Dangerous Drugs and Defective Products
If you've been hurt by a medical product, we'll fight for the justice you deserve
Every manufacturer has a responsibility to produce safe, effective products and to warn consumers about any dangers that may emerge. Pharmaceutical companies and medical equipment manufacturers have a particularly grave responsibility because their products are designed to treat disease and save lives. When they fail in that responsibility, people can be seriously hurt or even killed.
Call Now If You or a Loved One Was Harmed By Any Products Below
- Viagra, Levitra, Cialis
Defective drugs and medical devices can cause harm in several ways. Sometimes, they simply don't work - which means people who depend on them are left with an untreated medical condition. In other cases, these products have side effects that are actively harmful to the body, ranging from headaches, nausea and vomiting to depression, anxiety and suicidal thoughts.
Dangerous products reach the market for several reasons. For instance, companies may rush products through the market without rigorous testing, using a "fast track" through the approval process. Sometimes, the design of a medical product is flawed; on other occasions, a properly designed product is made unsafe due to manufacturing errors. Issues also emerge when physicians prescribe drugs for purposes other than their intended use, known as "off-label" use.
Dangerous drug cases demand strong legal action. When you're going up against a pharmaceutical manufacturer, you need to make sure you give your case the attention it rightfully deserves. Drug companies routinely hire teams of lawyers to defend their interests, especially if they've been accused of making and marketing dangerous drugs to the public. An experienced attorney can investigate your claim and build a strong case against the drug company.
Don’t take chances when your future is at stake. Let the veteran attorneys at The Herrera Law Firm fight for the justice you need. Contact us for a free case evaluation.
Accutane (isotretinoin) was prescribed to treat severe acne or recalcitrant cystic nodular acne. The Food and Drug Administration (FDA) introduced Accutane in 2002, but withdrew the drug in July 2009. Prior to being pulled from the market, Accutane had yearly sales of more than $1.2 billion. Accutane worked by shrinking the oil glands in the skin.
Accutane is reported to have severe side effects, including risk of inflammatory bowel disease (IBD), birth defects, Crohn's disease, ulcerative colitis, depression and suicide. Some studies have also linked Accutane use to an increased risk of colon cancer.
Many people living with type II diabetes have taken the drug Actos (pioglitazone hydrochloride), which is a member of the thiazolidinedione class of drugs. Unfortunately, the drug has been linked to serious conditions in some people, including congestive heart failure (CHF), fractures, bladder cancer and, rarely, serious liver problems. In 2007, the Food and Drug Administration demanded increased warnings about Actos due to the link to congestive heart failure.
Avandia is another drug in the same class as Actos to be linked recently to serious side effects. Because Avandia users experienced an increased risk of heart attack, Avandia use was restricted in the United States.
Some people coping with osteoporosis and Paget's disease have used Fosamax (alendronate) to relieve symptoms. Manufactured by Merck, Fosamax is designed to increase bone density. About 10 million people have taken the drug, which has been linked to serious side effects including femur fractures and osteonecrosis, or "dead jaw," a severe form of bone damage in the jaw that often occurs after tooth extractions or other dental procedures. Other Fosamax side effects include a heightened risk of esophageal cancer and gastrointestinal tract problems.
Frequently prescribed to people suffering from type 2 diabetes, Invokana is a medication that helps to lower a person's blood sugar. When used in combination with diet and exercise, Invokana causes the kidneys to remove sugar through urine, lowering blood sugar and improving glycemic control.
However, because Invokana affects the kidneys, it has been associated with kidney failure - a serious medical condition that can cause toxins and fluid to build up in the body. This leads to symptoms ranging from weakness and confusion to sudden death. Invokana use has also been associated with heart attack and ketoacidosis - a medical condition in which high levels of toxic acids build up in the bloodstream.
Janssen Pharmaceuticals, which manufactures Invokana, has faced multiple lawsuits alleging that the drug company failed to warn patients and doctors about the serious dangers associated with the drug. Nevertheless, the company has not taken action to discontinue the medication or to notify users of the potential risks. If you or a loved one has become seriously ill after taking Invokana, contact our attorneys today to protect your legal rights.
Lipitor (atorvastatin) is prescribed to address heightened cholesterol levels. Many people who have used Lipitor and other statin medications have developed diabetes and even kidney failure. Pfizer, the manufacturer of Lipitor, is facing hundreds of lawsuits alleging its drug caused diabetes.
A warning from the U.S. Food and Drug Administration in 2012 stated that some statins, including Lipitor, may lead to an increased risk of elevated blood glucose levels and the development of type 2 diabetes. The federal agency ordered Pfizer to include a warning on its label informing consumers about the risk.
