California Injury Attorney Blog

The California Injury Attorney Blog tracks national drug and product recalls. Most recently, the nation has been under a massive recall of shell eggs. This is a significant food safety issue and we want our readers to take precautions to avoid illness.

The recent recalls became necessary after hundreds of consumers across the country became ill with Salmonella Enteritidis (SE). This illness can be serious and is a common cause of food poisoning.

Millions of shell eggs have now been recalled from store shelves. The FDA also has extensive questions and answers on its website to help consumers avoid becoming ill from these eggs.

The recall involves Wright County Egg and Hillandale Farms, Inc. both of which are the subject of ongoing investigations that include environmental sampling at company facilities. The sampling indicates that these facilities are the source of the contaminated shell eggs. More specifically, the bacteria may have originated at the feed mill for these facilities, which is located several miles away.

There are many brand names involved in this recall because the eggs are packaged and distributed by many companies around the country. About 500 million eggs are now involved in the recall. A list of the brands involved can be viewed here.

The FDA says that it is continuing its investigation of the sources of the contamination. That includes assessments of farm conditions, including environmental sampling. Other important areas are being reviewed such as sanitation, security and the like.
Investigators are also looking at whether these facilities share common practices and sources that could lead to such a large contamination.

This is the largest national Salmonella outbreak since records on such outbreaks started in 1970. The largest prior outbreak was in 1994 and involved ice cream.

The FDA continues to issue inspection reports for some of the companies that have been subject to the recall. If you would like to read these reports, click here and here.

The consumer attorneys at San Francisco's Hersh & Hersh have many years of experience in protecting the public against dangerous and defective products, medical devices and pharmaceuticals. If you have any questions about consumer safety, please contact us for a free consultation with one our lawyers.

The California Injury Attorney Blog wants you to know about the risks and complications associated with surgical mesh. This is used to treat such conditions as Pelvic Organ Prolapse or POP and Stress Urinary Incontinence or SUI.

Surgical mesh is often used to repair these conditions and is placed transvaginally, sometimes with the use of surgical tools that are considered minimally invasive. There are a number of vaginal mesh manufacturers and many of them have reported complications to the Food and Drug Administration (FDA).

The complications associated with this procedure can be very serious. The complications that have been most often reported include: infection, pain, vaginal epithelium erosion, urinary problems, and the return of the very conditions for which the procedure was performed in the first place. Additional complications include perforations that occur during the procedure of the bladder, bowels and blood vessels.

All of the complications associated with the use of transvaginal surgical mesh can bring pain and discomfort to patients, as well as a major reduction in quality of life. Sometimes, the treatment for these problems includes the removal of the mesh. Other treatments include those for infection and other conditions caused by the procedure or subsequent problems arising after the procedure.

If you, or a loved one, has had a surgical mesh procedure and has experienced pain, discomfort or the POP or SUI has not improved, you may need additional treatment.

To learn more about your legal rights with regard to this procedure, please contact the California personal injury law firm of Hersh & Hersh to talk with a lawyer about your situation.

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.

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