Navistar Bus Recall

Navistar, the manufacturer responsible for MaxxForce brand diesel engines, school and commercial buses, trucks, personnel carriers and vehicle parts, has recalled multiple school bus models because of safety defects. Navistar is based in Fort Wayne, Indiana, and manufacturers a number of heavy-duty vehicles for everything from construction and farm use to people and cargo conveyance. The BE and CE series buses are built by subsidiary IC Bus.

Navistar plans to initiate a recall for certain models year 2011 and 2012 IC RE school buses manufactured from February 4, 2010 until June 16, 2011 and 2011 and 2012 bus models IC RE made between August 24, 2010 and June 8,2011.  The National Highway Traffic Safety Administration (NHTSA) issued a report that these models have a positive battery cable that might rub against the hydraulic cooler reservoir-mounting bracket. This defect could lead to an electrical short, which in some cases could result in a fire. No information was given as to how many buses may be affected by this defect. The New York Times reported that up to 15,500 buses could be affected by this recall.

Navistar also plans to recall approximately 340 buses with model years 2011 and 2012 CE and RE manufactured from October 8, 2009 until April 14, 2011 because they were made without, or with improperly installed, floor channel reinforcements. This means the buses do not conform with seat back rear force displacements requirements and raise the risk of passenger rearward ejection.

In December of 2011, Navistar recalled certain model year 2012 International Durastar and IC Bus HC Heavy trucks and buses manufactured from February 10, 2011, through February 18, 2011, that were equipped with a Meritor MFS08 Series Non-Drive front steer axle. During the assembly process, the steering attachment bolts may have been insufficiently torqued. Insufficient torque of the steering arm bolts may result in bolt fatigue and fracture and/or arm separation, thereby potentially resulting in loss of steering control and increasing the risk of a crash. No injuries were associated with these recalls. Navistar plans to notify owners soon and work with them to repair the buses free of charge.

Our firm is currently investigating claims for those people who have been by a recalled Navistar bus. If you would like a free case evaluation, please contact Booth Samuels at toll free 1-866-515-8880 or at booths@pittmandutton.com.

ILLINOIS CONGRESSMAN: NCAA = MAFIA

Source:  Fox News

Illinois Congressman Bobby Rush said Tuesday "I think you would compare the NCAA to Al Capone and to the Mafia."

Rush made the accusations at the forum called to look at the impact of "back-room deals, payoffs and scandals" in college sports. The congressman spoke after hearing from a couple of mothers of former student-athletes who complained of ill treatment by schools after their sons suffered injuries.

One mother, Valerie Hardrick, said the University of Oklahoma refused to grant a waiver for medical hardship that would allow her son, Kyle Hardrick, to play basketball at junior college after transferring from OU. Prior to Tuesday's forum, Hardrick's family provided to The Associated Press documentation showing that team doctors diagnosed him with a torn meniscus in his knee and wrote down on practice logs that he should be held out because he was hurt. Hardrick's family said the university has refused to pursue the waiver unless the family agrees to a settlement that would prohibit him or his family members from enrolling at Oklahoma or any of the universities governed by its board of regents. The proposed settlement also would prevent the Hardricks from filing a lawsuit against the university.

"My insurance does not cover all of Kyle's medical bills," an emotional Valerie Hardrick said. "The University of Oklahoma refused to pay for Kyle's surgery, his rehab, and his medication. The university actions also allowed Kyle to be released without appropriate medical treatment before consulting his original surgeon."

The NCAA requires schools to certify that an athlete has insurance coverage for athletically-related injuries, up to the deductible of the NCAA Catastrophic Injury Insurance Program (currently $90,000). The insurance coverage can be offered by the school, a parent or a personal policy of the athlete.

Two NBA players also participated in the forum, Thaddeus Young of the Philadelphia 76ers and Shane Battier, a free agent who last played with the Memphis Grizzlies.Battier described a college regimen at Duke that included a workout at 6:30 a.m., followed by classes, practice between 4 and 7:30 p.m., and wrapping up schoolwork at 11:30 or midnight.

"It is a full-time job," he said.