Because some Lipitor users developed type 2 diabetes before the label change, we believe Pfizer failed to warn users of the risk, which means the corporation must be held accountable. Even with the label change, we believe consumers do not have enough information about the risks to make an informed decision.
In 2014, a Canadian study found Lipitor, Zocor, Crestor and other statins pose serious health risks to users. The findings raise questions about whether these drugs are safe for certain users, whether Pfizer failed to properly warn consumers of this risk, and whether doctors overprescribe statins after a serious cardiovascular event has occurred.
Other recent studies have linked Lipitor and other statins to an increased risk for developing cataracts, which is a vision disorder causing the lens of the eye to become cloudy. These side effects can have a huge negative impact on Lipitor users' quality of life.
Paxil (paroxetine) is designed to treat patients with depression, anxiety disorders, and other stress-related conditions. Paroxetine is an antidepressant in a group of drugs known as selective serotonin reuptake inhibitors (SSRI). SSRIs help restore the balance of serotonin.
Paxil's benefits, however, may be overshadowed by serious and potentially deadly side effects. Potential adverse side effects include violent behavior and agitation. GlaxoSmithKline, the manufacturer of Paxil, already has faced lawsuits linked to the drug.
Pregnant women or those who are trying to get pregnant should avoid Paxil, which is linked to Persistent Pulmonary Hypertension in the Newborn (PPHN), a condition affecting the heart and lungs of infants. Babies can suffer brain or kidney damage because they are unable to breathe properly due to constricted blood vessels which cut off oxygen to the body.
Also, people with heart disease who use Paxil may be at risk of premature death, according to a recent Duke University study.
Pradaxa is the brand name of a blood thinner, dabigatran, used to reduce the risk of stroke or blood clots. It is most frequently prescribed to people with irregular heartbeats, or atrial fibrillation - a condition that typically affects the elderly.
The safety of Pradaxa, however, is being questioned. The U.S. Food and Drug Administration (FDA) in 2011 received reports of 3,781 adverse side effects and 542 deaths. Some of those serious side effects include:
- Heart attack (myocardial infarction)
- Acute coronary syndrome (ACS)
- Stomach pain
- Gastrointestinal symptoms like dyspepsia
After receiving reports linking Pradaxa to bleeding, the FDA in December 2011 announced a safety review of Pradaxa. The agency wants to find out if bleeding events are more frequent with Pradaxa patients than expected. According to an Aug. 19, 2012, report in USA Today, Pradaxa's adverse reports and deaths were higher than all other monitored drugs in 2011. Millions of people take the drug twice a day, and sales are greater than $1 billion.
According to an Archives of Internal Medicine study in January 2012, researchers found a link between Pradaxa and slightly higher risk of heart attack or acute coronary syndrome when compared with similar medicines. Researchers compared the use of Pradaxa to other anticoagulants like warfarin, enoxaparin or a placebo and found the increased risk ranged from 27 to 33 percent in patients who used Pradaxa.
Reglan (metoclopramide) is a medication used to treat persistent heartburn and other conditions of the stomach or intestines. Some pregnant women have used Reglan to fight the symptoms of morning sickness or to stimulate lactation. However, Reglan use has been linked to a serious movement disorder called tardive dyskinesia, which leads to the following rarely reversible symptoms:
- Lip smacking
- Puckering and pursing of the lips
- Rapid eye movements or blinking
- Tongue protrusion
- Rapid movements of the fingers, arms, legs and trunk
Reglan also is linked to Neuroleptic Malignant Syndrome (NMS), a rare, but life-threatening disorder characterized by muscle rigidity.
The FDA has only approved Reglan for short-term use, up to 12 weeks. However, 30 percent of Reglan patients are given the drug for 12 months or longer. The risk of adverse side effects increases when the drug is used over a long period of time.
Risperdal, or its generic equivalent risperidone, is an antipsychotic used to treat disorders such as schizophrenia, bipolar disorder and certain behavioral disorders. The drug was originally approved in 1993 specifically to treat schizophrenia in adults. In 2006 and 2007, the FDA approved several additional uses for the medication, including treatment of several disorders in children.
Risperdal lawsuits tend to focus on inappropriate marketing conducted by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. Specifically, lawsuits allege that the drug was marketed for use in children shortly after the medication was first approved in 1993, even though the FDA did not approve the drug for any use in children until 2006. Janssen Pharmaceuticals first sought approval to use the drug for pediatric patients in 1996, but the application was denied. At that time, the FDA noted suspicion that the drug was already being used "off-label" for pediatric patients.
