Every day, Americans are injured by side effects of dangerous drugs. For many, their only recourse is to file lawsuits against the companies that sell the products.
The pharmaceutical industry makes sky-high profits that allow them to move quickly from one faulty drug to the next. From 2004 to 2008, Pfizer, one major pharmaceutical company, took in $245 billion. During that same time period, another company, Eli Lilly, made $36 billion from just one of its drugs (Zyprexa).
Between 2004 and 2010, major drug companies paid out $7 billion in fines, penalties and lawsuits — just a drop in the bucket when compared with soaring profits. No one seems to care that every day, Americans are injured or killed by dangerous prescription drugs.
Since 2000, the Food and Drug Administration (FDA) has approved an average of 24 drugs a year, including many that pose health risks and serious long-term side effects.
|Drug companies help this happen when they conduct flawed or dishonest clinical trials by:|
|Failing to report negative results to the FDA.|
|Studying side effects for a short period of time.|
|Studying a tiny group of people.|
The FDA responds to adverse reactions to drugs in a variety of ways, such as meetings, reports, reviews, demands for more trials, letters to doctors, added warnings to labels, and requirements that patients enroll in special programs for drugs. FDA action, however, can take years — something patients may not have.
Consumers who have been injured by a prescription drug often take action of their own by filing lawsuits against drug companies. These lawsuits can cover exorbitant medical costs, as well as pain and suffering. The most important role of the lawsuits is that they speak the drug companies’ language — money — and can teach them a lesson.
|Among the dangerous drugs out there are:|
|Type 2 diabetes drugs Avandia and Actos.|
|Antidepressants Paxil, Prozac, Effexor, Zoloft and Lexapro.|
|Mood stabilizer Depakote.|
|Birth control pills Yaz and Yasmin.|
|Acne medication Accutane.|
|Blood thinners Pradaxa and Xarelto|
|Osteoporosis treatment Fosamax.|
|GranuFlo and NaturaLyte, which are used in dialysis.|
|Hair loss pill Propecia.|
These drugs come with side effects that range from birth defects and liver damage to suicidal behavior, blood clots, bladder cancer, Crohn’s disease, heart attacks, strokes, uncontrollable bleeding and heart failure.
Actos (pioglitazone) received FDA approval in 1999, and was celebrated as the next great type 2 diabetes drug. It has been prescribed to 10 million people around the world. Actos’ bright future began to grow dim in 2007, however, when the FDA added a black-box warning to the label, warning patients of the risk of heart failure.
In 2011, the FDA added another warning to the Actos label — for bladder cancer. The label change came after Takeda Pharmaceuticals, which manufactures Actos, released study results showing that long-term use of Actos increases the risk of bladder cancer by 40 percent. France and Germany banned Actos in 2011. The FDA is waiting until final results from that study are released in 2013 to take any further action on Actos.
While the FDA sits on its hands, a new study published in the British Medical Journal shows long-term use of Actos increases the risk of bladder cancer by 83 percent. Thousands of patients have filed lawsuits after going through multiple surgeries, radiation and chemotherapy — all thanks to the would-be miracle drug Actos.
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Avandia, another type 2 diabetes drug, also launched in 1999, but was later implicated in heart attacks. The FDA estimates that Avandia caused 83,000 heart attacks from 1999 to 2007, the year in which the FDA added a black-box warning to the drug. In September 2010, the FDA significantly restricted use of Avandia, allowing access only to a select group of doctors and patients.
GlaxoSmithKline has settled at least 35,000 Avandia lawsuits, paying out $3 billion in late 2011 to settle cases involving several of its drugs as well as a government investigation. The two-year investigation by the U.S. Senate Finance Committee revealed that the drug company knew of the heart risks associated with Avandia for a long time and tried to hide concerns about the drug.
In 1992, SmithKline Beecham — which would later become GlaxoSmithKline — launched Paxil (Paroxetine), which is a selective serotonin reuptake inhibitor (SSRI). Like other antidepressants, Paxil carries a black-box warning that it can increase suicidality in children, adolescents and young adults.
FDA reported in 2006 that 11 suicide attempts had occurred in patients given Paxil in trials. Based on the allegation that GlaxoSmithKline misled consumers about Paxil’s safety — including increasing suicidal behavior — a $64 million class-action suit was settled in 2007.
One FDA study shows that pregnant women who take Paxil during the first trimester have double the risk of having a baby with a heart defect, compared to other women. GlaxoSmithKline has spent almost $1 billion to settle birth-defect litigation.
