Yourlawyer.com (Medtronic Pacemakers News)

Medtronic Cardiac Rhythm Disease Management Site Gets FDA Warning Letter

Thu, 19 Nov 2009 00:00:00 -0800

Device maker giant, 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

Wed, 23 Sep 2009 00:00:00 -0700

Senator Charles Grassley (R-Iowa) has expanded his investigation of Dr. David Polly. As we've reported previously, the relationship between Dr. Polly, head of spine surgery at the University of Minnesota, and 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

Fri, 11 Sep 2009 00:00:00 -0700

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.

Lawsuits Allege Medtronic, Other Firms Illegally Marketed Surgical Ablation Products

Thu, 16 Jul 2009 00:00:00 -0700

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.

Medtronic Warned on SynchroMed Drug Pumps, MiniMed Insulin Pump Manufacturing

Thu, 25 Jun 2009 00:00:00 -0700

Medtronic Inc. has received a warning letter regarding its 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 Issues Class I Recall for Some Pacemakers

Thu, 11 Jun 2009 00:00:00 -0700

Medtronic Inc. is issuing a Class I recall for certain Medtronic Kappa and Sigma pacemakers because of wiring issues that may cause the devices to fail. A Class I recall is the Food & Drug Administration's (FDA) most serious recall action, and is issued when there is a reasonable probability that the use of the device will cause serious adverse health consequences or death.

The Medtronic pacemakers involved in this recall include:

Kappa Series 600/700/900
Sigma Series 100/200/300

According to the FDA, the recall affects around 21,000 of the more than 1.7 million Kappa or Sigma pacemakers implanted in patients worldwide. Most of the devices affected by the recall have been implanted in patients five years or longer.

On May 18, 2009, Medtronic Inc. issued a letter to physicians, alerting them to the problem. The company followed up with a patient letter on May 27, 2009. At that time, the company warned that the devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery. In the May 18 letter to doctors, Medtronic said it had received reports of two patient deaths where it is possible, but unclear whether a wire separation issue may have been a factor.

Patients with malfunctioning pacemakers may experience a return of symptoms associated with abnormal heart rate, such as fainting or lightheadedness. In rare cases, pacemaker-dependent patients may experience serious injury or even death.

The FDA is recommending that patients with the cited models of Kappa and Sigma pacemakers should determine if their pacemaker is part of this recall by contacting Medtronic at 1-800-505-4636 or going to the firm's Web site. Patients who have these recalled pacemakers and those who are unsure if their pacemakers are affected should follow up with their primary care physician or cardiologist.

Medtronic Announces Job Cuts, Restructuring

Wed, 07 May 2008 00:00:00 -0700

Still struggling in the wake of last year's Sprint Fidelis Defibrillator Lead recall, medical device maker Medtronic Inc. says it plans to cut 1,100 jobs worldwide as part of a restructuring plan. Medtronic's business has been hurt, not just by the Sprint Fidelis recall, but by the declining worldwide demand for implantable defibrillators, which has been shrinking since Medtronic and competitors recalled faulty products in 2005.

Medtronic suspended sales of the Sprint Fidelis Leads in October 2007 after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis Leads are being told to leave the defective components in place unless they fracture.

Last November, Medtronic said the Sprint Fidelis recall hurt revenue in its Cardiac Rhythm Disease Management unit by $130 million, and it also absorbed $31 million in costs to write off the Sprint Fidelis leads recalled during the quarter in which the recall occurred. Medtronic's revenue grew 12 percent in its most recent quarter, though revenue in the cardiac rhythm disease management unit rose just 3 percent.

According to Reuters, as part of the restructuring effort, Medtronic will move its endovascular manufacturing operations to Galway, Ireland, from Santa Rosa, California. The endovascular division makes stent grafts to treat aortic abdominal aneurysms. It also intends to relocate the diagnostic and monitoring portion of its cardiac rhythm disease management business to Minneapolis from the Netherlands.

This is not the first time Medtronic has been forced to make job cuts. Last year, the company eliminated a total of 900 jobs in its cardiac rhythm management, cardiovascular, and Physio-Control external defibrillator businesses.

Medtronic faces many lawsuits over the defective Sprint Fidelis Lead, as well as some of its other defective medical devices. Last December, the company agreed to pay out $114 million to settle product liability lawsuits filed as the result of injuries cased by its malfunctioning Marquis line of implanted cardiac defibrillators.

