There are more product liability lawsuits filed against prescription drug manufacturers than against all other industries combined. Under strict product liability laws, drug manufacturers may be held liable for ANY serious injuries or deaths caused by their products regardless of the care they took to prevent defects.

Hazardous waste presents serious problems not only to humans but to the environment as well. Environmental law matters are particularly complex, not only due to the maze of federal, state and local laws involved but also because these laws are often highly technical in nature.

Brent Cordell

Attorney at Law

Board Certified Specialist in Personal Injury Trial Law

1 844 - 8LEGAL8 (1 844 853-4258)

Recalled Drugs A-C:


 

PLEASE NOTE: This is not a comprehensive list of FDA drug recalls. For current information on drugs recalled by the U.S. Food and Drug Administration visit FDA.gov.

A drug is considered "defective" in cases when its potential risks or side effects are determined to outweigh its intended benefits, or when the manufacturer fails to provide adequate warning of the risks. In many of these cases the plaintiffs allege that manufacturer was aware of the dangers posed by the product but deliberately chose to conceal that information from consumers.

All pharmaceutical drugs introduced to the U.S. market must be pre approved by the Food and Drug Administration (FDA). Drug manufacturers are required to adequately test each product before seeking FDA approval, and their labels must properly disclose all information involving potential side effects in order to reduce the risks of misuse and adverse events. However, drug manufacturers can and do minimize or conceal adverse side effects to facilitate this approval process. Furthermore, the FDA lacks the time or resources to perform rigorous follow-up research and screening of the product.

In cases where a significant number of serious injuries or deaths are discovered to be related to a drug, the FDA will normally launch an investigation to determine if the drug is actually defective. In severe cases the FDA will issue a Drug Recall and pull the drug from circulation. But in other cases additional warnings may simply be required and the drug may continue to be marketed to consumers.


 

Abilify product liability attorney Abilify® (aripiprazole)

Abilify is an atypical antipsychotic drug used to treat symptoms of bipolar disorder, schizophrenia and depression. Although the risk for side effects seemed relatively low when Abilify was originally approved for use in the United States by the FDA in 2002, the manufacturer (Bristol-Myers Squibb) has received multiple complaints from people who have required patient assistance because of serious problems they have encountered.

On at least four occasions dating back to 2004, the FDA has issued warnings related to the possibility of side effects associated with the use of Abilify, including 'Black Box' warnings that explain the possibility of diabetes, seizures, depression, suicidal thoughts and death.

"Antidepressants may increase suicidal thoughts or behaviors in some children, teenagers, and young adults, especially within the first few months of treatment or when the dose is changed. Depression and other serious mental illnesses are themselves associated with an increase in the risk of suicide. Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, unusual changes in behavior, or thoughts of suicide. Such symptoms should be reported to the patient's healthcare provider right away, especially if they are severe or occur suddenly. ABILIFY®(aripiprazole) is not approved for use in pediatric patients with depression."


 

Accutane product liability attorney Accutane® (isotretinoin)

Accutane (isotretinoin) is a popular drug for severe acne created by Hoffmann-LaRoche Inc. Originally marketed as a chemotherapy drug, it was later found to treat acne that has not responded to antibiotics.
The medication is a derivative of vitamin A and works by controlling the oil in the sebaceous glands. The acne it treats consists of nodules with a diameter or 5 mm or greater.

Isotretinoin is linked to severe bowel disease and other side effects. The drug works for severe (cystic) acne, providing long-lasting and sometimes complete reduction of acne for 80 percent of patients. However, clear skin may be accompanied by serious side effects like Crohn's disease. Following numerous reports of adverse events – and after doctors noted potential dangers with the drug -the FDA issued a black-box warning.

Roche stopped manufacturing Accutane in 2009, but generic brands of the medication -Amnesteen, Claravis and Sotret- are still available.
The alleged Accutane side effects generally deal with damage to the gastrointestinal tract and digestive system of the body, and examples of commonly reported Accutane side effects include:

  • Crohn's disease – Crohn's disease is a condition that attacks any portion of the digestive tract. Specifically, Crohn's disease causes severe inflammation of the internal wall of the digestive tract, leading to complications with the ingestion of food and to chronic and severe internal pain.
  • Ulcerative colitis – Ulcerative colitis is a condition that attacks the large intestine in much the same way as Crohn's disease can strike anywhere within the digestive system. This disease involves the development of inflammation and of ulcers on the interior wall of the large intestine that leads to intense pain.
  • Inflammatory Bowel Disease (IBD) – IBD is basically a catch-all term that can describe either of the two alleged Accutane side effects above.

