North Carolina Injury Lawyer Blog

Johnson & Johnson is announcing the recall of two lots of Duragesic pain patches. The recall, by its PriCara Division, is being issued because tears in the patches could expose users to the product’s gel and may result in an overdose. The recalled patches were made by ALZA Corp.

Recalled lots include:

• Duragesic 50 mcg/hr patches, lot number 0817239
• Sandoz Inc 50 mcg/hr patches, lot number 0816851

J & J is conducting the recall with the Food and Drug Administration. This is not the first recall involving improperly sealed Duragesic pain patches. In February 2008, J & J recalled some 32 million Duragesic Pain Patches over similar concerns. In 2004, Janssen Pharmaceuticals Products recalled 75 patches over leakage concerns also.

In 2007, the Food and Drug Administration issued a warning that accidental overdoses have been associated with use of the pain patch. The FDA has received over 100 reports of deaths that may have been related to use of fentanyl pain patches.

Duragesic, also known as fentanyl, is an opioid pain reliever that is 100 times stronger than morphine. You are not supposed to use fentanyl if you have drug allergies or a history of mental illness, seizures, breathing problems, heart problems, drug or alcohol dependence, low blood pressure, depression, liver disease, kidney disease, a brain tumor, or a head injury. Direct skin exposure to the gel that is inside the patch can cause respiratory problems, nausea, drowsiness, sedation, serious health complications, or lead to fatal overdoses.

Direct Exposure to Duragesic’s Gel:
If you or anyone has come into direct contact with fentanyl gel, it is important that you wash the skin completely with water only. Do not use soap or rub the skin too much. Do not directly handle patches that are torn or have cut edges. Use gloves or tissue instead. You can also get rid of the patches by flushing them down the toilet.

Medical device makers and pharmaceutical drug manufacturers are supposed to make sure that their products are safe for consumer use and free from defects that can cause illness, injury, or death. If you or someone you love was injured by a defective or dangerous medical device, you may be able to file a products liability claim or lawsuit against the negligent manufacturer.

J&J Recalls Two Lots of Pain Patch, The Wall Street Journal, December 31, 2008

Duragesic Patch Recall Adds to Johnson & Johnson Patch Woes, News Inferno, February 13, 2008

Related Web Resources:

Duragesic

Johnson & Johnson

US Food and Drug Administration

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The family of a man who died after he was implanted with a cardiac defibrillator is suing Boston Scientific for his wrongful death. They allege that the defibrillator was defective and caused his death. Boston Scientific used to be called Guidant Corp. Also named as defendants in the products liability lawsuit are Guidant Puerto Rico Corp. and Guidant Sales Corp.

Joseph Robert was implanted with an Implantable Cardioverter Defibrillator (ICD), a Medtronic InSync Sentry defibrillator with Guidant leads, on October 26, 2000. This device is designed to monitor the person’s heart and when there is rapid, abnormal heart rhythm, the ICD is supposed to send energy to the heart muscle so that the heart can beat at a normal rate again.

In 2005, Roberts was admitted to a hospital for an ICD upgrade to a Vitality 2 biventricular automatic implantable cardioverter-defibrillator. His original ICD was being replaced because it had been found defective and dangerous. Roberts died nearly three weeks after the second device was implanted.

Patsy Roberts, one of the plaintiffs in this products liability wrongful death case, says that in 2007, she found out that Boston Scientific recalled the Vitality 2 because it was considered dangerous and defective also.

The plaintiffs claim that the defendants were grossly negligent and engaged in fraud, misrepresentation, breach of express warranties, breach of continuing duty to warn, breach of implied warrant of fitness, and breach of warrant of merchantability. They also say that the defendants violated the Texas Deceptive Trade Practices-Consumer Protection Act.

They are asking for damages for Joseph’s pain, suffering, and mental trauma before he died, as well as for their own pain and suffering, loss of consortium, loss of affection, grief, and other associated costs.

In North Carolina and South Carolina, our defective medical device lawyers have represented victims and their families whose lives have been catastrophically affected by a defective Guidant cardiac defibrillator. We believe that manufacturers of defective medical devices and the other liable parties should be held financially liable for your pain, suffering, and associated costs.

