Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

This recall applies to devices bearing Catalog (REF) Number 145281-ENT, Lot Number MH136952. The affected products were manufactured only on December 17, 2009 and distributed only on December 22, 2009.

According to the recall notice, the recall has been issued because devices with the affected Lot Number may not have been sterilized.

On January 4, 2010, Gyrus ACMI called or visited their customers to inform them about a recall of this device. On January 27, 2010, the firm sent a follow-up letter to their customers and implanting surgeons with a description of the issue and instructions for the return of the affected product.

Patients should contact their physicians to discuss symptoms that may result from use of the affected products.

Gyrus ACMI may be contacted at 1-800-773-4301.

According to a Boston Scientific press release, the company is halting sales and retrieving field inventory of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) because it  did not get approval from federal regulators for changes to its manufacturing processes. The seven brands affected are:  COGNIS®, CONFIENT™, LIVIAN™, PRIZM™, RENEWAL®, TELIGEN® and VITALITY™.  The Company's pacemakers and other products are not affected by the is action.

All of the devices in the recall were acquired by Boston Scientific in 2006 when it purchased medical device manufacturer Guidant Corp., of St. Paul, Minn., for $28.4 billion.

Boston Scientific informed the FDA on Sunday that it hadn't filed for approval and would withdraw its devices.   While Boston Scientific did not use the word "recall" in its press release, The Wall Street Journal said the FDA has characterized the action as such.

The recall is expected to take a heavy toll on the company's bottom line.  According to The Wall Street Journal, Boston Scientific will lose about $5 million in sales each day it can't sell the devices.

The AB5000 Circulatory Support System supplies power to disposable blood pumps used to support the left and/or right sides of the heart. According to the recall notice, the computer may shut down (stop pumping) without an alarm. This defect may cause serious injuries or death.

At the start of the recall, the company phoned their customers and followed up with a letter dated January 27, 2010. According to the recall notice, Abiomed sales representatives delivered the letter at the time the product repairs were carried out.

The Catalog Number affected by this recall is 0015-0000. The recalled devices bear Serial Numbers AD5001 through AD5496, except AD5006 and AD5018. The devices were manufactured and distributed between May 2003 and December 2009.

Class 1 recalls is the Food & Drug Administration's the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Customers seeking additional information about this recall may contact the company at 1-800-554-8666.

In a letter dated March 6, DePuy warned doctors that recently analyzed data from Australia suggested that the ASR had a higher-than-expected failure rate when used in traditional hip replacement on certain types of patient. According to the letter, patients of small stature, a group that typically includes women and patients with weak bones, faced the highest risk.

The New York Times is reporting that since the beginning of 2008, the the Food and Drug Administration (FDA)  has received about 300 complaints on the ASR involving patients in the U.S who received it, the Times said. Most of those patients underwent an operation to have the device replaced soon after getting it.

This warning came months after DePuy announce it was phasing out the ASR for declining sales.

According to the Times, the warning from DePuy followed more than two years of reports that the device was failing in patients only a few years after implant, requiring costly and painful replacement operations.  DePuy had already said it would phase out ASR, supposedly for declining sales.

HomeChoice systems are intended for automatic control of dialysis solutions exchange in the treatment of adult and pediatric renal failure patients undergoing peritoneal dialysis. According to the recall notice, the action was taken because of reports of patients overfilling their abdominal cavities, a complication known as Increased Intraperitoneal Volume (IIPV). Over the last two years, Baxter has received serious injury reports and at least one patient death report associated with the use of HomeChoice and HomeChoice Pro peritoneal dialysis cyclers.

Baxter said it is still investigating the source of the problems and is working on changes to labeling and software to prevent patient errors.

Baxter has advised patients and caregivers to watch for the potential signs of IIPV. These include: difficulty breathing; vomiting or spitting up; a child complaining of a “funny feeling” in the abdomen; a child crying during therapy without other apparent reasons; difficulties feeding; feeling full, bloated, or overfilled after treatment; abdominal pain or discomfort; expanded or tense abdomen; localized swelling around the genital area (labia, scrotum) or groin region, belly button, the tunnel tract of the peritoneal dialysis catheter or the PD catheter exit site; leakage of fluid from the PD catheter exit site; and unexpected increase in blood pressure. If patients or caregivers notice any of these symptoms, they should stop the device, initiate manual drain, and contact their healthcare provider immediately.

According to Baxter, children and non-verbal patients may be at increased risk because of their smaller size and/or inability to communicate. Increased monitoring of these patients is recommended. Other vulnerable populations include critically ill patients and patients with pulmonary and hemodynamic instability.

Model numbers affected by this recall include: 5C4471, 5C4471R, 5C8310, 5C8310R, 5C4474, 5C4474R, R5C8320, R5C8320R, T5C4441, T5C4441R, T5C8300, T5C8300R, 5C4474D and 5C4474DR. The recall notice does not require the physical return of HomeChoice units and patients may continue using them. Baxter’s recall notice said it was important that clinicians review the prescription settings for devices to help reduce prescription errors and weigh the risks and benefits of continued use of this device by their patients.

According to The Wall Street Journal, plaintiffs in the lawsuit are Enda Dodd, an engineer formerly in Medtronic’s vascular business in Santa Rosa, Calif., and Tricia Nowak, a former sales representative in the same division. According to The Wall Street Journal, they both claim to have been fired because they protested illegal marketing by Medtronic. Their lawsuit was filed in U.S. District Court in Boston and unsealed Friday.

The lawsuit accuses Medtronic of “unlawfully and unabashedly” marketing biliary stents for off-label uses. The lawsuit also alleges that the use of bile-duct stents in arteries has resulted in the need for additional surgery, perforated vessels, stroke, heart attack and death.