Battier called the NCAA's decision last week to allow conferences to provide student-athletes up to $2,000 in spending money "a great start."

"Is that a game-changer? No. What is a game-changer? A game-changer is guaranteeing four-year scholarships. That's a game-changer," Battier said. "A game-changer is, `If you commit to our school, and you graduate, we will pay for any graduate degree that you would like to pursue."'

Ramogi Huma, president of the National College Players Association, called the $2,000 a step in the right direction. But he said it shouldn't be optional, and that it still leaves a shortfall. His group has calculated the average scholarship shortfall for men's basketball and football at the Football Bowl Subdivision level at around $3,200.

Read more: http://www.foxnews.com/politics/2011/11/01/illinois-congressman-compares-ncaa-to-mafia/#ixzz1cYpC4ILb

J & J Mesh Product Based on Recalled Product.

Source: Bloomberg

Pelvic Mesh treats incontinence and a condition called pelvic organ prolapse, in which internal organs slump into the vagina. They were allowed on the market as result of the agency’s approval process, known as 510(k), which relies on the notion that if one device has been cleared by the FDA then similar devices need little if any testing in patients.

The chain of approvals that began with Boston Scientific’s device highlight a key flaw in the 510(k) process, said Amy Allina, a policy director at the National Women’s Health Network, a Washington-based advocacy group.  The system lets manufacturers win clearance for a product by citing its similarity to an already approved device, known in FDA jargon as a “predicate.” That second device can be cited as the basis for a third, the third to clear a fourth and so on.

“If a first iteration is recalled, they don’t necessarily look at the second, third or fourth things that are based on that,” Allina said in an interview. The system, she said, “is a mess.”

The story began in 1996, when Boston Scientific won clearance for ProteGen, the first vaginally implanted mesh designed specifically to treat incontinence. Two years later, J&J won approval for a similar device, called Gynecare TVT. Under the 510(k) system, J&J wasn’t required to conduct human testing because the company claimed its device was “substantially equivalent” to the Boston Scientific device.

A year later, Boston Scientific voluntarily pulled about 20,000 ProteGen meshes, saying it had received 123 reports of problems, including discomfort, painful sex, and erosion of vaginal tissue. Nonetheless, J&J and at least two other manufacturers, American Medical Systems and Covidien Plc (COV), soon came out with products that traced their design back to ProteGen.

The FDA has said it doesn’t know the number of women who have received the implants since 1998, though it estimates almost 300,000 were used in 2010.

In the case of vaginal mesh implants, the FDA continued approving the hammock-like devices made by J&J and other companies based on their similarity to Boston Scientific Corp. (BSX)’s ProteGen even after it was pulled amid safety complaints. Today, the makers of the entire category of implants face more than 600 lawsuits from women who claim the devices caused serious injury.

The complaints are the latest to implicate the approval process for medical devices at the U.S. Food and Drug Administration, which has cleared faulty hip implants and numerous other products.

In the case of Johnson and Johnson, this is nothing new.  How may recalls have we seen from this company in the last 36 months.  Where was the FDA when other countries with databases were recalling J&J's faulty hips that now may have affected 34,000 Americans and subjected them to toxic levels of heavy metals.  I guess those guys just don't want to mess up those cushy jobs waiting for them when they leave government service to cash in.

In July, the FDA issued a statement saying it is unclear whether prolapse implants provide any benefit over traditional surgery. The statement came three years after the agency first acknowledged a problem in a 2008 report that said mesh complications were serious, if rare. An advisory panel of physicians said last month that the FDA should demand more clinical testing of the devices.

To learn more about Pelvic Mesh Implants, visit: http://www.pelvicmeshlawyer.com/about_mesh_implants.html

Huntsville Neurosurgeons Identified in WSJ article: Taking a Double Cut, Surgeons Implanting Their Own Devices

Source:  WSJ

In the weekend edition of The Wall Street Journal, John Carreyrou and Tom McGinty investigate the ownership of medical device companies whose products the surgeons implant in their patients.

