"Ask a Lawyer" - Mesh Implants

I am a 38 years old woman who had a mesh implant three years ago.  Now I am having awful issues with it.  I read that there is a lawsuit over these implants.  Will the lawsuit make the company pay for removal? Angie, Dora

Also called a sling, patch, and tape, a mesh implant is a surgical mesh device used to treat pelvic organ prolapse and stress urinary incontinence in women. Several medical device manufacturers such as C.R. Bard, Johnson & Johnson, American Medical Systems, and Boston Scientific manufactures and sells surgical mesh products designed for implantation. Recently, the FDA and thousands of patients have been questioning the safety of these products; the FDA even issued a warning to patients and healthcare providers regarding the potential risks of this product.

More than 5,000 patients filed injury reports to the FDA during 2005 and 2014. The FDA estimates that failure rates for mesh devices may be as high as 10 percent. Device failure can result in serious complications such as:  scarring, recurrence of condition, inflammation, mesh erosion, urinary problems, and pain.

Why did the FDA approve a product with such a high failure rate? 

The first mesh device was approved in 1996 under the FDA code 510(k), a clearance process that does not require the manufacturer to conduct thorough testing of the product. Although the device was recalled after three years, due to overwhelming numbers of injury reports, dozens of medical device manufacturers have been able to receive clearance for products similar to the recalled mesh.

If you are satisfied with your treatment, it is not necessary for you to take further action. However, it is important for all patients to go through annual and other routine check ups to ensure complications do not develop in the future.

If you have suffered health complications, patients may file a product liability lawsuit against the medical device manufacturers.  Compensation claimed in a lawsuit will include an amount to pay for a revision or removal.  Presently, several companies are facing lawsuits from women who have been harmed as a result of mesh devices such as: Gynecare, TVT, Avaulta, Gynemesh, Elevate, Perigee and Advantage Mid-Urethral Sling

Patients who have been injured by a surgical mesh implant and are considering legal action should contact a professional product liability lawyer as soon as possible.

Product Liability lawyers at Nelson, Bryan and Jones have accumulated years of experience litigating against large corporations on behalf of wrongfully injured consumers. With a track record of successfully taking on large corporations, our attorneys have recovered millions of dollars in settlements and verdicts for seriously injured victims. For more information on how the lawyers at Nelson, Bryan and Jones can help you, please call us today to schedule a free consultation.

Nelson, Bryan and Jones represents clients in the following areas: Social Security Disability, Motor Vehicle Accidents, Wrongful Death Cases, Personal Injury Actions, Defective Products, Insurance Disputes and Bad Faith, Fire Loss cases, Trucking Accidents, Worker’s Compensation, Drug Recalls, Employment Law and Property Damage Claims.

FDA Orders Warning Labels on Testosterone Drugs

The Food and Drug Administration said Tuesday that it is requiring drugmakers to warn patients that testosterone products may increase the risk for heart attacks and strokes.

From WebMD:

March 4, 2015 -- Testosterone-boosting drugs taken by millions of American men have never been proven to be safe or effective for treating aging-related problems, the U.S. Food and Drug Administration says.

On Tuesday, the agency also said the drugs can increase the risk of heart attack and told manufacturers they must add that caution to the warning labels on the products, the Associated Press reported.

A similar warning about testosterone drugs was issued last summer by Canadian health officials.

The agency also told drug companies must clarify that the drugs are only approved to treat low testosterone levels caused by injury or disease.

For years, testosterone pills, patches, gels and injections have been marketed as treatments for low testosterone levels, and sales of the drugs have risen to more than $2 billion.

"There's been a very successful advertising campaign to make men feel that whatever their problem is, the answer is to buy more testosterone," Dr. Sidney Wolfe, of the consumer advocacy group Public Citizen, told the AP.

Last February, the group petitioned the FDA to have testosterone drugs carry a boxed warning -- the most serious type -- about heart risks, but the FDA said there was "insufficient evidence" for such a warning and rejected the petition.

The FDA launched a safety review of testosterone drugs in January 2014 after two federal studies linked them with higher rates of serious problems such as heart attack and stroke. However, other studies have suggested an association between testosterone replacement and longevity, the AP reported.

Men's testosterone levels naturally decrease after age 40, but there is disagreement on whether this actually causes problems such as lower bone density and less energy.

"Ask a Lawyer" - Defective Hip Replacements

I had hip replacement surgery about 4 years ago in Birmingham.  A metal hip was put in and now I am hearing on TV that metal hips may be defective.  What do I need to do?    Vivian T., Jasper, AL

Hip replacements are usually very successful.  As we age, we all want to remain physically active, even when our natural bodies may start to wear out.  As a result, more than 285,000 total hip replacements are performed each year.

An artificial hip includes two parts, a cup and a ball. Originally, one part was made of metal and the other of plastic. About 10 years ago, manufacturers came out with a model that used metal on both sides. Soon, these “sturdier” devices accounted for about one-third of all hip replacements.

