D-Day is Today for the NCAA

from AAJ Newsbrief

     In a 1,500-word feature, the Los Angeles Times (6/20, Wharton, 692K) offers a preview of today’s hearing in the O’Bannon lawsuit, a case challenging the idea of amateurism in college sports. The judge “must decide if thousands of current and former college players can join as plaintiffs in what would become a class-action suit,” which could then “potentially chang[e] the business of Saturday afternoon football games and March Madness.” The Times notes, “Big Ten Conference Commissioner Jim Delany filed a legal declaration stating that changes to the current system might force his member schools to ‘downsize the scope, breadth and activity of their athletic programs,’ shifting to a model that resembles the smaller, less glamorous Division III”; however, “some experts believe there is enough money to spread around.” The article states that it is not clear whether the judge would hear oral arguments or make a decision on Thursday and quotes a variety of academics and university officials on both sides of the issue. “The simple, straightforward truth is that the NCAA has never licensed student-athlete likenesses,” said NCAA executive vice president and general counsel Donald Remy.

        USA Today (6/19, Berkowitz, 1.71M) adds, “Lawyers involved with the case are not anticipating that she will issue a ruling Thursday, but her questions and reactions to each side’s arguments may provide hints about her thinking on two separate, but related, issues: the immediate legal requirements for class certification and the broader merits of the plaintiffs’ case.”

        The New York (NY) Times (6/20, B12, Eder, Bishop, Subscription Publication, 1.68M) reports that in 2008, “N.C.A.A. executives, in private communications, opposed any notion that college football and basketball players should get a cut of the profits.” According to the Times, “A review of numerous e-mails sent by N.C.A.A. officials and video game executives suggests that the N.C.A.A. has long had a goal of ensuring it makes as much money as possible while doing everything it can to keep students from being paid,” but the NCAA “disputes that video game avatars and live broadcasts of games have violated athletes’ rights.” The Times prints a number of internal NCAA emails between executives to make its point before quoting Remy as saying, “It is a healthy dialogue that occurred in the organization.”

        In a separate story, USA Today (6/20, Berkowitz, 1.71M) reports, “Video game manufacturer Electronic Arts went to great lengths to make sure the avatars in its college football and college basketball games resembled actual student-athletes, and high-ranking NCAA officials knew about, and approved of, the practice, lawyers for the plaintiffs in an anti-trust suit against EA, the NCAA and the Collegiate Licensing Co., wrote in portions of documents unsealed Wednesday night.” The information, made public the day before a hearing in the case, came from “portions of documents that originally were filed in a redacted form in late April.” The article states that “NCAA spokesman Bob Williams could not be reached for immediate comment.”

        In a column for Sports Illustrated (6/19, 3.21M), Michael McCann offers a case primer, including a “comprehensive breakdown of where the case stands in advance of Thursday’s hearing.” Notably, McCann writes, “Although she would not acknowledge this, Wilken may have already made up her mind on certification after reading written materials submitted by both sides. In that case, she would use Thursday’s hearing to test her conclusions.” However, he also writes that U.S. District Judge Claudia Wilken has an “even-handed” reputation, although she “usually certifies classes.” McCann states that Sports Illustrated analyzed her 29 orders of class certification, finding she only denied it six times, or 21 percent. Partial certification was granted five times, with full certification being granted 18 times.

        In a separate Sports Illustrated (6/19, 3.21M) column, Andy Staples examines what is at stake in the hearing. For Staples, “The immediate answer is: nothing. Wilken probably won’t issue a ruling until later this summer on whether to certify the class.” Staples says that the case will not end college sports, no matter the outcome. “In the real world, people don’t simply walk away from multibillion-dollar businesses. In most of the potential outcomes, the NCAA will continue to operate in a fashion similar to the way it operates now. Even in the complete nightmare scenario for the NCAA, some organization will still exist to govern major college sports,” he writes.

        A separate New York (NY) Times (6/20, B14, Bishop, Subscription Publication, 1.68M) story profiles other key figures in the lawsuit, including Sonny Vaccaro, who said, “June 20 is the most important day in amateur athletics history.” According to the Times, “Vaccaro has become a key figure in the lawsuit, one of several whose roles have evolved along with the case.” Other people mentioned as playing a key role include Harry Flournoy and Sam Keller, former student-athletes who, according to the Times, believe they should be compensated for images that resemble their likeness.

