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Posts in the ‘Pharmaceutical Litigation’ category

Concerns with Pradaxa Usage Grow, May be Linked to Severe Bleeding

Posted on May 3rd, 2012

Individuals who have taken the blood thinner Pradaxa, may be entitled to compensation if they have suffered severe bleeding, a GI bleed, brain hemorrhage, peripheral artery clot, ischemic stroke, or heart attack. Attorneys at the Goldenberg Heller Law Firm are looking into whether injured Pradaxa users have a legal claim for monetary compensation, and would like to hear from Pradaxa users who have experienced any severe bleeding while taking the drug.

In 2011, the FDA announced that it was looking into reports of serious bleeding events by users of Pradaxa. The FDA also advised users to seek medical attention at the appearance of any signs of severe bleeding.

Approved by the FDA in 2010, Pradaxa is a blood thinning medication used to reduce the risk of a stroke in people with non-valvular atrial fibrillation. Although blood thinners like Pradaxa and Coumadin are known to have risks of severe bleeding, Coumadin has an antidote. Pradaxa does not have this antidote, and it may therefore be difficult to stop the bleeding if an unexpected injury has occurred.

The Pradaxa attorneys at our firm would like to speak with people who have taken this drug and experienced a GI bleed, brain hemorrhage, or any serious bleeding event. Please contact Katie Hubbard, or call 1-800-782-8492 for a free review of your potential Pradaxa claim.

A look back at thalidomide – 50 years later

Posted on February 17th, 2012 by Robert D. Rowland

Recently the FDA office of Women’s Health released a message authorized by Margaret Hamburg, M.D. about the beginning of the FDA and Thalidomide. It was called “one of the biggest medical tragedies of modern times.” Introduced as a sedative drug in the late 1950s, thalidomide was commonly used to treat the symptoms of morning sickness. From 1957 until 1961 it was sold across the world, but was taken off the market after being found to cause a number of birth defects. More than 10,000 children in 46 countries were born with deformities. These were the famous “flipper babies”.

Yet thalidomide never had a significant impact on the United States. Why? Because before it could reach the market in the U.S., pharmacologist and M.D. Frances Oldham Kelsey refused to give the Food and Drug Administration (FDA) approval to Richardson-Merrell to market thalidomide. She strongly believed further studies were needed. Kelsey discovered that although thalidomide was being used across the globe, it hadn’t received much testing; In fact, it hadn’t even been tested on pregnant animals. Her decision to deny FDA approval exemplified the need for scientific product development, regulation and review.

In the aftermath of the thalidomide tragedies, the United States Congress enacted the Kefauer-Harris amendments in 1962 requiring proof of safety and efficiency before a drug can receive approval for sale in the U.S.

This turning point led to a new era of medical responsibility and science that has continued to this day. All new drug applications must demonstrate “substantial evidence” of the drug’s efficacy for a marketed indication, in addition to the existing requirement for pre-marketing demonstration of safety.

It’s funny to hear politicians argue that government regulation is holding back our economy. FDA regulation is holding back pharmaceutical companies who, in their rush to market, put profits over people. We still need a strong FDA, “one endowed with the necessary resources to ensue smart, sound, and science-based regulation”.

Contact Robert D. Rowland here.

Asthma and pre-term labor medication Terbutaline warning due to infant brain damage

Posted on December 1st, 2011 by Robert D. Rowland

Terbutaline, an asthma medication that’s commonly prescribed to halt pre-term labor and premature birth, has been shown to leave the brains of children susceptible to other chemicals ubiquitously present in the environment. A Duke University Medical Center study found that rats exposed to Terbutaline suffer greater brain cell damage than those not given the drug upon secondary exposure to insecticides.

Nearly 20 percent of all pregnancies in the United States result in early labor, and an estimated one million women are treated with Terbutaline or similar drugs to halt early contractions every year. The use of Terbutaline for use in pre-term labor and premature birth is not approved by the FDA. In fact, in 1997 the FDA issued its first warning concerning the potential dangers associated with the use of Terbutaline for the treatment and prevention of pre-term labor.

Studies show a link between the use of Terbutaline during pregnancy and an increased risk of brain damage and cognitive deficits, which may become noticeable at infancy, continue through adolescence and cause permanent disabilities. Researchers at Duke suggest that exposure predisposes newborns and infants to fall victim to particular ailments and medical conditions later in life.

The National Asthma Education and Prevention Program has now recommended women with asthma no longer take Terbutaline while they are pregnant, as the drug may penetrate to the fetus and affect brain development.

Terbutaline is sold under the brand names Brethine and Bricanyl. If you or a loved one has suffered from the effects of this drug, contact Robert D. Rowland.

Bladder Cancer Warning For Diabetes Drug Actos

Posted on October 26th, 2011 by Robert D. Rowland

In June of 2011, the FDA issued a new warning of increased bladder cancer risk associated with use of the diabetes drug Actos (pioglitazone), after analysis of a 5-year study of the drug by manufacturer Takeda Pharmaceuticals.

The results of the Actos study showed an increased risk of bladder cancer among long-term users of the drug, and a greater risk of bladder cancer among users exposed to the highest cumulative dose. The FDA is now requiring that new information about an increased risk of bladder cancer be added to the Warnings and Precautions section of the Actos label.

The FDA has also acknowledged a recent 10-years study in France, which suggests an increased risk of the bladder cancer with Actos use. As a result of this study, France has banned Actos, and Germany is advising doctors not to start Actos in new patients.

Symptoms of bladder cancer can include:
• Abdominal pain
• Blood in the urine
• Bone pain or tenderness
• Fatigue
• Painful urination
• Urinary frequency
• Urinary urgency
• Urine leakage (incontinence)
• Weight loss

If you or a loved one has suffered using Actos or pioglitazone, contact Robert D. Rowland.

