Drug & Device News

Insurer Not Out of Body Part Theft Fiasco

A body-parts-for-cash scandal that sent three Philadelphia funeral directors to prison last year has sparked a wave of litigation in the state and federal courts, and a federal judge's recent ruling on insurance coverage promises to keep the cases alive. In a major setback for the insurer, Nationwide Mutual Insurance Co., U.S. District Judge Michael Baylson in Philadelphia rejected the argument that guilty pleas by the participants conclusively proved that all of the conduct was intentional and therefore could not be treated as negligent conduct that triggers insurance coverage.

Funeral home operators Louis and Gerald Garzone and their employee, James McCafferty Jr., have already confessed that they sold corpses to Biomedical Tissue Services, a New Jersey-based company that took bodies from funeral homes in New York, New Jersey and Pennsylvania. Among the corpses plundered was that of veteran BBC broadcaster and “Masterpiece Theatre” host Alistair Cooke. Judge Baylson determined that each of the of the lawsuits had to be individually screened to determine whether any of them contained negligence-based claims that would trigger coverage under the funeral home's policies.

Actor and Wife Want Case Heard in Drug Company's Backyard

Actor Dennis Quaid and his wife want their case against Baxter Healthcare Corp. heard in Illinois, the home of the drug company. An Illinois appellate court, however, upheld dismissal of the case because it agreed with the lower court that the proper venue for the action was California, the place where the plaintiffs' twins accidentally received an overdose of the blood thinner Heparin. These mix-ups had happened before, ostensibly because of confusing labeling of the differing strengths of the drug. The Quaids say that these previous similar incidents should have prompted the company to alter the labels in order to make it clearer which bottles contained the smaller doses appropriate for infants. They have asked Illinois' Supreme Court to review the dismissal. Baxter spokeswoman Erin Gardiner defended the dismissal on the basis that the overdosing occurred in California, where the plaintiffs and most of the defendants reside. The Quaids' attorney, Susan Loggans of Chicago's William Harte, disagrees: “If a plaintiff doesn't have the right to go to a defendant's home state and face what would normally be considered a hostile jury because the plaintiff knows what's best for its own case, then you'll be virtually blocking any innocent person from doing what is best for them and allowing the defendant to control where any case is filed.” Loggins pointed out that the case is not being brought as one for medical malpractice (the matter has already been settled with the hospital) and is instead concerned primarily with the workings of Baxter and how their decisions concerning labeling were made. Because its employees and former employees are primarily in Illinois, this is the proper forum, she feels.

No Rise in Autism Rates, According to UK's NHS

New evidence that the MMR (Measles, Mumps, Rubella) inoculation is not the cause of the apparent rise in autism in the developed world was recently made public by Britain's National Health Service (NHS). In September, the NHS conducted a survey of Britain's households to learn how many adults in the population could be classified as having an autism spectrum disorder. In testing the members of about 4,000 households, the researchers found that one person in 100 over the age of 18 had such a disorder ' about the same as the proportion of young children in the British population diagnosed with autism or asperger's syndrome. Because the current MMR shot became available only in the early 1990s, the study bolsters the position of those who refute any relationship between MMR inoculations and the apparent increase in autism, pointing instead to an oft-cited alternative reason for the supposed epidemic: greater understanding of the symptoms of autism that has lead to increased diagnosis. A pdf of the study's results can be accessed at: http://www.ic.nhs.uk/webfiles/publications/mental%20health/mental%20health%20surveys/Autism_Spectrum_Disorders_in_adults_living_in_households_throughout_England_Report_from_the_Adult_Psychiatric_Morbidity_Survey_2007.pdf.

Personalized Medical Treatment Method Held Patentable

In a closely watched case that is expected to aid the field of personalized medicine, the Federal U.S. Circuit Court of Appeals has ruled that a medical treatment method is patentable. The Sept. 16 opinion in Prometheus Laboratories Inc. v. Mayo Collaborative Services reversed a lower court's ruling invalidating Prometheus' patents that cover methods of adjusting the dosage of certain drugs, used to treat autoimmune diseases such as Crohn's disease, depending on a patient's particular metabolism. The district court had found that the correlations between the effectiveness and toxicity of the drug for a patient and the patient's metabolites were natural phenomena resulting from a natural body process.

