Defective Drugs
Accutane (also known as isotretinoin) is an acne medication manufactured by
Roche Pharmaceuticals. Accutane has come under scrutiny by the Food and Drug
Administration due to psychiatric side effects, including birth defects, lupus,
inflammatory bowl disease and suicide.
Acetaminophen and Liver Failure (e.g. Tylenol)
The drug found in Tylenol and many other over the counter and prescription
drugs, is the number one cause of drug induced liver failure in the U.S. The
potential for liver failure is greatly increased when this drug is combined with
alcohol or during periods of fasting (due to illness, anorexia or malnutrition).
Actiq is a narcotic painkiller that looks and tastes like a lollipop and was designed
to speed relief to cancer patients. The Food and Drug Administration approved
Actiq for cancer patients who suffer from intense pain. Recent studies show that
more than 80% of patients who use the drug are using it for reasons other than
treating cancer pain. Instead, doctors are prescribing it "off label" for pain related
to migraines or back pain. Actiq use has been linked to overdose, addiction and
Actos is prescribed to treat type 2 diabetes. It has recently been linked to
increased likelihood of bladder cancer. Sale of Actos has been suspended in some
European countries.
Actonel is used to treat osteoporosis (os-te-o-pur-o-sis). Although used to
strengthen bones, some patients develop a serious disease called osteonecrosis
(os-teo-ne-crosis) which is the deterioration of the jaw bone. Symptoms include
loosening of the teeth, severe infections and swelling.
Advair, a drug used for the long term treatment of Asthma may be associated with
an increased risk of respiratory deaths and other life-threatening Asthma episodes,
according to information collected by the FDA.
Alli (Orlistat)
The over-the-counter weight loss drug Alli has been linked to liver, kidney and
pancreas damage.
Avandia (Rosiglitazone Maleate)
Avandia is prescribed to treat type 2 diabetes. It has recently been linked to
increased likelihood of heart attack, stroke and sudden death.
Aredia is used to treat osteoporosis. Although used to strengthen bones, some
patients develop a serious disease called osteonecrosis (os-teo-ne-crosis) which is
the deterioration of the jaw bone. Symptoms include loosening of the teeth, severe
infections and swelling.
Baycol® (also called cerivastatin) was pulled from the market after it was linked
to at least 40 deaths. Eventually, the number of deaths associated with the use of
Baycol® rose to more than 100. Baycol®, a cholesterol-lowering drug which is
suppose to reduce a patients' risk of heart attack, was taken by nearly 700,000
Americans. Food and Drug Administration physicians have linked the drug to a
rare muscle side effect which destroys muscle tissue and then releases it into the
bloodstream. Most commonly, patients suffer severe muscle pain concentrated in
the lower back and calf muscles. In the severe cases, it leads to kidney failure and
Bextra is a nonsteroidal anti-inflammatory drug (NSAID) known as a COX-2
inhibitor used to relieve the symptoms of arthritis and pain related to menstraul
cramping and migraine headaches. On April 7, 2005, Bextra was taken off the
market. Bextra was prescribed to millions of patients over the years, and despite
the potential risks of deadly SJS, heart attack and strokes, it is still available for
Byetta, a drug used to treat diabetes, has been linked to acute pancreatitis, a
sometimes fatal inflammation of the pancreas. Symptoms of acute pancreatitis
include severe abdominal pain. Byetta has also been linked to kidney failure.
Chantix is a prescription drug used to help people stop smoking. Chantix side
effects may include suicidal thoughts, depression, violent behavior, heart trouble,
seizures and diabetes.
Clomid (Birth Defects)
Children born to women who use the prescription fertility drug Clomid have a
higher incidence of severe types of birth defects such as cleft palate or spina
According to data published by the Food and Drug Administration (FDA), the
anti-cholesterol drug Crestor® may be linked to kidney damage and a painful
muscle condition called rhabdomyolysis. A recent study published in the Journal
of The American Heart Association revealed that patients taking Crestor® are
more likely to develop serious side effects than patients taking Lipitor®
(atorvastatin), Zocor® (simvastatin), or Pravachol® (pravastatin). During clinical
trials, patients taking Crestor® experienced proteinura (elevated levels of protein
in the urine) as well as hematuria (blood in the urine). The presence of blood and
elevated levels of protein in urine could be signs of serious liver toxicity.
