Drug manufacturers produce and promote hundreds of new medications each year. Sometimes these drugs, which are meant to help people get better, cause adverse side effects that outweigh their benefits. Even though these products are tested, regulated, and approved by the Food and Drug Administration (FDA), many drugs have harmful side effects. Pharmaceutical companies have a legal obligation to you for any injuries you suffer from their dangerous drugs or defective medical products.
If you or someone you know has suffered an injury after taking a dangerous pharmaceutical drug, please contact our class action lawyers in Orlando online or at (407) 712-7300 for a FREE case evaluation. We represent our clients on a contingency fee basis, meaning we don’t get paid unless we reach a settlement.
Colling Gilbert Wright & Carter serve clients in Orlando, Florida and nationwide.
There are many details involved in dangerous drugs claims, and our lawyers want you to know:
- When to File a Dangerous Drugs Claim
- What Makes a Drug Dangerous
- Who Can Be Held Liable
- Dangerous Drugs Claims We Represent
- How Our Lawyers in Orlando Can Help
When to File a Dangerous Drugs Claim
When pharmaceutical companies put a new drug on the market, they have a responsibility to you, as the consumer, to make sure what they are selling is safe. If unforeseen problems develop while the drug is available to consumers, these same companies are responsible for alerting doctors and consumers to the problem.
Unfortunately, some unscrupulous companies continue to market the drugs even after serious health hazards and side effects (even wrongful death) have been reported. Sometimes drug companies don’t recall certain drugs because they have a lot invested in the drugs and more money to make from them.
You could have a dangerous drug claim if the drug you were prescribed had adverse side effects you were not made aware of such as:
- Your medication has been linked to cancer and you were diagnosed with cancer after taking the drug.
- You suffered an injury such as heart failure or kidney damage due to the medication.
Time is of the essence when pursuing a claim regarding dangerous drugs and their effect(s) on you. If you’re not sure if you have a valid case, reach out to our attorneys to discuss your options.
What Makes a Drug Dangerous
Drugs are studied before being allowed on the market to ensure they are safe, but unfortunately, manufacturers have learned how to manipulate the system for profit. The U.S. Supreme Court has made it clear the manufacturer is the only one with access to the knowledge necessary to properly label drugs, and therefore, it is their responsibility to make sure the labeling is accurate and complete. Drug companies, though, regularly decide they would rather hide risks and market dangerous drugs for profit. Their hope is that by the time risks come out they will already have made their profit.
Defective or dangerous drugs can result from design flaws, errors in the production process and serious side effects that are not publicized. Additionally, these drugs can become dangerous when deceptive marketing techniques are used, or they are prescribed for off-label, non-approved uses. There are also times when a pharmaceutical drug is given FDA-approval and released for patient use before it has been fully tested.
Other ways a drug can become dangerous include:
- Studies were not conducted long enough to determine the long-term side effects.
- The drug was approved with little testing because it was similar to another medication already on the market.
- The medication was manufactured in a facility that doesn’t require FDA-approval.
- Side effects of the drug were underplayed by sales representatives or not printed on the label even after research showed a link to that side effect.
Who can be Held Liable
There are many moving parts when it comes to the release, production and distribution of a pharmaceutical drug, and each party has a responsibility to follow the FDA’s guidelines. When a patient is harmed by a medication, they can file a dangerous drug claim against the responsible party for negligence, strict product liability or failure to warn. Our lawyers can help you determine who is at fault for your injuries or the loss of a loved one, which may include:
- The manufacturer
- The testing facility
- The pharmaceutical sale representative
- Your doctor for medical malpractice
- Your pharmacy
- The hospital or clinic you were treated at
Dangerous Drugs Claims We Represent
Our lawyers at Colling Gilbert Wright & Carter represent clients who have suffered pharmaceutical injuries or lost a loved one due to a defective or dangerous drug. We’re currently helping patients who have experienced adverse side effects from these drugs and more:&
- Actos and Bladder Cancer
- Pradaxa and Deadly Side Effects
- Byetta and Januvia
- Darvocet and Darvon
- Dilantin and Sevens-Johnson Syndrome (SJS)
- Ortho Evra
- Abilify and Compulsive Behaviors
- Onglyza and Heart Failure
- Xarelto and Uncontrolled Bleeding
- Taxotere & Permanent Hair Loss
Actos and Bladder Cancer
Actos is a drug intended to treat Type 2 Diabetes. In this form of diabetes, sometimes described as noninsulin dependent diabetes or adult onset diabetes, your body produces enough insulin, but your cells do not respond to the insulin and do not take in glucose. Common side effects of Type 2 Diabetes include fatigue, hunger, thirst, infections, increased urination, blurred vision and erectile dysfunction. Type 2 diabetes has no cure: You need to take treatment medication for life.
