Archive for September, 2008

Operating rooms on fire

Thursday, September 25th, 2008

When you go into the hospital for surgery, you’re not supposed to come out with second and third degree burns.

But, according to some recent research, that’s what’s happening to 550-650 patients a year in this country. Dozens of patients suffer disfiguring burns and some are even killed as a result. This is according to a copyrighted story broadcast on MSNBC.

The problem is that anesthesiologists typically place a mask over the patient’s face during surgery. In addition to anesthesia, the mask often contains highly flammable, pure oxygen. When the surgeon begins to use some of the new, powered surgical tools like electro cardio pencils or lasers, especially near the mask, the result could be a flash fire.

Whatever the source, the head and neck region is grimly suited to hosting fires, especially in a high-oxygen atmosphere.

Like other shocking medical errors, such as objects left behind after surgery or operations on the wrong body part, surgical fires are regarded as a rare problem.

Not all states require hospitals to report these incidents and many are under reporting operating room fires. In fact, many hospitals and doctors have settled the resulting lawsuits out of court and requiring non-disclosure agreements as part of the settlement.

Paxil Birth Defect Suit Filed On Behalf of Child Born With Aortic Stenosis

Tuesday, September 23rd, 2008

A defective drugs attorney has filed an action on behalf of an infant against Glaxo SmithKline in the Court of Common Pleas in Philadelphia.

The infant’s mother was prescribed the antidepressant Paxil during her first trimester by her physician, who was unaware of any warnings that the drug shouldn’t be taken by a woman who is pregnant. The pregnancy proceeded without incident and the baby was delivered at full term.

After leaving the hospital the child began to experience problems and was eventually referred to a pediatric cardiologist. An echocardiogram was performed and the parents were told that the baby had a number of cardiac deformities including severe aoritic stenosis, coarctation of the aortic valve and mitral stenosis.

At only 5 months of age the baby underwent a balloon valvuloplasty to improve blood flow through the aorta. Now, at age five,  this child is scheduled for a another heart operation and will likely have many more before he graduates elementary school.

This family isn’t the only one in this country battling drug manufacturers over adverse side effects. Hundreds of lawsuits have been filed against Glaxo SmithKline claiming that children were born with significant congenital cardiac abnormalities after their mothers used Paxil during pregnancy.

The financial burden of caring for a child or other loved one harmed by defective drugs is enormous. It is important to contact a trained and experienced defective drugs attorney for professional insight into a possible Paxil settlement.

Study links some antibiotic use to cerebral palsy

Tuesday, September 23rd, 2008

The Reuters news service is reporting that a once-used practice of giving antibiotics to some women at risk of premature birth may have increased the odds their children will develop cerebral palsy and other problems.

The report references a  study published in the journal Lancet, which looked at women at risk of premature labor who had no signs of infection. Doctors now recommend antibiotics only for women whose waters have broken prematurely or have an obvious infection.

The findings reaffirm that doctors should not use antibiotics for premature labor when the mother’s water is intact and if there is no infection, said researchers at the University of Leicester who commissioned the study.

One startling finding, for women whose water did not break and who got two popular antibiotics together, the chance their children would develop cerebral palsy nearly tripled.

While it was known children born prematurely are more prone to functional problems later in life, the link to cerebral palsy was unexpected.

Hiding the Truth

Wednesday, September 17th, 2008

It should not be a surprise by now that drug manufacturers will do just about anything to get and keep their products on the market. However, it does still present as an unpleasant shock to learn that 30 percent of antidepressant drug studies are never published because they showed that the tested drug failed to work.

On top of that, some of the negative studies that got published were reworked to make it appear as if the experiment had yielded a positive outcome.

This information was unearthed by a research team lead by Eric Turner of the Oregon Health & Science University. Their results were recently published in the New England Journal of Medicine.

Turner’s group looked at 74 studies of 12 different antidepressants and found that all but one of the 38 positive tests were published as compared to only three of the studies that turned up negative, and about a dozen other negative experiments were re-written as to appear positive.

Several of the culprits are widely-used antidepressant medications. For example, Paxil (by GlaxoSmithKline) produced seven negative studies, five of which were never printed. Wellbutrin SR (also by GSK) had only three total studies to its name, two of which were negative and never published. Zoloft (from Pfizer) was studied five times with three unpublished negative showings and a fourth negative that was rewritten as if the drug had in fact worked.

Since adverse effects to these drugs can be catastrophic, it is critical that you talk to your doctor and even contact an experienced defective drugs attorney for professional insight.

Do Vaccines Cause Autism?

Wednesday, September 17th, 2008

Though not much is known about the causes of autism, angry families in the United States are blaming childhood vaccines.

In 2004, the Institute of Medicine promised there was no credible evidence showing that the preservative thimerosal contained in some vaccines caused autism, but that has not stopped nearly 5,000 lawsuits alleging the contrary.

It is a general contention among all the pending lawsuits that the vaccines containing thimerosal were the cause of autism in the children—they do, however, disagree on exactly how.

Some of the birth trauma attorneys handling these cases say that only the thimerosal in the vaccines caused the neurological disorders. Others argue that the injections also contained a form of mercury that overexcited certain brain cells. To settle this discrepancy, the Office of Special Masters of the claims court has instructed plaintiffs to carry out three tests for each of the theories.

Thimerosal has been removed from standard children’s vaccines, but remains in flu vaccines that are packaged as multiple doses. Unfortunately, the Center for Disease Control and Prevention says single dose flu vaccines are available only in limited numbers for the time being. Until more are produced for and distributed to the children in need of them, the threat of adverse thimerosal side effects remains.