Celebrex is a NSAID (Non-Steroidal Anti-Inflammatory Drug) prescribed for the
relief of osteoarthritis, management of acute pain in adults and relief of
rheumatoid arthritis symptoms. Recent study shows that patients taking Celebrex
are two times more likely to suffer from a heart attack or stroke. There are other
reports showing that patients who take Celebrex are at an increased risk of
developing uclers.
Darvon, Darvocet (propoxyphene)
Pain relievers sold under the name Darvon, Darvocet and other generic names
containing the active ingredient propoxyphene (pro pox e fene) were pulled from
the market by the FDA after a study revealed that the drugs may cause potentially
fatal irregular heart rhythms.
Denture Creams
Zinc found in denture creams such as Super Poligrip, Fixodent and others, can be
ingested through the gums or stomach and cause zinc poisoning, paralysis and
other serious neurological disorders.
Depakote (Birth Injury)
Depakote, a drug prescribed for bipolar disorder and other conditions has been
linked to serious birth defects.
Effexor (Birth Defects)
Some babies born to mothers who took Effexor during pregnancy may have
increased rates of heart defects or other birth defects.
Ephedra (also known as Ephedrine, Ma Huang and Epitonin)
Ephedra is an ingredient used as a dietary supplement, energy booster or to aid
with respiratory illness. In some cases it has been reported that people have
experienced strokes and heart attacks after using products containing ephedra.
Effective March of 2004, the FDA banned retail sales of dietary supplements
containing ephedra.
Fen Phen, Pondimin & Redux (Pulmonary Hypertension)
Ephedra is an ingredient used as a dietary supplement, energy booster or to aid
with respiratory illness. In some cases it has been reported that people have
experienced strokes and heart attacks after using products containing ephedra.
Effective March of 2004, the FDA banned retail sales of dietary supplements
containing ephedra.
Fosamax (Also: Zometa or Aredia)
Fosamax (generic name - Alendronate) is a type of drug known as bisphonates
used to treat osteoporosis in post menopausal women. Although Fosamax and
other bisphosphonates are designed to strengthen bone, for reasons not yet
understood, they can have the reverse effect and weaken bones instead. This
condition is a serious bone disease called osteonecrosis of the jaw (ONJ) or "dead
Jaw". This can also cause femur bone fractures. The Food and Drug
Administration and Novartis, the manufacturer of bisphosphantes used in cancer
chemotherapy, issued a warning letter to health care professionals on September
24, 2004.
Gadolinium with MRI or MRA Scan (NSF or NFD)
An injectable dye used with some MRI or MRA scans is linked to a serious
disorder called Nephrogenic Systematic Fibrosis (NSF) or Nephrogenic Fibrosing
Dermopathy (NFD), which can be fatal. Symptoms of NSF/NFD include
thickening or tightness of skin, difficulty walking, joint pain and skin sores.
Hormone Replacement Therapy (HRT)
The National Heart, Lung and Blood Institute conducted a clinical study on
women taking Hormone Replacement Therapy such as PREMPRO, PROVERA
or PREMARIN. Their research showed an increased risk of breast cancer and
several other serious side effects such as heart attacks, strokes and blood clots.
Hydroxycut recalled 14 of its products after the FDA discovered that their use
could potentially result in serious side effects including liver damage, seizures,
muscle damage, kidney failure and other problems.
Impotence (Viagra, Levitra, Cialis)
A growing number of documented cases show that use of Viagra, Levitra or Cialis
may be linked to temporary or permanent vision loss in one or both eyes.
Infuse Bone Graft (Spinal Fusion Surgery)
The Medtronic InFuse bone graft system used a liquid bone protein which
encouraged bone growth in spinal fusion surgery. Its use in non-FDA approved
types of fusion surgery may have led to serious adverse affects.
Ketek was approved in 2004 for the treatment of acute bacterial infections from
chronic bronchitis, sinusitis and pneumonia. Recent reports indicate a link
between this drug and liver damage and liver failure.
Levaquin (Tendon Injuries)
Levaquin is one of a group of antibiotics that have been linked to tendon injuries,
including tendon rupture.
