New Mexico Injury Lawyer Blog

Last week the Food and Drug Administration (FDA) advisory panel recommended that Avandia - a popular diabetes drug linked to higher risk of heart attack - contain either stronger warning labels or restrict its use.

Avandia is developed and manufactured by GlaxoSmithKline.

In addition to a well-documented increased risk of heart attack, Avandia has been shown to lead to other health complications such as:
• Stroke
• Congestive heart failure
• Liver damage
• Swelling of arms and legs

In the wake of last week's recommendation for stronger warning labels, the FDA has put a hold on the long-term TIDE study, which compared Avandia with a similar diabetes drug, Actos. Critics have long questioned the ethics of using diabetic patients as "human guinea pigs" to assess the level of risk associated with taking Avandia.

As New Mexico personal injury attorneys concerned about dangerous drugs, not only do we support stopping the clinical trials of Avandia which continue to put more consumers at risk, but believe this dangerous drug must be taken off the market before more people suffer deaths ad serious injuries as the result of Avandia.

Continue reading "Avandia Clinical Trials Partially Stopped " »

The Sixth Circuit Court of Appeals has recently submitted a question to the Food and Drug Administration requesting a response to its position on immunity. At issue is the claim by manufacturers that because the FDA regulates prescription drugs, once the drugs they make have received FDA "approval," drug manufacturers cannot be held liable for the harm - sometimes life threatening - these products cause.

In the landmark case, Wyeth v. Levine, the U.S. Supreme Court determined that federal regulation of prescription drug labels does not grant manufacturers liability.

Makers of Reglan, a generic drug used to treat Gastroesohageal reflux (GER) and Gastroesophaegeal reflus disease (GERD) are now trying to use preemption arguments to avoid liability for harm caused by use of their dangerous products.

Reglan poses the threat of developing Tardive Dyskinesia (TD), a disabling and permanent movement disorder often characterized by shaking spells, blinking and slurred speech. Users have claimed that the generic drug's label failed to warn consumers of the risks of use.

Last year, the Eight Circuit determined that generic manufactures must provide warnings, even if the name-brand drug label doesn't contain the warning.

Continue reading "Manufacturers of dangerous drugs should not be immune from liability" »

This past week new studies reported that Avandia poses a substantially greater risk of heart attacks for its users. Avandia is a diabetes drug prescribed to thousands of diabetics in New Mexico and throughout the United States.

In one study, published by the AMA, researchers studied more than 227,000 people who took Avandia and found a significantly increased risk of stroke, heart failure and death.

In another study, published in the Archives of Internal Medicine, confirmed Steven Nissen's 2007 report indicating that Avandia can increase the risk of heart attack by 43%.

However, recent statements by the FDA indicate that even where studies indicate a product is dangerous, little urgency exists to remove it. The head of FDA's drug approval division, Janet Woodcock defends Avandia's safety, stating its benefits still outweigh its risk. With Avandia, several years of reports and thousands of lawsuits have provided both concrete and anecdotal evidence of the potentially fatal side effects of the drug.

Continue reading "New Reports Link Avandia To Increased Risk Of Heart Attack" »

Reglan is a presciption drug pushed by pharmaceutical companies to patients to treat Gastroesophageal relfux (GER) Gastroesophaegeal reflux disease (GERD). Many studies dating back from the 1970s, have shown that Reglan is ineffective in resolving GER and GERD. A 2006 study published in Nature Clinical Practice: Gastroenterology & Hepatology concluded that "the evidence base for the use of [metoclopramide for GERD] is weak, with little or no sustained effect on acid exposure or healing of esophagitis." The studies also indicate patients suffer from irreversible side effect if used for longer than a 12 week period called Tardive Dyskinesia. TD is a tragic life-long medical condition that causes involuntary and abnormal body movement.

TAKE ACTION

If you or a loved one has taken Reglan and have experienced any of the harmful side effects listed below please seek the help of the Branch Law Firm. Fill out a contact form or call us today so that we can conduct a thorough evaluation of your Reglan use and any damaging or irreversible symptoms that you have experienced.

According to Bloomberg News, 94% of researchers who found positive results from using Avandia had financial ties to pharmaceutical companies. Avandia, is a controversial diabetes drug that has been linked to increased sharp increased risk of heart attack and death.

