Kentucky Injury Lawyer Blog

Pfizer, GlaxoSmithKline, Merck, Eli Lilly, Bristol-Myers Squibb, AstraZeneca, Baxter, SciClone are a few of the drug manufacturers that the United States Department of Justice (DOJ) is investigating for violation of bribery laws and corruption in foreign markets under the Foreign Corrupt Practices Act. The probe centers around payments from the companies to others, including foreign government officials and doctors. Of interest to the DOJ is any payments that may have influenced clinical trials.

Dangerous and defective drugs are responsible for many injuries and death nationwide. Our profession calls this area of law products liability. Consulting a lawyer experienced in handling these matters is usually easy. Most lawyers will provide a complimentary initial consultation to evaluate a claim or case and let the person know if they can help.

This consumer protection information is provided by Louisville, Kentucky attorney Will Nefzger, a partner at Bahe Cook Cantley & Jones PLC. Click here, and it will take you to a page containing biographical and contact information and here to e-mail Will directly.

Deputy FDA Commissioner Josh Sharfstein reported that the agency is investigating whether or not Glaxo broke the law by withholding data indicating Avandia may carry an increase risk of heart attacks. The Wall Street Journal reports that the FDA is currently reviewing documents that Glaxo released to the Senate Finance Committee as part of the committee’s two year investigation of the drug.

Time magazine reports that FDA reviewer Robert Misbin became concerned about Avandia in 2006 after he saw data suggesting a 31% increase in heart attack risk associated with use of the drug. Senator Charles Grassley, a ranking member of the Senate Finance Committee has already stated that the makers of Avandia shouldn’t have waited so long to alert doctors and patients about Avandia’s potential risks.

The Deputy Commissioner’s statements are the most recent bad news for GlaxoSmithKline. The pharmaceutical company already faces multiple lawsuits and has faced increasing federal scrutiny of Avandia for over three years. The New York Times also referenced potentially uncounted adverse events associated with Avandia in a recent article regarding the potential bribery or FDA and other government officials.

If you or someone you know suspects they have suffered a heart attack or other injury due to Avandia, you should consider discussing the issue with a products liability attorney. The attorneys of Bahe Cook Cantley & Jones are actively litigating Avandia cases. To consult with Shawn Cantley about these issues: Shawn's Mail

Johnson & Johnson has agreed to a $75 Million national settlement related to allegations that its subsidiary, Ortho-McNeil-Janssen Pharmaceuticals schemed to improperly market the drug Topamax for uses that were not approved by the Food & Drug Administration.

The Commonwealth of Kentucky’s share of the settlement is nearly $2 million.

The FDA and J&H Besta Corp have recalled the Joyful Slim Herb Supplement and the Slim-30 Herb Supplement due to traces of sibutramine, commonly known as Meridia, contained in the supplements.

Earlier this year the FDA issued a warning to patients about the use of sibutramine after their review suggested it was associated with an increase risk of stroke and heart attack amongst patients with cardiovascular disease, Medpage Today reports.

Although the company has yet to receive a report of an adverse event from taking the supplement, customers who have purchased the product should cease use and return it to the company for a refund.

When a company produces a defective product, such as unreasonably dangerous drugs, they can be liable for the damages caused from the products. This area of the law is known as products liability . Should you or someone you know be injured by a dangerous drug, such as the supplements mentioned above, you should consider contacting an attorney. The attorneys of Bahe Cook Cantley & Jones, PLC frequently handle these types of cases. To speak with Shawn Cantley about these issues: Shawn's Mail

The U.S. Food and Drug Adminstration (FDA) is investigating whether commonly used blood pressure medicines, known as ARB's, may increase the risk of cancer.

The new review began after a new study suggested the medicines could increase cancer risks for those that take the, according to the New Jersey Star-Ledger.

Angiotensin Recepter Blockers (ARBs) are used by patients to treat high blood pressure and the class of drugss includes the top-selling druges Cozaar and Avapro as well as Atacand, Benicar, Diovan, Micardis, and Teveten. The FDA review is examining, among other things, the same Micardis side effects we reported on earlier this month.

As we have stated before, patients are urged to continue taking the drugs, at least until they have a chance to consult with their doctors about other medicines.

