Articles Posted in Professional Liability and Malpractice

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.

The California Injury Attorney Blog posted recently on the recall of Children’s Tylenol. The fact is, as consumer protection attorneys, we have been at the center of infant safety for many years and our lawyers have represented children and families who have been hurt by defective drugs and devices.

For example, in recent years we were at the center of the largest national crib recall, representing a family whose infant died due to a defective crib. We also represented those injured by defective bassinettes and supported the subsequent national basinette recall.

We have represented and supported grieving families and brought them some closure for tragic events. And now, we post on the final chapter of another tragedy involving infants and their families.

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

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

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

All over the United States, fertility clinics help individuals in their desire to become parents. Some are very successful. Some are not.

But one thing these clinics have in common is they are subject to very little regulation, if any, with regard to the handling of egg fertilization in the laboratory. The result of mishandling is often disastrous. In a case just filed by Hersh & Hersh on behalf of a San Francisco couple, a San Francisco fertility clinic created anguish by doing just that.

The National Law Journal online and law.com’s newswire report on this recently-filed action, as well as a $1 million settlement in another case filed by Hersh & Hersh several years ago.

One of the plaintiffs in the case filed went through a great deal to get her eggs harvested for fertilization. Her husband donated his sperm. The harvesting was successful. The fertilization was thought to have been as well.

Then came the horrors. The couple was told that the lab had mistakenly fertilized some of the wife’s eggs with another man’s sperm. After the couple was told about this, the lab destroyed the embryos without the couple’s consent and in violation of their agreement with the couple. The fact is, there were a limited number of eggs and resulting embryos that were viable at all.

With the high stakes and consequences of such actions, one wonders when fertility clinics will be regulated to ensure they properly handle all aspects of the process of fertilization. Hersh & Hersh hopes this will happen before more families suffer from avoidable errors in the laboratory.

Read more about the Aschero matter at nlj.com and lawyersandsettlements.com.
Continue reading