Bertram & Graf, L.L.C.
4717 Grand Avenue, Suite 800
Kansas City, MO 64112

Phone: 800.200.6303
Fax: 816.523.8258

8400 E. Prentice Ave., Penthouse Suite
Greenwood Village, CO 80111

Phone: 303.409.7711
Fax: 303.409.7714

Pharmaceutical Product Liability

Every year, thousands of people nationwide suffer serious harm or death from prescription and over-the-counter medications. Unknowing patients take these dangerous pharmaceuticals because they have been approved by the U.S. Food and Drug Administration (FDA) or prescribed by a trusted physician. Tragically, many defective drugs are inadequately tested or have insufficient warnings on their labels. At Bertram & Graf our lawyers represent clients who suffer serious health consequences as a result of dangerous pharmaceuticals or defective medical devices. Our attorneys assist clients in lawsuits against negligent drug makers to achieve justice. If you have suffered serious injuries or health problems as a result of a dangerous medication or medical device, contact our product liability lawyers and schedule a consultation.

ACCUTANE
AVANDIA®
BARD AVAULTA MESH®
DEPUY ASR TOTAL HIP REPLACEMENT®
DEPUY PINNACLE HIP DEVICE®
DIACETYL®
DURAGESIC® Pain Patch
FEN-PHEN
GADOLINIUM®
KETEK®
PAXIL® Birth Defects
REGLAN® (metoclopramide)
STEVENS-JOHNSON SYNDROME (SJS)
TOPAMAX
WELLBUTRIN
YAZ
ZOLOFT

ACCUTANE®

Accutane is a form of vitamin A. It reduces the amount of oil released by oil glands in your skin, and helps your skin renew itself more quickly. Accutane is used to treat severe nodular acne. It is usually given after other acne medicines or antibiotics have been tried without successful treatment of symptoms. Accutane was first developed to be used as a chemotherapy medication for the treatment of brain cancer, pancreatic cancer, and more. It is still used in the treatment of these cancers to this day because of its ability to kill rapidly dividing cells

Accutane has come under scrutiny by the Food & Drug Administration due to psychiatric side effects, including suicide, depression and other serious conditions. Some studies may also link Accutane to an increased risk of colon cancer.

AVANDIA®

AVANDIA®, or rosiglitazone, is an anti-diabetic drug manufactured by Glaxo Smith Kline. It is primarily used in the treatment of Type II diabetes mellitus. Recently, drugs containing AVANDIA® have been linked to significantly increased risk of heart attack.

On August 1, 2007, the FDA said that the diabetes pills should carry new warnings about cardiovascular risk. Although the FDA committee voted to keep AVANDIA® on the market, it voted that the evidence showed that the drug added to the risk of heart attacks.

BARD AVAULTA MESH®

Bard Avaulta Mesh has been used in treating pelvic organ prolapse (POP) and stress urinary incontinence (SUI), two health problems that have been troubling women for many years. A pelvic organ prolapse (POP) occurs when a pelvic organ, such as your bladder, drops ("prolapses") from its normal position and pushes against the walls of your vagina. This can happen if the muscles that hold your pelvic organs in place become weak or stretched from childbirth or surgery. Pelvic organ prolapse can cause pain or problems with bowel and bladder functions or interfere with sexual activity. Transvaginal surgical mesh products are designed to help manage these conditions and to alleviate the pain and discomfort suffered by women who live with these health problems every day.

On October 20, 2008, the U.S. Food and Drug Administration issued an FDA Warning regarding serious complications associated with transvaginal placement of surgical mesh, including Bard Avaulta surgical mesh. The Bard Avaulta FDA Warning stated that, over the last three years, it has received more than 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair Pelvic Organ Prolapse and Stress Urinary Incontinence.

DEPUY ASR TOTAL HIP REPLACEMENT

The DePuy ASR is a large diameter, metal-on-metal hip replacement system. Metal-on-metal hip implants, which were introduced about a decade ago, have ball-and-socket joints that are made from metals like cobalt and chromium. They became popular because it was thought that metal-on-metal would be more durable than earlier types of implants.