Prozac (fluoxetine) is an antidepressant made by Eli Lilly that hit the market in 1987. Prozac is an SSRI that is used for depression, obsessive compulsive disorder (OCD), bulimia nervosa and panic disorder.
This medicine that has been prescribed to over 50 million people worldwide may cause serotonin syndrome and increases the risk of suicidal thinking and violent behavior.
In 1989, Prozac made the news as one man, Joseph Wesbecker, wounded 12 people and killed eight, before killing himself . Just weeks before the shooting, Wesbecker had started taking Prozac. The victims’ families sued Eli Lilly and lost. In 2011, a 16-year-old boy received a three-year sentence after stabbing one of his friends. His doctor attributed his actions to a Prozac-induced mood disorder.
More than 150 lawsuits have been filed faulting Eli Lilly for not properly testing Prozac to show that it may make users aggressive and suicidal. Eli Lilly is also facing lawsuits over birth defects that resulted from a woman’s use of Prozac during pregnancy.
In 2006, the FDA added labeling to all SSRIs warning of the increased risk of pulmonary hypertension in the newborn (PPHN), which can be fatal.
Approved in 1993, Effexor (venlafaxine) is manufactured by Wyeth — which was later purchased by Pfizer — to treat depression, generalized anxiety disorder, social anxiety disorder and panic disorder. In 2005, sales of Effexor totaled $3.5 billion.
In 2003, Wyeth warned health care professionals that in children ages 6 to 17 Effexor was not shown to be effective or safe, causing hostility and suicidal events. The U.K. General Practice Research Database was used in 2007 to compare antidepressants Celexa (citalopram), Prozac (fluoxetine), dothiepin and Effexor. The study showed that Effexor carries the highest risk of suicidality.
Effexor and all antidepressants carry the FDA’s black-box warning about the risk of suicide during the early stages of treatment, especially in kids. Effexor use during pregnancy can cause serious birth defects, and many parents have sued Pfizer after their baby has suffered.
Zoloft (sertraline) is an antidepressant created by Pfizer and approved by the FDA in 1999. By 2011, nearly 100 million people had taken Zoloft. Mainly used to treat major depressive disorder, Zoloft is part of the SSRI drug class. SSRIs come with a risk of suicidality and violent behavior, especially in children and adolescents.
Using Zoloft while pregnant can lead to birth defects, including persistent pulmonary hypertension in infants (PPHN), which can be fatal. In May 2012, more than 60 Zoloft lawsuits were filed on behalf of babies born with birth defects.
Approved by the FDA in 2002 to treat depression and anxiety, Lexapro (escitalopram) is a popular SSRI but is associated with birth defects. The drug, made by Forest Laboratories, had sales topping $355 million in 2011.
Dozens of lawsuits have been filed after women took Lexapro and gave birth to children with birth defects. Birth defects resulting from Lexapro include persistent pulmonary hypertension of the newborn (PPHN), limb defects, spina bifida, cranial defects and neural tube defects.
Depakote (divalproex sodium) is an anticonvulsant and is used to treat mood disorders, seizures and migraines. It was approved for its first indications by the FDA in 1983. The drug later was illegally marketed for unapproved uses, such as for youths with bipolar or seniors with dementia. As a result, Abbott Laboratories, the drug’s manufacturer, was required to pay $700 million in criminal penalties.
Many women have filed lawsuits against Abbott Laboratories, after Depakote led to birth defects such as developmental delays, spina bifida, cleft palate and bodily malformations. A 2006 study showed that 20 percent of women taking the medication while pregnant gave birth to children with birth defects, and as a result the FDA gave the medication a black-box warning concerning potential birth defects.
There are a number of testosterone replacement drugs currently on the market. The most popular and most prescribed drug in the U.S. is AngroGel (testosterone gel) manufactured by Abbott Laboratories’ subsidiary, AbbVie.
The National Institutes of Health (NIH) funded one of the most recent studies published in PLOS ONE. The study was based on the records of 55,000 men who were prescribed testosterone in the U.S. Researchers found the risk of heart attacks doubled for men who had used testosterone during the first three months. There have been other studies that also show an increased cardiovascular risk.
Based on these findings, watchdog group, Public Citizen, petitioned the FDA to add a black box warning to all testosterone drugs. Dr. Sidney Wolf wrote in an article published in BMJ on February 27, 2014 that 1 in 167 men over aged 65 will have a heart attack because of testosterone drugs. For men under 65 with preexisting heart conditions, that risk jumps to 1 in 100.
