Articles Posted in Dangerous Drugs

In highly regulated industries like the pharmaceutical industry, medicines typically undergo rigorous testing to ensure the safety of the drug before it goes on the market. But even drugs that have been on the market for years may later prove to be dangerous. Consumers that have been injured after taking a drug they believed to be safe may be entitled to compensation for their injuries through a Maryland product liability claim.

A “failure to warn” claim in Maryland is based on the contention that a defendant failed to adequately warn consumers of the risks involved with a product. In a claim involving a pharmaceutical drug, a manufacturer may be liable for failing to disclose the side effects of a drug or failing to disclose an unreasonably dangerous condition, for example. In general, a manufacturer is responsible for warning consumers of the risks of using a product, unless the risks are so obvious or well known that a warning is not required. Warnings must clear, direct, and easy to understand. Maryland courts will consider the knowledge and expertise of consumers in deciding whether a consumer can reasonably be expected to understand the risks of the product.

FDA Calls for Zantac to be Pulled From Market due to Probable Carcinogen

It is important for you to know that you know that if you were injured or became sick from taking a prescription or over-the-counter medication, you may be able to obtain Maryland injury damages by filing a dangerous drug lawsuit. Unfortunately, even though drug manufacturers are supposed to make sure that their medications are safe for patients to use, and warn of possibly dangerous side effects, this isn’t always the case.

In recent products liability news, a woman who took Humira to treat her Crohn’s disease is suing Abbott Laboratories because she says that the drug Humira caused her to sustain permanent damage to her optic nerves. Jamie Bixby says that when she called the drug manufacturer’s helpline to report that she was experiencing eye pain, a nurse told her that the symptoms weren’t related to Humira. Bixby eventually sought emergency care when one of her eyes began experiencing blurred vision with black holes. An eye doctor later said that Bixby’s optic nerves had sustained permanent injury.

In her dangerous drug complaint, Bixby contents that if Abbott had warned her or her gastroenterologist that her eye pain could have been caused by taking Humira, she would have stopped taking the medication right away and immediately gotten the medical help she needed. She says that before Abbott started marketing Humira to Crohn’s patients, it should have known the potential risk it posed to the eyes—especially as similar drugs reportedly have caused similar optic nerve deterioration. Bixby notes that those other drugs, which are made by competitors, warn about this specific injury risk.

According to the Food and Drug Administration, babies born to moms who used Topamax while pregnant are at greater risk of being born with a cleft palate or a cleft lip. The government agency says that medical professionals should warn patients in the childbearing age range that the drug, used to treat epileptic seizures and prevent migraine headaches, could cause oral birth defects. If your child was born with a cleft palate and you were taking Topamax (or one of its generic versions) while pregnant, you should contact our Owing Mills products liability lawyers right away.

Data from the North American Antiepileptic Drug (AED) Pregnancy Registry shows that the risk or oral clefts can go up if the baby is exposed to Topamax (topiramate) during the first trimester of pregnancy. Exposure to topiramate as a single therapy upped the prevalence of oral clefts by 1.4%. The prevalence for infants exposed to other antiepileptic drugs was .38-.55%. The prevalence for infants of moms who did not take any antiepileptic medication was .07%.

FDA says topiramate should be accompanied by a stronger warning and it will now fall under the Pregnancy Category D, which indicates a positive evidence of human fetal risk. However, a person currently taking the drug shouldn’t stop without first talking to his or her doctor.

The Cleft Palate Foundation says that 6,800 babies with an oral birth defect annually. That’s one out of every 594 newborns.

Not only can a cleft palate severely alter someone’s appearance, but it can also result in speech defects, teeth misalignment, ear infections, digestion problems, and feeding issues. A child may have to undergo multiple surgeries to repair the birth defect. Costly speech therapy and orthodontic work may also be required.