A federal antikickback law prohibits medical device makers from paying surgeons to use their products.  Mindful of the law, big device makers entered into partnerships with spinal surgeons, paying them consulting fees and royalties for help designing their products. In some cases, surgeons receiving payments would use that company's devices exclusively and would author research favorable to those products, company documents obtained by congressional investigators show. 

Critics of such arrangements say they give surgeons an incentive to do
more operations, and that the conflict of interest has led to unnecessary back surgeries that waste health-care dollars and often do patients more harm than good. "Patients are having huge operations that are un-indicated because of this," says Scott Lederhaus, a neurosurgeon in Pomona, Calif., and member of the Association for Medical Ethics, an organization of doctors that focuses on conflicts of interest. 

The inherent conflict of interest is fueling concern. In June, five U.S. senators asked the Inspector General of the Department of Health and Human Services to open an investigation into physician-owned device companies, citing concerns that the surgeons involved have a financial incentive to "perform more procedures than are medically necessary." 

Many of the products at issue are approved by the FDA pursuant to the 501(k) process. Under this process, surgeons only have to submit mechanical-testing data attesting that their implants are "substantially equivalent" to existing ones. The FDA
usually gives its green light within 90 days. This process has been under increasing criticism as abuses continue to mount and virtually everything has become substantially equivalent.

The article highlights Spinal USA. 

In the spring of 2007, FDA inspectors paid a surprise visit to Spinal  USA's offices. They assessed the company with 14 violations, ranging from failing to maintain master records for its devices to having no system in place to track and label them, according to a warning letter the agency issued to the company. The violations were "symptomatic of serious problems," the warning letter stated.

A spokesman for Spinal USA said its rapid growth caused it to run afoul of FDA procedures. He said the company hired an experienced manager to oversee quality control in February 2008, and a second FDA inspection that September cleared the company of the violations.  During a third visit in December 2010, FDA inspectors found problems with the way Spinal USA was storing bone products, which the company also addressed.

So why would surgeons use Spinal USA product and why is it that so many neurosurgeons in Huntsville, Alabama would jump on the product bandwagon?
According to the article, in 2007, four spine surgeons in Huntsville, Ala. to invested in the company. Those surgeons, Gilbert Aust, Cyrus Ghavam, Morris Seymour and Larry Parker, switched to using Spinal USA implants in most of their surgeries, according to a local representative for a big medical-device maker.

Four more Huntsville spine surgeons subsequently joined Spinal USA, giving the company a relationship with eight of Huntsville's current 15 spine surgeons. Spinal USA also expanded to Mobile, Ala., where it recruited two surgeons.

Dr. Aust, who is chairman of Spinal USA, confirmed that he and Drs. Ghavam, Seymour and Parker are investors. The company declined to comment on its other surgeon investors.

At Huntsville Hospital, one of the city's two hospitals, 351 spinal-fusion surgeries were performed on Medicare patients in 2009, up from 333 in 2006, before Spinal USA came to town, a Wall Street Journal analysis of Medicare claims data shows. At Crestwood Medical Center, the city's other hospital, there were 187 such operations on Medicare patients in 2009, up from 107 in 2006, the analysis shows. Huntsville Hospital says it spent $5.6 million on Spinal USA products in its most recent fiscal year. 

Dr. Aust is quoted as saying that he performs such hardware replacements for medical reasons, not financial ones. He says he doesn't see anything wrong with the fact that they benefit him financially by contributing to Spinal USA's sales. "I know some people in the profession don't think it's ethical,but I just don't see it," he says. 

The federal antikickback law doesn't specifically address the issue of surgeons using medical devices made by companies they co-own, but HHS's Office of the Inspector General has issued regulatory guidance for complying with the statute: Among other things, it advises that no more than 40% of a company be owned "by investors who are in a position" to "generate business" for it. 

Dr. Aust says he and Spinal USA's other surgeon investors own "the majority of the company," but are working on lining up outside investors. The Spinal USA spokesman says its surgeon owners are in compliance with federal laws because their shares of profits are proportional to their ownership stakes, not to how much business they generate through their surgeries. He adds that more than 60% of the company's business is generated by surgeons who aren't owners. 

