Former Notre Dame guard, Skylar Diggins is the latest athlete to sign with Jay-Z’s new sports agency. Being one of Jay-Z’s clients has its perks as Diggins received a new Mercedes CLS as a graduation gift. Diggins was drafted by the WBNA’s Tulsa Shock. Diggins joins Roc Nation’s growing client list which includes Robinson Cano of the New York Yankees and Victor Cruz of the New York Giants.

In a 22-8 vote, the NBA’s Board of Governors voted in favor of keeping the Kings franchise in Sacramento. This vote follows the recommendation of the NBA relocation committee. Hedge fund investor, Chris Hansen, and Microsoft CEO, Steve Ballmer, previously engaged in negotiations with the Maloof family (the current franchise owners) to buy the team and move them to Seattle. The Hansen group’s total offer which included  a relocation fee was valued at $625 million.  The NBA is now pushing for a deal with Vivek Ranadive, CEO of TIBCO and Mark Mastrov, founder of 24 Hour Fitness. The Ranadive group of investors has offered $525 million for the franchise.

After a resurgence of racism in English soccer, the  English Football Association is set to vote on a propsed five game ban. The new measure will apply to those found guilty by the Football Association of any discrimination. Racism is not just an issue in English soccer, but a serious problem that plagues the sport in other European countries as well. For example, in Italy, referrees were forced to briefly stop the game between AC Roma and AC Milan due to fans’s racist chants. FIFA and UEFA are taking note of the increasing problem of racism and vow to take action. UEFA is seeking to institute a potential ten game ban in response to such racism.

Chicago Cubs owner, Tom Ricketts has filed renovation plans (estimated cost of $500 million) with the City of Chicago for renovations to Wrigley Field. The renovation plans include among other things, a 6,000-square-foot video screen to be installed in left field. Ricketts explained that such an addition would help to bring in ad sales. Ricketts estimates that without such video screen capabilities, the Cubs lose out on an estimated  $20 million in ad revenue each year.

The renovation of Wrigley Field has met the resistance of the neighboring community and the owners of local rooftop establishments, who agreed to a 20-year partnership with the Cubs in 2004. Pursuant to the 2004 agreement  the rooftop owners pay the Cubs 17% of their gross revenues each year. The rooftop owners are concerned that the addition of a new video screen would obstruct their view of the ballpark. The rooftop holders have threatened legal action in the past, but perhaps the possibility of the Cubs leaving Wrigley Field will spur negotiations between the parties.

  by  Ron Cogswell 

Summary:

Focusing on the National Football League’s recent decision to expand a recent pilot program that encourages team physicians and trainers to use a specially designed downloadable App intended to diagnose concussions and mitigate the risk of long-term permanent injury, the article discusses the FDA’s proposed regulation of mobile medical devices and medical Apps as described in its July 2011 “Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications.”  The article also provides industry with strategic recommendations for steps that can be taken now when designing and developing similar mobile Apps to expedite and improve the FDA review and approval process.  Specifically, industry can:

• Familiarize itself with FDA’s proposed regulatory approach as described in its 2011 Draft Guidance and the included criteria for determining whether a proposed App falls within the scope of the FDA’s regulatory authority.
• From the very beginning, design devices and corresponding Apps with the FDA’s proposed regulatory requirements and standards in mind.
• Develop and adopt a regulatory approval strategy early in the development process that possibly includes upfront FDA interaction to avoid future approval obstacles.
•  Identify  the various performance standards against which testing will likely be required prior to submitting either a 510(k) or PMA to FDA for review; and plan accordingly for the testing to be completed beforehand..
• Pay special attention to Data Security and Data Protection if your proposed device involves the wireless transmission of personal patient data to a third-party recipient.
• Seek guidance beforehand on what the FDA’s mHealth Product Reviewers are expecting to see upon reviewing a related mobile medical device or App submission.