Men who suffered heart attacks and strokes are already filing lawsuits against testosterone replacement drug makers.
Birth Control Pills
Yaz and Yasmin
Released in the United States in 2006, Yaz (drospirenone/ethinyl estradiol) is a birth control pill manufactured by Bayer. Yaz is a sister drug to Yasmin, which was approved in 2001. Both medications contain drospirenone/ethinyl estradiol, so they carry the same risk.
From 2008 to 2009, Yaz was the top-selling birth control pill in the United States. In April 2012, Yaz continued in popularity as the fourth best-selling oral contraceptive. Yet several studies show that Yaz puts women at an increased risk for blood clots. Blood clots can contribute to deep vein thrombosis (DVTs), pulmonary embolism (PE), stroke or heart attack.
On April 10, 2012, the FDA required Yaz to include a warning that drospirenone-containing pills increase the risk of blood clots by threefold. Also, a former FDA commissioner, David Kessler, filed an affidavit, claiming that Bayer withheld early reports of blood clots from the FDA in 2004.
A multidistrict litigation (MDL) has been set up in Illinois to handle the 10,000-plus lawsuits over Yaz and Yasmin side effects.
Approved by the FDA in May 1982, Accutane (isotretinoin) is an oral medication from Roche that was once available for treating acne. Prescribed to more than 13 million patients, many users experienced cured acne after four to five months of treatment.
Serious side effects from Accutane include inflammatory bowel disease, ulcerative colitis, Crohn’s disease, suicidal thoughts, birth defects, liver damage and gastrointestinal disorders. The Adverse Event Reporting System (AERS), a computer database of post-marketing adverse side effects, includes around 23,000 Accutane reports from 1982-2002, covering everything from alopecia (hair loss) and depression, to headache, dry skin and induced abortion.
As of 2002, 172 babies had been born with a congenital defect or anomaly after the mother had taken Accutane. Through 2002, there was a cumulative total of 173 suicides in association with Accutane.
The FDA met with Roche, the manufacturer of Accutane, in 2000 to set up a program to ensure that no woman took Accutane during pregnancy and that no pregnancies would occur while a woman was taking Accutane. The SMART (System to Manage Accutane Related Teratogenicity) program was designed to minimize the risk of birth defects by requiring a qualification sticker on prescriptions, consent forms, an information guide, a patient video, a guide for those who prescribe drugs and pharmacists and carton instructions.
Warnings concerning severe stomach pain, diarrhea and rectal bleeding were hidden in 3,000 words of possible side effects, and in 2005 Kamie Kendall won $10.5 million in damages after having her colon and rectum removed.
Andrew McCarrell won $25 million after having his colon removed in 2007. In 2009, Roche Pharmaceuticals responded to multiple personal injury lawsuits by removing Accutane from the market. But the legal settlements didn’t end there. In 2012, Gillian Gaghan was awarded $2 million for injuries related to inflammatory bowel disease after using Accutane for six months.
Crestor (rosuvastatin), made by AstraZeneca, was approved in August 2003. It is known to lower bad cholesterol up to 52 percent. Global sales reached $6.6 billion in 2011.
Crestor belongs to a class of drugs known as statins. Crestor can cause rhabdomyolysis (muscle tissue damage), kidney (renal) failure and chronic or abnormal bleeding.
The FDA has written letters to AstraZeneca demanding it stop running commercials that exaggerate the drug’s benefits and downplay its dangers. In 2005, the FDA added a warning to the drug that all patients who use high doses of Crestor — 40 mg a day — are at an increased the risk of developing life-threatening muscle damage.
Sydney Wolfe from the Public Citizens Health Research Group — a nonprofit advocacy organization that represents consumer interests in Congress — said that in two years Crestor was linked to 117 cases of rhabdomyolysis and 41 cases of kidney failure, 11 of which resulted in death.
Millions of Americans take blood thinners to reduce the risk of stroke caused by atrial fibrillation (irregular heartbeat). For decades, patients had limited options for blood thinners with most taking warfarin, a medication that requires diet changes and regular blood tests. All of that changed in October 2010, when the FDA approved Boehringer Ingelheim’s Pradaxa (dabigatran), a blood thinner that does not require the same maintenance as warfarin. Within two years, more than 3.7 million U.S. patients had filled Pradaxa prescriptions.