Actos may be one drug where the manufacturer intentionally concealed risks to increase profits. There has long been a suspicion that the drug was linked to increased risk of bladder cancer. We know that in 1999 Takeda Pharmaceuticals, the manufacturer of Actos, submitted data from a carcinogenic study — intended to reveal cancer risks — in which male rats developed bladder tumors. Unlike many animal studies, the rats in this study were not given huge doses, just doses equivalent to the normal human dose.
Bladder cancer was not added to the warning label, though, because Takeda argued that cancer in the rats did not signal a risk for humans. They also pledged to study cancer risk in a ten-year post-marketing study. Unfortunately, after millions of people have taken the drug, we see the same pattern as in the 1999 carcinogenic study. Actos has been shown to be associated with an up to 40 percent increase in the risk of bladder cancer.
Pradaxa and Deadly Side Effects
Pradaxa is a blood thinning medication approved to reduce the risk of strokes in patients with a form of irregular heartbeat, called atrial fibrillation. Unfortunately, the drug may have deadly side effects. Pradaxa can cause deadly hemorrhaging, and unlike the alternative drug, Pradaxa has no antidote.
With no good monitoring method, the drug may increase risks for some people. We already know that the drug has been associated with high numbers of adverse events, including more than 500 severe, sometimes fatal, hemorrhages.
You cannot test how well Pradaxa is working, and this may result in some patients receiving a larger dose of the medication than necessary, increasing their risk of serious bleeding events. In addition, the kidneys remove Pradaxa from the body, making it a dangerous drug for patients with decreased kidney function, which is common in older patients.
Another danger of Pradaxa is that there is no antidote. If a patient has a serious bleeding event from Pradaxa, the effects cannot be stopped — you must wait until they resolve spontaneously.
Zithromax and Heart-Related Death
Zithromax was approved by the FDA in 1991. Commonly used for treating tonsillitis, respiratory infections, urinary tract infections, and other bacterial infections, Zithromax has been prescribed to hundreds of thousands of people. It also generated an estimated $450 million for Pfizer in 2011.
The potentially deadly side effects of this medication was reviewed by the FDA in 2011, as well as other drugs like it called macrolides. Compared to other antibiotics, macrolides have been known to cause problems with heart rhythms in the past, including prolongation of QT interval. This can then lead to a fatal condition called torsades de pointes in which the heart’s electrical axis can rotate by 180 degrees.
This latest study, published by the New England Journal of Medicine, found that 2.5 times as many patients were dying from heart problems in the first five days of treatment compared to other antibiotics. The study shows that there are 47 deaths per million people when taking Zithromax over amoxicillin. This number seems small, but when patients who are already at risk of heart problems take the drug, the death rate jumps to 245 per million.
The FDA says that individuals who are taking Zithromax or azithormycin should continue to take their medication until they speak to their doctor. However, if you are taking this potentially deadly drug, it is important that you contact your doctor immediately.
Byetta and Januvia
The popular diabetes drugs Byetta and Januvia have been linked to an increased risk for life-threatening adverse side effects including pancreatic cancer. The FDA is currently investigating a report, which indicates these dangerous drugs can dramatically raise users’ risk for pancreatitis, a severe inflammation of the pancreas.
The FDA previously issued a warning about a heightened risk of pancreatitis—both nonfatal and fatal instances—linked to Byetta, Januvia and other incretin mimetic drugs. The agency is now investigating one recent analysis of data that suggests these medications may increase a patient’s risk of pancreatitis six fold.
There is also evidence of pre-cancerous cell changes in pancreatic tissue samples taken from patients using these drugs. The recently published findings of a study conducted by researchers with the University of California indicate a link between Byetta and Januvia and heightened risk for pancreatic cancer. The same study also noted a possible relation between Byetta and an increased risk for thyroid cancer.