Late last month, Medtronic announced it had reached an agreement with Food and Drug Administration (FDA) over quality system improvements for its external defibrillators. The agreement addressed concerns raised by the FDA during inspections and outlined actions Medtronic’s Physio-Control subsidiary must take to resume unrestricted distribution of the portable electronic devices. Physio-Control stopped U.S. shipments in January 2007 due to quality problems.

Medtronic Unit Agrees to Consent Decree

Mon, 28 Apr 2008 00:00:00 -0700

An agreement has been reached by a unit of Medtronic Inc. on a consent decree with the U.S. Food and Drug Administration (FDA) over quality system improvements for its external defibrillators. The agreement—which is subject to court approval—addresses concerns raised by the FDA during inspections and outlines actions Medtronic's Physio-Control subsidiary must take to resume unrestricted distribution of the portable electronic devices. Physio-control is a maker of external defibrillators,

Automated external defibrillators, or AEDs, are becoming more and more available in office buildings, schools, and other public venues for use by bystanders to help a person suffering from sudden cardiac arrest. Physio-Control stopped U.S. shipments in January 2007 due to quality problems. Medtronic said shipments to meet critical customer requirements and certain specified public health needs will continue; however, in September, Medtronic announced plans to eliminate about 200 jobs in the Physio-Control unit. The consent decree agreement requires court approval.

Meanwhile, last October, Medtronic announced it was suspending sales of the Sprint Fidelis lead, a vital component in its implantable defibrillators.   According to Medtronic, the Sprint Fidelis lead, a wire that connects the Medtronic defibrillator to the heart, could fracture inside a patient’s blood vessel, delivering a massive electrical jolt.   This malfunction can cause extreme pain, or—in the worse case scenario—death.   At least five deaths were linked to a malfunctioning Sprint Fidelis lead used with an implantable Medtronic defibrillator.

The Sprint Fidelis lead has been used in implantable Medtronic defibrillators since 2004; most patients who received the devices since then have the faulty leads.   Sprint Fidelis leads were used only in cardiac defibrillators—or complex devices with defibrillation capacity—not conventional pacemakers. Some patients with congestive heart failure use devices that included this defibrillation ability, and those were among the machines that use the Sprint Fidelis lead.

A company review of 30 months of data indicated the defibrillator lead had a continuing fracture problem.   According to the company’s own estimates, approximately 2.3%, or 4,000 to 5,000 people with a Sprint Fidelis lead will experience fracture within 30 months of Medtronic defibrillator implantation.   Patients whose Sprint Fidelis lead fractures will require a dangerous surgical procedure to replace the wire.

Implantable defibrillators are meant to keep the heart beating regularly and to shock the heart back to its proper rhythm in the event the heart stops. A defibrillator lead is a thin wire attached to the heart wall that delivers an electrical impulse. When a defibrillator wire detaches or breaks, the device will fail, leaving a patient at risk for death because the device does not sense the need for a shock, is unable to deliver the shock, or delivers an unnecessary shock. Lead fracture can cause the device to beep, alerting the patient to seek immediate medical attention; however, the fracture can also cause a massive electrical shock resulting in extreme and sudden chest pain. Worse, the fracture can deplete the battery, rendering the defibrillator unable to deliver a necessary, life-saving shock to the heart. If the wire perforates the heart wall, the heart can bleed into its pericardial sac causing cardiac tamponade, a lethal condition where pressure builds around the heart preventing it from beating effectively. Unfortunately, heart perforation is generally discovered after the wire has made it through the heart wall.

Medtronic Pushes for Expansion of 'Sunshine Act'

Wed, 27 Feb 2008 00:00:00 -0800

Medical device maker Medtronic Inc. said on Tuesday that a proposed bill aimed at curbing inappropriate relationships between companies and physicians should require all device makers to be included, not just big ones. The proposed "Sunshine Act" was introduced earlier this year by Senators Chuck Grassley and Herb Kohl and would require companies to publicly disclose—via the Internet—certain payments made to physicians for help with product development, research, and training. Currently, the bill excludes companies with an annual revenue of less than $100 million as well as physician-owned companies, which Medtronic claims accounts for 75 percent of the companies in the medical device industry. Medtronic said "a level playing field for all companies is appropriate and that these entities should operate under the same disclosure requirements, recognizing that transparency can help alleviate any real or perceived conflicts of interest with these types of companies as well."

