Yourlawyer.com (Medtronic Infuse Bone Graft News) http://www.yourlawyer.com/topics/overview/Medtronic_Infuse_Bone_Graft Sat, 21 Nov 2009 06:32:56 -0800 pixel-app en Medtronic Cardiac Rhythm Disease Management Site Gets FDA Warning Letter http://www.yourlawyer.com/articles/read/17299 Thu, 19 Nov 2009 00:00:00 -0800 http://www.yourlawyer.com/articles/read/17299 Medtronic, Inc., just announced that it received a warning letter from the U.S. Food & Drug Administration (FDA).

According to the Twin Cities Business Journal, the letter came after an inspection of Medtronic’s Mounds View Cardiac Rhythm Disease Management site and concerned: “Corrective and preventative action and field-action timeliness, review and documentation of field action recommendations, supplier qualification and controls, and medical-device reporting timeliness,” said the Business Journal. Medtronic has 15 days to respond to the warning letter.

Medtronic said it will respond to the letter within the mandated timeframe and stated that it is in the process of implementing revised processes in response to the letter, said the Business Journal. Medtronic also said that, according to the FDA’s letter, the agency wrote that the firm’s proposal “appear to be adequate to address the concerns raised in the letter and will be confirmed upon re-inspection,” quoted the Business Journal.

In a statement, Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic said, quoted the Business Journal, “Medtronic remains committed to providing the highest quality products to our customers and is working with FDA to resolve all remaining issues as quickly as possible.”

This is not the first warning letter Medtronic has received in recent months.  In June we wrote that Medtronic received a warning letter regarding its SynchroMed II Drug Pumps and MiniMed Paradigm Insulin Pump. In the letter, the FDA cited Medtronic for taking too long to recall the SynchroMed pumps. The letter also said that an inspection conducted last year at the Puerto Rican plant where both pumps were made found that Medtronic failed to establish and maintain quality controls in manufacturing. SynchroMed II pumps are implantable devices used to deliver medicine to the spine. The devices have been recalled on several occasions.

According the FDA warning letter, some SynchroMed pumps were released for distribution and implanted in patients even though they were not filled with a needed propellant. The problem was not discovered during the manufacturing process even though the pumps went through a propellant weight check, the letter said.

The pumps were recalled for this problem in May 2008, after Medtronic received two reports of SynchroMed pumps being removed from patients because of a lack of propellant. “FDA is concerned with your failure to initiate a recall for devices affected by the propellant problem in a timely manner,” the warning letter, dated June 1, states. “It took almost two years from when the missing propellant was initially identified to conduct a recall.”

The FDA letter also criticized Medtronic for failing to notify the agency within 30 days of at least two reports of potentially serious patient issues with MiniMed Paradigm Insulin Pumps, and for failing to have a person qualified to make a medical judgment determine if reported problems had anything to do with a patient’s death or serious injury. According to the letter, training records indicated that the employee who evaluated MiniMed pump reports only had a high school diploma with some additional in-house training.

]]> Grassley Putting More Heat on Spine Surgeon with Medtronic Ties http://www.yourlawyer.com/articles/read/17024 Wed, 23 Sep 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/17024 Medtronic Inc. has been under scrutiny.

Grassley's probe of Dr. Polly has already revealed that he had been paid $1.2 million by Medtronic between 2003 and 2007 for consulting work. Dr. Polly had come under fire in July for not disclosing his relationship with Medtronic when he testified before a Senate committee in 2006 urging more funding for research into combat-related injuries. According to Minneapolis-St. Paul Business Journal,  Dr. Polly never told the panel that he was a Medtronic consultant, and was billing the company $6,000 for his appearance.

In July, Grassley sent Medtronic a letter, asking if its payments to Dr. Polly represent a conflict of interest. Grassley also charged in the letter that Dr. Polly gave Medtronic updates on government-sponsored research in violation of an agreement with the university and may have provided inaccurate information to a university ethics committee.  Medtronic has said it was not aware that Dr. Polly had failed to tell the Senate committee about his financial ties to the company when he testified. Both the University of Minnesota and Medtronic have launched investigations of the allegations in Grassley’s letter.

Following his May 2006 testimony, Dr. Polly and his colleagues at the University of Minnesota received a $466,644 Department of Defense grant for a two-year study involving Infuse Bone Graft, a Medtronic product. At the time, because of his relationship with Medtronic, the University asked Dr. Polly if an alternate non-Medtronic product could be used in the research.  According to the Pioneer Press, documents obtained by Grassley indicated that Dr. Polly told the University that  Infuse "the only commercially available off shelf growth factor to date,"

Now the Pioneer Press is reporting that Grassley has written to the University of Minnesota raising issues of possible conflict of interest regarding Dr. Polly's Infuse research.  He is questioning Dr. Polly's earlier assertion that Infuse was the only product suitable for his research.  The letter says Michigan-based Stryker Corp. has provided information that appears to contradict Dr. Polly's claims, and  that Stryker was selling a similar product in 2006.

Recently, Dr. Polly has defended his choice of Infuse by stating that the Stryker product as approved under a special "humanitarian device exemption," which limits sales to 4,000 devices per year, the Pioneer Press said.  But Grassley is not buying that argument, writing in his letter that the Stryker product "never exceeded sales of 4,000 units in 2006, so that point appears to be irrelevant."

According to the Minneapolis Star-Tribune, Grassley has also sent a separate letter to  University President Robert Bruininks, asking him to turn over any communications between the school and Dr. Polly.  But the school, citing privacy laws, said it will only do so if Dr. Polly consents.

In addition, the Star-Tribune is reporting that Grassley also sent letters  to Mark Eustis, chief executive of Minnesota's Fairview Health Services, and Timothy Healy, head of Team Spine-Minnesota Inc,  a distributor of spine surgery products,  requesting information regarding their relationship.  

]]> Medtronic Advisory Says Some Concerto, Virtuoso Defibrillator Batteries May Deplete Prematurely http://www.yourlawyer.com/articles/read/16968 Fri, 11 Sep 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16968 Medtronic Inc. has issued an advisory for 6,300 Concerto CRT-D and Virtuoso implantable defibrillators.  According to the advisory, the batteries on these devices may be depleted sooner than normal

According to a letter sent to physicians, the devices affected by this advisory will give a 90-day advanced warning if the batteries are nearing depletion. Medtronic maintains that the battery issue  does not compromise device functionality or affect therapy delivery.  The company said it has received no reports of death or injury attributed to this issue.

The  Concerto and Virtuoso devices in the affected subset were manufactured primarily in 2006 and can be traced to a specific subset of low voltage capacitors, Medtronic said.  So far, there have been no related confirmed failures in Concerto and Virtuoso devices outside of this subset, including devices that were manufactured during the same time, the letter said.

Medtronic is offering  the following recommendations for patients with Virtuoso and Concerto CRT-D  devices in the affected subset:

  • Physicians should continue routine follow-up sessions at least every three months in accordance with product labeling.
  • Physicians should verify that the Low Battery Voltage Recommended Replacement Time (RRT) alert is programmed to “On-High.”  This provides an audible, alternating tone when the device reaches RRT. These devices are shipped with this alert programmed nominally to “On-High.”
  • Physicians may consider monitoring patients through CareLink. The CareLink home monitor can be used to automatically notify the clinician when the device reaches RRT.


Patients can determine if their device is included in this advisory by visiting http://CVSNList.medtronic.com.  Patients will need the serial number of their device, which is available on their Medtronic patient identification card.

]]> Medtronic-Paid Spine Surgeon Resigns From Medical Group Board Amid Probe http://www.yourlawyer.com/articles/read/16916 Wed, 26 Aug 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16916
As we've reported previously, Polly had come under fire for not  disclosing his relationship with Medtronic when he testified before a Senate committee in 2006 urging more funding for research into combat-related injuries. According to Minneapolis-St. Paul Business Journal, Polly never told the panel that he was a Medtronic consultant, and was billing the company $6,000 for his appearance.  

