Wilmington Personal Injury Lawyer - Medical Malpractice

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 Against North Carolina State Employees

Jean Martin — Fri, 22 May 2009 12:14:03 GMT

The government and governmental agencies have protection from lawsuits under the theory of sovereign immunity, which precludes lawsuits against the government without its consent. Governments can waive sovereign immunity to allow for lawsuits.

In 1951, North Carolina adoped the State Tort Claims Act which allows injured persons and grieving families to file suit against state agencies and state employees for acts of negligence. Under the State Tort Claims Act, a state agency, state employees or agents of the state may be sued for injury to another for the negligence and carelessness caused of a state employee or agent acting within the course and scope of their employment.

An action under the State Tort Claims Act must be filed with the North Carolina Industrial Commission within three years of the date the cause of action accrued or within two years of the date of death in the case of a wrongful death. Under the State Tort Claims Act, the liability of the State is determined under the same principles applicable a private person under the laws of North Carolina. This simply means that the State has no greater protection or available defenses than would private citizen who was sued for negligence. As the injured party, although you have to bring your claim in a particular court of law, you have the same rights and claims against the State for the negligence causing the injury as you would if a private citizen would have been at fault.

Types of claims that may be brought under the State Tort Claims Act include:

* medical malpractice at a state hospital

* wrongful death in automobile accident caused by state employee driving a state vehicle

* gross negligence during a police chase

* premises liabilty at a state owned property or facility

Citizens need to be aware that they do have rights to bring lawsuits against the state for negligent acts of state employees or agents.

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

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

Blood Thinner Heparin Recalled - UPDATED 2/12/08

Jean Martin — Tue, 29 Jan 2008 09:52:32 GMT

Baxter Healthcare Corporation has announced the voluntary recall of multiple lots of its blood thinner Heparin. Heparin is used to prevent blood clots in people who have certain medical conditions or who are undergoing certain medical procedures that increase the chance that clots will form. The doses subject to the recall are primarily used for hemodialysis and cardiac invasive procedures.

UPDATE 2/12/08: The FDA has cautioned doctors to stop using Heparin manufactured by Baxter Healthcare after receiving 350 reports this year of vomiting, nausea and breathing difficulty. 4 deaths have also been reported. Government inspectors are examining Baxter's manufacturing sites to determine the cause of the problem. Baxter Healthcare produces about half of the heparin used in the United States.

The company began recalling the lots on January 17, 2008 due to an increase in the number of reports of adverse patient reactions that may be associated with the product. Adverse patient reactions have included: stomach pain or discomfort, nausea, vomiting, diarrhea, decreased or low blood pressure, chest pain, fast heart rate, dizziness, fainting, unresponsiveness, shortness of breath, feeling your heart beat strong or fast, drug ineffectiveness, burning sensation, redness or paleness of skin, abnormal sensation of the skin, mouth or lips, flushing, increased sweating, decreased skin sensitivity, headache, feeling unwell, restlessness, watery eyes, throat swelling, thirst and difficulty opening the mouth. Some of these reactions may be severe or life threatening.

National attention has recently been focused on Baxter and Heparin because of an overdose of the drug given to the newborn twins of actor Dennis Quaid due to a mix-up between vials of different Herpain doses that both have blue labels. The same error killed three infants and harmed three others in 2006.

Originally posted at InjuryBoard by Jean Martin

More Hernia Repair Patches May Be Defective

Jean Martin — Fri, 25 Jan 2008 16:02:06 GMT

Many patients who had experienced abdominal pain, constipation, bowel obstructions and bowel adhesions after hernia repair surgery contacted a lawyer to determine their legal rights only to be told that they did not have a case because the specific mesh patch used in their surgery was not subject to a recall. We at Shipman & Wright, LLP knew that the defect in the patches had to go beyond any potential defect in the recoil ring and beyond the limited number of patches subject to the recall because too many patients were complaining of the same problems. Now a judge has agreed that the issue should be explored.

What does this mean for you? If you suffered from abdominal pain, bowel adhesions, bowel obstructions or bowel perforations after hernia surgery using a mesh patch for the repair, you may indeed have a legal claim, even if you were previously told that you did not.

On December 22, 2005, the FDA announced a recall of several lots of the Kugel Mesh hernia repair patch. The recall notice advised of failure and breakage of an internal coil ring that could lead to bowel perforations, bowel adhesions, abdominal pain, fever, and tenderness at the implant site or other unusual symptoms. The recall has been expanded twice to include additional shapes, sizes and production lots of the Kugel Mesh Patch, but not all Kugel patches were recalled.

The judge hearing the cases in the Kugel Mesh Patch Litigation MDL has recently expanded the scope of the MDL to include more patches than what were recalled. The judge has also opened up the MDL to include additional Davol and Bard mesh patches, including some that did not contain an internal ring, but were made of a special bi-layered material similar to the Kugel Mesh patches.