Biliary stents are approved by the Food and Drug Administration (FDA) to keep open bile ducts that have narrowed. According to a report published in The New York Times in January 2008, more than one million patients suffering from clogged arteries and veins in their torsos and legs received biliary stents that had not been approved or tested for this use. Even though they are not approved for this use, physicians can use FDA approved medical devices or drugs in any way they see fit – something known as off-label use.

In the case of the biliary stents, such off-label uses are estimated to account for as much as 90 percent of the market, the Times said. What’s more, between 2003 and 2006, nearly 88 percent of the 561 problems reported to the FDA involving biliary stents occurred in off-label uses. According to The Wall Street Journal, selling biliary stents for use in peripheral arteries has become a $900 million annual business.

According to The Wall Street Journal, the lawsuit appears to parallel a federal investigation by the Department of Justice in Boston into marketing of the biliary stents.

In December, Boston Scientific reported that the part connecting the defibrillator’s case to the leads to the heart had come loose on defibrillators implanted under the chest muscles of two patients. However, the company said in January that the problem had been fixed on defibrillators in production. Boston Scientific also said the problem was limited only to those patients who had a Cognis or Teligen defibrillator implanted under their chest muscles, rather than those who had it under the skin. About 5 percent of patients receiving the devices have had them implanted under chest muscles.

According to the HeartRhythm article, the design defect recently caused a Cognis defibrillator to deliver an unnecessary shock to the heart of an 84-year-old man who had the device implanted just under his skin. The authors said Boston Scientific has received two other reports of problems in patients who got the defibrillators implanted above their chest muscles, The Wall Street Journal said.

William Maisel, an authority on medical device safety and an assistant professor at Harvard Medical School, and Joseph Germano at Winthrop University Hospital in Mineola, N.Y. authored the article. According to The Wall Street Journal, Germano has been paid to speak on behalf of Boston Scientific and other device makers.

Boston Scientific did confirm those reports in a statement it issued Wednesday. However, according to The Wall Street Journal, the company said its own testing showed the problem didn’t cause the defibrillator to deliver inappropriate shocks. Boston Scientific also criticized HeartRhythm for publishing the article without a “detailed engineering analysis.”

The Becton Dickinson recall involved 2.8 million BD Q-Syte Luer Access Device, as well as 2.9 million BD Nexiva units containing 5 million BD Q-Syte devices that were distributed in the United States, Asia, Canada, Europe, Mexico, the Middle East, South Africa and South America. Becton Dickinson & Co. is investigating reports of one death and one serious injury that may be linked to the recalled devices. Product failures occurred on lots of BD Q-Syte and BD Nexiva units distributed from November 2008 through November 2009, Becton Dickinson said.

According to the Acacia Inc. recall notice, the following REF (catalog) and lot numbers, which were sold in the U.S., are included in its recall:

MPS Acacia IV Extension Set with BD Q-Syte REF:

385150, 385151, 385164, 385165, 385166

Lot Numbers:

A1950, A1951, A1967, A1979, A2055, A2056, A2099, A2100, A2101, A2104

The approximately 217,000 IV Extension Sets with BD Q-Syte that were recalled were distributed in the United States exclusively to Becton Dickinson for distribution worldwide, which includes the United States, Canada, Europe, Asia, Australia, and North and South American Countries.

This recall was initiated on Dec. 18, 2009 after Acacia received information from Becton Dickinson of complaints received due to air entry through the bottom disk of the Q-Syte septum. Acacia has not received any customer notification of product failures with the Acacia IV Extension Sets with BD Q-Syte.

Becton Dickinson investigated and determined the root cause to be a manufacturing deviation . The root cause has been corrected by Becton Dickenson and preventive measures, including additional inspections and preventive maintenance of the line, have been implemented, the recall notice said.

Acacia has notified the U.S. Food and Drug Administration and other worldwide health agencies, as necessary, and is working with them to coordinate recall activities. Clinicians or distributors with questions can contact Acacia at 1-800-486-6677 between 8:00 AM and 5:00 PM Pacific Standard Time, Monday-Friday, or dial directly at 714-257-0470.

The recall was initiated on Oct. 28, 2009 after the company received complaints of problems due to air entry through a part of the device. According to the recall notice, the devices could cause an air embolism or leakage of blood or IV therapy, which could lead to serious injury or death. Becton Dickinson is investigating reports of one death and one serious injury that may be linked to the problem.

The following REF (catalog) and lot numbers, which were sold in the U.S., are included in the recall:

BD Q-Syte REF: 385100, 385101, 385102, 385108, 385150, 385151, 385164

Lot Numbers: 8268863, 8269020, 8275798, 8305510, 8305511, 8308321, 8308323, 8308330, 8309553, 8331937, 8331940, 8331944, 8354558, 8354561, 9007921, 9009643, 9009646, 9028838, 9035029, 9035032, 9012072, 9007918, 9035042, 9035044, A1967, A1979, A2056, A1950, A2399, A1951

The following REF and lot numbers, which were sold outside of the U.S., are also included in the recall:

BD Q-Syte REF: 380510, 385100, 385101

Lot Numbers: 8310565, 8331938, 8331946, 9007907, 9008474, 9028892

The following REF (catalog) and lot numbers of BD Nexiva were sold in the U.S and internationally and are included in the recall:

BD Nexiva REF: 383530, 383531, 383532, 383533, 383534, 383536, 383537, 383538, 383539, 383540, 383647, 383649

Lot Numbers: 8238450, 8248349, 8248355, 8249034, 8249035, 8259950, 8263293, 8263294, 8269338, 8270576, 8270579, 8274555, 8274565, 8275207, 8275210, 8275429, 8283964, 8284049, 8284050, 8290311, 8291980, 8295761, 8296792, 8296793, 8305438, 8308349, 8309299, 309662, 8311150, 8311167, 8312211, 8312220, 8319016, 8319936, 8319961, 8322609, 8330279, 8331763, 8331771, 8338737, 8338738, 8340302, 8340308, 8345951, 8345957, 8347056, 8347058, 8358628, 9007360, 9013864, 9013867, 9013868, 9015539, 9016819, 9020033, 9022039, 9026722, 9034319, 9041552

According to the company’s recall notice, product failures occurred on lots of BD Q-Syte and BD Nexiva units distributed from November 2008 through November 2009. Becton Dickson said the root cause has been corrected and preventive measures, including additional inspections and preventive maintenance of the line, have been implemented.

