You may be eligible to file a Tylenol Autism ADHD Lawsuit / Acetaminophen Autism ADHD Claim if you or a loved one used Tylenol and/ or Acetaminophen during pregnancy, and your child was subsequently diagnosed with ADHD or Autism Spectrum Disorder.
Legal action is being strategized by our attorneys for Horizon Therapeutics’ failure to properly warn patients of potential hearing loss side effects.
You may be eligible to file a Tepezza Lawsuit if you or a loved one took Tepezza and subsequently suffered permanent hearing loss or tinnitus.
If you or a loved one took Elmiron and subsequently suffered vision loss, blindness, or any other eye injury linked to the prescription drug.
Contact the Elmiron Lawyers from TorHoerman Law.
Get a free online case evaluation and find out if you qualify for compensation instanly.
You may qualify to participate in a 3M Combat Arms Earplugs Lawsuit if:
Over 140,000 Exactech hip, knee and ankle implants have been recalled due to packaging errors that can lead to the breakdown of parts vital to the device’s function.
If you or a loved one suffered injuries from an Exactech implant device, you may be entitled to financial compensation.
You may be eligible to file a Hair Straightener Cancer Lawsuit if you or a loved one used chemical hair straighteners, hair relaxers, or other similar hair products, and subsequently were diagnosed with:
Get a free online case evaluation and find out if you qualify for compensation instanly.
Over one million people, who were present at Camp Lejeune (North Carolina) between 1953 and 1987, may have been exposed to toxic substances in the water.
The Camp Lejeune Contaminated Water Lawsuit can apply to you, a family member, or a loved one who lived at Camp Lejeune (North Carolina) and suffered health effects from the decades of water contamination that occurred.
Toxic chemicals in Aqueous Film-Forming Foam (AFFF Firefighting Foam) have been linked to numerous types of cancer, including:
AFFF Firefighting Foam lawsuits aim to hold manufacturers accountable for putting peoples’ health at risk.
If you have been exposed to Paraquat and diagnosed with Parkinson’s disease may be eligible to pursue compensation, and entitled to participate in the paraquat lawsuit.
Contact us today to see if you qualify for the Paraquat Parkinson’s Disease Lawsuit!
Get a free online case evaluation and find out if you qualify for compensation instanly.
Our firm is about people. That is our motto and that will always be our reality.
At TorHoerman Law, we believe that if we continue to focus on the people that we represent, and continue to be true to the people that we are – justice will always be served.
Without our team, we would’nt be able to provide our clients with anything close to the level of service they receive when they work with us.
Our team is what has made TorHoerman Law a very special place since 2009.
Get a free online case evaluation and find out if you qualify for compensation instanly.
The United States Food and Drug Administration, the FDA, reviews and approves new prescription drugs and medical devices before companies can put them on the market. The FDA’s Center for Drug Evaluation and Research (CDER) is responsible for ensuring that drugs sold in the U.S. are both safe and effective. While the FDA approval process is used to keep consumers safe, the government regulatory agency’s methodologies have garnered scrutiny. Many have argued that the agency’s processes are flawed and responsible for keeping lower-cost drugs off of the market.
Pharmaceutical companies hoping to sell new prescription drugs, vaccines, and biologics in the United States must gain FDA approval.
The FDA drug-approval process involves five steps:
FDA researchers work to determine if a drug is safe if the benefits outweigh risks, and if the drug-manufacturing process ensures a consistent, quality product:
The FDA approval process exists to ensure consumers do not take unsafe prescriptions. Unfortunately, the FDA Process has been called into questioning for unsafe practices. FDA approval does not guarantee that a drug or medical product is safe, and the U.S. manufacturers recall thousands of products and prescriptions each year. If you believe that an FDA-approved drug led to adverse side effects or injuries, visit the ‘Should I Report a Drug Injury or Drug Side Effect?’ page.
The Food and Drug Administration’s process for approving generic drugs is a bit different. Generic drug manufacturers do not need to repeat the same clinical trials conducted for the brand-name drug that they are replicating. The company submits an abbreviated New Drug Application (NDA) that contains the same steps as an NDA without the initial animal and human laboratory tests. Instead, generic drug manufacturers must prove that the drug is essentially the same as the brand-name drug. This includes verifying that the ingredients are as effective in treating the illness or condition as the brand-name drug is and that the generic drug produces the same reaction in the human body. After approval, generic drug manufacturers often still have to find a way around brand-name companies’ patents.
Drug patents can make it difficult for generic drugs to make it to market. While generic-drug companies are allowed to work on drugs for FDA approval before the brand-name patent expires, the brand-name company has the legal advantage. Generic-drug manufacturers are required to notify the patent holder if they are challenging the existing patent; this includes claims that the patent is not valid or that the generic drug does not infringe on the brand patent. The brand-name company then has 45 days to respond. The company can file a suit against the generic-drug maker. If courts determine that the generic-drug infringes on the brand-names patent, the FDA cannot approve the generic drug for at least 30 months. Current U.S. drug patents are valid for 20 years from the date the application is filed. This makes it difficult for generic drugs to make it to market.
