Bloomberg: J & J Marketed Vaginal Mesh Without Approval

Deutsch: Logo (Photo credit: Wikipedia)According to Bloomberg News writers David Voreacos and Alex Nussbaum, Johnson & Johnson sold a vaginal mesh implant for three years before U.S. regulators approved the device.

J&J’s Ethicon unit introduced the Gynecare Prolift device in March 2005, touting it in an annual report as an “innovative and effective surgical option” for weakened pelvic muscles.

Here is the problem. The U.S.Food and Drug Administration said it learned of the Prolift in 2007, when J&J sought approval for a related product. The FDA cleared both devices in May 2008.

Johnson & Johnson’s unauthorized sales might cost it more to resolve lawsuits over the product.

J&J’s unauthorized sales might cost it more to resolve lawsuits over the product. J&J already has endured recalls of artificial hip implants and over-the-counter drugs. Three J&J units have pleaded guilty in the past two years to bribery or illegal marketing of drugs. A fourth agreed to plead guilty in a marketing case.

This type of conduct again raises questions about the FDA’s approval process, which lets companies introduce products without human testing if the agency decides they’re similar to devices already for sale, or so-called predicates.

An FDA report in July found a fivefold jump in deaths, injuries or malfunctions tied to vaginal mesh for prolapsed organs. In September, an advisory panel urged the FDA to reclassify such mesh as “high-risk” devices needing human testing.

In Atlantic City, patients’ lawyers are seeking to interview more than 70 company witnesses, including Gary Pruden and Sheri S. McCoy, the leader of J&J’s pharmaceutical and consumer products unit. Both Pruden and McCoy previously served as company group chairman and worldwide franchise chairman of Ethicon.

Less than 1% of of implanted medical products are subjected to the strenuous PMA (pre-market approval) process of the FDA. And the draft legislation put together by the House Energy and Commerce Health Subcommittee would actually allow the approval process to go even faster. The Senate Health, Education, Labor and Pensions Committee's draft bill does provide some additional protections for patients once devices are on the market, but does nothing new to prevent potentially unsafe medical devices from being sold in the first place.

But according to a new poll by our publishing pals Consumer Reports, 82% of Americans believe that preventing safety problems is more important than limiting safety testing in order to prevent delays and encourage innovation.

91% of poll respondents said each implant should be safety tested before being sold even when similar implants were in use.

71% said that a new device should not be allowed to be sold based on its similarity to an existing implant that has a safety problem or has been recalled.

94% indicated that medical device makers should be required to do long-term monitoring of implants if there are safety concerns or problems with a particular device. Existing law gives the FDA only limited authority to require such long-term safety monitoring.

95% said that effective consumer protections for medical implants should include a nationwide system for tracking medical implants so patients can be notified about safety problems or recalls. No such system currently exists in the U.S. even though it was required by Congress' previous reauthorization of the law.

66% indicated a high level of concern about safety decisions or recommendations made by expert committees that included doctors who had current financial relationships with medical device makers.
Industry lobbyists have been pushing lawmakers to weaken current rules designed to prevent such conflicts of interest. The Senate and House discussion drafts remove current caps on the percentage of expert committee members that can be granted waivers if they have a conflict of interest, a provision championed by consumer advocates five years ago.

"Recent problems with metal hip implants and surgical mesh have shown how our current system fails to ensure medical devices are safe and effective," said Lisa Swirsky, senior policy analyst for Consumers Union. "Unfortunately, the House bill weakens current standards to speed up device approvals rather than improving safety oversight. The Senate bill offers some improvements but it should be strengthened to require stricter safety testing of new implants and life sustaining devices. Congress should recognize that the public is far more concerned about making sure devices are safe and work than how quickly they are made available."

The Depuy hip problems came to light, in part, due to tracking systems in place in other countries, which indicated higher than normal failure rates. In this country, the information received by doctors is often limited to data provided by the manufacturer and their sales representatives, which is often times false and misleading.

As one of my clients told me this morning, "I don't need a doctor to tell me that my hip has failed and needs to be removed, I live it every day."