Following his May 2006 testimony, Polly and his colleagues at the University of Minnesota received a $466,644 Department of Defense grant for a two-year study involving Infuse Bone Graft, a Medtronic product.   When the University of Minnesota approved Polly’s government-funded Infuse study, it said at the time that his “consulting duties for Medtronic appear sufficiently separate from the research he is performing.” Right after the study was approved by the University, Polly billed Medtronic for writing up a different Infuse study.

A probe conducted by Sen. Charles Grassley (R-Iowa) revealed that Polly had been paid $1.2 million by Medtronic between 2003 and 2007 for consulting work.  As we reported previously,  Polly’s billing records revealed that he billed Medtronic $50,000 for lobbying-related costs. According to The Wall Street Journal, Polly traveled to Washington, D.C. and met with members of Congress several times in 2005 and 2006. The Journal also reported that Polly’s “billing rate was $4,750 for an eight-hour day in 2007, and he billed as many as 13,000 minutes a quarter — or 216 hours over three months. In some months, he conducted at least some Medtronic business  "nearly every day.”

Late last month, Grassley  sent Medtronic a letter, asking if its payments to Polly represent a conflict of interest  Grassley also charged in the letter that Polly gave Medtronic updates on government-sponsored research in violation of an agreement with the university and may have provided inaccurate information to a university ethics committee.

Medtronic has said it was not aware that Polly had failed to tell the Senate committee about his financial ties to the company when he testified.   Both the University of Minnesota and Medtronic have  launched investigations of the allegations in Grassley's letter.

Dr. Joseph Zuckerman, president of the American Academy of Orthopaedic Surgeons said Polly resigned from his board position because he did not want to be a distraction. "The (academy) believes that relationships between industry and physicians can be very productive, innovative exchanges that occur for the good of patients and medical advancements," Zuckerman said in the statement. "However, when those relationships come under scrutiny, as Dr. Polly's have, we believe this creates an unnecessary distraction from (the academy's) mission."

]]> Surgeon in Medtronic Infuse Study Scandal Resigns http://www.yourlawyer.com/articles/read/16889 Wed, 19 Aug 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16889 Medtronic Inc.'s Infuse Bone Graft, has resigned from his post at Washington University Medical School, according to The New York Times.

As we’ve reported previously, the study, which  Kuklo conducted during his tenure at Walter Reed Army Hospital , claimed to show that wounded soldiers’ leg injuries healed better when Infuse was used. But an Army investigation found several problems with it. For one thing, the study cited higher numbers of patients and injuries than Walter Reed officials could account for. Kuklo also did not obtain the Army’s required permission to conduct the study, and investigators at Walter Reed have also concluded that Kuklo forged his co-authors signatures on the study.  Kuklo's study was published in the Journal of Bone & Joint Surgery last August, but retracted it in March.

In June, Medtronic disclosed that over a ten year period, it had paid Kuklo roughly $850,000 in direct and direct payments. Between 2000 and 2006, he was paid to train other physicians in how to implant Medtronic products. In 2006, he signed on as a consultant for the company, a relationship which ended earlier this year. However, Medtronic has maintained that it had nothing to do with Kuklo’s Infuse study.

After leaving Walter Reed, Kuklo joined the faculty at Washington University Medical School in St. Louis in 2006.  Last month, the school revealed  that Kuklo failed to properly disclose his financial relationship with Medtronic. When he failed to make that disclosure, Kuklo was working on two studies that involved Medtronic products, the Journal said. The University said it stopped Kuklo’s Medtronic-related research in February of 2008, and learned of his relationship with the company in May 2007.

The school also said that Kuklo had discovered “extensive personal health information” for soldiers treated at the Walter Reed Army Medical Center from 2006 and before on computers used by Kuklo. The privacy of medical records is strictly regulated by the Health Insurance Portability and Accountability Act (HIPAA).

Kuklo had been on a voluntary paid leave while Washington University investigated the allegations against him.  According to a New York Times report, Kuklo proffered his resignation on July 30.  It will be effective Sept. 30, and between now and then will have no clinical, research, or educational duties for the University between now and that date.

]]> Infuse Bone Graft Researcher Failed to Tell Senate Committee He was Paid by Medtronic During 2006 Testimony http://www.yourlawyer.com/articles/read/16807 Wed, 29 Jul 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16807 Infuse Bone Graft, has been used to treat wounded soldiers.

Following his May 2006 testimony, Dr. David Polly and his colleagues at the University of Minnesota received a $466,644 Department of Defense grant for a two-year study involving Infuse, the Journal said.

According to the Journal, Polly was paid more than $1 million by Medtronic from 2004 to 2007.  When the University of Minnesota approved Polly's government-funded Infuse study, it said at the time that his "consulting duties for Medtronic appear sufficiently separate from the research he is performing."  Right after the study was approved by the University, Polly billed Medtronic for writing up a different Infuse study.

Polly's billing records revealed that he billed Medtronic $50,000 for lobbying-related costs.  According to The Wall Street Journal, Polly traveled to Washington, D.C. and met with members of Congress several times in 2005 and 2006.  The Journal also reported that Polly's "billing rate was $4,750 for an eight-hour day in 2007, and he billed as many as 13,000 minutes a quarter -- or 216 hours over three months. In some months, he conducted at least some Medtronic business on nearly every day."

Senator Charles Grassley, R-IA, who has been investigating the financial relationships between medical companies and researchers, has sent Medtronic a letter, asking if its payments to Polly represent a conflict of interest.  According to a report in the Minneapolis-St. Paul Business Journal, Grassley also charged in the letter that Polly gave Medtronic updates on government-sponsored research in violation of an agreement with the university and may have provided inaccurate information to a university ethics committee.

According to The Wall Street Journal, Medtronic said it was not aware that Polly had failed to tell the Senate committee about his financial ties to the company when he testified in May 2006.  However, this is not the first time that Medtronic's relationship with an Infuse researcher has raised questions.  

Earlier this month, we reported that another spine surgeon, Dr. Timothy Kuklo had failed to report his financial relationship with Medtronic to Washington University medical school in St. Louis. When he failed to make that disclosure, Kuklo was working on two studies that involved Medtronic products, the Journal said. The University said it stopped Kuklo’s Medtronic-related research in February of 2008, and learned of his relationship with the company in May 2007. Dr. Kuklo is currently on a paid personal leave at the request of the university.

Dr. Kuklo is the former Army surgeon who has been accused of falsifying data in a study involving Medtronic’s Infuse Bone Graft product - which he conducted during the time he received payments from Medtronic- while on the staff of Walter Reed Army Hospital.

]]> Lawsuits Allege Medtronic, Other Firms Illegally Marketed Surgical Ablation Products http://www.yourlawyer.com/articles/read/16753 Thu, 16 Jul 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16753 Medtronic Inc., St. Jude Medical Inc., AtriCure Inc. and Boston Scientific Corp. all allegedly paid kickbacks to doctors in order to convince them to use their surgical ablation products to treat the heart-rhythm defect called atrial fibrillation, according to lawsuits recently unsealed in Texas.   According to The Wall Street Journal, the lawsuits were filed by former employees of the companies.

Allegations of kickbacks by medical device makers are nothing new.  For example, in 2007 a New Jersey based federal probe found  that some orthopedic device makers made lucrative payments to U.S. physicians  between 2002 and 2006 as a way to encourage doctors to favor their products. Stryker Orthopedics cooperated with prosecutors and escaped a fine, but agreed to federal monitoring for 18 months. The other companies, Zimmer Holdings Inc., Depuy Orthopaedics Inc., Biomet Inc. and Smith & Nephew Inc. agreed to a $311 million settlement with the Justice Department and the U.S. Department of Health and Human Services.

The lawsuits detailed by The Wall Street Journal, which were filed in federal court in Houston, are related to an inquiry in Texas by the U.S. Justice Department that was previously disclosed by several of the companies in filings with the Securities and Exchange Commission.  They were originally filed in 2007, the Journal said.

According to the Journal, the lawsuits allege that a "fraudulent marketing and inducement campaign" involving kickbacks to doctors and hospitals resulted in excessive charges to the Medicare insurance program.  For example, several of the suits allege that Boston Scientific, Medtronic and AtriCure marketed surgical ablation equipment as a treatment for atrial fibrillation even though it was not approved by the Food and Drug Administration to treat that condition.

