Bayer Diabetes Care has initiated a voluntary market recall of test strips—or sensors—that are used exclusively with the Contour TS Blood Glucose Meter.  In the course of its routine quality control monitoring processes the Bayer Diabetes Care identified a manufacturing issue with defective devices from specific lots.  The defect could result in blood glucose readings with a positive bias that is outside of their product specifications and test results may demonstrate results 5-17% higher.  This problem is with the strips only—and only with specific test strips used with the Contour TS Blood Glucose Meter—and is unrelated in any way to the Contour TS meter itself.  Also, the Contour TS test strip recall has no impact on the performance of strips used with other Bayer meters including the Ascensia Contour and Ascensia Breeze2 systems.

The affected Contour TS strips were produced during the initial manufacturing process on new manufacturing equipment designed for the new Contour TS strips.  The cause of the problem has been identified and corrective actions have already been implemented, including incorporating additional quality control measures to prevent recurrence.  “The quality of our products and the results our customers receive are very important to Bayer and, as such, we are notifying regulatory authorities, healthcare professionals and customers in the countries where Contour TS is marketed—France, Austria, Turkey, Korea, Mexico, and predominantly through mail order channels in the United States,” said Bayer in a prepared statement.

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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.

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A canned green bean recall has been issued amid botulism fears. New Era Canning Company in Michigan said Friday that it was voluntarily recalling 1,026 cans of green beans because they may be contaminated with bacteria that cause botulism, a life-threatening illness.  New Era Canning Company said it was recalling 171 cases of GFS (Gordon Food Service) Fancy Blue Lake Cut Green Beans with the lot code 19-H-7FL and UPC 939-0111-873.  Each case contained six cans in six-pound, five-ounce sizes.  The canned green beans were distributed to food service customers in Alabama, Arkansas, Georgia, Illinois, Indiana, Kentucky, Mississippi, Missouri, North Carolina, Tennessee, and Virginia and were sold through GFS Marketplace stores in Indiana, Kentucky, and Tennessee.  The potential contamination was discovered through testing by the Food and Drug Administration (FDA).

Clostridium botulinum can cause life-threatening illness or death; however, no illnesses have been reported to date.  Consumers should not eat the beans even if they do not look or smell spoiled.  “New Era Canning in conjunction with the U.S. Food and Drug Administration and the Michigan Department of Agriculture is thoroughly evaluating all processes and procedures to determine the cause of the problem,” the company said.

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A contaminated Sierra Pre-Filled Syringe made a leukemia patient seriously ill, and now she is suing the maker of the defective devices.  The 30-year-old Illinois woman reportedly spent 9 days in the hospital as a result of the bacterial infection she contracted from the Sierra Pre-Filled Heparin Syringe she used as part of her home treatment.  Late last week, the tainted Sierra Pre-Filled Syringes where pulled from the market after dozens of blood infections where traced to them.

Around 40 people have been sickened in Texas and Illinois by the tainted Sierra Pre-Filled Syringes, including 20 outpatients at Rush University Medical Center in Chicago; no deaths have been reported.  Of the 20 Rush outpatients who fell ill, 14 required hospitalization.  Doctors at Rush were able to trace the infections to heparin-filled Sierra Pre-Filled Syringes the patients used during home treatment for cancer and other ailments.  Heparin is a blood thinner and the syringes are used to clear out catheters and intravenous lines.  The infections were caused by bacterium called Serratia marcescens found in a single batch of the heparin-filled syringes made in North Carolina, by a company called Sierra Pre-Filled.  Serratia marcascens generally causes fever, chills and vomiting, but responds well to antibiotics.  However, in cancer patients, the blood infection can be much more serious because the immune systems of such patients are already compromised.  In such cases, infections caused by the bacteria could be life-threatening.

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Maine can no longer keep the prescription writing habits of the state’s doctors secret. A federal judge just ruled that a new Maine law making doctors’ prescription-writing habits confidential violates the Constitution. 