The Beale shoulder pump trial was being closely followed by lawyers involved in similar suits, as it was viewed as a good gauge on how juries will rule in other pain pump injury cases. Many prominent surgeons testified at Beale’s trial that it was now generally accepted in the orthopedic community that pain pumps were the cause of the chondrolysis cases seen after surgeries like Beale’s.

Commonly called intra-articular pain pumps, device like the one made by I-Flow are used after surgeries to deliver local anesthetics to a specific area through a plastic tube. Such pain pumps became popular with orthopedic surgeons in the late 1990s because they were seen as an alternative to extended hospital stays and safer than prescribing narcotic painkillers. However, they were never actually approved by the Food & Drug Administration (FDA) for use in joint surgery.

Lawsuits have been filed around the country by people who claim they developed Post Arthroscopy Glenohumeral Chondrolysis (PAGCL), following the use pain pumps, such as the one manufactured by I-Flow, after shoulder surgery. PAGCL is a relatively rare condition in which joint cartilage in the shoulder dies. PAGCL can cause a lifetime of pain and disability. The condition has ended athletic careers, and in the most severe cases, victims have had to undergo joint replacement surgery.

In 2007, the American Journal of Sports Medicine showed a direct link between PAGCL and the use of pain pumps during shoulder surgery. Other studies have produced similar findings. In November 2009, the FDA issued a warning about the association between chondrolysis and pain pumps. At the time, the agency said it had reviewed 35 reports of the condition in patients given continuous intra-articular infusions of local anesthetics with pain pump devices. Almost all of the reported cases of chondrolysis (97%) occurred following shoulder surgeries, the FDA said. At the time the FDA issued the warning, it ordered manufacturers of local anesthetics and pumps to change labels to discourage doctors from such uses.

I-Flow, one of the largest manufacturers of pain pumps, submitted requests to receive FDA approval for the use of one of its pain pump for shoulder surgeries three times, but those were rejected. Despite the FDA’s stance, such devices were increasingly used off-label in joint surgeries.

According to The Wall Street Journal, Medtronic says its own research shows the Sprint Fidelis leads survive for three years at least 95.4% of the time, for a failure rate of 4.6%. But a report from the University of Rochester published in the January issue of the American Journal of Cardiology said the three-year survival rate of 426 Medtronic leads inserted in patients there was 90.8%, meaning 9.2% failed. A report from the Mayo Clinic published last February in the journal HeartRhythm said the estimated rate of failure among 848 leads implanted there after three years of use was 12.1%.

Another HeartRhythm study published in October 2008 by the University of Ottawa found the risk of a Sprint Fidelis facture “increased significantly with time.” In November, a separate Mayo Clinic study showed the failure rate for Sprint Fidelis leads after two years was 20.4% in patients younger than 50, while the rate in older patients was only 3.5%.

A lead is a wire that connects an implantable defibrillator to the heart. If a lead 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.

Medtronic Inc.’s Sprint Fidelis lead was removed from the market in October 2007, following reports of 5 deaths due to lead fractures. In March 2009, we reported that Medtronic sent a letter to doctors informing them that the faulty wires were a “possible or likely contributing factor” in as many as 13 deaths. Four of the deaths occurred when doctors tried to remove defective Sprint Fidelis leads from patients. Now, The Wall Street Journal is reporting that according to the Food & Drug Administration (FDA) database, 12 additional deaths allegedly linked to the Sprint Fidelis have been reported to the agency since last March.

Dozens of lawsuits have been filed  against I-Flow, Stryker, Sorenson by the victims of shoulder pain pump injuries. These lawsuits claim the manufactures of pain pumps knew they were dangerous when used in joint surgery, and that they ignored the finding from various studies. The manufacturers of pain pumps also stand accused of promoting unapproved uses of the products.

Earlier this month, an Oregon jury ordered I-Flow to pay $5.5 million to a Portland man and his wife after finding the company liable for damaged cartilage to the man’s right shoulder. The lawsuit alleged that I-Flow knowingly marketed its On-Q Painbuster to orthopedic surgeons even though the FDA rejected approving the device for that use. According to the Oregon lawsuit, despite three rejections from the Food & Drug Administration, I-Flow issued a press release on June 2, 1998, announcing that the agency had approved its pain pump for orthopedic use.

According to court documents, the plaintiff’s doctor had no idea that the I-Flow pain pump he used was not approved by the FDA , nor did he know the pump actually caused the permanent damage to his patient’s shoulder joint. The man’s doctor would later discover that nearly 49 patients he had treated with the I-Flow pain pump had similar complications after surgery.

PAGCL is a relatively rare condition in which joint cartilage in the shoulder dies following the use of I-Flow, Stryker, Sorenson and other brands of pain pumps. PAGCL can cause a lifetime of pain and disability, and in the most severe cases, victims have had to undergo joint replacement surgery.