Those charges were made by a former Boston Scientific salesperson, who the Journal says, claimed to have been fired after complaining about the company's allegedly illegal practices.

All of the companies involved in the lawsuits told The Wall Street Journal that they were cooperating with the probe.  Boston Scientific is no longer in the ablation business, the Journal said.

]]> Infuse Bone Graft Study Doc Didn't Tell School He Was Paid by Medtronic http://www.yourlawyer.com/articles/read/16748 Wed, 15 Jul 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16748 Infuse Bone Graft study apparently did not tell his current employer that he had been a paid consultant to Medtonic Inc.,  The Wall Street Journal is reporting.

Infuse Bone Graft, which is manufactured by Medtronic., contains recombinant human Bone Morphogenetic Protein (rhBMP-2), a protein released naturally by the body. It is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia. It is also approved for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation.

Last July, the Food & Drug Administration (FDA) warned that the use of Infuse Bone Graft and similar products had caused serious problems when they were used off-label in cervical spine (neck) surgeries. Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries.

As we’ve reported previously, a study conducted by Dr. Timothy Kuklo during his tenure at Walter Reed Army Hospital claimed to show that wounded soldiers’ leg injuries healed better when Infuse was used, was published in the Journal of Bone & Joint Surgery last August, but retracted in March. An Army investigation found several problems with it. For one thing, the study cited higher numbers of patients and injuries than Walter Reed officials could account for. Kuklo also did not obtain the Army’s required permission to conduct the study, and investigators at Walter Reed have also concluded that Kuklo forged his co-authors signatures on the study.

Kuklo is now retired from the Army.  According to The Wall Street Journal, he joined  the faculty of Washington University medical school in St. Louis in 2006.  In a letter to Sen. Charles Grassley (R-Iowa) dated  June 23, Washington University's medical-school Dean Larry J. Shapiro said Kuklo failed to properly disclose his financial relationship with Medtronic.  

When he failed to make that disclosure, Kuklo was  working on two studies that involved Medtronic  products, the Journal said. The University said it stopped Kuklo's Medtronic-related research in February of 2008, and learned of his relationship with the company in May 2007.

The letter also said that the university discovered "extensive personal health information" for soldiers treated at the Walter Reed Army Medical Center from 2006 and before on computers used by Kuklo.   According to the Journal, the privacy of medical records is strictly regulated by the Health Insurance Portability and Accountability Act  (HIPAA).

According to The Wall Street Journal, Kuklo is on a paid personal leave at the request of the university.

]]> Infuse Bone Graft Study Info Sought by Senate Armed Services Committee http://www.yourlawyer.com/articles/read/16726 Thu, 09 Jul 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16726 Infuse Bone Graft study, which was conducted at Walter Reed Army Hospital by former Army surgeon Timothy Kuklo.

Infuse Bone Graft, which is manufactured by Medtronic Inc., contains recombinant human Bone Morphogenetic Protein (rhBMP-2), a protein released naturally by the body. It is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia. It is also approved for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation.

Last July, the Food & Drug Administration (FDA) warned that the use of Infuse Bone Graft and similar products had caused serious problems when they were used off-label in cervical spine (neck) surgeries. Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries.

As we’ve reported previously, Kuklo's study, which claimed to show that wounded soldiers’ leg injuries healed better when Infuse was used, was published in the Journal of Bone & Joint Surgery last August, but retracted in March. An Army investigation found several problems with it. For one thing, the study cited higher numbers of patients and injuries than Walter Reed officials could account for. Kuklo also did not obtain the Army’s required permission to conduct the study, and investigators at Walter Reed have also concluded that Kuklo forged his co-authors signatures on the study.

Kuklo retired from the Army in 2007. Last month, Medtronic disclosed that over a ten year period, it had paid Kuklo roughly $850,000 in direct and direct payments to Kuklo. Between 2000 and 2006, he was paid to train other physicians in how to implant Medtronic products. In 2006, he signed on as a consultant for the company, a relationship which ended earlier this year.  However, Medtronic has maintained that it had nothing to do with Kuklo's Infuse study.

According to The Wall Street Journal, in a letter to  Army Secretary Pete Geren, Sens. Lindsey Graham (R.- S.C.) and Ben Nelson (D.- Neb.) asked for the results of the Army's investigation.  The Senators are just the latest to express an interest in the Kuklo debacle.

Late last Month,  Medtronic revealed that it had received a subpoena from the U.S. Attorney’s office in Boston, MA. In addition to information on Kuklo’s Infuse study,  the subpoena also sought  information about “contracts, research grants, speaking and education programs, and payments for certain named physicians.”

Sen. Charles Grassley (R.- Iowa) has also been investigating the Kuklo Infuse study as part of his investigation into the financial relationships between medical firms and doctors and researchers.

]]> Infuse Bone Graft, Other BMP Protein Products Linked to Complications in Neck Spine Surgery http://www.yourlawyer.com/articles/read/16695 Wed, 01 Jul 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16695 Infuse Bone Graft, may be responsible for serious complications when used to treat neck pain, and may not be cost effective, according to a new study. The study, conducted by researchers at Brigham and Women's Hospital in Boston, found that when used in the neck region of the spine, some complications from BMP products like Infuse could be life-threatening.

BMP products have become very popular since they were first introduced.  According to the Associated Press, some small studies have shown that these products allow better healing of the bone and fewer repeat surgeries to fix failed spinal fusions. The product also makes it unnecessary to surgically harvest the patient's own bone from the shin or hip for a graft.  

However,  last year, the Food & Drug Administration had warned that off-label use of these products - specifically when used in cervical spine (neck) fusion surgeries - had been linked to serious, and sometimes serious complications.  According to the Associated Press, BMP can make  bone grow in unwanted places if it's incorrectly used, and there are no official guidelines for its use.

This latest BMP  study, which appears in the Journal of the American Medical Association, focused on  Infuse and on another bone-growth product from Stryker Corp.   It looked at records of more than 325,000 spinal fusions from 2002 to 2006.  They found that 7% more patients experience a complication before leaving the hospital when they received a BMP product front of the neck region of the spine.  That's a 50% higher rate compared to when the product wasn't used.   When BMP products where used in other areas of the spine, however, there were no more complications compared with other spinal fusion treatments.

The study also raised questions about the cost of products like Infuse Bone Graft. Fusion surgeries of the neck cost around $46,000 when the products were used, compared to $31,000 when they are not.  According to The Wall Street Journal, use of the products "was associated with higher total hospital charges for all categories of fusions.”

]]> Medtronic Warned on SynchroMed Drug Pumps, MiniMed Insulin Pump Manufacturing http://www.yourlawyer.com/articles/read/16677 Thu, 25 Jun 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16677 SynchroMed II  Drug Pumps and MiniMed Paradigm Insulin Pump.  In the letter, the Food & Administration (FDA), cites Medtronic for taking too long to recall the SynchroMed pumps.  The letter also said that  an inspection conducted  last year at the Puerto Rican plant where both pumps were made found that Medtronic failed to establish and maintain quality controls in manufacturing.

SynchroMed II pumps are implantable devices used to deliver medicine to the spine.   They have been recalled on several occasions.

According the FDA warning letter, some SynchroMed pumps were released for distribution and implanted in patients even though they were not filled with a needed propellant. The problem was not discovered during the manufacturing process even though the pumps went through a propellant weight check, the letter said.

The pumps were recalled for this problem in May 2008, after Medtronic received two reports of SynchroMed pumps being removed from patients because of a lack of propellant.  "FDA is concerned with your failure to initiate a recall for devices affected by the propellant problem in a timely manner," the  warning letter, dated June 1, states. "It took almost two years from when the missing propellant was initially identified to conduct a recall."

The FDA letter also criticized Medtronic for failing to notify the agency within 30 days of at least two reports of potentially serious patient issues with  MiniMed Paradigm Insulin Pumps, and for  failing to have a person qualified to make a medical judgment determine if  reported problems had anything to do with a patient's death or serious injury.   According to the letter, training records showed that  the  employee who evaluated MiniMed pump reports only had a high school diploma with some additional in-house training.

