not approved by the FDA.

Medtronic Encouraging Unapproved Use of Infuse

There have been several complaints about off-label use of Infuse, and patients have suffered obstruction of the airways leading to breathing problems after insertion. Lack of oxygen can cause brain damage in a patient. Patients often need tracheotomies to relieve pressure on their airways, and require respiratory and feeding support.

Infuse Medical Device Lawsuits

Medtronic is facing a Department of Justice probe into allegations of promotion of off-label use. However, for patients who have been injured because of such unapproved use, there is a way to obtain justice – through a defective medical device or product lawsuit against the company with the help of a medical injury lawyer. If you or a loved one has been injured by an off-label use of Infuse - meaning use of the product anywhere, except on the lower back or in oral treatments – then you may be entitled to compensation for your suffering. Contact the experienced medical injury lawyers at Arnold & Itkin LLP for a free evaluation of your case.

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