Recently, researchers from the University of California, San Francisco (UCSF) argued that medical devices are not subject to the same rigorous review process as pharmaceuticals and this must change. The team also found that once a device receives Food and Drug Administration (FDA) approval, an independent technology review could help identify which devices are beneficial. According to the team, this data would improve health professionals' awareness of "the potential promise and pitfalls of new technology.”

The analysis evaluated the federal review process, how devices come to market, how scientific literature reports on clinical trials involving medical devices, and the effectiveness of independent review boards in improving a technology's medical benefit. Out of thousands of medical technology applications submitted annually to the FDA, less than 100 undergo the scrutiny required for new drugs. Most new applications are approved through an expedited FDA process that considers new devices similar to those already approved. Also, the FDA relies on manufacturers and clinical investigators to initiate recalls and failure reports when a technology is not beneficial or is potentially harmful to patients.

The team suggested assessments by objective third parties as well as FDA approval to ensure deficiencies in clinical evidence and patient safety issues that may arise after approval are recognized earlier on. Independent review organizations provide transparent, objective evaluations, such as the California Technology Assessment Forum (CTAF) which conducts open, public meetings. Among others, their review board is comprised of experts in medicine, representatives from medical professional societies, technology manufacturers, policy makers, and insurance providers. The UCSF Division of General Internal Medicine currently subcontracts with CTAF to provide technology assessments. To be considered in an assessment, CTAF requires information be published or accepted by a peer-reviewed journal, encouraging companies to publicize their trial results. “CTAF also requires improvements in patient-oriented outcomes, not surrogate markers….we want to see improvements in disease-free survival and patient quality of life, not just a reduction in tumor size," said Tice, attending physician in the Division of General Internal Medicine at UCSF. The authors suggest independent review boards summarize their findings into uncomplicated take-home messages patients can easily locate.

Medtronic Defibrillator Lawsuit Settlements Take a Toll on Profits

Fri, 22 Feb 2008 00:00:00 -0800

Medtronic Inc.'s profits are off sharply, in part because of problems the company has had with its defective implantable defibrillators. Medtronic's third-quarter earnings plunged 89.0% from the prior year on charges from lawsuit settlements stemming from defective defibrillators and acquisition costs.

According to Forbes.com, overall sales at Medtronic jumped 12.0% to $3.4 billion, up from $3.1 billion in the third quarter of 2006, due to strong international sales. But because of lawsuit settlements and other charges, Medtronic's net income for the third quarter fell to of $77.0 million, or 7 cents per share, down from $710 million, or 61 cents per share, in the prior year.

The charges that hit Medtronic's bottom line included $275 million for the settlement of lawsuits stemming from its recalled Marquis line of implantable defibrillators, which treat rapid heart rhythms, and a stent patent infringement case by Cordis, a subsidiary of Johnson & Johnson. The Marquis settlement dates back to February 2005, when Medtronic warned of a potential battery shorting problem in various Marquis-brand defibrillators. According to the Wall Street Journal, 11,000 of the machines were surgically removed and replaced with a different device in the U.S. and 2,000 more such removals took place overseas. The Food & Drug Administration (FDA) classified Medtronic’s action as a Class II recall. In a Class II recall, there is either a possibility that the device will cause temporary or reversible health problems, or there is a remote chance that the device will cause serious health problems.

Plaintiffs in the suits against Medtronic argued that the company knew for years that there was a potential for product defects but sold its stock of potentially defective devices and didn’t advise patients that safer devices were available. The company had argued that it fulfilled every obligation in terms of reporting the problem, including seeking and receiving FDA approval in 2003 to implement battery design changes. But despite its claims that it acted properly, Medtronic settled thousands of defective Marquis Defibrillator lawsuits in December.

Medtronic has long been plagued by safety problems surrounding its ICDs and other devices. In April 2004 Medtronic announced that it was recalling its Micro Jewel II Model 7223Cx and the Medtronic GEM DR Model 7271 ICDs after they had been linked to at least four deaths and one injury. Medtronic said at the time that some of the recalled defibrillators failed to charge properly, resulting in the late delivery or no delivery of cardiac shock therapy. In January 2007 the FDA announced that the agency started an investigation looking into accusations by a former Medtronic engineer that the medical-device company didn’t sufficiently test its new Concerto cardiac device for patients with congestive heart failure. The Concerto device is one that can resynchronize the heartbeat of a patient and also provide backup defibrillator capability to save the patient’s life if the heart goes into cardiac arrest.