Article:

Recently, the New York Times reported upon a decision by the National Football League to expand league-wide a 2012 pilot program involving the use of a post-injury sideline assessment tool.[1]  The expanded program will permit all team physicians and trainers to use the assessment tool, which is composed of an iPad and a downloadable App (“NFL Concussion App”) to compare a player’s personal pre-season baseline and post-injury test results on a side-by-side basis in real time.  This can then be used to diagnose concussions and determine whether a player should be removed from a game to limit the potential risk for long-term injury.

In July 2011, the U.S. Food and Drug Administration (“FDA”) published its draft guidance describing how it intends to regulate mobile medical applications (“2011 Draft Guidance”).[2]  Focused specifically on those devices used to support the U.S.’s growing reliance on mobile health technologies or “mHealth” in clinical practice, the 2011 Draft Guidance provides a proposed regulatory blue print for industry and Agency employees themselves to consider when commercializing such products.

The 2011 Draft Guidance applies to mobile platforms that are handheld in nature, including products such as mobile smartphones, iPhones and iPads, patient monitoring devices, and other wireless devices, and on which a mobile medical application operates if the  product meets the following statutory definition of a medical device:

“. . . an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent’ that is ‘intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man. . .’ or ‘. . . intended to affect the structure or any function of the body of a man or other animals…’ and is either ‘used as an accessory to a regulated medical device or transforms a mobile platform into a regulated medical device. . .”[3]

Of all the mobile medical applications available on the market for clinician and patient use today,the FDA only intends to regulate a very small subset of that total number.  These include those intended for uses similar to existing medical devices.  Examples of such products include Apps that provide a questionnaire for collecting patient specific results and either: (1) compute the prognosis of a particular condition or disease; (2) perform calculations that result in an index or score; (3) calculate dosage for a specific medication or radiation treatment; or (4) provide recommendations that aid a clinician in making a diagnosis or selecting a specific treatment for a patient.[4]

But did the FDA really intend to regulate iPads and things like the NFL Concussion App?

Even if that was not the Agency’s intent, in practice that is very much what might feasibly happen.  According to the New York Times article,

“The mandatory post-injury sideline concussion assessment tool, instituted for the 2012 season along with a baseline test done during physicals at the start of preseason, will now be used in app form by all 32 teams, a method that was tried by a handful of teams in a pilot program last season.  The hope is that being able to compare the results of a baseline test and a post-injury test side by side in real time will speed diagnosis and help doctors and trainers recognize when a player should be removed from a game. The league also plans to have independent neurological consultants on the sideline during each game to assist the team physician in diagnosing and treating players.”[5]

Intended for the purposes of diagnosing player post-impact concussions, the NFL Concussion App appears to fall within the scope of the FDA’s 2011 Draft Guidance rendering it an FDA regulated medical device just like an infrared brain hematoma detector (21 CFR 882.1935) which requires the submission and clearance of a 510(k) notice; or a self-expanding peripheral stent system (FDA product code: NIP) which requires Agency Pre-Market Approval.  Under the FDA’s proposed regulatory model, it is possible that even some modifications or updates to the NFL Concussion App might trigger the need for supplemental submission and Agency review.

And when the NFL Concussion App is expanded beyond the NFL itself to other sports like hockey, wrestling, soccer and skiing, and the App is modified for use in those particular sports, will subsequent Agency review be needed? ?  If yes, is it possible that FDA officials might seize uncleared devices during the middle of Wrestle Mania 2014 or high school soccer games

Although laughable, a variation of this hypothetical scenario could in fact be reality if the FDA finalizes and then strictly enforces the current language of the 2011 Draft Guidance.  Accordingly, the FDA should amend its proposed regulatory approach before finalizing and implementing the system contained in the 2011 Draft Guidance.  FDA’s final requirements should provide greater clarity on what constitutes a regulated mobile medical device and medical App; and provide greater flexibility when making changes to an existing cleared medical App.