Artificial hips, made from metal and plastic, typically last about 15 years. But the metal-on-metal replacements are failing much sooner. Plus, they are “shedding” metallic debris that damages tissue and bone and leads to symptoms like skin rashes, neurological changes such as hearing and vision impairment, and psychological problems like depression. Patients with these metal-on-metal implants have also been found to have high levels of metal ions in their blood stream. This is evident from the microscopic particles escaping into the body.

An estimated 500,000 patients in the United States have received metal-on-metal hips from a variety of manufacturers. This is one of the biggest medical device failures in recent decades. With all of this new information, metal-on-metal devices are now used in only about five percent of hip replacement procedures.

In May 2011, the U.S. Food and Drug Administration ordered a post-market surveillance study on metal-on-metal hip replacements to see if they were shedding high levels of metallic debris. In January 2013, the FDA proposed that companies making metal-on-metal artificial hip joints produce medical evidence demonstrating their safety in order to stay on the market. Any new devices of this type will require human clinical evidence before they are approved.

Patients who already have a metal-on-metal hip must decide what to do. About 93,000 patients received a model manufactured by the DePuy division of Johnson & Johnson.  It was recalled in mid-2010. An internal analysis conducted by the company following this recall estimates that the all-metal device would fail within five years in nearly 40 percent of patients who received it. The company did not release this information, but it became public in early 2013 as a court document.

If you have this specific type of metal-on-metal hip replacement implant, you should regularly see your doctor for a routine evaluation of the hip joint. There are specific recommendations for patients with this implant about what tests and monitoring should be done and if further surgery should be considered.

At Nelson, Bryan and Jones, we are actively representing many people who have had metal hip replacements like you.  There are settlement options that may become available very soon.  Most people who have metal hips will need an attorney to help them navigate through a very complex claims process.  Please give us a call if you would like to talk further about your legal remedies. 

Please send the questions to:
Ask the Attorney
P. O. Box 2309, Jasper, AL 35502

205-387-7777
or email to bob@nelsonbryanjones.com

No representation is made that the quality of legal services to be performed is greater than the quality legal services performed by other lawyers.

"Ask a Lawyer" - Product Liability (Unguarded Machine)

I was hurt recently by a machine at work that wasn’t guarded properly.  It was only my second week running that particular piece of equipment.  My supervisor told me that I should look into a product liability lawsuit.  What are my chances of success? Peyton S., Jasper

Peyton, I am sorry you were hurt.  You should definitely consult with an attorney with experience handling Product Liability cases.  There are a lot of issues that will factor into whether the case will be successful.  Let me give you some basic information on Product Liability law.

Product liability lawsuits are grouped into three categories. The first category involves defectively manufactured products, meaning that a mistake was made either at the factory or between the factory and wherever the product was purchased, resulting in a faulty product. The second category involves defectively designed products, meaning that the product is dangerous in some way even though it was correctly manufactured. These cases involve an entire line of products that are unreasonably dangerous. The third category involves a failure to provide adequate warnings or instructions regarding the proper use of the injury-causing product. 

Many product liability claims arise out of the use of pharmaceutical drugs with dangerous side effects.  Often, the side effects of the drugs were unreasonably dangerous or the manufacturer did not warn the patient of those side effects.  

There are three general types of evidence you will need in order to win your lawsuit:

·      First, you must prove you have been injured or suffered some other kind of damage and that the defect was the specific cause of your injuries or damages.

·      Second, you must prove the product involved in your case was defective or lacked proper warnings or instructions.

·      Finally, you must prove that you were using the product in more or less the manner in which it was intended to be used.

In Alabama, you must file a defective product liability lawsuit within two years of the date of injury. If you fail to file your lawsuit before this statute of limitations expires, the judge will throw out your case, no matter how good your claim may be. There are a few exceptions if the injury is not discovered "or should have been discovered" until after the two years has passed. This is especially true in such cases involving defective drugs.

One of the most important aspects of evaluating a products liability claim is determining what types and amounts of damages you have suffered.  Compensatory damages are intended to restore you to the condition you were in before the injury occurred by attaching a dollar value to each of the bad things that happened to you as a result of the injury. These damages include "economic" losses such as medical expenses, lost wages or profits, and any damage to your property. They also include certain "non-economic" losses, such as pain and suffering.  If a judge or jury finds that the defendant has acted particularly badly, you may also be entitled to punitive damages that will punish a defendant for its conduct and to deter others from engaging in similar conduct.

Nelson, Bryan and Jones represents clients in the following areas: Social Security Disability, Motor Vehicle Accidents, Wrongful Death Cases, Personal Injury Actions, Defective Products, Insurance Disputes and Bad Faith, Fire Loss cases, Trucking Accidents, Worker’s Compensation, Drug Recalls, Employment Law and Property Damage Claims.

Please send the questions to:
Ask the Attorney
P. O. Box 2309, Jasper, AL 35502

205-387-7777
or email to Bob@NelsonBryanJones.com

or jasper@mountaineagle.com

No representation is made that the quality of legal services to be performed is greater than the quality legal services performed by other lawyers.