Content Related To 'drugs-medical-devices'

Birth Control Patch Cases Being Settled and Sealed

by Sandra Cassidy, Associate Corporate Counsel for Counsel Financial Services March 4, 2008 Johnson & Johnson will pay $1.25 million for the death of a 14-year-old who suffered blood clots in her lungs after using the Ortho Evra birth control patch. Five million women have used the patch since it came on the market in […]

COMMENTARY: FDA Amendments Act Scandal Protects Big Pharmaceutical Companies

by Robert A. Schwartz, Attorney at Law Feb. 6, 2008 On Jan. 16, 2008, the Food and Drug Administration issued a proposed rule that directly contradicts Congress’ expressed intent when it passed the Food and Drug Administration Amendments Act of 2007 (FDA Amendments Act of 2007). The act bestows the responsibility to warn consumers of […]

Merck Vioxx Settlement Has Some Attorneys Uneasy

by Robert A. Schwartz, Attorney at Law Nov. 21, 2007 Pharmaceutical company Merck & Co. has negotiated a multibillion-dollar settlement to resolve the outstanding Vioxx product liability claims in the U.S., though some plaintiffs’ attorneys are concerned about participating in the settlement. The $4.85 billion settlement, reached in the U.S. District Court, Eastern District of […]

COMMENTARY: Vioxx Suit & the Greatest Posturing of All Time

by Robert A. Schwartz, Attorney at Law Nov. 12, 2007 After more than three years of telling the world that it did nothing wrong and that it will defend itself case by case for as long as it takes, Merck did a 180-degree turn when it announced Nov. 9 that it had settled most of […]

COMMENTARY: Bayer Fraud or “Regrettable Human Error”?

by Robert A. Schwartz, Attorney at Law Nov. 6, 2007 A Nov. 5 Associated Press story reported that under government pressure, Bayer said it would immediately halt worldwide sales of anti-bleeding drug Trasylol. The Food and Drug Administration asked the manufacturer to stop selling the drug, approved in 1993 to prevent excessive bleeding during heart […]

COMMENTARY: Wyeth Lawsuit – Runaway Jury or Runaway Pharmaceutical Company?

by Robert A. Schwartz, Attorney at Law Oct. 16, 2007 Twelve jurors in a Reno, Nev., trial found that pharmaceutical giant Wyeth’s hormone-replacement therapy drugs caused breast cancer in the three Nevada women who brought the lawsuit. The jury awarded the three women compensatory damages in the following amounts: $10.5 million to Jeraldine Scofield, 74; […]

Gadolinium

Lea en español Gadolinium Gadolinium is a rare Earth element used in medical applications. The FDA approved gadolinium as contrast agent for MRI procedures. During an MRI procedure, the element is injected into a patient’s vein and accumulates in abnormal tissue, making the tissue bright. Even small tumors are easier for doctors to detect on […]

Zelnorm

Lea en español Zelnorm is the trade name for tegaserod, a 5-HT4 agonist used for the management of irritable bowel syndrome and constipation. The pharmaceutical company Novartis markets the prescription drug under the trade names Zelnorm in the U.S. and Zelmac in other countries. In 2002, the Food and Drug Administration approved Zelnorm for short-term […]

Ketek

Ketek is a prescription antibiotic used for cases of acute bacterial illnesses such as chronic bronchial infections, pneumonia, sinusitis and lung infections. Its use has come under scrutiny after multiple cases of liver toxicity were reported associated with the drug. In March 2006, the Annals of Internal Medicine published an article documenting the cases of […]

Avandia

In 1999, the Food and Drug Administration approved Avandia, the brand name for an anti-diabetic drug. The FDA’s primary medical reviewer questioned Avandia’s safety before FDA approval. After nearly a decade of use and many studies related to the cardiac risk related to the drug, the debate continues. New studies, the American Diabetes Association and […]

Hormone Replacement Therapy

Hormone replacement therapy (HRT) is a medical treatment used to provide women with relief from the symptoms of menopause, perimenopause and postmenopause. When menopause occurs, the drop in estrogen and progesterone levels can cause a woman to experience periods of sweating and heat (hot flashes), vaginal discomfort (itching, burning and dryness) and a loss of […]

Mirapex

Mirapex (pramipexole) is an antidyskinetic (dopamine agonist) used to treat Parkinson’s disease. Mirapex was approved by the FDA in 1997 and is manufactured and distributed by Boehringer Ingelheim and Pfizer. The drug works by imitating the actions of dopamine in the brain that help control muscle tremors associated with Parkinson’s disease. Mirapex is also used […]

Tequin

Lea en español Tequin (gatifloxacin) is an antibiotic used to treat bacterial infections in the lungs, in the sinuses and on the skin. It is also used to treat urinary tract infections, kidney infections and some sexually transmitted diseases. The Food and Drug Administration approved Tequin in 1999. Tequin Linked to Diabetes and Blood-Sugar Problems […]

