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.
We do our best to get to know our clients, understand their situations, and get them the compensation they deserve.
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.
The THL Team commits to the sincere belief that those injured by the misconduct of others, especially large corporate profit mongers, deserve justice for their injuries.
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, known as 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 regulatory agency’s methodologies have garnered widespread scrutiny. Many have argued that the agency’s processes are flawed and responsible for keeping lower-cost drugs off of the market. Soaring prices of U.S. healthcare, along with high-profile pharmaceutical lawsuits in recent years, have raised many questions about how the system works and who it benefits the most.
Pharmaceutical companies hoping to sell new prescription drugs, vaccines, or other treatments in the United States must gain FDA approval. Companies pursue a five-stage drug development process, and they must present evidence to the CDER from each phase.
These five phases outline the basic process that most new drugs and devices follow, but there are variations and exceptions based on the type of product and the condition it’s intended to treat.
Companies and consumers have long complained that the FDA approval process is too slow, particularly in the case of potentially life-saving drugs. In response, the agency has implemented certain programs that can speed up the approval of drugs in certain cases. There are four types of expedited approaches that a manufacturer may request if they believe their product fits the criteria:
These four approaches each differ slightly in their qualifications and their advantages for approval, but all are essentially designed to speed up the development of much-needed drugs. An example would be new treatments for serious conditions like cancer or Alzheimer’s. In the case of the COVID-19 pandemic, vaccine applications received priority review due to the urgent need and demand.
Drugs known by name brands are typically those brought to market as a new drug by a particular company. As a brand new drug, vaccine, or medical device, products are typically subject to extra scrutiny within the five-stage process outlined above.
After conducting sufficient research on the drug’s efficacy and safety, a pharmaceutical company submits a New Drug Application (NDA) to the FDA. The NDA must include extensive data and test results, manufacturing specifications, and the proposed label for the product (including usage instructions, effective dosage, and potential risks).
FDA scientists and researchers then review the company’s submitted labeling, information, and research. This is when the agency determines if the findings prove that the drug meets the safety and quality standards. Note that the agency itself usually does not test drugs before making a decision, it only reviews data provided by the sponsoring company. The FDA may, however, inspect the manufacturing facilities before approval.
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 NDA that contains many of the same steps but without as many initial 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.
The FDA medical device approval process follows essentially the same five stages as the drug approval process. In the case of devices, companies submit a pre-market notification to the FDA. The agency then examines the evidence from all prior research and clinical trials, looking for sufficient proof that the device’s benefits outweigh the risks. Even so, faulty devices sometimes make it to market and cause harm to medical patients.
The entire process can take years for potentially risky devices, but as with new drugs, there are ways that companies and the FDA can speed up the approval.
Even though the process of approving a drug can be lengthy and contain many steps, dangerous products can still slip through the cracks, and untold numbers of people are affected every year. TorHoerman Law keeps a list of current bad drug and medical device lawsuits, but these represent just a fraction of the total claims regarding side effects, personal injury, and wrongful death due to pharmaceutical products — many of which don’t ultimately get very far in the court system.
On top of all this, the United States spends far more on healthcare per person than other high-income nations, meaning Americans pay more for drugs and treatment than most other people in the world. Because of several faults in the FDA approval process, many pharmaceutical products can maintain their high prices — much to the chagrin of most Americans who can’t afford these high prices.
This fact, along with persistent problems like the COVID-19 response and the opioid overdose epidemic, has raised serious criticisms of the FDA process and its outcomes.
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 and therefore massive control over price in the market.
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 the generic drug does not infringe on the brand patent. If courts determine that the generic drug does infringe on a 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 why lower-cost, generic drugs don’t always make 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 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 potentially cheaper prescription drug prices. In fact, the Federal Trade Commission (FTC) estimated that from 2010 to 2020, pay-for-delay agreements cost American consumers $3.5 billion per year. The FTC has filed several antitrust lawsuits against such agreements and has recommended that Congress pass legislation to protect consumers, but no comprehensive law has yet been enacted at the federal level.
Other widely voiced criticisms of the FDA involve conflicts of interest in the drug approval process and agency committees. Common concerns include:
While a certain amount of conflicting interest may be unavoidable to maintain expert oversight, the breadth of these criticisms suggests substantial room for improvement for FDA to prioritize public safety over pharmaceutical industry profits.
The FDA’s post-approval monitoring of drugs and devices has also been criticized as inadequate. Many people argue that the agency is not doing enough to monitor the safety and effectiveness of drugs once they are on the market, and that this lack of accountability puts the public at risk.
The fact that thousands of drugs and devices are recalled every year in the U.S. suggests serious flaws in the approval system, but surprisingly, the FDA does not have the authority to mandate the recall of drugs in the same way it does vaccines or medical devices. This means that although the FDA can recommend the removal of a drug from the market, the decision to recall is ultimately left up to the manufacturer.
Because pharmaceutical companies hold so much sway, the onus often falls on consumers to hold them accountable in the form of lawsuits. Unfortunately, members of Congress have introduced bills at the federal level designed to strip away consumer rights and further shelter pharmaceutical companies from accountability. If you wish to report a case of drug injury or side effects, expert legal help is crucial for improving your odds against pharmaceutical corporations.
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!
The firm went above and beyond. Thank you for everything.
The attorneys at THL were extremely helpful with the legal aspects of setting up my small business.
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