August 4, 2009 - The Senate HELP (Health, Education, Labor and Pensions) Committee will hold a hearing at 2:30pm (ET) today titled, "Protecting Patients from Defective Medical Devices". The hearing is being held to discuss the Medical Device Safety Act of 2009. This Act, if passed, will undue the Supreme Court's ruling in the Riegel case last year. Basically, the Riegel ruling prevents people injured by defective medical devices from being able to file a lawsuit to recover damages caused by the device.
The committee will hear from the following people at the hearing today:
William H. Maisel, MD, MPH, Director, Medical Device Safety Institute, Beth Israel, Deaconess Medical Center, Harvard Medical School, Boston, MA
Professor Thomas O. McGarity, Joe R. and Teresa Lozano Long Endowed Chair in Administrative Law, University of Texas School of Law, Austin, TX
Michael Mulvihill, Patient, Bettendorf, IA
Peter Barton Hutt, Esq., Senior Counsel in Food and Drug Law, Covington & Burling, Washington, DC
Michael Roman, Patient, Kirkwood, MO
Tuesday, August 4, 2009
Wednesday, July 22, 2009
Major League Baseball Umpire Advocates for Passage of Medical Device Safety Act
July 21, 2009 - The New Haven REgister reprots that Mark Hirschbeck, a Major League Baseball umpire, is among those advocating for Congress to pass the Medical Device Safety Act of 2009. According to the article, Hirschbeck states that what started as routine hip replacement surgery cost him his career and has led to years of pain.
Hirscbeck underwent hip replacement surgery in June 2003. About a month after his surgery, while recovering on his couch he heard a "pop". The ceramic hip used in his surgery had shattered.
Hirschbeck underwent several surgeries to replace the hip suffering several infections along the way. Finally, a doctor removed all the ceramic and metal from his hip and started himon antibiotics to clear the infection. Once he was free of infection he received a non-ceramic hip replacement. While Hirschbeck is doing better, he still has pain and can't sit or stand for long periods of time. His career as a Major League umpire is over.
Hirschbeck has filed a lawsuit against the manufacturer of the original hip he received. However, a U.S. Supreme Court case decided last year ruled that medical device manufacturers like the one who made Hirschbeck's hip, are immune from lawsuits challenging the products safety or effectiveness.
The Medical Device Safety Act of 2009, if passed, would allow cases like Hirschbeck's to proceed to trial. That is why Hirschbeck has gone to Washington, D.C. to lobby lawmakers to pass the Medical Device Safety Act. The bill is currently in committee.
Hirschbeck and many others like him just want their day in court and tell a jury their story. So many who have been seriously injured by faulty medical devices just want the companies to be held accountable, but that won't happen without the passage of the Medical Device Safety Act.
Hirscbeck underwent hip replacement surgery in June 2003. About a month after his surgery, while recovering on his couch he heard a "pop". The ceramic hip used in his surgery had shattered.
Hirschbeck underwent several surgeries to replace the hip suffering several infections along the way. Finally, a doctor removed all the ceramic and metal from his hip and started himon antibiotics to clear the infection. Once he was free of infection he received a non-ceramic hip replacement. While Hirschbeck is doing better, he still has pain and can't sit or stand for long periods of time. His career as a Major League umpire is over.
Hirschbeck has filed a lawsuit against the manufacturer of the original hip he received. However, a U.S. Supreme Court case decided last year ruled that medical device manufacturers like the one who made Hirschbeck's hip, are immune from lawsuits challenging the products safety or effectiveness.
The Medical Device Safety Act of 2009, if passed, would allow cases like Hirschbeck's to proceed to trial. That is why Hirschbeck has gone to Washington, D.C. to lobby lawmakers to pass the Medical Device Safety Act. The bill is currently in committee.
Hirschbeck and many others like him just want their day in court and tell a jury their story. So many who have been seriously injured by faulty medical devices just want the companies to be held accountable, but that won't happen without the passage of the Medical Device Safety Act.
