Wilmington Personal Injury Lawyer - defective product

Serious Health Issues Associated With Bard Avaulta Transvaginal Mesh/Sling Products

Jean Martin — Mon, 17 Aug 2009 12:00:30 GMT

For many women, there is nothing more gratifying and joyous than being pregnant and having a child. However, there are some health problems that may occur later in life as a result of child birth. Pelvic organ prolapse is one such problem and it occurs when the pelvic muscles become weak or damaged either because of injury or due to old age and the muscles cannot adequately support the pelvic organs any longer. It is estimated that half of women who have children will suffer from some form of prolapse at some point in their lives and that while the condition itself is not serious or life-threatening, it can still cause a great deal of distress to the patient and ought to be treated.

One such treatment method is a surgical procedure in which a device known as a transvaginal mesh is inserted to help treat the problem; sometimes the device is referred to as a sling. The procedure is still fairly novel and new materials are frequently used by companies trying to develop new designs for the product. Slings and meshes have been promoted as an excellent treatment option for women suffering from some degree of prolapse. One company that makes transvaginal meshes is Bard Avaulta. Their product has been used to treat incontinence and other problems associated with a prolapse. However, there have been problems and now the company and its products have had warnings and recalls issued against them.

The problems affecting the meshes and prompting the recalls and warnings include pain, infection, urinary trouble, recurrence of prolapse, incontinence and vaginal erosion. There have also been some problems reported in the actual process of inserting the mesh in the patient, though these are not generally thought to be a result of a defect in the product itself. In October of 2008, the FDA made a public warning to consumers warning them about the complications that had been reported in conjunction with the insertion and use of the mesh sling. In the FDA public warning, the FDA reported that there had been over one thousand reports of problems which were reported in transvaginal meshes made by nine different manufacturers. The result of the public warning was to alert women who thought that their problems were unique to the problems other women were also having and resulted in calls by consumers for a recall of Bard Avaulta’s product.

This was an important development in the transvaginal mesh problem because many women had been experiencing problems but due to the sensitive nature of their health problems and because of their assumption that it was either an extension of their original health issue or a unique problem to them, these patients were underreporting their problems with the product. The result of the FDA warning and calls by the public for a recall is that there is a rather strong case to be made that the Bard Avaulta product is defective. A defective product which remains on the market and/or which injures a consumer may allow a patient who was injured to recover in a suit or may even result in a class action suit against the manufacturer. As of today, there are still no recalls which have been issued for Bard Avaulta transvaginal meshes or slings nor have any been issued to any of the other eight manufacturers.

For consumers who have been injured, it is important to remember that you are not just an injured consumer, but a victim. If you have been injured, do not be afraid to contact an attorney or an advocacy group, such as Truth in Medicine, to find resources that may be able to help you. To avoid potential injury or to minimize injuries, should they appear, it is important for women to be involved in their own treatment, to engage their physicians in a dialogue and not to suffer in silence. Always remain aware of new findings, studies and reports about meshes and slings but also do not be afraid to question and speak with your physician about these resources as not all reports are complete and accurate. As a consumer of health care products, you should not be subjected to defective or dangerous products; remain vigilant of your own health and any changes you experience after any procedure; your health and well-being are the most important things you have.

Originally posted at InjuryBoard by Jean Martin

Lawsuits Filed in 2007 Fatal Boating Accident

Jean Martin — Wed, 15 Apr 2009 17:20:05 GMT

Two years ago this month, a fatal boating accident occurred on Smith Mountain Lake in Virginia. Now the estates of the two men killed in that accident have filed lawsuits against the boat's owner, the boat manufacturer, the company that performed maintenance on the boat and others. The lawsuits allege that faulty maintenance and manufacture caused the 33-foot Hacker Craft boat to capsize, resulting in the deaths of Richard Smith and David Reynolds.

A post-accident investigation by the Virginia Department of Game and Inland Fisheries determined that a combination of high winds and a malfunctioning cooling system that caused the boat's hull to fill with water made the boat capsize and sink. The manufacturer of the cooling system has also been named in both lawsuit. Both lawsuits seek over $10 million in damages for the deaths of these men.