Symptoms of PAGCL include:

• Shoulder Pain (in motion or at rest)
• Shoulder Stiffness
• Clicking/Popping Shoulder
• Grinding Shoulder
• Shoulder Weakness
• Inhibited Shoulder Motion

Commonly called intra-articular pain pumps, devices made by I-Flow, Stryker, Sorenson and are used after surgeries to deliver local anesthetics to a specific area through a plastic tube. Such pain pumps became popular with orthopedic surgeons in the late 1990s because they were seen as an alternative to extended hospital stays and safer than prescribing narcotic painkillers. However, they were never actually approved by the Food & Drug Administration (FDA) for use in joint surgery.

According to The New York Times, in 1998, one pain pump manufacturer, McKinley Medical, asked the FDA for permission to revise its labeling to indicate that the pumps could be inserted in joints. The agency refused because it said no previous devices had proved such a use to be safe. Despite the FDA’s stance, such devices were increasingly used off-label in joint surgeries.

When used in shoulder surgery, the intra-articular pain pump catheter is placed into the shoulder joint. The pump remains in the shoulder for several days to deliver controlled doses of pain medication. T. Unfortunately, use of pain pumps in this way carries serious risks. Exposing cartilage to the painkiller for such an extended amount of time has a toxic effect. In 2007, the American Journal of Sports Medicine showed a direct link between PAGCL and the use of pain pumps during shoulder surgery. Other studies have produced similar findings.

In November 2009, the FDA issued a warning about the association between chondrolysis and pain pumps. At the time, the agency said it had reviewed 35 reports of the condition in patients given continuous intra-articular infusions of local anesthetics with pain pump devices.

Almost all of the reported cases of chondrolysis (97%) occurred following shoulder surgeries, the FDA said. At the time the FDA issued the warning, it ordered manufacturers of local anesthetics and pumps to change labels to discourage doctors from such uses.

If you or someone you know were diagnosed with PAGCL following shoulder surgery, there is a good chance that a pain pump made by  I-Flow, Stryker, Sorenson or some other manufacturer is to blame.  To discuss your case with one of our experienced should pain pump injury lawyers, please fill out our online form, or call 1 800 LAW INFO (1-800-529-4636) today.

The recall involves the Edwards Lifesciences Inc. Aquarius Hemodialysis System in model numbers GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04. This product was manufactured from July 12, 2007 through March 18, 2009 and distributed from July 12, 2007 through March 18, 2009. Edwards Lifesciences, LLC is located at 1 Edwards Way; Irvine, California; 92614-5688.

A hemodialysis system is used to clean waste products and extra fluid from the body after the kidneys have failed. The system also monitors the fluid going into and out of the patient.

Edwards Lifesciences received reports of clinically significant fluid imbalance. When a certain level of fluid imbalance is detected, the Aquarius will trigger an alarm; however, users are able to override this alarm and continue therapy. By repeatedly overriding the balance alarm without solving the issue, such as a closed clamp or kinked line, it is possible to remove too much fluid from, or replace too much fluid to, the patient. In extreme cases, this defect could result in a decrease or increase in the volume of the circulating blood, which may result in serious injuries or death.

On January 11, 2010, the company sent its customers an Urgent Product Recall letter that included the description of the affected product, problem, and potential hazard; advice on action to be taken; revised device labeling; information concerning the planned software upgrade to prevent users from bypassing the fluid balance alarm more than five times in a 20-minute period; instruction to pass the notice on and inform all other employees within the company/organization who needed to be aware of the problem; and instruction to transfer the notice to other organizations on which this action had an impact and other organizations may have received the potentially affected devices through a transfer.

Baxter International, Inc. is the U.S. distributor of the Aquarius system and can be reached at the Baxter Clinical Help Line at 1-888-736-2543.

Class I recalls are the Food & Drug Administration's most serious type of recall, and involve situations in which there is a reasonable probability that use of a product will cause serious adverse health consequences or death.

The Trailblazer Support Catheters subject to this recall were manufactured from September 11, 2009 through September 29, 2009 and distributed from September 21, 2009 through October 27, 2009. A complete list of model and lot numbers included in this recall can be found here.

On November 6, 2009, ev3 Endovascular, Inc. sent a letter to their customers detailing the recall. All affected products have since been returned to the firm.The recall included about 350 devices.

Lead wires are placed into a major vein and attached to interior heart muscle for the purpose of monitoring heart rhythm and transmitting electric shocks should an irregularity occur. If a lead breaks, the implantable cardiac defibrillator (ICD) can emit a massive and painful shock. And, in the worse case scenario, the fractured lead can prevent an ICD from sending a necessary, lifesaving shock to the heart.

The Sprint Fidelis lead was removed from the market in October 2007 following reports of deaths due to lead fractures. Medtronic sent a letter to doctors informing them that the faulty wires were a “possible or likely contributing factor” in as many as 13 deaths. Four deaths occurred when doctors tried to remove defective Sprint Fidelis leads from patients. Although physicians did tell the device maker about the problems, Medtronic apparently disregarded the complaints and initiated a massive, $100 million ad campaign for its ICD products, according to a recently filed lawsuit. Medtronic claimed surgical technique, not faulty device leads, were to blame. Defective devices continued to be implanted until Medtronic finally issued a recall following what the plaintiffs described as ICDs failing at “an alarming rate” worldwide, according to the Madison Record previously.

Replacing a lead is dangerous and 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 were told to leave the defective components in place unless they fracture; a choice with which many patients are uncomfortable. According to a prior report in The New York Times, because of the risks involved, patients implanted with a Sprint Fidelis lead and their doctors often face difficult choices.

