Off Label Use of Medical Products Increasing: Is Using a Prostate Product on Your Brain a Good Idea?

English: Logo of the . (Photo credit: Wikipedia)

As reported by the StarTribune, the use of off label medical products is increasing rapidly.  While the FDA regulates the approved use of medical devices, physicians have complete discretion to use medical devices in any way they think it will help their patients. This discretion comes with risks.  Just ask the women who got surgical mesh for incontinence.  The FDAs oversight only applies to device makers, not physicians.  The FDA repeatedly says its not our place to say how patients should be treated.

So, what gives.  First, progress in technology requires risk.  That's a fact.  However, the rub comes when the risk is not relayed to the to patients, damage occurs, and everyone points their finger at someone else.  In theory, all too often it plays out as follows.  A new use for a product is developed.  Medical device manufacturers improperly market for off label uses--- it just happens---because there is too much money at stake. Physicians are told by the cute sales reps who bring lunch literally every day how great this new off label use is of the product.  The physician, who enjoys those great, all expenses paid educational trips to exotic locations and the nice sales reps, start using the product in a manner not approved.

You know how the story ends.

If you are going to use me a Guinea pig, then tell me that you are going to use me as a test case and let me decide if my condition, my pain, etc is such that I am willing to take the risk.  Is that really too much to ask?

Blue Cross Won't Reinstate Cancelled Alabama Policies---I Wonder Why?

Blue Cross has announced that it won't reinstate cancelled Alabama policies that don't comply with the Affordable Care Act.  According to a statement released by BC/BS, the reason is that it would "increase costs for customers and increase risk for the company."

Let's examine that statement.  It seems absurd to me.  All we have heard is that the ACA will increase costs and, as such, BC/BS jacks our premiums out the roof because of the unknowns of the ACA and because it will not allow for denials based on pre-existing conditions. HMMM.  So, let me get this straight---Blue Cross increase rates due to the ACA, but after the criticism overwhelms the administration and Obama gives insurance companies the right to extend coverage for another year, BC/BS balks?

This is about money.  Blue Cross owns this state.  If you think this is not about money, then you probably believe that college football is not a business but an academic endeavor.

Hang on, it is going to be a bumpy ride from here.

Latest News on Depuy Settlement

The following is the latest article from the Wall Street Journal regarding the Depuy Hip Settlement:

http://online.wsj.com/news/articles/SB10001424052702304439804579207761883559166

Depuy Hip Settlement Announcement To Come Tuesday; First Stryker Hearing on Thursday

Terms of the Depuy Hip settlement will be formally announced Tuesday, November 19th in Ohio.  An "open status conference" is scheduled in front of United States District Judge David Katz in Toledo Ohio, who is overseeing the litigation.

Media reports are putting the "average" settlement at $300,000 to $350,000 per case.  I think this number is confusing in that it does not break out simple revisions, double revisions, re-revisions, and "extreme" wage loss cases, etc.  Reported failure rates in the United States are 37 percent and in Australia are 44%.

Two days later, the Judge Frank will hold the first hearing in the Stryker Hip litigation in Minneapolis as those claims begin in earnest.

What Does The Depuy Hip Settlement Mean for Stryker Hip Patients, Biomet Hip Patients, Wright Hip Patients, and Smith & Nephew Hip Patients

Now that Johnson & Johnson has reportedly settled the Depuy ASR Hip litigation, or at least a large portion of if, what does that mean for other manufactures facing claims regarding their products.  Prior to this settlement, the only major recall settlement had been the Sulzer hip settlement.  That settlement was roughly $1B.  In size, this settlement dwarfs that settlement.  Johnson and Johnson paid more in attorneys fees to defend these cases than Sulzer paid in settlement.

What this does do is set some sort of value that Stryker and others can use to quantify its risk and develop a settlement strategy.  It also gives Stryker an idea of its cost to litigate these claims.

Johnson and Johnson has decided not to settle non revised cases at this time.  It will be interesting to see if Stryker and other manufacturers opt for a different tactic in trying to buy peace in the form of future payments based on a sliding scale if the implant fails in the future.

Depuy Reportedly Ready To Pay $4 Billion Dollar Settlement of Defective Hip Claims

Bloomberg is reporting that Depuy will agree to a $4 Billion dollar settlement in the recalled ASR hip litigation.  If accurate, this will be one the largest product liability settlements ever.