Originally posted at InjuryBoard by Jean Martin

Settlement Reached in Case of Newborn Burned By Malfunctioning Respirator/Humidifier

Jean Martin — Fri, 21 Nov 2008 14:48:45 GMT

In the winter of 2007, a newborn suffered severe and permanent injuries, including disfiguring burns, as a result of malfunctioning respirator and humidifier. Thermal burn resulted in air so hot that it melted the plastic tubing to the baby's nose. Lawyers for the family today announced that a settlement had been reached in the case for $18.5 million.

This is a terrific result. Children are our most precious resource and deserve the best protection and the utmost care. It is truly tragic when something so horrific happens to a child, especially a newborn. I am happy to hear that the negligent defendants did the right thing and settled this case without having the family go through a lengthy and arduous lawsuit.

Originally posted at InjuryBoard by Jean Martin

Vytorin and Zetia - Consumers Ripped Off

Jean Martin — Mon, 31 Mar 2008 10:35:11 GMT

Doctors are being urged to cut their prescriptions of the popular cholesterol-lowering drugs Vytorin and Zetia in patients. A recent clinical study showed that Vytorin and Zetia were far more expensive yet far less effective than statin drugs. The study did not raise significant safety issues among patients treated with Vytorin, but did suggest that patients need not pay the higher cost for Vytorin because it is no more effective than the cheaper generic statin drugs.

Consumers have been duped and have been paying more for drugs that did not work as well as cheaper generics that they were already taken. Our firm is investigating potential consumer fraud claims on behalf of users of Vytorin and Zetia.

Vytorin is a combination of Zocor (manufactured by Merck) and Zetia (made by Schering-Plough). Vytorin and Zetia had more than a combined $5 billion in annual sales last year.

The study looked at whether Vytorin was better at reducing thickening of a neck artery than Zocor, an older statin drug that is readily available in generic form. The results found that showed neither drug affected the size of patients' artery walls even though they cut LDL, or so-called "bad" cholesterol, levels after two years on treatment. It was expected that Vytorin would have shown a small reduction in the plaque build-up in the arteries of artery walls because it lowered LDL cholesterol levels almost 30% more than levels were cut among patients on Zocor alone.

Some lawmakers have accused the manufacturers of delaying the results of these studies because the companies knew the results would be negative and would hurt the sales of Vytorin and Zetia. Both drugs cost more than Zocor, which is now available as a generic drug. The companies have denied the accusations.

Originally posted at InjuryBoard by Jean Martin

Patients Receiving Trasylol 2.5 Times More Likely to Die, According to Study

Gary Shipman — Thu, 21 Feb 2008 16:14:02 GMT

A study released this week in the New England Journal of Medicine concluded that patients receiving the Bayer antibleeding drug, Trasylol, were at a 64% greater risk of death than patients who did not received another medication or no medication at all.

The study, based upon research conducted at Duke University Medical Center. looked at approximately 10,000 patients who had undergone bypass surgery at Duke, and concluded that 6.4 percent of patients who received Trasylol died within 390 days of the surgery. Bayer pulled the medication from the market after a Canadian study was halted because of deaths.

The lawyers at Shipman & Wright, LLP are actively involved in the investigation of cases involving death or serious injury to patients who took Trasylol.

Originally posted at InjuryBoard by Gary Shipman

ATV Rollover Accidents - Yamaha Rhino's Defective Design

Jean Martin — Tue, 19 Feb 2008 18:53:25 GMT

Despite its unsafe reputation, the Yamaha Rhino ATV is still being sold. With several fatalities, accidents, and serious injuries, the Rhino is considered among the most dangerous all-terrain vehicles available. From severed limbs and head injuries to broken bones and numerous deaths, the list of those who have experienced a traumatic event as a result of the Yamaha Rhino continues to grow.

Unlike other ATVs, the Rhino rolls over during turns even at low speeds on flat surfaces because it is top heavy, narrow, and the tires are too small. Even when used at minimum speeds, the Rhino's disproportionate design makes it a hazardous vehicle to operate or ride in.

Though Yamaha has made alternative safety measures available to customers, Yamaha has not changed the basic design of the Rhino or accepted responsibility for the faulty design. Yamaha has merely made amendments to the Rhino owner's manual and has offered advice for safer operation. The Yamaha Rhino ATVs are dangerous and should not be used unless you want to risk being another statistic.

