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.

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