Scrub Tech Who Tampered With Syringes Pleads Guilty

Former Colorado surgery scrub tech Kristen D. Parker pleaded guilty in September to charges of product tampering and other drug charges based on her theft of syringes containing the painkiller Fentanyl Citrate while she was performing her professional duties at Colorado's Rose Medical Center. During her guilty plea, Parker admitted to injecting herself with the drugs and then replacing the liquid in the syringes with saline solution, leaving the altered syringes for use on patients. Several of those patients blame Parker for the fact that, like her, they now have hepatitis C. Parker, who could have faced life in prison for her crimes, is to be sentenced to a 20-year term.

First Fosomax Case Ends in Mistrial

The first trial alleging jawbone deterioration from the use of the osteoporosis treatment drug Fosomax has ended in a mistrial. The jurors who heard the case in U.S. District Court in Manhattan deadlocked in September after a week of deliberation. At that point, they indicated that they could not come to a consensus on the issues of negligence and failure to warn. The plaintiff, Shirley Boles, is a retired Florida resident who claimed that her use of the drug over a period of several years caused her to develop jawbone necrosis, a painful and irreversible condition. More than 1,000 similar cases are still awaiting trial.

FDA Approves Donor Screening Test for Antibodies to HIV

The U.S. Food and Drug Administration (FDA) in September gave its approval to the Abbott Prism HIV O Plus assay, a screening tool designed to detect the presence of certain antibodies to HIV. It tests for antibodies to HIV type 1, groups M (the most common subgroup of the virus in the United States) and O, and HIV type 2. The assay is licensed to screen donated blood and blood specimens, as well as donor organs from both living and deceased donors. When positive results are obtained through this new screening tool, supplemental tests are required.

Vitamin's Health Claims Challenged

The Washington-based Center for Science in the Public Interest (CSPI), a nonprofit health advocacy group, is suing the German drug giant Bayer for allegedly making false claims concerning its Men's One A Day multivitamin. The group says that Bayer mislead consumers into believing that the selenium in the vitamin could reduce the risk of prostate cancer.

In a statement, Bayer said that it has “based a portion of the promotion for One A Day Men's Formula on the U.S. Food & Drug Administration's permitted qualified health claim that 'Selenium may reduce the risk of certain cancers.' ' The FDA changed its permitted qualified health claim earlier this year and Bayer is in the process of revising the packaging and promotional materials for its One-A-Day Men's and One-A-Day Men's 50+.”

Insurer Not Out of Body Part Theft Fiasco

A body-parts-for-cash scandal that sent three Philadelphia funeral directors to prison last year has sparked a wave of litigation in the state and federal courts, and a federal judge's recent ruling on insurance coverage promises to keep the cases alive. In a major setback for the insurer, Nationwide Mutual Insurance Co., U.S. District Judge Michael Baylson in Philadelphia rejected the argument that guilty pleas by the participants conclusively proved that all of the conduct was intentional and therefore could not be treated as negligent conduct that triggers insurance coverage.

Funeral home operators Louis and Gerald Garzone and their employee, James McCafferty Jr., have already confessed that they sold corpses to Biomedical Tissue Services, a New Jersey-based company that took bodies from funeral homes in New York, New Jersey and Pennsylvania. Among the corpses plundered was that of veteran BBC broadcaster and “Masterpiece Theatre” host Alistair Cooke. Judge Baylson determined that each of the of the lawsuits had to be individually screened to determine whether any of them contained negligence-based claims that would trigger coverage under the funeral home's policies.

Actor and Wife Want Case Heard in Drug Company's Backyard

Actor Dennis Quaid and his wife want their case against Baxter Healthcare Corp. heard in Illinois, the home of the drug company. An Illinois appellate court, however, upheld dismissal of the case because it agreed with the lower court that the proper venue for the action was California, the place where the plaintiffs' twins accidentally received an overdose of the blood thinner Heparin. These mix-ups had happened before, ostensibly because of confusing labeling of the differing strengths of the drug. The Quaids say that these previous similar incidents should have prompted the company to alter the labels in order to make it clearer which bottles contained the smaller doses appropriate for infants. They have asked Illinois' Supreme Court to review the dismissal. Baxter spokeswoman Erin Gardiner defended the dismissal on the basis that the overdosing occurred in California, where the plaintiffs and most of the defendants reside. The Quaids' attorney, Susan Loggans of Chicago's William Harte, disagrees: “If a plaintiff doesn't have the right to go to a defendant's home state and face what would normally be considered a hostile jury because the plaintiff knows what's best for its own case, then you'll be virtually blocking any innocent person from doing what is best for them and allowing the defendant to control where any case is filed.” Loggins pointed out that the case is not being brought as one for medical malpractice (the matter has already been settled with the hospital) and is instead concerned primarily with the workings of Baxter and how their decisions concerning labeling were made. Because its employees and former employees are primarily in Illinois, this is the proper forum, she feels.