If you are among the families battling autism and believe a loved one has been harmed by a one of these childhood vaccines, it important to contact an experienced birth trauma attorney and defective drugs attorney for professional insight.

Families sue hospital, drug maker over baby deaths

Monday, September 15th, 2008

According to an Associated Press story, the families of two newborns who died after they were inadvertently given massive doses of heparin have sued an Indianapolis hospital and the Illinois-based company that makes the blood thinner.

The suit filed recently in Marion Superior Court against Methodist Hospital and Deerfield, Ill.-based Baxter Healthcare Corp. doesn’t specify damages.

The suit was filed by an defective drug attorney for the parents of two of the three newborns who died in September 2006 following injections of heparin 1,000 times greater than the recommended dose for infants. Also suing are the parents of two infants who were overdosed but survived.

The error occurred in part because of a mix up over labeling.

A Baxter spokeswoman said the deaths were tragic but preventable, and it is vital that clinicians always read the name and dose of a drug before giving it to a patient. Baxter changed the labeling on its heparin vials in October 2007.

A spokesman for Clarian Health Partners, of which Methodist is part, said the company did not have all the details of the litigation and had no comment.

Actor Dennis Quaid and his wife sued Baxter last year after their newborn twins got massive doses of the blood thinner at a hospital.

These families aren’t the only ones battling drug companies over wrongful deaths due to defective drugs or defective labeling. It is advisable to locate an experienced defective drug attorney in case legal advice is necessary for a heparin lawsuit or settlement .

Fixing Riegel vs. Medtronic

Friday, September 12th, 2008

Back in February, the United States Supreme Court dealt a hefty blow to citizen protection to seek compensation after being injured by a defective medical device. In this landmark case, our highest court ruled against Charles Riegel, the victim of a defective balloon catheter used during his angioplasty procedure. Though Riegel was seriously injured at the negligent hands of Medtronic, the court found that Federal regulations overruled state law, rather than the two working in tandem as it had been before.

The repercussions of this decision have yet to take their full effect. As Public Citizen lawyer Allison Zieve noted, “The possibility of being held liable for injuries their products cause creates an invaluable incentive for manufacturers to make their products as safe as they can, to revise labels… and to remove unsafe products from the market.”

Luckily, the consumer advocacy group Public Citizen is working to remedy this gaping hole in consumer protection. With the support of Representatives Henry Waxman and Frank Palone, and Senators Ted Kennedy and Patrick Leahy, they are trying to push through the Medical Device Safety Act of 2008. This new legislation would nullify the implications of the Supreme Court ruling, and give power back to the injured.

Problems with Gardasil

Friday, September 12th, 2008

Negative reports keep flooding in regarding Merk & Co. Inc.’s popular vaccine, Gardasil. Gardasil was approved two years ago by the Food and Drug Administration to prevent the spread of human papillomavirus, a virus that is known to cause cervical cancer in a small percentage of the women and girls who contact it.

According to the FDA, Gardasil has been the subject of about 8,000 “adverse event” reports since the drug went on the market. Complaints range from nausea to paralysis and a total of 15 reported deaths. Approximately 16 million American girls and women have been given Gardasil, which has in general been widely supported by schools and other institutions, especially here in Texas.

The Center for Disease Control and Prevention contends that none of the reported deaths were due to the receipt of Gardasil, but continues to investigate the negative reports.

Ugly side of Botox

Friday, September 12th, 2008

It turns out that the popular cosmetic treatment Botox may have some ugly side effects, especially when used for off-label treatments. A class action lawsuit has been filed in California by Botox users against its manufacturer, Allergan Inc., alleging failure to warn, along with several other individual cases.

Botox comes from botulinum toxin Type A, which in its raw form, is a very deadly poison. It was approved by the Food and Drug Administration almost 20 years ago for soothing wrinkles. The FDA warned back in back in February that they were investigating reports of serious reactions in botulinum-based drugs such as Botox and Myobloc.

The lawyers for the plaintiffs in California claim three deaths associated with Botox use. In Texas, a 69-year-old nurse died after getting Botox injections for her neck and shoulder pain, as well as a 7-year-old girl with cerebral palsy who was receiving the shots to control the spasms caused by her disease. In Arizona, a 71-year-old woman died after losing the ability to speak or swallow, most likely caused by a cosmetic Botox treatment she received in a mall clinic.

The consumer group Public Citizen reports 16 deaths due to Botox (or Myobloc) between 1997 and 2006 as well as 180 patients that developed life-threatening conditions and 87 hospitalizations.

Most reports of adverse side-effects due to Botox treatment have come out of off-label use. Though Botox is essentially only approved to treat wrinkles, some doctors use it to treat migraines, spasms and pain.

FDA strengthens arthritis drug warnings

Monday, September 8th, 2008

The US Food and Drug Administration (FDA) has ruled to include stronger warnings for fungal infections caused by arthritis drugs.

The warnings apply to drugs like Amgen, Inc.’s Enbrel, Johnson & Johnson’s Remicade, Abbott Laboratories’ Humira, and UCB SA’s Cimza. The drugs Enbrel, Remicade, and Humira were among the top 25 selling drugs last year, with $13.5 billion in combined sales.

They are usually used to treat rheumatoid arthritis. According to the FDA, at least 241 patients have developed histoplasmosis—an infection caused by a fungus found in the Ohio and Mississippi river valleys. Twelve of the 45 reported deaths were caused by doctors who didn’t recognize the infection and delayed treatment for the infection; even more deaths have been reported from other fungal infections.

The FDA has forced companies to strengthen their existing cautions in the strictest form of caution: a black box in the drugs’ prescribing information. The drug manufacturers must also educate doctors about the risks and symptoms of fungal infections.