In October 2007, Medtronic announced that it was suspending sales of the Sprint Fidelis lead, a vital component in its implantable defibrillators. According to Medtronic, the Sprint Fidelis lead, a wire that connects the Medtronic defibrillator to the heart, could fracture inside a patient’s blood vessel, delivering a massive electrical jolt. This malfunction can cause extreme pain, or in the worse case scenario, it can be fatal. At least 5 deaths have already been linked to a malfunctioning Sprint Fidelis lead used with an implantable Medtronic defibrillator.

Medical Device Makers Get Lawsuit Protection from US Supreme Court

Thu, 21 Feb 2008 00:00:00 -0800

Medtronic Inc. and other medical device makers got a gift from the US Supreme Court yesterday, after it ruled that Food & Drug Administration (FDA) pre-market approval of a medical device shields companies from state product liability lawsuits. While the Supreme Court ruling will nullify some medical device product liability lawsuits currently making their way through state courts, it is unclear how great an affect it will really have, because most medical devices on the market today went through a different approval process than the one at issue in this case.

According to The New York Times, the Supreme Court's decision was one sought by the Bush Administration, which since 2004 has been trying to reverse longstanding federal policy that “premarket approval” of a new medical device by the FDA overrides most claims for damages under state law. In the case considered by the Supreme Court, Medtronic had argued that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require FDA approval of medical devices preempt product liability lawsuits in state courts. That law clearly says that states can’t maintain requirements that are different from federal standards. But Congress didn’t specify if those federal standards preempted state common law claims. Medtronic and the Bush Administration asserted that allowing state personal injury lawsuits against the makers of defective medical devices amounts to a state “requirement” different from FDA requirements because such complaints are based on state laws.

Eight members of the Supreme Court agreed. In his majority opinion, Justice Antonin Scalia wrote that permitting state juries to impose liability on the maker of an approved device “disrupts the federal scheme,” under which the FDA has the responsibility for evaluating the risks and benefits of a new device. Justice Scalia wrote that state tort law amounted to such an additional requirement. He said the 1976 law “speaks clearly to the point at issue,” regardless of the federal government’s previous or current positions.

The sole dissenter on the court, Justice Ruth Bader Ginsberg, clearly disagreed. In her dissent, the Justice wrote that court had misread Congress’s intent in adding the pre-emption clause to the law. All Congress intended when it wrote the law was to prevent individual states from imposing their own premarket approval process on new medical devices, Justice Ginsberg argued.

Several lawmakers quickly voiced their disapproval of the Supreme Court's decision and promised quick action to reverse it. “The Supreme Court’s decision strips consumers of the rights they’ve had for decades,” Rep. Henry Waxman (D-Calif) told The New York Times. “This isn’t what Congress intended, and we’ll pass legislation as quickly as possible to fix this nonsensical situation.”

It's not clear how many current state medical device lawsuits might be barred as a result of this ruling, but it does not ban all of them. According to The New York Times, most medical devices now available reached the market through a different process, under which the FDA. found them to be “substantially equivalent” to those marketed before the 1976 law took effect. The Supreme Court ruled in 1996 that this approval process does not pre-empt state damage suits against manufacturers. The decision also does not ban state lawsuits against medical devices that are not manufactured according to FDA specifications, and lawsuits can still be brought under state laws that mirror federal laws.

But the Bush Administration is still not finished with the pre-emption issue. According to The New York Times, next Monday, the Supreme Court will hear another FDA. pre-emption case, Warner-Lambert Co. v. Kent. The issue in that case is whether a state lawsuit can be based on the claim that a drug maker committed fraud by misrepresenting or withholding information from the FDA during the approval process. The Bush Administration has taken the side of drug makers in that case. The Administration is also arguing in Wyeth vs. Levine - a case the Supreme Court is taking up next term - that, in the case of FDA approved drugs, a shield exists against state product liability lawsuits even though the Food, Drug and Cosmetic Act of 1938 does not contain a pre-emption clause.

