California Injury Attorney Blog

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." »

Last week a jury awarded a couple in Georgia $317 thousand against Yamaha for injuries sustained by the husband while using his Yamaha off-road Rhino-model recreational-utility vehicle. Other cases are pending against Yamaha for product liability for alleged defects in the off-road vehicle.

More cases are expected to follow given that this case was not an extreme injury. As reported by law.com, plaintiffs' counsel expects to see many other cases already filed in Georgia to go-ahead based on this verdict.

In this case, the injuries were not extreme, but the jury still found liability against Yamaha. The injured plaintiff was turning when the vehicle tipped over and trapped his leg which was crushed under its weight.

Plaintiffs' argued that the Rhino should have had a barrier to protect the rider's legs. The company placed doors on the Rhino after this accident occurred. According to the plaintiffs' lawyers, the jury, which took ten hours in deliberations after a two-week trial, was swayed by Yamaha's failure to test the Rhino for possible issues with occupant containment.

Yamaha is maintaining a "Truth About Rhino" website which states the company "is disappointed by the jury's decision to find for the plaintiff in this case and will pursue all appropriate legal remedies, including possible appeal."

Continue reading "Yamaha Takes $317 Thousand Hit in Georgia Off-Road Vehicle Case " »

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" »

Recently, the California Injury Attorney blog posted our readers on the dangers of the use of gadolinium as an MRI contrast agent with particular at-risk patients.

Who is at risk?
Patients with severe kidney disease or generally severe renal insufficiency, need to be very well-informed about gadolinium dangers if they are about to have an MRI or related study with a contrast agent.

Gadolinium use in these patients can lead to a condition called nephrogenic systemic fibrosis (NSF) or another condition nephrogenic fibrosing dermopathy (NFD). If such a patient has had an MRI with contrast and begins to have NSF or NFD symptoms, it is important to see a medical professional. The following are some things to be aware of with regard to MRI with contrast agents.

Talk with your doctor.
For patients with severe renal insufficiency, it is very important to talk with a medical professional about whether use of a contrast agent is necessary. If it is necessary, it is then critical that the amount of gadolinium used is carefully managed and that any prior use of contrast agents be taken into account. In other words, it is very important that there is some passage of time before this agent is used again before it has been eliminated from the patient's body.

Some doctors might suggest that hemodialysis patients have that procedure after a contrast MRI to help remove the gadolinium from these compromised patient's bodies.
There is no data on whether this "elimination" process can help reduce the risk of developing NSF or NFD.

Symptoms to watch for after an MRI.
After an MRI with a contrast agent make sure to watch for any issues involving changes in skin, such as hardening, thickening or tightening; color changes on the skin, such as reddening or dark patches; burning or itching of the skin; joint pain or tightness; pain in hips or ribs. Other symptoms include yellow spots on the whites of the eyes and deep pain in hips or ribs.

Continue reading "Symptom Watch After MRI with Contrast Agents" »

Many Americans have had an MRI. But many Americans may not realize the dangers involved for some patients in the use of contrast agents with MRI. Contrast agents help healthcare professional see internal structures more clearly on an MRI. There are some basics that are important to know.

Nearly three years ago, the United States Food and Drug Administration (FDA) issued a request for a black box warning for the labeling of gadolinium-based contrast agents used for the enhancement of MRI imaging. The warning was targeted to patients with severe kidney insufficiencies and those involved in liver transplantation (both before and after surgery) or with chronic liver disease.

The FDA's warning request was intended to generate warnings in the use of these contrast agents in patients with these severe kidney insufficiencies and other issues. Patients with severe kidney insufficiency that receive gadolinium-based agents are at risk for developing serious health issues including, nephrogenic systemic fibrosis (NSF) or another condition nephrogenic fibrosing dermopathy (NFD), from the use of gadolinium.

This 2007 warning request came after a June 2006 warning to health care professionals regarding some of these risks. These conditions are very serious indeed. The symptoms include serious problems with organs, skin and connective tissue that may not only result in broken bones, but seriously impact patient movement. Patients began to notice problems early on or some time after an MRI using these contrasting agents. Unfortunately, NSF or NFD can develop in patients that have been exposed to the contrast agent once, or multiple times.

At the time of the boxed warning request, the FDA said it had been "carefully monitoring potential safety signals related to these contrast agents after receiving reports about the risk of this potentially life-threatening disease." Years later, patients are still suffering from the debilitating impact of these serious conditions when MRI contrast agents have been used on them and they were at risk for these conditions.

There are five gadolinium-based contrast agents used in the United States and these include: Magnevist (gadopentetate dimeglumine), Ominiscan (gadodiamide); OptiMARK (gadoversetamide); MultiHance;(gadobenate dimeglumine);and Prohance (gadoteridol).

If you would like to read more about the FDA's black box warning request and about gadolinium, click here.

Continue reading "Know the Dangers of Gadolinium Contrast Agents" »

Recently, the makers of Tylenol® (McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc.) consulted with the Food and Drug Administration to voluntarily recall many over-the-counter children's and infants liquid products. The specific bottles involved in the recall and their lot numbers are listed on the Tylenol website and include products that were made between April and June 2008.