Bloomberg says that the "average" claim will be $300,000.  The New York Times is reporting "$350,000.  There are several unknowns in that figure.  First, does that include co-pays, deductibles, and medical subrogation paid by Depuy already to some claimants?  Also, since that is an "average" number, it would seem to include people who had bilateral failures that had to be revised and whose claims arguably worth twice that amount.  There are also those people who are re-revisions in that the revision failed.

In the end, I think you will see a number closer to $250,000.

For months, the leadership of the case and the court has been trying to keep a lid on the terms of the settlement that were being negotiated but it appears as if the lid has been blown off now.

Federal Judge Selects Alabama Lawyer to Plaintiffs Steering Committee in Stryker Hip Litigation

Federal Judge Donovan W. Frank, who is presiding over the Stryker hip implant cases centralized from around the country to Minnesota has made his leadership selections.  Chris Hellums, of Pittman Dutton & Hellums in Birmingham, Alabama has been selected to serve on the Plaintiffs Steering Committee.

The Stryker implant MDL was established in June of 2013 and the number of cases continues to climb rapidly, with many believing that the number could reach or exceed 20,000.

Pittman Dutton & Hellums has been active in representation of individuals harmed by recalled orthopedic devices, representing clients nationwide.  These devices include products manufactured by Stryker, Depuy, Wright, Zimmer, Biomet and Smith & Nephew.

The Stryker hip implants, like other recalled hip products, have the potential to "fret" or corrode at the neck juncture.  Unlike the Depuy ASR implants, which seemed to fail at the junction between the ball and the cup, the failure of the Stryker Rejuvenate and ABG II implants occurs in the neck, requiring removal of the stem from the femur in what has been described by one surgeon as "removing rebar from concrete."

When the implant frets, metal debris and tiny particles of cobalt and chromium gets into the surrounding issue and the bloodstream, often resulting in necrosis and pseudotumors in the hip cavity. Once this occurs, it will progressively get worse until the implant is removed.

If you have one of these implants, it is imperative that you consult a physician and insure that you have regular blood test for cobalt and chromium.

You should also consult an attorney before you sign any documents allowing Broadspire, a company hired by Stryker, to obtain confidential medical records to help Stryker build their case against you and speak with your physician.

Styker Agrees to Settlement With U.S. Government

The medical device maker Stryker will pay the federal government $13.3 million to settle allegations that it bribed public health officials overseas to secure business, a violation of the Foreign Corrupt Practices Act.

The Securities and Exchange Commission (S.E.C.) said Stryker subsidiaries made $2.2 million in illegal payments to government employees in Argentina, Greece, Mexico, Poland and Romania from August 2003 to February 2008. Stryker made the payments to get or retain business, but it recorded them as legitimate consulting and service contracts, travel costs, charitable donations and commissions.

The S.E.C. claims that Stryker made $7.5 million in illicit profits as a result of the illegal payments. Stryker will pay the Treasury $7.5 million, plus $2.3 million in interest. It will also pay a $3.5 million civil penalty.

According to the S.E.C., Stryker had anticorruption corporate policies, but did not do enough to put them in action and legitimately regulate its operations. The company virtually ignored its internal compliance programs.

The Department of Justice and the S.E.C. began investigating the payments in 2007. The government has since closed its investigation into the matter.

Johnson & Johnson Enters Into the Third-Largest Pharmaceutical Settlement EVER

Johnson & Johnson is paying the third-largest pharmaceutical settlement ever to settle civil and criminal fines that it improperly marketed and promoted the antipsychotic drug Risperdal.  Much of the conduct occurred when current Johnson & Johnson CEO Alex Gorsky was vice president for sales and marketing or president of the pharmaceutical unit.

The United States Attorney General said that the company "recklessly put at risk the most vulnerable members of our society."  In response, Johnson & Johnson's vice president and general counsel said "This resolution allows us to move forward and continue to focus on delivering innovative solutions that improve and enhance the well-being of patients.

However, it is hard to understand the extent to which the company could move on given that Mr. Gorsky is now the CEO.  "Stockholders and patients will pay the price for the fraud," said Partick Burns, co-director of Taxpayers Against Fraud, and advocacy group for corporate whistle-blowers.  Gorsky not only keeps his job, and his lavish benefits and bonuses, but ends up as CEO.