 

Actiq product liability attorney ACTIQ® (fentanyl citrate)

Actiq (fentanyl citrate) is an extremely powerful narcotic which is delivered in the form of a lollipop by placing the drug in a lozenge on the end of a stick. When the narcotic lollipop is placed against the cheek of the mouth and sucked on, the medication is delivered directly into the blood stream. It usually provides relief of even the most severe pain within 15 minutes. The FDA approved Actiq in November 1998 for treatment in cancer patients suffering pain which could not be relieved by other medications.

The Actiq fentanyl lollipop is a narcotic pain medication which is only intended for treatment of break through cancer pain in patients who are already opioid tolerant.

Although it has only been approved for use by cancer patients, the manufacturer negligently allowed the medication to be prescribed to treat less serious ailments, such as chronic back pain, knee pain and head aches. It has been estimated that over 80% of Actiq users do not have cancer, and there have been allegations the sales representatives actively promoted the drug for non-cancer uses.

As a result of aggressive promotion and advertisement by the manufacturer, Cephalon, Inc., the Actiq lollipop has been widely prescribed to individuals who never should have received the drug. There have been hundreds of reports of overdose and death as a resolve the fentanyl lollipops.
The candy-like method used for the powerful fentanyl delivery combined with widespread prescription for non-approved uses has resulted in serious and potentially fatal injuries. The medication has also been abused, resulting in death for many users. There have also been reports of children dying after they mistook the powerful narcotic for candy.


 

Actos (pioglitazone) bladder cancer product liability attorney Actos® (pioglitazone)

Based on FDA's review of data from a planned five-year interim analysis of an ongoing, ten-year epidemiological study, they have informed the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.

A recent epidemiological study conducted in France also suggests an increased risk of bladder cancer with pioglitazone. Based on the results of this study,both Germany and France have officially banned use of the drug although Actos is still available in the US. The Actos warning concerning the potential for bladder cancer will appear on the labeling per the request of the FDA.

Actos controls blood sugar and is sometimes sold in combination with metformin (Actoplus) Met, glimepiride (Duetact).) and Actoplus Met XR. It is estimated that over 2 million people currently use these drugs and need to be warned about the risk of Actos bladder cancer. Symptoms of Actos Bladder Cancer may include blood or red color in urine, an urgent need to urinate, pain while urinating and pain in back or lower abdomen. The FDA Actos Warning said diabetes patients taking Actos should tell their doctor if they have any of the above symptoms relating to Actos bladder cancer. Patients should talk to their doctors before making any changes to their medicine use and talk to their doctors about any concerns they have with using Actos.

Shortly after the Actos bladder cancer FDA warning was released, the agency announced that it approved a label update which cautioned that use of Actos for more than a year may increase a user's risk of developing bladder cancer. Because we believe that patients were not adequately warned about the possible risk of Actos bladder cancer prior to this label update, we are offering a free case review to Actos, ActoPlus Met, ActoPlus Met XR, and Duetact users who were diagnosed with bladder cancer to determine if legal recourse is available.


 

LifeCell AlloDerm hernia  product liability attorney Alloderm®

AlloDerm is a surgical mesh used in hernia repair and breast reconstruction surgery. It was originally developed in 1994 by LifeCell as a graft for burn patients and is intended to promote tissue growth in the areas where it is surgically inserted so that a patient's cells will effectively repopulate the treated area. AlloDerm is made from donated human cadaver skin. The donated skin goes through a process to remove all of the cells in the top layer and the entire dermis, leaving the collagen and elastin framework of the skin.

When used in hernia repair, AlloDerm has been linked to serious complications including hernia recurrence, abscess and infection due to mesh tear and adhesion problems. In many cases victims of AlloDerm hernia repair complications must undergo additional surgical procedures to correct the problem.

Alloderm is manufactured by LifeCell, and has only recently been marketed for hernia repair. Much of the information supporting this use of AlloDerm was actually funded by LifeCell and few long term studies have followed people who received AlloDerm for hernia repair. Unfortunately, when AlloDerm has been used for hernia repair, it appears to be failing at an alarming rate.