Despite the FDA's issuance of a formal safety alert concerning the risks associated with Avandia, GlaxoSmithKline continues to market and sell the drug.

The FDA has now also decided to hold public hearings in July to determine whether Avandia should be removed from the market after scores of lawsuits in New Mexico and across the country have been filed based on the increased risk of heart attack resulting from Avandia usage, along with several studies showing a substantial correlation.

While reviewing documents in preparation for the hearing, Mayo Clinic researchers noted that an astounding 45% of the researchers who had weighed in on the Avandia controversy had financial conflicts of interests and about a quarter of those failed to report those conflicts.

Continue reading "NEW MEXICO DANGEROUS DRUGS - AVANDIA RESEARCHERS TIED TO CONFLICTS OF INTERESTS" »

Recent allegations of research collaboration between the FDA's top drug official - Dr. Janet Woodcock - and a pharmaceutical company underscore the potential for conflicts of interests and the high stakes involved in drug marketing. In fact, over the years the FDA has been involved in many conflicts of interests involving dangerous drugs.

In August, 2009 Amphastar Pharmaceuticals, Inc. filed an ethics complaint against Woodcock alleging that she delayed approval of Amphastar's application for approval of a generic blood thinner because of her ties to it's competitor, Momenta Pharmaceuticals, Inc.. Woodstock co-authored medical articles with Momenta while both companies were competing to win FDA approval for their generic blood thinners.

Although ultimately Woodcock was cleared, this episode shows how closely FDA officials may work with those pharmaceutical companies who seek their approval. It is crucial these contacts be disclosed. The drugs that are eventually approved by those officials are the ones that end up in our bodies. Where the motives of officials at the FDA are compromised, it is those individuals who end up taking the potentially dangerous drugs that suffer the consequences.

This is not the first time Woodcock has come under fire. From the late 1990s through the early 2000s several dangerous drugs approved by the CDER on her watch were pulled from the market because they were sickening and killing people. She has also been criticized for her handling of Avandia, a diabetes drug linked to fatal heart attacks and heart failure.

Continue reading "New Mexico Dangerous Drugs - FDA Conflicts of Interest Compromise Our Safety" »

The U.S. Senate Finance Committee has recently issued a report on Avandia, a controversial drug produced by GlaxoSmithKline ("GSK") to control diabetes.

According to the report, GSK knew of possible heart attack risks tied to Avandia many years before the information became public.

The report unequivocally states "GSK had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner."

However, according to the report, GSK failed to warn patients and states: "GSK executives intimidated independent physicians, focused on strategies to minimize findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that the rival drug ACTOS (pioglitazone) might reduce cardiovascular risk."

This latest report reveals in great detail the length that pharmaceutical companies are willing to go to avoid revealing legitimate health risks associated with their drugs. It further exposes the widespread practice of pharmaceutical companies using supposedly "independent" scientific research to bolster their claims, when in actuality the company has sponsored the research.

Adding to the controversy, questions remain why the U.S. FDA continued to allow clinical trials of Avandia even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007.

In addition to heart attacks, Avandia has been linked to several significant health risks including:

• Congestive heart failure
• Liver damage
• Increased cholesterol levels
• Swelling of arms and legs
• Anemia
• Fluid retention

Continue reading "New Mexico Dangerous Drugs - GlaxoSmithKline Has Duty To Warn Of Avandia Risks " »

Despite growing claims of gallbladder problems and increased litigation, Bayer Health Care Inc. continues to market Yaz and Yasmin, without adequate warning of the potential gallbladder risks.

If you've been taking one of these birth control pills, contact a New Mexico personal injury attorney immediately for more information.

The popular birth control pill Yaz, and its counterpart Yasmin, have been linked to severe gall bladder problems, including gallstones, in otherwise healthy women. Often, these women had no gall bladder problems nor had any of the traditional risk factors for gall bladder disease before taking the pills. Typical risk factors include multiple pregnancies, obesity and rapid weight loss.

Under normal circumstances, bile is produced by the liver and travels to the gallbladder, where it stays until it is released into the small intestine. However, the composition of bile is changed in women who take Yaz and Yasmin. Studies have linked the hormones in Yaz and Yasmin to increased cholesterol levels in bile that causes the bile to harden and form gallstones. Gallstones can become excruciatingly painful and cause gallbladder inflammation and disease.