We recently wrote that three additional lawsuits were filed against Medtronic, Medtronic USA, Medtronic International Technology, and Medtronic Puerto Rico Operations by three patients in a 60-count suit. This may only be the tip of the iceberg for both Medtronic and the industry. Med City News says that the huge recall has cost Medronic in a variety of ways, including legal bills and a drop in sales. More is expected, not only for Medtronic, but the industry as a whole.

The UBS report referred to studies that say lead failures could reach an alarming 30 percent within four years, said Med City News, which added that Medtronic data states a three percent failure rate in three years. “’Fidelis may cast a long shadow’ over the $5 billion ICD market,” said the report, quoted Med City News. Of significant note, another study found that healthy patients are at greater risk of lead failure because of their expected longevity, said Med City News.

The report also stated that “Experience with Fidelis may support tougher regulatory process,” referring to U.S. Food and Drug Administration (FDA) approval for Class III devices via pre-market approval (PMA) supplements, quoted Med City News. Class III devices are considered the riskiest. Of concern is that a PMA supplement approval for a Class III device is considerably easier to obtain versus other Class III-type applications, which was a problem in the case of the Sprint Fidelis since improvements to the leads were touted as “minor changes” and enabled Medtronic to seek a PMA supplement (Sprint Fidelis was approved under a PMA supplement, not a new PMA) leaving experts at a loss to describe what qualifies as a minor change.

The claims arise from allegations that Spectranetics illegally imported unapproved medical devices and provided them to physicians for use in patients, conducted a clinical study in a manner that failed to comply with federal regulations, and promoted certain products for procedures for which the company had not received Food and Drug Administration (FDA) approval or clearance.

Spectranetics manufactures, distributes, and sells certain medical lasers and related peripheral devices, such as lead wires that guide the lasers through vascular tissue and catheters that carry and contain the lasers inside veins. These include, specifically, said the Colorado US Attorney’s Office: The CVX-300 Medical Laser and the CliRpath Turbo Laser Catheter, the TURBO Elite Laser Ablation Catheter, and the TURBO-Booster Laser Guide Catheter.

Spectranetics entered into a civil settlement agreement and a non-prosecution agreement with the U.S. and also entered into a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services.

According to the non-prosecution agreement, officers and employees who acted on behalf of the company engaged in multiple areas of wrongdoing, specifically, illegally importing unapproved medical devices from overseas manufacturers, distributing those devices for use in human patients, and failing to meet its reporting obligations to the U.S. Food and Drug Administration (FDA) regarding a study named “CORAL” (COronary graft Results after Atherectomy with Lasers) and another study in connection with these devices.

Under the terms of the non-prosecution agreement, Spectranetics accepted responsibility for its conduct, instituted remedial measures to prevent this conduct in the future, and will continue to cooperate in the ongoing criminal investigation. Because of this, Spectranetics will not be criminally prosecuted. Under the civil settlement agreement, the U.S. alleged that, as a result of its conduct, Spectranetics caused false Medicare claims to be submitted during times from 2003 to 2008. “It is important to hold those who submit false claims to Medicare responsible for their actions,” said U.S. Attorney David Gaouette.  “Settlements such as this help to protect the integrity of the Medicare system.”

“The Department of Justice will be vigilant in pursuing cases against medical device companies that break the law and defraud taxpayers,” said Tony West, Assistant Attorney General for the Justice Department’s Civil Division.

“Our compliance agreement with Spectranetics holds the company and its executives accountable for violations of Federal health care program and FDA requirements,” said Daniel R. Levinson, Inspector General of the Department of Health and Human Services. “Records from Spectranetics’ clinical investigations will be audited by an Independent Review Organization to ensure compliance with FDA rules—including reporting of adverse events.”

The Journal of the American Medical Association (JAMA) said many of these devices receive approval to release after jut one study, said the Journal, which noted that medications generally undergo a variety of tests. Although cardiac devices do receive the strictest of FDA review processes, the study published in JAMA points out that these processes are not as stringent as drug review standards, said the Journal. "The bar for evidence of benefit should be higher for devices because they are implanted and cannot simply be discontinued, as drugs can," the researchers said, quoted the Journal.

The other study, which appears in the American Journal of Therapeutics, had, as one of its authors, a medical reviewer from the agency’s cardiovascular device division, said the Journal. In that study, the researchers found that studies presented to obtain cardiovascular device approval "frequently lack important details," said the Journal, citing the paper. One such important detail was found to be who conducts research, added the Journal.

We recently wrote that even though medical device recalls have increased in recent years, the FDA has not devised an effective process for notifying the public about dangerous devices. According to an earlier Associated Press (AP) report, lack of such a process has put patients in danger. For instance, in 2008, 2,500 defective medical devices were recalled. More than 1,000 recall notices were sent out in the first seven months of 2009 involving medical devices, of those, 100 were deemed Class I, the FDA’s most serious recall, which is issued when there is a “reasonable probability of adverse health consequences or death.” Finding these recalled devices is no easy task, particularly after they have been implanted into someone’s body, such as in cardiovascular devices.

Acting FDA device division director Jeffrey Shuren admitted to cardiovascular clinical trial issues, reported the Journal.

Both studies involved researchers reviewing some 80 cardiovascular devices approved from 2000 through 2007 said the Journal. JAMA looked at University of California, San Francisco research that reviewed public FDA summaries of device safety and efficacy, said the Journal. William Maisel from Boston’s Beth Israel Deaconess Medical Center and who was a part of the study discussed in the American Journal of Therapeutics, said data unreliability was critical to “why we have been pushing the FDA to raise its clinical trial standards for medical devices," quoted the Journal.