A study published in the journal Hernia in 2008 reported that the overall complication rate associated with AlloDerm hernia repairs among patients at one institution was as high 24 percent. Most of the complications seen in that study involved hernia recurrence, while one rejection and two infections were reported. According to another study app. 8 percent of AlloDerm patients require explant surgery, compared to 1.6 percent in control groups. Serious AlloDerm complications can cause injuries to nearby organs, nerves and blood vessels and may require patients to undergo mesh explant, or the removal of the graft.

LifeCell began promoting Alloderm for hernia repair and abdominal reconstruction surgery in 2000 without adequately testing the product, providing instructions on the proper use or warning consumers and the medical community about the risk of AlloDerm patch complications with hernia repair. A number of serious problems have occurred where the mesh has begun to stretch, expand, thin out or sag once implanted. Although the manufacturer knew that the AlloDerm graft should be "pre-stretched" if it was going to be used during a hernia repair, they failed to adequately share this information with surgeons. AlloDerm lawsuits allege that LifeCell knew or should have known that the patch was not suitable for hernia surgery as marketed, and that it did not have proper warnings and instructions that may have reduced the risk of complications.

As a result of LifeCell's decision to place profits before consumer safety, thousands of people were needlessly exposed to a risk of painful and debilitating injury following hernia repair, which may permanently impact their quality of life.


 

AndroGel product liability attorneyAndroGel (testosterone gel) ®

AndroGel is manufactured by AbbVie Inc., which branched off from Abbott Laboratories, one of the true giants of the pharmaceutical industry. In the past three years this prescription testosterone-based gel has generated at least one billion dollars in revenue during each 12-month period. It is one of the best-selling pharmaceutical medications currently on the market in the United States.

This form of testosterone replacement therapy (TRT) is beginning to create problems for consumers who have used it to help overcome low testosterone levels. Men who have used this product have shown a dangerous propensity to encounter serious heart and circulatory system problems including heart attacks, strokes and high blood pressure. These AndroGel side effects tend to arise relatively soon after a person begins to use this product, but in some cases it may be too late to fully overcome the harm done by the time the side effects become apparent.

Although AndroGel is one of the leading products within the testosterone replacement therapy market, these medications are extremely prevalent overall. Some estimates indicate that as many as three percent of all American men under the age of 40 either are undergoing or have undergone testosterone replacement therapy. Men have taken this step because 'low-T' can lead to a lack of energy, muscle tone, sexual performance and in some cases a lack of mental focus. TRT is supposed to help alleviate these problems.


 

Avandia product liability attorneyAvandia® (rosiglitazone maleate)

Avandia is GlaxoSmithKline's trade name for the drug rosiglitazone, and was approved by the Food and Drug Administration (FDA) in 1999 for the treatment of Type 2 diabetes. Avandia is in the class of medications called thiazolidinediones, or glitazones, which includes Rezulin (troglitazone) and Actos (pioglitazone). All three drugs in the thiazolidinedione family have had problems. Rezulin was recalled in 2000, after it was shown to cause liver damage, and Avandia use was severely restricted by the FDA in 2010 after it was linked to tens of thousands of heart attacks, strokes and heart failures. The FDA removed the restrictions in late 2013. The third glitazone — Actos — has repeatedly been linked to an increased risk of heart failure and bladder cancer, but has not yet been recalled.

GlaxoSmithKline claimed its clinical trials of Avandia revealed only that the drug produced mild side effects. In fact, in those clinical trials and in the many years since, Avandia was associated with a significant increase in the risk of myocardial infarction (heart attack).

To date, tens of thousands of patients and their families have filed lawsuits against GlaxoSmithKline because of Avandia's life-threatening complications. One estimate links the medication to as many as 100,000 heart attacks, strokes and heart failures, including many deaths. Many Avandia lawsuits have been resolved through litigation, and Glaxo's potential liability may exceed $6 billion. The company has also settled various civil suits relating to its manipulation of medical research concerning Avandia and its withholding of the drug's safety data.


 

Benicar product liability attorney Benicar® (Olmesartan medoxomil)

Benicar is a medication that is used to treat hypertension, and it was originally approved for use in the United States by the FDA in 2002. It was approved for use by children in the United States in 2010. Benicar is manufactured by Daiichi Sankyo, and it has been estimated that the drug is one of the most widely used in the world.

