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.

• Print
• Comments
• Trackbacks
• Share Link

Already facing heat for its Medtronic lead and defibrillator injury scandals, the medical device major now faces new issues. An eminent researcher and spine surgeon at the University of Wisconsin admitted that he received payments from the company to the tune of $19 million to develop and promote the Infuse Bone Graft, among other things.

The researcher, Thomas Zdeblick, received payments over a 5 year period and, according to the Wall Street Journal, the payments were made to help in the development and promotion of spinal products, including the Infuse Bone Graft. These facts were revealed in a letter written by Senator Charles Grassley to the University, as part of his investigation in the conflict of interest arising from pharmaceutical companies' payments to doctors. The University of Wisconsin policies require doctors to reveal payments of up to $20,000, but does not require specification of payments beyond $20,000. The University policies on this matter are in line with the policies enforced by other universities and medical research centers. The University admitted that its medical disclosure requirements are inadequate and officials said they will be changing the rules to require doctors to specify exact payment amounts received from companies.

Technically, there is nothing wrong with Zdeblick's failure to reveal the $19 million he received over the years.  Zdeblick claims that he disclosed his financial relations with Medtronic to his patients and always has. However, this is Medtronic we are talking about, a company that has recently come under suspicion of encouraging off-label use, which is illegal. Just a few weeks ago, the family of a California woman who died after Infuse was inserted in her neck against FDA approved uses, filed a medical injury lawsuit against Medtronic for pressuring the doctor to use the bone growth product in an unapproved manner. The nexus between pharmaceutical companies and medical researchers is well known. However, it has increasingly been scrutinized by lawmakers and medical injury lawyers who would like to see scientists and researchers given more independence from the influence of pharmaceutical companies.

There are several ways in which a monetary relationship between a researcher and a drug company can impact the safety of medical products. First, there is always the risk of drugs and devices being pushed for approval simply for financial gain.  A conflict of interest also exists when a doctor is paid by a company for developing a product and then goes on to promote the same product to patients; no one can argue that there is bias in a situation like this. The only party that suffers when unethical things like this happen are the patients injured by defective products and drugs and their families.

Medical Injury Litigation

Taking on big name companies like Medtronic Inc. requires the expertise of an experienced medical injury lawyer who has the resources necessary to handle your case. Here at Arnold & Itkin LLP we have successfully resolved many medical injury and defective medical product cases.

If you've been injured by the use of a defective medical product, drug or device, contact a medical injury lawyer at Arnold & Itkin LLP for a free evaluation of your claim.

• Print
• Comments
• Trackbacks
• Share Link