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.

Image via Wikipedia

In what was probably what was the worst kept secret in legal circles, the Judicial Panel on Multi-District Litigation assigned all Depuy ASR hip cases to United States District Judge Katz. The judge will supervise evidence gathering efforts regarding the hip implants which were recalled by Johnson and Johnson's Depuy Orthopedics unit on August 26th. According to Depuy, the implants were recalled after researchers found many patients needed revision surgery because of design defects. Recently, receipents have tested positive for toxic level of chromium and cobalt as a result of the implant failure.

DePuy Hips--Kickbacks, Deferred Prosecution and the role of Surgeons

Image via Wikipedia

In 2007, Depuy avoided criminal prosecution over financial inducements paid to surgeons to use their hip and knee products by signing a Deferred Prosecution Agreement and paying civil settlements to the Departments of Justice and Health and Human Services of $84.7 million.



The Department of Justice alleged that Depuy routinely violated the anti-kickback statute by paying physicians to exclusively use their products. In announcing the settlement, United States Attorney Christopher J. Christie stated "prior to our investigation, many orthopedic surgeons in this country made decisions predicated on how much money they could make--choosing which device to implant by going to the highest bidder."

The government alleged that these agreements were in place between 2002-2006, which happens to be when many of the now recalled Depuy ASR hips were implanted. Government officials also stated that surgeons failed to disclose the payments to the hospitals where the surgeries were performed, and more importantly, to the patients the devices were installed.

As the Depuy litigation proceeds, both Depuy and some surgeons are going to have some difficult questions to answer.

Patients who return to the physicians who installed the recalled devices need to be aware these relationships exist, inquire of their physician as to whether or not they engaged in such kickback agreements and never let their physician influence them to sign releases allowing Depuy to obtain their medical records.

BREAKTHROUGH IN CHINESE DRYWALL LITIGATION

To date, homeowners with “Made in China” or similar markings that didn’t specifically identify a manufacturer were designated as having an “indeterminate” or “unascertainable” manufacturer. Unlike homeowners with “Knauf” markings, these homeowners were forced to litigate their claims without a manufacturing defendant. This has been a huge disadvantage to those homeowners devastated by faulty Chinese Drywall.

Recently however, markings used on drywall manufactured by Taishan Gypsum Ltd. (Taishan) and its subsidiary Tai’an Taishan Plasterboard Co. Ltd. (TTP) have been identified through documents produced in the litigation out of New Orleans. Of particular importance is the acknowledgement by TTP that it marked boards with “made in china meet or exceed ASTM C1396 04 standard” and “DRYWALL 4feetx12feetx1/2inch” stamps, as well as other non-descript markings. This revelation may allow us to identify board previously unknown as being manufactured by Taishan or TPP. Attorneys are working on additional discovery to further identify other manufacturers deemed to have “indeterminate” or “unascertainable” manufacturers.

Based on this extremely important discovery, there will be new opportunities for homeowners who previously could not identify the manufacturer of their drywall. District Court Judge Eldon Fallon has already ordered Taishan to pay seven Virginia families a total of $2.6 million in remediation damages.
If you believe you have defective Chinese drywall in your home and experienced repeated AC coil failures, electrical issues, appliance failures, tarnished fixtures, sulfur odors in your home and/or suffer with respiratory issues, nose bleeds, headaches and or unexplained rashes, please contact me.

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

Related articles

• Chinese Drywall Manufacturer to Repair 300 Homes (cbsnews.com)
• Chinese firm to fix 300 U.S. homes ruined by corrosive drywall (usatoday.com)

DEPUY HIP RECALL: COMMONLY ASKED QUESTIONS

Image via Wikipedia

I have reviewed perhaps 100 potential claims for individuals who received recall letters from their physicians indicating they had received a Depuy recalled hip.
Typical questions include:

QUESTION: SHOULD I RETURN TO MY PHYSICIAN WHO CONTACTED ME?