U.S. District Judge John Woodcock concluded that the law—which was scheduled to take effect January 1, 2008—would prohibit “the transfer of truthful commercial information” and “violate the free speech guarantee of the First Amendment.” The law had been challenged by IMS Health of Norwalk, CN, Wolters Kluwer Health of Conshohocken, PA, and Verispan of Yardley, PA, organizations which collect, analyze, and sell medical data to pharmaceutical companies, government agencies, and researchers. The companies said the law would prevent the health care community from monitoring the safety of drugs and make it difficult to track defective drugs. Backers of the measure say it is one of several laws passed by Maine legislators that aim to address high health care and prescription drug costs. In a decision issued Friday, Woodcock said he relied heavily on an April 30th ruling by U.S. District Judge Paul Barbadoro in New Hampshire that rejected a similar law in which Barbadoro cited unconstitutional free speech restrictions—the decision was appealed in the 1st U.S. Circuit Court of Appeals in Boston. A similar case is also pending in Vermont. The primary sponsor of Maine’s legislation, Democratic Representative Sharon Treat, said she was disappointed with the ruling and anticipates an appeal.

The suit originated in August in Maine and Vermont federal courts challenged laws making doctors’ prescription-writing habits confidential and asked the court to block the states from enforcing their laws, saying the statutes are unconstitutional and citing violations of the 1st Amendment by barring transfer of lawfully obtained information and the 14th Amendment by impeding interstate commerce. At that time, Maine Attorney General Steven Rowe said the suit was not a surprise, given the legal challenge in New Hampshire, adding, “We will vigorously defend the constitutionality of the law and oppose efforts to have its enforcement enjoined.

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Sierra Pre-Filled Heparin Syringes have been recalled by the Food & Drug Administration (FDA) after it was discovered that the medical devices were contaminated with dangerous bacteria.  The Centers for Disease Control and Prevention (CDC) is also investigating dozens of blood infections linked to the Sierra Pre-Filled Syringes contaminated with bacteria.  In announcing the Sierra Pre-Filled Syringe recall, the FDA said that an ongoing inspection of Sierra Pre-Filled showed that the firm is “not in compliance with the Quality System regulation and failed to have adequate controls to ensure necessary sterility of its pre-filled syringes”.

Around 40 people have been sickened in Texas and Illinois by the tainted Sierra Pre-Filled Syringes, including 20 outpatients at Rush University Medical Center in Chicago; no deaths have been reported.  Of the 20 Rush outpatients who fell ill, 14 required hospitalization.  Although all responded quickly to antibiotic treatment, one patient remains hospitalized as of Tuesday, said Dr. John Segreti, hospital epidemiologist.

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A New Haven pediatrician was reprimanded for medical malpractice, after “diagnosing” and “treating”  Lyme disease over the phone.  Dr. Charles Ray Jones was fined $10,000, and placed on two years probation by Connecticut state regulators this week.  The Connecticut Medical Examining Board voted unanimously to impose sanctions when they confirmed that  the 77-year old New Haven doctor violated care standards by diagnosing Lyme disease in two children and prescribing antibiotics based on a phone conversation with their mother, months before examined them.  The board found Jones broke standards by failing to reconsider his diagnoses of the children when lab tests results were negative for the tick-borne disease and that Jones was wrong to prescribe antibiotics for nearly a year without repeat exams and with no arrangements with another doctor—the patients live out of state, in Nevada—to monitor side effects and results of long-term antibiotic therapy.

Jones’s lawyer, Elliott Pollack, said he will appeal the board’s decision adding, “This board has made a very serious error without sufficient evidence and contrary to compelling evidence,” saying the board’s ruling was “a classic example of government treading where it’s not ready to tread.”  Pollack compared Jones to other “nonconformists” ostracized by the medical community before having their innovations validated.  Jones, who says he has treated over 10,000 children with Lyme disease, insists long-term antibiotics are the best remedy and believes doctors fail to diagnose Lyme disease because patients don’t have what the medical establishment says are the telltale symptoms:  Rash and achy joints.  Jones says under 10% of Lyme patients have the rash when seen by a doctor.