Federal officials said the company knew that Risperdal posed serious risks for older adults, like an increased risk of strokes, but played them down.  Johnson and Johnson also knew that children were susceptible to certain health risk from taking the drug, including the possibility that boys could develop breasts through elevated production of the hormone prolactin, federal officials said.  Despite this, J&J told its sales representatives to visit child psychologists and mental health facilities that mainly focused on children and to promote the drug for defecit hyperactivity disorder and obsessive-compulsive disorder.

Anti-Seizure Drug Potiga Gets Black Box Warning for Vision Loss

English: Logo of the U.S. Food and Drug Administration (2006) (Photo credit: Wikipedia)

Glaxo's anti-seizure drug Potiga now comes with a black box warning.  A boxed warning, sometimes called a black box warning, is an alert that sometimes appears on the package insert for certain drugs. It is the strongest warning the FDA requires and signifies that medical studies indicate that the drug carries significant risk of serious or life threatening adverse effects.

The label chance was announced today after risks were flagged in April.  The warning identifies abnormalities of the eye, vision loss and skin discoloration, all of which may become permanent.

Federal Judge Denies NCAA Motion to Dismiss O'Bannon lawsuit

Disclosure:  Chris Hellums and the firm of Pittman Dutton & Hellums represent Tyrone Prothro who is a named class representative in the O'Bannon lawsuit.


Federal Judge Claudia denied the NCAA's motion to dismiss the Federal Antitrust lawsuit brought by Ed O'Bannon, Tyrone Prothro, and others.  In her ruling, she held that the 1984 Supreme Court cited by the NCAA which, coincidentally they lost, did not apply.

In NCAA vs. The Board of Regents of The University of Oklahoma was the 1984 United States Supreme Court opinion which held that the NCAA's television limitations was a violation of Sherman and Clayton Antitrust Acts.  Prior to 1953, there was no prohibition on televising games. Pennsylvania, in fact, televised all of their games.  In 1953, the NCAA determined that there would only be one game per week, and no team could be on TV more than once per season.  The revenue would be shared by the teams playing on television and guess who, the NCAA.  In 1981, Oklahoma and Georgia sued.  The NCAA lost at both the trial level and at the United States Supreme Court.

Judge Wilken ruled that none of the NCAA's arguments provides for a dismissal of the case at this stage.

A link to the order issued by Judge Wilken is attached below.


Ed O'Bannon NCAA order.pdf

Pittman Dutton & Hellums Files Concussion Lawsuit Against NCAA

Pittman Dutton & Hellums attorney Chris Hellums, along with Columbia, South Carolina attorney John Nichols, filed a nationwide class action lawsuit against the NCAA last week. The lawsuit claims that the NCAA was negligent in protecting its football players from the dangers of head trauma and brain damage from concussions. The lawsuit seeks medical monitoring and damages.

The named Plaintiff in the lawsuit is Stanley Doughty. Stanley’s case is compelling. A native of Amite, Louisiana, Stanley was recruited to play football at the University of South Carolina and did so for three years. He decided to forego his senior year at South Carolina and signed a $400,000 contract with the Kansas City Chiefs.

After signing a contract with the Chiefs, but before he could even begin training camp, the Chiefs’ doctors told Stanley that they would not medically clear him to play on account of injuries he sustained while playing football in college.  He was also told he and would need surgery. Thereafter, Stanley was released by the Chiefs, and to this day, has still not received his needed surgery.

Meghan Walsh, writing for The Atlantic magazine, published an excellent story on May 1, 2013, chronicling Stanley’s life.That story can be found at this link: 

http://www.theatlantic.com/entertainment/archive/2013/05/i-trusted-em-when-ncaa-schools-abandon-their-injured-athletes/275407/

 The links below provide additional information on Stanley's story and the lawsuits.

http://www.wltx.com/news/national/article/253928/2/Former-Gamecock-Files-Concussion-Suit-Against-NCAA

http://www.al.com/sports/index.ssf/2013/10/ex-south_carolina_football_pla.html

http://www.postandcourier.com/article/20131023/PC20/131029727

Related articles

• Former USC defensive tackle joins concussion suit against NCAA

Stryker Rejuvenate and ABG II Filings Continue---Just How Many are in Alabama?

It seems as though daily, a new case is filed against Stryker related to their recalled Rejuvenate and ABG II hip systems.  Many of these filings are transferred into the MDL (Multi-District Litigation) which is being overseen by United States District Judge Frank.

