University of Florida Bans Cheerleader Aerial Stunts

University of Florida (UF) cheerleaders will no longer be allowed to perform aerial stunts or tumbles during football games. UF administrators say the decision was not made lightly but the timing is interesting.

Three days before the announcement was made in November, a cheerleader for the Orlando Magic fell off a teammate’s shoulders and crashed to the floor, breaking a rib and fracturing three vertebrae.

In October, a study released by the American Academy of Pediatricians (AAP) found cheerleaders suffered a disproportionally high number of skull fractures, spine injuries, and catastrophic injuries. The AAP’s recommendation was that cheerleaders be treated like other athletes and cheerleading should be designated a sport. That would require high schools and colleges to follow the rules set by a sport governing body.

In addition, to keep the sport safer, the AAP recommends participants need to receive physicals in advance of the season and coaches need to be trained on spotting gymnastics stunts.

Twenty-nine states already treat high school cheerleading as a sport, reports the Wall Street Journal. There about approximately 400,000 primarily girls who participate in high school cheering in the U.S.

Not all high school cheerleading involves tumbling but as cheerleading has become more athletic, involving aerial moves and pyramid formations, hospital visits have jumped 400 percent from 1980 to 2007.

The University of Florida Athletic Association confirmed the school was taking action, “a proactive stance to protect cheerleaders, who represent the University of Florida with enthusiasm and class, and allow them to lead cheers at Gator games for years to come.”

The cheerleaders are not too happy about the decision and have been expressing their attitudes about the decision on social media. Many feel the accident could have been prevented largely because, in this case, there was no spotter behind the cheerleader who fell.

The American Association of Cheer Coaches and Administrators has a strict set of guidelines that profession and competitive cheerleading teams are supposed to follow.

Five Hour Energy Linked to 13 Deaths

The government is releasing information about a growing number of injuries associated with those so-called energy drinks. Among them, 5-Hour Energy, a highly caffeinated energy shot that also contains vitamins and a substance called taurine. It’s marketed to “hardworking adults” who just need a little boost of energy.

Since 2009, 5-Hour Energy has been named in some 90 adverse event filings with the U.S. Food and Drug Administration (FDA) including heart attacks, spontaneous abortion, convulsions and death.

The reports are coming from the public and medical professionals into the FDA’s adverse events database, which the New York Times reports is difficult to verify.

Last Friday, the FDA released reports of injuries related to Red Bull, a top-selling energy drink including 21 adverse events or complications including heart problems and vomiting. The drink maker said it was unaware of such events and that Red Bull is safe.

Monster Energy has been named in five fatality reports, according to the FDA.

Consumer Reports says Monster Energy contains about 215 milligrams of caffeine.

An 8 oz cup of coffee has from 100 to 150 mg of caffeine. While the link between adverse events including death to energy drinks is inconclusive, the FDA warns to check with your doctor before drinking them.

The Substance Abuse and Mental Health Services Administration, a federal agency, reports there were 13,000 emergency room visits in 2009 linked to energy drinks.

Regulation is inconsistent at the very least.

Rockstar, 5-Hour Energy, and Monster Energy are regulated as a dietary supplement. Manufacturers are required to contact the FDA with adverse events it hears about. Meanwhile Red Bull, NOS, and AMP are marketed as a beverage, with no requirements on the manufacturer to report to the FDA.

Reports of adverse events were made public concerning Monster Energy and 5-hour Energy only because they were released by the FDA under the Freedom of Information Act.

Sens. Richard Durbin of Illinois and Richard Blumenthal of Connecticut have contacted FDA commissioner Dr. Margaret Hamburg to further discuss the regulation of energy drinks.

In 2010, there were 17 fatality reports that mentioned weight loss or dietary supplements, however there are 50,000 products that fall within that category, says the head of the dietary supplement division within the FDA.

Sales of energy drinks grew to $8.9 billion last year, the Times attributes to Beverage Digest, a trade publication.

Individual Lawsuits Filed Against Mentor Corporation’s Relating To Its ObTape Transobturator Product

Today, attorneys Kelly Hyman and Brenda Fulmer filed two more individual lawsuits against Mentor Corporation relating to its ObTape transobturator product which was withdrawn from the market in March of 2006.  The first case was filed on behalf of a Gulf County, Florida woman who was implanted with the defective Mentor ObTape medical device in 2004. Since implantation, she has suffered a number of complications that have necessitated costly medical treatment, hospitalizations, and surgery.

The second case was filed on behalf of a Charlotte County, Florida resident who was also implanted in 2004 with the negligently designed ObTape TVT tape product. Since 2004, she has undergone extensive medical treatment, hospitalizations, and surgeries in Southwest Florida and the Tampa Bay area due to significant injuries and disabilities stemming from a catastrophic failure of the implant to perform as intended and warranted.

The entire class of TVT tapes, transvaginal meshes and bladder slings has been under a cloud of safety concerns for several years now due to an excessive rate of product failures. When a pelvic mesh device fails, unfortunately, the defective product causes such significant damage to the patients, such that even surgical removal of the eroded implant as well as reconstruction may not be enough to restore their ability to have normal sexual relations or avoid chronic pain. The materials utilized in this ill-conceived class of medical devices undergo significant chemical changes when implanted in a woman’s body, which can lead to chronic infections, pelvic pain, hardening of the mesh, scarring, formation of adhesions, shrinkage of the mesh, sexual dysfunction, urinary problems, disfigurement, bleeding, injury to other vital organs, and extrusion of the medical device or pieces of the medical device through the vaginal wall.