Risperdal has been shown to over-stimulate the pituitary gland, which can cause a condition called gynecomastia, the development of breast tissue in males. Boys who develop gynecomastia can suffer significant emotional and mental trauma in addition to the physical changes. Risperdal is also associated with premature breast development in girls and other serious risks such as movement disorders, diabetes and heart disease.
The prescription drug Taxotere, or its generic equivalent docetaxel, is primarily prescribed to women undergoing treatment for breast cancer. It is a chemotherapy drug injected intravenously and used to prevent cancer cells from growing and dividing.
Unfortunately, Taxotere has been linked to permanent alopecia - that is, loss of hair. Taxotere's manufacturer was aware of this side effect as early as 2005, yet the prescription label was not updated until 2016. Moreover, an alternative drug, Taxol, offers similarly effective treatment without the side effect of permanent hair loss.
Because of the manufacturer's failure to warn patients of the side effects, thousands of women are now permanently bald. Had they been properly warned of the dangers of Taxotere, they could have used Taxol. While hair loss is commonly associated with cancer treatment, it is a very rare side effect of treatment for breast cancer. You need to contact us if you or a loved one suffered permanent hair loss during breast cancer treatment. Taxotere is likely to blame - and you may be entitled to compensation.
In early 2014, the U.S. Food and Drug Administration (FDA) issued a medical safety alert warning doctors of potentially harmful side effects and cardiovascular risks associated with testosterone therapy medication for men. The agency issued the statement after studies by the U.S. National Cancer Institute and University of California, Los Angeles, found an increased risk of heart attack, stroke, pulmonary embolism (PE), deep vein thrombosis (DVT) and other potentially fatal health complications.
- Men over age 65 face a two-fold risk of suffering heart attack within the first 90 days of undergoing testosterone therapy or taking testosterone medication, the UCLA study found.
- Men age 65 and younger with a history of heart disease could face a two- to three-fold risk of heart attack and other adverse cardiovascular reactions, according to UCLA researchers.
- Testosterone therapy patients face a nearly 30 percent increased risk of heart attack, stroke or death when compared to patients not on testosterone medication, according to a Journal of the American Medical Association study.
- Men with the following conditions who are using testosterone treatment: artery blockage, diabetes, high cholesterol, obesity, plaque buildup, a prior heart attack.
Testosterone treatment products come in the form of gels, creams, injections and pills and are marketed under the following brand names:
The pharmaceutical companies that manufacture and market testosterone treatment products stand to gain significant profits. Testosterone therapy is a billion-dollar industry that grew fivefold between 2000 and 2011. An estimated 5.3 million prescriptions for testosterone treatment were written in 2011 alone, thanks in part to aggressive marketing from pharmaceutical companies,
In their rush to make profits, these companies sometimes fail to adequately warn both medical professionals and consumers about potentially dangerous side effects. They might even withhold this important information from the public, leaving millions of men at risk.
Topamax (topiramate) is prescribed for people needing treatment for epilepsy and seizures. The US Food and Drug Administration (FDA) has issued a warning about the risk birth defects in children whose mothers took Topamax during pregnancy.
In some cases, women who took Topamax during their final trimester gave birth to babies who suffered the following birth defects:
- Cleft lip
- Cleft palate
- Fetal and skeletal deformities
- Genital defects
The FDA on March 4, 2011, reclassified the drug from a Pregnancy Category C to a Category D. This is a more serious change that was made after receiving information showing an increased risk of birth defects.
Tylenol (acetaminophen) is used as a painkiller, but the popular medicine has been linked to liver disease, or liver failure. Liver disease due to acetaminophen toxicity is common - indeed, acetaminophen is the top cause of liver failure.
The following are a few symptoms of liver damage due to Tylenol or acetaminophen:
- Loss of appetite
About 8 billion Tylenol pills are taken each year. Acetaminophen overdose is cited in roughly 56,000 emergency room visits each year in the United States. An estimated 400 deaths are attributed to Tylenol overdose. Some consumers may mix Tylenol with other drugs containing acetaminophen, which can lead to an overdose.
People who exceed the maximum dose of 4,000 mg of acetaminophen are at risk of liver damage. The only known cure for acute liver failure is a liver transplant.