Of the Benicar side effects associated with the use of the drug, sprue-like enteropathy appears to be the most severe. Sprue-like enteropathy leads to symptoms that can appear to be similar to celiac disease, which is a condition whereby people have negative reactions to gluten.

In July of 2013, the FDA made an announcement stating that this medication would from that point forward include a label warning regarding the risk of Benicar side effects including sprue-like enteropathy. This announcement covered Benicar and drugs that were also marketed under the following names:

  • Benicar HCT
  • Azor
  • Tribenzor
  • Olmesartan medoxomil (generic equivalent)

 

Byetta product liability attorneyByetta® (exenatide)

Type 2 diabetes is a condition that more and more people are fighting, and the fight against type 2 diabetes requires daily diligence.

One widely used medication is Byetta,introduced to the American market in 2005. Byetta helps control glucose levels by mimicking a synthetic hormone known as GLP-1. As is often the case with new medications, there were some early reports of what would now be considered relatively minor Byetta side effects, including nausea, vomiting, diarrhea, headaches, acid reflux and decreased appetite.

Unfortunately, a study was subsequently done by researchers at UCLA that tied the use of Byetta with much more serious side effects that included pancreatitis, pancreatic cancer and thyroid cancer.

Obviously, these alleged Byetta side effects are extremely serious and could put people's lives in danger if they are allowed to develop without early and aggressive medical intervention. Since the results of this study were released, the FDA has published some warnings regarding the potential risks regarding these alleged Byetta side effects. Recently, the FDA has once again announced that it will be reviewing statistics and other forms of data regarding patients who were using Byetta and who had developed the serious side effects that were mentioned above. No word was given as to when this analysis would be complete nor was any indication provided as to what action, if any, the FDA would take based on those findings.
What is known at this point is that people who have used Byetta to help control the symptoms of type 2 diabetes have suffered immeasurably. People who have been diagnosed with a serious health problem that could be related to the use of this medication need to take immediate action on several fronts in order to protect themselves.


 

Celexa product liability attorneyCelexa® (Citalopram Hydrobromide)

It's estimated that as many as 15 million people in the United States are fighting a daily battle against depression. One of the leading medications for dealing with the symptoms of depression is known as Celexa, which is manufactured by Forest Laboratories. Unfortunately, reports of serious Celexa side effects eventually began to surface, leading not only to action by the FDA but also to the filing of Celexa lawsuits.

Celexa is an antidepressant medication that's a member of a group of drugs that's known as Selective Serotonin Reuptake Inhibitors, or SSRI's. Celexa performs much like other SSRI medications in that it helps to regulate the brain's chemistry such that it keeps the patient on more of an even keel in terms of the synapse messages in the brain and how they move.

Studies have shown that women who use Celexa or a different SSRI medication during the third trimester of pregnancy face a higher risk of having children born with at least one Celexa birth defect. Celexa has been strongly associated with a variety of birth defects including Primary Pulmonary Hypertension and Abdominal, Heart and Cranial birth defects.

In response to the growing number of reports regarding alleged Celexa side effects, the FDA has issued a warning regarding the use of certain antidepressant medications during the late stages of pregnancy. In 2006, the FDA issued a specific warning regarding the dangers faced by children of mothers who used SSRI medications during the late stages of pregnancy of developing PPHN. Overall, SSRI medications such as Celexa can be dangerous for pregnant women and others.


 

Chantix product liability attorneyChantix® (varenicline)

Chantix is manufactured by Pfizer, one of the largest pharmaceutical companies in the world. Chantix is available via prescription and is usually administered to people who need immediate and forceful help in the quitting of smoking habits. Chantix works by releasing a substance known as Varenicline, which is a form of salt, into the system. This Varenicline attaches to receptors in the brain much like nicotine, which is the addictive substance in cigarettes. Therefore, Chantix helps wean someone off of a nicotine addiction in this manner.

Reports of serious Chantix side effects have begun to surface, and for some people these alleged side effects were actually deadly. Specifically, examples of common Chantix side effects have included mood and behavioral changes, Vivid and extremely strange dreams, Suicidal thoughts and Suicide. Estimates indicate that as many as 400 people who were taking Chantix attempted suicide, and more than 30 people who were using this medication in order to quit smoking succeeded at taking their own lives.

As a result of these reports of Chantix side effects, the FDA has required that a warning be attached to the labels of Chantix regarding these risks. In addition, the Federal Motor Carrier Safety Administration announced that Chantix could impair driving ability and the Federal Aviation Administration has banned the use of this medication for pilots and air traffic controllers.