In Alabama, we continue to receive calls from individuals who have not been advised, or just recently been advised, that they have the recalled product.  Just this week, we received calls from Birmingham, Anniston, and Fairhope from individuals who received the recalled product.  I believe there may be hundreds, and perhaps thousands, of the recalled devices in Alabama.

Many believe they don't have a recalled product because their hip "is not a metal on metal."  While the Rejuvenate and ABG II are not metal on metal constructs, they have been recalled and unfortunately, the damage caused by the Stryker hip is often as bad, and sometimes worse, than the metal on metal devices recalled by Depuy and others.

Why is this the case?  The reason is that the Stryker problem is in the stem, not the ball and the cup.  Fretting  in the stem causes the same problem as the metal on metal ball and cup designs; however, because the failure is in the stem, in order to correct the problem, the stem must be removed from the femur. Stryker stems were often selected by physicians because they adhered so tighly to the femur.  Unfortunately, surgeons are describing revisions of Rejuvenates and ABG IIs as askin to breaking rebar out of concrete.

If you think that you may have a recalled Stryker hip system, it is important that you evaluate your options and take special care to select a revision surgeon, should revision surgery become necessary.

Stryker Recalls Spine Plate

Fda (Photo credit: Wikipedia)

The U.S. Food and Drug Administration (FDA) has issued a class one (1) recall on the Stryker Spine OASYS Midline Occiput Plate. The plate is commonly used as an implant in spinal surgeries. The failure of these implants can cause serious side effects such as blood loss, nerve injury and a need for revision surgery.

Class I recalls are the most serious – involving situations “in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death,” the FDA reported in the safety alert. If a patient begins suffering from symptoms such as pain, weakness, or numbness, “urgent evaluation is needed,”

In the FDA’s initial recall announcement of the product, issued on May 30, 2013, it noted that the Oasys Midline Occiput Plate is part of the Oasys System, which is used in spinal surgery to promote fusion and provide stabilization at the junction between the occipital bone and the vertebrae in the cervical and thoracic spine.

The Products made by Stryker that were reported to possibly have failures were distributed between April 23, 2010 and February 12, 2013. It is estimated the roughly 1300-1500 of the recalled plates may exist in the U.S. and another 880 internationally.

In 2009, Stryker recalled their Rejuvenate and ABG II modular-neck hip stems due to corrosion at the modular neck junctions.  As a result of the failures, toxic metal debris may enter the soft tissue of the hip cavity or the blood stream. The Rejuvenate and ABG II recall has resulted in hundreds lawsuits and many expect the number to reach into the thousands. 

Related articles

• Stryker Corp. earnings weighed down by charges related to product recalls and cost of company acquisitions

MAPCO Facing More Lawsuits

Three class actions have been filed in Alabama against MAPCO for alleged security breaches. Pittman, Dutton & Hellums, P.C., filed one of those suits on behalf of a Tuscaloosa resident.

 Although the extent of the breach is unknown at this time, it is thought to be enormous. It may be that all 377 of MAPCO stores have been hit. The MAPCO family of stores include MAPCO Express®, MAPCO Mart®, Discount Food Mart™, Delta Express®, Fast Food & Fuel™.

 Another article has been published detailing the breach and the lawsuits. Tracy Kitten, the journalist covering the story, did an excellent job: http://www.bankinfosecurity.com/mapco-express-sued-over-malware-attack-a-5894

  The relevant dates of the security breach occurred between March 19-25, April 14-15 and April 20-21 of 2013. If you used a credit or debit card at any MAPCO location  and were injured by the MAPCO breach, please contact Chris Hellums at 1-866-515-8880 or by email at chrish@pittmandutton.  

MAPCO Gas Stations Experiences Serious Security Breach

MAPCO Express, a retail gas station and convenience store company based out of Brentwood, Tennessee, experienced a major security breach earlier this year. MAPCO has locations in Alabama, Tennessee, Georgia, Kentucky, Mississippi, Virginia and Arkansas.

On May 6, 2013, MAPCO first publicly announced that it was hit by a wide-reaching security breach that left thousands of customers exposed to fraud and identify theft from transactions that date back as far as March of this year.  Computer hackers stole the credit/debit card information of MAPCO customers and have been making unauthorized transactions with this financial information.

Rules that cover transactions on credit cards, check cards, and debit cards require merchants to validate a series of security measures, such as the establishment of firewalls to protect databases.  Among other things, merchants, such as MAPCO, are prohibited from storing unprotected cardholder information. 