Wrongful death suit filed against Boston Scientific over cardiac defibrillator, Southeast Texas Record, April 21, 2008

Sudden Cardiac Deaths, Get the Facts 2006, AmericanHeart.org

Related Web Resources:

Boston Scientific

FDA: Some Guidant Defibrillators Recalled, WebMD, June 17, 2005

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Now, more than ever, it is important to speak with an experienced defective medical device attorney to discuss your case. In an 8-1 vote today, the U.S. Supreme Court voted to place new limits on defective medical device lawsuits filed against Medtronic Inc. and other medical device manufacturers: Patients cannot sue a medical manufacturer if the product that caused the injury was cleared by a strict federal review process.

In this latest case, the Supreme Court barred a lawsuit filed by the widow of a man who was permanently injured when his Medtronic heart catheter burst while he underwent angioplasty surgery. The Medtronic product had been gone through the U.S. Food and Drug Administration’s pre-market approval process. When the device burst, the patient developed a complete blockage and had to undergo emergency bypass surgery. He died three years ago.

The Bush administration and medical device manufacturers had both argued in favor of precluding state law claims with the more rigorous pre-market review process.

This new ruling could work in favor of medical devices makers that have been named as defendants in the thousands of defective products lawsuits that are still pending. It could also work in favor of drug manufacturers. Drug makers are also trying to get the U.S. Supreme Court to place limits on lawsuits filed by people injured from taking a dangerous or defective drug.

Lawsuits that will be most impacted by the ruling are cases involving medical devices that have undergone the FDA’s yearlong pre-market approval process. This is an arduous process, which is why only 43 new applications were filed in 2005. A fast-track review is available to new devices that are similar to products that are already being sold in the marketplace.

The Supreme Court’s ruling does leave room for defective medical device lawsuits filed under state rules that are considered parallel to federal requirements.

Our North Carolina and South Carolina defective products law firm has helped many injured patients and their families recover compensation from medical device makers and drug manufacturers. We have the experience and resources to help you explore your options and take the necessary and available steps to pursue your case.

Patient Medical-Device Suits Curbed by Top U.S. Court, Bloomberg.com, February 20, 2008

Justices Make It Tougher to Sue Medical Device Makers, The New York Times, February 20, 2008

Related Web Resources:

Read the Supreme Court Decision, Justia & Oyez

Medtronic, Inc.

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Medical device manufacturer Medtronic wants the U.S. Supreme Court to rule that medical device makers are exempt from products liability lawsuits, if a device that caused the injury is FDA approved.

The specific case, Riegel v. Medtronic, stems from a personal injury lawsuit filed by the family of Charles Riegel, a man whose Medtronic-manufactured balloon catheter burst while he was undergoing a medical procedure to clear his arteries.

In the lawsuit against Medtronics, Riegel cited negligent design and labeling and manufacturing issues. The catheter was FDA approved. The lawsuit was thrown out at both the U.S. District Court level and the US Court of Appeals level before arriving at the Supreme Court.

Medtronics claims that amendments to the Food, Drug, and Cosmetic Act say that FDA-approved medical devices are preempted from product liability lawsuits in state civil courts. The amendments, however, do not say that federal standards are preempted by state common law claims. This, however, is what Medtronics is claiming and the Bush Administration supports with the device maker’s assertion.

If the Supreme Court decides that Medtronics is right, anyone injured by a defective medical device won’t be able to file a personal injury claim or lawsuit.

Last December, Medtronics agreed to pay $114 million to settle 2,682 products liability lawsuits by people who had used the company’s Marquis implanted cardiac defibrillators. A battery problem had caused some of the defibrillators, implanted in patients at risk of heart attacks, to fail. ICD’s had to be surgically replaced in 11,000 patients.

Last year, Medtronic announced an international recall of heart-defibrillator wires, which were fracturing at a rapid rate. Some 235,000 people have these wires implanted in their chests.

If you have been injured or suffered health problems or have had to undergo a medical procedure because of a defective medical device, you should contact our North Carolina or South Carolina products liability law firm immediately.

Medtronic Supreme Court Case Could Have Dire Consequences for Consumers Injured by Defective Medical Devices, NewsInferno, January 3, 2008

Medtronic to Pay $114 Million In Settling Heart-Device Suits, The Wall Street Journal, December 21, 2007

Related Web Resources:

Riegel v. Medtronic, Supreme Court Docket

Medtronic

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