Depuy Hip Replacement Cases Consolidated

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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

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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

• Drywall Manufacturer to Repair 300 Homes in First Major Drywall Settlement (propublica.org)
• More details emerge about drywall settlement (knoxnews.com)

DEPUY--WHAT TO DO IF YOU RECEIVE A RECALL LETTER

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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 THAT A PHYSICIAN IN NORTHWEST ALABAMA HAS ONLY ORDERED XRAYS, TOLD ALL OF THE PATIENTS WHO CONTACTED ME 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 FOR FREE CARE FROM DEPUY MAY COST YOU IN THE FUTURE---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

GMAC and the Foreclosure Problem: Has the Dam Finally Broken on Fraudulent Foreclosures

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Initial reports were that GMAC had stopped foreclosures in 23 states.  GMAC then issued the following response:

     "Recent reports have stated that GMAC Mortgage instituted a moratorium on all residential foreclosures in 23 states," the statement said in response to media reports saying that the lender had imposed the moratorium. "This is not true. In fact, all new residential foreclosures are continuing in the ordinary course of business with no interruption in our usual practice."

What Gives and Where is this Going!!!!!!

Various accounts have described how one officer of GMAC Mortgage’s servicing unit has admitted during testimony that, while he signs thousands of affidavits each month in order to affect steps in the foreclosure process, he does not have personal knowledge of certain critical facts in the affidavit which he asserts to be true.

Why is this a problem?  A supporting or opposing affidavit must be made on personal knowledge, set out facts that would be admissible in evidence, and show that the affiant is competent to testify on the matters stated. 

What are the implications of the GMAC Mortgage actions and how serious are the problems? GMAC Mortgage and similarly situated parties contend that there is nothing fundamentally wrong with their foreclosure process and this is simply a procedural issue which is readily curable. In contrast, advocates for borrowers in foreclosure have indicated that the questionable affidavits are only the “tip of the iceberg” and represent the beginning of the end for the foreclosure mills and the banks, servicers and trustees who have been seeking to exercise foreclosure under false pretenses. The heightened scrutiny and increasing interest by state attorneys general means we may finally get to the bottom of a long-running “he said-she said” dispute.

NOT SO FAST

Consumer protection attorneys have for years claimed that finance companies and their servicers  have been playing fast and loose with the rules.  Specifically, there are have been allegations that almost all foreclosures were tainted by assignments and alonges (the documents that transfer ownership) that were fraudulently signed, not at the time of assignment, but to effectuate the foreclosure.

SECURITIZATION MAKES MATTERS WORSE

Think of it like this.  During the boom, mortgages are being pumped out faster than oil in the gulf coast.  Those mortgages were being assigned faster than Bernie Madoff could steal money and being cut into pieces faster than an onion on a Ginsu knife commercial.  Those pieces were being securitized and resold on Wall Street.  No one thought that loans for 120% of the value of the property would ever go down and anyone would ever default.  They were making money so fast they never thought they might have to comply with the law and actually LEGALLY assign the paper.

So, the paper ends up in securitized trusts (a legal entity) governed by New York trust law, i.e. legal requirements must be met before it goes into the trust--like actual assignments.

HERE COMES TROUBLE

Then one day someone has to foreclose.  In order to foreclose you must prove that you actually own the paper.  

MAKE IT UP AS YOU GO

In order to get paid, servicers must actually foreclose on the property.  Many lawyers have argued that these entities literally had people sit in rooms all day and sign affidavits and assignments so that the properties could be foreclosed. 

IS THIS THE END OR JUST THE BEGINNING

GMAC Mortgage and other banks may hope to sell the story line that its problem is limited to a lone “rogue servicing officer.” Unfortunately, the servicing officer in question indicated in his testimony that he prepared 10,000 or more affidavits per month. 

IF YOU BELIEVE THIS WAS NOT AND INSTITUTIONAL PROBLEM, I HAVE A PYRAMID SCHEME I WOULD LIKE TO SELL YOU.