The FDA warning letter stemmed from an inspection of Medtronic's Puerto Rican facility that occurred from  November 12, 2008 through December 15, 2008. The company has 15 working days from the date it received the warning letter to respond to the FDA.  The FDA letter warned Medtronic that failure to promptly correct  violations could result in regulatory action being initiated without further notice.

]]> Medtronic Says Subpoena Seeks Info on Infuse Bone Graft Study http://www.yourlawyer.com/articles/read/16675 Wed, 24 Jun 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16675 Infuse Bone Graft study conducted by a former army surgeon.  According to The Wall Street Journal, the subpoena was revealed in  a  disclosure to the Securities and Exchange Commission (SEC) Medtronic made yesterday.

The study in question was conducted by Dr. Timothy Kuklo, and involved veterans at Walter Reed Army Hospital.  As we’ve reported previously, the study, which claimed to show that wounded soldiers’ leg injuries healed better when Infuse was used, was published in the Journal of Bone & Joint Surgery last August, but retracted in March. An Army investigation found several problems with it. For one thing, the study cited higher numbers of patients and injuries than Walter Reed officials could account for. Kuklo also did not obtain the Army’s required permission to conduct the study, and investigators at Walter Reed have also concluded that Kuklo forged his co-authors signatures on the study.

Kuklo retired from the Army in 2007.   Last week, Medtronic disclosed that over a ten year period, it had paid Kuklo roughly  $850,000 in direct and direct payments to Kuklo. Between 2000 and 2006, he was paid to train other physicians in how to implant Medtronic products. In 2006, he signed on as a consultant for the company, a relationship which ended earlier this year.

According to The Wall Street Journal, in 2007, the year he submitted the questionable Infuse study to at least two medical journals, Kuklo was paid a total of $356,242 by Medtronic. In 2008, the year the study was published, Medtronic paid Kuklo $249,772.  Medtronic has maintained that it had no part in Kuklo’s Infuse study.

According to the Journal, the subpoena Medtronic received was issued by the U.S. Attorney's office in Boston, MA.  In addition to information on Kuklo's Infuse study, Reuters is reporting that prosecutors are also seeking information about "contracts, research grants, speaking and education programs, and payments for certain named physicians."

Reuters is also said that in the same SEC filing, Medtronic disclosed that it was served with another subpoena - this time from the New Jersey Attorney General.   The subpoena is  "seeking documents related to clinical studies, its financial arrangements with certain physicians, and clinical research done by certain physicians and health care providers."   The company did not say if the two subpoenas were related, Reuters said.

The Kuklo affair is just the latest incident to raise questions about the  Infuse Bone Graft product, as well as Medtronic’s relationships with doctor consultants. In September, the Wall Street Journal reported that at least three-quarters of the roughly 200 “adverse events” reported to the Food & Drug Administration involved off-label uses of Infuse Bone Graft. According to the Journal, doctors paid consulting fees by Medtronic have promoted off-label use of Infuse by, among other things, authoring articles that present unapproved uses in a favorable light.

]]> Author of Questionable Infuse Bone Graft Study Got Big Bucks from Medtronic http://www.yourlawyer.com/articles/read/16659 Fri, 19 Jun 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16659 Medtronic Inc. has confirmed that it paid hundreds of thousands of dollars to an ex-Army surgeon who is accused of falsifying data in a study he conducted on the company's Infuse Bone Graft product. According to the Associated Press, Medtronic paid the surgeon - Dr. Timothy Kuklo - $850,000 over a 10 year period.  

Kuklo retired from the Army in 2007. According to the Associated Press, Medtronic made both indirect and direct payments to Kuklo between 2001 and May 2009.  Between 2000 and 2006, he was paid to train other physicians in how to implant Medtronic products.  In 2006, he signed on as a consultant for the company.

Kuklo has been accused of falsifying data in an Infuse Bone Graft study while he was assigned to Walter Reed Army Hospital.  As we've reported previously, the study, which claimed to show that wounded soldiers’ leg injuries healed better when Infuse was used, was published in the Journal of Bone & Joint Surgery last August, but retracted in March. An Army investigation found several problems with it. For one thing, the study cited higher numbers of patients and injuries than Walter Reed officials could account for. Kuklo also did not obtain the Army’s required permission to conduct the study, and investigators at Walter Reed have also concluded that Kuklo forged his co-authors signatures on the study.

According to The Wall Street Journal, the total paid to Kuklo includes $356,242 he received in 2007, the year he submitted the questionable Infuse study to at least two medical journals.   In 2008,  the year the study was published, Medtronic says it paid  Kuklo $249,772, the Journal said.

The Kuklo affair is just the latest incident to raise questions about Infuse, as well as Medtronic’s relationships with doctor consultants. In September, the Wall Street Journal reported that at least three-quarters of the roughly 200 “adverse events” reported to the Food & Drug Administration involved off-label uses of Infuse Bone Graft. According to the Journal, doctors paid consulting fees by Medtronic have promoted off-label use of Infuse by, among other things, authoring articles that present unapproved uses in a favorable light.

Doctors are free to use approved medical devices in anyway they see fit. However, manufacturers are forbidden from promoting any use that has not received FDA approval - known as off-label use.  In November, Medtronic also said it had received a subpoena  from the Department of Justice as part of a probe of possible off-label marketing.

Medtronic has maintained that it had no part in Kuklo's Infuse study.  But according to the Associated Press, the uproar it caused is the reason the company has decided to disclose its payments to Kuklo - something it had once refused to do.  The disclosure followed several letters written by Sen. Charles Grassley (R-Iowa), who has been investigating the financial relationships between device makers and doctors.  Among other things, Grassley has been asking why Medtronic failed to list Kuklo as a paid consultant when it submitted a list of such physicians to him in October.   A Medtronic spokesperson told the Associated Press that it was releasing Kuklo's information on a "one-time basis in the interest of transparency in this unique case."

Kuklo and is now on staff at Washington University School of Medicine in St. Louis.  Medtronic ended its consulting agreement with him in May.

]]> Grassley Wants to Know Why Infuse Study Doctor Was Left Off List of Consultants Paid By Medtronic http://www.yourlawyer.com/articles/read/16578 Thu, 21 May 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16578 Medtronic's Infuse Bone Graft product that apparently contained falsified data.

According to The New York Times, which originally broke the Kuklo story, Grassley has been investigating Infuse for some time over claims that Medtronic illegally promoted its off-label use. Some have charged that the company paid doctor consultants to hype such uses.  According to The Wall Street Journal, Medtronic had submitted a list of  22 consultants to the Senator in October, but Kuklo's name wasn't on that list.   Grassley has now written a letter to Medtronic asking why.

A Medtronic spokesperson told The Wall Street Journal that Kuklo was a consultant for the company starting in 2006. The spokesperson also said that Kuklo was a consultant until earlier this month, but  is "no longer active as a consultant."  

According to the Associated Press, Medtronic maintains that Kuklo's name was omitted because Grassley only asked for names of doctors who had consulting contracts for Infuse, and Kuklo was a "general consultant."  The company said it is cooperating with Grassley's investigation.

As we reported last week, Kuklo’s Infuse Bone Graft study, which claimed to show that wounded soldiers’ leg injuries healed better when the product was used, was published in the Journal of Bone & Joint Surgery last August, but retracted in March. An Army investigation found several problems with it. For one thing, the study cited higher numbers of patients and injuries than Walter Reed officials could account for. Kuklo also did not obtain the Army’s required permission to conduct the study, and investigators at Walter Reed have also concluded that Kuklo forged his co-authors signatures on the study.

Kuklo is no longer at Walter Reed, and  is now on staff at Washington University School of Medicine in St. Louis.

]]> Dodgy Infuse Bone Graft Study Catches Grassley's Attention http://www.yourlawyer.com/articles/read/16569 Tue, 19 May 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16569 Infuse Bone Graft study conducted at Walter Reed Army Hospital has caught the attention of medical industry watchdog, Sen. Charles Grassley (R-Iowa).  According to The Wall Street Journal, Grassley has sent letters about the study to Walter Reed, Medtronic, Inc., the  Journal of Bone & Joint Surgery, and the Washington University School of Medicine in St. Louis.  Dr. Timothy Kuklo, the former Walter Reed surgeon who conducted the study on Medtronic's Infuse product,  is now on staff at Washington University.