        Columnist Nathan Fenno, in the Washington (DC) Times (6/20, 76K), writes, “Before competing, each athlete must sign a “Student-Athlete Statement” to be kept on file for six years. No negotiation. No option not to sign. The statement affirms, among other things, that the NCAA owns the rights to the athlete’s name and image. Bylaw 12.5.” Fenno continues on to criticize the system of amateurism in college sports.

        In an opinion piece for ESPN (6/20), Tom Farrey writes, “Lost in the finger-pointing is the fact that the collective storm of crises confronting the NCAA today was inevitable.” According to Farrey, the issue stems from a boon in commercialization brought about by the 1984 Supreme Court ruling in the Board of Regents vs. NCAA case. “If the 1984 case was settled differently, we wouldn’t have these issues,” said Gary Roberts, law school dean at Indiana University-Purdue University at Indianapolis and a former NCAA faculty rep. “The NCAA wanted to limit commercialization of college basketball and football to one game a week, and one network. If that lid had been kept on, we wouldn’t have the unleashed commercialization we see today.” 

British Medical Journal---Safety of Metal on Metal Hip Implants Questioned

New hip (Photo credit: okadots)

February 28, 2012

The British Medical Journal reported today that a million or more Americans have had metal on metal orthopedic implants installed since 2003.  That number continues to climb as as manufacturers continue to promote metal on metal devices.  This, despite the recall of devices (Depuy ASR), growing evidence of exposure to toxic and potentially carcinogenic metal ions, and the unprecedented requirement by the FDA that manufacturers conduct post-marketing studies.

Startling Highlights Contained in the Report Include the Following:

*Failure rates for all metal on metal hip implants is currently 13.6% as opposed to 3.3% for implants made of other materials.

*Multiple studies and research organizations have warned about the carcinogenic potential of metal-on-metal hip implants.

*Internal Depuy memos from July 2005 identify potential immune function changes and carcinogenic concern.

*Because of concerns, Depuy sales representatives were given paper entitled "Setting the record straight on metal hypersensitivity" written by Dr. Thomas Schmalzried (Depuy's hired consultant, stooge, or whatever you want to call him).

*In 2006, based on concerns, the MHRA (Medicines and Healthcare Products Regulatory Agency) committtee concluded that "there is evidence to suggest that some metal-on-metal hip replacements may be associated with increased DNA changes.

*Data showed raised metal ion levels in the Depuy Pinnacle were available since 2008, yet the device was promoted as the alternative for the subsequently recalled Depuy ASR.

*Speaking of the lax regulatory environment, one Depuy product manager responded to an email stating that "you could literally implant a tent rod if you wanted!"

Unfortunately for those with MOM implants, I fear that the news is only going to get worse.  The revision rate on our Depuy ASR clients is currently 46% and climbing.

If you have a MOM hip implant, it is imperative that you have regular blood tests for cobalt and chromium.

For additional information, feel free to contact me at Chrish@PittmanDutton.com

Related articles

• Serious concerns over Metal on Metal Hips - British Medical Journal (earlsview.com)
• Metal scare over hip replacement joints (guardian.co.uk)
• Jeremy Laurance: The regulator needs to recover its grip, fast (independent.co.uk)
• Hip implant fiasco highlights regulatory failings in Europe (guardian.co.uk)
• Thouands with metal-on-metal hip implants will need annual checks - WalesOnline (walesonline.co.uk)
• Metal Hip Implant Concerns - Potentially Bigger Scandal Than Breast Implants (medicalnewstoday.com)

What did Johnson & Johnson know about their hips and when did they know it?

According to the New York Times, a year before Johnson & Johnson's Depuy division recalled their ASR hip systems, Pamela Plouhar, vice president of Depuy Orthopedics, reported privately to top executives that the FDA was going to refuse to approve the device after data showed it failed prematurely in "significant" numbers.  The device was on the market overseas starting in 2003 and was marketed in the United States in 2005 under a loophole in the law.