We have written that many patients implanted with heart devices are not aware of recent recalls of the implantable devices and do not understand the dangers they might face. Recent recalls of implanted defibrillators have forced some patients to have them removed. In some, malfunctions led to additional cardiac procedures or complications and even death.

A defibrillator lead is a thin wire attached to the heart wall that delivers an electrical impulse via the defibrillator.  When the 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.  If the wire perforates the heart wall, the heart can bleed into its pericardial sac causing cardiac tamponade, a lethal condition in which pressure builds around the heart preventing it from beating effectively.  Unfortunately, heart perforation is generally discovered after the wire has made its way through the heart wall.

Last month, the Boston Scientific agreed to pay $296 million to settle another Justice Department probe into Guidant’s handling of heart devices.

According to a report in the Pioneer Press, this latest settlement involves allegations that Guidant designed four post-market studies in 2003 and 2004 as a means to increase device sales by paying doctors to use the company's pacemaker and defibrillators.  The U.S. Department of Justice had alleged  each physician who participated in the post-market studies was paid a fee of between $1,000 and $1,500 that was designed to induce the doctors to switch some of their business to Guidant.

Under the agreement, Boston Scientific will pay a $22 million penalty.  The company has also agreed to enter into a Corporate Integrity Agreement (CIA) with the Office of Inspector General for the U.S. Department of Health and Human Services. The CIA requires enhancements to certain compliance procedures related to financial arrangements with health care providers. It is limited to the firm’s cardiac rhythm management business, which became part of Boston Scientific through the Guidant acquisition.

Boston Scientific said in a statement that by agreeing to the settlement, it was not admitting wrongdoing.

“The FDA considers post-marketing reports of acute pancreatitis (fatal and non-fatal hemorrhagic or necrotizing pancreatitis), acute renal failure and thyroid neoplasms as ‘new safety information’ and is requiring Amylin to conduct additional studies,” the FDA letter said.

Thyroid neoplasms usually refer to cancer of the thyroid.

According to a  statement Amylin released yesterday, some of the studies required by the FDA have already begun.  The company maintained that so far, none have shown an increased risk of pancreatitis.  That did little to quell investor concerns however, and Amylin stock fell nearly 10 percent in trading yesterday.

Byetta was approved  in 2005 to help type 2 diabetics on other medications better control blood sugar when other drugs were not adequate.  Just this past October, Byetta was approved as a stand-alone therapy for type 2 diabetes.

 In August 2008, the FDA issued a health alert announcing that  six patients taking Byetta had died from pancreatitis.  When the FDA approved the expanded use of Byetta, it also announced that the drug's prescribing information would warn about the risk of pancreatitis in patients with severe kidney disease.  In November, the agency approved a new label for  Byetta amid reports the medicine may cause kidney problems.

According to Bloomberg.com, when Amylin announced the expanded Byetta approval, it made no mention of the additional studies.

As we’ve reported in the past, ghostwriting involves the act of a drug company producing a journal article aimed at either counteracting criticism of a drug or embellishing its benefits. Usually, a drug maker hires a professional writing company to draft the article, and recruits a physician to sign off as the author. Once the article has been published, drug sales reps often present copies of the piece to physicians as evidence that the drug covered in the article is safe and effective.

One example of such a ghostwriting program was the  so-called CASPPER program uncovered earlier this year by attorneys representing plaintiffs in Paxil lawsuits. According to an Associated Press report on the program, one memo instructed Glaxo salespeople to approach physicians and offer to help them write and publish articles about their positive experiences prescribing Paxil. 

Glaxo is far from the only drug company to use such a program.  A survey published just last September in the Journal of the American Medical Association found that 7.8 percent of 900 research articles, reviews, or editorials that appeared in six general medical journals in 2008 were written by un-credited ghostwriters. 

Institutions that receive NIH funding are supposed to keep track of the industry money their researchers receive.  However, recent investigations by Senator Charles Grassley, R-Iowa,  indicate that there have been violations or lax enforcement of those rules.   In October, the Senator asked NIH to explain how 14 NIH-funded university researchers  were able to receive payments from Merck & Co. "to promote its controversial anti-cholesterol drug Vytorin."

Last July, Grassley asked 23 medical schools  information about conflicts of interest policies and requirements for disclosure of financial relationships between faculty and the drug industry.  In a letter to the schools, Grassley outlined a number of disturbing conflicts on the part of researchers at NIH funded schools, including Emory, Stanford and Harvard universities.

The plan for the new ethics rules were announced earlier this week by NIH head Francis Collins during an interview with CSPAN's Newsmakers program.  During the interview, Collins said he was shocked at some of the conflicts Grassley had revealed.  

According to the class action lawsuit, Becky Coudert had a scan on Sept. 8 at Huntsville Hospital in Alabama. She said she soon lost her balance, had trouble with her memory and her hair fell out in a narrow band from ear to ear.  The complaint, filed in U.S. District Court in Alabama, claims the GE Healthcare CT scanner lacked safety features to warn of radiation overdoses.

The lawsuits seeks a minimum of $5 million to set up a fund to cover future healthcare costs and payments, specifically providing regular monitoring for brain cancer in all affected patients.

In October, the Food & Drug Administration (FDA) announced it was investigating CT scan overdoses. The FDA probe was launched after Cedars-Sinai Medical Center in Los Angeles confirmed that 206 patients mistakenly received eight times the regular dose of radiation during CT brain scans. Just last week, the FDA released interim results of its investigation. In addition to the cases at Cedars-Sinai, the agency identified at least 50 additional patients who were exposed to excess radiation of up to eight times the expected level during their CT brain scans.

To date, all of the radiation overdose cases involve more than one manufacturer of CT scanners. The FDA has not yet determined if the overdoses were the result of human error or some sort of equipment problem.

