Drug Recalls and Pharmaceutical Litigation
INJURED BY A DANGEROUS DRUG OR DEFECTIVE MEDICAL DEVICE?
Over three billion prescriptions are written each year in the United States, according to the U.S. Food and Drug Administration. Millions of Americans rely on pharmaceutical drugs to maintain and improve their lives. The last thing you should expect to happen when taking medications is for your well-being and quality of life to be put at risk. People use pharmaceutical drugs and medical devices to improve their lives, help heal from injuries, and to treat or cure ailments. It is unacceptable on the part of drug manufacturers when medications that are supposed to help you cause you severe or fatal injuries instead.
Unfortunately, a drug is not necessarily safe simply because the FDA has approved it for use. Although the FDA oversees the approval of all pharmaceutical medications, dangerous drugs continue to make it to market and cause irreparable injuries and illnesses to unsuspecting victims. Side effects that can cause debilitating and life-changing injuries may have been discovered in testing, but the FDA may still approve the drug as long as these side effects do not happen too often.
WHY ARE PHARMACEUTICAL DRUGS RECALLED?
A recall is when a product is removed from the market or a correction is made to a product due to being defective or harmful.
According to the FDA, drugs are removed from the market when the potential risks outweigh the intended benefits. When the safety issues cannot be fixed or addressed properly, the drug is taken off the shelves. Oftentimes these safety issues, dangerous side effects, and harmful reactions are not known when the FDA made their approval. A year or more may pass before the manufacturer of the drug or the FDA discover the problems caused by the drug or device.
In some cases, the drug manufacturer will issue a voluntary recall after discovering an issue with a drug. Several different factors can lead to a drug being recalled by the drug maker or the FDA. A recall may occur if the drug is:
- A health hazard
- Packaged poorly
- Poorly manufactured
THREE CLASSES OF FDA RECALLS
According to the FDA, a recall can be conducted by the drug manufacturer, requested by the FDA, or ordered by the FDA. There are three classes of recalls:
- Class I Recall: This is a situation in which there is a reasonable probability that the use of or exposure to the recalled product will cause serious adverse health consequences or death.
- Class II Recall: This is a situation in which use of or exposure to a recalled product may cause temporary or reversible adverse health consequences and the chance of severe adverse health events is remote.
- Class III Recall: This is a situation in which use of or exposure to a recalled product is not likely to cause an adverse health issue.
In addition, the FDA can also issue a medical device safety alert, which is a situation where a medical device may present an unreasonable risk of substantial harm.
COMMON SEVERE INJURIES CAUSED BY DANGEROUS DRUGS OR DEFECTIVE MEDICAL DEVICES
More than four million people require a visit to the emergency department, doctors’ office, or outpatient facility each year due to an adverse event from a medication. An additional 117,000 require hospitalization due to these events (FDA). Every medication — prescription and over-the-counter — has a list of potential side effects. However, many pharmaceutical drugs have been shown to cause severe and sometimes fatal harm.
Severe injuries and illnesses that may result from a dangerous pharmaceutical drug include:
- Birth defects
- Pregnancy complications
- Blood disorders or excessive bleeding
- Gastrointestinal problems
- Heart disease
- Heart attacks
- Brain damage
- Kidney failure
- Movement disorders
- Developmental disorders
- Liver damage
- Mood disorders, depression, suicidal thoughts or actions
This is by no means an exhaustive list of the serious side effects that can result from a defective drug. If your or a loved one have suffered from one of these illnesses or injuries, you may be entitled to compensation for the damages you have incurred.
LARGEST PHARMACEUTICAL DRUG RECALLS IN THE UNITED STATES
Over the past several decades, some of the largest pharmaceutical drugs that have been recalled have caused severe and life-altering injuries and death for thousands of victims. The following dangerous drugs were infamously recalled after being found harmful instead of helpful:
- Accutane — an acne medication that was on the U.S. market for 27 years prior to being recalled in 2009. Thousands of lawsuits were filed against the manufacturer, Hoffman-La Roche, which lead to multiple million-dollar verdicts. Accutane was recalled after being linked to an increased risk of birth defects in pregnant women as well as inflammatory bowel disease and suicidal thoughts.
- Darvocet and Darvon — an opioid pain reliever that was on the market between 1955 and 2010. The drugs were found to cause toxicity in the heart and was linked to more than 2,000 deaths between 1981 and 1999.
- Bextra — a pain reliever and anti-inflammatory drug that was pulled from U.S. markets in 2005. Bextra was linked to an increased risk of heart attack, stroke, gastrointestinal bleeding, and serious skin conditions, such as Stevens-Johnson syndrome and erythema multiforme. In addition, the FDA concluded that the drug produced by G.D. Searle & Co. did not show any advantages over other non-steroidal anti-inflammatory drugs.
- Propulsid — a nighttime medication used to combat heartburn associated with gastroesophageal reflux disease (GERD). Produced by Janssen Pharmaceutica, this drug was available to consumers for seven years before being recalled in 2000. There were more than 270 cases of severe cardiac arrhythmias reported in people taking Propulsid, resulting in 70 deaths.
- Fen-Phen — a combination of two drugs (dexfenfluramine and fenfluramine) used as a diet aid. The combination of the name brands Redux and Pondimin were withdrawn from the market in 1997 after thousands of people reported serious heart valve defects or lung damage. An estimated six million people took the drug combination, and the drug maker, Wyeth, set aside more than $21 billion to deal with the plethora of lawsuits.