Even though some folks suffered the same problems - abdominal pain, constipation, bowel obstructions and bowel adhesions - many lawyers would not take their claim because the patch used had not been recalled. In contrast, Shipman & Wright, LLP filed the claims on the basis that the problems extended beyond that stated in the recall notice. We are happy that a judge has agreed to consider the issue and stand poised to file other cases on behalf of clients who were turned away by other attorneys.

Originally posted at InjuryBoard by Jean Martin

Zetia and Vytorin - That Which Does Not Kill Us Make Us Sicker?

Jean Martin — Tue, 15 Jan 2008 09:38:32 GMT

Yesterday it was announced that, once again, new highly-touted medications are not effective, and worse, may actually do more harm than good. Results from a study regarding Zetia and Vytorin were finally released after much delay and speculation. Much to the public's chagrin, the reports are that Zetia and Vytorin may slightly reduce cholesterol, but they do not reduce plaque build-up in the arteries, and in some cases actually increase the production of plaque. This is not good news for the millions of people who are paying as much as $4 a day for these medications and who need pharmaceutical treatment of their life-threatening heart conditions.

Zetia and Vytorin are marketed as cholesterol-lowering medications by manufacturers Merck and Schering-Plough. Vytorin is a combination of generic Zocor and Zetia. Zetia and Vytorin are prescribed 100,000 times a day and together generate annual sales of $5 billion, with sales up 25% in the most recent quarter over the same period last year.

The study on these drugs was finished in April 2006, but the results were just now made public. There had been much speculation that the results were negative because of the long delay in publishing the data. The manufacturers are acknowledging that Vytorin and Zetia have never been shown to prevent heart attacks or other life-threatening events, in stark contrast to other cholesterol-lowering medications. The public should be outraged that ineffective drugs were allowed to be sold in the first place and should be additionally angry that the manufacturers held these results for so long, each day jeopardizing the health of those patients who have been prescribed Zetia and Vytorin. Knowing that the study showed an increase in the production of plaque in the arteries, the manufacturers should have acted sooner. As it is, Zetia and Vytorin are still being sold.

Cardiologists now have to decide the proper course of treatment for their patients in the wake of these negative results. Patients should never stop taking any prescription medications without the advice of their doctor, but patients taking Zetia and Vytorin should immediately contact their doctors to discuss this situation.

Zetia has been linked to other conditions, including blood disorders involving platelet production. Shipman & Wright, LLP has been investigating these claims on behalf of clients. Now additional investigation will be conducted to determine if patients have other legal claims to pursued.

Originally posted at InjuryBoard by Jean Martin

Judge Orders Release of Information on Doctors

Gary Shipman — Thu, 30 Aug 2007 17:22:00 GMT

A United States District Court Judge in Washington has ordered the Health and Human Services Department to turn over information about doctors from the Medicare claims database by September 21. The ruling came in a case filed by a consumer group that sued HHS seeking the release of information that had previously been considered private.

Judge Emmet G. Sulllivan concluded that the release of the information would provide for a "significant public benefit" in ordered the release of claims information involving more than 700,000 doctors nationwide. The consumer group "Consumer's Checkbook" filed the action, and anticipates that it could have the information available, on-line, within a couple of months from receiving it.

For more information on this subject matter, please refer to the section on Medical Malpractice.

Originally posted at InjuryBoard by Gary Shipman

Doctor sued for medical malpractice in boy's death

Gary Shipman — Tue, 10 Jul 2007 16:58:19 GMT

The parents of a boy sued a Pennsylvania doctor for medical malpractice arising from the death of their 4 year old son.

The autistic boy died of cardiac arrest at the doctor's office after undergoing a procedure known as chelation therapy, a procedure designed to treat heavy metal poisining. The presence of Mercury has long been believed to be a cause of autism in children, and the procedure is approved by the FDA.

Chelation removes heavy metals from the body and is approved by the Food and Drug Administration only for acute heavy-metal poisoning that has been confirmed by blood tests. Some people who believe autism is caused by a mercury-containing preservative once used in vaccines say chelation may also help autistic children.
"This is a real human tragedy that never should have happened," said the attorney for the family. "The doctor had no business administering this drug to a child, and he only made matters worse by giving it much too quickly."

For more information on this subject, please refer to our section on Medical Malpractice and Negligent Care.

Originally posted at InjuryBoard by Gary Shipman

Wilmington Personal Injury Lawyer - Medical Malpractice

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

Lawsuits Against North Carolina State Employees

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

FDA Issues Warning About Heparin

More Health Problems From Fosamax

Blood Thinner Heparin Recalled - UPDATED 2/12/08

More Hernia Repair Patches May Be Defective

Zetia and Vytorin - That Which Does Not Kill Us Make Us Sicker?

Judge Orders Release of Information on Doctors

Doctor sued for medical malpractice in boy's death