California Injury Attorney Blog

Earlier this month Pottery Barn Kids issued a voluntary recall for repair of its drop-side cribs. There are about 82,000 of these in the marketplace.

The hazard involves entrapment, which can lead to suffocation and the possibility of a fall. The cribs' drop-sides can detach when hardware breaks. Pottery Barn Kids wants consumers to stop using these cribs and to contact the company to receive a free kit intended to correct the problem.

The Pottery Barn Kids crib recall underscores the larger issues with crib safety, which are currently being addressed by the United States Consumer Product Safety Commission (CPSC). The CPSC has recently proposed new testing rules for full-size and smaller cribs. The purpose of the new standards is to deal with the serious and sometimes tragic consequences of defective and poorly designed infant cribs.

The California Injury Attorney Blog has posted on the dangers of defective cribs and bassinettes. Moreover, Hersh & Hersh has been involved with some of the most important crib and bassinette recalls in United States history. We have represented families that have suffered tragic losses due to these defective products.

Over the past several years, we have seen defects that include dangers due to defective design and hardware, detachment of side rails and other defects that have resulted in entrapment and suffocation deaths or falls.

The mandated improvements are based on The Consumer Product Safety Improvement Act of 2008 (CPSIA). This Act required mandatory safety standards for infant and toddler products.

The recent rules are the subject of a notice of proposed rulemaking. The specific details of the proposed modifications can be found here. Briefly, summarized, the essential modifications require specific crib testing such as mattress support, side impact and stress tests in which screws would not be tightened to replicate long term use.
According to the CPSC, its staff expects to finalize the proposed mandatory crib standards in 2010.

Web Resources

The public can report a dangerous product or a product-related injury to the CPSC Hotline at (800) 638-2772. Visit CPSC's web site at www.cpsc.gov.

Important Contact Information

If you believe your child has been injured by a defective product, please contact the California personal injury and trial lawyers at Hersh & Hersh. We will provide a free consultation for you.

The California Injury Attorney Blog has kept our readers posted on the heart-related dangers associated with the diabetes drug, Avandia. Last week, after months of anticipation, the FDA advisory panel convened to provide its conclusions on the RECORD study, funded by the drug's manufacturer GlaxoSmithKline. The panel's recommendations move on to the FDA.

The public has needed clarity on this for some time now, but they did not get it from the advisory panel's recommendation to the FDA. Although the Advisory Panel did not pull the drug from the market, the debate was heated and the vote interesting as 17 members voted to keep the drug on the market but want new restrictions, three said nothing needs to be added to the warnings, and 12 sought a recall of the drug from the market.

Avandia's competing drug Actos does not appear to have the same level of cardiovascular risk associated with it. At least that is what the scientific community is saying at the moment.

The New York Times has reported that the drug's manufacturer has spent a great deal of effort over the past decade pushing back the safety issues with regard to Avandia. One recent editorial in the courier-journal.com, calls this "intolerable' and also calls for the FDA to "represent and demand transparency."

So after three years of consistent erosion to the safety data on this drug, doctors can still prescribe it and diabetes patients can still use it. And, some of those patients will suffer injury because they are taking the drug.

The panel's call for additional label warnings is not much help to the public in deciding how to deal with diabetes treatment. Cleveland Clinic's Chief Cardiologist says the additional warnings will eliminate "95%" of the drug's use, but in the end it is up to the FDA to decide whether to adopt the panel's recommendation and until then, the medical community and diabetes patients and their families must carefully weigh the documented risks in taking this medication.

For more information on Avandia and its risks, please visit hershlaw.com. If you are a diabetes patient and have suffered a cardiac event while taking Avandia, please contact Hersh & Hersh to speak directly with a lawyer about your situation. We will provide a free evaluation of your rights to recover for your injuries.

This week, the Food and Drug Administration (FDA) gathers its panel of outside medical experts to determine the fate of Avandia, a diabetes drug. The California Injury Attorney Blog has posted previously on the Avandia controversy and more information is available here.

The Wall Street Journal has an interesting angle on Avandia's moment of truth. They write that a big part of Avandia's fate can be viewed "[a]gainst a backdrop of legal maneuvering and internal struggles" within the FDA.

The question of Avandia's safety and the studies that have shown it to increase heart-attack, and other cardiac events, would seem to be the main event this week. But the WSJ says this is a "battle that could redefine" FDA's response to drug safety after approval and sale to the public.

The criticism of Avandia continues into this new phase of review. The diabetes drug was one of GlaxoSmithKline's big sellers until serious medical issues with its use began to arise. Another drug called Actos, which is made by Takeda Pharmaceutical Co., is also part of the review going on at FDA this week although the issues with Actos do not appear to be the same as with Avandia.

The larger issues center around how FDA handles Avandia in light of the safety issues it has presented. It has yet to be withdrawn from the market, despite evidence that it is harmful to some users. One study linked it a 43% increase in risk of heart attack. The recent study, called RECORD, funded by Glaxo and has been viewed critically and apparently came up with a different outlook on the heart attack risk.

At least one FDA doctor has said that the recent study was not well designed and has led to inaccurate results. As the Boston Globe reports, the issues regarding the safety of Avandia linger as the advisory panel convenes to consider what to do about this drug. Some in the FDA are calling the recent clinical trials, flawed.

We will keep you posted on the FDA's review.

Continue reading "FDA Convenes Avandia Panel " »

The California Injury Attorney Blog has posted previously on boxed warnings issued by the United States Food and Drug Administration (FDA) for such drugs as Avandia. It is very important to learn about any warnings related to medications you are taking. These warnings are very important for both the public and healthcare professionals. This time we share important information about the drug Plavix.

Earlier this year, the FDA added a boxed warning to Plavix, which is used as an anti-blood clotting medication. Plavix has been the second-best selling drug in the world.
The drug is intended to reduce various risks, including heart attack, stroke and death in patients with heart disease. The drug is supposed to make platelets less likely to form blood clots.

In order for the drug to work, it has to be converted by the liver to its active form through the liver enzyme, CYP2C19. When this does not happen, the drug is not effective and researchers have been documenting the problem for some time.

In fact, the original warning label for this problem has been included since 2009. The additional warning added in March 2010, is intended to warn patients and healthcare professionals that for patients deemed "poor metabolizers," the drug is not effective and those patients "may not receive the full benefits of the drug."

The FDA's boxed label warning includes information about the fact that the drug is not as effective in patients considered poor metabolizers. It also notes genetic testing that can be done to identify whether a patient has the requisite CYP2C19 function. And suggests alternative medications for those patients that fall into these categories.

Although patients have been advised not to stop taking Plavix unless they are told to do so by a healthcare provider, there are more proactive things that patients can do. Patients should ask about the possibility of taking a genetic test that will identify whether the drug will be effective.

Related Web Resources

For more information on the issues with Plavix, visit the Reuters update for the black boxed warning.

Hersh & Hersh

If you have questions or concerns about the use of Plavix, or if you have been taking the medication and have suffered a cardiac event while taking it, we are here to help. Contact the lawyers at San Francisco, California's Hersh & Hersh for a free consultation and for more information. We represent clients across the nation.