Pittsburgh Dangerous Drug Attorney
Injuries from Dangerous Prescription Drugs
Every year in the U.S., countless individuals are injured, made ill, or killed by over-the-counter (OTC) or prescription drugs that are supposed to be safe. As most drugs available to the public have been approved by the United States Food and Drug Administration (FDA), people believe that these drugs will not cause any harm. Unfortunately, many prescription and OTC drugs have harmful side effects that are ignored by their manufacturer or even by the FDA. As a result, a number of injuries and illnesses can result. If you were the victim of a dangerous drug, we encourage you to speak with a Pittsburgh personal injury lawyerfrom our law office today.
Explanation of the FDA Drug Review Process
The FDA is very thorough in the manner that they expect drugs to be tested and reviewed. First, a drug must be adequately gone through preclinical testing – typically on laboratory animals. If the FDA approves the drug is safe enough to be tested on humans, it will move into clinical trials. This can only be done after the drug has been reviewed both by the FDA and a local institutional review board (IRB). The IRBs will oversee the clinical trial – including schedule, type of participants, dosages and more. The first phase of clinical trials will be conducted typically on healthy participants to determine common side effects.
If there isn't anything particular toxic revealed during this phase, it will move into the second phase. During this, the study will shift its purpose from toxicity to effectiveness. They will thus move into controlled trials comparing patients on the drug alongside patients using placebos. If effectiveness is shown, the third phase may begin which will test effectiveness on a much larger scale – the studies ranging from several hundred to several thousands, as opposed to the range of a dozen to several hundred in phase 2.
Following the three phases of testing, the drug sponsor will officially fill out a new drug application (NDA), which will ask the FDA to approve the drug on a large scale for marketing. Once this is received by the FDA, they will have 60 days to review the NDA and decide whether or not it is actually fit to be filed. If there is anything about the application which is incomplete, it may be rejected immediately. After that, under the Prescription Drug User Fee Act, the FDA must review at least 90 percent of NDAs and act upon them within 10 months. If a drug is labeled as a "priority," it is the goal to have it reviewed within 60 days.
While this is an extremely thorough process, there are some instances where a drug can be put on priority review, accelerated approval or fast track. This allows for drugs which could potentially have life-saving qualities to get on the market sooner. While the entire review process is designed to test consumer safety, there are instances where mistakes can be made or testing can be shallow without the thoroughness needed.
The FDA can be stretched thin—especially when put on strict deadlines—which can sometimes allow for defective drugs and medical devices to make their way onto the market. Worse, there are some drugs that marketers may put on the market without FDA approval at all. For this reason, if you or a loved one has been injured by a drug, you may have grounds to file a claim. You should not hesitate to consult with a knowledgeable lawyer about your potential case today.
Dangerous Drugs in Pittsburgh: Representation from an Injury Lawyer
If you have suffered injury or illness as a result of a dangerous drug, it is recommended that you contact a personal injury attorney as soon as possible. An FDA approval does not release a drug's manufacturer from liability in the event that the drug causes you harm in some way. Manufacturers are expected and required to utilize the most stringent safety tests in order to ensure that they are free from harmful side effects and to provide information regarding known side effects, potential defects or other complications. With an attorney's help, you may have a strong chance of recovering significant compensation for expenses related to your injuries.
Attorney Frank Walker's priority in every personal injury case is to obtain results. Our firm fights for positive outcomes on behalf of clients, regardless of the circumstances surrounding their cases. We understand that many dangerous drug cases involve manufacturers with sizeable legal teams. That does not intimidate us. If you have been injured by a dangerous drug, we will take swift legal action to protect your rights and increase the likelihood of a beneficial resolution to your case.
Contact a Pittsburgh injury attorney from our firm today to schedule an appointment.