British Medical Journal---Safety of Metal on Metal Hip Implants Questioned

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)

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 completely 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 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.

Depuy Hip Replacement Cases Consolidated

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

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.

DEPUY: COMMONLY ASKED QUESTIONS

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 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

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 WHAT IS 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 Systems

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.

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

Tsunami Continues in Arbitration War--Congressman Rails against Arbitration Abuses

Bloomberg News (7/22, Van Voris, Rosenkrantz) reported, "A congressional staff investigation into the biggest U.S. consumer debt-collection arbitrator found 'deeply disturbing' abuses, U.S. Representative Dennis Kucinich said" yesterday at a hearing before a House subcommittee he chairs. "A report on the investigation, released yesterday, claims that the National Arbitration Forum, a Minnesota company that handled most consumer debt-collection arbitrations in the U.S., misled consumers and hid ties to debt-collection firms." Said Kucinich, "The debt collection industry and the alternative legal system that has been created around it can no longer be ignored by the federal government."
The Minneapolis Star Tribune (7/22) reported, "Minnesota Attorney General Lori Swanson backed federal legislation Wednesday that would protect consumers from 'fine print' arbitration contracts that forfeit their legal rights against creditors. 'Millions of Americans are giving away that right without even knowing it,' Swanson told a panel of the House Oversight and Government Reform Committee." Also appearing before the committee was Mike Kelly, CEO of Forthright, "which provides administrative services for the" NAF. Kelly "defended the company's work as a simple and cost-effective alternative to the courts, saying that without access to arbitration, consumers would be the losers."
The AP (7/22, Choi) reported that Kenneth Clayton of the American Bankers Association testified that "arbitration is a valuable way for consumers and businesses to resolve disputes in a very low cost and fair manner. Take it away and consumers will suffer." But "a study by Public Citizen found that credit card companies track arbitrators' rulings and do not enlist the arbitrators who rule against them."
Jones: "arbitration revolution" possible. In a blog at the Wall Street Journal (7/22), Ashby Jones wrote, "It's too soon to say, in all likelihood, but we could be in the early stages of an arbitration revolution."

AAA & NAF suspend arbitrations over consumer debt collections pending new guidelines

The Wall Street Journal (7/22, Sidel, Sharma) reports, "Two major arbitration firms are backing away from the business of resolving disputes between customers and their credit-card and cellphone companies, throwing into disarray a controversial system that prevents unhappy consumers from filing lawsuits. The American Arbitration Association said Tuesday it will stop participating in consumer-debt-collection disputes until new guidelines are established." The National Arbitration Forum, in a settlement with Minnesota Attorney General Lori Swanson, had earlier said "it would stop accepting new cases as of Friday. Their retreat has big implications for credit-card and cellphone companies, which generally require customers to agree to mandatory arbitration." Consumer advocates "have criticized the practice for years, saying consumers often don't realize they are waiving their right to sue when they sign contracts with the companies."

The Wall Street Journal (7/22, Kim) reports, "Consumer advocates say the development opens the door for customers to take their grievances to court instead of being forced to settle their disputes through the arbitration process. 'In the long run, I think this is the beginning of the end of forced arbitration in all consumer contracts, from credit cards, to nursing homes to cellphones,' said Ed Mierzwinski of U.S. PIRG, a consumer-advocacy group."

The San Francisco Chronicle (7/22, Abate) reports, "A congressional committee will hold hearings today at which NAF and its adversaries will argue about whether consumers are put at a disadvantage by the common practice of requiring that disputes be arbitrated rather than fought in court." Carol Kaplan, "a spokeswoman for the American Bankers Association, which represents many credit card issuers, said most consumer contracts are probably written in such a way that another arbitrator could be designated to replace National Arbitration Forum. But Paul Bland, a staff attorney with the advocacy group Public Justice, said NAF was the designated arbiter in so many consumer agreements, including cell phone contracts, that no other arbitration service is big enough to replace it."

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

FDA Eyes Lantus after European Studies Warn of Increased Cancer Risk

The FDA said it is reviewing the safety of Lantus, an artificial form of insulin which had sales of $3.45 billion in 2008, and is in talks with Sanofi about whether any additional studies need to be conducted to determine the drug's safety since it has a potential link to increased cancer risks.