As we reported last week, Kuklo's  Infuse Bone Graft study, which claimed to show that wounded soldiers’ leg injuries healed better when the product was used,  was published in the Journal of Bone & Joint Surgery last August, but retracted in March.  An Army investigation found several problems with it.  For one thing, the study  cited higher numbers of patients and injuries than Walter Reed officials  could account for. Kuklo also did not obtain the Army’s required permission to conduct the study, and investigators at Walter Reed have also concluded that Kuklo forged his co-authors signatures on the study.

According to The New York Times, which originally broke the Kuklo story, Grassley has been investigating Infuse for some time over claims that Medtronic illegally promoted its off-label use.  Some have charged that the company paid doctor consultants to hype such uses.  Kuklo, who was at Walter Reed between 2003 and 2007,  is a paid consultant for Medtronic, but the company maintains he wasn't affiliated with it when he worked on the Walter Reed study, The Wall Street Journal said.  However, the Times has reported that during that time, he was paid travel  expenses by Medtronic for attending medical conferences and other events.

The Times is also reporting that Medtronic did not include Kuklo on its list of paid consultants when Grassley requested that information in September, despite the fact that he often gave talks on Infuse.

According to The New York Times, Grassley's letter to Walter Reed requested information about any payments Kuklo may have received from Medtronic during his tenure there.  He also wants information on the Army's  investigation as well as relevant conflict-of-interest policies.

According to The Wall Street Journal, Grassley has also asked the Journal of Bone & Joint Surgery why it published Kuklo's study after it had been rejected by another journal.  He also wants to know if the publication had been told that Kuklo had a financial relationship with Medtronic.

Infuse Bone Graft contains recombinant human Bone Morphogenetic Protein (rhBMP-2), a protein released naturally by the body. It is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia. It is also approved for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation.

Last July, the Food & Drug Administration (FDA) warned that the use of Infuse Bone Graft and similar products had caused serious problems when they were used off-label in cervical spine (neck) surgeries. Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries.

]]> Retracted Infuse Bone Graft Study Used Falsified Data, Forged Signatures http://www.yourlawyer.com/articles/read/16562 Fri, 15 May 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16562 A scandal involving Medtronic Inc.'s Infuse Bone Graft has erupted in the U.S. Army.  According to The Wall Street  Journal,  "a number of serious questions" have been raised about an Infuse study conducted by Dr. Timothy R. Kuklo, former surgeon at Walter Reed Army Medical Center in Washington, D.C.

Infuse Bone Graft contains recombinant human Bone Morphogenetic Protein (rhBMP-2), a protein released naturally by the body.  It is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia.  It is also approved for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation.  

In July, the Food & Drug Administration (FDA) warned that the use of Infuse Bone Graft and similar products had caused serious problems when they were used off-label in cervical spine (neck) surgeries.   Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries.

According to the Journal, Kuklo's Infuse study claimed to showed that wounded soldiers' leg injuries healed better when the product was used.  But  Walter Reed was unable to verify its conclusions. According to a report in the St. Louis Post-Dispatch, the study cited higher numbers of patients and injuries than the hospital could account for.  Kuklo also did not obtain the Army’s required permission to conduct the study. According to The Wall Street Journal, investigators at Walter Reed have also concluded that Kuklo forged his co-authors signatures on the study. 

The Journal of Bone and Joint Surgery, which published Kuklo's article last August,  retracted it in March.  

The New York Times is reporting that Kuklo is now an associate professor at the Washington University medical school in St. Louis.  The Times said that Kuklo is a paid consultant for Medtronic, and had also given talks on Infuse while at Walter Reed.  A Medtronic official also confirmed to the Times that the company financially supported some of Kuklo's research at Walter Reed, but said the Infuse study was not funded by Medtronic.  The official would not say when Kuklo was hired as a consultant, nor how much he has been paid, the Times said.

The Kuklo affair is just the latest incident to raise questions about Infuse, as well as Medtronic's relationships with doctor consultants.   In September, the Wall Street Journal reported that at least three-quarters of the roughly 200 “adverse events” reported to the FDA involve off-label uses of Infuse Bone Graft. According to the Journal, doctors paid consulting fees by Medtronic have promoted off-label use of Infuse by, among other things, authoring articles that present unapproved uses in a favorable light.

Doctors are free to use approved medical devices in anyway they see fit.  However, manufacturers are forbidden from promoting any use that has not received FDA approval - known as off-label use.  Concerns over off-label Infuse procedures have sparked a Congressional investigation into possible illegal  promotion by Medtronic.  In November, Medtronic also said it had received a promotion from the Department of Justice as part of a probe of possible off-label marketing.

]]> Medtronic Marketing Of Cardiac Ablation Therapy Sparks DOJ Probe http://www.yourlawyer.com/articles/read/16187 Fri, 06 Mar 2009 00:00:00 -0800 http://www.yourlawyer.com/articles/read/16187
Cardiac ablation therapy  involves threading devices through tubes in the circulatory system to burn, freeze or otherwise kill diseased  heart cells.  The therapy is used to treat irregular heart beats.

According to Bloomberg News, Medtronic and other medical device makers have said they plan to enter the ablation market.  As part of that effort, last year Medtronic acquired CryoCath Technologies Inc., of Kirkland, Quebec.  In February, the company also announced its intention to acquire Ablation Frontiers Inc. of Carlsbad.

The Department of Justice (DOJ) informed Medtronic of the cardiac ablation therapy probe via a letter Feb. 9.  According to Bloomberg News, Medtronic has said it would comply with the probe.

In November, Medtronic revealed  that the DOJ was investigating the marketing of one of its bone growth products, Infuse Bone Graft. The product is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia.  Infuse Bone Graft is also approved for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation.

In July, the Food & Drug Administration (FDA) warned that the use of Infuse Bone Graft and similar devices had caused serious problems when they were used off-label in cervical spine (neck) surgeries. In September, the Wall Street Journal reported that at least three-quarters of the roughly 200 “adverse events” reported to the FDA involve off-label uses of Infuse Bone Graft.  The Journal said that most of these complications cases involve unwanted bone growths near nerves or in areas outside targeted fusion sites.

The Wall Street Journal also reported that doctors paid consulting fees by Medtronic have promoted off-label use of Infuse by, among other things, authoring articles that present unapproved uses in a favorable light.  

During a conference call with analysts last November, Medtronic chief executive Bill Hawkins said  that the company was complying with the Justice Department’s request, but insisted that Medtronic was not promoting off-label use of Infuse.  Hawkins said that if doctors were using the bone graft product in off-label procedures, it was because they had determined it “was the best therapy for their patients.”

]]> University Responds to Conflict-of-Interest Scandal http://www.yourlawyer.com/articles/read/15938 Tue, 27 Jan 2009 00:00:00 -0800 http://www.yourlawyer.com/articles/read/15938 Reacting to the widely publicized conflict-of-interest scandal, University of Wisconsin (UW) officials say they are taking steps to resolve the problem at their School of Medicine and Public Health, The Capital Times said.

Dr. Thomas Zdeblick is the UW researcher who received $19 million in payments over five years from Medtronic, Inc., for his help in developing and promoting its spine products, specifically, the Infuse Bone Graft.  According to an earlier Wall Street Journal report, payments amounted to far more than he ever disclosed to UW.  Also, the Journal noted, UW maintained a policy requiring its researchers to disclose when they receive over $20,000 from a device or drug maker, but no other details are required.  The Milwaukee Journal Sentinel reported that over 30 UW physicians exceeded the threshold in 2006 and 2007.

Zdeblick told the Journal he does not receive royalties from any Medtronic products he uses, and has been telling patients about his financial ties to device makers since 1991.  According to the Journal, Zdeblick has received royalties for helping to develop Medtronic’s Infuse Bone Graft.