FDA: Risk of oral birth defects in children born to mothers taking topiramate, FDA, March 4, 2011
Related Web Resources:

Cleft Palate Foundation


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Supreme Court Hears Arguments in Drug Litigation Lawsuit Pitting Wyeth Against Woman Who Lost Her Arm After Taking Anti-Nausea Drug Phenergan, Maryland Accident Law Blog, November 7, 2008

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A jury in the United States has ordered drug manufacturer Roche to pay $12.9 million to three Accutane users who say they developed chronic bowel disorders from using the popular acne drug. The jury determined that the Swiss drug maker failed to properly warn of the side effects that can result from using Accutane.

The patients began using Accutane more than 10 years ago when they were teenagers to treat their acne. As a result of using the acne drug, two of the patients say they now require long-term drug rehabilitation and the third patient has to have his colon removed.

This is not the first drug litigation lawsuit filed against Roche that links Accutane to inflammatory bowel disease. This is the fourth IBD civil trial the Swiss Drug maker has lost.

This week, the US Supreme Court heard arguments in a drug litigation lawsuit pitting a musician, whose arm was amputated after she was given an anti-nausea drug, and drug maker Wyeth. Diane Levine’s arm had to be removed after a physician’s assistant accidentally injected the anti-nausea drug Phenergan into her artery in April 2000. She was administered the drug at a clinic where she was treated for migraine headaches.

Levine sued the clinic, the supervising physician, and the physician’s assistant who injected the drug into her artery for medical malpractice and settled with all parties out of court. She sued Wyeth for its alleged failure to warn clinicians that they should use the safer IV drip, instead of the intravenous “push” method, to administer to Phenergan to her.

A civil jury awarded Levine $7.4 million million, and a judge reduced the amount to $6.7 million. The Vermont Supreme Court upheld the verdict.

This week, a Food and Drug Administration panel will review the effect of the flu medicine Tamiflu on the brain. 55 children in the United States reportedly exhibited abnormal behavior and other brain effects after taking the medication. 22 of the cases included serious symptoms, such as delirium, convulsions, and delusions.

Globally, more than 1800 children who have taken Tamiflu showed similar effects worldwide. Five children in Japan died because of psychiatric or neurological problems. Seven adults died because of neuropsychiatric problems.

75% of the 48 million prescriptions for Tamiflu are administered in Japan. Last March, the Japanese government issued a warning that Tamiflu’s use be restricted in young people.

There is no concrete evidence to show that Tamiflu causes problems in the brain or abnormal behavior. Terry Hurley, a spokesperson for drugmaker Roche Laboratories, says flu patients who have not taken Tamiflu also showed these symptoms. However, if a child or adult was injured from taking Tamiflu, he or she may have grounds to file a dangerous drug claim or lawsuit against Roche Laboratories.

Tamiflu is Roche’s number nine best-selling drug and, according to the Tamiflu Web site, it is the “number one doctor-prescribed flu medicine.” The FDA has recommended Tamiflu for use in children and adults over age one. Tamiflu is used as a flu vaccine and to treat flu symptoms.

FDA safety reviewers are recommending that Tamiflu labels be updated to include information about possible neuropsychiatric side effects.

The FDA’s review of Tamiflu comes a little over one month after the makers of several infant cold medicines voluntarily recalled infant cold medicines Dimetapp, Robitussin, Pediacare, Triaminic, Little Colds, and Tylenol because of accidental overdose concerns.

Earlier this month in Chicago, a woman sued Walgreen Co. and McNeil for the wrongful death of her 4-month-old son who died after taking Infant Tylenol Cold Decongestant Plus Cough and Pediatric Drops-Cough Plus Cold, which are two over-the-counter medications.

FDA panel to review Tamiflu’s effect on brain, USA Today, November 26, 2007
Lawsuit alleges Illinois infant died from cold medicine ingredient; mother suing 2 companies, International Herald Tribune/AP, November 14, 2007
Makers Pull Cold Medicines for Infants,, October 11, 2007


Related Web Resources:

FDA Questions the Safety Of Asthma Drugs for Kids, The Wall Street Journal, November 24,2007

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