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Whooping cough—or pertussis, a bacterial respiratory infection—considered a disease of a bygone era is making a comeback.  Outbreaks of whooping cough in four states of the sometimes-fatal disorder, despite mandatory vaccinations for children of school age, public health officials said Wednesday. 

Whooping cough is a highly infectious condition marked by an unstoppable urge to cough.  “Just as we have been reminded that tuberculosis is still with us, we are seeing the reemergence of pertussis, a bacterial respiratory infection,” said Dr. Len Horovitz, a pulmonary specialist at Lenox Hill Hospital in Manhattan. “Children who have not been adequately vaccinated with the standard DPT vaccine are at risk, as are adults whose immunity to the bacterium may have faded over decades.”

Although the number of cases this year is lower than in 2006, most occurred within the past several weeks with outbreaks in Pennsylvania, South Carolina, Wisconsin, and Ohio; a Colorado baby died last month after coughing to death.  Cases this year have been at their lowest nationwide since 2000, at only 8,051; however, doctors do not believe pertussis has been completely removed.  There were only 1,010 cases nationwide in 1976 that range is now seen yearly in New York state alone. 

Although New York is not among states experiencing an outbreak, the number of pertussis cases in recent years has ranged from a low of 450 in 2002 to a high of 1,969 in 2005.  There were 1,091 confirmed cases last year—the most recent year for complete statistics—said Jeffrey Hammond, spokesman for the New York State Health Department. 

Nationally, the number of cases so far this decade has been as high as 25,800, according to statistics from the Centers for Disease Control and Prevention (CDC).  “It has made a comeback, but the recognition of the disease is better and our ability to diagnose and treat it is also better,” said Dr. Thomas Clark, a CDC medical epidemiologist. 

He said the pertussis bacterium produces a toxin, which accelerates the formation of thick mucus in the lungs that, in turn, causes an uncontrollable urge to cough.  “The incidence of pertussis waxes and wanes in cycles, mostly on the order of three to four-year cycles,” Clark said.

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The rejection of Provenge by the Food & Drug Administration (FDA) has some in Congress crying foul.  Shares of the Dendreon Corporation jumped sharply Thursday after lawmakers called for hearings to investigate the rejection of the company’s experimental prostate cancer drug, Provenge.  Dendreon rose from $1.34, to $6.98 and the stock almost tripled after a panel of advisers recommended that the FDA approve the treatment; the agency rejected Provenge in May.  While the FDA pointed to concerns about its potential side-effects and effectiveness, two Congressmen are concerned that one FDA advisor’s connections to competing pharmaceutical company could have doomed its approval.

Representatives Dan Burton, Michael H. Michaud, and Tim Ryan said they wanted an inquiry into potential conflicts of interest for two members of the advisory panel who had argued against approval of Provenge.  “There is reason to believe that serious ethics rules were violated” by the two advisers, the lawmakers wrote in a letter.   Dendreon won a 13-to-4 vote in favor of Provenge at the meeting of cancer advisers to the FDA in March.  While the agency usually follows the advice of its panels, it said on May 9 that Dendreon would have to produce results from another study to win approval.  Dendreon lost almost $1 billion in market value.

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Phosphates, toxic substances used in a great number of household products, are causing untold environmental damage.  The Canadian federal government is considering banning phosphates in a wide variety of household and industrial products.  Environment Canada plans to hire experts to analyze the socioeconomic and environmental impacts of proposed new restrictions on phosphates and the government has set aside nearly $68,000 for the study.  Consultants will examine possible control scenarios, including a total ban on phosphorus in detergents and cleaning products and will issue a report by next May.  Manitoba and Quebec have announced plans to limit phosphate concentrations in dishwasher detergents to 0.5 per cent by 2010 and have called on Ottawa to do the same.

“When someone puts soap in their dishwasher in Edmonton, that makes its way into Lake Winnipeg,” Manitoba Water Stewardship Minister Christine Melnick said Monday.  “We really need the sort of inter-jurisdictional co-operation that a national strategy would bring about.”  Ms. Melnick welcomed news of the federal study, saying federal Environment Minister John Baird, who was unavailable to comment Monday, has been non-committal on the issue.

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