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Dangerous Drug Tort
Every year, pharmaceutical companies manufacturer and market hundreds of new prescription medications. In the United States, drugs must be approved and regulated by the Food and Drug Administration before they reach consumers, but the Centers for Disease Control and Prevention (CDC) reports that pharmaceuticals kill more than 40,000 people every year despite federal oversight. In one recent year, pharmaceutical deaths exceeded traffic fatalities. According to recent studies by the CDC, it’s estimated that half of all drugs marketed to Americans can cause injurious effects.
If you or someone you love has been hurt by a dangerous drug or medical device, you may be entitled to a financial settlement from the responsible party through a dangerous drug tort claim. Drug manufacturers have a duty to run sufficient tests before submitting a drug for approval by the FDA and include warnings potential side effects on the drug label. Manufacturers also have a responsibility to promote products only for FDA-approved purposes.
Unfortunately, drug manufacturers sometimes fail in these duties. This may be due to oversight, or it may be intentional to increase profits at the expense of consumers. A mass tort attorney in Los Angeles can help you seek compensation for your injuries through mass tort litigation. Call us today at (310) 954-7248.
Why Are Dangerous Drugs on the Market?
There are many issues that may lead to dangerous drugs:
- Regulatory gaps. The FDA has a great deal of authority to regulate medications, but there are limited to this power and big regulatory gaps. As an example, compounding pharmacies were first created to mix drugs for specific patients when no pre-existing drugs existed. As they were created as small pharmacies, they were regulated by local authorities. Eventually, these pharmacies began to serve a new function while mass-producing drugs to handle drug shortages. The FDA lacked the authority to regulate compounding authorities which led to a massive meningitis outbreak that killed 50 people and sickened more than 700.
- Loopholes. There are several loopholes in the FDA approval process. One of the biggest is the 501(k) approval process which allows a medical device to receive fast-track approval with minimal testing if there is an existing approved product on the market. Many dangerous drugs have made their way to consumers through this loophole, including transvaginal mesh products and metal-on-metal hip replacement products.
- Insufficient long-term testing to find all side effects.
- Drug reps who do not disclose side effects.
- Off-label prescribing of approved medications.
Liability for Dangerous Drugs
Drug manufacturers are held strictly liable for injuries if they sell defective or dangerous medication or market medication for uses not approved by the FDA. Manufacturers have the responsibility to conduct appropriate tests before a drug is submitted for approval by the FDA. Drug manufacturers must also include warnings and potential side effects on the label for consumers and physicians.
Doctors and pharmacists also share some responsibility in ensuring a product does not cause harm to consumers. Doctors must prescribe the best medication for a patient’s illness or injury as some drugs have potentially serious side effects or the potential to cause long-term damage and there may be an alternative medication with fewer risks for the patient.
Dangerous drugs usually cause the most harm to consumers within the first 12 months and early adopters of new drugs are often those who suffer the most harm. Unfortunately, drug manufacturers sometimes continue to market drugs to consumers even after evidence of serious side effects have been found.
Pharmaceuticals may be dangerous for many reasons, including:
- Drug is defective due to manufacturer error
- Consumer was not warned of potential side effects
- Drug has a design flaw
Examples of drugs that may have hurt patients in California include:
- Ortho Evra
When a drug is considered potentially dangerous, the FDA will conduct an investigation to determine whether side effects outweigh benefits of the drug. If this is the case, the FDA will issue a drug recall that may remove the drug from the market or require additional warnings on the label.
Xarelto is a blood-thinning drug made by Bayer HealthCare and Janssen Pharmaceuticals that has been linked to a risk of severe and even fatal bleeding. When the drug was introduced, it had no antidote or reversal agent and doctors struggled to stop bleeding in patients undergoing surgery while taking Xarelto.
By comparison, a similar drug called warfarin can be reversed with vitamin K. Since its introduction, more than 4,000 lawsuits have been filed against the manufacturer of Xarelto alleging failure to warn patients and doctors of the increased risk while taking Xarelto.
If you believe you have been injured by the use of Xarelto, it’s important to contact an attorney as your statute of limitations may have expired or may soon expire and prevent you from bringing a claim against the responsible parties. If you have been injured by any of these drugs, then you should contact the Los Angeles Injury Group and Tawni Takagi for a free consultation. Call us today at (310) 954-7248.
Zofran is medication manufactured by GlaxoSmithKline and approved to treat vomiting and nausea in people after surgery or chemotherapy, although it was often prescribed off-label to treat morning sickness in pregnant women. Studies have found an association between the use of Zofran during the first trimester of pregnancy and severe birth defects like heart malformation and cardiac septum defect in particular.
More than 250 Zofran lawsuits have now been filed against the manufacturer alleging insufficient warning for doctors and patients. If your baby was born with birth defects and you took Zofran during the first trimester of your pregnancy, you may be entitled to compensation against the manufacturer. Call us today at (310) 954-7248.
Mass Tort Litigation in California
Mass tort litigation allows one or several attorneys to represent many clients on individual cases while collaborating to help their clients seek the greatest compensation possible for their injuries. The mass tort system is unique in that it allows attorneys for many clients to pool discovery, gathering documents and witness depositions together and sharing the information for every individual trial or settlement negotiation.
Contact a Dangerous Drug Tort Attorney in Los Angeles
Drug manufacturers should be held accountable when they release dangerous products on the market. If you have been hurt by a dangerous or defective drug, contact the Law Office of Tawni Takagi today for a free consultation to learn more about your rights and seek compensation through a dangerous drug tort claim. Call us today at (310) 954-7248.