Pittman, Dutton & Hellums, P.C., has filed a complaint against MAPCO for those injured by this security breach. A recent story in The Tuscaloosa News was published on its affiliated website which discusses the story:

http://www.tuscaloosanews.com/article/20130625/NEWS/130629888/1291/living?Title=Northport-lawyer-sues-convenience-store-chain&tc=ar

The  dates of the security breach occurred between March 19-25, April 14-15 and April 20-21 of 2013. If you used a credit or debit card at any MAPCO location  and were injured by the MAPCO breach, please contact Chris Hellums at 1-866-515-8880 or by email at chrish@pittmandutton.com

NCAA: Public Statements vs. Private E-mails--You Decide

Here is the public statement made by the NCAA regarding O'Bannon lawsuit:

The NCAA's chief legal officer, Donald Remy said in a statement: "While the NCAA is still reviewing this filing, it appears to be more of the same -- baseless theories supported only by inaccurate speculation aimed at destroying amateurism in college athletics. (emphasis added)... [T]he plaintiffs take out of context quotes and statements from representatives of member conferences and institutions, and even NCAA officials, and attempt to weave them together to support their faulty theory. ..."The fact remains -- the NCAA is not exploiting current or former student-athletes but instead provides enormous benefit to them and the public. Plaintiffs are wrong on the facts and wrong on the law. The NCAA remains hopeful the court will agree and deny this motion."

Now, lets looks at the internal documents and see what they say:

NCAA President Myles Brand (Photo credit: Wikipedia)

NCAA president Myles Brand, now deceased, sent an email expressing frustration about the NCAA's  issue of commercializing college athletes.

In 2008, Brand wrote: " ... I have come to believe that the problems we are having with commercial activity are rooted in institutional expenditure rates. It is primarily because of the need for additional revenue that institutions — and the national office — are seeking ways to commercialize their rights, and those of (student-athletes). If expenditure rates had only increased at the (Consumer Price Index) for the past two decades, we would not be having this discussion."

Did he just say that they were commercializing the rights of players (I refuse to use the fictional term student athlete created by the NCAA).  Sounds like Brand is saying that if schools did not spend money like drunken sailors, we could keep this really good gig going without attracting any attention.  You decide.  

How about this exchange between EA Sports and CLC and NCAA executive Greg Shaheen:

Shaheen writes to Battle, in part: "Re: the S/A likeness, this will come in stages, we suspect. We're trying to determine the best strategy to get it all passed over the next two legislative cycles. The current take is that we need to do this first phase and then go back for photos and video games in the next phase. The read is that if we lump it all together, it will become loaded down and be killed."

Battle's reply to Shaheen included the following: "I will tell Joel just to hold off and that we have things under control working behind the scenes."

The potential pitfalls of athletes' likenesses being used in videogames was apparent to NCAA staffers two years earlier, according to another exhibit submitted by the plaintiffs.

In an e-mail in August 2005 to NCAA executive Kevin Lennon, NCAA governance staffer Steve Mallonee wrote " ... since our current rules/interpretations only preclude the actual use of the (student-athlete's) name, picture or physical likeness in commercial promotions/activities, these computerized video games are basically allowed to do what they are doing. The jersey number along with the position and vital statistics is clearly an attempt to have the public make the association with the current student-athlete. And it appears to be working. The Best Damn Sports Show was aired several weeks ago and had (Southern California football players) Matt Leinart and Reggie Bush acknowledging that they were in the video game."

Continuing and then referring to a newspaper story, Mallonee wrote: "That then raises the issue of whether getting in line with technology means being more restrictive or lenient with our rules. The article would imply that we might relax our rules a bit. The biggest concern I have is that such a position really does allow for the maximum commercial exploitation of the (student-athlete) and if that occurs, will it be long before we can defend not giving them a piece of the profits?"

What is EA's motto:  If it is in the game, it is in the game!  I guess the NCAA's motto should be " it just looks like a duck, but it is really a rabbit."

Source:  USA Today

NCAA: Come On Man

It seems like everyone has an opinion on the Ed O'Bannon case which is currently pending in California.  Class certification was argued last week before Judge Claudia Wilkin.  The result of that case could have a profound impact on college sports.  For full disclosure, I represent Tyrone Prothro, who is one of the class representatives in that case.

Here are some "come on man" facts:

1.  Student-Athlete:  Where was this term derived?  It is a fiction created out of thin air by Walters Byers (more on him later) to deflect attempts to pay workers compensation benefits to injured players.