Despite the concerns, the FDA said patients should continue taking Lantus, a diabetes drug, which is made by Sanofi-Aventis SA's (SNY).

The Paris based company said it is committed to working with the FDA to clarify the situation surrounding its artificial form of insulin, Lantus. A company spokesman said Sanofi stands behind the drug's safety.

Studies published Friday in Diabetologia, the journal of the European Association for the Study of Diabetes, showed a possible link between Lantus and cancer. The FDA criticized the studies in an early communication warning posted Wednesday on its Web site.

The agency said the duration of follow-up for patients in the studies was shorter than what is generally considered necessary to evaluate cancer risk from drug exposure.

"Further, inconsistencies in findings within and across individual studies raise concerns as to whether an association between the use of insulin glargine and cancer truly exists," the FDA said, using the scientific name for Lantus.

Europe's drug regulator is also reviewing the studies.

The London-based European Medicines Agency (EMEA) on Monday said the studies into the possible link between insulin analogues and the risk of developing cancer were worthy of more in-depth investigation. The European Union's drug regulator said its Committee for Medicinal Products for Human Use will now carry out a detailed assessment of them.

A co-author on one of the studies, Professor Edwin Gale of Bristol University in England, said the FDA is misinterpreting the point of the information.

"We don't believe that these studies show that insulin turns healthy cells into cancerous cells, which would take much longer to evaluate. But we do believe they are evidence that insulin makes cancers grow more quickly and that this can be evaluated within three years."

We'll be eying these reports for more follow ups.

Source

Florida appellate court upholds Florida Law regulating "generic drug swapping"

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

FDA: previous failures and potential powers

Although the Food and Drug Administration touts on its website its task is "protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics and products that emit radiation," the past few years have exposed an underfunded and understaffed organization that has been slow to react, or taken no protective action at all, in response to potential dangers.

Recent examples of contaminated food products, destructive dietary supplements and harmful homeopathic remedies and drugs have highlighted the need for a more proactive, tougher FDA regulatory agency.

The new FDA commissioner, Dr. Margaret A. Hamburg, is taking the lead in trying to facilitate a strengthened regulatory agency for American consumers. Until now, the FDA has been a more reactive agency with limited powers as shown in the past few years with normal household products on the market hurting Americans who purchase and use them.

Fortunately, Dr. Hamburg said that to oversee the increasing flood of imported foods, medical devices and drugs, the F.D.A. would have to create far more partnerships with foreign regulators. “Under my leadership, we’ll see a somewhat more aggressive posture with respect to enforcement,” she said. Unanimously confirmed by the Senate in May, praised by conservative Republicans and liberal Democrats alike, Dr. Hamburg maintains wide support among a diverse and often fractious set of industry, consumer and patient advocacy groups.

The FDA has already made strides, but I expect to see tougher regulations and restrictions on companies producing dietary supplements, homeopathic remedies, medical devices, pharmaceuticals, food, tobacco, and plastics. Currently, the FDA does not regulate dietary supplements or homeopathic remedies (highly diluted drugs made from natural ingredients), which are taken by more than half of Americans and have grown into an estimated $25 billion industry, causing consumers to be guinea pigs to companies’ recipes for healthier life. The sector remains one of the least regulated under current laws: the Dietary Supplement Health and Education Act of 1994 requires that the manufacturer of a dietary supplement, not the FDA, ensure its safety before it is marketed. The FDA is responsible only for taking action against any unsafe product after it's on the market.

U.S. District Court Judge Jack Weinstein in ruling on one Zyprexa case in 2008 said

"Compared to its peer agencies in other parts of the world, the FDA has arguably failed consumers and physicians by over-relying on pharmaceutical companies to provide supporting research for new drug application. The result of such claimed governmental failures arguably causes overuse and overpricing of pharmaceuticals, resulting in mass litigations such as this one for Zyprexa."

Let’s hope the new FDA Commissioner stands by her word and allows Americans to consume safer products, food, and medical devices.