The makers of Byetta and Januvia face a growing number of lawsuits filed on behalf of those who suffered severe, and in some cases deadly, adverse effects. These cases allege the pharmaceutical makers in question failed to adequately warn patients about the risks of their drugs.
Darvocet and Darvon
The FDA announced in November 2010 that the widely used prescription painkiller drugs Darvocet and Darvon were being recalled. Each drug contains propoxyphene and Darvocet contains acetaminophen. According to the FDA, the benefits attached to the painkillers do not outweigh their risks, which are serious and life threatening. In addition to the name brand drugs, the FDA also announced that the generic versions were going to be pulled from the market.
Evidence presented over several decades shows that Darvocet and Darvon pose a significant and real danger to patients. In 1978, Public Citizen, a consumer watchdog group, submitted findings to the FDA to petition for the recall of the drugs due to an increased risk of suicidal tendencies, as well as toxins building up in the heart. In addition to suicidal thoughts and toxic buildup, both Darvocet and Darvon are highly addictive. If this wasn’t enough, data showed propoxyphene to be only slightly more effective than acetaminophen in reducing pain.
It is believed that propoxyphene has resulted in more than 2,100 deaths since those first early findings. The main cause for these deaths has been heart rhythm anomalies.
Although the FDA waited until 2010 to pull Darvocet and Darvon from the market, the U.K. pulled the drugs in 2005. After the U.K. announced its recall, Public Citizen again petitioned the FDA in 2006. In 2008, they filed a lawsuit against the FDA over its failure to act on the petition. An agency advisory panel then conducted additional studies into the safety of Darvocet and Darvon. Based on the strength of the evidence, the panel voted to recall the painkillers.
Dilantin and Sevens-Johnson Syndrome (SJS)
Dilantin (generic name “phenytoin sodium”) has been used for a long time to control seizures. It is an anti-epileptic and helps to control grand mal and temporal lobe seizures. Epilepsy is the best-known condition that involves seizures. It is not curable but can be managed with medications such as Dilantin.
Phenytoin sodium is also sold as:
- Phenytek (by Mylan Laboratories)
- Eptoin (in India by Abbott Group)
- Epanutin (in Israel and the UK by Parke-Davis, which is now part of Pfizer)
A side effect of Dilantin that has been reported to the FDA is Stevens-Johnson Syndrome (SJS). It is an emergency condition requiring immediate hospitalization. It has another form also, called Toxic Epidermal Necrolysis (TEN). Both conditions feature lesions on the mucous membranes (mouth, lips, eyes, anal and genital areas) and a skin rash with blisters.
The rash has a purple or red color and spreads, causing the upper skin layer (epidermis) to die and peel off. This creates severe pain and danger of infection, and the patient is treated in a hospital burn unit. SJS can be fatal.
It is not surprising that Dilantin would have many potential side effects, since it works on the brain, modifying electrical communication between brain cells. Some of the other possible side effects include:
- Slurred speech
- Difficulty with learning
- Numbness in the hands or feet
- Difficulty with breathing
- Unusual bruising or bleeding
Not everyone has all possible side effects. As with most FDA-approved drugs, most people have few side effects and SJS is very rare. However, it is severe and potentially lethal, and the FDA wants better communication to medical professionals and patients about who should avoid Dilantin.
Lipitor and Diabetes
Lipitor and other statins, including Crestor (rosuvastatin) and Zocor (simvastatin), work by inhibiting a liver enzyme that affects cholesterol production, helping reduce the risk of heart disease. Since the FDA approved Lipitor in 1996, a growing number of patients began experiencing high levels of sugar in the blood and developing diabetes. Multiple studies confirmed an association between the use of Lipitor or another statin and an increased risk for developing diabetes, particularly in post-menopausal women who had other risk factors for diabetes such as obesity, high blood-sugar levels, high cholesterol and high blood pressure.
Pfizer had not previously warned about a heightened risk for diabetes, and in 2012, the FDA mandated changes to the safety information for Lipitor and other statins. Unfortunately, the revised warnings came too late for many already affected by the drugs.