Legal analysis by Shawn Cantley [profile], Shawn's Mail:

Drug manufacturers owe those taking their medicines a duty not to design or manufacture unreasonably dangerous drugs as well as to warn users of the potential dangers of their medicines. Breaching those duties can result in the manufacturer facing civil liability for any injuries they cause.

If ARB's do turn out to increase cancer risks, their makers could face such liability. More facts would be necessary to know the extent of civil liability, if any. If you or someone you know have been inured by these types of drugs, you might consider speaking with a products liability attorney that specializes in dangerous drugs. They can provide you with counsel, help you determine if you have a case, and if so, how to proceed.

The FDA expert panel voted 20 to 12 earlier today to keep Avandia on the market. The vote comes just days after a former FDA official claimed that GlaxoSmithKline, the makers of Avandia, withheld a study that showed Avandia might cause heart attacks, Bloomberg reports. The news is another blow to Avandia we the FDA continues hearings that could result in the drug being pulled from the market.

Reuters reports that the FDA will have the final decision but the panel's vote is a big boost to GlaxoSmithKline. The vote came just days after Dr. Rosemary Johann-Liang, a former FDA manager, revealed that a 2001 study revealed that Avandia posed a greater risk than other medicines. Dr. Johann-Liang was being deposed in relation to a lawsuit against Avandia when she also stated that Glaxo didn't give the FDA an email that concluded Avandia "strengthened the signals" of heart attacks and other ailments.

This is the second FDA employee or ex-employee to criticize GlaxoSmithKline's handling of Avandia. Earlier this week, I posted about an FDA official criticizing Avandia's clinical trials, and Larry Jones wrote an in-depth piece covering the Avandia hearings. As recently as 2006 Avandia generated over $3 billion in sales so the recent studies and FDA comments could represent a huge blow to one of GlaxoSmithKline's flagship drugs.

Dangerous drugs, such as Avandia, might cause injuries or death. If an unreasonably dangerous or defective drug injures consumers than they may have legal claims against the manufacturer and could be compensated any losses they have suffered. Lawyers call this area of the law products liability.

Consulting an experienced products liability attorney is usually easy and can help you determine if you have a case.

This consumer protection information is provided by Louisville, Kentucky attorney Will Nefzger, a partner at Bahe Cook Cantley & Jones PLC. Please feel free to contact me directly for if you have any questions or would like more information. Just click here, and it will take you to a page containing biographical and contact information and here to e-mail Will directly. As always, we will keep you updated as developments with Avandia and other potentially dangerous drugs or products occur.

The popular GlaxoSmithKline diabetes drug Avandia may soon be pulled off the market by the Federal Food & Drug Administration because of the dangerous propensities of the drug. The drug has been known to cause increased risk of heart attacks, stroke, and congestive heart failure in users.

Today marks day two of hearings underway by the FDA ro determine whether the FDA will pull Avandia off of the market and force a recall of Avandia.

Beginning Tuesday, the 33 members of the FDA's advisory committee began a hearing to determine whether or not to recall Avandia. During the first day of hearings, a safety study by GlaxoSmithKline came under attack throughout the hearing.

"You can't trust it, and if we do trust it, we're engaging in the willing suspension of disbelief," said FDA scientist Dr. David Graham.

Last week, in a strongly worded FDA report, the company's study was called "inappropriate and biased." The FDA said that GSK repeatedly submitted sloppy data and failed to follow up on reports of problems among patients, including deaths.

The FDA panel could vote as early as today on whether to remove Avandia from the market.

Published estimates indicate sales of Avandia have dropped from about $3 billion in 2006 to about $1 billion.

In a study published in June, Dr. Graham found that patients on Avandia are more likely to suffer stroke, heart failure or premature death than patients who used another drug.

GSK also "failed to publish studies that found serious health risks associated with Avandia in a timely manner and actively promoted the drug despite the known safety concerns" according to the Senate Finance Committee.

Bahe Cook Cantley & Jones attorney Larry Jones says, "I applaud the FDA for finally forcing the makers of Avandia to answer the tough questions about this drug. It has caused numerous instances of heart attack, stroke and congestive heart failure, which in turn has caused numerous families to suffer the heartache of losing a loved one. If GSK wanted to make billions off of a drug, it should have carefully tested Avandia before putting it on the market. Instead, GSK put profits over people and hid the bad data about Avandia."