In the meantime, companies developing and manufacturing mobile devices should be familiar with the 2011 Draft Guidance and its criteria for determining whether a proposed App falls within the scope of FDA regulation.  Companies should be designing their devices and corresponding Apps with the 2011 Guidance Document in mind.  It would be prudent for companies to develop FDA regulatory approval strategies at the same time they are thinking about items such as performance testing, data privacy and security, and power sources.

The United States Postal Service (“USPS”) has filed a complaint in the United States District Court for the District of Columbia alleging false claims, fraud, breach of contract, and unjust enrichment. The complaint joins former teammate, Floyd Landis’s suit (Landis v. Tailwind Sports Corp.). According the the complaint, Armstrong and his Tailwind Sports teammates were paid over $40 million by the USPS from 1998 to 2004.

The Atlantic Coast Conference (“ACC”) announced that it will enter into a grant of rights that promises to bring stability to the conference. A grant of media rights turns over all of the member schools’ media rights to the conference. This move gets rid of the need to set exit fees because if a school were to try to leave it would need to buy back its media rights or else continue to let the conference receive its revenue until the expiration of the grant. Both options would risk considerably more money than the $30-50 million exit fees the ACC has set in the past. Under the new deal which extends through 2026-2027, current and future members schools will receive approximately $17 million a year. The Big Ten, Pac-12, and Big 12 are the only other conference to have similar arrangements.

by Chuck Haven

Background

The New England Patriots received some good news when the Lancaster County District Court in Lincoln, Nebraska handed down cornerback Alfonzo Dennard’s sentence of two years probation and thirty days in jail; a sentence that will not interfere with the NFL regular season.  Dennard was found guilty of felony assault of a police officer and misdemeanor resisting arrest stemming from an altercation outside of a bar in Nebraska, where Dennard played college football.  The altercation took place before Dennard was an NFL player but after his college career had concluded. It is yet to be seen if the NFL will impose its own penalties on Dennard. How Commissioner Goodell’s office handles this situation will set an important precedent going forward.

Dennard and his attorney, Terry Dougherty, outside of Lancaster County courthouse (Photo by: Nati Harnik, Associated Press)

Prior to his arrest Dennard was projected to be as high as a second-round draft pick, but his stock rapidly fell after reports of potentially severe sentences surfaced.  Dennard’s charges carried a maximum of six years in prison, which scared teams away from drafting him in a position proportional to his talent.  Instead, Dennard slipped all the way to the seventh round, where the New England Patriots decided to take a chance on the troubled defensive back.

Punishment

Under Goodell, the NFL has been stern with regards to the punishment of players for off field transgressions.  Goodell has stood by the suspensions of NFL players who have been arrested, citing the need for the NFL to be represented by “outstanding people as well as great football players, coaches, and staff.”  Many assume that Goodell cannot punish Dennard because his arrest occurred before becoming an NFL player.  However, Dennard receiving punishment from the NFL on top of his criminal sentence is not unfathomable.

During the NFL lockout in 2011, running back Cedric Benson was arrested for misdemeanor assault.  Benson was not currently under contract with an NFL team, but was signed by the Bengals when the lockout was lifted.  Benson was suspended three games under the NFL Player Conduct Policy.  Unlike Dennard, Benson had previously been in the NFL and had previously been arrested while under NFL contract, earning him a warning.  Benson appealed his suspension, claiming that the NFL did not have the authority to suspend him for actions while not under contract.  The NFL reduced the suspension to one game, but expressly rejected the argument that the NFL cannot suspend players for off field transgressions while not under contract.

The suspension of Benson was not the only time the NFL’s ability to regulate those not within the league has come into question.  In 2004 Maurice Clarett claimed that the NFL Collective Bargaining Agreement was in violation of Federal Antitrust laws because it restricted those who could play in the league based on age, and that college players like Clarett had no ability to participate in the negotiations that ratified the Agreement.[1]  The court struck this down, holding that the NFL and NFL Player’s Association had the right to bargain on matters that affect current players, even if the terms agreed upon also affect players who are not currently in the league.  Much like the Clarett case, here the NFL Collective Bargaining Agreement designates power to the Commissioner to punish, and designates the appeals process as well.  With the power to punish being explicitly laid out in the Collective Bargaining Agreement, and past findings that players can be punished for their actions even while not under contract, it seems likely that Goodell could suspend players for arrests while not in the NFL if he so chooses.

