Drug Approval Process Intended to Protect Consumers

The drug and medical device approval process as regulated by the U.S. Food and Drug Administration (FDA) is extensive. An approved drug entering the market has likely spent 10-14 years in development and testing at a cost of $350 million. A large majority of drugs do not ever make it through the process.

Given the extensive vetting process, most medicines used by consumers are safe. Though the risks are low, the costs of drug injury are high. If an unsafe drug or medical device reaches consumers, it is likely to cause significant harm, even death. How does this happen if the FDA approval process is so thorough? The cases where drugs are found to have risks or dangers not found in clinical trials are relatively rare, but they do occur. It is more likely to find a manufacturer, doctor, or pharmacist has failed to provide appropriate information on a drug’s risks or a drug that has been improperly marketed and prescribed for a purpose not approved by the FDA.

Rhoads & Rhoads personal injury lawyers have been protecting the rights of the injured throughout Western Kentucky for over 45 years. If you or a loved one have been injured by a defective drug, our team of experienced personal injury trial attorneys and knowledgeable support staff are available to provide you legal advice and help you through this difficult time and get you the financial recovery you deserve.

The Dangerously Common Practice of “Off-Label” Marketing

When a drug is tested, it is tested and approved for use in treating specific conditions. If a pharmaceutical company markets an FDA-approved drug for a non-approved condition, it is called “off-label” marketing and is completely illegal. Zofran is a drug currently at the heart of numerous lawsuits related to “off-label” marketing. Zofran was approved by the FDA to prevent nausea for chemotherapy patients. Soon after, the pharmaceutical company, GlaxoSmithKline (GSK), began to market the drug for use in treating the nausea of expectant mothers.

Doctors prescribed Zofran for the morning sickness of a million pregnant women each year despite the fact that this use was “off-label” and had not been tested nor approved by the FDA. Current lawsuits against GSK allege Zofran caused birth defects, including cleft palate, heart defect, gastrointestinal or congenital respiratory defects, or limb defects such as clubfoot.

Who Can Be Held Liable in Defective Drug Cases?

Drug Manufacturers/Pharmaceutical Companies Non-prescription or over-the-counter (OTC) medication is required to have proper labeling and written disclosures included with the packaging of the medication. Prescription drugs require the manufacturer to provide an intermediary, such as a doctor, with the proper warnings associated with the risks of taking a specific drug. As long as the intermediary has been educated of all risks, the pharmaceutical manufacturer is considered to have provided the proper duty of care to the public.

Doctors It is the prescribing doctor’s responsibility to inform the patient of all risks associated with the prescribed medicine. The patient must be able to make an informed decision on whether the personal risks involved outweigh the benefits of taking the prescribed drug. A doctor may be held liable if he or she does not disclose all risks.

Pharmacists A pharmacist who fills a prescription with the wrong drug or medication can be held liable for wrongful death or any injury or illness to the patient resulting from the mistake. Many pharmacies are understaffed or overworked due to the growing demand for prescription drugs. A growing trend in filling prescriptions with online pharmacies has created a new liability. Ensure you receive the proper drug from a reputable online pharmacy that follows all FDA guidelines.

Owensboro KY and Madisonville Defective Drug Attorneys — No Recovery, No Fee

With lawyers in Owensboro and Madisonville, Rhoads & Rhoads represents drug injury victims throughout Western Kentucky. We offer free initial consultations, and all personal injury cases are taken on a contingency fee basis, which mean there is no payment required up front. We get paid only if we win or settle your case, so there is NO RISK involved.

Call our law firm at 888-709-9329 for a free consultation or contact us by e-mail to schedule an appointment with one of our Madisonville or Owensboro personal injury attorneys.