There are several hundred lawsuits that have been filed against Mentor Corporation over the withdrawn ObTape product, most of which are pending in the multi-district litigation proceedings pending before Judge Clay Land in the United States District Court for the Middle District of Georgia in Columbus. Cal Warriner of Searcy Denney serves as co-lead counsel of this MDL while Brenda Fulmer and Kelly Hyman of the law firm are involved in ongoing document review, depositions, and trial preparation for the first bellwether trials in this coordinated action.

Mentor Corporation (and its successor Coloplast) also faces dozens of lawsuits over its Aris pelvic mesh product. Cases involving the Aris device are pending in a separate MDL in West Virginia. Decision-making regarding the design and marketing of the Aris device, however, are part of the liability store in the Mentor ObTape lawsuits that are currently being prepared for trial.

Doctor Blames Attorneys for Surgical Mesh Controversy

This is a tough one to believe. A Minneapolis doctor issued a press release going on the attack against plaintiffs’ lawyers who are representing women seriously injured by synthetic mesh used to treat prolapse and incontinence

Dr. Jon Nielsen doesn’t let the facts get in the way.

Nielsen, a doctor at Oakdale Obstetrics & Gynecology in the Minneapolis, Minnesota used to deliver babies until this year. His biography says he has transitioned into relieving the medical complications for women that accompany aging. But in his release he tells patients that “plaintiff lawyers are in ‘attack mode’ and have demonized the MESH rather than the PROCEDURES that were ineffective.”

In other words – blame the bad lawyers and bad doctors, not the mesh.

It was in 2008 and again in 2011 that the federal watchdog agency, the U.S. Food and Drug Administration (FDA) issued a Public Health Safety Notification that said mesh complications are “not rare” and may include “pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems.” There were also reports of “recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems.”

Surgeries using synthetic mesh to treat prolapse and incontinence have left thousands of women in mental and physical anguish, facing additional surgeries, and an uncertain financial future since the injuries often lead to permanent disability.

It doesn’t sound like a problem caused by a lawyer.

That is not the only misinformation or spin the good doctor is disseminating. He says “most of these surgical products have also been removed from the market,” referring to mesh that erodes through the vagina.

That simply is not true.

Most synthetic polypropylene mesh remains on the market with the exception of four meshes that Ethicon (Johnson & Johnson) announced in June it was gradually phasing out as well as Bard’s Avaulta mesh the company decided to pull from the U. S. market in July.

Why then does Dr. Nielsen say, “the vast majority of this information (mesh controversy) comes from law offices trying to secure business. Second, the mesh is not the problem, only certain surgeries using the mesh.”

In reality there were nearly 4,000 mesh-related injuries the FDA found in a three-year period from January 2008 to December 31, 2010. And many of those mesh injuries were associated with “mid-urethral slings” used to treat incontinence which Dr. Nielsen says “are not criticized or questioned by the FDA.”

However in the FDA’s July 2011 warning it says concerning mesh slings placed abdominally, “FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date.”

Litigation over synthetic mesh used to treat prolapse and incontinence is growing with five manufacturers facing thousands of cases consolidated in the Southern District of West Virginia and a sixth MDL in the Middle District of Georgia.

Already we know the result of the first trial that concluded in July in Bakersfield, California state court. Jurors there determined the Avaulta Plus Biosynthetic Support System vaginal implant caused Christine Scott’s chronic pain, mesh erosion, and incontinence and that she and her husband deserve the $5.5 million damage award after the Bard mesh eroded into her vagina, perforated her colon, leading to eight surgeries so far and ongoing, severe pain.

These are not cases born of some trial lawyer’s fantasy but real life injuries that the manufacturers knew or should have known would occur.

Will Florida Be The Epicenter For DePuy ASR Hip Litigation

Cal Warriner and Brenda Fulmer of the Searcy Denney Mass Tort Unit filed yet another case against DePuy earlier this month for a client with a defective ASR metal-on-metal hip implant.

This latest individual lawsuit was filed on behalf of an Orlando woman who underwent hip implant surgery in late 2006 at Osceola Regional Medical Center by Dr. Michael Karr, a local orthopedic surgeon.  She was implanted with a DePuy ASR metal-on-metal hip implant which was manufactured and distributed by DePuy, a division of Johnson & Johnson, located in northern Indiana.  In August of 2010, she was notified that her hip implant had been recalled by DePuy.  This recall notice was issued by DePuy long after it first discovered that its metal-on-metal hip implants were defective.  There had been evidence for several years prior to 2010 that showed that patients worldwide who were implanted with DePuy ASR hip implants were experiencing premature failure of the devices as well as metallosis, pseudotumor formation, and other serious complications.  This Orlando woman was diagnosed with metallosis after lab tests confirmed elevated levels of cobalt and chromium in her bloodstream.  In March of 2011, she underwent another painful hip arthroplasty surgery to remove the recalled DePuy implant.  She and her husband are seeking damages for pain and suffering, unpaid medical expenses, lost wages, loss of earning capacity, and future medical expenses.

This lawsuit was filed in state court in Orange County, Florida, and also includes a local independent distributor and its sales representatives who were present in the operating room during the plaintiff’s surgeries and provided critical product information to the surgeon in addition to DePuy.  Most of the several thousand lawsuits pending against DePuy are part of MDL No. 2197, the coordinated federal court proceedings involving the recalled DePuy ASR hip implants, which is pending before Judge David Katz in Toledo, Ohio.  Judge Katz will be holding an important hearing on June 5, 2012, in Philadelphia, at which time he is expected to schedule the first trials in the MDL proceedings.  It is likely that the individual cases that will be chosen for bellwether trial preparation and be eligible for these early trial settings will hail from either Northern Ohio or Southern Florida, as these are regions where Judge Katz holds hearings.