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Pharmaceutical Litigation
Diflucan Birth Defects
Hip Implants
Infuse Bone Graft
Meningitis Outbreak
NaturaLyte and GranuFlo
Ortho Evra
PPH and Weight Loss Drugs
SimplyThick Formula Additive
Transvaginal Mesh
FDA Approval
Dangerous Drugs & Your Rights
Pharmaceutical Litigation FAQ

Pharmaceutical Litigation Attorney

Dangerous Drugs & Medical Devices

Have you or a loved one been the victim of side effects from a dangerous drug or injuries caused by a defective medical device? Defective, dangerous medical devices and drugs cause countless injuries each year. Our attorneys are here to help injured patients take legal action to seek financial compensation that will cover their medical care and more. Napoli Bern Ripka Shkolnik, LLP handles pharmaceutical litigation for clients across the United States. We have recovered more than $3 billion since 2000 alone and are prepared to put our experience to work for you. It starts with a free consultation, which you can arrange by calling us toll-free at 888.870.2757.

Through the years, drugs of all kinds, from the acne medication Accutane to the type 2 diabetes medication Avandia, have all exhibited extremely dangerous side effects in some patients, which has led to numerous Food and Drug Administration (FDA) warnings and recalls. Injured consumers across the U.S. have filed lawsuits against the pharmaceutical companies that manufacture these dangerous drugs. Some, such as Zoloft and all other antidepressants, have been ordered to include boxed warning labels (often referred to as "black box" labels) to inform patients of the potential risks. Others, including the birth control pill YAZ, have had to alter their marketing strategies because their original approaches were misleading. In extreme cases, some prescription and over-the-counter drugs have been recalled and pulled from the market, voluntarily or at the request of the FDA.

Undisclosed health risks or inadequate studies may have been the reason that some of these drugs were allowed on the market in the first place. In other scenarios, the seriousness of side effects simply were not known until the drug was subject to widespread use. Prescription drugs are not the only cause for concern. Medical devices such as transvaginal mesh and hip replacement products such as the Durom Cup have caused serious problems in patients, leading to pain, immobility and even revision surgeries. Our firm represents patients and consumers who have been injured by the very drugs or devices they thought would bring them comfort.

We have helped thousands seek justice in the complex field of pharmaceutical litigation. Let us help you.

FDA Involvement: Safety Alerts, Warnings and Drug Recalls

Prescription medications are a valuable resource for many people suffering acute or chronic medical conditions. Most Americans will take at least one prescription drug at some point in their life. With proper testing and studies, clear labeling and sufficient warnings regarding side effects and drug interactions, these medications can substantially increase quality of life and life expectancy.

Unfortunately, serious or potentially fatal side effects of many pharmaceutical drugs only become known after they are released on the market and large numbers of people are affected. The FDA has the important - and demanding task of regulating drugs and medical devices. In spite of their efforts, dangerous drugs and devices may make it to the market.

When this occurs, the FDA typically receives reports from injured patients and may conduct reviews of these reports and other studies to determine what action should be taken to protect patients. In most cases, this is an update to the labeling to warn of side effects, risks or adverse reactions in certain types of patients. If the FDA determines that the drug's risks outweigh the benefits, it may require a recall. Pharmaceutical companies may also voluntarily recall their products after FDA investigations and too many reports of adverse effects.

Can clinical trials be trusted?

The FDA approves drugs based partly on efficacy and drug side effects reported in clinical trials. Pharmaceutical companies may also perform additional trials after a drug is on the market. These can yield important information when performed correctly and when all results are properly reported, but the way the pharmaceutical industry performs clinical trials has fallen under scrutiny.

A 2010 report by the U.S. Department of Health and Human Services found that prescription drug trials conducted outside the United States and used as a basis for U.S. drug approvals lack oversight by the FDA. In 2008, 80% of FDA drug approvals were based in part on foreign clinical trial data. 8% included only foreign study data. Yet in 2008, the FDA inspected less than 1% of foreign clinical trial sites. The investigation also found the FDA is completely unaware of many foreign clinical trials or their results because pharmaceutical companies or drug sponsors often do not submit Investigational New Drug (IND) forms to notify the agency.

A study funded by the U.S. government and published August 2010 in Annals of Internal Medicine entitled "Outcome Reporting among Drug Trials Registered in ClinicalTrials.gov" examined 546 clinical drug trials conducted between 2000 and 2006. The study found that clinical trials funded by the pharmaceutical industry were more likely to report positive drug outcomes than trials funded by other sources.

In September 2010, the FDA changed requirements for reporting risks or adverse reactions found during clinical trials, after an inquiry by the Senate Committee on Finance, which oversees the FDA, found that pharmaceutical giant GlaxoSmithKline knew of potential cardiac risks of the company's prescription drug Avandia (rosiglitazone) years before it became public and failed to disclose those risks.

The FDA first approved Avandia in 1999. Between then and when heart attack side effects came to public light in 2007, the FDA estimates that Avandia caused approximately 83,000 heart attacks. The new FDA rule requires that pharmaceutical companies or drug sponsors report clinical trial findings that suggest a significant risk to study participants or any suspected adverse reactions that occur at a rate higher than expected within 15 days of becoming aware of findings. These did not previously require reporting to the FDA.

FDA Approval Requirements for Medical Devices

The FDA also regulates medical devices, including everything from tongue depressors to heart valves, medical implants such as hip replacements, diagnostic devices such as MRI machines and treatment devices such as infusion pumps. New medical devices must go through a premarket approval (PMA), which requires makers of the medical device to provide clinical trial data to prove it is safe and effective. However, many new medical devices never go through this process. If a maker can prove their device is substantially similar to another device already approved for market, that device can get FDA approval through the 510(k) process, which requires no clinical evidence.

This FDA fast track process for medical device approvals is facing scrutiny from a U.S. Senate Special Committee after a study published in the February 2011 issue of Archives of Internal Medicine found that the majority of defective medical devices recalled by the FDA due to serious or fatal device side effects were approved using the 510(k) process. Defective medical devices have affected the lives of millions of people, including such medical devices as defective hip implants, defective defibrillators and defective infusion pumps.

Call to Speak with a Skilled Medical Injury Lawyer

Many serious and potentially fatal injuries from defective medical devices, medication side effects or drug interactions discovered after a medical device or drug has been on the market have prompted increased warnings on the device or drug labeling and restriction of the drug's use. Some have resulted in a medical device or drug recall. Anyone who suffers serious side effects from a defective medical device or prescription medication, or those who lost a loved one to a fatal side effect, may have grounds to file a lawsuit to recover damages such as medical expenses, loss of wages or financial support or the wrongful death of a loved one.

Contact a pharmaceutical injury attorney of Napoli Bern Ripka Shkolnik LLP today and find out if you are entitled to compensation for your injury.

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