Last year, the Food and Drug Administration (FDA) warned that use of the Infuse Bone Graft and similar devices caused serious problems when used off-label in cervical spine (neck) surgeries; the device is named in several lawsuits that claim Medtronic improperly promoted off-label use, and is the subject of a Justice Department investigation.  Medtronic has also been named in three “whistleblower” lawsuits filed by former employees alleging Medtronic paid doctors to use Infuse Bone Graft and other Medtronic spine products.  Medtronic agreed to pay $40 million to settle two of the cases, but admitted no wrongdoing.

In a joint letter to Senator Charles Grassley (Republican-Iowa), UW System President Kevin Reilly and UW-Madison Chancellor Carolyn Martin said, “A task force was established for this purpose, with the goal of identifying, managing, and eliminating conflicts of interest in clinical care," quoted Capital Times.  Earlier this month, UW initiated a month-long pilot program to give patients details about external income earned by doctors and posted signs in seven clinics indicating their doctors might be compensated by drug and device makers, according to the letter, said the Capital Times.

Grassley and Democratic Wisconsin Senator Herb Kohl collaborate on efforts to ensure full disclosure on the financial amounts physicians receive from drug and medical device companies.  Last week, the senators introduced the Physician Payments Sunshine Act of 2009, said the Capital Times, which was created to establish a national standard to require drug, device, and biologic makers to report payments to doctors, the paper said, adding that the legislation also requires transactions be documented on a searchable, public database.

Earlier this month the Journal reported that Grassley wrote to Reilly about his concerns with UW-Madison's reporting requirements and specifically pointed out the Zdeblick issue.  In addition to other items, Grassley asked if Zdeblick implanted any of the devices into patients since January of 2006 and how many times such implantations took place.  Grassley also requested the disclosure forms provided to such patients that indicate the surgeon’s ties to the device/device maker, said The Capital Times.

The Capital Times reported that Reilly and Martin said Zdeblick implanted 68 Premier Anterior Cervical Plate Systems, 89 Novus LT Cages, five Vantage Anterior Fixation Systems, and 17 Prestige Discs.  The two wrote that they were unclear if the senator was looking for a copy of the standard consent form or the individual, signed form.  Because of this, said The Capital Times, UW only provided a blank consent form.

A review last week by the Capital Times revealed that UW has no legal right to share in the payouts to Zdeblick since it only requires its researchers to patent inventions through the Wisconsin Alumni Research Foundation (WARF) when funded with federal money.

]]> Spine Doctors Mandated to Disclose Financial Ties to Industry http://www.yourlawyer.com/articles/read/15933 Mon, 26 Jan 2009 00:00:00 -0800 http://www.yourlawyer.com/articles/read/15933 medical device companies as well as the dollar amounts associated with those relationships, the Wall Street Journal (WSJ) reported.

At the urging of lawmakers and in response to lawsuits, the 5,000 member North American Spine Society (NASS) is requiring its researchers to make these financial disclosures, said the WSJ, when those researchers present studies at medical conferences.  The Journal explained that some of these well-known surgeons have been involved in financial relationships in which large amounts—sometimes in the millions—were paid to them by industry.

NASS noted this requirement “is not a voluntary guideline, but a binding covenant which applies to all relationships engaged in by all participants in all” activities of the NASS and that not disclosing this information is a “sanctionable offense,” Nass said, according to the WSJ.  And while the sanctions would impact a doctor’s NASS standing, sanctions would not affect a physician’s ability to practice medicine, said the WSJ.

“It just became clear that more transparency is better,” the spine society’s ethics-committee chairwoman, an Arizona-based orthopedic surgeon, Marjorie Eskay-Auerbach, said, quoted the WSJ.  Niether Eskay-Auerbach nor Catherine D. DeAngelis, editor in chief of the Journal of the American Medical Association, knew of other such policies in effect elsewhere.  “I’m sure this is because of Senator [Chuck] Grassley” (Republican-Iowa), said DeAngelis.  Grassley has publicized the millions of dollars industry has paid to some prominent physicians.  “I’m sure they’re saying we’d better police this ourselves or the feds will,” DeAngelis said to the WSJ.
For instance, Medtronic Inc. paid a surgeon and researcher $19 million over five years to help Medtronic develop and promote it’s spine products, including the Infuse Bone Graft; according to an earlier WSJ report, the Medtronic payments received by University of Wisconsin researcher Dr. Thomas Zdeblick amounted to far more than he ever disclosed to the school.

In July, the U.S. Food and Drug Administration (FDA) warned that use of the Infuse Bone Graft and similar devices caused serious problems when they were used off-label in cervical spine (neck) surgeries; the device is named in several lawsuits that claim Medtronic improperly promoted off-label use, and it is the subject of a Justice Department investigation.  Medtronic has also been named in three “whistleblower” lawsuits filed by former employees that alleged the company paid doctors to use the Infuse Bone Graft and other Medtronic spine products.  Medtronic agreed to pay $40 million to settle two of the cases, but admitted no wrongdoing.

The Medtronic Infuse Bone Graft is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia.  The Food & Drug Administration (FDA) has also approved it for use in two dental bone-grafting procedures:  Sinus augmentation and localized alveolar ridge augmentation.   The FDA has not approved this device for any other procedure and using it on the neck area, or operating from the back side, is considered off-label.
]]> Infuse Bone Graft Doc Got $19 Million from Medtronic http://www.yourlawyer.com/articles/read/15871 Fri, 16 Jan 2009 00:00:00 -0800 http://www.yourlawyer.com/articles/read/15871 Infuse Bone Graft.   According to a report in The Wall Street Journal, the Medtronic payments received by University of Wisconsin researcher Dr. Thomas Zdeblick amounted to far more than he ever disclosed to the school.

According to The Wall Street Journal, Wisconsin has a policy requiring its researchers to disclose when they receive more than $20,000 from a device or drug maker.  No other details - such as the exact amount received -  are required.  Wisconsin's policy is pretty similar to other universities' rules, the Journal said.

So following those rules, each year from 2003 to 2007, Zdeblick told the University that he’d received $20,000 or more from Medtronic. One year, he reported getting $40,000 or more.  But as a letter from Sen. Charles Grassley (R-Iowa) states, the money Zdeblick received went well beyond $20,000, or even $40,000.  According to Medtronic's records, he received anywhere between 2.6 million to $4.6 million in royalty and consulting payments per year.

"I am concerned that Wisconsin's reporting requirements do not go far enough to fully capture a physician's potential conflict of interest," Sen. Grassley's January 12 letter said.  He is asking for more information from Wisconsin regarding Zdeblick's disclosures, and also wants to know if the doctor received royalties for  Medtronic products used at the school's hospital.

According to the Journal, the dean of the University of Wisconsin's medical school acknowledge that the school's disclosure rules were inadequate, and should be toughened to require researchers to report specific payment amounts.  

Zdeblick told the Journal that he does not receive royalties from any Medtronic products he uses, and has been telling patients about his financial ties to device makers since 1991.

According to the Journal, Zdeblick has received royalties for helping to develop Medtronic's Infuse Bone Graft.  In  July, the Food & Drug Administration (FDA) warned that the use of Infuse Bone Graft and similar devices had caused serious problems when they were used off-label in cervical spine (neck) surgeries.  The device is named in several lawsuits that claim Medtronic improperly promoted off-label use, and it is the subject of a Justice Department investigation.

Medtronic has also been named in three “whistleblower” lawsuits filed by former employees that alleged the company paid doctors to use Infuse Bone Graft and other Medtronic spine products. Medtronic agreed to pay $40 million to settle two of the cases, but admitted no wrongdoing.

]]> Study Finds Medtronic Infuse Bone Graft Frequently Used Off Label http://www.yourlawyer.com/articles/read/15845 Tue, 13 Jan 2009 00:00:00 -0800 http://www.yourlawyer.com/articles/read/15845 Medtronic's Infuse Bone Graft are off label, according to a new Cleveland Clinic study.  This is disturbing, as off-label use of bone graft products like Infuse has been linked to serious complications.

Infuse Bone Graft contains recombinant human Bone Morphogenetic Protein (rhBMP-2), a protein released naturally by the body.  It is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia.  It is also approved for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation.  