CT scans are extremely popular as a diagnostic tool.  According to the Journal, use of the scans has  tripled in the U.S. since the early 1990s to more than 70 million in 2007.   Though there have always been concerns regarding the cancer risks associated with radiation from CT scans, but it hasn't been clear how high those risks actually are.

Concerns over the safety of CT scans were heightened recently, when the Food & Drug Administration (FDA) announced in October that it was probing 206 radiation overdoses from CT brain scans reported at Cedars-Sinai Medical Center in Los Angeles.  Last week, the agency said it had found 50 more instances of such overdoses at several other hospitals.

The first study detailed by The Wall Street Journal found that radiation doses received in a single CT scan varied greatly among the hospitals, with some patients receiving only one-tenth the radiation that others got.  For this study, researchers looked at 1,000 adult patients at four hospitals.  They projected that the dose of radiation received in a single heart CT scan at age 40 would later result in cancer in 1 in 270 women and 1 in 600 men.  For those receiving a head CT scan, 1 in 8,100 women and 1 in 11,080 men would likely develop cancer from the radiation, the study said. 

The second study, which analyzed information from several databases, estimated that 29,000 future cancers could be related to CT scans received in 2007, The Wall Street Journal said.  The cancer risk was greatest for younger patients, and the study projected that the greatest number of cancers would occur the abdomen and pelvis.

• "On September 16, 2009, the Company received a subpoena from the Office of Inspector General for the Department of Health and Human Services in the District of California requesting production of documents relating to the Company’s cardiac rhythm medical devices, including revenue, sales, marketing and promotional documents, documents relating to reimbursement communications to customers pertaining to the devices, documents relating to scientific studies and registries pertaining to the devices, and documents relating to payments or items of value provided to customers. The Company will comply as required with the terms of the subpoena."

The FDA began investigating radiation overdoses from CT perfusion scans in October after patients at Cedars-Sinai Medical Center in Los Angeles began complaining of symptoms of radiation overdose.  Now, according to the AP, the FDA is investigating the use of CT scans at Glendale Adventist Medical Center and Providence St. Joseph Medical Center in Burbank, California.

Alicia Gonzalez, a spokeswoman for Glendale Adventist said the specialty scan that appears to be linked to the problem is no longer in use, said the AP. ''This procedure has been discontinued,'' she said in a statement, quoted the AP. St. Joseph Medical Center had no comment, said the AP.

In October we wrote that reported complaints numbered at 206, reports are now up to 260, according to the AP. Some reports have also been received from an unnamed Huntsville, Alabama hospital, said the AP.

These cases, to date, involve more than one manufacturer of CT scanners. Some of these patients reported hair loss or skin redness following their scans. High doses of radiation can cause cataracts and increase the risk of some forms of cancer.

On the basis of its investigation to date, the FDA is providing interim recommendations for imaging facilities, radiologists, and radiologic technologists to help prevent additional cases of excess exposure that include:

• Facilities assessing whether patients who underwent CT perfusion scans received excess radiation
• Facilities reviewing their radiation dosing protocols for all CT perfusion studies to ensure that the correct dosing is planned for each study
• Facilities implementing quality control procedures to ensure that dosing protocols are followed every time and the planned amount of radiation is administered.
• Radiologic technologists checking the CT scanner display panel before performing a study to make sure the amount of radiation to be delivered is at the appropriate level for the individual patient.
• Practitioners adjusting the radiation dose so it is appropriate for each study if more than one study is performed on a patient during one imaging session.

• Navigation System II-Cart, Stryker Catalog # 7700-100-000, Serial #s 100715-100735
• PC SPC-1 Assembly>, Stryker Catalog # 700-101-201; Lot # K7P00F6000
  

• Lot range: S28117 through S29174
• Catalog numbers: VPR-ISH 5 X 85, VPR-ISH 6 X 85, VPR-ISH 7 X 85, VPR-ISH 5 X 45, VPR-ISH 6 X 45, VPR-ISH 7 X 45

• Instruct the patient and/or caregiver about how to use the system, potential complications and their signs/symptoms, and what to do if complications occur.
• Request that the patient and/or caregiver demonstrate use of the system, and document his/her proficiency.
• Assure that the patient and/or caregiver understands the warnings associated with NPWT system use.
• Provide the patient with a written copy of the patient labeling from the NPWT system manufacturer, if available. Encourage the patient to keep these materials and instructions for use readily accessible.

The recall has been directed to anesthesiology healthcare professionals and hospital risk managers and both Centurion Medical Products and the FDA have notified healthcare professionals about the Class I recall that involves Premie Pack, Kit Code LM 110 and Full-Term Meconium Pack, Kit Code LM115. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

The pediatric tracheal tubes used in these kits, which were manufactured with an internal diameter smaller than indicated on the label, could result in an inability to remove secretions and cause partial or complete blockage of the airway and the inability to ventilate the patient. The recalled products were distributed from January 1, 2007 through September 22, 2009. 

A tracheal tube is inserted through the nose or mouth into a patient’s windpipe in order to ensure that the airway is not obstructed and that oxygen or anesthesia reaches the lungs. These tubes are used in both adults and pediatric patients, but not newborns or infants.
The FDA indicated that the following models and lots are involved in the recall:

Model/Product Code: These are the Portex uncuffed pediatric sized tracheal tubes which were subject to a prior Class I recall with Smiths Medical:
•    2.5 mm product code 100/105/025
•    3.0 mm product code 100/105/030
•    3.5 mm product code 100/105/035
•    2.5 mm product code 100/111/025
•    3.0 mm product code 100/111/030
•    3.5 mm product code 100/111/035
•    2.5 mm product code 100/126/025
•    3.0 mm product code 100/126/030
•    3.5 mm product code 100/126/035
•    2.5 mm product code 100/141/025
•    3.0 mm product code 100/141/030
•    3.5 mm product code 100/141/035.