Tuesday, July 21, 2009
Executives Plead Guilty in Illegla Trials of Bone Cement
According to Bloomberg News, two executives from Synthes Inc., a medical device maker, pleaded guilt for their role in the company's illegal trials of bone-mending cement that led to the death of three patients. The 52-count indictment accuses executives at Synthes Inc, which is based in West Chester, Pa., of bypassing FDA approval of the trials while knowing that their products, Norian XR and Norain SRS, posed significant risks.
Michael D. Huggins and John J. Walsh pleaded guilty on Monday in federal court in Philadelphia to one misdemeanor count of shipping misbranded Norian XR across state lines. Each faces as much as one year in prison and a $100,000 fine according to United States attorney Michael Levy. Mr. Huggins' lawyers, Gregory Poe and Catherine Recker said in an e-mailed statement that "Mr. Huggins has always made clear that he did not do anything knowingly or intentionally wrong."
Michael D. Huggins and John J. Walsh pleaded guilty on Monday in federal court in Philadelphia to one misdemeanor count of shipping misbranded Norian XR across state lines. Each faces as much as one year in prison and a $100,000 fine according to United States attorney Michael Levy. Mr. Huggins' lawyers, Gregory Poe and Catherine Recker said in an e-mailed statement that "Mr. Huggins has always made clear that he did not do anything knowingly or intentionally wrong."
Thursday, June 25, 2009
Medtronic Warned by FDA on Pain Pump and Insulin Pump
Medtronic Inc. received a warning letter on June 1, 2009 from the FDA regarding its SynchroMed II Drug Pumps and MiniMed Paradigm Insulin Pump. The FDA citesMedtronic for taking too long to recall the SynchroMed Pumps. The letter also said that a 2008 inspection 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,implantable devices used to deliver medicine to the spine, have been recalled on several occasions including in May 2008. The Pumps were recalled in 2008 because 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 FDA letter said. The letter went on to say, “FDA is concerned with your failure to initiate a recall for devices affected by the propellant problem in a timely manner. It took almost two years from when the missing propellant was initially identified to conduct a recall.”
The FDA letter also noted that Medtronic failed 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. Training records showed that the employee who evaluated MiniMed pump reports only had a high school diploma with some additional in-house training.
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.
SynchroMed II pumps,implantable devices used to deliver medicine to the spine, have been recalled on several occasions including in May 2008. The Pumps were recalled in 2008 because 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 FDA letter said. The letter went on to say, “FDA is concerned with your failure to initiate a recall for devices affected by the propellant problem in a timely manner. It took almost two years from when the missing propellant was initially identified to conduct a recall.”
The FDA letter also noted that Medtronic failed 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. Training records showed that the employee who evaluated MiniMed pump reports only had a high school diploma with some additional in-house training.
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.
Friday, June 19, 2009
FDA Medical Device Approval System Broken
At the subcommittee's hearing on the Medical Device Safety Act of 2009, Rep. Frank Pallone Jr. (D-NJ), chairman of the health subcommittee of the House Energy and Commerce Committee said that "there is evidence that the Food and Drug Administration (FDA) approval system for medical devices is 'broken' and a comprehensive review of the major issues and potential problems is needed" according to CQ HealthBeat. During the same hearing, Marcia Crosse, the Goverment Accountability Office's director of Healthcare, said "that the GAO has repeatedly pointed to shortcomings in the medical device approval process that continue today." Pallone called for the standards, procedures and rules for certain approving certain devices need to be adjusted to meet modern needs in getting the devices to those in need with confidence in their safety.
Wednesday, June 17, 2009
Hearing on Medical Device Safety Act of 2009
On June 18, 2009, the Health Subcommittee of the House Energy and Commerce Committee will have a hearing on the Medical Device Safety Act of 2009 (H.R. 1346). The Act, if passed, would reverse the United States Supreme Court's decision in Riegel v. Medtronic handed down last year. As a result of that case, injured patients are barred from suing medical device makers for injuries caused by faulty devices. The hearing tomorrow is titled, "Medical Devices: Are Current Regulations Doing Enough For Patients?"