Spinal USA declines to say how much its surgeon owners earn from the company. But a filing in the personal bankruptcy case of spine surgeon Michael Molleston, one of its investors, says Dr. Molleston received $26,000 a month from Spinal USA as of Nov. 19, 2008, when the filing was made. Dr. Molleston couldn't be reached for comment. 

Medicare data showed that a doctor in Jackson, Mississippi  with a similar agreement performed spinal fusions more frequently than many of his peers. In 2008 and 2009, he performed 278 spinal fusions on Medicare patients, tenth most in the nation, according to the Journal's analysis of Medicare claims data. In 150 of those cases, or 54%, the patients' diagnosis was degenerative disks. 

Considering the catastrophes we are seeing in medical devices and the murky relationships between physicians and pharmaceutical and medical device companies, everyone should consider asking their surgeon to disclose these type of arrangements and Congress should mandate it. 

Related articles

• Surgeons Implant Devices They Make (online.wsj.com)
• You: Taking Double Cut, Surgeons Implant Their Own Devices - Wall Street Journal (news.google.com)
• Medtronic pays 5 surgeons $7m kickbacks in just 9 months: The rape of Medicare (ktwop.wordpress.com)

Former U.S. Senator Fred Thompson and other Lawyers: State Farm covered up support of candidate in most expensive judicial race in U.S. history.

Former Tennessee Republican Senator and others have filed suit accusing  insurance giant State Farm of defrauding the Illinois Supreme Court by covering up its support of the Republican candidate in the most expensive state judicial race in U.S. history.

A petition was filed last week, asking the court to reconsider its decision to void a $1 billion verdict against State Farm. The petition is based on an investigation by a former FBI agent Michael Reece.

"The bottom line of my investigation is that State Farm used the Illinois Civil Justice League to elect Judge Karmeier and Judge Karmeier knew it," Reece stated in his affidavit that accompanied the petition.

The petition alleges Karmeier received at least $2.5 million and up to $4 million in contributions from State Farm during the 2004 campaign against his opponent, Democrat Gordon Maag. Karmeier declined to recuse himself from the class-action case against State Farm because of a conflict of interest and eventually cast his vote to void a $1 billion judgment.

In a 2009 ruling, the court stated a West Virginia appellate judge should have recused himself from a case where the judge received $3 million in campaign contributions, then overturned a verdict against a contributor.

The U.S. Supreme Court decided the judge should have recused himself because of the "serious risk of actual bias."

The Illinois case dates back to 1997 when it was filed in Williamson County. The suit alleged State Farm breached its contract with policyholders when it directed the use of non-original parts in vehicles damaged in crashes. A jury awarded $465 million to some State Farm customers. Williamson County Associate Judge John Speroni awarded $730 million to other policy holders.

In 2001, the Appellate Court let stand a $1.05 billion judgment.

The Supreme Court heard oral arguments in May 2003.

Karmeier, then a circuit judge in Washington County, announced six months later that he would run as a Republican for Illinois Supreme Court.

Karmeier was elected to the Supreme Court in November 2004.

State Farm later represented to the Supreme Court that it provided $350,000 to the Karmeier campaign when plaintiffs' attorneys requested Karmeier recuse himself from the class-action decision.

Nine months after Karmeier was elected, he sided with a 4-2 majority to void the judgment against State Farm. To overturn an appellate decision, there must be a four-justice majority. If that does not occur, the appellate court ruling stands.

Reece discovered evidence that State Farm lobbyist Bill Shepherd vetted Karmeier for the job, helped direct Karmeier's campaign, along with Illinois Civil Justice League head Ed Murnane, used the league's political action committee, JUSTPAC, to raise $2.5 million and "funneled" it to Karmeier's campaign, according to his affidavit filed with the recent petition.

"The Shame of College Sports" by Taylor Branch, ATLANTIC MAGAZINE

"A litany of scandals in recent years have made the corruption of college sports constant front-page news. We profess outrage each time we learn that yet another student-athlete has been taking money under the table. But the real scandal is the very structure of college sports, wherein student-athletes generate billions of dollars for universities and private companies while earning nothing for themselves."