 

Clomid product liability attorneyClomid® (Clomiphene)

Clomid is commonly known as a fertility drug that's manufactured by Sanofi-Aventis U.S. LLC, which is an American subsidiary of a parent French pharmaceutical company. Clomid works by basically serving as a boost of estrogen that prompts women who are having trouble generating enough eggs to become pregnant to raise their levels of egg production. Clomid is taken in pill form for what is usually five days near the normal cycle for the would-be mother.

Many women in the United States have trouble becoming pregnant, and when this situation arises many will turn to the help of medication in order to successfully begin a pregnancy. In recent years, many different drugs have been designed to help with this effort, and one of the leading medications in this regard is known as Clomid. Reports of serious Clomid side effects are generally centered on the possibility that women who had used Clomid at certain times would have children born with serious birth defects.

Women who had used Clomid for two months prior to conception and during the first month of a pregnancy had children who were born with one or more of the following birth defects:

  • Brain defects
  • Under-developed esophagus
  • Omphalocele
  • Craniosynostosis
  • Cloacal exstrophy
  • Hypospadias & Penoscrotal Hypospadias
  • Heart defects

Every one of these alleged Clomid birth defects is extremely serious, and some such have proven to be fatal. When a mother struggles with becoming pregnant before she even begins to carry a child, she and the father are likely emotionally invested in that child to a degree that's difficult to understand. When all of that work, expense and hope results in having a child that's born with a severe birth defect, those parents obviously suffer emotionally


 

Crestor product liability attorneyCrestor® (rosuvastatin calcium)

Crestor is prescribed in conjunction with a program of exercise and restricted diet in an effort to lower dangerously high cholesterol levels. It was originally approved for use in the United States by the FDA in 2003. Crestor is known as a 'stati', which is a type of drug that works to lower the amount of 'bad' cholesterol and triglycerides in the blood stream while helping to raise the levels of 'good' cholesterol. This process tends to help minimize the risks associated with prolonged periods of high cholesterol.

Crestor side effects were extremely dangerous and in some cases deadly. Even though the FDA has issued public health warnings regarding the potential dangers of Crestor side effects, the medication remains on the market and people are still likely suffering from Crestor side effects even though they may not have yet realized it.

Crestor side effects include Kidney damage and failure, heart failure and rhabdomyolysis; an otherwise rare condition whereby a large number of skeletal muscle cells suddenly die, releasing an enormous amount of muscle protein into the circulatory system which eventually settles in the kidneys. Once this substance moves into the renal system, if the kidneys are unable to expel it severe damage can result.

Under strict product liability laws, drug manufacturers may be held liable for ANY serious injuries or deaths caused by their products regardless of the care they took to prevent defects.

 

Drug related product liability claims fall under three basic headings:

  • Defectively manufactured pharmaceutical drugs claims involve injuries caused by drugs that have been improperly manufactured or have become contaminated in the manufacturing process. This may occur at the manufacturing facility, during shipping, through a compounding pharmacy or at any point between the manufacturing facility and the location where you actually receive the drug.
  • Pharmaceutical drugs with dangerous side effects claims involve drugs that may be properly manufactured but still have side effects which result in injury. These cases often involve drugs that have been on the market for a long time before research shows that they increase risks of injury. In some cases victims may claim punitive damages if they can show that a manufacturer knew of the danger but deliberately concealed it.
  • Improperly marketed pharmaceutical drugs. The "marketing" of a pharmaceutical drug refers to the warnings, instructions, or recommendations concerning the use of that drug. This category often involves injuries caused by a failure to provide adequate or accurate warnings regarding a dangerous side effect or a failure to provide adequate instructions regarding the safe and appropriate use of the drug. The "bad advice" may have been given by the manufacturer or by a doctor, pharmacist, sales rep, or some other medical provider.

A defective product lawsuit may include a combination of these claims; i.e., claims based on a drug with a dangerous side effect may be coupled with a claim based on the failure to warn of that side effect.

If you believe that you or a loved one has suffered serious personal injury from a defective drug, you may be eligible to seek compensation for your medical expenses, pain and suffering, loss of income, diminished earning capacity and more. Under product liability laws the manufacturer, distributor and seller can all be held liable for your injuries.

 

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