Drug injury is a cause of death to nearly 100,000 people in the United States as a result of the side-effects of drugs prescribed by doctors. Prescription drugs must be approved by the FDA before sold to the U. S. public. Medical doctors, however, are authorized to prescribe these drugs for what is called off-label use for purposes not intended or approved by the FDA.
Brien Roche is an experienced injury attorney serving all of Northern Virginia, including Fairfax, McLean, Vienna, Burke, Annandale, Falls Church Reston, Centreville, Manassas, Alexandria, Herndon, Arlington, and Loudoun County. Call, or contact us for a free consultation.
Drug Injuries Resulting From Off-Label Use
Drug injury litigation is taken seriously by the pharmaceutical companies and is hard fought by them and by the physicians who are on their payroll. Many doctors prescribe medication based on their allegiance with the drug industry and not necessarily based on patient need. For example, one drug may have been approved for one use by the FDA, but doctors, based on anecdotal evidence, are allowed to prescribe the drug for other purposes. This can be dangerous. Before taking a particular medication, it is important to read the allowed use and if the prescribed use does not match this then you ask your physician why it is being offered.
It is always somewhat dangerous for a physician to prescribe medication for such an off-label use but it is not unheard of that such a thing be done. If that off label use results in some injury to the patient, that may be a basis for a claim against the physician that prescribed the medication.
Claims against the manufacturer for damage resulting from uses that are not disclosed as part of the package insert become a bit more problematic because the manufacturer may be immune from suit in certain instances provided it complied with the FDA required disclosures. Although the use may be off label some manufacturers in fact encourage physicians to prescribe for such usage in order to increase sales. This goes back to the sometimes all too cozy relationship that exists between physicians and the drug company representatives that are selling the drugs.
Drug injuries from intended or off-label use can be devastating. The handling of these claims calls for knowledgeable and aggressive representation. If you have been injured as a result of the improper prescription of a drug you need a drug injury lawyer on your side. Brien Roche, a Fairfax, Va. and D.C. area attorney, has more than 35 years experience in personal injury and medical malpractice law and has garnered substantial compensation for his clients. Contact us today for a free consultation regarding your claim.
Questions Regarding Drug Research
A November 25, 2012 article in The Washington Post raised some serious question as to whether or not drug research can be trusted.
In 2006, the drug maker GlaxoSmithKline was able to publish a substantial article in the New England Journal of Medicine dealing with its new drug Avandia for diabetes treatment. The article reported that Avandia was the best of the available medications to treat the condition.
What was not so readily apparent is that the trial that reached this conclusion was funded by the drug maker and all of the authors of the article had, in fact, been recipients of money from the manufacturer. What was not disclosed is that the drug actually raised the risk of heart attacks.
It was subsequently determined by the Food and Drug Administration that the drug had been associated with 83,000 heart attacks and deaths.
The New England Journal of Medicine is one of the premier medical journals in the country. It is looked to by many practitioners as the gold standard for reliability.
As of August of 2012, the New England Journal of Medicine, for the one year period prior to that date, had published a total of 73 articles on original studies of drugs. Of those articles 60 were funded by pharmaceutical companies and the vast majority were co-written by company employees.
Aside from Avandia, the New England Journal of Medicine has also published research articles of Vioxx. That underlying trial was funded by Merck as was co-written by two company employees.
After the publication of that article it was determined that the authors had failed to disclose evidence of heart troubles associated with the medication. The drug was eventually pulled from the market and according to the FDA it had caused approximately 27,000 heart attacks and cardiac related deaths.
According to The Washington Post article one professor by the name of Justin Bekelman reports that the odds of coming to a conclusion favorable to the industry are 3.6 times greater where the research is sponsored by the industry.
The intervening review by peers is obviously not enough to remove the taint of company bias because the peers who are reviewing these studies frequently do not have the underlying data.
In the case of Avandia, the manufacturer withheld important information from the academics, chose not to do some trials because they might have unfavorable results and then published the results of an unfinished trial even though the results were inconclusive.
From the very beginning with Avandia the company scientists were aware of potential heart dangers. The company actually considered a full blown trial to evaluate that issue but before doing so conducted a study to determine whether or not the trial might harm the drug’s reputation. That analysis showed potential that the trial may harm the drug in terms of its public perception and therefore it was decided not to conduct the full blown trial.
An independent study that was conducted by a physician from the Cleveland Clinic did finally conclude that Avandia raised the risk of heart attacks by 43 percent and of death from heart problems by 64 percent.
The obvious message to be sent is that any research sponsored or in any way overseen by the industry is probably tainted in some fashion.
Other Helpful Articles For Drug Injury Cases
- Drug labs have been under increasing scrutiny since the New England fiasco in the summer of 2013. In addition now to the compounding pharmaceutical companies that have been under scrutiny, the labs that test their products are also under scrutiny. … Continue reading
- As previously indicated on this blog, drug injury from compounding pharmacies such as NECC of Framingham, Massachusetts are alarming. The fungus that contaminated the pain medication has caused several incidents of meningitis resulting in several deaths. The fungus causing the disease is very slow to grow … Continue reading
- Failure to warn claims involving generic drugs took a significant hit on June 23, 2011 with the decision of Pliva, Inc. v. Mensing from the U.S. Supreme Court. In that decision, the Court diluted the Wyeth decision by concluding that … Continue reading
- This page within Virginia Tort Case Law is a compilation of cases reported by the Virginia Supreme Court and summarized by Brien Roche dealing with the topic of Product Liability-Drugs. See Va. Code § 54.1-3400. See Va. Code § 54.1-3427 as to dispensing … Continue reading
- Medication errors are on the rise according to the Agency for Healthcare Research and Quality,the lead federal agency charged with improving quality,safety and efficiency of health care for all Americans. This agency reports that in 2008 1.9 million people became ill … Continue reading