February 2011 Archives

Mislabeled Warfarin Tabs Could Lead to Hemorrhage

February 28, 2011, by JONES WARD PLC

The FDA has announced that certain Warfarin Sodium Tablets (Jantoven), 3mg, are being recalled because of dangerous mislabeling.

The manufacturer, Upsher-Smith Laboratories,has recalled one lot of Jantoven Warfarin Sodium, USP, 3mg Tablets. The recalled lot is numbered as #284081, with an expiration date of September 2012.

If you have questions about how to identify the recalled tablets, there is a way to tell the difference between the 3mg and 10 mg tablets. Feel free to shoot us an email if you want to know how. Or better yet, here are some photos:

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The product lot was distributed to wholesalers, retail chains and independent pharmacies throughout the United States. The primary risk of substituting 10mg warfarin for 3mg warfarin is overdosing more than 3 times the labeled amount which leads to excessive anticoagulation that could be expected to result in life-threatening hemorrhage in patients.

Toyota Recalls Millions More Vehicles

February 24, 2011, by Jasper Ward

More than a year after first admitting that its cars could be unsafe due to unintended acceleration, Toyota expanded the list of recalled models to include cars that go back as far as 2003. The recall, affecting floor mats, now includes 2.1 million more Lexus and Toyota vehicles. The mats can get stuck against gas pedals, which causes pedal entrapment and can cause the vehicle to speed up and the driver to lose control.

The recall comes after a year long federal investigation and comes at the request of federal regulators.

Toyota said the new models they are admitting are affected by the defect are:

Lexus GS: 2006 and early 2007
Lexus RX: 2004 through 2006 and early 2007
Toyota Highlander: 2004 through 2006
Toyota 4Runner: 2003 to 2009
Lexus LX: 2009 to 2011
Toyota RAV4: 2006 through 2010

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Medtronic Pain Pumps Recalled By FDA

February 22, 2011, by Jasper Ward

Medtronic's infusion pumps are implanted into the abdomen to gradually deliver drugs or fluids to patients. During the refill process, the inadvertent injection of all or some of the prescribed drug directly into the patient instead of the pump has resulted in drug overdose and death. On January 14, 2011, Medtronic sent a letter to physicians reminding them of the proper refill procedures. Medtronic has also taken steps to update the warning labels and instructions.

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Despite these actions, on February 16, 2011, the U.S. Food and Drug Administration (FDA) issued a Class I recall on Medtronic's infusion pumps. Class I recalls are the most serious issued by the FDA. In order to classify as a Class I recall, there must be a reasonable probability that the use of the product will cause serious harm or death.

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500,000 Burlington Bassinets Recalled Due to Fall Hazard

February 18, 2011, by Jasper Ward

According to a new study released by the journal Pediatrics, an average of 26 children suffer crib-related injuries every day. Since 2007 the U.S. Consumer Product Safety Commission has recalled roughly 11 million cribs, playpens and bassinets. Yesterday the Commission added 500,000 bassinets manufactured by Burlington Basket Company to the list. The voluntary recall affects models having folding legs secured by white plastic pins. If these pins are not properly in place the bassinets can collapse causing injuries to infants.

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Topamax During Pregnancy May Cause Cleft Lip or Cleft Palate

February 15, 2011, by JONES WARD PLC

The federal Food and Drug Administration issued an alert last week notifying consumers and medical professional of an increased risk of development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with Topamax (topiramate) during pregnancy.

The active ingredient in Topamax (Topiramate) is an anticonvulsant medication used to treat patients with epilepsy. It is also used to prevent migraine headaches.

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According to the FDA, if you are taking topiramate and you are planning to get pregnant, you should notify your doctor immediately.

Authorities Recall 4,600 Oasis Playsets

February 8, 2011, by Jasper Ward

On February 8, 2011, the U.S. Consumer Product Safety Commission and Escalade Sports issued a recall on approximately 4,600 Oasis playsets. According to the Commission, the green plastic swing seats on these playsets can crack and break in half, causing children to fall to the ground. These falls can lead to serious injuries especially if the child is young. The Commission asks consumers to stop using the playsets immediately and contact Escalade Sports for additional information.

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GE CT Scan Overexposure To Brain Radiation Alleged In New Lawsuit

February 7, 2011, by Jasper Ward

Plaintiffs in California have brought what appears to be the first of many likely lawsuits against GE and hospitals for injuries resulting from overexposure - as much as eight (8) times the recommended dosages - to radiation during CT brain perfusion scans. The overexposure can reportedly cause hair loss, cataract problems and potentially increase the risk of cancer.

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According to the hospital sued in the California case, the settings on the machine and the way it is manufactured mean there's a very good chance similar injuries or overexposure incidents have occurred in radiology departments across the U.S.

The FDA is recommending steps to fix the problems, including making sure the default settings matched the recommended settings from the manufacturer, making sure the dose information was easily viewable by the machine's operator, changing settings to make sure the dosage information was correct before proceeding and protecting the settings so that only the manufacturer could change them.