You may be one of the millions of men who have used Viagra (sildenafil citrate) since it was approved by the Food and Drug Administration in March 1998. The blockbuster erectile dysfunction drug has been the target of many lawsuits over a variety of claims. Other drugs used to treat impotence, including Levitra (vardenafil) and Cialis (tadalafil), have also been linked to serious side effects including blurry vision and hearing problems. The vision problems are known scientifically as "non-arteritic anterior ischemic optic neuropathy (NAION)." The FDA in 2005 ordered Pfizer to include warnings on the label about vision loss.
More recently, some men who have used Viagra have needed treatment for melanoma (skin cancer). A 2014 study published in JAMA Internal Medicine reviewed data involving more than 25,000 men over a 10-year period. After learning that at least 142 men using Viagra were diagnosed with skin cancer, researchers concluded their use of the medication was "significantly" linked to an increased risk of cancer. In fact, the study found that men using Viagra face a skin cancer risk that is nearly double compared to men who do not take the drug.
Cialis and Levitra are similar to Viagra, but the two drugs were not included in the study because they were not approved by the FDA when the study began. However, these two drugs last longer in the body than Viagra does, which means they may pose an even greater cancer risk.
Xarelto is an anticoagulant (blood-thinner) prescribed to people who are at risk of deep vein thrombosis (DVT) and pulmonary embolism. The U.S. Food and Drug Administration approved the product in July 2011.
Developed jointly by Bayer AG and Johnson & Johnson's Janssen Pharmaceuticals, Xarelto has been marketed as a new oral blood thinner treatment alternative to warfarin (Coumadin). Research has found that bleeding events occur more commonly in Xarelto patients than patients on either warfarin or Pradaxa (another blood-thinner).
Internal bleeding can be a difficult medical condition to diagnose. These are some warning signs:
- Unusual bleeding in the gums or from the nose and unusually heavy menstrual bleeding
- Bleeding in the stools (bright red or black in color)
- Blood clots
- Vomiting blood
- Headaches or dizziness
- Pain, swelling or new drainage at wound sites
Alarmingly, no available antidote exists for people who suffer bleeding complications.
Metal-on-metal hip implants are devices with ball and socket components made of metal. The two types of metal-on-metal hip implants are traditional total hip replacement systems and resurfacing hip systems. When the metal ball and cup components rub together as a patient walks or runs, the device may produce shards of metallic debris that destroys the tissue and bone. Soft tissue damage may result in pain, implant loosening, device failure and the need to have the device surgically removed and replaced with another hip implant.
Other side effects linked to defective metal-on-metal hip devices include bone loss and destruction of tissues like tendons, muscle, and ligaments around the hip joint.
In particular, the DePuy ASR hip replacement system did not go through a thorough pre-market approval process with the FDA, which resulted in an unusually high number of early failure rates often requiring additional surgery. As a result, the manufacturer issued a recall of two types of hip implants.
The two products recalled are the DePuy ASR Hip Resurfacing System (launched in 2003) and DePuy ASR XL Acetabular System (launched in 2004). According to DePuy, 1 in 8 patients who received either of the products needed to have a revision surgery, or a second surgery, within five years. About 93,000 people may be affected by the product recall.
Recently, a $2.5 billion settlement was announced. DePuy's parent company, Johnson & Johnson, agreed to the settlement to resolve thousands of lawsuits.
DePuy is not the only manufacturer to run into issues with defective hip replacements. Stryker Orthopaedics issued a voluntary recall on certain hip implant models in July 2012 after reports of complications causing tissue inflammation and infection and metal toxicity. According to the company's own statement, the Stryker Rejuvenate and ABG II hip stems contain metal components that may rub together and cause metal debris to become loose.
Stryker had sold about 20,000 of the devices in the United States prior to the recall, which means thousands were put at risk of suffering from metal ion poisoning, or metallosis, hip replacement failure and other devastating side effects.
Regardless of whether they are experiencing the adverse symptoms, all hip replacement patients who had surgery since 2003 should consult with their doctors about these hip recalls. The doctor may need to scan or X-ray the hip and conduct a blood test. If a serious problem is discovered, a second hip replacement surgery may be required.
The Mirena intrauterine contraceptive device (IUD) is a small, T-shaped product made of flexible plastic and designed to prevent pregnancy. The device is implanted into a woman for up to five years. The IUD releases the hormone levonorgestrel, which works to prevent pregnancy by thinning the lining of the uterus.
The FDA in 2000 approved the product for drug use. It is recommended for use by women who have at least one child. Currently, about 2 million women in the United States use the IUD, which is manufactured by Bayer HealthCare Pharmaceuticals.