Medtronic Supreme Court Case Could Have Dire Consequences for Consumers Injured by Defective Medical Devices

Thu, 03 Jan 2008 00:00:00 -0800

Medtronic Inc., the maker of the defective Sprint Fidelis Defibrillator Lead, has asked the US Supreme Court to shield it and other medical devices makers from state product liability lawsuits. In Reigel vs. Medtronic, the medical device maker argued before the Supreme Court on December 4 that the mere fact that medical devices are approved by the Food & Drug Administration (FDA) preempts patients from bring lawsuits in state courts if they are injured by a defective device. If Medtronic somehow convinces the court to ban such lawsuits, consumers will lose an important protection against defective medical devices.

Medtronic vs. Reigel stems from a lawsuit filed by the family of a New York man who suffered severe medical complications when a Medtronic-made balloon catheter burst during a procedure to clear his arteries. The man’s family sued Medtronic, claiming his injuries were caused by the catheter’s negligent design, manufacture and labeling, despite the fact the device had won FDA approval. The case was thrown out by a US District Court judge and then by the US Court of Appeals.   The family is now appealing to the US Supreme Court.

Medtronic is arguing that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require FDA approval of medical devices preempt product liability lawsuits in state courts. That law clearly says that states can’t maintain requirements that are different from federal standards. But Congress didn’t specify that those federal standards preempted state common law claims. But Medtronic believes that the amendments do just that. Before the Supreme Court, the company argued that allowing state personal injury lawsuits against the makers of defective medical devices amounts to a state “requirement” different from FDA requirements because such complaints are based on state laws.

This is not the first time Medtronic has tried this argument. In a Florida court in 1993, Lora Lohr and her husband had sought damages for an allegedly faulty pacemaker lead manufactured by Medtronic. The company argued that the Medical Device Amendments preempted any damages claims because the device had been approved for marketing by the FDA. In Medtronic vs. Lohr, the Court held that none of the Lohrs' damages claims were preempted by the 1976 law.

In the Reigel lawsuit, Medtronic is trying the preemption argument again, but this time, the FDA is on its side.   During the Lohr lawsuit, the FDA sided with consumers and argued that the 1976 law did not disallow state lawsuits against FDA approved devices.   But now, the agency has reversed itself and is arguing Medtronic’s side. In fact, US Deputy Solicitor General Edwin Kneedler, on behalf of the Bush Administration, argued before the Supreme Court on December 4th in support of Medtronic’s position. The Bush Administration believes that the FDA approval process is adequate to protect consumers from dangerous medical devices. Unfortunately, past experience has not proven this to be true.

The past several years have proven that FDA cannot be trusted to keep consumers safe. In some case, the agency has approved drugs - like Vioxx and the Ortho Evra birth control patch – based on sloppy or falsified test data. In other cases, the FDA testing process completely missed defects. This is what happened with the Medtronic Sprint Fidelis Lead, where its high fracture rate did not become apparent until it had been implanted in tens of thousands of people. In many cases, it is only through litigation that it is discovered that medical manufactures withheld information about defective products from the FDA and the public.

The Supreme Court’s decision in Reigel vs. Medtronic will have serious implications for consumers. If Medtronic is successful, patients injured by defective medical devices will have no recourse in state courts to seek compensation for their injuries.   And manufacturers like Medtronic will not have to fear the financial consequences of unleashing dangerous medical devices on an unprotected public.

Medtronic Settles Defective Defibrillator Lawsuits for $114 Million

Wed, 26 Dec 2007 00:00:00 -0800

Medtronic Inc., the maker of the defective Sprint Fidelis Defibrillator Lead, announced last week that it had reached a settlement agreement regarding another of its faulty medical devices. The company has agreed to pay out $114 million to settle product liability lawsuits filed as the result of injuries cased by its malfunctioning Marquis line of implanted cardiac defibrillators. Despite the huge settlement agreement, Medtronic said it does not admit liability in the litigation.

Implantable cardioverter defibrillators, or ICDs, provide shocks to stop hearts from potentially dangerous rapid beating. They treat patients at risk for sudden cardiac death, which is the leading natural cause of death in the U.S. In February 2005, Medtronic warned of a potential battery shorting problem in various Marquis-brand defibrillators. According to the Wall Street Journal, 11,000 of the machines were surgically removed and replaced with a different device in the U.S. and 2,000 more such removals took place overseas. The Food & Drug Administration (FDA) classified Medtronic's action as a Class II recall. In a Class II recall, there is either a possibility that the device will cause temporary or reversible health problems, or there is a remote chance that the device will cause serious health problems.