In  July, the Food & Drug Administration (FDA) warned that the use of Infuse Bone Graft and similar devices had caused serious problems when they were used off-label in cervical spine (neck) surgeries.   Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries.

For their study, researchers at the Cleveland Clinic saw off-label use of Infuse decrease in Medicare-aged patients but increase for non-Medicare patients, a trend that the investigators said was concerning. “I think these data really emphasize we have to critically study the off-label use of bone biologics,”  Isador H. Lieberman, MD, lead author on the study said.

On-label non-Medicare Infuse usage rose to about 127,200 units in 2007 and off-label use increased to about 24,200 in 2007 or 14.3 percent. During the period analyzed, 17.3 percent of all Infuse usage was off-label. The researchers noted an increase in on-label use among the Medicare population from about 9,200 to about 13,000 units, or 7.9 percent of Infuse sales. Off-label use of Infuse also increased in that group, but the percentage of total sales actually went down from 6.5 percent to 2.5 percent.

In September, the Wall Street Journal reported that at least three-quarters of the roughly 200 “adverse events” reported to the FDA involve off-label uses of Infuse Bone Graft.  The Journal said that most of these cases involved unwanted bone growths near nerves or in areas outside targeted fusion sites.

Doctors are free to use approved medical devices in anyway they see fit.  However, manufacturers are forbidden from promoting any use that has not received FDA approval - known as off-label use

As we’ve previously reported, problems stemming with from off-label use of Infuse have resulted in the filing of several lawsuits against Medtronic.  In December, a  lawsuit was filed by the family of a woman who received Infuse during neck graft surgery, and later died.  That lawsuit claims that a Medtronic sales representative was in the operating room before and during the patient’s surgery, and encouraged her doctor to use Infuse in the off-label procedure.

Last week, we also reported on a Texas woman who a was preparing to file a lawsuit that blames off-label use of Infuse for injuries she suffered after cervical spine surgery.  The woman's lawyer said her physician will “provide testimony stating ways in which Medtronic has promoted the off-label use of the product among physicians”.

The Minneapolis Firefighters’ Relief Association also filed a class-action shareholder lawsuit against Medtronic on Dec. 12, alleging that the company did not reveal that most of its revenue came from off-label use of Infuse, did not reveal that off-label use was causing major complications and did not disclose that it adopted an unlawful marketing campaign to promote its use.

Off-label use of Infuse Bone Graft was also the subject of a subpoena filed by the U.S. Department of Justice in November.  Medtronic insists that it does not promote off-label use of Infuse, and claims  that if doctors were using the bone graft product in off-label procedures, it was because they had determined it was the best therapy for their patients.

]]> Medtronic Infuse Bone Graft to be Named in Another Lawsuit http://www.yourlawyer.com/articles/read/15792 Tue, 06 Jan 2009 00:00:00 -0800 http://www.yourlawyer.com/articles/read/15792 Infuse Bone Graft product.  According to a report on the website "Finance and Commerce", a Texas woman is preparing to file a lawsuit that blames off-label use of Infuse for injuries she suffered after cervical spine surgery.

Infuse Bone Graft contains recombinant human Bone Morphogenetic Protein (rhBMP-2), a protein released naturally by the body.  It is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia.  It is also approved for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation.  

In  July, the Food & Drug Administration (FDA) warned that the use of Infuse Bone Graft and similar devices had caused serious problems when they were used off-label in cervical spine (neck) surgeries.   Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries.

In September, the Wall Street Journal reported that at least three-quarters of the roughly 200 “adverse events” reported to the FDA involve off-label uses of Infuse Bone Graft.  The Journal said that most of these cases involved unwanted bone growths near nerves or in areas outside targeted fusion sites.

Doctors are free to use approved medical devices in anyway they see fit.  However, manufacturers are forbidden from promoting any use that has not received FDA approval - known as off-label use.

According to "Finance and Commerce",  a draft of a lawsuit being prepared on behalf of Mary Selke claims that use of Infuse during her cervical spine surgery caused bone to form in her neck, impeding her breathing and swallowing to the extent that she required emergency surgery.   "Finance and Commerce" also reported  that Selke's lawyer said her physician will "provide testimony stating ways in which Medtronic has promoted the off-label use of the product among physicians".

As we've previously reported, Medtronic already faces a lawsuit filed by the family of a woman who received Infuse during neck graft surgery, and later died.  That lawsuit claims that a Medtronic sales representative was in the operating room before and during the patient's surgery, and encouraged her doctor to use Infuse in the off-label procedure.

Off-label use of Infuse Bone Graft was also the subject of a subpoena filed by the U.S. Department of Justice in November.  Medtronic insists that it does not promote off-label use of Infuse, and claims  that if doctors were using the bone graft product in off-label procedures, it was because they had determined it was the best therapy for their patients.

According to "Finance and Commerce", the Minneapolis Firefighters’ Relief Association has also filed a class-action shareholder lawsuit against Medtronic on Dec. 12, alleging that the company did not reveal that most of its revenue came from off-label use of Infuse, did not reveal that off-label use was causing major complications and did not disclose that it adopted an unlawful marketing campaign to promote its use.

]]> Spine Doctors Mandated to Disclose Financial Ties to Industry http://www.yourlawyer.com/articles/read/15932 Thu, 01 Jan 2009 00:00:00 -0800 http://www.yourlawyer.com/articles/read/15932 Some doctors will be required to disclose their financial ties to medical device companies as well as the dollar amounts associated with those relationships, the Wall Street Journal (WSJ) reported.

At the urging of lawmakers and in response to lawsuits, the 5,000 member North American Spine Society (NASS) is requiring its researchers to make these financial disclosures, said the WSJ, when those researchers present studies at medical conferences.  The Journal explained that some of these well-known surgeons have been involved in financial relationships in which large amounts—sometimes in the millions—were paid to them by industry.

NASS noted this requirement "is not a voluntary guideline, but a binding covenant which applies to all relationships engaged in by all participants in all" activities of the NASS and that not disclosing this information is a "sanctionable offense," Nass said, according to the WSJ.  And while the sanctions would impact a doctor’s NASS standing, sanctions would not affect a physician’s ability to practice medicine, said the WSJ.

"It just became clear that more transparency is better," the spine society's ethics-committee chairwoman, an Arizona-based orthopedic surgeon, Marjorie Eskay-Auerbach, said, quoted the WSJ.  Niether Eskay-Auerbach nor Catherine D. DeAngelis, editor in chief of the Journal of the American Medical Association, knew of other such policies in effect elsewhere.  "I'm sure this is because of Senator [Chuck] Grassley" (Republican-Iowa), said DeAngelis.  Grassley has publicized the millions of dollars industry has paid to some prominent physicians.  "I'm sure they're saying we'd better police this ourselves or the feds will," DeAngelis said to the WSJ.
For instance, Medtronic Inc. paid a surgeon and researcher $19 million over five years to help Medtronic develop and promote it’s spine products, including the Infuse Bone Graft; according to an earlier WSJ report, the Medtronic payments received by University of Wisconsin researcher Dr. Thomas Zdeblick amounted to far more than he ever disclosed to the school.

In July, the U.S. Food and Drug Administration (FDA) warned that use of Infuse Bone Graft and similar devices caused serious problems when they were used off-label in cervical spine (neck) surgeries; the device is named in several lawsuits that claim Medtronic improperly promoted off-label use, and it is the subject of a Justice Department investigation.  Medtronic has also been named in three “whistleblower” lawsuits filed by former employees that alleged the company paid doctors to use the Infuse Bone Graft and other Medtronic spine products.  Medtronic agreed to pay $40 million to settle two of the cases, but admitted no wrongdoing.

The Medtronic Infuse Bone Graft is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia.  The Food & Drug Administration (FDA) has also approved it for use in two dental bone-grafting procedures:  Sinus augmentation and localized alveolar ridge augmentation.   The FDA has not approved this device for any other procedure and using it on the neck area, or operating from the back side, is considered off-label.

