09.13.13
Court Stands by Plaintiff in Medtronic Lawsuit
In March 2009, Cristina Ramirez, M.D., went under the surgeon’s knife for a lumbar fusion procedure to alleviate back pain. Her surgeon used Infuse, a bio-engineered bone graft substitute made by Minneapolis, Minn.-based Medtronic Inc. Following her surgery, she began experiencing severe and ongoing pain. She had developed uncontrolled bone growth, causing nerve impingement, in the area where her surgeon implanted Infuse.
Though the U.S. Food and Drug Administration (FDA) approved Infuse in 2002, the device was not approved for use for posterior lumbar interbody fusion. It was only approved for an anterior approach. The FDA was concerned about potential adverse effects, such as abnormal bone growth of the kind that Ramirez experienced. However, thousands of U.S. patients nationwide have been implanted with Infuse during procedures involving off-label use, including posterior lumbar interbody fusion. Off-label use of Infuse by physicians constituted nearly 90 percent of the $800 million in revenue that Infuse generated for Medtronic in 2011.
Ramirez sued Medtronic. The complaint charged that Medtronic failed to warn the FDA of severe side effects associated with use of its spinal fusion product Infuse when used for surgeries other than that originally presented to the FDA. The complaint further alleged that Medtronic aggressively promoted off-label uses of its device using journal articles, advertising media, sales representatives and consultants and paid leading physicians to urge the purchase and use of Infuse. Off-label promotion of prescription drugs and medical devices violates federal law.
The medical device giant fought back, attempting to get the lawsuit thrown out of court. However, on Aug. 21, U.S. District Court Judge G. Murray Snow of the District of Arizona denied in large part Medtronic’s motion to dismiss the personal injury lawsuit on grounds that the claims are preempted by federal law.
“We are gratified that the court rejected Medtronic’s effort to close the doors to the courthouse on Dr. Ramirez and the many other patients that were implanted with the Infuse bone growth protein,” said Kent L. Klaudt, lawyer at the plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein LLP, which represents Ramirez. “The court’s carefully reasoned ruling reaffirms that manufacturers who violate federal safety laws cannot then evade state tort liability to injured patients.”
Medtronic asserted that the complaint should be dismissed because the Infuse device was approved by the FDA. As such, Medtronic argued, any claims against a medical device manufacturer under state law for fraud, negligence, design defect, and failure to warn of dangers were preempted because they conflict with the FDA’s approval of the design and label of the device.
The court created a bright-line rule distinguishing cases in which the manufacturer in question, although aware of the off-label use, complies with federal regulations applicable to the device from cases where the core of the claim is that the plaintiff was injured due to an off-label use tied to the manufacturer’s promotion of such uses. As the court explained, the rationale for the preemption of state law claims regarding an FDA-approved medical device “vanishes when the plaintiff brings a claim against a manufacturer that arises out of a use that has not be reviewed by the FDA but has been promoted by the manufacturer.”
“Any medical device manufacturer that misleadingly promotes its products for uses never approved by the FDA, and then fails to report to the FDA significant adverse events associated with those non-approved uses of the device, should be held accountable for severe injuries caused by the device,” added Klaudt. “That is basic fairness and creates a powerful incentive for manufacturers to properly design, test, and market their products.”
More Worries for Medtronic
An ongoing lawsuit is not the only obstacle Medtronic has faced this year. In July, a missing box of health records in Minnesota prompted company officials to warn more than 2,700 patients about a potential breach of privacy.
The medical device behemoth sent letters to patients in early July informing them of the situation and it arranged for patients to receive identity protection services, Medtronic spokeswoman Cindy Resman told the St. Paul Pioneer Press.
There have been no reports of any patient data misuse, Resman said in a prepared statement.
“These documents did not contain sensitive or intrusive information,” she said in the statement. “For a small portion of patients, however, it’s possible that additional information was in the box, including insurance company data, contact information and limited patient records.”
In early July, a box of training records went missing from a facility in Minnesota, Resman said. Most of the documents and records in the box dated back to 2008 and were connected with training in the use of insulin pumps or continuous glucose monitoring devices.
Medtronic believes the box only has been misplaced and remains on company facilities. However, there is “at least a possibility,” Resman said, that the box no longer is under Medtronic’s control.
Some patient records included Social Security numbers, but Resman believes that number to be a small percentage of the entire box. Medtronic contacted a total of 2,764 patients.
In addition to issuing letters to patients, Medtronic notified the federal government about the situation. Companies and other organizations are required to report breaches of unsecured protected health information that affect 500 or more individuals.
In 2011, Minneapolis-based Fairview Health Services notified about 1,200 patients about a potential privacy breach after a box of patient health and billing records went missing. At the time, Fairview information privacy director Lois Dahl said federal law dictates that patients must be notified of a security breach of health information within 60 days.
Other Medtronic News: Company Completes Cardiocom Acquisition
In happier news for Medtronic, On Aug. 12, the company closed the acquisition of Cardiocom, a privately held developer and provider of integrated telehealth and patient services for the management of chronic diseases, in an all-cash transaction of $200 million.
