Archive for October, 2008

What your doctor left behind could kill you

Friday, October 31st, 2008

The Food and Drug Administration is warning doctors — and the public — about an growing but largely unrecognized problem plaguing surgery patients: UFDs.

Unretrieved device fragments, medical devices that break and leave behind potentially deadly debris after surgery, is responsible for at least 72 deaths and 4,675 injuries since 2003, an FDA database reports.

This is on par with mistakes that have received far more attention — sponges and instruments left in abdominal cavities — with this difference: doctors usually know they’re there, but they either make no attempt to retrieve the devices or are unsuccessful when they try.

FDA records show that more than 200 medical devices contribute to the problem. The most common problem occurs when wire guides for catheters used in heart operations break or fracture, leaving the device or fragments behind. Bone screws used in orthopedic operations are often culprits as well.

Some health workers don’t tell their patients about the broken devices, sending them home with pieces that have the potential to migrate throughout the body, or to interact with future procedures such as magnetic resonance imaging.  One worry is that metal objects can overheat during MRIs, scorching patients from the inside.

While the FDA works to develop some sort of reporting system, it’s up to patients to protect themselves. Ask doctors to explain potential complications of medical procedures and devices well before surgery begins. If a device is being removed, they should ask to see it. Afterward, they should ask if anything was left behind.

If you are suffering from this sort of problem, seek out an experienced lawyer who can help you with professional insight and to determine what sort of financial compensation is available.

More problems with Avandia

Friday, October 31st, 2008

A consumer watchdog group has filed a new petition with the FDA to have GlaxoSmithKline’s diabetes drug Avandia recalled because, in addition to its other side effects, it contributes to liver failure.

Public Citizen’s Health Research Group (HRG) release a study of 14 cases of liver toxicity after taking the drug. Twelve of the cases were fatal.

Besides the Avandia-induced liver failure, the petition  pointed out several other serious side effects associated with Avandia, including a 40 percent increase in the risk of heart attack and a two-fold risk of congestive heart failure.

If you or a loved one have been taking Avandia and have suffered severe side effect, you should contact your doctor, but also an experienced dangerous drug attorney for professional insight.

Senators probe industry ties between doctors and device manufacturers

Monday, October 27th, 2008

Two US lawmakers have asked a group of doctors and researchers to disclose the amount financial and other support they have received from five companies that manufacture medical devices.

The manufacturers include Abbot Labs, Medtronic Inc. and Johnson & Johnson, companies that, in the past, have been the subject of defective medical product lawsuits.

The lawmakers, Senators Charles Grassle and Herbert  Kohl, have been looking into the financial ties between doctors and industry. They have sponsored legislation that would force drug companies and device makers to disclose their spending on doctors.

Despite manufacturer claims, the safety of several medical devices, especially heart stents and particularly drug coated stents – is far from established.  Several studies have linked the devices to blood clots and heart attacks.

In fact, a recent study indicated that Medtronic’s Endeavor drug-coated stent was associated with more heart attacks and deadly blood clots than another stent made by Johnson & Johnson.

Faulty medical devices can cause injuries, even death. If you or a loved one has been harmed because of a defective stent or other medical device, contact an attorney for professional insight into developing litigation. This may be the only way for you to recover some of the costs you and your family bear for these mistakes.

Reports of serious drug reactions hit record

Friday, October 24th, 2008

The Associated Press is reporting the number of serious drug reactions and deaths reported to the government shot up in the first three months of this year, setting a record.

According to the report, the Food and Drug Administration received nearly 21,000 reports of serious drug reactions, including reports of more than 4,800 deaths.

Two drugs accounted for a large share of the latest reports. One was the blood thinner heparin. Most of the drug’s problems were prompted by tainted heparin imported from China.

The other was Chantix, a new kind of anti-smoking drug from Pfizer.

The 20,745 cases reported from January through March was 38 percent higher than the average for the previous four calendar quarters, and the highest for any quarter, the report said.

The number of deaths, 4,824, was a nearly threefold increase from the last calendar quarter of 2007. The FDA said contaminated heparin was largely to blame.

New Avandia suit filed in Texarkana

Wednesday, October 22nd, 2008

A Northeast Texas man has filed a personal injury suit against Smithkline Beecham Corp., doing business as GlaxoSmithKline, claiming Avandia cause a series of heart attacks.

After being diagnosed with type 2 diabetes in May of 2000, the man took Avandia for seven years as a way to improve control of his blood sugar levels. Now he believes the drug caused him to have heart attacks in 2003 and in 2006.

The suit claims that GlaxoSmithKline did know or should have known that Avandia can cause “heart injury, excessive fluid retention, fluid-overload disease, congestive heart failure, heart attack, liver damage, liver failure, and severe injury to the heart leading to cardiac arrest or death.”

As a result of several studies, in May 2007, the FDA issued a safety alert advising patients that there is a potentially significant risk of heart attacks and heart-related deaths. In November 2007, GlaxoSmithKline gave the drug a black box warning.

The suit alleges GlaxoSmithKline negligently allowed the public disclosure of positive information, but withheld or concealed negative information about Avandia’s safety and effectiveness.

If you have experienced adverse effects from taking Avandia or any other defective drug, you should seek the advice of a skilled, defective drugs attorney and determine if you are due any compensation for your injuries.