Lexapro & Celexa
Antidepressants such as Lexapro and Celexa may be linked to suicidal behavior.
The FDA has asked drug companies to strengthen warnings for these
antidepressants to include an increased risk of suicide in some people.
Lipitor was prescribed to help lower Cholesterol. Its ability to producecholesterol, thus preventing or reducing the harmful build-up of plaque in arterywalls has contributes to heart disease, stroke and other maladies. Symptomsassociated with this drug are muscle pain and kidney problems or dark urinerelated health problems.
Meridia is a prescription weight loss pill that was taken off the market because
studies linked it to an increased risk of heart attack and stroke.
Neurontin was approved for sale in the mid-1900s as a treatment for epileptic
seizures. However, it was believed that approximately 80 percent of all Neurontin
prescription were filled for unapproved medical conditions. Neurontion is
believed to be linked to suicidal behavior.
Oral Sodium Phosphates (Fleet)
Patients often take oral sodium phosphates, such as Fleet Phospho-soda to clean
their intestines before a colonoscopy. However, taken at higher doses, these
products can cause severe problems such as kidney damage.
Ortho Evra (Birth Control Patch)
Ortho Evra birth control patch may be three times more likely to cause a
stroke or a blood clot than leading birth control pills. According to the Associated
Press, in 2004 about a dozen women, primarily in their late teen's and early 20's,
died from blood clots and a dozen more survived strokes and other blood clotrelated
problems including deep vein thrombosis, pulmonary embolisms and heart
Oxycodone, Codeine or Hydrocodone (Birth Defects-Painkillers)
Children born to women who use painkillers such as Codeine, Oxycodone and
Hydrocodone while pregnant have a higher incidence of birth defects such as cleft
palate or spina bifida.
Pain Patch
On July 15, 2005 the FDA issued a Public Health Advisory concerning the use of
Pain Patches (Fentanyl transdermal) in response to reports of deaths in patients
using the patch.
The Pain Patch is indicated for the management of severe, chronic pain (such as
cancer pain) that cannot be managed with less powerful drugs. If the medication
leaks out of the patch, exposure to the medication can result in inadvertent
ingestion or increased transdermal absorption of the active opiate component
fentanyl, leading to potentially life-threatening complications.
Pain Pump (Shoulder Surgery)
A new study has revealed that a pain pump used to deliver pain medicine
following shoulder surgery may cause the destruction of shoulder cartilage.
Paxil, Lexapro, Zoloft, Prozac, Celexa & Effexor (Birth Defects)
Recent studies of pregnant women who took SSRI antidepressants during their
pregnancy show increased rates of heart defects among their newborns.
Permax (Paroxetine HCI)
The Mayo Clinic research has discovered what may be a link between
Pergolide Mesylate (per-go-lied mess-a-late), sold as Permax, and serious heart
valve disease. Three women who were taking Pergolide for Parkinson's disease
developed serious heart valve damage in spite of having no history of heart
disease. Two of the three women required surgery as a result.
Results of a recent study show that taking the anti-clotting drug Plavix (generic
name: Clopidogrel) along with aspirin to prevent heart attacks may actually
increase the risks of strokes, heart attacks and death. No benefit of combining the
two drugs has been found; in fact, combining these drugs may cause more harm
than good in people who are at high risk.
The blood thinner Pradaxa may increase the risk of serious bleeding problems as
well as death.
Propecia Propecia is sold by Merk to treat hair loss but recent studies have shown that its
use can lead to sexual dysfunction.
The Psoriasis prescription drug Raptiva has been linked to a deadly brain
infection, Lymphoma and other serious infections.
Reglan (Generic: Metoclopramide) is a drug prescribed for acid reflux disease.
Long term use can cause a serious neurological disorder called Tardive
Dyskinesia. Reglan has also been linked to other illnesses such as Neuroleptic
Malignant Syndrome (NMS) which can be fatal.
Propulsid has been prescribed to aid in the relief of migraine and cluster
headaches. In some cases it has been reported that people have experienced heart
attacks, strokes, hypertension, and some have died. Usually an incident will occur
shortly after taken, or within a few days of taking Propulsid.