Chris Hellums is the managing shareholder of Pittman Dutton & Hellums.  He is currently litigating wrongful foreclosure cases.  He can be reached toll free at 866-515-8880 or by e-mail at Chrish@pittmandutton.com

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• GMAC Mortgage Statement on Speculation Related to Foreclosure Moratorium (prnewswire.com)

CHINESE DRYWALL CLAIMS STILL BEING ACCEPTED IN MDL

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.

Depuy Recalls Total Hip System

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.

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.

Federal Court Reinstates Claim Redux, commonly known as "Fen-Phen ", Should Have Not Been Offered to American Public

A Ohio Federal Court of Appeals Reaffirms that Diet-Drug Redux, commonly known as "Fen-Phen" Should Never Have Been Marketed to the American Public. 

Why?  The Court of Appeals indicated that the Plaintiff's death was due in part to Wyeth's pre-approval...

TIME MAGAZINE Cover re: Redux

The Court of Appeals reinstated a deceased victim's claim that the recalled diet drug Redux (commonly called fen-phen) linked to her death should never have been marketed to the American people by Wyeth due in part to its pre-approval concerns about potentially lethal side effects. 

 In the same ruling, the Court held that Federal regulation does not preempt state consumer-protection law

In remanding the case to the trial court, the Court of Appeals held that Federal drug regulations do not preempt state law negligence claims, and indicated that the Supreme Court's 2009 landmark pharmaceutical manufacturer preemption decision (Wyeth v. Levine) may apply beyond inadequate warning-label claims.

Importance?  This prevents drug companies being shielded from appropriate state neglignce claims from millions of Americans who get seriously injured taking these prescription medications that do not display adequate warnings due to misrepresentations about these serious lethal side effects to the FDA during the drug approval process. 

In its decision, the appeals Court stated, "...we are not persuaded that it is always impossible to comply with both state law duties and FDA regulations in the process leading up to FDA approval." It added, "...we cannot agree with the district court's conclusion as, not only is there a presumption against preemption, but the case law supports the conclusion that Congress did not intend to preempt state tort law claims when it passed the Food, Drug, and Cosmetics Act (FDCA)."

Punitive Damages

The Court of Appeals also reinstated and remanded to the trial court Plaintiff's claim for punitive damages.


In reversing key sections of the trial court's finding for the defendant on summary judgment in Wimbush v. Wyeth et.al., 6th Cir. No. 09-3380, the three-judge appeals panel held that the trial judge erred in concluding that the U.S. Food and Drug Administration (FDA) preempted the Buchanan family's negligence claims that the drug should never have been made available to Americans given Wyeth-Redux's known health risks, particularly Primary Pulmonary Hypertension (PPH).

 Redux/ Fen-Phen Causes Primary Pulmonary Hypertension

Although Redux was on the market  for a relatively short period, it is estimated that Wyeth has paid thousands of victims of Redux and its predecessor, Pondimin – and/or their survivors – more than $20 billion in damages. In evaluating the potential side effects of Redux, researchers noted that Primary Pulmonary Hypertension (PPH) is a devastating pulmonary disease for which there is still no cure, and the associated heart-valve problems may and often did require high-risk heart surgery. The controversial, high-risk diet drug had previously been evaluated and pulled from pharmacies overseas and it was banned in some individual states before the total recall.
The drug company, which spent more than $50 million marketing the wildly popular and profitable drug after its launch in April 1996, pulled it on September 15, 1997 at the request of the FDA and under mounting criticism by independent researchers and reports in respected medical journals.

 Mrs. Buchanan, the Plaintiff, was a dedicated 66- year-old nurse from Maple Heights, Ohio who took the weight-loss drug during 1996 and 1997, who lost her life to PPH in 2003 within a few months after filing her complaint.

See also:
http://www.pbs.org/wgbh/pages/frontline/shows/prescription/hazard/fenphen.html

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

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• 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)

Avandia Letter Described as "Misleading"

The FDA ordered GlaxoSmithKline to write certain physicians describing the July expert advisory panel discussion regarding the risks of Avandia, their controversial diabetes medicine.  However, many are calling the letter misleading.  The letter was sent to physician investigators in the Tide trial, a trial the F.D.A ordered GSK to top recruiting new patients.