Likely Outcome

Dennard was certainly harmed by his actions.  As stated above, he fell from a possible second round draft pick to a seventh round pick.  The difference in the contract signed by the Patriots’ second round pick, Tavon Wilson, and seventh rounder Dennard is vast.  Wilson was signed for a $4.2 million, with $2.7 million guaranteed.  Dennard, on the other hand, received a $2.17 million contract with just $58,000 guaranteed.  This disparity in guaranteed money is incredibly important, as NFL contracts can be severed at any moment.

The money lost by Dennard due to his arrest is unlikely to elicit any sympathy from Commissioner Goodell.  Instead, if Dennard is able to avoid further punishment from the NFL it is likely because of Dennard’s first time offender status.  It seems likely that Commissioner Goodell will not attempt to punish Dennard, but not because he does not feel that he has the power to lay punishment on someone for actions taken before signing an NFL contract.  The Commissioner has made it abundantly clear that to represent the NFL, a player must act responsibly, or else suffer the consequences.

Following the Boston Marathon bombings on Monday, April 15th, other Boston venues have taken heightened security measures. Both the TD Garden and Fenway have increased security with bomb sniffing dogs and extra police officers. The tragic events in Boston have led other stadiums around the country to take a look at their own security measures. For now the heightened security means extra security officers, but it would not be surprising to see metal detectors or a ban on backpacks implemented in the future.

Established in 1910, the National Collegiate Athletic Association (NCAA) purports to protect today’s student-athletes from exploitation.  The NCAA has little control over how member institutions run their athletic departments, but maintains almost exclusive control over eligibility guidelines for student-athletes.  These eligibility standards control not only potential student-athletes deciding which school to attend, but also controls enrolled student-athletes competing interscholastically.  As legislator, prosecutor, and judge, the NCAA has the right to enforce the rules that it puts in place and hand down punishments as it sees fit.[1]  However, the NCAA has recently come under severe criticism for the way in which it handled investigations into alleged NCAA rule-breaking at the University of Southern California (USC), University of California Los Angeles (UCLA), and University of Miami.  The NCAA has been accused of unethical behavior for the way it conducted each investigation.[2]

USC

While investigating USC, the NCAA concluded that an assistant football coach, Todd McNair, was complicit in Reggie Bush receiving improper benefits from marketing agents.  McNair was banned from coaching at any NCAA institution for a year.  McNair lost his NCAA appeal, and sued the NCAA for “libel, slander, breach of contract and four other alleged offenses.”[3]  McNair also took issue “with the one-sided examination policy established by the NCAA, which doesn’t allow those targeted by investigations to cross-examine witnesses used.”[4]  Los Angeles Superior Court Judge Frederick Shaller denied the NCAA’s motion to dismiss and his opinion stated the NCAA showed “ill will or hatred” towards McNair in its investigation.[5]  Shaller also labeled the NCAA as “malicious” in its investigation.

UCLA

Shabazz Muhammad was one of the most highly recruited high school basketball players in the country before he decided to go to UCLA.  After enrolling at UCLA, the NCAA announced that they were investigating circumstances surrounding unofficial visits Muhammad took during his recruitment.  The visits were paid for by a man that Muhammad claims as a close family friend.[6]  During the investigation, the boyfriend of the lead investigator on the Muhammad case was overheard on an airplane declaring the NCAA would find Muhammad ineligible and he would not play for the rest of the year.[7]  At this point, the NCAA had only requested documents from Muhammad’s family eight days prior, and had yet to receive the thousands of pages of documents it had requested.  The timing of this statement led Muhammad’s personal attorney to question the impartiality of the NCAA investigation and suspected that the NCAA had already prejudged Muhammad’s guilt.[8]  In November of last year, the NCAA and UCLA reinstated Muhammad after he paid a $1,600 fine and sat out three games.[9]  The $1,600 fine is normally accompanied with a ten game suspension, yet the NCAA chose to levy only three games, which normally correlates to a $600 fine.[10]