Plaintiffs in the suits against Medtronic argued that the company knew for years that there was a potential for product defects but sold its stock of potentially defective devices and didn't advise patients that safer devices were available. The company has argued that it fulfilled every obligation in terms of reporting the problem, including seeking and receiving FDA approval in 2003 to implement battery design changes. Yet in spite its claims that it acted properly, Medtronic is now settling thousands of defective Marquis Defibrillator Lawsuits. The company will pay a total of $114 million, as it settles 2,682 cases for $95.6 million as well as $18.5 million in attorneys' fee.

Medtronic, the largest manufacturer of ICDs, has had other problems with many of its devices. In April 2004 Medtronic announced that it was recalling its Micro Jewel II Model 7223Cx and the Medtronic GEM DR Model 7271 ICDs after they had been linked to at least four deaths and one injury. Medtronic said at the time that some of the recalled defibrillators failed to charge properly, resulting in the late delivery or no delivery of cardiac shock therapy. In January 2007 the FDA announced that the agency started an investigation looking into accusations by a former Medtronic engineer that the medical-device company didn't sufficiently test its new Concerto cardiac device for patients with congestive heart failure. The Concerto device is one that can resynchronize the heartbeat of a patient and also provide backup defibrillator capability to save the patient's life if the heart goes into cardiac arrest.

In October 2007, Medtronic announced that it was suspending sales of the Sprint Fidelis lead, a vital component in its implantable defibrillators. According to Medtronic, the Sprint Fidelis lead, a wire that connects the Medtronic defibrillator to the heart, could fracture inside a patient’s blood vessel, delivering a massive electrical jolt. This malfunction can cause extreme pain, or in the worse case scenario, it can be fatal. At least 5 deaths have already been linked to a malfunctioning Sprint Fidelis lead used with an implantable Medtronic defibrillator.

Defective Medtronic Defibrillator Leads Cause Serious Injuries Even Death

Mon, 15 Oct 2007 00:00:00 -0700

Medtronic Inc. announced today that it was suspending sales of the Sprint Fidelis lead, a vital component of its implantable defibrillators. According to the company, the lead can fracture, causing serious and sometimes fatal injuries in patients.   At least five deaths have been linked to the defective Sprint Fidelis lead.

The Sprint Fidelis lead is a wire that attaches a Medtronic implantable defibrillator to the heart.   The Sprint Fidelis lead has been used in implantable Medtronic defibrillators since 2004.   It is a component of cardiac defibrillators -- or complex devices with defibrillation capacity -- and not conventional pacemakers. Some patients with congestive heart failure use devices that included this defibrillation ability, and those were among the machines that use the Sprint Fidelis lead.

Medtronic decided to suspend sales of the Sprint Fidelis lead after its own data analysis revealed that the leads had a problem with fracturing. If a lead fractures, it can create a massive electrical shock that causes the patient extreme and sudden chest pain. In the worst case scenario, the fracture of a Sprint Fidelis lead can deplete the Medtronic defibrillator’s battery. If this happens, the Medtronic defibrillator can fail to deliver a necessary, life-saving shock to the heart. According to Medtronic’s own estimate, about 2.3%, or 4,000 to 5,000 people with a Sprint Fidelis lead will experience fracture within 30 months of having a defibrillator implanted.   Those patients whose Sprint Fidelis lead fractures will require a dangerous surgical procedure to have the wire replaced.

The Medtronic implantable defibrillator analysis is not the first time that the Sprint Fidelis lead has caused concerns. Earlier this year, another study published by the Minneapolis Heart Institute found that a significant number of patients with the component had experienced painful shocks when the defibrillator fired unnecessarily. Medtronic was made aware of the Minneapolis study’s findings, but did not believe that there was enough evidence to reach any conclusions about the performance of the Sprint Fidelis lead. However, in March, the company did send doctors a letter outlining concerns with the defibrillators.

