Archive for the ‘product defects’ tag

FDA to Investigate Safety of Essure Birth Control

August 6th, 2015 at 12:11 pm

birth control safety, safety of essure birth control, Westport Personal Injury LawyerReports of serious concerns over a popular contraceptive, used by countless women, is coming under federal review due to multiple reports of dangerous medical complications suffered by women who have used the device.

The Food and Drug Administration (FDA) has announced that they are reviewing the safety of the implant Essure. The contraceptive device is manufactured by Bayer and has been on the market since 2002. The device is made of two metal coils which are inserted into the fallopian tubes as a way to block contraception.

However, the FDA says that they have received more than 5,000 complaints of medical issues, including abdominal pain, fatigue, headaches, and weight fluctuations, by female patients prescribed Essure since its approval. More than 400 women and/or their doctors have reported the coils moving away from the fallopian tubes and into other parts of the patient’s reproductive system.

There have also been reports of five fetal deaths, which occurred when the Essure device failed to prevent pregnancy.

Since its approval, the Essure device has been implanted into approximately 750,000 women. Based on the number of complaints the FDA has received, this means approximated one in every 150 women has had a problem with the device.

The FDA has scheduled a public hearing to be held on September 24, 2015 to review the safety of the product. The hearing will include the agency’s Obstetrics and Gynecology Devices Panel. This hearing is being scheduled due in part to a New York television news channel’s investigation regarding the inconsistencies which took place during the clinical trials of Essure. These trials, which failed to disclose complaints by trial patients, were presented to the FDA in order to get the agency’s approval for the device.

If you have experienced medical complications or other issues from having the Essure device implanted, or any other medical device issues, contact an experienced Westport personal injury attorney to find out what legal recourse you may have for your pain and loss. For a free initial consultation about your case, call Attorney Richard H. Raphael at 203-226-6168 today.

DOJ Announces Guilty Plea and $25 Million Fine against Drug Company

March 13th, 2015 at 7:00 am

drug company, fine against drug company, Westport personal injury lawyerThe U.S. Department of Justice (DOJ) has announced that McNeil Consumer Healthcare, the company that manufactures Tylenol, Motrin, and several other popular over-the-counter medications, has agreed to plead guilty to one federal criminal charge in the case the government filed against the company for selling medications contaminated by pieces of metal. The company, which is a subsidiary of Johnson & Johnson, has also agreed to pay a $25 million fine.

According to the DOJ, in 2009, complaints were made by consumers who found “black specks” floating in bottles of liquid Infants’ Tylenol they had purchased. Testing revealed those particles to be nickel, iron and chromium. The contaminated products had all been manufactured at a plant in Pennsylvania.

An investigation by the company found that those particles had been introduced into the medication at some point during manufacturing. However, not only did the company not take the necessary steps to fix the issue at the plant, they continued to sell the contaminated products for another year before finally issuing a recall in 2010. To compound the problem of contaminated medication, when announcing the recall, McNeil also announced that the products may have contained more of an active drug ingredient than what was put on the packaging labels.

The company claims that no child was injured from the tainted products. One family did file a lawsuit against the company after their 4-year-old son died; however, the lawsuit was dismissed by a court because the boy’s death had occurred after the recall.

In addition to the contaminated medication, the company has come under federal scrutiny several times over the past few years for other dangerous faulty manufacturing issues. These issues included incorrect direction labeling on medications as well as products which had moldy odors. These problems have resulted in millions of bottles of medicines having to be recalled.

If you or a loved one have been injured due to a dangerous or defective product, contact an experienced Westport personal injury attorney to find out what your legal options may be against the product’s manufacturer. Attorney Richard H. Raphael has extensive experience representing clients in product liability cases. Call 203-226-6168 for a free consultation.

Spewing Shrapnel from Defective Air Bags Leads to Automotive Recall

January 22nd, 2015 at 7:00 am

automotive recall, chest injuries, defective air bags, defective car part, nationwide automotive recall, Westport personal injury, product defects, Westport personal injury attorneyImagine being involved in a low-impact car crash and having your air bag, a device designed to protect your safety, explode causing shrapnel to spray throughout your vehicle. This is the type of situation that many drivers have faced over the last several months due to defective air bags manufactured by Japanese automotive supplier Takata.

What began as a regional recall, focused specifically in high-humidity states, has now become a nationwide safety concern affecting approximately 7.8 million vehicles from 10 different automakers, according to Consumer Reports.

The catastrophic events linked to Takata air bags have included explosive shrapnel as a result of air bags inflating too quickly after collisions such as rear-end car accidents. Over 100 personal injuries and at least five fatalities have been reported thus far, which has prompted the recall expansion. Honda was the first to take its recall nationwide as demanded by the National Highway Traffic Safety Administration, but in recent weeks, Ford, Mazda, Chrysler, and BMW have also followed suit, as reported by The New York Times.

Takata’s president has stepped down as the company continues involvement in this worldwide safety issue linked to its air bags installed in vehicles from 2002 through 2008. There are still lingering questions about the cause of more recent air bag injuries and which cars specifically are at inherent risk.

Car manufacturers are responsible in alerting consumers of any defectiveness regarding their products in a timely manner. If they are negligent in doing so, injuries can occur for which they hold accountability. Takata air bags have been directly linked to tragic events putting millions of people in danger. A woman in South Carolina has been the most recent victim reporting chest injuries sustained as a result of excessive force of the Takata air bag installed in her 2001 Honda.

If you or someone you know have been seriously injured as a result of a defective car part in Connecticut, contact a qualified Westport personal injury today. You may be eligible for compensation, which could help pay for any medical expenses acquired as a result of your injuries. Call our office for a free case evaluation.

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