This, of course, is in direct conflict with public statements by Johnson & Johnson which insisted that its internal studies refuted complaints by surgeons and regulators in other companies. Johnson & Johnson maintained that the failures were the result of improper placement of the implants by physicians--a position I continue to hear parroted by uninformed doctors or physicians still on Johnson & Johnson's gravy train.

There is only one problem with this defense----the data came from clinical studies performed by surgeons hand picked by Depuy and who received royalties and consulting fees associated with it.  In other words, Depuy's hand picked surgeons were seeing failures at the same rate as other Depuy surgeons who were using the product.

In addition to this email, documents filed with a Senate committee indicate knowledge of a serious problem in 2008, nearly 2 years before the hips were recalled.

Of course, lost in this discussion were the hundreds, if not thousands of people who are now suffering crippling injuries as Depuy continued to mislead both surgeons and consumers about the condition of its product.

Related articles

• Johnson & Johnson CEO resigns after series of missteps (money.cnn.com)
• Flawed DePuy Hip Implant Had Early F.D.A. Notice (nytimes.com)
• Hip Implant the FDA Rejected Was Marketed Abroad - New York Times (nytimes.com)
• Regulator dithering put hundreds of hip patients at risk (smh.com.au)
• J&J DePuy - Hip Implant that U.S. Rejected Was Sold Overseas (earlsview.com)

NCAA: WHO IS WALTER BYERS AND WHAT HAS HE SAID ABOUT THE COMMERCIALISM OF AMATEUR NCAA ATHLETES?

"Today, the NCAA Presidents Commission is preoccupied with tightening a few loose bolts in a worn machine, firmly committed to the neoplantation belief that the enormous proceeds from college games belongs to the overseers (the administrators) and supervisors (coaches). The plantation workers performing in the arena may receive only those benefits authorized by the overseers. The system is so biased against human nature and simple fairness in light of today's high dollar, commercialized college marketplace that the ever increasing number of primary and secondary NCAA infractions cases of the 1990s emerge in the current environment as mostly an indictment of the system itself."

Walter Byers, Unsportmanlike Conduct, 1995

For many of us who live in the south, terms like "plantation" and "overseer" invoke strong images and thoughts. So, when I read these words (and others I will detail) in Walter Byers book, written in 1995, I immediately took notice.

WHO IS WALTER BYERS? Walter Byers served as executive director of the NCAA from 1951 to 1987. Among other things, he started the NCAA enforcement program, pioneered a national academic rule for athletes and negotiated more than 50 television contracts. I think this qualifies him to opine on the subject of amateurism and compensating players.

As the NCAA entered the 90s, they had just disposed of the Jerry Tarkanian matter. For those of us old enough to remember, Tark the Shark was a successful basketball coach at UNLV. The NCAA went to war with Shark the Tark and the shark bit back. Who won depends on who you ask.

The case had all of the usual story lines. Money, cars, admissions issues, suspect grades, all in the backdrop of sin city. Throw in an upstart program (not Kentucky or UCLA) and you have a made for television movie. If there had only been sports talk radio and the internet back then.

As it always does, the NCAA considered itself victorious. Good had defeated evil. The case would serve notice to potential violators. And, it proved the NCAAs essential point, that being if you allowed money into amateur athletics, the conduct would be worse than what occurred at UNLV.

Against this backdrop, the NCAA dug in on its position on amateurism, emphasized its public relations campaign (that sound familiar--"where does the money go" ads we see on TV now), expanded it's enforcement and compliance departments, and enlarged its bureaucracy.

Was the NCAA right? By 1995, Walter Byers, who some say created the NCAA in its current form, didn't think so.  Fast forward 16 years. Have we finally reached the tipping point?

More coming in Part II

Chris Hellums is the managing shareholder of Pittman Dutton & Hellums. He currently represents former Alabama wide receiver Tyrone Prothro in In Re NCAA Student-Athlete Name and Likeness Licensing Litigation, Case No. 09-cv-1967-CW.