No Rise in Autism Rates, According to UK's NHS

New evidence that the MMR (Measles, Mumps, Rubella) inoculation is not the cause of the apparent rise in autism in the developed world was recently made public by Britain's National Health Service (NHS). In September, the NHS conducted a survey of Britain's households to learn how many adults in the population could be classified as having an autism spectrum disorder. In testing the members of about 4,000 households, the researchers found that one person in 100 over the age of 18 had such a disorder ' about the same as the proportion of young children in the British population diagnosed with autism or asperger's syndrome. Because the current MMR shot became available only in the early 1990s, the study bolsters the position of those who refute any relationship between MMR inoculations and the apparent increase in autism, pointing instead to an oft-cited alternative reason for the supposed epidemic: greater understanding of the symptoms of autism that has lead to increased diagnosis. A pdf of the study's results can be accessed at: http://www.ic.nhs.uk/webfiles/publications/mental%20health/mental%20health%20surveys/Autism_Spectrum_Disorders_in_adults_living_in_households_throughout_England_Report_from_the_Adult_Psychiatric_Morbidity_Survey_2007.pdf.

Personalized Medical Treatment Method Held Patentable

In a closely watched case that is expected to aid the field of personalized medicine, the Federal U.S. Circuit Court of Appeals has ruled that a medical treatment method is patentable. The Sept. 16 opinion in Prometheus Laboratories Inc. v. Mayo Collaborative Services reversed a lower court's ruling invalidating Prometheus' patents that cover methods of adjusting the dosage of certain drugs, used to treat autoimmune diseases such as Crohn's disease, depending on a patient's particular metabolism. The district court had found that the correlations between the effectiveness and toxicity of the drug for a patient and the patient's metabolites were natural phenomena resulting from a natural body process.

Scrub Tech Who Tampered With Syringes Pleads Guilty

Former Colorado surgery scrub tech Kristen D. Parker pleaded guilty in September to charges of product tampering and other drug charges based on her theft of syringes containing the painkiller Fentanyl Citrate while she was performing her professional duties at Colorado's Rose Medical Center. During her guilty plea, Parker admitted to injecting herself with the drugs and then replacing the liquid in the syringes with saline solution, leaving the altered syringes for use on patients. Several of those patients blame Parker for the fact that, like her, they now have hepatitis C. Parker, who could have faced life in prison for her crimes, is to be sentenced to a 20-year term.

First Fosomax Case Ends in Mistrial

The first trial alleging jawbone deterioration from the use of the osteoporosis treatment drug Fosomax has ended in a mistrial. The jurors who heard the case in U.S. District Court in Manhattan deadlocked in September after a week of deliberation. At that point, they indicated that they could not come to a consensus on the issues of negligence and failure to warn. The plaintiff, Shirley Boles, is a retired Florida resident who claimed that her use of the drug over a period of several years caused her to develop jawbone necrosis, a painful and irreversible condition. More than 1,000 similar cases are still awaiting trial.

FDA Approves Donor Screening Test for Antibodies to HIV

The U.S. Food and Drug Administration (FDA) in September gave its approval to the Abbott Prism HIV O Plus assay, a screening tool designed to detect the presence of certain antibodies to HIV. It tests for antibodies to HIV type 1, groups M (the most common subgroup of the virus in the United States) and O, and HIV type 2. The assay is licensed to screen donated blood and blood specimens, as well as donor organs from both living and deceased donors. When positive results are obtained through this new screening tool, supplemental tests are required.

Vitamin's Health Claims Challenged

The Washington-based Center for Science in the Public Interest (CSPI), a nonprofit health advocacy group, is suing the German drug giant Bayer for allegedly making false claims concerning its Men's One A Day multivitamin. The group says that Bayer mislead consumers into believing that the selenium in the vitamin could reduce the risk of prostate cancer.

In a statement, Bayer said that it has “based a portion of the promotion for One A Day Men's Formula on the U.S. Food & Drug Administration's permitted qualified health claim that 'Selenium may reduce the risk of certain cancers.' ' The FDA changed its permitted qualified health claim earlier this year and Bayer is in the process of revising the packaging and promotional materials for its One-A-Day Men's and One-A-Day Men's 50+.”