This is the information that has been reported. Rezulin was prescribed to treat
type 2 diabetes. As of March 21st, 2000, Rezulin was taken off the market
because of reports concerning liver damage and liver failure.
Risperdal (Ris-per-doll) was approved by the FDA in December 1993. It has
recently been reported that serious side effects can result from taking Risperdal
including a condition called Tardive Dyskenesia (Tar-dive Disk-en-easy-ah). This
is a movement disorder which can cause a loss of muscle control and is often
referred to as False Parkinson's.
Serzone is used to treat depression. On Januray 2002, new warning regarding the
association of Serzone with liver-failure was placed on the drug labeling. From
April 1, 2002 through May 12, 2003, FDA adverse event data recorded a total of
20 reports of death due to liver failure in people using Serzone.
Serevent, a drug used for the long term treatment of Asthma may be associated
with an increased risk of respiratory deaths and other life-threatening Asthma
episodes, according to information collected by the FDA.
Seroquel (quetiapine) is a popular antipsychotic drug administered for treatment
of schizophrenia and bipolar disorder. A number of studies have linked Seroquel
to an increased risk of diabetes. The FDA has also issued a public health advisory
concerning increased mortality rate among elderly patients treated for dementia.
Topamax (Birth Defects)
Topamax is a prescription drug approved to treat epilepsy and migraine
headaches. Children born to women who use Topamax while pregnant have a
higher incidence of birth defects such as cleft palate.
Tequin (generic name - Gatifloxacin) is an antibiotic used to treat sinus, lung and
urinary tract infections as well as certain venereal diseases. Bristol-Myers Squibb
has quietly pulled the drug from the market after studies revealed concerns about
serious blood sugar-related side effects.
Transvaginal Mesh
Women who have had surgery to repair Pelvic Organ Prolapse (POP) or Stress
Urinary Incontinence (SUI) using a surgical mesh device have reported
complications such as infections, pain and scarring.
Vioxx was most often prescribed to aid in the relief of arthritic pain. On
September 30, 2004, Merck, the manufacturer of Vioxx, recalled Vioxx
worldwide after a study showed that Vioxx increased the incidence of heart
attacks and strokes.
Zicam (Cold-Eeze)
These over the counter cold remedies contain zinc gluconate (ZINK GLUE koe
nate) which has been shown to cause a loss of smell. The manufacturer of Zicam,
Matrix Initiatives, did not do any studies on its product concerning loss of smell
prior to putting Zicam on the market.
Zocor (also known as Simvastatin) is used to reduce LDL (bad) cholesterol and
increase HDL (good) cholesterol in your blood. These actions may reduce the risk
of hardening of the arteries, which can lead to heart attacks, stroke, and peripheral
vascular disease.
Zometa is used to treat osteoporosis. Although used to strengthen bones, some
patients develop a serious disease called ostenonecrosis which is the deterioration
of the jaw bone.
Zyprexa (Olanzapine)
A study examining 8 years of data collected by FDA identified 289 cases of
diabetes in patients taking Zyprexa. Of these 289 cases, 225 were newly
diagnosed cases, 100 of which developed ketosis (a serious complication of
diabetes). In addition, 22 people developed pancreatitis.
Medical Devices
Aneurysm (Stent) Surgery
Guidant Corporation subsidiary Endovascular Technologies recently pled guilty
to 10 felonies and agreed to pay $92.4 million in penalties related to the Ancure
"stent-graft" device, which was used during operations to treat abdominal aortic
aneurysms (bulges in the wall of the main artery leaving the heart). Charges
include shipping misbranded products and lying to the government; the company
was charged with failing to report as many as 2,600 malfunctions since
September, 1999.
According to the Food and Drug Administration, complications occurred during
the insertion or removal of the device when it would get stuck or lodged in the
patient's body, which often led to internal bleeding, damaged arteries and/or
surgery to remove the device. In the most severe cases, open heart surgery was
Blood Clot Filter (Bard Vena Cava Filters)
Vena Cava filters are placed in a large vein to trap blood clots before they travel
to the lungs. Severe injuries may occur when pieces of the device break off and
move in the body.