Below is a link to this article.  It is a must read for anyone interested in these issues:


http://www.theatlantic.com/magazine/archive/2011/10/the-shame-of-college-sports/8643/


Here are a couple more highlights:

“I’M NOT HIDING,” Sonny Vaccaro told a closed hearing at the Willard Hotel in Washington, D.C., in 2001. “We want to put our materials on the bodies of your athletes, and the best way to do that is buy your school. Or buy your coach.”

Vaccaro’s audience, the members of the Knight Commission on Intercollegiate Athletics, bristled. These were eminent reformers—among them the president of the National Collegiate Athletic Association, two former heads of the U.S. Olympic Committee, and several university presidents and chancellors. The Knight Foundation, a nonprofit that takes an interest in college athletics as part of its concern with civic life, had tasked them with saving college sports from runaway commercialism as embodied by the likes of Vaccaro, who, since signing his pioneering shoe contract with Michael Jordan in 1984, had built sponsorship empires successively at Nike, Adidas, and Reebok. Not all the members could hide their scorn for the “sneaker pimp” of schoolyard hustle, who boasted of writing checks for millions to everybody in higher education.
“Why,” asked Bryce Jordan, the president emeritus of Penn State, “should a university be an advertising medium for your industry?”
Vaccaro did not blink. “They shouldn’t, sir,” he replied. “You sold your souls, and you’re going to continue selling them. You can be very moral and righteous in asking me that question, sir,” Vaccaro added with irrepressible good cheer, “but there’s not one of you in this room that’s going to turn down any of our money. You’re going to take it. I can only offer it.”
William Friday, a former president of North Carolina’s university system, still winces at the memory. “Boy, the silence that fell in that room,” he recalled recently. “I never will forget it.” Friday, who founded and co-chaired two of the three Knight Foundation sports initiatives over the past 20 years, called Vaccaro “the worst of all” the witnesses ever to come before the panel.

For all the outrage, the real scandal is not that students are getting illegally paid or recruited, it’s that two of the noble principles on which the NCAA justifies its existence—“amateurism” and the “student-athlete”—are cynical hoaxes, legalistic confections propagated by the universities so they can exploit the skills and fame of young athletes. The tragedy at the heart of college sports is not that some college athletes are getting paid, but that more of them are not.


Today, much of the NCAA’s moral authority—indeed much of the justification for its existence—is vested in its claim to protect what it calls the “student-athlete.” The term is meant to conjure the nobility of amateurism, and the precedence of scholarship over athletic endeavor. But the origins of the “student-athlete” lie not in a disinterested ideal but in a sophistic formulation designed, as the sports economist Andrew Zimbalist has written, to help the NCAA in its “fight against workmen’s compensation insurance claims for injured football players.”

"The Shame of College Sports" by Taylor Branch, ATLANTIC MAGAZINE

"A litany of scandals in recent years have made the corruption of college sports constant front-page news. We profess outrage each time we learn that yet another student-athlete has been taking money under the table. But the real scandal is the very structure of college sports, wherein student-athletes generate billions of dollars for universities and private companies while earning nothing for themselves."


Below is a link to this article.  It is a must read for anyone interested in these issues:


http://www.theatlantic.com/magazine/archive/2011/10/the-shame-of-college-sports/8643/

NCAA: THE PROBLEM IS TITLE IX-THAT'S NOT WHAT WALTER BYERS SAYS

One of the arguments made is that Title IX is the cause of the financial problems of many college programs.  Walter Byers addressed that argument in his book Unsportsmanlike Conduct in 1995.  For those who don't know Byers, he 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.

In his book he says the following about Title IX:

     The costs of Title IX and the entry of women into the big time should not be blamed for today's      highly publicized financial problems for college sports.  Two-platoon football was the culprit in the 1960s, and Title IX was held responsible in the 1980s.  As we enter the 1990s, the complaints of insolvency are louder than ever.  The most frequently proposed cures are a national football playoff and conference realignments to gain more TV dollars.  AT THE HEART OF THE PROBLEM IS AN ADDICTION TO LAVISH SPENDING. (emphasis added).