ANSWER: PERHAPS. IN MY EXPERIENCE, MOST DOCTORS HAVE BEEN VERY SUPPORTIVE OF THEIR PATIENTS. THEY ARE ORDERING XRAYS, MRIs, BLOOD TESTS, AND BONE DENSITY TESTS. THESE TESTS ARE IMPORTANT.
I HAVE RECEIVED SEVERAL REPORTS OF A PHYSICIAN IN NORTHWEST ALABAMA HAS ONLY ORDERED XRAYS, TOLD ALL OF THE PATIENTS THAT THEY WERE FINE, AND OPENLY STATED THAT THEIR PAIN ONSET OCCURRED WHEN THEY RECEIVED THE RECALL LETTER. THE WIFE OF ONE OF MY CLIENT'S REPORTEDLY QUIPPED TO THE DOCTOR THAT HE OBVIOUSLY HAD NOT LOOKED AT HER HUSBAND'S CHART IN IN THE TWO YEARS SINCE HIS SURGERY AND CERTAINLY HAD NOT LIVED WITH HIM OR HE WOULD KNOW OTHERWISE.

IF THIS IS YOUR PHYSICIAN, YOU PROBABLY KNOW IT. I WOULD NOT RETURN AND WOULD FIND A SURGEON WHO DOES HIP REVISION SURGERY TO EVALUATE YOUR HIP.

QUESTION: SHOULD I SIGN THE DOCUMENTS MY DOCTOR GAVE ME?

ANSWER: ABSOLUTELY NOT!!!!! THERE ARE DIFFERENT VERSIONS OF THIS DOCUMENT, BUT THEY ALLOW DEPUY TO OBTAIN YOUR MEDICAL RECORDS AND IN SOME CASES, OBTAIN YOUR DEFECTIVE DEVICE IF IT IS REMOVED. YOUR INFORMATION WILL ALSO BE PROVIDED TO DEPUY'S ADJUSTERS HANDLING THE CLAIMS.

QUESTION: DO I HAVE TO GO BACK TO MY DOCTOR FOR THIS TO BE COVERED?

ANSWER: NO: IN FACT, A CLASS ACTION HAS BEEN FILED AGAINST DEPUY CLAIMING THEY ARE MISLEADING CONSUMERS. IN THAT COMPLAINT, THEY ALLEGE:


"In our opinion, DePuy's 'offer' may deceive potential claimants into believing that the company has actually agreed to advance or reimburse their costs for medical monitoring or revision surgery. In fact, no specific offer to pay medical costs has been made and no specific plan for reimbursement has been announced. Moreover, DePuy has stated that before reimbursement of expenses will be provided, it will review the patient's medical records to determine if the patient meets DePuy's criteria for payment. According to DePuy, the medical records must confirm that the revision is related to the ASR recall and 'not some other type of cause, such as a traumatic fall.' Blaming the device failure on a fall, or another cause, such as physician error, patient misuse, pre-existing condition or underlying diseases is a standard litigation defense in these types of cases. Thus a patient who releases medical records to DePuy may do nothing but provide DePuy with a jump start on litigation defenses."


OPTING TO ALLOW DEPUY TO DIRECT YOUR MEDICAL CARE MAY COST YOU IN THE LONG RUN---IN PREVIOUS MEDICAL IMPLANT LITIGATION I HANDLED, PATIENTS WERE OFFERED FREE MEDICAL CARE. WHAT THEY WERE NOT TOLD WAS THAT THE MANUFACTURER PAID THE DOCTORS THE BILL RATE AS OPPOSED TO THE INSURANCE, MEDICARE OR MEDICAID REIMBURSEMENT RATE ,WHICH IS MUCH LOWER. WHEN IT CAME TIME TO SETTLE THEIR CLAIMS, THE MANUFACTURER DEMANDED CREDIT FROM THE SETTLEMENT FOR WHAT THEY PAID, WHICH WAS 3 OR 4 TIMES WHAT THE INSURANCE CARRIER WOULD HAVE PAID. THIS IS A NICE CARROT USED TO KEEP THE PHYSICIANS HAPPY AND IN THE BOAT.

QUESTION: WHAT ELSE DO I NEED TO KNOW?

ANSWER: FIRST, THERE IS OFTEN A VERY CLOSE RELATIONSHIP BETWEEN THE MAKERS OF DEVICES AND THE PHYSICIAN WHO INSTALL THEM. TRIPS, SEMINARS, CATERED LUNCHES ARE NOT UNCOMMON. OFTEN THE PHYSICIAN AND THEIR ORTHOPEDIC REPS, AS THEY ARE CALLED, HAVE CLOSE PERSONAL RELATIONSHIPS. THERE IS NO DOUBT DEPUY WILL SEEK TO EXPLOIT THIS RELATIONSHIP, IF IT CAN BE EXPLOITED, TO OBTAIN RELEASES AND MEDICAL RECORDS (TO PREPARE THEIR DEFENSE THAT THE FAILURE IS UNRELATED).