Congress, FDA tussle over contaminated heparin supplier

Wednesday, October 22nd, 2008

The FDA and Congressional investigators are fighting over its refusal to release information on which Chinese companies supplied a tainted blood thinner that has led to at least 81 deaths in the United States.

Heparin is a widely used blood thinner, frequently given in large doses to patients in order to prevent clotting during complex medical procedures such as kidney dialysis or heart surgery.

Most of the heparin sold in the United States is manufactured from ingredients made in China, a major supplier of drug ingredients to the United States.

The FDA suspects that the deadly heparin originally became contaminated in a Chinese factory, but has refused to tell Congress which companies supplied heparin ingredients to the United States from China. The agency says that confidentiality agreements with the producers bar it from revealing any of their names.

The FDA claims that it does not have the legal authority to prevent the importation of Chinese-manufactured drugs, citing a Memorandum of Agreement that regulates relations between the FDA and China. The memorandum was signed in order to speed the process of allowing FDA inspection of Chinese drug factories in the first place.

Instead, the FDA is relying on companies to voluntarily test their heparin ingredients before distributing them in the United States. Yet such testing failed to reveal the tainted ingredient between January 2007 and February 2008.

Baxter, the country’s major manufacturer of the drug, has developed a new testing method that can distinguish between pure heparin and oversulfated chondroitin sulfate.

One of the plants that the FDA has inspected was Changzhou SPL, a supplier for Baxter. The factory is majority owned by Wisconsin-based Scientific Protein Laboratories Inc. (SPL), the world’s major supplier of heparin’s active ingredient.

At least 12 lawsuits have been filed against Baxter by patients and their family members who claim they were harmed by the tainted drug.

One of three Paxil lawsuits settled

Monday, October 13th, 2008

Two lawsuits filed by West Virginia families claim the antidepressant Paxil was responsible for their children’s birth defects.

The Food and Drug Administration (FDA) announced in December 2005 that it was requiring Glaxo to add warnings of birth defects to the drug’s prescribing information. This decision was fueled by two studies that showed that women who took Paxil during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect than women who took other antidepressants or women in the general population.

The lawsuits claim that Glaxo knew that Paxil was associated with birth defects prior to the 2005 label change and that the heart birth defects that are present in their children wre the result of their mother’s Paxil use during pregnancy.

The women involved in the lawsuits claim that they took Paxil because Glaxo promoted the drug as a safe alternative to pregnant women. However, when their children were born, they suffered from congenital injuries and disorders and birth defects, as well as heart defects and developmental delays.

Also, a class action lawsuit has been settled that will reimburse health plans that paid for children and young adults who receive Paxil. While the drug is not approved for use in children, doctors often prescribe the drug when they see fit. While Paxil isn’t necessarily a defective drug, several studies have shown that Paxil and similar antidepressants cause suicides in teenagers.

If you or a member of your family were prescribed Paxil and suffered adverse side effects, you should contact an experienced defective drug attorney for professional insight.

Heart problems, death increase linked with inhaler drug

Tuesday, October 7th, 2008

Millions of people who use inhaler drugs for bronchitis and emphysema may have a higher risk of heart attacks and death according to a new study.

While the results from this study are not conclusive, doctors are being urged to closely monitor their patients that are using the inhalers. Most patients at risks have both emphysema and chronic bronchitis, but all who are taking drugs for chronic obstructive pulmonary disease (COPD) are at risk.

The drugs tiotropium (sold as Spiriva Handihaler) and ipratropium (sold as Atrovent) are used by more than 8 million people worldwide daily to relax muscles and open lung airways. The new study found that using either drug for more than one month appeared to increase chances for both fatal and non-fatal heart problems (including heart attacks) by more than 50 percent.

In about 7,400 patients on either drug, 135 people (1.8 percent) developed heart problems over a period of several weeks to several years.

While these numbers seem small, patients are urged to reduce heart risks like quitting smoking, keeping blood pressure and cholesterol under control, and using oxygen before starting the drugs.

Do cell phones REALLY cause cancer?

Tuesday, October 7th, 2008

With cellphones, the most ubiquitous electronic device on the planet, being marketed to children as young as 6, the notion that cell phones can cause cancer is scary.

Is it true that these small, convenient devices can give you tumors? Studies say yes, according to Dr. Ronald Herberman, director of the University of Pittsburgh Cancer Institute, and Dr. David Carpenter, director of Institute for Health and the Environment at University of Albany when they both recently testified in front of the House Subcommittee on Domestic Policy.

Citing a study performed by Dr. Lennart Hardell in Sweden, Herberman said, “I cannot tell this committee that cell phones are definitely dangerous. But, I certainly cannot tell you that they are safe.”

The study reports that people who use cell phones have double the chance of developing malignant brain tumors and tumors on the hearing nerve (called acoustic nueromas). The study also says that people under 20 were five times more likely to develop brain cancer.

However, some doctors believe that more evidence is needed for a more conclusive connection. Some studies have not found an increase in tumors associated with the first 10 years of cell phone use, and studies on the increased risk of tumors diagnosed on the side of the head the cell phone is used have not given consistent results.  Many studies have shown that radio frequency energy DOES cause “biological effects,” not all of these effects are considered harmful. These effects could be related to a cancer risk, but they have not yet been properly studied in a laboratory.

While the current studies do not have enough conclusive results to prove that cell phones cause cancer, heavy users should keep these thoughts in mind.