All blood thinners make patients more susceptible to bleeding accidents, however, with Pradaxa there is no antidote to stop bleeding, which can lead to disabling or fatal injuries. Hundreds of bleeding accidents associated with Pradaxa have been reported, and 542 deaths were reported in 2011.
Studies of Pradaxa also show an increased risk of heart attack and heart disease compared with warfarin. Nearly 200 people have filed Pradaxa lawsuits, most of which are consolidated in a multidistrict litigation (MDL) in Illinois.
One of the newest blood thinners is Xarelto (rivaroxaban), approved by the FDA in July 2011. Xarelto is approved for use after knee and hip replacement surgery to reduce the risk of blood clots. In November 2011, the drug’s indications were expanded to include atrial fibrillation (AF).
There is no bleeding antidote for Xarelto, which means users of the drug can experience dangerous, uncontrollable bleeding events. Additionally, since the drug was fast-tracked, unknown side effects may also be putting patients at risk.
The FDA approved Fosamax (alendronate sodium), made by Merck, in 1995 to treat osteoporosis in postmenopausal women. It is estimated that millions worldwide have used the drug for osteoporosis and other indications, including Paget’s disease.
Some people taking Fosamax have suffered from injuries such as ONJ, or jaw death, joint and muscle pain, atrial fibrillation, and inflammation and ulcers of the esophagus. Nearly 1,000 people have filed lawsuits against Merck after experiencing severe side effects.
Initially approved for acute pain such as rheumatoid arthritis in adults or menstrual related symptoms, Vioxx (rofecoxib) was available from 1999 to 2004. Vioxx is a part of a class of drugs called non-steroidal anti-inflammatory drugs, or NSAIDs, and functions like ibuprofen. Merck manufactured the drug which reached sales of $2.5 billion in 2003.
Multiple studies revealed that this drug meant to assist patients was actually increasing the risk of heart attack. September 2004 Merck voluntarily withdrew the drug from the market. Over 60,000 people have filed claims against Merck after Vioxx use led to heart attacks, strokes and other injuries.
The company set up a $4.85 billion dollar fund to assist in resolving consumer claims. Additionally, Merck pleaded guilty to charges based on illegal marketing and agreed to pay fines of $950 million.
Reglan (metoclopramide) was approved by the FDA in 1980 and is used to treat migraines, heart burn, acid reflux, nausea, vomiting and gastroparesis, a digestive condition. In 2011, around 1 million people filled prescriptions of Reglan. That same year the Institute for Safe Medication Practices released a report that 1,180 cases of Tardive Dyskinesia resulted from Reglan use.
Tardive Dyskinesia (TD) occurs as a side effect of certain medications and is a neurological disorder causing uncontrollable rapid movements of the face and the body. Severe cases can inhibit talking, walking and eating. Because of this, over 5,000 people have filed lawsuits against manufacturers of metoclopramide.
GranuFlo and NaturaLyte
Many people with acute or chronic kidney failure receive dialysis treatment with GranuFlo and NaturaLyte. Fresenius Medical Care (FMC), the world’s leading provider of kidney dialysis services and products, manufactures these two products. They were approved in 2003 to assist in dialysis treatment. The products are now used by around half of dialysis patients.
Because dialysis machines were not properly calibrated, patients have suffered from excessive amounts of acid in the blood, which can lead to organ damage, heart arrhythmia, heart attack, coma and death. In 2012, these two products briefly were recalled to clarify dosing instructions. FMC now faces mounting lawsuits, after more than 900 patients suffered cardiac arrest after using their products.
Hair Loss Pill
Propecia and Proscar
Men struggling with male-pattern baldness or enlarged prostate may take Propecia or Proscar, which both include finasteride and are manufactured by Merck. The FDA approved Proscar in 1992 and Propecia in 1997.
The FDA’s adverse event database received hundreds of reports of erectile dysfunction associated with use of finasteride. Even after discontinuing use of the drug, patients may experience side effects. In April 2011, the FDA required updates to the drug label informing users that libido disorders, ejaculation disorders and orgasm disorders can occur during and after use of finasteride. The label also includes a warning concerning increased risk of high-grade prostate cancer.
The reckless behavior of the drug companies shows no signs of changing. Negative clinical trials are never reported or overlooked, and the FDA buys in. Doctors write millions of prescriptions that may be damaging the health of innocent patients. Only by holding companies accountable in court for threatening their very lives, can patients help prevent others from suffering from the same faulty drugs.