Defibrillator Lead Wire (Medtronic & St Jude)
Medtronic & St Jude have pulled their Sprint Fidelis defibrillation lead wires from
the market after fractures in the leads were linked to five patient deaths. Patients
with these lead wires may have received a warming letter from the manufacturer.
DePuy ASR Total Hip Replacement
DePuy Orthopaedics pulled the ASR hip implant from the market after reports of
the device failing shortly after implant surgery.
A large number of patients reported crippling pain following surgery, often
requiring additional surgery to have this device replaced.
Gastric Bypass Staplers
The FDA has received reports of numerous deaths and other injuries resulting
from defective staples used in gastric bypass surgery.
Guidant Medtronic Cardiac Defibrillators
Guidant recalled 50,000 of its implantable cardiac defibrillators because of
defects. Guidant reported there had been 45 device malfunctions, and seven
patients with the recalled devices died.
Guidant Cardiac Defibrillators are programmed to deliver a potentially life-saving
electrical shock when the heart rhythms go awry. Due to a faulty switch that could
prevent delivery of the shock, patients who currently have one of the defective
models implanted may be at risk.
Guidant / Medtronic Pacemakers
Guidant Corporation has warned doctors that about 28,000 of its earlier
generation pacemakers may malfunction and need to be replaced in some patient.
The problem involves a bad seal which allows moisture into the pacemaker
causing it to gradually degrade.
For patients that depends on the pacemakers to maintain a normal heart rate,
failure of the device can cause sudden faintness or loss of consciousness, and can
result in death.
Knee Replacement Surgery
News reports revealed problems with 2 models of Smith & Nephew cementless
artificial knees that led to a recall in September, 2003. The two models, the
Oxinium Genisis 2 and the Profix 2 were used in implant operations between June
of 2002 and March, 2003. These models failed to bond properly and became
loose. As a result, many patients required additional corrective surgery, suffered
infections and experienced further joint and muscle damage, often leading to
painful rehabilitation.
Kugel Hernia Patch
The Bard® Composix® Kugel® Mesh Patch is used to repair hernias caused by
thinning or stretching of scar tissue that forms after surgery. The patch is placed
behind the hernia through a small incision. The patch is then held open by a
"memory recoil ring" that first allows it to be folded for insertion, and then causes
it to spring open and lay flat once it is in place. The recoil ring that opens the
patch can break, leading to bowel perforations and to abnormal passageways
between the intestines and other organs. Symptoms associated with ring breakage
include abdominal pain, fever and tenderness at the implant site.
The FDA has been receiving reports of complications related to stent devices used
most often in angioplasty and abdominal aneurysm surgeries. Common problems
include clot formation, leakage around the device, respiratory alterations and
blood pressure changes.
Follow-up surgeries for removal or replacement may be required to repair these
problems. In the worst cases, these complications may lead to rupture of the
device or death.
Toxic Substances/Toxic Torts
Asbestos (Mesothelioma)
Mesothelioma is a form of cancer that develops in the tissues of cells that line the
lungs, heart and stomach. These tissues are called mesothelial cells and they
become infected by inhaling particles of dust from asbestos fibers.
It is estimated that about 3,000 to 4,000 cases of mesothelioma are diagnosed
each years in the US.
Symptoms of mesothelioma may not appear until 20 to 50 years after exposure to
asbestos. Shortness of breath, cough, and pain in the chest due to an accumulation
of fluid in the pleural space are often symptoms of pleural mesothelioma.
Benzene is known carcinogen linked to leukemia and various other forms of
cancer. Although Benzene was banned as a solvent in the U.S. more than 22 years
ago, it's estimated that more than 3 million workers are exposed every year.
People working with petroleum solvents are at the greatest risk of exposure, both
from inhalation and absorption through skin contact.
Bone/Tissue Implant Surgery
The FDA has issued a warning that some bone and skin tissue taken from
cadavers and later used in surgery may not have been properly screened for
infectious disease. As a result, individual who have had a bone, skin or tissue
transplant or a spinal fusion since 1998 may be at risk for contracting infectious
diseases such as HIV and hepatitis.