Symptoms of gallbladder problems include - but are not limited to:

• Pain or discomfort in the upper right side of the abdomen
• Nausea
• Diarrhea
• Abdominal bloating
• Jaundice

However, in many cases, gallstones are asymptomatic. The stones may not be discovered until years later when they become extremely painful. At that point, surgical removal of the gall bladder may be your only option. Even after surgery is completed, many women still face gallbladder removal side effects.

Continue reading "New Mexico Women Taking Yaz At Risk For Gallbladder Disease" »

A soon to be published report by the American Diabetes Association has found that the number of heart attacks by diabetic patients who took Avandia is double that of those who took a different oral diabetic medication. In the study, Harvard University researchers analyzed clinical data from more than 26,375 patients from 2000 to 2006 in the Boston area who took at least one oral diabetes medication. Of these patients, the incidence of heart attack among Avandia users was more than double that of those who used a different drug.

Further, a jointly sponsored study by both GlaxoSmithKline and i3 Drug Safety showed that diabetic patients who took Avandia had a 35-41% increased risk of heart attack over users of Actos, Avandia's main competitor.

These findings reinforce the claims of thousands of former users - that Avandia causes serious illnesses and complications, including heart attack and death, within an already vulnerable population. In fact, over 13,000 former Avandia users have filed claims against GlaxoSmithKline in both Federal and State court as the result of significant illnesses and complications.

However, despite these known, life-threatening dangers associated with Avandia, GlaxoSmithKline still continues to market and sell the drug, placing thousands of people at risk. This is unacceptable.

Continue reading "Harvard Study Links Avandia To Increased Risk of Heart Attack" »

In a victory for consumers, last Friday the Fifth Circuit Court of Appeals agreed with the lower court that individuals may sue generic drug makers in state court for the "failure to warn" consumers of of potentially dangerous side effects from taking their drugs. This decision shadows last March's Supreme Court decision in Wyeth v. Levine, which held that federal law did not pre-empt state law failure to warn claims against pharmaceutical companies.

The U.S. Fifth Circuit of Appeals joins a handful of federal district courts that have extended Wyeth v. Levine to cover generic drugs. However, the issue has divided a "rapidly growing" number of district courts which may increase chances of Supreme Court review.

The Tenth Circuit Court of Appeals has not yet weighed in on whether Wyeth v. Levine extends to generic drug manufacturers.

However, as dedicated personal injury attorneys concerned about dangerous drugs, we believe that the right to sue in state court for the failure to warn must apply equally to generic drugs as it does to their name brand counterparts. Any other conclusion would lead to inconsistent results and unjustly deny recourse to those who suffer dangerous side effects as the result of taking generic drugs.

Last week an Ohio woman, Mae Walker, filed a lawsuit against the maker of the popular birth-control pill Yaz. She joins hundreds of women across the county claiming that the company - Bayer - failed to warn about the serious, and possibly life-threatening side effects of taking Yaz.

Walker's suit alleges that she developed deep vein thrombosis (DVT) in her left leg after taking Yaz for about a year. DVT is especially dangerous because of the potential for pulmonary embolism - a life-threatening condition where the blood clot breaks off and travels to the lung. Fortunately for Walker, she was hospitalized and given anti-clotting medication to help prevent this serious complication.

Lawsuits concerning Yaz, Yasmin, and Ocella - are gaining momentum all over the United States. At issue - Bayer's duty to warn women about the potential side effects of taking this popular contraception. These consequences include an increased risk of death, blood clots, strokes, kidney failure and even sudden death.

Many perfectly healthy women such as Mae Walker, have developed serious side effects after taking these birth control pills. It is unknown how many women in New Mexico alone have taken Yaz, Yasmin or the generic equivalent, Ocella.

Along with claim of inadequate warnings, many lawsuits also include allegations of improper advertising and marketing by Bayer. Yasmin was aggressively marketed as being better than other oral contraceptives for acne, weight control and premenstrual syndrome (PMS).

Continue reading "New Mexico Dangerous Drugs - Yaz and Yasmin Lawsuits Gaining Momentum" »