2.  Tax exempt status:  College Sports enjoys tax free status because it is not a commercial enterprise.   Hmmm.  Does that pass the smell test?

3.  Olympics:   "Dead in Eight Years."  This is what was said about allowing professionals in the Olympics.  That certainly didn't happen.  The Olympics are more popular than ever.

4.  Bill Russell, Oscar Robinson, Harry Flourney:  These are others who have joined the lawsuit.  Does anyone really think that it is OK for the NCAA, EA Sports, et. al to make money off video games that use the images of guys that never even played when there were video games?  For those of you who don't know Harry Flourney, he was the captain of the Texas Western team from 1966 who defeated Kentucky for the NCAA championship.  How is it that when they used his image in the movie "Glory Road" they had to get his permission and he was compensated, but the NCAA and EA don't even have to ask his permission.

5.  $3000 in pocket change:  This is not what the players receive, or has even been put on the table as part of the "full scholarship" sideshow.  No, this is what some National Merit Scholars get from some Universities to attend--and they are generating revenue how???

6.  Laughing:  What Judge Wilkin appeared to do when NCAA lawyers tried to argue that the billions they were getting was for access to their venues.

7.  Walter Byers:  Don't know who he is?  For 37 years, he ran the NCAA.    He coined the term "student athlete."  He created the enforcement department at the NCAA.  He fought Jerry Tarkanian.  He pushed for (and got)  the tax exempt status.  He negotiated  50 plus multi-million dollar media contracts.  What does he say?  At the end of his career he wrote a book called Unsportsmanlike Conduct.  In 1997, he argued  that college sports had become a high dollar commercial enterprise and argued that athletes should have the same access to free markets as coaches and colleges.  Wow!

Look, we all love our college teams.  We have team spirit.  The status quo is good for us as we tailgate and watch the sport get better and better.  However, exploitation is ugly.  The NCAA's "amateurism" now really looks like a blatant money grab and restraint of trade.  The emails that have been unsealed in the case expose the hypocrisy at the NCAA.   The bubble almost burst with the Michigan Fab 5. Now seems clear that a giant meteor is headed right at the NCAA.  Can they avoid the direct hit and the ultimate fallout.  Time will tell, but if their actions are any indication, they still don't believe there are such things as meteors.

Related articles

• The latest in the Ed O'Bannon case, and why the NCAA's headed for change
• Ed O'Bannon's NCAA Lawsuit Returns To Court In Push To Get College Athletes Paid
• Infographic: This Lawsuit Could End the NCAA As You Know It
• Lawsuit threatens NCAA money machine. That's good

NCAA: Hearing Day is Today in the Biggest Case in NCAA History

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.” 

Related articles

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• Ed O'Bannon vs. The NCAA: EA Sports producer admits to using player likenesses in games
• 13. Ed O'Bannon vs EA Sports
• Spreading the wealth

Washington Post: When Businesses Give to Judges, They Get What They Want

The Washington Post recently ran an interesting story on partisan election of judges.  This is obviously not a new story, but a recent academic study seems to confirm the hypothesis that many have surmised. The study, done by Emory law professor and economist Joanna Shepherd study looks at how state judicial systems go about securing judges for their highest courts. There are four ways states select these judges:  merit selection by the state legislature, other appointment systems, state-wide non-partisan elections, and partisan elections.

Of those judicial selection methods, Shepherd then looked to see which justices’ decisions were most influenced by big campaign contributions. It’s no surprise:  justices that were elected to the bench through a partisan election were much more likely to make judicial decisions based on the amount of campaign contributions they had received. The reasoning is simple. “When judges are elected, that means they have to raise campaign money — a lot of money, in fact. And the amounts in question have risen considerably in recent decades.” Judges, whether consciously or not, are more likely to rule in favor of businesses that have donated to their campaign in order to ensure that the campaign donations won’t dry up in the future.

The statistics from Shepherd’s study tell the same story:  “…a justice getting 1 percent of his contributions from business would vote for business 46.5 percent of the time. However, a justice getting 25 percent of contributions from business would vote in its favor 62.1 percent of the time.” As further evidence, Shepherd notes that, “In the last term before mandatory retirement, the favoritism toward business litigants by judges facing partisan and non-partisan elections essentially disappears,” which shows that judges are less likely to vote pro-business when they no longer need to raise money.

I think there are many who think of judges as politicians in robes. In many states, that’s what they are … They seem to think judges should be a reflex of the popular will.