ON THE OTHER HAND, MANY PHYSICIAN ARE PATIENT ADVOCATES AND SOME HAVE EVEN ADVISED CLIENTS TO SEEK LEGAL REPRESENTATION.
CHRIS HELLUMS recently served as lead counsel in the Total Body Formula Multi District Litigation and is representing clients from across the country with Depuy claims.

For a free case evaluation, he can be reached at Chrish@PittmanDutton.com or toll free at 1-866.515-8880

CHINESE DRYWALL CLAIMS STILL BEING ACCEPTED IN MDL

Image via Wikipedia

Lead Counsel, Arnold Levin, has decided that the Plaintiff Steering Committee may file additional interventions or complaints against Knauf, Taishan, and any other identifiable Chinese manufacturer. Knauf, one of the largest manufacturers of defective Chinese Drywall, has accepted service for home owners in the MDL litigation out of New Orleans.


The toxic Chinese drywall plaguing most of the Gulf Coast was used in the construction of homes in the Birmingham area. The drywall was imported into the U.S between 2005 and 2008 and used particularly in 2006, when there was a shortage of building supplies after several hurricanes and during the building boom. The toxic material is known to emit a sulfuric compound that corrodes metals and may cause upper respiratory problems. While a sulfur odor in a home may indicate the product was used, the main indicator would be if the homeowner has had to replace air conditioning coils more than once over the past few years. Also, home owners can look on the back of the drywall, possibly in the attic, to see if it has any Chinese markings such as “Knauf-Tianjin” or is stamped “Made in China.”



There are many reasons to choose to litigate through the MDL against Knauf. U.S. District Court Judge Eldon Fallon ordered Knauf Plasterboard Tianjin Co. Ltd., a committee of attorneys representing plaintiffs and certain drywall installers, suppliers and insurers to participate in mediation in New Orleans in August. Fallon wanted the parties to discuss the "global resolution of claims," according to an entry in the court record. Fallon "encouraged all parties to consider global settlement rather than individual resolution of claims." Fallon has ordered the same parties to participate in mediation again in September. This is very promising for homeowners affected by Chinese drywall.

If you believe you have defective Chinese drywall in your home and experienced repeated AC coil failures, electrical issues, appliance failures, tarnished fixtures, sulfur odors in your home and/or suffer with respiratory issues, nose bleeds, headaches and or unexplained rashes, please contact me.

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

J & J DEPUY unit accused of selling hip systems without FDA approval

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In another shot to beleaguered J&J, the FDA has hit it's DEPUY unit with selling hip systems without approval.

The FDA said in the letter that the company has been selling its TruMatch Personalized Solutions System, which makes artificial knee products, and the Corail Hip System without "market clearance" and in violation of the Federal Food, Drug, and Cosmetic Act.

The agency ordered DePuy to immediately stop selling the Corail products or face further enforcement action.  Failure to comply could result in product seizure, injunction or civil penalties.

Depuy has 15 days to comply with the order.

If you believe that you have received a defective Depuy Hip System, contact attorney Chris Hellums at Chrish@pittmandutton.com or call toll free 1-866-515-8880 for a free case evaluation.

Depuy Recalls Total Hip Systems

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DePuy Orthopaedics, Inc., announced it is voluntarily recalling the ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System used in hip replacement surgery. According to some reports, 1 in 8 patients with these hips required a replacement surgery, also known as revision surgery, to replace the implants. The risk for revision was higher with ASR head sizes below 50 mm in diameter and among female patients. Many observers expect this already high failure rate to increase dramatically as problems with the DePuy ASR hip systems become more widely publicized.


Depuy issued the following statement: "We regret that this recall will be concerning for patients, their family members and surgeons," said David Floyd, president, DePuy Orthopaedics. "We are committed to assisting patients and health care providers by providing information through multiple channels and paying for the cost of doctor visits, tests and procedures associated with the recall."

Denying that its decision to do so was related to reports of failures of the ASR systems, late last year DePuy ceased sales of the products. By that time, almost 100,000 of the systems had been implanted in patients worldwide. DePuy Orthopaedics, Inc. is the orthopedic subsidiary of Johnson & Johnson.