Women taking Lipitor should consult with their physicians and undergo blood-sugar testing. Lipitor patients should also be aware of the early warning signs of type 2 diabetes, which include:
- Increased thirst and hunger
- Frequent urination
- Sudden weight loss despite eating regularly
- Blurry vision
- Chronic infections or slow-healing wounds
- Patches of darkened skin
Pfizer is facing mounting lawsuits that allege the company failed to adequately warn medical professionals and patients about the risks of Lipitor and the importance of monitoring blood-sugar levels.
Ortho Evra is a transdermal contraceptive applied to the skin in the form of an adhesive patch. It was marketed as a convenient alternative to birth control pills. The hormones are embedded in the patch’s adhesive layer and are slowly released when the patch is applied to the skin. The patch is applied once a week, and it was designed to stay on during bathing or exercise.
The efficacy of the birth control patch has been in question after research indicated 23 deaths related to the patch. About 17 of those deaths appeared to be blood clot related. Dozens more women in their teens and twenties suffered strokes and other blood clot related events.
Ortho Evra is considered a “combination hormonal contraceptive,” and the most common injuries associated with the patch have been blood clots, which can be life-threatening. In addition to the potentially fatal blood clots, women using the patch have been known to suffer:
- Heart attack
- Thromboembolism and thrombotic disorders
- Deep vein thrombosis (DVT)
- Gallbladder disease
- Hepatic neoplasia
Due to the many adverse side effects associated with Ortho-Evra, the FDA ordered that changes be made to the patch’s label. In November 2005, a new warning stated that women who use the patch are exposed to approximately 60 percent more total estrogen in their blood than if they were taking a birth control pill. The FDA required the manufacturer to add another warning about the increased risk of injury due to the high levels of estrogen released from the patch because the patch had been marketed with claims stating that it was just as safe as the pill.
Selective serotonin reuptake inhibitors (SSRI) are a type of antidepressant medication prescribed for treating depression, anxiety disorders and some personality disorders such as obsessive-compulsive personality disorder (OCD) and eating disorders. A low level of serotonin is one of several symptoms of clinical depression—SSRIs are designed to elevate the level of this chemical. Serotonin is necessary to metabolize stress hormones in our body, and low levels of it can result in anxiety and depressive disorders.
SSRIs have been linked to various health problems, most notably birth defects in children born to mothers taking the drugs during pregnancy. Zoloft (generic sertraline), manufactured by Pfizer Pharmaceutical, has been linked to infants being born with persistent pulmonary hypertension (PPHN). Research has shown infants born to mothers who took Zoloft or other SSRIs after their 20th week of pregnancy were six times more likely to have PPHN than infants born to mothers not taking anti-depressants during pregnancy.
SSRI side effects include, but are not limited to:
- Diminished libido
- Appetite/weight fluctuations
- Increased feelings of depression and/or anxiety
- Muscle ache/weakness
- Suicidal thoughts
Paxil (generic paroxetine), manufactured by GlaxoSmithKline, is prescribed for the treatment of depression, obsessive-compulsive disorder, panic disorder, and anxiety disorder and has become one of the most widely used SSRIs for treating anxiety disorders. Paxil has been named in several lawsuits involving adolescents and suicidal tendencies and suicide attempts.
There have been lawsuits that allege Glaxo promoted Paxil for use in children, yet failed to provide information regarding its harmful side effects, including an increase in suicidal behavior. Also, the risk of cardiovascular birth defects in infants born to mothers taking Paxil is significantly higher than infants born to mothers not taking the SSRI.
How Our Lawyers in Orlando Can Help Your Dangerous Drugs Claim
The Law Offices of Colling Gilbert Wright & Carter are known for our tenacity in fighting for our clients and are ready to help you with your dangerous drugs claim. The impact pharmaceutical injury can have on your life, and the lives of your loved ones, is often severe, and you should be focused on getting well. Our lawyers can make sure you receive the compensation you deserve for damages you’ve incurred such as medical expenses, loss of quality of life and wrongful death.
If you or a loved one have experienced a pharmaceutical injury after taking a defective or dangerous drug, please contact our attorneys in Orlando today at (407) 712-7300 to schedule a FREE consultation. Colling Gilbert Wright & Carter serve clients in Orlando, Florida and nationwide.