“Pay-for-delay” agreements are another reason for lower-cost, generic drugs not making it to market. These agreements – also referred to as “reverse payment” agreements or “exclusion payment” agreements – are patent litigation settlements where a brand-name drug company pays the generic manufacturer to drop its patent challenge (see above) and keep its lower-cost product out of the market. This lets the brand-name company maintain high prices while potentially monopolizing the market. Pay-for-delay agreements hurt consumers who lose out on cheaper prescription drug prices.
The Federal Trade Commission (FTC) reported that pay-for-delay agreements have significantly delayed substantial consumer savings for prescription drugs. In fact, the agency estimated that from 2010 to 2020, pay-for-delay agreements would cost American consumers $35 billion – $3.5 billion per year. The commission recommended that Congress pass legislation that protects consumers from the agreements. California became the first state to sign legislation against pay-for-delay agreements in October of 2019.
Manufacturers of over-the-counter (OTC) drugs have several options when seeking FDA approval for market. OTC drug manufacturers can submit New Drug Applications and undergo similar procedures and standards as prescription drugs, vaccines, and biologics mentioned earlier. OTC manufacturers can also submit approval through the FDA’s OTC monograph. An OTC monograph specifies all FDA-accepted ingredients, formulations, testing parameters, and labeling for over 80 therapeutic classes of over-the-counter drugs. Manufacturers whose OTC drugs follow existing monograph specifications can go to market without additional FDA review. If an OTC drug does not fit a monograph, the manufacturer must submit a New Drug Application. The FDA regularly updates OTC drug monographs to include newly accepted labels and ingredients.
Many have argued that the FDA drug-approval processes are substandard or flawed. Just because a drug is FDA-approved does not guarantee that the drug will be risk-free. Manufacturers recall thousands of drugs every year in response to reported side effects, injuries, and other issues. Learn more about reporting drug injuries and drug side effects here.
United States consumers deserve the right to hold drug companies accountable. For example, if you took a prescription medication that led you to develop stomach cancer, the manufacturer should be accountable. Unfortunately, members of Congress have introduced bills at the federal level design to strip away consumer rights and reduce pharmaceutical company accountability. The House Judiciary Committee passed a bill known as the Fairness in Class Action Litigation Act of 2017 – HR 985. The bill makes it harder for victims of bad drugs and their lawyers to take action against pharmaceutical companies. The bill is a transgression against consumers and their rights given by the 7th amendment, which states: “If someone harms you for the sake of profit, they should have to pay for the damages you endured because of your injury.”
Read on to learn about the Fairness in Class Action Act to learn more about HR 985 and what can be done.
The FDA drug-approval process is designed to protect consumers from dangerous and adverse side effects. While the agencies’ regulations do increase safety and accountability, millions of Americans are at risk every year of complications, injuries, and even death from bad drugs. TorHoerman Law maintains a detailed list of current bad drug lawsuits. If you suffered any injuries or complications because of a bad drug, contact us today to learn more about your options.
California, State of. “Governor Gavin Newsom Signs Legislation Banning ‘Pay for Delay’ to Fight Runaway Prescription Drug Costs.” California Governor, 8 Oct. 2019, www.gov.ca.gov/2019/10/07/governor-gavin-newsom-signs-legislation-banning-pay-for-delay-to-fight-runaway-prescription-drug-costs/.
Center for Drug Evaluation and Research. “FDA’s Drug Review Process: Continued.” U.S. Food and Drug Administration, FDA, www.fda.gov/drugs/drug-information-consumers/fdas-drug-review-process-continued.
Center for Drug Evaluation and Research. “FDA’s Role in Drug Recalls.” U.S. Food and Drug Administration, FDA, www.fda.gov/drugs/drug-recalls/fdas-role-drug-recalls.
Center for Drug Evaluation and Research. “Frequently Asked Questions about the FDA Drug Approval Process.” U.S. Food and Drug Administration, FDA, www.fda.gov/drugs/special-features/frequently-asked-questions-about-fda-drug-approval-process.
Center for Drug Evaluation and Research. “Patent Certifications and Suitability Petitions.” U.S. Food and Drug Administration, FDA, www.fda.gov/drugs/abbreviated-new-drug-application-anda/patent-certifications-and-suitability-petitions.
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TorHoerman Law was responsible for handling a medical case for our family. I was extremely impressed with their professionalism and ability to react quickly. They also did a nice job keeping us updated with the case throughout the process. This was the first time experiencing a situation like this and Tor Hoerman law did an excellent job from start to finish.
TorHoerman Law is an extraordinary law firm – a firm that truly makes the client’s best interests the primary concern. Their team of personal injury lawyers are experienced, personable, and well versed in a range of litigation areas. They are supported by a dedicated team of staff that are as equally friendly and helpful. I would recommend TorHoerman Law for any personal injury litigation needs.
All of my questions were answered quickly and in a way I could understand. Steve and the entire staff were friendly and professional.
I highly recommend this law firm! The attorneys and staff at THL worked hard, communicated every step of the process, kept me well informed at all times, and exceeded all expectations! The staff is kind, considerate, professional, and very experienced. Look no further, call now!
Top-notch, hardworking attorneys!
A wonderful and professional legal team. They helped me when I needed expert legal representation! Thank you TorHoerman Law!
They contacted me the next day. Very nice people!
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