California Injury Attorney Blog

As California trial and injury lawyers, we have litigated cases involving dangerous supplements and medications that have caused injury and even death. We have represented victims and families whose lives have been changed by dangerous products that have ultimately been recalled by the FDA.

In our view, public access to medical and health information can be a good thing. But is also a mixed blessing when consumers have access without sufficient information or clinical testing.

We cannot foresee the future of the use of mobile media devices and medical information, but the Food and Drug Administration has just published draft guidelines that might give us all an indication as to where things are headed.

It is not surprising that mobile applications are becoming more widespread in the medical and health fields. It is also not surprising that the U.S. Food and Drug Administration is now seeking public comment on its intention to oversee some limited medical and health mobile applications using their regulatory authority. The FDA's focus is narrow, but the development of guidelines in this area is another sign of the booming apps market and the regulation of medical and health information which has become more and more accessible to the public.

Quoting an outside source, the FDA notes the 500 million smart phone and other mobile device users will use a healthcare app in the next five years. Whether you use an app for fitness, calorie intake, diet guidance or other purposes -- these uses are on the rise.

Even physicians are now communicating with patients through email and can review test results, such as MRI's over mobile communications devices.

The director of the FDA's Center for Devices and Radiological Health (who is a physician and a lawyer) has noted: " 'The use of mobile medical apps on smart phones and tablets is revolutionizing health care delivery ... [o]ur draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don't work as intended.' "

The FDA has issued a draft of the guidelines they propose which is very focused in scope to "a small subset of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices." This subset includes mobile medical apps that: are added to existing medical applications, such as those involved with diagnostic tools and medical professionals' communications; or those that actually enable the mobile device to become a medical or diagnostic tool, such as the use of a mobile device to detect heart rhythms.

To review the agency's in-depth draft guidance document, intended for software manufacturers, distributors and others regarding the FDA's intentions to apply its authority in this area please click here. The current view of the FDA is to apply its authority and regulatory requirements only to a subset of mobile medical applications noted earlier. However, as usage grows and consumers are drawn to these applications, it is possible the regulatory scope will broaden.

The California injury lawyers of Hersh & Hersh represent consumers in a wide-range of health and medical injuries, including medical devices and dangerous drugs. We are currently representing clients injured by transvaginal surgical mesh, DePuy Hip implants and Zimmer NextGen Knee Replacements. Please contact our law office for a free consultation with one of our trial lawyers.

The Sacramento Bee reported recently that an effort is underway in California to pass a consumer-related bill that would protect consumers from renting or buying a car from a rental car company that is subject to a federal safety recall.

California Assembly Bill 753 is supported by the mother of a young woman and her sister who were both killed in a tragic crash in Monterey County in 2005.

Carol Houck's daughters were killed in a head-on collision on Highway 101 when they were driving a rented Chrysler PT Cruiser that had been subject to a safety recall. Ms. Houck has been dedicated to getting legislation passed to protect drivers from what happened to her children.

The bill's author is Democratic Assemblyman Bill Monning of Carmel who is pushing for the legislation to ensure that all rental car companies are required to protect consumers from recalled cars that have not been repaired. Some companies have voluntarily decided to do this, but that is not enough according to Monning and Ms. Houck who is also involved with Consumers for Auto Reliability and Safety (CARS), which is pushing for the bill's passage.

The deceased sisters' family was awarded $15 million in a wrongful death case filed against the rental car company and its holding company that rented them the recalled vehicle. The vehicle in which the young women were killed, had been rented repeatedly, despite the federal recall for a potentially dangerous leak in the steering wheel hosing which was never repaired. The rental car company eventually admitted negligence.

Some rental car companies have changed their policies regarding recalled cars, but others say the legislation should be narrowed to include only recalled cars for major safety issues.

What is the National Highway Safety Commission's position on this issue? "All safety recalls resulting from defects present an unreasonable risk to safety." The California Injury Attorney Blog agrees.

The San Francisco law firm of Hersh & Hersh has a long history of improving the health and safety of the consuming public. We support legislative efforts that protect consumers and we have a long and stellar history of creating those protections for victims of injury.

If you have any questions about our representation of victims and their families in personal injury and auto accident cases, contact our California office to speak directly with one of our attorneys.

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 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.

Reuters is reporting that an email from an FDA reviewer and known whistleblower appears to confirm findings that the diabetes drug Avandia carries a risk of serious cardiovascular problems. The findings have not yet been published, but as the California Injury Attorney Blog noted recently, the FDA is about to host its public meeting scheduled in July to report on the safety risks associated with Avandia.