He goes on to say that Presidents and Athletic Directors like the power, status, prestige and attention from prominent boosters that big time college programs bestow on them.

 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.

NCAA: Cars for Players-NO-Cars for NCAA staffers-YES

Image via Wikipedia

One of the most, well, I guess I should say more because there are so many, unbelievable stories told by Walter Byers in his book involves Wilt Chamberlain.  Wilt was recruited out of Philadelphia to the University of Kansas in 1955.  His recruitment was as high as his height.  As the story goes, Wilt chose Lawrence to alleviate his asthma problems.  He arrived driving a 1950 Buick, later replaced with a 1953 Oldsmobile  that came from the Greenlease-O'Neill Oldsmobile dealership in Kansas City. The ledgers showed that he was paying for the car at a rate of $25 per month, cash.  Unfortunately some of the cash payments were made when Wilt was out of town.   By 1957, Wilt was driving a 1956 Oldsmobile convertible obtained from a dealership in Lawrence, Kansas.

The NCAA concluded that the 1956 Oldsmobile transaction had been provided to Wilt at no cost.  This, along with other violations, landed Kansas on probation for two years.

All this sounds familiar, right.  Eric Dickerson, Reggie Bush, Terrelle Pryor, etc. etc.

Well, here is the ironic, and some might say, hypocritical "rest of the story"  as told by Byers in his book:

"In recent years, O'Neill Oldsmobile has been one of two dealers that have provided free Oldsmobiles for some 30 top-echelon NCAA staffers, ."  "In 1989-90, Steve Morgan and David Berst, the top NCAA enforcement officials at the time, were among those who rode comfortably in new Olds 98s furnished without charge by the automobile agency that took care of Wilt Chamberlain more than 30 years before."


I guess what is good for the goose is not always good for the gander.  I guess that is why Mark Emmert looks like a man trying to defend the indefensible in the Frontline interview.  Watch it here:

 http://www.washingtonpost.com/lifestyle/style/frontline-money-and-march-madness-ncaas-in-the-money--but-athletes-arent/2011/03/28/AF20beqB_story.html

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.

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.

Just Saying: 'Tort reform' harms us all

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Josh Moon with the Montgomery Advertiser wrote the attached article on Tort reform.  For anyone who saw the HBO documentary film Hot Coffee (http://www.hbo.com/documentaries/hot-coffee/index.html), which I would personally recommend to anyone interested in this issue,  I think you will find this article thought provoking and and worth reading.

http://www.montgomeryadvertiser.com/apps/pbcs.dll/article?AID=2011107030329

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).

DePuy Pinnacle MDL Update

Our firm has four of the first Pinnacle cases filed in the DePuy Pinnacle MDL and anticipates filing more in the coming months. We are seeing rapid failures of the device due to high cobalt levels in blood tests. Excessive levels of cobalt in the blood stream is a sign of metallosis, which can cause rashes, soft-tissue damage, peripheral neuropathy and pseudo-tumors.

The DePuy Pinnacle cases have been consolidated in the U.S. District Court for the Northern District of Texas under Judge James E. Kinkeade. Judge Kinkeade is currently presiding over at least one of the cases, and the Panel determined his current caseload will accommodate the litigation. There are approximately 57 DePuy Pinnacle hip lawsuits currently pending in federal courts nationwide and that number is expected to rise over the next few months.

DePuy is a subsidiary of Johnson & Johnson, one of the largest corporations in the world. DePuy recalled the ASR XL Acetabular hip system last August, after researchers found 13 percent of patients needed a repeat operation to fix problems with the implant. The company took a $280 million charge in the fourth quarter to pay for the recall. The company faces more than 500 lawsuits by patients who had the hip implants, most of which are consolidated in a separate MDL dealing only with ASR hips. There has been no recall of the DePuy Pinnacle hip.

Johnson & Johnson’s DePuy Orthopaedics division, a maker of artificial prosthetics such as hips and knees, has struggled with product recalls and lawsuits over faulty implants lately. It was announced earlier this year that the worldwide president would leave the company in March. The executive, David Floyd, has been president of the unit since 2007. He is leaving to pursue interests outside the company, a spokesman on behalf of the company, Lorie Gawreluk, said, declining to be more specific.