These products have unexpired use dates and could still be inadvertently given to infants and children. All products involved in the recall were manufactured in the United States, but were distributed to several other countries.

The reason for the voluntary recall? In the company's words, "some of these products may not meet required quality standards." Although there have been no medical issues with the use of these products, the company is taking what they deemed a precautionary measure because, "some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles."

This explanation, although somewhat vague is actually a good step. The company advises that the potential for serious medical problems is "remote" they do not want these products used.

They also noted that prior to new manufacturing at the plant where these products were made, they have taken a look across their manufacturing operations to ensure quality.

The California Injury Attorney Blog has posted on recent recalls of products that could otherwise harm or injure children and adults.

Related Web Resources

For specific recall information, please visit the Tylenol website.

Continue reading "Voluntary Recall of Infants' and Children's Tylenol®" »

The New York Times reports that AstraZeneca has agreed to settle a federal investigation of its marketing practices for the drug, Seroquel.

The settlement requires the company to pay $520 million and was announced on Tuesday by Attorney General Eric Holder. AstraZeneca denies the allegations, but agreed to the payment to avoid what would be protracted litigation with the government.

The drug was originally developed to treat schizophrenia. However, the pharmaceutical company allegedly paid doctors to market drugs for unapproved uses including uses by kids, the elderly, veterans and others. With federal investigations and whistleblower suits lingering, the company's sales and marketing was front and center in this matter. This is the latest settlement in a line of federal investigations into the illegal marketing of antipsychotic drugs.

The claims center around the contention that the company misled doctors and their patients by failing to disclose studies that showed this drug increases diabetes risk. They also are alleged to have emphasized favorable research while also failing to disclose risks.

The uses for kids and others were not approved by the Food and Drug Administration and caused various side effects. Kids gained weight and other patients died as a result of the off-label uses.

The California Injury Attorney Blog has reported previously on the off-label marketing case against Pfizer and its settlement. Similar cases have been settled with Eli Lilly for Zyprexa and other pharmaceuticals.

Related Web Resources

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

Continue reading "$520 Million Pay Out for Off-Label Marketing " »

Last week, Toyota got more bad news and more bad press about the safety of its cars. Its the kind of bad press no car manufacturer would want, especially one that has been a headline news story for months.

What happened this time? Consumer Reports tested the Lexus GX 460. They reported that its tests revealed a dangerous problem in handling the car. This in turn led to a Don't Buy recommendation by the popular consumer hot spot.

What went wrong with this car? In the Consumer Reports testing, when pushed to its limit, the rear of the car swerved making rollover a major risk. The electronic stability system did not engage until after the rear of the car had already slid out nearly sideways. The driver was not able to regain control of the auto until it was close to a roll-over.

A bit of good news for Toyota: the other Toyota SUV's tested by Consumer Reports did not have this problem.

Under the safety and governmental microscope, Toyota took fast note and its engineers replicated the slide. Toyota agrees -- there is a safety issue with the vehicle. In an unprecedented move, sales of the Lexus GX 460 were halted.

Toyota also has a big decision to make about fines. They must inform the National Highway Traffic Safety Administration this week about whether the company will pay the proposed fine of $16.4 million for the alleged failure to disclose information regarding the "sticky pedal" issue that has been haunting the company for months now. Failure to pay this fine could result in court action against Toyota.

Related Web Resources

For more information on the Toyota recall visit the company's recall site. To read more about the halt of sales for the Lexus GX 460 visit the New York Times and Huffington Post.

Continue reading "Auto Safety Woes Continue for Toyota" »

The California Injury Attorney Blog wants parents to know when products are recalled. Yesterday, Graco Children's Products Inc., recalled 1.2 million Harmony high chairs manufactured between November 2003 through December 2009.

The Consumer Product Safety Commission advises that screws can become loose on these high chairs, which can cause the chair to tip over. The company has received nearly 500 reports of this problem and about 25 of those resulting in injury.

The recall applies to chairs sold at many big box stores. Repair kits can be obtained by contacting the company directly at www.gracobaby.com or by calling an 800 number provided on the website.

This recall underscores the need for parents to be very careful about their purchases and particularly items purchased at garage or yard sales or handed-down from friends and relatives.

For more information on the specific models involved in this recall, please go to the Graco site.

Continue reading "High Chair Recall Alert" »

As Toyota continues to run its recall program on several car models, it is also trying to piece together the San Diego incident of early last week -- also known as "the runaway Prius." But was it?

Neither the federal government, nor Toyota inspectors, have been able to determine what actually happened to the car that sped up to 94 miles per hour on a San Diego, California freeway before being stopped by a fast-thinking California Highway Patrol officer.

In repeated tests this past week on the Prius that apparently malfunctioned, federal safety personnel and Toyota's experts found the car performed as it should and could not replicate the problem that its owner had on the road last week. "We would caution people that our work continues and that we may never know exactly what happened with this car," NHTSA said in a statement.