In addition to suspending sales of the Sprint Fidelis lead, Medtronic is also recalling all unused leads on the market.   But for patients with the defective Sprint Fidelis lead, the solution is not so simple.   Removing and replacing a lead is extremely risky, and can cause fatal complications. For that reason, Medtronic is urging physicians to reprogram the defibrillators to minimize the problem. Medtronic said the new programming would allow the implantable defibrillators to better monitor and warn of problems with the Sprint Fidelis leads. Medtronic said that it will pay to replace fractured Sprint Fidelis leads, and it will cover up to $800 in medical expenses not covered by a patient's insurance. However, Medtronic will not pay to replace Sprint Fidelis leads that are functioning properly.

This is not the first time problems have arisen with Medtronic implantable defibrillators. In 2004, the company recalled two models of its implantable defibrillators because they had a problem charging.   Those defective Medtronic implantable defibrillators have been tied to at least four deaths.

Medtronic Issued FDA Warning Letter over Marketing of Satellite Spinal System

Wed, 10 Oct 2007 00:00:00 -0700

Medtronic Inc. is in trouble for marketing its Satellite Spinal System for an unapproved use. On October 1, the Food & Drug Administration sent the company a letter that warned that an instruction manual for the medical device suggests using the Satellite Spinal System in ways that represent a “major” change from approved uses.

The Satellite Spinal System consists of spheres that can be inserted between spinal vertebras.   The system is intended to stabilize and hold together parts of spinal vertebrae while they heal.   This is accomplished by fusing the device to a bone graft.   But according to the FDA warning letter, Medtronic’s manual describes a nonfusion procedure without implantation of a bone graft. The FDA letter says that using the device in this way could “significantly affect its safety or effectiveness.” The FDA warning letter also cited other violations, including faulty and confusing instructions for the implantation of the Satellite Spinal System.

The Satellite Spinal System was approved for use this year and has been has been used in less than 1,000 surgeries. Only about 100 of the manuals cited by the FDA letter have been sent out, according to Medtronic.   A spokesperson for Medtronic told Reuters that it is trying to figure out how the manual ended up with faulty information.   The company said it would withdraw the manual.

The same FDA warning letter also faults Medtronic for announcing the availability of another spinal device in the US prior to its approval.   In a press release dated September 27, 2006, Medtronic said that the Arcuate Vertebral Augmentation System was available, even though it was not approved for marketing until March 2007.   The FDA letter also states that the press release made claims about the system for which the company did not obtain clearance.

The FDA has ordered Medtronic to stop distributing the manuals for the Satellite Spinal System, and the company has 15 days to respond in writing to the warning letter. The FDA letter says that if Medtronic fails to correct the violations cited in the warning letter, the company could be subject to regulatory action, including seizure, injunction or civil penalties.

In July, the FDA issued a warning letter to Medtronic for not promptly reporting problems with some of its medical devices that may have caused serious injury or death. The July warning letter detailed problems at a Minnesota plant that makes drug infusion pumps and neurostimulation devices. Both products are often used to treat chronic pain and neurological disorders.   Medtronic has since said that the problems leading to that warning letter have been resolved.

Medtronic Pacemakers Defect Injury Lawyer

Wed, 10 Oct 2007 00:00:00 -0700

Medtronic Pacemakers

Medtronic Inc. announced they are advising physicians of a potential problem in a small number of its Sigma pacemakers in which wires may separate from a circuit. No deaths or injuries were reported, though some users suffered dizziness or fainting, according to the Fridley-based medical-devices maker. An estimated 28,000 pacemakers, including 6,650 in the U.S., are covered by the advisory, which Medtronic said could be classified by the U.S. Food and Drug Administration as a recall.

Medtronic said the defect took place when a solvent used to clean pacemaker wires degraded them over time, causing the wires to break from the circuitry in 19 devices. Pacemakers help spark the heart to achieve a steady, timely beat. The company estimates that 47 to 84 units, all made between November 2001 and August 2004, could be affected over the 10-year life of the units.

"The risk to patients is extremely low, but we are alerting physicians to the issue to ensure they are aware of the situation and can appropriately care for their patients," said Steve Mahle, president of Medtronic's cardiac rhythm management division.

Although the company doesn't recommend replacing the devices "prior to normal elective replacement,'' it added that this decision should be left up to the doctor based on each patients unique circumstances.

If you or a loved one suffered injuries from a Medtronic Pacemaker, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.