Medtronic Defibrillators

Lea en español Implanted cardioverter defibrillators are small devices implanted below the collarbone to monitor and correct irregular rhythm of the heart (arrhythmias). Defibrillators release jolts of electricity that restore normal rhythms and prevent sudden cardiac death. These devices can also act as pacemakers when a slow heart rhythm is detected. Medtronic Recalls Cardiac Defibrillators […]

Medtronic Pacemakers

Lea en español In 2005, Medtronic issued a recall on its Sigma Series pacemakers because of a wiring defect that could cause device failure. The wiring defect was traced to a cleaning solvent used during production that causes deterioration of the wires over time. The wiring in question connects the main circuitry of the pacemaker […]

Neurontin

The FDA approved Neurontin in 1994 for treatment of partial seizures usually associated with epilepsy. It was later approved for pain management associated with postherpetic neuralgia as a result of shingles. Pfizer Markets Neurontin for Off-Label Use Shortly after Neurontin appeared on the market, the manufacturer, Pfizer, began intensive marketing of the drug for off-label […]

Ortho Evra

Lea en español Ortho Evra is a weekly birth-control patch worn on the skin to prevent pregnancy. It prevents pregnancy by delivering continuous levels of hormones through the skin and into the bloodstream. While Ortho Evra has proven successful for many women looking for alternatives to birth-control pills, attention has been brought to more serious […]

OxyContin

Lea en español OxyContin, manufactured by Perdue Pharma, is a prescription painkiller containing the drug oxycodone, a drug similarly found in Percocet and Percodan. It is a semi-synthetic opiod analgesic used to treat chronic and long-lasting pain. Depending on the dosage, OxyContin contains between 10 and 160 milligrams of oxycodone and is manufactured as a […]

Prempro

Lea en español The Food and Drug Administration approved Prempro in 1995 as a hormone-replacement therapy. Side effects became a concern after studies linked Prempro to a number of health problems. A major study of the long-term use of Prempro found that the drug significantly increases the risk of breast cancer, heart attack, blood clotting […]

Seroquel

Lea en español Seroquel is an atypical anti-psychotic medication used to treat symptoms of schizophrenia and bipolar disorder. Manufactured by AstraZeneca, Seroquel (quetiapine fumarate) is an oral medication that works by affecting neurotransmitter receptors in the brain. The Food and Drug Administration approved Seroquel in 1997 as a psychotropic medication and then again in 2006 […]

Sulzer Hip Implants

Lea en español Sulzer Orthopedics recalled 25,000 Sulzer hip implants in 2000 because of a defect caused by a lubricant used during the manufacturing process of the Inter-Op acetabular shell. The device was designed to fit into place and allow the surrounding bone to naturally bond to it. It was found that the oil-based residue […]

Trasylol

Lea en español Trasylol (aprotinin injection) is a drug approved to reduce blood loss during cardiopulmonary bypass surgery. A study performed by the Ischemia Research and Education Foundation found that the use of Trasylol doubled the risk of kidney failure in cardiopulmonary bypass surgery patients. This study also found that the risk of heart failure […]

Viagra

Viagra, manufactured by Pfizer, was the first erectile-dysfunction drug of its kind to be approved by the Food and Drug Administration. The drug, which is Sildenafil citrate, is used to treat male erectile dysfunction and pulmonary arterial hypertension. Attention has been brought to a number of cases of nonarteritic ischemic optic neuropathy related to the […]

Zyprexa

Lea en español Zyprexa, also known as olanzapine, is an atypical antipsychotic. While approved by the Food and Drug Administration for schizophrenia in 1996 and bipolar disorder in 2000, it is used off-label to treat psychosis, dementia, anxiety, anorexia and severe agitation. This type of antipsychotic drug blocks particular dopamine and serotonin receptors that are linked to […]

Adderall and Ritalin

Lea en español Both Adderall and Ritalin are psycho-stimulants used to treat Attention Deficit Disorder and Attention Deficit Hyperactivity Disorder, commonly found in children but sometimes carried into adulthood. Attention Deficit Disorder is characterized by short attention spans, an inability to concentrate and a lack of self control. Attention Deficit Hyperactivity Disorder has similar symptoms […]

Accutane

Lea en español Accutane is a Vitamin A derivative taken orally as a treatment for nodular and cystic acne that is resistant to less intense acne medications. The treatment, which usually lasts several months, reduces the sebaceous glands, thus decreasing the production of sebum, an oily substance that prevents skin from becoming dry. Side Effects […]

Fosamax

Lea en español Fosamax is prescribed to treat osteoporosis, a disease that causes bones to deteriorate and break. It is a bisphosphonate, designed to reduce the activity of cells that cause the breakdown of bones. Fosamax is manufactured by Merck and Co. and was approved by the FDA in 1999. Side Effects Common side effects […]

What Did They Know and When Did They Know It?

Robert A. Schwartz, Attorney at Law May 23, 2007 Wyeth and other pharmaceutical companies tested, manufactured, marketed, distributed, promoted and sold Premarin, Prempro and MPA (the synthetic progestin used in Prempro), hormone-replacement drugs prescribed for post-menopausal women to treat some of the problems associated with menopause. For decades, Wyeth and other manufacturers vigorously promoted the […]