Supreme Court decision protects makers of generic drugs

Posted on September 28th, 2011 by Robert D. Rowland

In a recent 5-4 decision in Pliva v. Mensing, the United States Supreme Court ruled that makers of generic drugs cannot be sued for failing to warn people of potentially dangerous side effects, as long as their warning labels contain the same warnings as their brand-name equivalents.

In Pliva v. Mensing, MN resident Gladys Mensing and LA resident Julie Demahy both sued Pliva and other generic manufacturers under their respective state laws, after they developed a severe neurological disorder after taking generic versions of the drug Reglan for digestive tract problems in the early 2000s. The drug contained the active ingredient metoclopramide, and the women alleged that the manufacturers had a duty to strengthen their warning labels as problems related to the long-term use of metoclopramide became evident.

Justice Clarence Thomas, writing for the majority, held that since federal regulations regulate generic drugs to have the same warning labels as their brand-name equivalent, this pre-empts any state personal injury law that would allow an individual to sue manufacturers for an insufficient label. Under most states’ laws, drug manufacturers must update their warning labels as they became aware of new risks. Justice Thomas even acknowledged that it “makes little sense” that those individuals injured by generic drugs have no state failure-to-warn claim when those injured by brand-name drugs do.

Justice Sotomayor, noted in dissent: “A drug consumer’s right to compensation for inadequate warnings now turns on the happenstance of whether her pharmacist filled her prescription with a brand-name drug or a generic. If a consumer takes a brand-name drug, she can sue the manufacturer . . . if she takes a generic drug, as occurs 75 percent of the time, she now has no right to sue”.

The Mensing decision is a victory for pharmaceutical companies and a defeat for injured consumers. There are still ways to hold some generic manufacturer’s liable for failure to warn of known dangers presented by their drugs, but the road to compensation just got a lot steeper.

Have you been harmed by a prescription drug – brand-name or generic? Let us help. Contact Robert D Rowland.

$25 Million Award in Accutane Inflammatory Bowel Disease Lawsuit

Posted on September 23rd, 2011 by Robert D. Rowland

A New Jersey judge has ordered Swiss drugmaker Roche, the maker of Accutane, to pay $25 million to a former user of the acne medicine who developed severe inflammatory bowel disease (IBD) after taking the drug.

Andrew McCarrell, 38, became sick after taking the drug for several months in 1995. He needed five surgeries, including one to remove his colon, and suffers daily pain and anguish from Accutane IBD. He won the verdict after NJ judge Carol Higbee denied Roche’s request for a new trial or remittitur.

One of the first Accutane cases to reach a jury in the United States, the case was originally filed in 2003 and first went to trial in 2007, resulting in a jury award of $2,619,000. The case was remanded for a new trial when Roche requested to introduce evidence on the total number of Accutane users.

The nine jurors ruled unanimously that McCarrell deserved $25 million in compensation for pain and suffering and $159,000 for past medical expenses. McCarrell claimed Roche violated New Jersey’s consumer fraud law.

Judge Higbee denied Roche’s requests for a new trial or a reduction in awarded damages to McCarrell, indicating that she found no sense of “wrongness” in the jury’s award in a 47-page opinion, stating:

“[McCarrell's] testimony and that of his wife and doctors presented a picture of probably the worst case of pain, suffering and loss of quality of life I ever heard described on my eighteen years on the bench.”

It doesn’t matter when you took Accutane or how long it took for your symptoms to appear – if you feel as though your personal use of Accutane has caused you issues, please contact Robert D. Rowland.

The Side Effects of Accutane – Inflammatory Bowel Disease (IBD)

Posted on March 24th, 2010 by Robert D. Rowland

The pharmaceutical drug Accutane has recently been the subject of news in both the medical and legal arenas. The link between the drug and Inflammatory Bowel Disease (IBD) has been shown in at least one preliminary study.

Goldenberg Heller Antognoli & Rowland’s Robert D. Rowland sat down with Heidi Turner of www.lawyersandsettlements.com to discuss the connection and how individuals can seek relief.

To read the article please visit www.lawyersandsettlements.com.

If you feel as though your personal use of Accutane has caused you issues, please contact Robert D. Rowland.

Be Picky When Hiring an Injury Attorney

Posted on November 24th, 2009 by The Firm

Whether you were injured in Illinois or Missouri…whether you were injured at work, on property, by a doctor, by a product, or in an automobile, finding the right attorney for you will be one of the most important decisions you will make. There are lots of lawyers out there – some are alike but some are very different. Would you go to just any doctor? Would you buy any house? No. Big decisions need to be made according to what is right for you.

Anyone can buy a fancy ad these days. That doesn’t make him a good lawyer. That doesn’t mean he will listen to your needs, and be responsive when you need him to be. Ask yourself what you expect from your attorney and then research and ask around to find the right match. Check out the attorney’s prior success and read testimonials. Most importantly, at least speak to or meet with the attorney in person before you hire him or her. If you do not feel comfortable with the attorney, it probably isn’t a good match.

Do you want a huge firm with so many cases that the attorneys are too busy to work on your file? Or do you want a smaller firm who is selective in what cases it takes so that the attorney can provide you with individualized attention? Do you want a firm with a proven track record and respected in the community? Do you want a responsive attorney that you can get a hold of? Do you want an attorney who will work on your file until completion or one that will pass your file off to other attorneys? These are all important issues that may affect how pleased you are with your choice of counsel. Choose wisely.

To learn more about hiring an attorney, contact Robert Rowland or fill out our contact form.