Miami

In February 2013, the University of Miami athletic department was served a notice of NCAA allegations accusing the school of lack of institutional control.[11]  The NCAA alleged Miami “allowed a booster named Nevin Shapiro to infiltrate its athletic department and have relationships with athletes that were both personal and — according to Shapiro — financial.”[12] The investigation that led to that conclusion came under serious scrutiny that resulted in the firing of the NCAA Vice President of Enforcement Julie Roe Lach.[13]  The NCAA does not have subpoena power to compel witnesses to comply in their investigations.[14]  To circumvent its lack of subpoena power to compel witnesses to comply with their investigations, the NCAA paid Shapiro’s attorney to allow an NCAA attorney to prepare questions and attend a deposition relating to Shapiro’s bankruptcy.  The lead investigator, Ameen Najjar, was also fired after disregarding NCAA general counsel’s advice to not pay Shapiro’s lawyer.  Due to its own malfeasance, the NCAA threw out 20% of the evidence used in the Miami investigation.  Now, Miami is asking the NCAA to completely dismiss the case against the university due to the NCAA’s unethical conduct that tainted the proceeding.[15]

The circumstances of these investigations certainly show a lack of institutional control but not from any of the schools under the microscope.  Instead, the NCAA has become the subject of media reports and speculation that it struggles to control the investigators on its staff.  Yet, NCAA President Mark Emmert, who oversees all aspects of the NCAA, continues to garner support from the NCAA executive committee.  Recently, the NCAA passed a rule holding head coaches more accountable for the actions of their assistants in program compliance with NCAA regulations.[16]  This is a logical rule that encourages coaches to become more involved with their assistants in the formation of recruiting strategies, among other things.  Despite the accountability that the NCAA demands from those under its watch, the NCAA does not appear eager to impose the same standards on itself, as Emmert, the NCAA’s equivalent “head coach,” faces no sanctions.

Emmert categorizes the poorly run investigations as “miscues.”  The “miscues,” however, illustrate a bigger problem: namely, the NCAA’s lack of accountability.  The obvious disregard for ethical rules demonstrated by NCAA investigators is disheartening for those “student-athletes” who must go through investigations, for their parents, and for the schools.  However, what is even more concerning is the lack of leadership that the NCAA has shown.  Emmert has become a lighting rod for criticism among all the “miscues” and deservedly so.  His past reveals tenures at the University of Connecticut, Louisiana State University, and Montana State University that were less than stellar.[17]  However, the common theme from all of those “miscues” is that Emmert himself avoided blame.  The current situation is no different.

What’s Next for the NCAA

Many critics believe the NCAA has fallen out of step with its original intent.  Commercialism has rendered the NCAA’s core tenant of “amateurism” a relic and the NCAA’s attempt to perpetuate the concept has accelerated its own demise.  The “miscues” highlight the NCAA’s downhill tumble towards irrelevancy.  The NCAA does not control the BCS or the new football playoff system, and also has “no discernible role in pivotal conference realignments.”[18]  The major role that the NCAA has been reduced to is that of the rule-maker and enforcer.  If the NCAA cannot effectively perform these duties then maybe it is time for a change in how college athletics are run.  According to many, it is possible that major college football may break away from the NCAA and form its own association where it can make its own rules.  Another possibility that will not necessarily get rid of the NCAA is the naming of a Commissioner that oversees each sport.  With either option the role of the NCAA is reduced severely below the already minor role it plays now.  It’s clear the NCAA must brush up on its ethical duties during investigations or run the risk that it puts itself out of business before everyone else does.  At the very least, it is time for new leadership that can guide the NCAA through these choppy waters.