For more information about the rights of those who have suffered a heart attack, stroke or congestive heart failure because of Avandia, call attorney Larry Jones at 1-866-587-0002 or contact Larry by email: click here to email Larry.

Avandia, also known as rosiglitazone, was dealt a serious blow Friday when an FDA official revealed that over a dozen individuals taking Avandia and suffering from serious heart problems were not counted in a study that proclaimed Avandia as safe.

The FDA reviewer, Dr. Thomas Marciniak, stated that the study, which has been relied on by Avandia’s maker GlaxoSmithKline, possessed serious flaws, the New York Times reports.

According to numerous reports and studies, taking Avandia might cause strokes and heart problems. The severity of its side effects has led the FDA to consider pulling the drug from shelves even though the drug already contains warnings about its dangers. We have previously reported on flaws in GlaxoSmithKline’s trials as well as the financial ties of their supporters.

Dangerous drugs, such as Avandia, can be responsible for injuries and even death. When an unreasonably dangerous or defective drug injures consumers those injured may have legal claims against the manufacturer and could be compensated for their losses. Lawyers call this area of the law products liability.

Consulting an experienced products liability attorney is usually easy and can help you determine if you have a case.

This consumer protection information is provided by Louisville, Kentucky attorney Will Nefzger, a partner at Bahe Cook Cantley & Jones PLC. Please feel free to contact me directly for if you have any questions or would like more information. Just click here, and it will take you to a page containing biographical and contact information and here to e-mail Will directly. As always, we will keep you updated as developments with Avandia and other potentially dangerous drugs or products occur.

The cancer drug known as Avastin can also cause significant kidney damage, the Los Angeles Times reports. According to a recent study, ten percent of patients using the drug to treat kidney cancer experienced organ damage and are therefore considered at highest risk.

In addition to kidney cancer, Avastin is also used to treat lung cancer, breast cancer, and eye conditions such as macular degeneration and diabetic retinopathy.This is the second time a major side effect has been discovered by Dr. Shenghong Wu and his team of researchers at the Stony Brook University Medical Center. Last year they found out that some patients on Avastin face an elevated risk of intestinal perforations.

As with other potentially dangerous drugs, patients should not stop using Avastin without consulting their doctors. Avastin was approved by the FDA in 2004 and is one of many drugs with previously unknown side-effects discovered shortly after their approval. If you or someone you know has been injured by potentially dangerous drugs, such as Avastin, you might be entitled to compensation for your injuries and should consider contacting a products liability attorney. The attorneys of Bahe Cook Cantley & Jones represent individuals injured by dangerous drugs and defective products. To consult with Shawn Cantley about these issues: Shawn's Mail

Bolstered in their pursuits by the results of a second study, the scientists that first raised the alarm about Avandia's dangers are calling for it to be pulled from the market. They might get their wish as outside advisers to the FDA will consider the issue in mid-july.

The second study found that one out of every 52 patients taking Avandia was harmed by the drug. Those results may provide the impetus the FDA needs to take action, according to the new study by the Cleveland Clinic.

Avandia underwent a similar analysis in 2007 but was kept on the market. The recent findings coupled with the old evidence could lead to a different result this time, according to a pair of articles recently published in Business Week.

Avandia has been linked to heart attacks and other cardiovascular complications. According to an FDA safety reviewer, almost 50,000 elderly Americans have died, suffered strokes, or developed heart failure after taking Avandia instead of a rival medicine.

Avandia lawsuits coupled with it being pulled from the market could cost GlaxoSmithKline dearly. Avandia generated more than $1.1 billion in revenue last year alone and the company has already agreed to pay out $60 million in an earlier round of lawsuits.

Those injured by Avandia should consider discussing their case with a pharmaceutical attorney. The attorneys at Bahe Cook Cantley & Jones are actively litigating many cases involving dangerous drugs. To consult with attorney Shawn Cantley about Avandia: [profile, Shawn's Mail]

For the full text of the Business Week articles: here and here.