FDA Warning: Atypical Femur Fractures Seen In Fosamax Recipients

As a result of ongoing investigations regarding Fosamax and the use of bisphosphonates (BPs) to treat osteoporosis, the FDA has announced that the risk of atypical fractures of the thigh will be added to the Warnings and Precautions section of all labels of BP drugs. Specifically, these atypical fractures are known as subtrochanteric and diaphyseal femur fractures. Recent studies strongly suggest there is a causal link between people who take BPs and the increased risk of these atypical fractures. Furthermore, not only are people who take BPs put in greater risk of fracture, these particular types of fracture are especially more dangerous than the more common femur fractures. Additionally, the use of BPs results in longer and more complicated healing of the bone.

What is a subtrochanteric and diaphyseal femur fracture?

Aytpical subtrochanteric femur fracture is a fracture occurring on the shaft of the femur immediately below the lesser trochanter. That is, right below the hip joint. These fractures are not common, rather they account for only 7% to 10% of all “hip/femoral diaphyseal fractures.”Furthermore, given the unique nature of this fracture, special implants are required in order for the fracture to heal, and they are also more susceptible to malunion or nonunion. Additionally, those affected are liable to suffer long term effects. One study indicated that after 2 years, about 50% of persons who suffered a subtrochanteric fracture did not recuperate their pre-fracture walking abilities and faced difficulties performing routine activities. A total of 71% could not live in the same conditions as they lived previously. 

A diaphyseal fracture on the other hand, is a fracture that occurs on the main or midsection of the femur. These of course are one of the more common fractures. What is significant however is that these fractures are more typically associated with high trauma incidents, whereas people taking BPs have incurred these fractures as a result of little to no trauma.

In general there are also other features seen in people taking BPs that make these particular subtrochanteric and diaphyseal fractures atypical. First, the fractures are transverse, that is a straight break perpendicular to the shaft of the femur, or it is a straight angled break.  Second, the breaks are clean, in that the bones are not crushed or splintered as you would expect from high trauma breaks. Third, incomplete fractures tend to occur on the lateral side of the femur. Finally, more minor features include fractures in patients whose bones show evidence of an increase in the thickness of the femurs wall, delayed healing, and patients also report that weeks prior to the fracture they experienced symptoms such as dullness and aching in their groin or thigh.  

What’s the cause?

The evidence of BP causing unusual femur fractures, has certainly convinced the FDA to prompt these new warning label requirements. Studies are showing that BPs do increase bone density and strength, that is after all exactly what they prescribed to do. That increased strength and density however is achieved by reducing bone turnover. This means essentially instead of “out with the old, in with the new,” as is the case for normal bone “remodeling,” it is more like, “keeping the old, and piling on the new.” The problem however is that bones naturally incur cracks and micro-damage, which is in turn naturally repaired by the body through the process of remodeling. Absent remodeling which is suppressed by the BPs, micro-damage begins to accumulate. Over time, the end result is a thicker, much denser bone, albeit one that is less structurally sound, thus the increased risk of these atypical fractures.

In the short run, it may be that using BPs to combat osteoporosis is an effective treatment. However, for those patients unaware of the risks associated with BPs, like those who have been affected by Fosamax, evidence indicates that whether a person should undergo long term treatment requires a careful assessment of the risks versus its benefits. For this reason the FDA specifically recommends that health care professionals reevaluate a patients need to continue BP therapy, especially for those who have been treated with BPs over five years. c

Chris Hellums can be contacted at Chrish@PittmanDutton.com

References:

---

[1] US Food and Drug Admin. FDA Drug Safety Commc’n: Safety Update for Osteoporosis Drugs, Bisphosphonates, and Atypical Fractures (2010).

[2] Shane E, Burr D. Ebeling PR, et al. Atypical Subtrochanteric and Diaphyseal Femoral Fractures: Report of a Task Force of the American Society for Bone and Mineral Research. 25 J. Bone Miner. Res. 2267 (2010).

HOMEOWNERS WITH KNAUF CHINESE DRYWALL MUST ACT NOW

The Plaintiffs Steering Committee has decided to file another Complaint for those homeowners who have drywall manufactured by the Knauf entities. The deadline to be submitted into the Multi-District Litigation out of New Orleans is Friday MARCH 18TH. Knauf has agreed to waive service thereby saving homeowners the expense and complications of filing through The Hague Convention for Service of Process Abroad. This may be the last chance to be included into the MDL. We believe that filing Knauf claims through the MDL is the most practical option for those homeowners affected by toxic and corrosive Chinese drywall.