Unfortunately, DePuy's recall of the ASR systems comes too late for patients that were sold these devices. Unlike most product recalls, this recall is for a product that has been implanted in a person's hip. As a result, the recalled product can only be replaced with the patient going through a painful and debilitating surgery and rehabilitation.

Attorney Chris Hellums and the firm of Pittman Dutton & Hellums has previously represented individuals numerous medical product failure claims. For a free case evaluation, contact Chris Hellums at Chrish@PittmanDutton.com or toll free at 866-515-8880.

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• J&J unit recalls hip replacement products (usatoday.com)

DEADLINE LOOMING FOR FILING CHINESE DRYWALL CLAIMS

SEPTEMBER 3RD DEADLINE FOR KNAUF INTERVENTIONS IN MDL


The Plaintiffs Steering Committee has extended the deadline for accepting additional claims against Knauf to be included on interventions until Friday, September 3, 2010 at 5 ET. It is doubtful that this deadline will be extended. Knauf, one of the largest manufacturers of defective Chinese Drywall, has accepted service for home owners in the MDL litigation out of New Orleans. A majority of the defective drywall was imported into the United States between 2005 and 2007.

Last week, U.S. District Court Judge Eldon Fallon ordered Knauf Plasterboard Tianjin Co. Ltd., a committee of attorneys representing plaintiffs and certain drywall installers, suppliers and insurers to participate in mediation in New Orleans. Fallon wanted the parties to discuss the "global resolution of claims," according to an entry in the court record. Fallon "encouraged all parties to consider global settlement rather than individual resolution of claims."

Knauf Gips, a family-owned German company with operations throughout the world, has argued for almost two years that it is not legally responsible for the millions of pounds of defective drywall that one of its subsidiaries in China has admitted exporting to the United States. But documents filed in Germany and in U.S. courts show that Knauf’s German umbrella company is closely involved in the management of its subsidiaries, including overseeing quality control, finding raw materials and dealing with rising concerns over the defective drywall.

If you believe you have defective Chinese drywall in your home and experienced repeated AC coil failures, electrical issues, appliance failures, tarnished fixtures, sulfur odors in your home and/or suffer with respiratory issues, nose bleeds, headaches and or unexplained rashes, please contact me.

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

Is Miracle Mineral Solution or MMS the next Total Body Formula?

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The F.D.A is warning consumers of "serious harm" from drinking Miracle Mineral Solution (MMS).

According to the F.D.A, the product, when used as directed, produces an industrial bleach that can cause serious harm to health.   Side effects include severe nausea, vomiting, and life-threatening low blood pressure from dehydration.
MMS is distributed on Internet sites and online auctions by multiple independent distributors. Although the products share the MMS name, the look of the labeling may vary.

The product instructs consumers to mix the 28 percent sodium chlorite solution with an acid such as citrus juice. This mixture produces chlorine dioxide, a potent bleach used for stripping textiles and industrial water treatment.
Unbelieveably, MMS claims to treat multiple unrelated diseases, including HIV, hepatitis, the H1N1 flu virus, common colds, acne, cancer, and other conditions.
The FDA continues to investigate and may pursue civil or criminal enforcement actions as appropriate to protect the public from this potentially dangerous product.

If you have suffered any negative side effects, consult a health care professional as soon as possible and retain the product.

This product recall is similar to the F.D.A recall of Total Body Formula, a vitamin supplement which was recalled after it was found to have toxic levels of selenium.

FOR A FREE CASE EVALUATION, CONTACT CHRIS HELLUMS AT CHRISH@PITTMANDUTTON.COM OR CALL TOLL FREE 1-866-515.8880
.

Related articles by Zemanta

• FDA Warns Consumers of Serious Harm from Drinking Miracle Mineral Solution (MMS) (nlm.nih.gov)
• FDA Warns Consumers of Serious Harm from Drinking Miracle Mineral Solution (MMS) (prnewswire.com)
• Can it get any worse?: industrial bleach as cancer and HIV cure (sciencebasedmedicine.org)

Debt Collection Companies Being Sued for Harrasment & Deceptive Tade Practices in Ohio, West Virginia, & New York

Ohio Attorney General filed a lawsuit Wednesday against a Cleveland debt collection agency
after getting calls from more than 200 Ohio residents complaining of threats, harassment and deception. Read the Ohio AG lawsuit here.

National Enterprise Systems of Solon, Ohio is accused of illegal collection practices.