Founded in 1997 in Chanhassen, Minn., Cardiocom’s technology enables healthcare providers to remotely monitor patients with chronic conditions such as diabetes and heart disease through products including home glucose monitors and interactive weight scale systems. The integrated solutions are aimed at reporting real-time patient data and proactive patient intervention programs to payers and healthcare providers based on accepted guidelines and evidenced-based protocols, which can result in better outcomes at a lower cost.
According to the medical device giant, the purchase bolsters its expansion of medical device product offerings to broader healthcare services and solutions. The first area of focus for Medtronic will be in heart failure, where the addition of the Cardiocom technology and patient services to its product offerings will expand its reach to more patients across the heart failure care continuum, according to the company.
“With broad healthcare reform initiatives focused on growing economic challenges, healthcare systems in every region of the world are striving to continuously improve outcomes, increase access, save cost, and improve the efficiency of healthcare delivery. The acquisition of Cardiocom is one step we are taking toward providing a combination of products and solutions that can help address those challenges,” said Omar Ishrak, chairman and CEO of Medtronic. “With our first integration of this technology focused on heart failure, we will have the unique opportunity to combine our diagnostics, therapies and patient management solutions. This combination will strengthen our ability to partner with providers and payers to help them reduce cost and improve quality.”
Daniel L. Cosentino, former CEO of Cardiocom, will become vice president and general manager of Cardiocom at Medtronic.
Centers for Disease Control and Prevention data states that seven out of 10 deaths in the United States are from chronic disease, with heart disease, stroke, cancer, diabetes and arthritis as the top five chronic diseases. Chronic diseases account for $3 of every $4 spent on healthcare or nearly $7,900 per every American.
To rein in the costs of chronic disease, hospitals and physicians are moving to initiate or improve value-based delivery models aimed at better managing and coordinating the care of high-cost, chronic disease patients. Hospitals are looking for more cost-effective care with the use of real-time patient data, earlier and more accurate interventions, and increased patient ownership and management of their disease. For example, one study of patients at the Veterans Health Administration showed the use of teleheath technology resulted in a 25 percent reduction in bed days of care and 20 percent reduction in number of admissions in heart failure.
As a result of new hospital re-admission penalties and a healthcare system trying to shift from fee-for-service to fee-for-value, the market for remote monitoring technologies is expected to grow significantly over the next few years. According to a report earlier this year from GBI Research, the U.S. market is expected to expand 184 percent, from $104.5 million in 2012 to $296.5 million by 2019.
In March 2009, Cristina Ramirez, M.D., went under the surgeon’s knife for a lumbar fusion procedure to alleviate back pain. Her surgeon used Infuse, a bio-engineered bone graft substitute made by Minneapolis, Minn.-based Medtronic Inc. Following her surgery, she began experiencing severe and ongoing pain. She had developed uncontrolled bone growth, causing nerve impingement, in the area where her surgeon implanted Infuse.
Though the U.S. Food and Drug Administration (FDA) approved Infuse in 2002, the device was not approved for use for posterior lumbar interbody fusion. It was only approved for an anterior approach. The FDA was concerned about potential adverse effects, such as abnormal bone growth of the kind that Ramirez experienced. However, thousands of U.S. patients nationwide have been implanted with Infuse during procedures involving off-label use, including posterior lumbar interbody fusion. Off-label use of Infuse by physicians constituted nearly 90 percent of the $800 million in revenue that Infuse generated for Medtronic in 2011.
Ramirez sued Medtronic. The complaint charged that Medtronic failed to warn the FDA of severe side effects associated with use of its spinal fusion product Infuse when used for surgeries other than that originally presented to the FDA. The complaint further alleged that Medtronic aggressively promoted off-label uses of its device using journal articles, advertising media, sales representatives and consultants and paid leading physicians to urge the purchase and use of Infuse. Off-label promotion of prescription drugs and medical devices violates federal law.
The medical device giant fought back, attempting to get the lawsuit thrown out of court. However, on Aug. 21, U.S. District Court Judge G. Murray Snow of the District of Arizona denied in large part Medtronic’s motion to dismiss the personal injury lawsuit on grounds that the claims are preempted by federal law.
“We are gratified that the court rejected Medtronic’s effort to close the doors to the courthouse on Dr. Ramirez and the many other patients that were implanted with the Infuse bone growth protein,” said Kent L. Klaudt, lawyer at the plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein LLP, which represents Ramirez. “The court’s carefully reasoned ruling reaffirms that manufacturers who violate federal safety laws cannot then evade state tort liability to injured patients.”
Medtronic asserted that the complaint should be dismissed because the Infuse device was approved by the FDA. As such, Medtronic argued, any claims against a medical device manufacturer under state law for fraud, negligence, design defect, and failure to warn of dangers were preempted because they conflict with the FDA’s approval of the design and label of the device.