Diacetyl-Lung Disease (Popcorn Lung)
According to the National Institue for Occupational Safety and Health (NIOSH),
from 1992 to 2000 eight former workers of a popcorn factory in Jasper, Missouri
developed a rare lung disease called bronchiolitis obliterans. The chemical
Diacetyl, a common ingredient in artificial butter flavoring, is believed to have
caused the lung disease. In the worst cases, the factory workers may eventually
need a lung transplant. Diacetyl is also found in dairy products, oils, vegetables,
coffee, vinegar and beer.
Oil Spill
BP's oil spill has resulted in significant damage to the fishery ecosystem and the
coast of Florida, Alabama and Louisiana.
Welding Rods
Exposure to welding fumes may be linked to the early onset of Parkinson's
Disease, as well as increased risk for certain types of cancer. Long term health
hazards associated with welding can be serious, and sometimes fatal.
Exposure to toxic substances released in welding smoke, such as cadmium and
arsenic, can put workers at an increased risk for several cancers, including lung
cancers and cancer of the larynx.
Product Liability Cases
ATV Rollover Accidents
All terrain vehicles (ATVs) have greatly increased the number
of serious injuries associated with their use. Hundreds of people, many under the
age of 16, die each year from ATV rollovers.
Chinese Drywall
Between 2003 and 2007 defective drywall imported from China was used in
homes built in the U.S. This drywall contains sulfur which often is detected by a
strong rotten egg smell. In addition to the smell, moisture, often from an air
conditioning system, can cause major corrosion in air conditioning systems,
copper fixtures, copper electrical wire and other metals.
Contact Lens Eye Infection
There is a possible link between the AMO Complete® MoisturePlus™ Multi-
Purpose Solution and 138 confirmed cases of Acanthamoeba Keratitis, a rare form
of Keratitis, which is described as a painful eye infection that can lead to
permanent vision loss or blindness. As a result of this link, there was a nationwide
recall of this contact lens solution.
There is also a possible link between corneal eye infections (keratitis) and other
multi-purpose contact lens solutions including but not limited to ReNu with
MoistureLoc & ReNu MultiPlus (Bausch & Lomb), Opti-Free (Alcon), SOLOcare
(Ciba Vision), and Complete® MoisturePlus™ Multi-Purpose Solution
(Advanced Medical Options).
Birth Injury (Cerebral Palsy)
Cerebral Palsy is a term that describes a group of disorders that affect movement
control. There is not one specific cause of cerebral palsy, however, it can be
caused by lack of oxygen to the brain or trauma to the head during labor and
Bypass Surgery (Hear Bypass)
The FDA has been receiving reports of complications related to a new aortic
connection device used in coronary bypass surgeries performed since spring of
2001. Common problems include blood clots, postoperative hemorrhage (leakage
around the device) and failure to attach properly. Followup surgeries may be
required to repair these problems. In the worst cases, these complications may
lead to a heart attack or death.
Lasik Surgery
Lasik eye surgery procedures are meant to correct faulty or myopic vision,
sometimes this procedure has tragic results. To lose your vision as a result of the
negligence of a medical professional is a very serious situation.
Medical Malpractice (Personal Injury)
Medical malpractice involves negligence by doctors or their staff at hospitals,
doctor's offices and nursing homes, and can lead to tragic injuries. According to
an article published in the Journal of the American Medical Association (JAMA),
more than 225,000 people die each year due to the actions of health professionals.
This has become the third leading cause of death in the United States, after deaths
from heart disease and cancer.
Additional Topics
Disability / Insurance Claim Denial
Insurance companies often unreasonably either limit or deny claims. Tactics
employed by insurance companies include delays in paying claims, failing to
actually research claims, reducing eligibility over time, and adding exceptions to
the contestability clause.
Investment Recovery
Smith Barney, Merrill Lynch and 9 major brokerage firms have agreed
to pay $1.4 billions in fines for conflict of interest and giving misleading advice to
individual investors.
One firm has set aside $1.5 billion to repay investors who lost their
money! Other brokerage firms have agreed to pay $675 millions for penalties.
Nursing Home Abuse
Every day, vulnerable people in nursing homes, assisted living centers and people
receiving home health care are abused and neglected by the very caregivers we
entrust with their well-being.
Vehicle Accidents
Millions of Americans are injured in car accidents every year. In 2005, more than
43,000 people died on American roads.


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