DePuy Orthopaedics is issuing a voluntary hip replacement recall of its ASR™ XL Acetabular Hip System and DePuy ASR™ Hip Resurfacing System. This ASR recall means additional testing and monitoring may be necessary. These systems first became available in July 2003. DePuy ASR acetabular cups are forged out of cobalt chrome. Physicians and their patients have discovered that, after being used even short periods of time, the rubbing of metal-on-metal in the artificial joint starts to cause the cobalt and chrome ions to escape and disperse to nearby parts of the body. When these ions relocate, they can infiltrate organs, produce local irritation, or even create cysts. Doctors have reported encountering these large cysts during revision surgery, having them break open and leak their contents.

DEPUY PINNACLE HIP DEVICE

The DePuy Pinnacle® product, like the ASR devices, utilizes a metal-on-metal design, which experts have identified as an unreasonably dangerous defect that can cause metal shavings to dislodge inside a patient's body, resulting in tissue damage, pseudo tumors, implant dislocation, bone loss, dangerously high blood metal levels, and other problems which ultimately require that the hip implant be explanted.

Although the U.S. Food and Drug Administration (FDA) has not issued a DePuy Pinnacle Hip Replacement warning, nor has DePuy voluntarily initiated a Pinnacle Hip Replacement recall, controversy has eroded consumer confidence in the device.

DIACETYL

Diacetyl is a natural byproduct of fermentation. It is a vicinal diketone (two C=O groups, side-by-side) with the molecular formula C4H6O2. Diacetyl occurs naturally in alcoholic beverages and is added to some foods to impart a buttery flavor. Diacetyl and acetoin are two compounds that give butter its characteristic taste. Because of this, manufacturers of margarines or similar oil-based products typically add diacetyl and acetoin (along with beta carotene for the yellow color) to make the final product butter-flavored, because it would otherwise be relatively tasteless.

The National Institute for Occupational Safety and Health has suggested that diacetyl, when used in artificial butter flavoring (as used in many consumer foods), may be hazardous when heated and inhaled over a long period.

DURAGESIC® Pain Patch

The DURAGESIC® pain patch contains a narcotic analgesic used to relieve moderate to severe chronic pain. Produced by Janssen Pharmaceutical Products, it was approved by the FDA in 1990. Recently, however, the DURAGESIC® pain patch has been linked to serious health risks. In July 2005, the FDA issued an alert stating that it is looking into reports of death and other serious side effects from overdoses resulting from use of the DURAGESIC® pain patch.

FEN-PHEN

Fen-phen was an anti-obesity medication (an anorectic) which consisted of two drugs: fenfluramine and phentermine. While one drug suppressed the appetite, the other drug prevented drowsiness. Patients quickly experienced dramatic weight loss and the drug was dubbed a "miracle pill".

The combination was found to cause damage to heart valves, and fenfluramine and dexfenfluramine were removed from the United States market in 1997. Critics cited data from the forthcoming release of the International Primary Pulmonary Hypertension Study (IPPHS) that linked derivatives of fenfluramine to primary pulmonary hypertension, a disease that thickens the capillaries in the lungs and makes breathing very difficult.

GADOLINIUM®

Gadolinium®, a metallic contrast dye that is injected in patients undergoing metallic resonance imaging (MRI), has been recently linked to a rare skin disorder in patients with kidney troubles. Nephrogenic systemic fibrosis can lead to burning, itching, stiffening, or discoloration of the skin. Doctors think the condition may be under-diagnosed in kidney patients who have undergone MRIs with contrast dyes.

KETEK®

KETEK ® (telithromycin) is a ketolid-class antibiotic manufactured by Sanofi-Aventis. Approved by the FDA in April 2004, the drug has been prescribed over five million times in the treatment of bacterial sinusitis and pneumonia and chronic bronchitis. It has come under fire in recent months because of allegations of adverse KETEK® side effects, which include liver damage, liver failure, and death. A congressional investigation is attempting to determine why the drug was approved even after a physician was convicted of fraud in clinical trials of KETEK®.