]]> FDA to Be Informed of Infuse Bone Graft Death http://www.yourlawyer.com/articles/read/15663 Fri, 12 Dec 2008 00:00:00 -0800 http://www.yourlawyer.com/articles/read/15663 Infuse Bone Graft product in an off-label procedure.  The death occurred in August, but according to a report in The Wall Street Journal, Medtronic is claiming it did not learn of the fatality until it was named in a lawsuit filed by the victim's family earlier this month.

Infuse Bone Graft contains recombinant human Bone Morphogenetic Protein (rhBMP-2), a protein released naturally by the body.  It is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia.  It is also approved for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation.  

Last month, Medtronic revealed that off-label use of Infuse Bone Graft was the subject of a subpoena filed by the U.S. Department of Justice.  The company insists that it does not promote off-label use of Infuse, and claims  that if doctors were using the bone graft product in off-label procedures, it was because they had determined it was the best therapy for their patients. Doctors are free to use approved medical devices in anyway they see fit.  However, manufacturers are forbidden from promoting any use that has not received FDA approval - known as off-label use.

In July, the FDA warned that the use of Infuse Bone Graft and similar devices had caused serious problems when they were used off-label in cervical spine (neck) surgeries.   Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries.

In September, the Wall Street Journal reported that at least three-quarters of the roughly 200 “adverse events” reported to the FDA involve off-label uses of Infuse Bone Graft.  The Journal said that most of these cases involved unwanted bone growths near nerves or in areas outside targeted fusion sites.

According to her family's Infuse Bone Graft lawsuit, Shirley Nesbitt received the graft during neck surgery, an off-label use of the product.  The lawsuit alleges that a Medtronic sales representative was in the operating room before and during Nesbitt’s surgery, and encouraged the doctor to use Infuse in the off-label procedure.  Nesbitt underwent her surgery on August 21, and suffered respiratory arrest on August 23, the lawsuit said.  According to the Journal, she was “kept alive by artificial means” until August 30.

Device makers are required to let the FDA know when a patient treated with one of their products suffers an adverse event.   In August, Medtronic informed the FDA that Nesbitt had fallen into a coma following her Infuse Bone Graft Surgery, the Journal said.   However, Nesbitt's death was never reported.  According to The Wall Street Journal, the hospital where Nesbitt died did not report the death to Medtronic, and the company said it only learned of the incident when the lawsuit was filed.

However, the Journal reports that Medtronic has been cited by the FDA before for not reporting adverse events related to some of its products.  Last year, the FDA issued a warning letter to Medtronic, saying it had failed to properly report adverse events related to devices in its neuromodulation business, the Journal said.

]]> Medtronic Cervical Bone Graft lawyer http://www.yourlawyer.com/topics/overview/Medtronic_Infuse_Bone_Graft Fri, 12 Dec 2008 00:00:00 -0800 http://www.yourlawyer.com/topics/overview/Medtronic_Infuse_Bone_Graft Medtronic Infuse Bone Graft Injury Lawyers

Keywords: Medtronic Cervical Bone Graft lawyer

The lawyers and attorneys at our firm are offering free consultations to individuals injured as a result of off-label use of the Medtronic Infuse Bone Graft.  Off-label use  of the Infuse Bone Graft has proven to be dangerous.  Recently, the Medtronic Infuse Bone Graft lawyers at our firm have become aware that Medtronic may have illegally promoted off-label use of Infuse.  If you or a loved one were injured after being implanted with this device in an off-label procedure, we urge you to contact one of our Medtronic Infuse Bone Graft injury lawyers as soon as possible to protect your legal rights.

Infuse Bone Graft contains recombinant human Bone Morphogenetic Protein (rhBMP-2), a protein released naturally by the body.  According to Medtronic's Website, the Infuse Bone Graft  provides a scaffolding where new bone can grow.  It is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia.  The Food & Drug Administration (FDA) has also approved it for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation. 

The FDA has not approved this device for any other procedure.  Using it on the neck area, or operating from the back side, is considered off-label. As our Medtronic Infuse Bone Graft injury lawyers have learned, other procedures with the device put patients at significant risk of injury.  The artificial protein contained in Infuse Bone Graft  can inflame nearby tissue. If the material isn't inserted properly, or if it leaks, it can cause bone growth in areas outside the surgical site.
 

Despite the dangers, the Medtronic Infuse Bone Graft injury lawyers at our firm know that off-label use of this graft is quite common.  In fact, at least three-quarters of the roughly 200 "adverse events" reported to the FDA involve off-label uses of the product.  In November 2008, the U.S. Department of Justices began an investigation to determine if Medtronic illegally promoted off-label use of Infuse bone Graft.
 

Danger of Infuse Bone Graft Off-Label Use

In July 2008, the FDA warned the Infuse Bone Graft had caused serious problems when it was used off-label in cervical spine (neck) surgeries.   The agency said it received 38 reports over four years of side effects, mainly swelling of neck and throat tissue, which resulted in compression of the airway and other structures in the neck. Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries.
 

Our Medtronic Infuse Bone Graft injury lawyers are aware that this device has hurt  many more patients after it was used in other off-label situations. According to a September 2008 Wall Street Journal investigation, most these complications  involved unwanted bone growths near nerves or in areas outside targeted fusion sites. That can lead to pain, repeat surgeries and, in some cases, emergency intervention.
 

Questions Surrounding Medtronic's Promotion of Infuse Bone Graft

The Medtronic Infuse Bone Graft Injury lawyers at our firm are investigating claims that the maker of this device has illegally promoted the off-label use of this product. Promoting the off-label use of a medical device is illegal, although doctors are allowed to use a device anyway they see fit.

The Infuse Bone Graft was approved in 2002, but before it was, The Wall Street Journal said the FDA had concerns about the product’s potential off-label uses.  At an advisory committee meeting discussing the product’s approval,  it asked FDA staff for recommendations on “guarding against off-label use of this product.”

According to transcripts of that meeting obtained by the Journal, Dr. Scott Boden, director of the Emory University Orthopaedics & Spine Center who helped present the committee with clinical trial data on behalf of Medtronic, told the panel that discussion about off-label use was “outside the scope of what we ought to be focusing on today.”  At the time he testified, Dr. Boden was being paid more than $100,000 a year by Medtronic, according to a lawsuit filed last year. Those payments continued at least through 2006, when he received at least $75,000, the Journal reported.

In May 2003, four other surgeons wrote a report for the Website Spine Universe that cited favorable results from using Infuse in the neck area and for fusing larger numbers of vertebrae. The authors included Atlanta surgeon Regis W. Haid Jr. and Emory University surgeon Gerald Rodts.  According to The Wall Street Journal, at least three of the four authors had financial relationships with Medtronic, but that was never mentioned in their article. 

Medtronic has also been named in three "whistleblower" lawsuits filed by former employees that alleged the company paid doctors to use Infuse Bone Graft and other Medtronic spine products. Medtronic agreed to pay $40 million to settle two of the cases, but admitted no wrongdoing.  The third lawsuit alleges that Medtronic illegally paid doctors inflated consulting fees and bogus royalty payments to promote off-label uses Infuse.
 

Senator Charles Grassley (R-Iowa) a frequent critic of the medical device industry, is also investigating Medtronic’s marketing practices.  Last year, the Senator  asked Medtronic’s Tennessee-based spine division to provide information about payments to 15 doctors. In a letter to Medtronic Grassley said he was concerned that  “inordinately high consulting fees, free travel and other perks distort decision-making among physicians and obscure the best interest of patients.”
 

During a conference call with investors in November 2008, Medtronic's chief executive revealed that the company had received a subpoena from Justice Department regarding off-label use of Infuse Bone Graft.  Hawkins said during the call that the company is complying with the Justice Department’s request, but insisted that Medtronic was not promoting off-label use of Infuse.  Hawkins said that if doctors were using the bone graft product in off-label procedures, it was because they had determined it “was the best therapy for their patients.”
 

Legal Help for Victims of Infuse Victims of Bone Graft Injuries

If you or someone you know sustained an injury due to the off-label use of the Medtronic Infuse Bone Graft, you have valuable legal rights.  Please fill out our online form, or call 1-800 LAW INFO (1-800-529-4636) to discuss your case with one of our experienced Medtronic Infuse Bone Graft lawyers.

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