Knauf Plasterboard Tianjin is one of the biggest manufacturers of defective Chinese drywall. Most of the defective and toxic drywall was imported into the United States between 2005 and 2007. Due to the large scale rebuilding efforts on the Gulf Coast after Hurricanes Katrina, Rita, Ivan and other storms, builders imported drywall from China because there was not enough domestic drywall for their needs. However, corrosive Chinese drywall is not limited to only the Gulf Coast States, but has been found in places such as Virginia. Unfortunately, most of this Chinese drywall is toxic, corrosive and defective.

Evidence of homes containing toxic Chinese drywall includes repeated AC coil failures, electrical issues, appliance failures, corroded wiring, tarnished fixtures and sulfur odors. Many toxic Chinese drywall homeowners are also afflicted with respiratory issues, nose bleeds, headaches and/or unexplained rashes. Those homeowners who previously experienced asthma or allergy problems have reported that their symptoms are much worse than before they moved into their Chinese drywall homes.

To be included in this Complaint, a homeowner must obtain evidence or indicia of Knauf Plasterboard (Tianjin) Co. Ltd. (“KPT”), Knauf Plasterboard, (Wuhu) Co. Ltd. (“Wuhu”), or Guangdong Knauf New Building Materials Products Co., Ltd (“Dongguan”) as the drywall manufacturer (photos, inspection reports, etc.). Typically, these Knauf entities marked their drywall with the words “Knauf” or “Knauf-Tianjin” in dot matrix print markings.

If you believe you have defective Chinese drywall manufactured by Knauf in your home and you suffer from the above mentioned home and health problems, please contact me immediately. This may be your last chance to be included in the MDL and you must act now.



FOR A FREE CASE EVALUATION, CONTACT BOOTH SAMUELS AT BOOTHS@PITTMANDUTTON.COM OR CALL TOLL FREE 1-866-515.8880

URGENT CHINESE DRYWALL DEADLINE

For those homeowners who have been affected by toxic Chinese Drywall, Friday January 21, 2011 may be their last chance to be included in the Multi-District Litigation out of New Orleans. The Plaintiffs Steering Committee has decided to file one more Complaint for those homeowners who have drywall manufactured by the Knauf entities. The PSC will arrange for service of this complaint, even if it has to go through the expensive Hague process. This may be the last time for homeowners to be included in this suit. Negotiations between the Plaintiffs and Defendants have resulted in a pilot program to remediate homes and it appears that that program may be extended for more homeowners.

About 3,000 homeowners, mostly in Florida, Virginia, Mississippi, Alabama and Louisiana, have reported problems with the Chinese-made drywall, which was imported in large quantities during the housing boom and after a string of Gulf Coast hurricanes. Inez Tenenbaum, chairwoman of the Consumer Product Safety Commission, the federal agency charged with making sure consumer products are safe, said some samples of the Chinese-made product emit 100 times as much hydrogen sulfide as drywall made elsewhere. The Commission recommended in a report that homes with toxic Chinese drywall be completed gutted and have issued guidelines saying electrical wiring, outlets, circuit breakers, fire alarm systems, carbon monoxide alarms, fire sprinklers, gas pipes and drywall need to be removed.

To be included in this Complaint, a homeowner must obtain evidence or indicia of Knauf as the drywall manufacturer (photos, inspection reports, etc.). Typically, Knauf marked their drywall with the words “Knauf” or “Knauf-Tianjin” in dot matrix print markings. Other evidence of homes containing toxic Chinese drywall include repeated AC coil failures, electrical issues, appliance failures, corroded wiring, tarnished fixtures and sulfur odors. Many toxic Chinese drywall homeowners are also afflicted with respiratory issues, nose bleeds, headaches and or unexplained rashes.

If you believe you have defective Chinese drywall manufactured by Knauf in your home and you suffer from the above mentioned home and health problems, please contact me immediately. This may be your last chance for inclusion into the MDL.

FOR A FREE CASE EVALUATION, CONTACT BOOTH SAMUELS AT BOOTHS@PITTMANDUTTON.COM OR CALL TOLL FREE 1-866-515.8880.