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FDA Notifies Patients, Healthcare Professionals About Avandia Label Changes

February 4, 2011, by Jasper Ward

The Food and Drug Administration today notified patients, doctors, hospitals and other healthcare professionals that more detailed information about the cardiovascular risks (including strokes and heart attacks) of the drug Avandia (rosiglitazone) has been added to the physician labeling and patient Medication Guide.

The FDA first released this information September 23, 2010, when they announced new restrictions on the prescription and use of the drug Avandia.

The drug label has been revised to include warnings that Avandia should only be given to people who are already treating with the medicine or whose blood sugar levels cannot be controlled with other anti-diabetes medicines.

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Will Zimmer NexGen CR-Flex Be Next Recalled Product?

February 2, 2011, by Jasper Ward

Physicians and researchers across the country have begun seriously examining the Zimmer NexGen CR-Flex Knee system and its high failure rates, raising questions about whether it will be the next product recalled.

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In 2010, the DePuy ASR was recalled due to a design defect that caused extremely high failure rates in patients and required multiple hip replacements.

Last March, surgeons Dr. Richard Berger and Dr. Craig Della Valle from Rush University Medical Center in Chicago, presented study results to a conference of the American Academy of Orthopedic Surgeons. Among their findings were that 36% of patients studied within 2 years showed signs of the knee replacement loosening. Unlike most knee implants, the NexGen is made of a porous fiber metal and a cobalt-chromium-molybdenum alloy, but is not attached to the knee with cement. Since being released, more than 150,000 Zimmer NexGen CR-Flex knee implants have been sold.

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Aflibercept and Stroke: Is there a connection?

February 2, 2011, by JONES WARD PLC

I currently represent a family who had a loved one that suffered a stroke while participating in a clinical trial for the cancer drug Aflibercept. My client ultimately died just months later. The drug, which is manufactured by Sanofi-Aventis, is currently in Phase III clinical trials.

Interestingly, it is my understanding that other participants in this study have experienced strokes or stroke like symptoms. And Sanofi-Aventis hasn't denied that their drug caused my client to have a stroke and incur substantial medical bills and miserable suffering during the last months of his life. Instead, their lawyer points out that my client "did have cancer afterall" and that the company shouldn't be liable for any more than his medical bills at most.

It is ridiculous that a company uses someone like my client as a guinea pig for a drug from which they will probably make billions of dollars marketing. Nonetheless, it is exactly this kind of behavior that causes me to want to fight that much harder. Once the litigation begins, I'll find out where the bones are buried. I can promise you that!

If you know anyone who has experienced a stroke during the Aflibercept trials, I'd love to hear from you. When people band together and share information, big companies are forced to acknowledge their wrongful behavior.

And if this drug is released to market, and Sanofi-Aventis doesn't warn about the risk of stroke, let this blog post be a testament to the fact that they possessed this information during the trials.

CBS News Report About ReQuip Causing Compulsive Gambling and Sex Behaviors

February 2, 2011, by JONES WARD PLC

At first blush, people laugh when they hear about stories like the one below. Surely a drug could never cause someone to be a compulsive gambler or sex addict. Surely not.

Well, stop laughing because it is true --and the manufacturers of drugs like Mirapex and ReQuip know it. In fact, the makers of Mirapex have even lost at trial on the issue. This is a serious problem that is causing people to lose hundreds of thousands (and sometimes millions) of dollars gambling. The drugs also cause compulsive sex and compulsive shopping behavior. We represent over a hundred such individuals and we've seen the toll that this has taken on their lives.

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The warnings of these side effects are hidden deep in the product warning sections, where most consumers never look. The companies try to escape liability under a legal doctrine known as the learned intermediary doctrine, which says that your doctor is charged with giving you the warnings if the manufacturer adequately warned the doctor. The problem, however, is that doctors prescribe thousands of drugs every year and don't have time to read the physicians desk reference from cover to cover every year. Therefore, consumers never get warned about serious side effects and the manufacturers escape liability many times.

I'll step off of my soapbox now and share the article with you. Here it is: ReQuip Lawsuit Article

Kentucky Justice Association Advocate Magazine Ad

February 2, 2011, by JONES WARD PLC

Here is our ad that ran in the latest issue of the KJA Advocate. Check it out!

Jones_Ward_Full_Page Ad.pdf

DePuy ASR Hip Implant Recall Fact Sheet

February 1, 2011, by JONES WARD PLC

Jones Ward PLC's recall attorneys are handling DePuy ASR hip implant recall cases for clients across the country.  As part of our investigation and consultation with experts, we have prepared the DePuy ASR Recall Fact Sheet for our fellow attorneys.  Since this document is intended for public consumption, we have decided to sanitize it to a certain extent.  If you are a lawyer representing injured victims, we'll be glad to share whatever information we have.  Feel free to ask if you have any questions.

If you would like me to email this document to you as a pdf, just drop me an email.  I'll be glad to share it.






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Louisville Top Lawyer: Lawrence L. Jones II Selected by Louisville Magazine as One of Louisville's Top Lawyers for 2011

February 1, 2011, by JONES WARD PLC

Jones Ward PLC attorney Larry Jones has been selected by Louisville Magazine as one of "Louisville's Top Lawyers" for 2011. The full list is slated to be published in the March issue of Louisville Magazine.