Dangerous Drugs Lawyer
If you are sick or need medication to control an existing condition, your natural instinct is to trust your doctor and the medication they are prescribing you. Sometimes, however, that medication causes severe adverse reactions. If you have been prescribed dangerous drugs, you are justified in looking for answers.
How Drugs are Regulated
When a pharmaceutical company is developing a new drug, they must go through a rigorous testing and approval process set by the Food and Drug Administration (FDA). When manufacturers are beginning the human testing process, an Investigational New Drug Application must be submitted to the FDA. This report contains all data from their animal testing and laboratory testing. They are also required to include toxicity data, manufacturing information, study methodology, and any data from previous human research.
The FDA then assembles a review team made up of a pharmacologist, project manager, medical officer, statistician, microbiologist, and chemist. Each team member will review their portion of the new drug, and review the original IND submission. If they give their approval, the drug will move onto clinical trials.
If all research is positive, the pharmaceutical company can then file something called a New Drug Application (NDA), which is an application to market the drug. Once the NDA is complete, the FDA review team has six to ten months to make a decision on whether or not to approve the drug. If it is approved, all reports that have been made by the review team are assembled into one action package, which serves as the record for FDA review.
Why Drugs are Recalled
Despite these testing protocols, long term side-effects can go unnoticed. Some drugs are recalled only after hitting store shelves. These drugs can be prescribed by doctors across America, and only reveal their adverse or deadly side effects after the fact. Recalled drugs generally fall into one of several categories:
- Faulty manufacturing processes
- Contaminated medications
- Faulty labeling
- Failure to adequately warn
Common Dangerous Drugs
Some of the most commonly known dangerous drugs are prescribed by medical professionals every day. Below is a list of some of these drugs, their manufacturers, and their adverse effect.
Risperdal: Risperdal is an antipsychotic drug meant to treat conditions such as psychosis, bipolar disorder, and schizophrenia. Due to pushing the drug for unapproved uses, downplaying serious side effects, and paying kickbacks to doctors, Johnson and Johnson agreed to pay over $2.2 billion to resolve criminal and civil investigations against the company in 2013. This is one of the largest payouts ever for healthcare fraud.
Pradaxa: Pradaxa is a blood thinner manufactured by Boehringer Ingelheim for conditions such as atrial fibrillation. Unlike its closest competitors, Pradaxa allows for much more freedom in diet and does not require weekly blood tests. However, it is also the drug most commonly linked to complications and deaths stemming from serious bleeding.
Invokana: Invokana is manufactured by Janssen Pharmaceuticals, a division of Johnson and Johnson. This drug has been used to treat type 2 diabetes. It has also been shown to cause diabetic ketoacidosis; which is a life-threatening condition that increases the acidity of the blood.
Lipitor: Lipitor is a medication commonly prescribed for managing cholesterol levels. Manufactured by Pfizer, its adverse effects include type 2 diabetes, liver damage, and memory loss. Lawsuits against Pfizer include failure to warn about dangers and labels lacking information regarding the risks for type 2 diabetes.
Xarelto: This is another blood-thinner, manufactured by Johnson and Johnson and co-marketed by Bayer. Problems arose when patients taking it began experiencing internal bleeding. Unlike other blood thinners, Xarelto has no antidote. This means that if someone is experiencing internal bleeding and they are using Xarelto, there is a much higher chance that bleeding will become uncontrollable and they could die.
Who is Liable?
Drug manufacturers have the responsibility to ensure their products are safe for consumers. With seven in ten people taking at least one prescription drug, a dangerous drug may impact thousands of people or more. When a drug has unknown side effects that are discovered after it has been released on the market, legal action is necessary to hold the manufacturer accountable. If a physician prescribes a medication “off-label,” or beyond the scope of what it is currently approved to treat, leading to harm, the physician, clinic, or hospital may also be named in a lawsuit to seek to recover damages.
Contact an Experienced Dangerous Drugs Attorney
If you or a loved one was prescribed a medication that then led to severe adverse effects, or even death, contact a highly skilled dangerous drugs lawyer as soon as possible. They will go over all medical records and product information to determine whether the manufacturer misbranded, mislabeled, or under-reported risks, and fight to get you the recovery you need. All dangerous drug cases are taken on a contingency fee basis – no fees unless we win for you. Contact Malloy Law Offices today for your free consultation regarding your case.