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.

FDA Orders Makers of Hip Systems to Conduct Post Market Studies

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      On the front of its Business Day section, the New York Times (5/11, B1, Meier, Subscription Publication) reported on the "unusual move" by the FDA to direct some 20 makers of "metal-on-metal" artificial hips to do postmarket studies because of "high early failure rates and severe health effects in some patients." The companies are being told to find out if the devices "are shedding high levels of metallic debris" that account for cases of disabling "soft tissue damage." Dr. William H. Maisel, deputy director for science at the FDA's Center for Devices and Radiological Health, said the FDA wants to know "about the entire category of implants, not any single manufacturer's device." He added, "Our concern is the product, not about a manufacturer."

        Bloomberg News (5/11, Farrell, Nussbaum) said the FDA order, dated May 6, went to Johnson & Johnson, "which is already facing more than 1,000 lawsuits over hip replacements," as well as companies such as Biomet Inc., Zimmer Holdings, and Stryker Corp., which said it didn't make a metal-on-metal product. Bloomberg News added, "The request comes nine months after DePuy Orthopaedics, a unit of New Brunswick, New Jersey-based J&J, recalled a hip-replacement system that had been implanted in 93,000 patients worldwide. 
        

DePuy Pinnacles Headed For MDL

 Attorneys, including myself,  who have filed lawsuits on behalf of individuals who have been injured by DePuy’s Pinnacle Hip Systems, have petitioned the U.S. Judicial Panel on Multidistrict Litigation to consolidate and centralized all similar claims before a single District Judge. If the panel agrees to form a DePuy Pinnacle MDL, a new MDL will be formed that will  focus solely on DePuy Pinnacle failures.

Interestingly, there will be individuals who have claims in both the recalled ASR MDL and the Pinnacle MDL.  Currently, we respresent several individuals who had recalled ASR implants which were replaced with Pinnacle implants, which also failed, and bi-lateral patients who have ASR implaints in one hip and Pinnacle implants in the other. 

My people who heard about the ASR recall investigated their implant system.  When they learned that they did not have a recalled ASR, but had Pinnacle systems, they did not obtain the blood tests given to ASR patients.  Rapidly developing evidence indicates that there are significant problems with some Pinnacle implant systems, resulting in failures similar to the ASRs.
If you or a loved one have had hip replacement surgery and have been implanted with a defective DePuy hip, you may be entitled to compensation for medical bills, pain and suffering, lost wages and other injuries. Our firm is currently investigating claims for those people who have been implanted with DePuy hip replacement devices, both ASR and Pinnacle. If you would like a free case evaluation, please contact Chris Hellums at toll free 1-866-515-8880 or at chrish@pittmandutton.com.

Topamax Under Scrutiny By FDA

Topamax was first approved in 1998 by the FDA for the treatment of seizures due to epilepsy. The drug is also referred to by the generic name Topiramate. In 2004, it was also approved for treating migraine headaches. It has been increasingly reported that Topamax has been linked to serious birth defects such as cleft palate/cleft lip. On March 4 of this year, the FDA required the manufacturers of Topamax to significantly strengthen warnings for the drug because of increasing data linking the product to certain types of birth defects including cleft lip/cleft palate and genital malformations including Hypospadias.

It appears that the greatest risk to the unborn baby comes from exposure to the drug during the first trimester of the pregnancy. During this extremely important developmental period, the mother may or may not know that she is pregnant. Therefore, it is not just women who know they are pregnant that are risk, but any woman of childbearing age taking Topamax. One study shows that expecting mothers on Topamax are 21.3 times more likely to give birth to infants with oral birth defects compared to the risk in a background population of untreated women.

Topamax is manufactured by Ortho-McNeil Pharmaceutical LLC, a subsidiary of Johnson & Johnson. From January 2007 through December 2010, approximately 32.3 million Topamax prescriptions were filled for over 4 million people in the United States. 