The lawsuit was filed in the Cuyahoga County Court of Common Pleas.

According to the lawsuit, debt collectors with National Enterprise Systems of Solon used abusive language, failed to verify debts and made unauthorized withdrawals from consumer bank accounts in violation of state and federal law.

Officials in West Virginia have also filed a similar lawsuit against the firm. Read the WV complaint here.


New York Attorney General has shut down a New York collection operation that consisted of at least nine debt collection companies across Western New York, run by Buffalo resident Tobias Boyland.

According to hundreds of consumer complaints filed with law enforcement agencies across the country, Boyland's employees violated state and federal law by routinely posing as law enforcement officials, threatening to arrest consumers and throw them in jail unless they made arrangements to pay the company immediately.

The Attorney General filed suit against Central Resource Management, Final Claims Asset Locators, Final Control Asset Locators, Interchange Payment Solutions, Next Step Services, Portfolio Asset Assurance, Silverbay Services, and Teleport..

Read the NY Complain Here.


Read the article here: http://www.dispatch.com/live/content/business/stories/2009/07/22/Collection_agency_lawsuit.ART_ART_07-22-09_A6_8LEHS6P.html?sid=101

Minnesota Attorney General Sues National Arbitration Forum for Fraud, Misrepresentation, Deceptive Trade Practices

Minnesota Attorney General Lori Swanson filed suit this week against the National Arbitration Forum of Minnesota, the nation's largest arbitration company for consumer credit disputes, accusing it of consumer fraud, false advertising and deceptive trade practices by "misrepresenting its independence" and hiding its "extensive ties" to the collection industry.

The Attorney General's lawsuit claims the National Arbitration Forum has ties to debt-collection law firms and works against consumers by virtue of having a mandatory arbitration clause set forth in a credit card, bank, or retail contracts. Hundreds of thousands of consumer disputes are resolved each year not by a judge or jury, but by a private arbitration system.

The Attorney General’s suit alleges that the National Arbitration Forum represented to consumers and the public that it is independent and neutral, operates like an impartial court system, and is not affiliated with and does not take sides between the parties.

The lawsuit alleges that the National Arbitration Forum, while holding itself out as impartial, works behind the scenes—alongside creditors and against the interests of ordinary consumers—to convince credit card companies and other creditors to insert arbitration provisions in their customer agreements and then appointing the Forum to decide the disputes.

The lawsuit alleges that the Forum pays commissions to executives whose job it is to convince creditors to put mandatory arbitration clauses in their customer agreements. The suit alleges that the Forum does this to generate arbitration filings in the Forum—and hence, revenue—for itself.

The lawsuit alleges that, despite telling consumers and the public that it is not affiliated or aligned with the collection industry, the Forum in fact has financial ties to the collection industry.

The lawsuit alleges that, beginning in 2006 and through 2007, Accretive—a family of New York private equity funds—engineered two transactions. In the first transaction, Accretive formed several equity funds under the name “Agora” (meaning “Forum” in Greek), which invested $42 million in the Forum.

In the second transaction, three of the country’s largest debt collection law firms—Mann Bracken of Georgia, Wolpoff & Abramson of Maryland, and Eskanos & Adler of California—merged into one large national law firm called Mann Bracken. Accretive then acquired the majority interest in a debt collection agency called Axiant, which acquired the collections operations of Mann Bracken. Through these transactions, Accretive took control of one of the country’s largest debt collection enterprises and became affiliated with the Forum, the country’s largest consumer collection arbitration company. The lawsuit alleges that Accretive principals remain actively involved with the Forum.

The lawsuit states that, in 2006, the Forum processed just over 214,000 consumer collection arbitration claims, of which 125,000, or nearly 60 percent, were filed by the above law firms.

Swanson said that the Forum was aware of the affiliation problem in 2006 when it negotiated its relationship with Accretive. She pointed to an email from an officer of the Forum to the hedge fund stating: “…we should certainly plan for unwinding any deal in the event shared ownership becomes an acute issue.”

We'll follow this interesting story.

View the complaint here:
http://capwiz.com/nacanet/attachments/MN_Complaint_Against_NAF.pdf

Sources:
MN Attorney General Press Release

http://www.politicsinminnesota.com/2009/jul14/3464/swanson-files-suit-against-national-arbitration-company

Business Week

FDA Eyes Acetaminophen & Evalutes Risks Assocaited With Its Use

The Food and Drug Administration is pondering what to do about the wildly popular painkiller in Tylenol, Excedrin, Nyquil, TheraFlu, Vicodin, Percocet and many other commonly used drugs to treat aches and pains and alleviate fevers.

