"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.

Zofran Breaking News - New Study shows that Zofran can cause birth defects including cleft lip, cleft palate, and congenital heart defects.

Zofran was approved by the U.S. Food and Drug Administration (FDA) to treat nausea and vomiting caused by chemotherapy and radiation. The drug was also prescribed to treat morning sickness in pregnant women, but it was not approved by the FDA for this use.

The Center for Birth Defects Research and Prevention recently published a study isuggesting that women who used Zofranduring the first trimester of pregnancy had a twofold increase risk of having a child with birth defects.

Possible Zofran defects may include cleft lip, cleft palate, and congenital heart defects. Although Zofran was not approved by the FDA for morning sickness, GlaxoSmithKline (GSK) promoted off-label use of the drug. GSK agreed to pay $3 billion in 2012 to settle numerous allegations including illegally marketing Zofran® for non-approved use. 

Mothers who took Zofran during pregnancy and had a child with cleft lip, cleft palate, or heart defects may be entitled to compensation.  Contact a Nelson Bryan and Jones (205-387-7777) to find out if you and your child are eligible for compensation.

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" - Xarelto

I was prescribed Xarelto to prevent strokes in October 2013. Because of Xarelto, I required hospitalization for severe bleeding. I understand there is a lawsuit I can join.  How do I make a claim?  Joanne, Jasper 

Joanne, we are actively representing clients who took Xarelto and developed bleeding issues.  Call us at 205-387-7777 and we can file a claim for you immediately.  Claims need to be filed quickly because time is running out.  Let me explain what experts believe is causing the problems.

What is Xarelto?

Xarelto was introduced three years ago, claiming it could change the quality of people’s lives that need to take blood-thinning medication daily.  It was touted as a superior alternative to Coumadin (warfarin). Coumadin has been the go-to medicine for prevention of strokes for the past 60 years. All blood thinners have a side effect of an increased risk of bleeding problems.  However, Xarelto has been linked to an increasing number of adverse event reports involving uncontrollable bleeding injuries.

Xarelto Uncontrollable Bleeding Allegations

Drug manufacturers failed to warn about dangerous side effects that caused uncontrollable bleeding that resulted in hospitalizations, the need for blood transfusions and in severe cases, death.  Severe injuries and deaths could have been averted if the pharmaceutical companies had not provided misleading information about blood monitoring, or if stronger warnings had been provided about the lack of a Xarelto reversal agent or antidote.

Xarelto: No Antidote

Unlike Coumadin (warfarin) that required constant blood monitoring, Xarelto was touted as a revolutionary product that was a once-a-day blood thinner that did not burden the patient with constant monitoring. Xarelto claimed that it is easier to use, since it does not require regular blood monitoring. Medical experts, however, insist that Xarelto blood monitoring actually helps doctors identify patients at the greatest risk of bleeding.

Coumadin bleeds can be quickly reversed in an emergency with vitamin K or blood transfusions. However, there is no approved bleeding antidote for patients using Xarelto, and many of the bleeding side effects have resulted in catastrophic outcomes after doctors were unable to control Xarelto bleeds.

Your family doctor is not to blame:

Your doctor prescribed an FDA-approved drug that was reasonable given your illness and your general health. He or she used all of the information available to prescribe the right medication to treat your condition.  However, the pharmaceutical company knew about the potentially fatal side effects and failed to tell your doctor about the risks. In this type of situation it is the pharmaceutical company, not your doctor, who is legally responsible for your injuries. 

Call 205-387-7777

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

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" - 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.

FIFTH Verdict Against Actos for Causing Bladder Cancer

CALL Nelson, Bryan & Jones today (205-387-7777) if you or a loved one have been diagnosed with cancer after taking Actos or a generic form of Actos

(Bloomberg) -- Takeda Pharmaceutical Co. was ordered by a jury Thursday to pay more than $2.3 million in damages for Actos diabetes drug causing  bladder cancer.

Jurors in Philadelphia deliberated more than eight hours over two days before finding that Takeda failed to properly warn John Kristufek’s doctors about Actos’s cancer risks.

The panel concluded Kristufek deserved more than $300,000 for his medical expenses and $2 million for pain and suffering tied to the cancer diagnosis, his lawyers said.

The jury also said Takeda showed “reckless indifference” to Kristufek’s health by hiding Actos’ risks, a finding that opens up the drugmaker to a potential punitive award. The panel will consider Friday whether to award those damages.

Kristufek is the fifth Actos patient to convince a jury that Takeda’s former top-selling drug causes bladder cancer. Last year, a federal jury in Louisiana ordered Takeda and Eli Lilly & Co., which at one time sold Actos in the U.S., to pay $9 billion to a shopkeeper who blamed his cancer on the drug. That award was cut to $36.8 million.

“Given the number of trial losses Takeda has suffered over Actos, the company should seriously consider negotiating some sort of global settlement,” said Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia. “They still face thousands of lawsuits over this drug.”

Actos has generated more than $16 billion in sales since its 1999 release, according to court filings. Sales peaked in the year ended in March 2011 at $4.5 billion, 27 percent of Takeda’s revenue at the time, according to data compiled by Bloomberg. Takeda now faces generic competition from Ranbaxy Laboratories Ltd. over the diabetes drug.

Kristufek and other former Actos users argue Takeda executives ignored or downplayed concerns about the drug’s cancer-causing potential before it went on sale in the U.S. in 1999 and misled U.S. regulators about the medicine’s risks.

Juries in California and Maryland in 2013 ordered Takeda to pay a combined $8.2 million in damages over the handling of the drug.

Last year, a Philadelphia jury awarded more than $2 million in damages to a retired accountant who blamed her bladder cancer on Actos.