Originally posted at InjuryBoard by Jean Martin

More Pain Patches Recalled

Jean Martin — Tue, 19 Feb 2008 12:11:23 GMT

On Monday, manufacturer Actavis announced a nationwide recall of its painkiller patches containing fentanyl due to a product defect that could result in drug overdose among patients and caregivers. The recall includes patches with an Abrika or Actavis label delivering 25, 50, 75 and 100 micrograms per hour with expiration dates of May through August 2009. This recall comes a week after a Johnson & Johnson unit pulled its fentanyl patches (Duragesic patches). The defect which can cause the patch to leak and expose patients or caregivers directly to the fentanyl gel. Exposure to fentanyl gel may lead to serious adverse events, including respiratory distress and possible overdose, which may be fatal.

Originally posted at InjuryBoard by Jean Martin

Duragesic Pain Patches Recalled

Jean Martin — Wed, 13 Feb 2008 18:07:15 GMT

Duragesic pain patches containing the prescription painkiller fentanyl were recalled Tuesday, because of a defect that could cause the patches to leak leading to a fatal overdose of the drug inside. Some of the patches may have a cut in the lining of the internal reservoir where the drug is stored in gel form. If the fentanyl gel leaks, it could cause a patient or caregiver to come into direct contact with this powerful drug. This could result in difficulty breathing and a potentially fatal overdose.

Fentanyl is mostly used to treat cancer pain, according to the FDA, and doctors say it's a stronger painkiller than morphine. The drug is intended for chronic pain yet the FDA found cases where doctors prescribed it for headaches or post-surgical pain.

Deaths caused by defective patches have been the subject of multiple lawsuits in the last several years. The U.S. Food and Drug Administration issued a safety warning in December over the patches, saying improper use can cause breathing difficulties and death. That followed a July 2005 alert put out by the FDA after 120 patients taking the drug died. Johnson & Johnson said in November that it faced 72 lawsuits over the patches. Juries in Texas and Florida concluded that defective patches caused the deaths of Michaelynn Thompson and Adam Hendelson. A Texas state court jury awarded Thompson's family more than $772,000 in damages, and a federal jury in Florida ordered the company to pay Hendelson's family $5.5 million.

Different manufacturing problems caused Johnson & Johnson to recall versions of the patches in 1994 and 1996. A 2004 recall covered patches supplying 75 micrograms of the drug.

The current recall covers patches in the U.S. and Canada that release 25 micrograms of fentanyl in an hour, Johnson & Johnson said. The expiration dates are on or before December 2009. Duragesic patches generated $1.16 billion in global sales last year, making them Johnson & Johnson's eighth-biggest selling product.

If this reservoir containing the gel form of the drug is cut, it can be seen when the foil pouch containing an individual patch is opened. Damaged patches should be flushed down the toilet and not handled. Skin that has been exposed to the gel should be thoroughly rinsed with water, but not washed with soap.

Originally posted at InjuryBoard by Jean Martin

FDA Issues Warning About Heparin

Jean Martin — Tue, 12 Feb 2008 16:50:36 GMT

The FDA on Monday advised doctors to refrain from using Heparin made by Baxter Healthcare after receiving 350 reports this year of vomiting, nausea and breathing difficulty. Heparin is a blood thinner used in surgery and dialysis. Officials first noticed problems after four children who were injected with heparin suffered serious allergic reactions. Government inspectors are examining Baxter's manufacturing sites to determine the cause of the problem, the FDA said. Baxter said it will temporarily stop manufacturing the drug and will cooperate with the investigation.

Originally posted at InjuryBoard by Jean Martin

Wilmington Personal Injury Lawyer - defective product

Serious Health Issues Associated With Bard Avaulta Transvaginal Mesh/Sling Products

Lawsuits Filed in 2007 Fatal Boating Accident

Settlement Reached in Case of Newborn Burned By Malfunctioning Respirator/Humidifier

Vytorin and Zetia - Consumers Ripped Off

Patients Receiving Trasylol 2.5 Times More Likely to Die, According to Study

ATV Rollover Accidents - Yamaha Rhino's Defective Design

More Pain Patches Recalled

Duragesic Pain Patches Recalled

FDA Issues Warning About Heparin

More Health Problems From Fosamax