Lot/Serial Numbers: These kits contain Portex uncuffed pediatric sized tracheal tubes which were subject to a prior Class I recall with Smiths Medical:
•    Premie Pack: 901087,903267,907307,910297,901218,908258,2009020990,2009022390
•    Full Term Meconium Pack: 01297,07097,09107,12037,06028,2008091501,2008120801,2009033001,2009062201

Centurion Medical Products of Howell, Michigan can be reached toll-free at 1-800-248-4058 (Eastern Time).

The complaints state that Lillian Tengstrand, Effie Thomas, and Marcus Williams received the implantable cardiac defibrillators (ICDs), which are surgically placed under the skin of the chest wall to decrease and increase heart rates, explained the Madison Record. Lead wires are placed into a major vein and attached to interior heart muscle. "Electrodes that sense the heart's rhythm are built into the lead wires and positioned in the heart, where they monitor the heartbeat and can transmit an electric shock to abort a dangerous 'overdrive pace,' a very rapid rhythm, or pace the heart at a normal rhythm if an irregularity is detected," the suit states, quoted the Madison Record.

If a lead breaks, the ICD can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent an ICD from sending a necessary, lifesaving shock to the heart. The Sprint Fidelis lead was removed from the market in October 2007 following reports of five deaths due to lead fractures. Medtronic sent a letter to doctors informing them that the faulty wires were a “possible or likely contributing factor” in as many as 13 deaths. Four deaths occurred when doctors tried to remove defective Sprint Fidelis leads from patients.

Replacing a lead is dangerous and 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 were told to leave the defective components in place unless they fracture. A choice with which many patients are uncomfortable. According to a report in The New York Times, because of the risks involved, patients implanted with a Sprint Fidelis lead and their doctors often face difficult choices.

"Any failure that compromises the ability of the lead to conduct electrical signals will result in a failure of the ICD to perform properly," the suit states. "Lead failures may include fractured wires, bending, insulation loss, loss of ability to capture changes in electrical characteristics in the ventricle chamber, abnormal lead impedance, sensing failure, and changes in tissue conductor interface," it added, quoted the Madison Record.

The plaintiffs were implanted with the Sprint Fidelis Lead Model Number 6949, allegedly defective due to “spot welding” to connect ICD cables to electrodes placed on the heart, say the three, reported the Madison Record. "The welding required to affix the Sprint Fidelis Lead cables can damage the fine, small wires in the cables," the complaint says. "The welding techniques used were inadequate and resulted in damage to the cables in many Sprint Fidelis Leads," reported the Madison Record, citing the complaint.

Although physicians did tell the device maker about the problems, Medtronic apparently disregarded the complaints and initiated a massive, $100 million ad campaign for its ICD products, said the plaintiffs. Medtronic claimed surgical technique, not faulty device leads, were to blame. Defective devices continued to be implanted until Medtronic finally issued a recall following what the plaintiffs described as ICDs failing at “an alarming rate” worldwide, according to the Madison Record.

•     Lot range: U0000025 through U0000059
•     Catalog numbers: 403545S, 403585S, 403645S, 403685S, 403745S, 403785S

28G 1/2cc, NDC 0603-6995-21
28G 1cc, NDC 0603-6996-21
29G 1/2cc NDC 0603-6997-21
29G 1cc, NDC 0603-6998-21
30G 1/2cc, NDC 0603-999-21
30G 1cc, NDC 0603-7000-21
31G 1/2cc, NDC 0603-7001-21
31G 1cc, NDC 0603-7002-21

All Accusure® Insulin Syringes regardless of lot number are subject to this recall. These syringes were distributed between January 2002 and October 2009 to wholesale and retail pharmacies nationwide (including Puerto Rico).

Consumers who have any Accusure® Insulin Syringes should stop using them and contact Qualitest at 1-800-444-4011 for reimbursement.  Qualitest is notifying all customers who received these syringes and arranging for the return of any affected product.

The  postmarket surveillance studies must address the following:

• the fusion rate for dynamic stabilization systems compared to traditional stabilization systems;
• the incidence rate, severity, and time course of adverse events for dynamic stabilization systems compared to traditional stabilization systems;
• the type, incidence rate, and time course of subsequent surgical procedures for dynamic stabilization systems compared to traditional stabilization systems; and
• the cause of failure for dynamic stabilization systems based on analysis of all reasonable available systems that have been removed from patients, along with any association between the patient’s demographic and clinical data and the device failure.

In reviewing the clinical data gathered from the postmarket surveillance studies, the FDA will consider whether labeling changes or additional preclinical and clinical testing requirements are necessary for these devices.
 

Critics of industry payments to doctors have long held that such relationships create conflicts-of-interest, and could unduly influence everything from research findings to prescribing practices.  According to The Wall Street Journal, several states, including Massachusetts and Vermont, have enacted laws requiring medical companies to disclose the payments they make to doctors.  On the federal level, the Physician Payment Sunshine Act would require similar disclosure.  The legislation is currently part of the health reform being considered in the U.S. Senate, the Journal said.

• Does the current 510(k) process optimally protect patients and promote innovation in support of public health?
• If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process?

• Create an internal task force on the use of science in regulatory decision-making
• Develop an effective compliance strategy
• Optimally integrate pre- and post-market information
• Increase transparency in decision-making
• Establish clear procedures to resolve differences of opinion
• Ensure the IOM will hold two public workshops during the next nine months as part of its review and publish a final report in March 2011 containing its conclusions and recommendations