The latest study apparently shows increased risks in the following percentages: risk of stroke 27%; risk of heart attack 25%; and, risk of death 17%. The research was based on data from about 230,000 patients, mainly over 65 years of age.

These findings, as well as the FDA's review of another major study, will be presented at the July advisory panel meeting. Avandia sales have dropped since a 2007 Cleveland Clinic study. It is widely thought the drug may be taken off the market after the July meeting.

The California trial lawyers at Hersh & Hersh represent patients harmed by Avandia across the nation. Please contact us for a free consultation with one of our experienced lawyers.

The story of Fen-Phen is long and arduous. The drug Fen-Phen caused serious injury and death and although it has been off the market for over ten years now, many patients were not diagnosed with the serious medical conditions that it caused until after they had stopped taking the diet pill.

The lawyers of Hersh & Hersh, who bring you the California Injury Lawyer Blog, were the first firm to take action against the drug manufacturer who made Fen-Phen. The firm was the first to file and settle a lawsuit making the connection between Fen-Phen diet pills and the progressive and potentially fatal disease, primary pulmonary hypertension (PPH).

The impact of the drug was of historic proportions, but not in a good way. Many people were harmed as these pills caused such serious injury in some cases the only way to survive was lung transplantation. The symptoms for many Fen-Phen users did not appear immediately. And when they did, they were serious or fatal.

Sadly, this is not the end for the impact that diet drugs and supplements can have on the unsuspecting public. The long term adverse health effects of taking some of these quick-fix drugs and supplements can be very dangerous indeed.

Diet drugs, supplements and other substances are sold to the public by the millions. We want our readers to be aware that there can be not only adverse medical consequences for taking diet drugs and herbal substances, but it is possible for these substances to interfere with other prescription medications a person is taking at the same time.

It is important to be knowledgeable about what you are taking and in what combinations. There are many resources available for this information. For example, the Mayo Clinic website has an entire section devoted to the importance of knowing what you are taking and how it will interact with your other medications.

The story of Fen-Phen is tragic. Arm yourself with information before taking herbal or other supplements that claim to be helpful or good for you.

Continue reading "Lessons Learned? Fen-Phen and Beyond." »

Since 1999, GlaxoSmithKline has been selling the drug Avandia for Type 2 diabetes. The medication Avandia has a single ingredient - rosiglitazone -- which has been linked to literally hundreds of heart attacks and heart failures. Other medications Avandamet and Avandaryl contain this ingredient. These medications still await their shelf life fate.

The risk of heart problems with this medication are well established and are the subject an FDA black boxed warning and FDA safety alerts issued in 2007 and 2010. In addition, in December 2008 the FDA issued Guidance for Industry recommending that manufacturers study heart safety in formulating diabetes treatments.

The 2007 black box warning clearly indicates that patients with symptomatic heart failure should not take the medication. It also states that the medication causes or exacerbates congestive heart failure in some patients. Finally, it notes that the data on the risk of myocardial ischemia are not conclusive and are under review.

The data still under review by the FDA includes a clinical study called "Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes" or RECORD, which was designed to evaluate the cardiovascular safety of rosiglitazone.

The FDA's completed review of this study is expected in July 2010. Once the FDA completes its review of the data from the RECORD study, the agency will present the cardiovascular safety data on rosiglitazone at a joint meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. At this time, the Advisory Committee will provide updates on "the risks and benefits of rosiglitazone in the treatment of type 2 diabetes."

In the earlier warnings, the FDA noted the following recommendations to patients taking Avandia and medications with rosiglitazone, including: don't stop taking the medication without healthcare professional advice; talk with your healthcare professional about concerns regarding this medication; read the risks included in the medication guide, and report side effects to the FDA's MedWatch.

Earlier this year, The New York Times published an extensive piece on Avandia and rosiglitazone. The article noted the opinions of several scientists who have urged the removal of Avandia from the market and as well as the ongoing "fierce debate" at FDA over whether to allow it to continue to be sold.

If you or a loved one has taken Avandia or a medication containing rosiglitazone and have had suffered heart attack or other cardiovascular problems, contact Hersh & Hersh for a free consultation on your legal rights.

Related Web Resources

Visit the Food and Drug Administration's site for more information on how drugs are approved for use.

Continue reading "Heart Attack and Related Risks Continue with Avandia Use" »