— Retired U.S. Supreme Court Justice Sandra Day O’Connor,making “a plea for preserving the impartiality and independence of the American judicial system,” the Chicago Tribune reports.

One must ask:  Are partisan elections a good idea?

 http://www.washingtonpost.com/blogs/wonkblog/wp/2013/06/11/when-businesses-give-judges-money-they-usually-get-the-rulings-they-want/

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Situation Gets Worse For Pilot Flying J

Two of Pilot Flying J’s executives, Arnold Ralenkotter and Ashley Judd, have recently pleaded guilty to the federal charges of conspiracy to commit mail fraud. Many expect a number of other executives to  have criminal charges brought against them in the near future for their participation in a scheme to reduce promised rebates to truckers across the country. The crimes could bring prison sentences of up to 20 years.  It will be interested to see if the CEO, Jimmy Haslem, will be implicated.

Haslem, who also owns the Cleveland Browns, told other NFL owners that he had no knowledge of the illegal scheme to cheat trucking companies.  In a 120 page affidavit, the FBI claims that Haslem did have some knowledge of the program.

The FBI raided Pilot’s headquarters in Knoxville, TN, on April 15, and it was there that the government found overwhelming evidence against Ralenkotter and Judd. Ralenkotter has since admitted to participating in the scheme from 2008 through April 2013. Ralenkotter’s attorney stated, “He knew it was wrong and indefensible, and we felt it was in his best interest to enter a guilty plea early.”

Details of the fraudulent scheme can be found here:

http://www.usatoday.com/story/money/business/2013/05/29/2-plead-guilty-in-feds-probe-of-truck-stop-chain/2370797/

Many Who Qualify Have Not Filed BP Claims Yet

More than 32,367 individuals and businesses in Alabama have filed claims in a settlement stemming from a class action lawsuit against BP over its 2010 Gulf of Mexico oil spill, but many who might qualify for settlement funds have not yet filed claims.   Thousands of Alabama individuals and businesses have filed and their claims are currently in process.

Of the claims filed thus far in Alabama, about 9,600 have been declared eligible and $573 million has been paid. Millions more have been paid to residents of neighboring states as well. In total, 172,000 claims have been filed in five states, and claims administrators have paid out more than $3.5 billion.

Businesses do not have to be located on the Gulf Coast to qualify for payment.  In fact, any business in Alabama qualifies.  An accounting formula is used to determine if a business lost revenue during the oil spill period. Businesses must demonstrate that their revenue during three consecutive months between May and December of 2010 was 15 percent lower than during a benchmark period from before the oil spill, and that revenue over the same three month period in 2011 was at least 10 percent higher than during the oil spill months. Claims must be accompanied by documents including federal tax returns.

Even if your business was healthy during these time periods, you may still qualify for the settlement.

Claimants must file by April 2014. This seems like a long way into the future, but the close out date is fast approaching. 

The BP Deepwater Horizon spill in April of 2010 dumped 5.9 million barrels of oil into the Gulf, more than 17 times the amount of crude that was spilled by the wreck of the Exxon Valdez tanker in 1989.

The attorneys at Pittman, Dutton & Hellums, P.C. are currently investigating BP claims. If you or someone you know, or represent, owns a business in Alabama, Louisiana, Mississippi and certain areas of Florida and Texas, you may qualify for a BP claim payment. Please contact Chris Hellums toll free at 1-866-515-8880 or via email at chrish@pittmandutton.com.

Trial Judge Affirms $8.3 Million Dollar Jury Verdict in First Trial Against Depuy for Recalled ASR Hips

A California Superior Court judge has denied DePuy Orthopaedics’ motions for new trial or judgment notwithstanding the verdict, upholding the $8.3 million judgment that resulted from the state’s first trial of a DePuy ASR hip implant case. The case is Kransky v. DePuy, BC456086, California Superior Court, Los Angeles County.

In March, the jury hearing the DePuy ASR recall lawsuit in California found the ASR hip was defectively designed, and awarded more than $8.3 million to the Plaintiff, Loren Kransky. Mr. Kransky sued the company under the theory that the ASR was defectively designed as well as DePuy's failure to warn his doctors that its product was dangerous. He claimed that the ASR hip caused him to suffer severe side effects, including metal poisoning. The jury found in favor of Mr. Kransky on the design defect claim and in favor of DePuy on the failure-to-warn claim.