Toyota Motor Sales (TMS), U.S.A., Inc. offered findings today on its own testing of the event. While a final report is not yet complete, Toyota says "there are strong indications that the driver's account of the event is inconsistent with the findings of the preliminary analysis."

The initial findings include the following:

• The accelerator pedal was working normally. Prius is not subject to a recall on this component which is made by another manufacturer than those under recall in other models.

• The front brakes did have overheating damage.

• The floor mats were not touching the accelerator pedal.

• The pushbutton power functioned correctly and should have worked as the 911 operator instructed this driver.

• Shifting into neutral was normal.

• The car's computer did not show any trouble codes. There was evidence of a rapid on and off shift between the accelerator and the brake which is not what would happen in an event like this.

Toyota engineers said that the report of this occurrence is puzzling based on the car's engineering. It appears there are two safety systems that would have had to fail at the same time for this Prius to continue out of control. And that may be very unlikely, but possible.

Meanwhile, the federal agency NHTSA continues to check out the claims of approximately 60 Toyota owners who say that their cars had sudden acceleration, even after they were repaired in the recall.

More information on the Toyota recall can be found at www.toyota.com/recall/.

Continue reading "Toyota to Press --Was San Diego Prius Really A Runaway?" »

The Associated Press reports that a bus operated by the Van Nuys, California-based company, Tierra Santa, Inc., rolled over on an interstate in Arizona and has left six people dead and 16 others injured.

Tragically, the bus was not operating legally. The Department of Transportation had not approved the operator to engage in interstate transportation of passengers using a commercial motor vehicle. It did so anyway.

The Federal Motor Carrier Safety Administration had denied the company's application to become a passenger carrier in December 2009. The bus crossed the border from Mexico into the United States at El Paso.

Why did this accident happen? We do not know that yet, but the investigation will determine the maintenance status of the bus as well as the driver's attentiveness at the time of the accident.

The accident occurred when the bus hit a pick-up truck, went off the shoulder, tried to move back onto the roadway and began rolling due to the overcorrection. This crushed the bus and several passengers were thrown from it. A second accident took place when another pickup tried to slow down as the bus was in trouble and a car hit that pickup.

The AP notes that federal investigators are already reviewing Tierra Santa's safety operations and confirms that it company never had federal operating authority.
Unfortunately, this could have been avoided had the operator followed the law.

On inspection last August, one bus was determined to be operating illegally and the federal government stopped its trip at that time. That vehicle had many safety issues. The officials are not sure whether that bus is the same vehicle involved in this recent accident.

Related Web Resources

Before you book a trip on a public carrier, such as a bus company, make sure that the company is licensed to carry passengers. Ask for their licensing information if you are uncertain. For more information, visit http://www.fmcsa.dot.gov.

Continue reading "Tragic Bus Accident Kills Six, Injures 16" »

The California Injury Attorney Blog wants you to be safe this spring as you get out on the road on your bike.

The California Department of Motor Vehicles (DMV) notes that every year thousands of people are injured and over 100 killed in bicycle accidents. These accidents can be caused by either the bicyclist's actions or the driver's actions.

As we approach the spring and summer months, here are some important reminders for both bicyclists and motorists. First and foremost, when riding a bike on a public road it is important to remember that the rules of the road apply to you as well as the drivers with whom you are sharing the road. The California Driver Handbook includes the rules and regulations you need to know.

Drivers beware. Before you turn right, merge into bicycle lanes or open doors next to traffic, remember to watch for bikes and respect their right of way.

Bicyclists be informed. Bicyclists should know the basic rules to keep safe which include maintaining control, reducing risk of head injury by always wearing a helmet, staying alert and visible, communicating your intentions and riding with motorists.

Bicycle control. There are several things to remember in controlling your bicycle. Make sure your bike "fits" you and is properly adjusted for your body. Why is this important? It is much easier to control a bike that is properly fit to your body. And when you are properly fit to your bike, you will be less tired while riding and feel more comfortable. Make sure to inspect your bike regularly so that it is working correctly as you ride and need to brake.

Do not drive a bike while under the influence. The California Vehicle Code (VC §21200.5) makes it unlawful to ride a bike while under the influence of drugs or alcohol. If you are under the age of 21, and over the age of 13 a conviction under this law will result in the suspension or the delay of your right to drive a car for one year.

Avoid serious injury -- wear your helmet Sometimes it is easy to forget that even a simple fall can cause a very serious injury. Protect your head and your fragile brain by wearing a helmet. Vehicle Code §21212 requires that bicycle riders under 18 years of age wear a bicycle helmet while riding on a public road. All bike riders should wear a helmet, regardless of age to avoid injury that could last a lifetime.

Enjoy your ride. Next post, we will share some additional things to remember as you get out on the road on your bicycle.

Related Web Resources

For more information on bike safety visit kidshealth.org where you can find all sorts of great information on keeping healthy and safe.

Continue reading "Spring to Safety (part 1) - Avoiding Bike Accidents & Injury " »