Johnson and Johnson has had a staggering number of recalled products in the last year and a half, notably the DePuy ASR Hip device recalled in the fall of 2010. In fact in April of 2011, Johnson & Johnson  recalled close to 57,000 bottles of Topamax because of complaints of an odor. This odor is believed to be caused by trace amounts of a chemical used to preserve the wooden pallets used in storage -- that's the same cause that prompted massive recalls of Tylenol and other over-the-counter medications at McNeil Consumer Healthcare.
In March of 2010, Ortho-McNeil pled guilty and paid $6.14 million in criminal fines for the misbranding of Topamax. Ortho-McNeil also paid an additional $75.37 million to resolve civil allegations (mostly reimbursement for fraudulent Medicare claims). The U.S. government said that Ortho-McNeil promoted Topamax by hiring doctors to join sales representatives in promoting Topamax for unapproved uses in unapproved doses for medical indications not covered by those programs. Reports indicate they promoted the drug as a way to help with weight loss and pain. The federal share of the civil settlement is $50,688,483.52, and the state Medicaid share of the civil settlement is $24,681,516.48.

Our firm is currently investigating claims for those people who have been injured by Topamax. If you would like a free case evaluation, please contact Chris Hellums at toll free 1-866-515-8880 or at chrish@pittmandutton.com.

Congressional Hearings on DePuy Hip Devices

On April 13, 2011, the United States Senate Special Committee on Aging conducted a hearing that focused on the DePuy ASR hip replacement recall and the role the FDA played in allowing this untested and dangerous product on the market.

The first witness to speak was Katherine Korgaokar, who was implanted with a defective DePuy ASR hip device. After learning of DePuy’s recall, Ms. Korgaokar underwent blood tests that found that her metal ions were 1,000% higher than they should be. Because of the extremely negative health effects of high cobalt and chromium levels in her body, her doctor recommended that she undergo a painful revision surgery to remove the recalled hip device.

Ms. Korgaokar’s testimony about the difficulty in recovering from the revision surgery is familiar to the thousands of patients who are in her shoes:

“The recovery from this second operation has been substantially more difficult than my first. The pain is much worse and it has been extremely difficult to get around. Only recently has my mobility improved to the point where I no longer need crutches. For the past three months I have essentially been confined to my home trying to get through this.”

The Government Accountability Office also testified about its findings in a recent report that found that the FDA is lacking in its ability to adequately protect the public from dangerous medical devices such as the DePuy ASR hip replacement. Among other things, the GAO found that:

“shortcomings in FDA’s oversight of the medical device recall process may limit the agency’s ability to ensure that the highest risk recalls are being implemented in an effective and timely manner. These shortcomings span the entire range of the agency’s oversight activities–from the lack of a broad-based program to systematically assess trends in recalls, to inconsistencies in the way FDA ensures the effective completion of individual recalls.”

Since DePuy was forced to recall the defective ASR hip implants in August, an MDL was formed to handle those lawsuits. Attorneys who have filed lawsuits on behalf of clients who have been injured by DePuy’s Pinnacle Hip System have petitioned the U.S. Judicial Panel on Multidistrict Litigation that all of the federal DePuy Pinnacle lawsuits be consolidated and centralized before a single District Judge. If the panel agrees to form a DePuy Pinnacle MDL, a new MDL will be formed that will solely focus on DePuy Pinnacle lawsuits.

This MDL will function in a similar manner as the MDL for ASR’s. All discovery and pretrial motions will be consolidated under one District Judge and the lawsuits will revert back to their original districts for trial, if necessary. Injuries from the Pinnacle Hip System are similar to ASR injuries: pain, swelling, inflammation and metal poisoning. High levels of cobalt and chromium found in blood and urine samples are causing the most alarm as metallosis can cause rashes, soft-tissue damage and pseudo-tumors.

If you or a loved one have had hip replacement surgery and have been implanted with a defective DePuy hip, you may be entitled to compensation for medical bills, pain and suffering, lost wages and other injuries. Our firm is currently investigating claims for those people who have been implanted with DePuy hip replacement devices, both ASR and Pinnacle. If you would like a free case evaluation, please contact Chris Hellums at toll free 1-866-515-8880 or at chrish@pittmandutton.com.

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.