However, this device is linked to serious side effects, including:
- Perforation of the uterus
- Ectopic pregnancy
- Device migration from the uterus
Already, lawsuits have alleged that Bayer HealthCare Pharmaceuticals failed to make women aware of the risks of the Mirena IUD; failed to conduct proper tests on the device; failed to use reasonable care in designing the Mirena IUD, among other allegations.
The FDA sent a warning letter to Bayer HealthCare Pharmaceuticals Inc. on Jan. 14, 2010, regarding a live consumer-directed program involving representatives for Mirena who traveled to consumers' homes. The targeted consumers were described as "busy moms." The representatives suggested that the use of Mirena "will result in increased levels of intimacy, romance, and by implication, emotional satisfaction." The FDA noted that claims made by the Mirena representatives "misleadingly overstate the proven efficacy of Mirena."
NuvaRing is a contraceptive device that prevents pregnancy by releasing synthetic forms of estrogen and progestin into the blood stream. The contraceptive device is designed for once-a-month usage by women. Doctors have widely prescribed NuvaRing in the United States, with about 7.5 million prescriptions written in 2009 alone. Pharmaceutical maker Organon, a division of Schering-Plough Corporation, introduced the contraceptive in 2002.
The birth control device, or vaginal ring, is linked to an increased risk of blood clots, stroke and other serious and potentially deadly side effects:
- Blood clots
- Deep vein thrombosis (DVT)
- Pulmonary embolism (blood clot in the lung)
- Abnormal bleeding
- Higher risk of breast cancer
- Heart attacks
- Benign liver tumors which may rupture
The following are some of the symptoms that may indicate health problems linked to NuvaRing:
- Chest pain or pain in the lower leg
- Severe abdominal pain
- Ankle swelling
- Difficulty breathing
- Shortness of breath
- Sudden onset of fever
- Vision problems
The U.S. Food and Drug Administration (FDA) has received more than 1,000 reports of injury due to blood clot or death among patients using NuvaRing. One study released in 2011 showed that ring contraceptives could increase blood clots by as much as 56 percent.
Another study conducted in Denmark and published in the British Medical Journal on May 10, 2012, found that the risk of blood clots was 90 percent higher for women using vaginal ring contraceptive devices compared to the risk for women using oral contraceptives. The New England Journal of Medicine published a study that vaginal ring contraceptives were linked to a 2.5- to 3-fold increased blood clot risk.
A laparoscopic power morcellator is a tool used in surgeries such as hysterectomies and other gynecological procedures. Surgeons use this tool to pulverize fibroids before removing them through a tiny hole in the core of the body. However, this tool has been linked to an increased risk of cancer in some patients.
According to the FDA, a small percentage of women have uterine sarcoma, a type of cancer The morcellator has a spinning blade, which may spread the malignant cells in the abdomen of hysterectomy or myomectomy patients. As the FDA states, the spread of cancer because of the device may cause potentially grave harm.
FDA officials say the morcellator has turned a treatable condition into a life-threatening disease. One doctor with the FDA said the procedure should not be performed for most women.
While it's not clear exactly how many women have been adversely affected by the morcellation procedure, cancer diagnoses related to the defective medical device may be in the thousands. That's because power morcellators were used in tens of thousands of procedures each year since 1995.
In April 2014, the FDA issued a safety communication urging doctors not to use these devices to remove uterine fibroids because of the cancer risk. The agency updated this communication in November 2014, stating in bold type that it warns these devices should not be used in the majority of women undergoing myomectomy (removal of uterine fibroids) or hysterectomy for the treatment of fibroids.
Since the FDA issued its warning, Johnson & Johnson, which has a subsidiary that makes many of the devices, suspended sales and said it planned to ask doctors to return the morcellators.
The transvaginal mesh is a surgical fabric. Women with leaky bladder problems or pelvic organ prolapse (POP), sometimes called bulging, fallen or prolapsed uterus have used this product. It is placed along the vaginal wall during surgery.
This medical device is linked to serious and potentially deadly side effects and injuries, including infection, severe pain, bowel, blood vessel and bladder perforation, vaginal scarring, mesh erosion and pelvic hemorrhaging. Some of these vaginal mesh insertion and mesh erosion injuries have led to a decrease in patient quality of life, including dyspareunia, which is painful sexual intercourse.
The Food and Drug Administration has received more than 1,000 reports from women who suffered serious complications. Transvaginal mesh recalls and vaginal mesh implant injury lawsuits have resulted in millions of dollars awarded in settlements. The FDA has suggested that doctors get more training to prevent further transvaginal mesh injuries, which may be sustained during insertion or from erosion of the mesh.