The court created a bright-line rule distinguishing cases in which the manufacturer in question, although aware of the off-label use, complies with federal regulations applicable to the device from cases where the core of the claim is that the plaintiff was injured due to an off-label use tied to the manufacturer’s promotion of such uses. As the court explained, the rationale for the preemption of state law claims regarding an FDA-approved medical device “vanishes when the plaintiff brings a claim against a manufacturer that arises out of a use that has not be reviewed by the FDA but has been promoted by the manufacturer.”
“Any medical device manufacturer that misleadingly promotes its products for uses never approved by the FDA, and then fails to report to the FDA significant adverse events associated with those non-approved uses of the device, should be held accountable for severe injuries caused by the device,” added Klaudt. “That is basic fairness and creates a powerful incentive for manufacturers to properly design, test, and market their products.”
More Worries for Medtronic
An ongoing lawsuit is not the only obstacle Medtronic has faced this year. In July, a missing box of health records in Minnesota prompted company officials to warn more than 2,700 patients about a potential breach of privacy.
The medical device behemoth sent letters to patients in early July informing them of the situation and it arranged for patients to receive identity protection services, Medtronic spokeswoman Cindy Resman told the St. Paul Pioneer Press.
There have been no reports of any patient data misuse, Resman said in a prepared statement.
“These documents did not contain sensitive or intrusive information,” she said in the statement. “For a small portion of patients, however, it’s possible that additional information was in the box, including insurance company data, contact information and limited patient records.”
In early July, a box of training records went missing from a facility in Minnesota, Resman said. Most of the documents and records in the box dated back to 2008 and were connected with training in the use of insulin pumps or continuous glucose monitoring devices.
Medtronic believes the box only has been misplaced and remains on company facilities. However, there is “at least a possibility,” Resman said, that the box no longer is under Medtronic’s control.
Some patient records included Social Security numbers, but Resman believes that number to be a small percentage of the entire box. Medtronic contacted a total of 2,764 patients.
In addition to issuing letters to patients, Medtronic notified the federal government about the situation. Companies and other organizations are required to report breaches of unsecured protected health information that affect 500 or more individuals.
In 2011, Minneapolis-based Fairview Health Services notified about 1,200 patients about a potential privacy breach after a box of patient health and billing records went missing. At the time, Fairview information privacy director Lois Dahl said federal law dictates that patients must be notified of a security breach of health information within 60 days.
Other Medtronic News: Company Completes Cardiocom Acquisition
In happier news for Medtronic, On Aug. 12, the company closed the acquisition of Cardiocom, a privately held developer and provider of integrated telehealth and patient services for the management of chronic diseases, in an all-cash transaction of $200 million.
Founded in 1997 in Chanhassen, Minn., Cardiocom’s technology enables healthcare providers to remotely monitor patients with chronic conditions such as diabetes and heart disease through products including home glucose monitors and interactive weight scale systems. The integrated solutions are aimed at reporting real-time patient data and proactive patient intervention programs to payers and healthcare providers based on accepted guidelines and evidenced-based protocols, which can result in better outcomes at a lower cost.
According to the medical device giant, the purchase bolsters its expansion of medical device product offerings to broader healthcare services and solutions. The first area of focus for Medtronic will be in heart failure, where the addition of the Cardiocom technology and patient services to its product offerings will expand its reach to more patients across the heart failure care continuum, according to the company.
“With broad healthcare reform initiatives focused on growing economic challenges, healthcare systems in every region of the world are striving to continuously improve outcomes, increase access, save cost, and improve the efficiency of healthcare delivery. The acquisition of Cardiocom is one step we are taking toward providing a combination of products and solutions that can help address those challenges,” said Omar Ishrak, chairman and CEO of Medtronic. “With our first integration of this technology focused on heart failure, we will have the unique opportunity to combine our diagnostics, therapies and patient management solutions. This combination will strengthen our ability to partner with providers and payers to help them reduce cost and improve quality.”
Daniel L. Cosentino, former CEO of Cardiocom, will become vice president and general manager of Cardiocom at Medtronic.
Centers for Disease Control and Prevention data states that seven out of 10 deaths in the United States are from chronic disease, with heart disease, stroke, cancer, diabetes and arthritis as the top five chronic diseases. Chronic diseases account for $3 of every $4 spent on healthcare or nearly $7,900 per every American.
To rein in the costs of chronic disease, hospitals and physicians are moving to initiate or improve value-based delivery models aimed at better managing and coordinating the care of high-cost, chronic disease patients. Hospitals are looking for more cost-effective care with the use of real-time patient data, earlier and more accurate interventions, and increased patient ownership and management of their disease. For example, one study of patients at the Veterans Health Administration showed the use of teleheath technology resulted in a 25 percent reduction in bed days of care and 20 percent reduction in number of admissions in heart failure.
As a result of new hospital re-admission penalties and a healthcare system trying to shift from fee-for-service to fee-for-value, the market for remote monitoring technologies is expected to grow significantly over the next few years. According to a report earlier this year from GBI Research, the U.S. market is expected to expand 184 percent, from $104.5 million in 2012 to $296.5 million by 2019.