Since all of these medicines have considerable amounts of acetaminophen in them, when you take them collectively, you're getting pretty close to the maximum daily allowance.

After a two day meeting, the FDA panel is calling for sweeping changes to review acetaminophen's safety since years of public education efforts have failed to alleviate the problem.

The FDA now recommends lowering the maximum amount allowed in over-the-counter medications from 4 grams to a lower, undisclosed amount. It also recommends adding a visible warning label on combination drugs that contain acetaminophen, and decreasing the dosage of Extra Strength Tylenol.

ACETAMINOPHEN DANGERS

Acetaminophen is generally very safe and effective, but in excess doses it can cause liver failure. And because acetaminophen is so common -- more than 24 billion doses were sold last year in the United States -- even rare side effects can add up to a lot of problems.

According to the FDA, from 1998 to 2003, acetaminophen was the main cause of acute liver failure in the United States.

According to a June 2006 report published in Pharmacoepidemiology and Drug Safety, between 1990 and 1998, each year there were an estimated 56,000 emergency room visits, 26,000 hospitalizations, and 458 deaths related to acetaminophen overdoses.

A 2007 report from the Centers for Disease Control and Prevention estimates that there are 1,600 cases of acute liver failure each year in the United States, and acetaminophen is the leading and most common cause of liver failure.

The drug is an ingredient in so many products that people often don't realize they are getting multiple doses that could exceed the safe levels. The panel even went as far as to narrowly recommend pulling Vicodin, Percocet and similar products that combine acetaminophen with powerful narcotics from the market altogether.

Now, while the FDA usually follows the advice of its advisory panels, it doesn't have to, and is unsure at this time what action they will take. The FDA panel was split about pulling drugs like Vicodin & Percocet since these drugs are important to so many millions of Americans.

More than 200 million doses of those drugs that combine acetaminophen with narcotics were sold last year in the United States, making them the most common prescribed class of drugs.

The agency could leave drugs like Vicodin and Percocet on the market with stronger, more prominent warning labels. They could also work out a compromise with the companies that make these products where they voluntarily reduce the dosages and take other steps to make them safer.

In the meantime, officials say consumers should pay careful attention to how much acetaminophen they are getting from various products to reduce the chances of suffering complications.

Sources:

Washington Post

WKBW - Buffalo

Examiner.com

Florida appellate court upholds Florida law against generic drug switching - even if the generic has been FDA approved

Today, a Florida state appellate court ruled that a Florida law banning the substitution of certain drugs must be followed, even if a generic version gets federal approval from the Food and Drug Administration.

A three-judge panel of the 1st District Court of Appeal unanimously said it would be unconstitutional for the Florida Legislature to give up its authority over generic swaps to the federal Food and Drug Administration.

The Florida law lists the drugs for which generics cannot be substituted. The appellate court ruled that the Legislature has to make any changes in that list.

The court sided with Abbott Laboratories, which appealed Administrative Law Judge Susan B. Harrell's decision to remove a thyroid drug, including its name-brand Synthroid, from the list.

"It upholds a fundamental right of patients to receive the medications that are prescribed and intended by their doctors," said Abbott spokesman Scott Stoffel in Chicago.

Abbott's drug is prescribed for patients whose thyroid glands don't make enough of a hormone that regulates energy and metabolism. Synthroid also is used to treat or prevent goiters - an enlargement of the thyroid gland - that can result from hormone imbalances, radiation treatment, cancer or surgery.

Harrell had ruled that a generic version made by Mylan Pharmaceuticals Inc. could be substituted because the FDA in 2007 had given it an A rating, which meant it was the therapeutic equivalent of Synthroid.

Harrell based her ruling on another provision of the law that removes a generic from the list if it gets an A rating in the FDA's "Orange Book."

District Judge William A. Van Nortwick wrote that Harrell should not have applied that provision to editions issued after the law was passed in 2001.

It's up to the Legislature to update the list each year based on revised versions of the Orange Book, though it isn't required to follow the FDA's guidance, Van Nortwick wrote.

Source: http://www.miamiherald.com/news/florida/AP/story/1108552.html