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!
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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.
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According to a report by the Institute for Safe Medication Practices (ISMP), the FDA’s Adverse Event Reporting System (FAERS) is flawed and needs modernization.
ISMP’s report is based on the analysis of 847,039 reports gathered over a 1-year period between 2013 and 2014 by FAERS.
With people reporting drug side effects and mounting lawsuits over those pharmaceutical drugs, it is time to take a closer look at this defective drug safety reporting system.
The FDA’s Adverse Event Reporting System (FAERS) is the U.S. government’s primary drug safety monitoring system used by drug manufacturers, consumers, and health professionals.
While the manufacturers are required to report all learned adverse events, it is voluntary for consumers and health professionals.
Essentially, FAERS is a database that houses information regarding the dangers of therapeutic drugs. Strengths of the system include:
Despite these strengths, FAERS is filled with flaws including:
A recent article from The Wall Street Journal sheds some light on how manufacturers are monitoring drug safety. The article may also explain the cause of drugmakers’ incomplete and low-quality reports of adverse events. Pharmaceutical companies are outsourcing drug safety monitoring to companies in India.
Here is how it works:
ISMP recommends updating FDA regulations and reports data elements, covering adverse events in infants and children such as birth injuries, having drug manufacturers ask specific questions such as “Was the drug suspected of contributing to the event?” to ensure the quality of adverse event reports.
The report notes that while drug manufacturers are reporting thousands of adverse events promptly to the FDA, the reports contributes little to monitoring the safety of therapeutic drugs.
New pharmaceutical deregulation proposals and cuts to federal spending on the monitoring of pharmaceutical drug safety could lead to an increase in FAERS reporting – but will this flawed system be able to handle such an increase? President Trump’s new national budget proposes dramatic cuts to the federally-backed National Institute of Health (NIH) and Department of Energy’s Office of Science.
Under the proposed budget the NIH, the single largest state medical research institute, will lose $5.8 billion or about 20% of its total funding.
The Office of Science, which supports research for 10 national labs as well as hundreds of Universities conducting research, is set to lose $900 million, around 20% of its total budget.
This means huge cuts to state-backed biomedical research helping to regulate U.S. healthcare and the pharmaceutical industry.
During his Feb. 28, Congressional Address, Trump also promised to decrease average national drug prices through a process of deregulation, “slashing the restraints” of the FDA.
The FDA has already been heavily criticized for their lenient regulatory trial periods.
But in a January meeting with big pharma lobbyists, Trump promised to shorten these trial periods, stating, “we’re also going to be streamlining the process, so that, from [the pharmaceutical industry’s] standpoint, when you have a drug, you can actually get it approved if it works, instead of waiting for many, many years.”
The meeting was followed by the release of an executive order that required federal institutions, including the FDA, to remove two regulations for each new rule that is proposed.
Dr. Robert Califf spoke of the potential harm of these regulatory cuts stating, “a lot of people are going to get hurt or end up taking ineffective drugs.” Califf was the acting FDA commissioner but resigned after the new administration took office.
Taking Califf’s place as FDA commissioner is Dr.
Scott Gottlieb, who previously served as the FDA’s deputy commissioner for medical and scientific affairs where he received criticism for his support of lowering FDA regulations.
When asked how he will combat the potential for increased adverse health effects due to deregulation and major cuts in state-research funding, Trump explained that he will call for an increase in FDA user-fees.
Big pharma can expect to pay more to participate in the market.
Though the exact details of these increased user-fees were not released in the new budget proposal, user-fees would need to increase by nearly double to cover the costs of the federal funding cuts.
On the face, increased user-fees seem like a good response; as Trump explained, “industries that benefit from FDA’s approval can and should pay for their share.”
But big pharma providing a majority funding for the department that is supposed to be regulating their products gives the industry, even more, an opportunity to intervene in the pre-market approval process of those products.
So, what does this all mean for the general public? With deregulation of FDA oversight, cuts in funding to institutions conducting government research and overview, and the potential for essentially the privatization of the FDA because of increased industry funding, it is likely we will see an increase in injuries and thus adverse event reports.
The FDA is already over-encumbered by adverse event reports, having too many reports coming into their system without the means to properly analyze every drug and injury that are reported (see birth injury). There were 1.2 million reports of side effects from medications filed with the FDA as of 2015.
That is an increase of almost 1 million reports since 2005.
These reports are completely voluntary and only pharmaceutical companies are required to report issues with their products.
Therefore, experts believe that these numbers are only a small portion, roughly 1-10%, of all adverse effects.
The proposed regulatory and budgetary changes will mean a higher potential for dangerous drugs entering the market, leading to an increase in adverse effects reporting.
At the current rate and with fewer resources to ease the burden of data analysis, there is no way that the FDA will be able to conduct a comprehensive analysis of adverse effects reports.
Rather than controlling potential risks by addressing them in a timely fashion, the FDA will have to pick-and-choose the drugs that they believe have the highest potential danger to consumers based on reporting; and for the drugs that do not fall under the criteria, but have been reported to have adverse effects, the FDA will have to wait until the effects become profound on a large enough scale to necessitate federal intervention.
With the reports steadily increasing and the FDA unable to analyze all the data, third-party private researchers have begun to step in and pick up some of the weight of data analysis.
Independent researchers, such as Advera Health are paid to analyze the potential harm of certain prescription drugs.
This information is used by insurance companies, drug companies, and other players in the pharmaceutical industry who want to determine the potential costs of the adverse effects of drugs.
These third-party companies are vital watchdogs and their right to data must be protected as the Trump administration looks to slash regulations.
The FDA claims that the data from the reports does not necessarily directly correlate to the ineffectiveness or potential danger of products and should not be used to determine potential costs.
But as Thomas Moore, senior scientist at the Institute for Safe Medication Practices, explains, “sheer numbers have some scientific weight.”
This is apparently the belief of the pharmaceutical industry, which is turning to these third-party researchers more often to help analyze the data from reports.
There are still some flaws in the data reports, however.
One major issue with the current FDA filing system is that, though it does offer statistics on how many adverse effects have been reported, it does not give any specific statistics on how many patients are using a certain drug.
Researchers may be inclined to analyze drugs with high volume reporting because a drug is more popular, while a much less popular drug with low volume reporting could boast much higher potential levels of harm for patients.
With the likelihood of a continued increase in adverse effects reporting, it will be important that independent researchers become more involved with data analysis of post-market pharmaceuticals.
Deregulation of the industry could open an entirely unforeseen level of dangerous products being introduced to the market, especially with big Pharma having a larger hand in the pre-market testing process.
A less effective pre-market testing process means that data collection once the drug hits the market will be even more important.
Adverse event reporting and analysis are necessary to ensure our safety.
With the lack of a strong reporting system and the likely possibility of an increase in adverse reports due to deregulation and budget cuts, federal oversight of pharmaceuticals products and adverse events could become a major challenge, leaving all consumers at risk.
28, 2015 January. “A CRITIQUE OF A KEY DRUG SAFETY REPORTING SYSTEM Executive Summary.” Quarter Watch: Monitoring FDA MedWatch Reports, www.ismp.org/QuarterWatch/pdfs/2014Q1.pdf.
McLain, Sean. “New Outsourcing Frontier in India: Monitoring Drug Safety.” The Wall Street Journal, Dow Jones & Company, 1 Feb. 2015, www.wsj.com/articles/new-outsourcing-frontier-in-india-monitoring-drug-safety-1422814766?KEYWORDS=drug%2Bsafety.
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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.
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