This hearing is a follow-up to the May 12, 2009 hearing on the Act. The June 18, 2009 hearing is coming on the heels of reports from the Wall Street Journal that new FDA Commissioner Margaret Hamburg says she is working toward earlier safety warnings to doctors as well as resolving some of the issues with the agency's medical device division.
Dr. Hamburg announced that she will look at the “division’s decision-making and” a fast-track “approval process for devices called 510(k),” said the Journal. Some devices, said scientists with the agency, have received 510(k) approval, but called for additional safety and efficacy information, explained the Journal.
The passing of the Medical Device Safety Act of 2009 would clear the way for the thousands of individuals seriously injured by recalled Medtronic Sprint Fidelis Leads to pursue their claims against the manufacturer. Given that these devices were approved during a self-titled "dysfunctional" period of the FDA, allowing injured paitents recourse in a court of law only seems fair.
This hearing is a follow-up to the May 12, 2009 hearing on the Act. The June 18, 2009 hearing is coming on the heels of reports from the Wall Street Journal that new FDA Commissioner Margaret Hamburg says she is working toward earlier safety warnings to doctors as well as resolving some of the issues with the agency's medical device division.
Dr. Hamburg announced that she will look at the “division’s decision-making and” a fast-track “approval process for devices called 510(k),” said the Journal. Some devices, said scientists with the agency, have received 510(k) approval, but called for additional safety and efficacy information, explained the Journal.
The passing of the Medical Device Safety Act of 2009 would clear the way for the thousands of individuals seriously injured by recalled Medtronic Sprint Fidelis Leads to pursue their claims against the manufacturer. Given that these devices were approved during a self-titled "dysfunctional" period of the FDA, allowing injured paitents recourse in a court of law only seems fair.
Medical Device Maker and Executives Indicted
On June 16, 2009, Synthes, Inc., and four of its executives were indicted on federal charges that they improperly promoted a bone filler for purposes not approved by the FDA. The indictment sends a strong message to similar companies. Usually Federal Prosecuters seek fines through civil lawsuits rather than bringing criminal charges.
Synthes and Norian Corporation are accused of encouraging the use of its bone filler, Norian XR, in unauthorized human trials. Norian XR was used in spinal procedures including verteplasty and kyphoplasty. Verteplasty and Kyphoplasty are procedures wherein a cementlike material is injected into a spinal fracture. Three people died during these human trials, though a direct link to Norian XR in these deaths had not been made yet.
Norian XR was approved by the FDA in 2002 for general bone repair. However, the company was warned against promoting the bone filler for spinal surgeries. The warning was based on information linking use of the bone filler in spinal procedures to the development of large bloodclots.
Norian faces potential fines of $28 million and Synthes faces fines of $8million. If convicted, the the executives could serve up to one year in prsion. The individuals charged in the indictment are Michael B. Huggins, president of Synthes Spinal Division; Thomas E. Higgins, Senior Vice President for Global Strategy; Richard E. Bohner, Vice President for Operations; and John J. Walsh, a Regulatory Affairs Executive.
Synthes and Norian Corporation are accused of encouraging the use of its bone filler, Norian XR, in unauthorized human trials. Norian XR was used in spinal procedures including verteplasty and kyphoplasty. Verteplasty and Kyphoplasty are procedures wherein a cementlike material is injected into a spinal fracture. Three people died during these human trials, though a direct link to Norian XR in these deaths had not been made yet.
Norian XR was approved by the FDA in 2002 for general bone repair. However, the company was warned against promoting the bone filler for spinal surgeries. The warning was based on information linking use of the bone filler in spinal procedures to the development of large bloodclots.
Norian faces potential fines of $28 million and Synthes faces fines of $8million. If convicted, the the executives could serve up to one year in prsion. The individuals charged in the indictment are Michael B. Huggins, president of Synthes Spinal Division; Thomas E. Higgins, Senior Vice President for Global Strategy; Richard E. Bohner, Vice President for Operations; and John J. Walsh, a Regulatory Affairs Executive.
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