March 2013 Archives

March 19, 2013

Doctors Urge FDA to Take Action on Energy Drink Dangers

Today numerous experts and medical doctors wrote a Letter from doctors to FDA 3.19.13.pdf to the U.S. Food and Drug Administration (FDA) concluding that:

"Based on our own research and our review of the published literature cited herein, we conclude that there is no general consensus among qualified experts that the addition of caffeine in the amounts used in energy drinks is safe under its conditions of intended use as required by GRAS standard, particularly for vulnerable populations such as children and adolescents. On the contrary, there is evidence in the published scientific literature that the caffeine levels in energy drinks pose serious potential health risks, including increased including increased risk for serious injury or even death."

The signatories to this letter are from prestigious teaching hospitals and schools including John's Hopkins, University of Maryland, Wake Forest School of Medicine, University of California Berkley, and UMass Memorial Medical Center.
energy drinks pic of cans.jpgThe doctors urge the FDA to take quick action to protect children and teens from the dangers of highly caffeinated energy drinks and to apply the "Generally Regarded as Safe" standard for soda to energy drinks and other beverages that contain caffeine as an additive.

The doctors also urged the FDA to require energy drink manufacturers to include caffeine content on product lables.

The letter first desccribes what Energy Drinks are and discusses that they are marketed to teenagers and young adults.

The letter does a good job of distinguishing energy drinks from coffee (see page 2). Basically the Letter explains that caffeine in coffee is naturally occurring, many energy drinks contain more caffeine than coffee, and coffee is typically served hot and consumed slowly while energy drinks are served cold and consumed rapidly (some manufacturers advertising and can design encourage teens to ingest large quantities quickly by saying things like "pound down" "Chug it down".

The article then discusses the health complications of energy drinks. The article discusses the FDA Adverse Event Reports, DAWN Drug Abuse Warning Network reports of increased Emergency Room Visits, Cardiovascular Complications, Seizures, Childhood Obesity, and other health issues related to the consumption of energy drinks. The report also discusses the combination of alcohol consumption and energy drinks. The Article states "consuming energy drinks mixed with alcohol is associated with serious alcohol related consequences such as sexual assault and driving while intoxicated."

Anyone interested in learning more about the dangers of energy drinks should read this letter. It is very well written and well documented with 66 footnotes citing to a large amount of scientific articles about energy drink dangers. Another great resource for information about the dangers of energy drinks is at GFMJustice.com

Of course if you or someone you know has suffered a heart attack or death after consuming an "energy drink" please contact us at 888-213-8140.

March 1, 2013

Transvaginal Mesh Injuries--Recent $11.11 Million Dollar Verdict in New Jersey


What is Transvaginal Mesh?

Thousands of women have been treated with transvaginal mesh products since 2002 and many have suffered injuries as a result. These products have been used since about 2002 to treat "Stress Urinary Incontinence" (SUI) and "Pelvic Organ Prolapse", also known as (POP). The trans vaginal mesh procedure was touted as an easier and safer alternative to hysterectomy surgery. Hundreds of thousands of women have had the procedure to treat stress urinary incontinence and pelvic organ prolapse. FDA Warning.jpg

Stress Urinary Incontinence is basically when urine leaks during physical activity such as running, coughing, sneezing or laughing). Pelvic Organ Prolapse (POP) is basically when the bladder falls from its normal position in the tummy and pushes against the vaginal walls. This often occurs after childbirth or surgery. Many of those who had the procedure later complained of complications including pain, infection, excessive bleeding; and many had to have follow up surgeries.


The Problems with Transvaginal Mesh

Scientific studies have found that women treated with vaginal mesh have a much higher likelihood of developing bladder perforation, urinary incontinence, and also that many women needed follow-up surgeries to correct these problems. The FDA (with the Cetner for Devices and Radkological Health) has also recognized the problems and in July 2011 issued a report titled Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse confiming the concerns in the scientific studies. The side effects of transvaginal mesh include the following:

• Mesh Erosion of the vaginal skin
• Pain during sexual intercourse
• Recurrence of Pelvic Organ Prolapse
• Urinary Incontinence (peeing on yourself)
• Internal Bleeding and Infection

FDA Action---Are they part of the problem or part of the solution?

The Food and Drug Administration (FDA) has been monitoring the problem with Transvaginal Mesh. In fact, in 2008 the FDA issued an alert to tell patients and doctors that ladies with vaginal mesh were suffering a high rate of complications. From January 2008 to December 2010 there were nearly 3,000 reports of injuries and/or death from linked to transvaginal mesh used for pelvic organ prolapse (POP) or Stress Urinary Incontinence (SUI). What is now clear is that transvaginal mesh was not properly tested before it was sold to consumers. The various manufacturers knew that the mesh product was very good at treating hernias, and therefore assumed that it would also be an excellent product when surgically placed in the vagina. The manufacturers pushed the product through the FDA's expedited 510(k) approval process which does not require testing since the mesh was similar to the mesh used to treat hernias. This presumption has proven wrong, and as a result of transvaginal mesh manufacturers rush to get their product to the market, literally thousands of women have suffered life altering injuries. The FDA issued an Updated Alert in July 2011 in which it states

"Based on an updated analysis of adverse event reports reported to the FDA and complications described in the scientific literature, the FDA identified surgical mesh for transvaginal repair of POP as an area of continuing serious concern...The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repairs of POP are not rare."

February 2013 ---First Jury Verdict in Vaginal Mesh Case

The first Vaginal Mesh Lawsuit went to trial in New Jersey and the jury returned a verdict on February 25, 2013 of compensatory damages in the amount of $3.35 Million Dollars in compensatory damages against Johnson & Johnson, and $7.76 million in punitive damages for a total vaginal mesh verdict of $11.11 Million Dollars. While our firm did not handle this particular case, the verdict is important because it provides insight as to the potential value of vaginal mesh cases. Of course every case is different and the outcome in one case does not guarantee the outcome in any other case. That said, there are over 1,800 other vaginal mesh lawsuits pending throughout the USA and I am sure that vaginal mesh manufacturers such as Johnson and Johnson, C.R. Bard, Mentor, Boston Scientific, Gynecare, Tyco, Covidien, and American Medical Systems will have to take this large verdict into consideration as the decide whether to litigate or settle future transvaginal mesh lawsuits. The case involved a 47 year old lady from South Dakota who had a transvaginal mesh product called Ethicon Gynecare Prolift. The jury found that Ethicon failed to warn the patient's surgeon of the risks associated with Prolift vaginal mesh and that the defendant also improperly marketed the device.

Call Us For A Free Case Evaluation From A Female Intake Specialist 888-213-8140

If you or someone you love has been injured as a result of a Pelvic Mesh product, then call us at 888-213-8140 to discuss your legal rights.