During that trial, evidence was introduced which indicated Johnson & Johnson and its subsidiary, DePuy Orthopaedics, had knowledge that the ASR hip product was defective years before the recall was announced. The recall occurred in August 2010. However, that information was not shared with the public at large or the medical community. According to a New York Times report published on April 16th, much of the same evidence was introduced in a second trial that concluded last month in Illinois state court. However, the jury hearing that case found for Johnson & Johnson.

Los Angeles Superior Court Judge J. Stephen Czuleger issued his decision from the bench following a hearing May 24 and has scheduled a hearing in June on the plaintiff’s attorneys’ request for approximately $1.2 million in costs. DePuy submitted its motion for JNOV April 17^th in the corporation’s bid to persuade Judge Czuleger to throw out the verdict. In their motion, Depuy argued that the jury had erred and its verdict was inconsistent.Thus far, there has been no written order.

Judge Czuleger ruled that although there was a "legitimate conflict" in the evidence at trial as to when DePuy knew that its ASR hip implants were dangerous, this did not bar Mr. Kransky's ability to hold DePuy liable for a defectively designed product. The judge also rejected DePuy's claim that the overall body of evidence was insufficient to support Mr. Kransky's verdict, noting that there was "strong evidence" in support of his claim.

Court records indicate that there are more than 11,000 DePuy ASR hip lawsuits currently pending throughout the United States, most of which have been filed in a multidistrict litigation underway in U.S. District Court, Northern District of Ohio. The first trials in the MDL are expected to begin in September 2013. That date is subject to change as the first bellwether case has been continued already this year. The ASR MDL is titled In re: DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation – MDL 2197.


Our firm is currently investigating claims for those people who have been implanted with the DePuy hip replacement devices, both ASR and Pinnacles. If you would like a free case evaluation, please contact Chris Hellums at toll free 1-866-515-8880 or at chrish@pittmandutton.com.
 

Manufacturer and Implanting Physician of Vaginal Mesh Found Liable

http://www.businessweek.com/news/2012-07-25/bard-doctor-lose-verdict-over-vaginal-mesh

                Bloomberg Businessweek

Currently, there are hundreds of lawsuits pending alleging that vaginal-mesh implants made by Murray Hill, New Jersey-based Bard, Boston Scientific Corporation and other companies have caused organ damage in women.

A jury in California has recently held C.R. Bard, Inc., manufacturer of the Bard Avulta Plus transvaginal-mesh implant, liable for injuries caused to plaintiff Christine Scott. The devises are used to treat pelvic organs that bulge, or prolapse, or to deal with incontinence. Scott was implanted with the device in 2008 and afterwards had to undergo as many as nine surgical procedures to deal with problems caused by the device.

In her complaint, Scott alleged that the Bard Avaulta Plus vaginal-mesh implant was defectively designed and that the manufacturer had failed to warn about its safety risks. Her attorney produced evidence in hopes of showing the jury that Bard did not properly test the device before putting it on the market. In its ruling, the California jury found that Bard officials knew or should have known that surgeons “performing pelvic-floor repair would not realize the potential risks” posed by the implant. As a result, the jury ruled that Bard was 60% at fault and Christine Scott’s implanting surgeon, Dr. Tillakarasi Kannannan, 40% liable for the injuries Scott sustained as a result of the vaginal-mesh device.

In their verdict, the jury ruled that together, C.R. Bard, Inc. and Dr. Tillakarasi Kannannan are to pay $5.5 million to Scott and her husband. The damages awarded are in order to compensate both plaintiff and her husband for their financial and emotional suffering caused by the vaginal-mesh device Christine had implanted back in 2008.

In an e-mail statement, Scott Lowry, a Bard spokesman, stated that “while we empathize with the complications suffered by the plaintiff, those complications are not the fault of any conduct by the company.” Lowry went on to say that “[the company] believe[s] the evidence establishes that our Avaulta mesh products, cleared by the FDA, are safe and effective and provide significant benefits to patients.”

A 2011 report by the U.S. Food and Drug Administration found that vaginal mesh products should be classified as posing high risk to patients based on a review of side-effect reports from January 2008 to December 2010. In January of this year, in attempt to investigate the safety of vaginal mesh implants, the FDA ordered 31 manufacturers to study the rates of organ damage and other complications occurring as a result of the implants. Both Bard and Johnson & Johnson were included in the manufacturers required to conduct these studies. These studies must be conducted over the period of three years.