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FDA and Prescription Drugs

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FDA and Prescription Drugs

The Food and Drug Administration (part of the US Health and Human Services Department) is primarily designed to safely regulate foods, dietary supplements, drugs, and vaccines.  In some cases, primarily with dietary supplements and drugs, the FDA approves products that end up having side effects that are harmful or even fatal. 

In those cases it pays to have an attorney familiar with cases involving the government and large corporations and insurance companies.  Napoli, Bern, Ripka (New York based personal injury attorneys) have successfully sued several companies that marketed harmful products that were initially given FDA approval. 

In many cases, the work of Napoli, Bern, Ripka led to new laws being passed which made the world safer for everyone as potentially harmful products were taken off the market and victims received appropriate compensation for the harm they endured. 

One of the most memorable cases came against AHP who marketed the popular diet drug Fen-Phen.  After a great deal of study using patient echocardiograms it was found that use of Fen-Phen led to valvular heart disease and pulmonary hypertension in some patients. 

Napoli, Bern, Ripka got millions of dollars in awards for our clients after the FDA had requested to withdrawl Fen-Phen from the market in 1997.  But with so much money in biotech and the quest to bring new drugs to market as quickly as possible (often without adequate review), the public needs an advocate who is willing to fight against large drug companies, insurance companies, and the government to get awards for those who were the victims of negligence. 

Napoli, Bern, Ripka always reviews your case for free if you feel you have been the victim of a drug or supplement that the FDA had approved.  Whether it’s been a drug that has been already been the subject of legal action by victims such as yourself or one that hasn’t been, Napoli, Bern, Ripka offers advantages to other law firms who handle these cases. 

For one, all of our legal and medical team (including a physician/attorney and RN on fulltime staff) are in-house and this leads to greater efficiency and prevents your case from being lost in the shuffle. 

Second, we have access to the nation’s top experts in fields as diverse as pathology, neurology, oncology, cardiology, toxicology, pharmacology, accident reconstruction and surgery. 

But most importantly to ensure that all clients, regardless of the size of their bank account, receive a fair chance in the justice system we accept cases on a contingency basis.  Many law firms will only take your case after you’ve paid a large retainer. 

Not only will Napoli, Bern, Ripka review your case for free but we’ll also take the case on a contingency basis allowing you to have the same top-notch attorneys and medical experts on your side that you know the drug companies and insurance companies will have on theirs. 

In this day and age of more and more options being given to treat a myriad of diseases and afflictions, the average person needs a law firm that is willing to stand up to those that are marketing drugs and supplements that can have potentially dangerous side effects.  Napoli, Bern, Ripka has over 40 years of experience being that law firm and will continue to do so in the future.    

Library for FDA and Prescription Drugs:

  • Gardasil   
    Description: It all started 2 years ago when Merck & Co. started administering Gardasil, a cervical-cancer vaccine, to girls and women. Over 8,000 adverse reactions have been recorded by the Federal health officials. Gardasil was licensed by the Food and Drug Administration in June 2006 for females ages 9 to 26. Sold worldwide, it's been given to more than 8 million US girls and women, Merck says. The vaccine is aimed at warding off strains of the human papillomavirus, or HPV, which can lead to cancer. The vaccinations cost a total $360. Securities and Exchange Commission documents show Merck made $1.5 billion in Gardasil sales last year.
  • Ancure   
    Description: Ancure is a synthetic graft device that is used to repair abdominal aortic aneurysms. In March 2001 Guidant, the company that manufactures Ancure, suspended production of the device and announced a recall of all existing Ancure inventory. Contact Napoli Bern if you have had this procedure.
  • Baycol   
    Description: Baycol, one of a family of popular cholesterol-lowering drugs, was pulled from the U.S. market by its manufacturer because of reports linking the pill to 31 deaths. Contact Napoli Bern if you have been injured by Baycol.
  • Fen-Phen   
    Description: "Fen-Phen," the popular name for the combination of the drugs fenfluramine (Pondimin) and phentermine, has been on the market in the United States for several decades. Doctors prescribed the drug combination to help control obesity.
  • Fosamax   
    Description: Fosamax, also known as alendronate, is an osteoporosis drug manufactured by Merck & Company. Since Alendronate is a bisphosphonate, it may help to reduce bone fractures (by increasing bone mass for instance).
  • Ortho Evra   
    Description: Ortho Evra is the first transdermal (skin) patch approved for birth control. The weekly prescription patch releases norelgestromin (a progestin hormone), and ethinyl estradiol (an estrogen hormone), through the skin into the blood stream to prevent pregnancy. The U.S. Food and Drug Administration approved Ortho Evra, manufactured by Ortho McNeil, a subsidiary of Johnson & Johnson, in November 2001.
  • Guidant Defibrillators and Pacemakers   
    Description: FDA is notifying health care providers and patients that the Guidant Corporation is recalling certain of its implantable defibrillators and cardiac resynchronization therapy defibrillators. These devices can develop an internal short circuit without warning, resulting in failure to deliver a shock when needed.
  • Primary Pulmonary Hypertension   
    Description: The legal definition of primary pulmonary hypertension (also known as PPH, idiopathic pulmonary hypertension, and pulmonary hypertension) is a rare condition in which the blood pressure in the arteries of the lungs is abnormally high. The condition is often fatal and is primarily found in female patients aged 20-40 years old. The cause of primary pulmonary hypertension is unknown. It is considered a progressive disease, often leading to congestive heart failure, respiratory failure, and eventually death.
  • Seroquel   
    Description: Seroquel, also known as quetiapine fumarate, is an antipsychotic used to treat schizophrenia and symptoms of psychotic disorders such as hallucinations, delusions, and hostility. The U.S. Food and Drug Administration (FDA) approved Seroquel in 1997.
  • Serzone   
    Description: Serzone, also known as nefazodone hydrochloride, belongs to a class of medications known as antidepressants. Manufactured by Bristol-Meyers Squibb Company, Serzone fights mental depression by increasing natural substances in the brain. The U.S. Food and Drug Administration approved Serzone in 1994.
  • Trasylol   
    Description: Trasylol is manyfactured by Bayer Pharmaceuticals and is designed for patients who undergo Cardiopulmonary Bypass (CPB) for Coronary Artery Bypass Graft (CABG) surgery. Trasylol has been linked to adverse events including stroke, encephalopathy, heart attack and kidney damage, and studies have shown that there are cheaper and safer generic options options available.
  • Medtronic Defibrillators   
    Description: Medtronic and the Food and Drug Administration (FDA) have issued statements that Medtronic is voluntarily removing its Sprint Fidelis defibrillation leads from the market as the electrical wires are “prone to fracture in a small number of patients which can cause the defibrillator to deliver unnecessary shocks or not operate at all.”
  • Avandia   
    Description: The U.S. Food and Drug Administration (FDA) is aware of a potential safety issue related to Avandia (rosiglitazone), a drug approved to treat type 2 diabetes. Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia.

Videos about FDA and Prescription Drugs:

 

 

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