Dr. David Graham, an F.D.A. medical officer, gave an impassioned presentation at the advisory meeting arguing that the study should be stopped because patients in the trial are being exploited. None of
his arguments were referenced or described in GlaxoSmithKline’s letter.

Other members of the advisory committee complained that the company’s letter was biased.

The dispute is part of an ongoing battle over what the committee actually decided in July. The committee’s most important vote was whether Avandia should remain on the market and, if so, how. Five different options were offered. Three panel members voted for no change; 7 voted to add more warnings to the drug’s label; 10 voted to severely restrict the drug’s marketing; and 12 voted that the drug should be withdrawn. One abstained.
If the drug is withdrawn, this latest dispute will disappear since the Tide trial itself would likely end.

For more on this story, see  Glaxo Memo on Avandia Is Questioned (prescriptions.blogs.nytimes.com)

AVANDIA: Lawsuits , FDA Restrictions and continued FDA Investigation

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Avandia, GlaxcoSmith Kline’s blockbuster diabetes drug, has faced intense scrutiny the last three years for links to heart problems. Last Friday, Time magazine reported that deputy FDA commissioner Josh Sharfstein said the agency is investigating whether Glaxo broke the law by holding back data from the FDA indicating the drug carried an increased risk of heart attacks.

Sen. Chuck Grassley, the ranking member of the Senate Finance Committee has been investigating Glaxo and Avandia for over two years, and released dozens of internal Glaxo documents in February, 2010 relating to those potential cardiovascular risks. The committee sent copies of those documents to the FDA.

In July, 2010 GSK received disturbing news from the FDA.

The FDA ordered GlaxoSmithKline to stop enrolling new patients in a clinical trial of its diabetes drug, Avandia.

The clinical trial, called TIDE, was mandated by the FDA to assess safety risks of the drug, which is prescribed to treat type-2 diabetes.

The FDA said the action does not mean the drug will be removed from the market. But the agency is demanding that GlaxoSmithKline update physicians and ethics oversight boards involved in the trial regarding all new safety information about the drug.

The second was the when 21 members of the 33 member Food and Drug Administration advisory committee panel  voted to restrict the sales of Avandia due to its potential risk for causing heart attacks.

Twelve voted to completely remove Avandia from the market; 10 voted for allowing sales to continue but with new label revisions and possible restrictions; 7 voted to add more warnings while 3 voted for no change at all. We’ll be watching the final decision from the FDA.

                         OUR FIRM IS INVESTIGATING AVANDIA CLAIMS. 

CONTACT CHRIS HELLUMS TODAY FOR A FREE CASE EVALUATION: 866-515-8880 or Chrish@pittmandutton.com . 

For further research and investigation read:
• Wall Street Journal Blog: “Another Twist in the Chronicles of Avandia!”
http://blogs.wsj.com/health/2010/08/13/another-twist-in-the-chronicles-of-avandia/%20%20
• 33 Member FDA panel votes to restrict Avandia
o http://prescriptions.blogs.nytimes.com/2010/07/14/blogging-the-f-d-a-panel-on-avandia/%20

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• Glaxo Memo on Avandia Is Questioned (prescriptions.blogs.nytimes.com)
• Another Twist in the Chronicles of Avandia! (blogs.wsj.com)

Alabama Supreme Court Justices Deny Improper Contact

Alabama Supreme Court justices deny alleged allegations by Tuscaloosa businessman Stan Pate and others that Governor Riley intervened in the electronic Bingo case. According to reports, Pate and others allege that Riley intervened to get the case assigned to Justice Glenn Murdock. Victoryland issued a statement repeating Pate's allegations. Casino officials also indicated that they were told by Republican insiders that Riley contacted members of the Supreme Court and influenced the assignment of the case.


For further information, see the attached link:


http://http//blog.al.com/spotnews/2010/08/alabama_justices_deny_improper.html