NUVARING®

NuvaRing is a popular and effective form of birth control. NuvaRing is available by prescription and is a flexible ring made out of plastic. It releases estrogen and progrestin over the course of three weeks. The ring is removed for seven days and then a new ring is inserted. Using NuvaRing properly will help prevent pregnancy, but may also cause the onset of many side effects. NuvaRing contains desogestrel that makes NuvaRing a third generation contraceptive.

There have been reports of many serious side effects in users of NuvaRing®, including pulmonary embolism, deep vein thrombosis, strokes, and heart attacks.

PAXIL® Birth Defects

Paroxetine or paroxetine hydrochloride (sold under the trade name PAXIL® in the United States) is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) type. It was released onto the market in 1992 by the pharmaceutical company Glaxo Smith Kline, and has since become one of the most prescribed antidepressants on the market. Pregnant women taking PAXIL® have a greater chance of having babies with birth defects, especially heart defects, than women who have used other antidepressants or no antidepressants.

REGLAN® (metoclopramide)

REGLAN® (metoclopramide) is a prescription drug commonly used for the treatment of gastrointestinal conditions such as gastric reflux and diabetic gastric stasis. However, studies have linked REGLAN® to various nervous system disorders. Long-term use of REGLAN® has been linked to a number of serious side effects including tardive dyskinesia, Parkinson's-like symptoms, severe depression, and others.

TOPAMAX

Topamax is an anticonvulsant medication approved for use alone or with other medications to treat patients with epilepsy who have certain types of seizures. Topamax is also approved for use to prevent migraine headaches.

FDA notified healthcare professionals and patients of an increased risk of development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with topiramate (Topamax) during pregnancy. Because of new human data that show an increased risk for oral clefts, topiramate is being placed in Pregnancy Category D. Pregnancy Category D means there is positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women may be acceptable in certain situations despite its risks.

REGLAN® (metoclopramide)

STEVENS-JOHNSON SYNDROME (SJS)

Stevens-Johnson Syndrome (SJS) is a potentially deadly skin disease that usually results from a drug reaction. SJS has been associated with over-the-counter pain relievers including Advil, Motrin, Tylenol and Children's Motrin. Antibiotics include those based on sulfa, phenytoin or penicilli and anti-seizure medication, such as Dilantin and Phenytoin. SJS is caused by an extreme allergic reaction to drugs or by underlying infections and malignancies, it affects the mucous membranes and the skin, eventually resulting in the epidermis (the outer layers of skin) separating from the dermis (inner layers of skin).

WELLBUTRIN

Wellbutrin (bupropion) is an antidepressant medication. It works in the brain to treat depression. Wellbutrin is used to treat major depressive disorder and seasonal affective disorder. At least one brand of bupropion (Zyban) is used to help people stop smoking by reducing cravings and other withdrawal effects.

However, women who were on Welbutrin medication ran more than double the risk of giving birth to a baby with heart defect known as left outflow defects (restriction in flow of blood from the heart to the rest of the body) as compared with women who were not on such medication. The condition needed urgent surgical intervention in the newborn babies.

YAZ

Yaz or Yasmin (generic: Ocella) are birth control pills that have been manufactured by Bayer HealthCare Pharmaceuticals. As one of the top selling oral contraceptives, Yaz has been a popular choice for women across the U.S.

Despite its popularity, the birth control pill has been linked to serious, potentially fatal side effects, including heart attack, stroke, pulmonary embolism and blood clots.

ZOLOFT

Zoloft is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Zoloft affects chemicals in the brain that may become unbalanced and cause depression, panic, anxiety, or obsessive-compulsive symptoms. Zoloft is used to treat depression, obsessive-compulsive disorder, panic disorder, anxiety disorders, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD).

Mothers who have taken antidepressants such as Zoloft during their pregnancy because they thought it was safe have given birth to babies with birth defects ranging from cleft lip to life-threatening congenital heart defects and, in some cases, the babies have been required to get full heart transplants.