- Rezulin — an antidiabetic and anti-inflammatory drug manufactured by Pfizer. The drug was recalled after causing liver failure in scores of patients, leaving 63 dead. Approximately 35,000 claims were filed against Pfizer. Rezulin was on the market between 1997 and 2000.
- Vioxx — a NSAID pain reliever used to treat arthritis and other chronic and acute pains that was on the market for more than five years between 1999 and 2004. Merck recalled the dangerous drug after being linked to more than 27,000 heart attacks or sudden cardiac deaths between 1999 and 2003. The medical journal Lancet estimated that 88,000 Americans suffered from heart attacks due to Vioxx, 38,000 of which died. In 2007, Merck announced that it would pay $4.85 billion to end thousands of lawsuits, which is considered one of the largest drug settlements ever.
HAVE YOU BEEN INJURED BY ONE OF THESE DRUGS OR DEVICES?
There are many drugs that have been released on the market to consumers that have been proven to cause severe, adverse effects. Potentially dangerous drugs and medical devices include:
This is only a small sampling of the drugs that can cause severe and potentially fatal injuries. If you were harmed by a drug not found on this list, don’t worry. No matter which drug caused your injuries, our experienced dangerous drug lawyers are available 24/7, nights and weekends to hear your claim. Learn more about specific dangerous medications and devices by exploring the medications links on the left-side menu.
WHAT IS A BLACK BOX WARNING?
First issued in 1979, a black box warning is the strictest labeling requirement that the FDA can mandate for a pharmaceutical drug. These black box warnings alert consumers of serious and potentially fatal hazards associated with the prescription medication. A warning with a black box around it means an adverse drug reaction could potentially be lethal. Some black box warnings are issued immediately after the drug is approved. However, many are issued only after adverse events have been proven with the drug.
The FDA will issue the black box warning label after receiving a series of reports of severe, adverse reactions to the drug. The black box warning also serves as a reminder to pharmacists to be cautious and mindful when prescribing certain drugs to patients who may be at a greater risk of an adverse event. Many people sustain serious illnesses or injuries after being given the wrong drug or incorrect dosage of a prescription. If you or a loved one were the victim of pharmaceutical malpractice, our experienced pharmaceutical litigation attorneys are available to hear your claim.
WHY DO I NEED AN ATTORNEY FOR MY MEDICATION OR DRUG INJURY?
Every year, more than 200,000 people die from drugs approved by the FDA. As you might expect, litigation against the pharmaceutical giants that manufacture dangerous drugs and medical devices can be intimidating, complicated, and expensive.
In order to fight these battles on behalf of clients, it takes an experienced staff of attorneys and an enormous amount of legal and financial resources. Thomas J. Henry is one of only a few attorneys who is willing to engage in this David versus Goliath fight. Our dangerous drug attorneys are experienced in pharmaceutical litigation and are equipped with the legal resources necessary to take on the largest pharmaceutical companies in the world. We bring in the best medical device and pharmaceutical drug experts from across the country to provide expert reports and testimony on your behalf.
If you or a loved one suffered an injury or illness due to a dangerous pharmaceutical drug or medical device, contact our experienced injury lawyers at Thomas J. Henry. The pharmaceutical companies deserve to be held liable, and you deserve to be compensated for your injuries.
DAMAGES FROM A DEFECTIVE DRUG OR MEDICAL DEVICE
Dangerous drugs and defective medical devices can leave you or a loved one in a world of hurt — physically and financially. Thomas J. Henry is honored to represent individuals harmed by the negligence of the pharmaceutical and medical device industry. When these companies put profit before safety, your health and livelihood is put at risk. Damages from defective drug or medical devices may include:
- Lost wages or income
- Medical expenses
- Pain and suffering
- Wrongful death
UTILIZING THE BEST EXPERT WITNESSES FOR YOUR DANGEROUS DRUG CASE
The success of a pharmaceutical drug case can hinge on finding and using the best expert witnesses possible on your behalf. An expert witness provides specialized knowledge and brings expertise that average people may not have. Their reports and testimony can play an extremely important role in developing your personal injury case to its fullest.
We have spent decades finding the best expert witnesses in the United States. At Thomas J. Henry, each expert witness we employ has went through a rigorous examination and questioning process, ensuring they are the right witness for the case. We are continuously looking for innovative ways to use expert witnesses in dangerous drug and defective medical device injury lawsuits.
Experts used in your dangerous drug litigation may include:
- Regulatory compliance consultants
- Drug injury causation experts
- Forensic scientists
Pharmaceutical drug cases can be complicated, so employing the services of the experts listed above can be vital in providing pertinent information. Thomas J. Henry employs a multitude of experts in every personal injury matter, ensuring our clients that their case is taken seriously and put in the best position to achieve the maximum amount of compensation for their injuries or the loss of a loved one.
CONTACT AN EXPERIENCED DANGEROUS DRUG AND MEDICAL DEVICE ATTORNEY
If you or a loved one has been the victim of a dangerous pharmaceutical drug or medical device, you may be entitled to compensation. You deserve dynamic representation from a law firm with the resources necessary to take on the pharmaceutical companies. Thomas J. Henry has a track record of helping clients receive record-breaking verdicts, settlements, and judgments. Contact our experienced drug recall and pharmaceutical litigation attorneys 24/7, nights and weekends for a free case review.