Monthly Archives: March 2008

Expert Doctor: Lilly Should Have Warned about Zyprexa Dangers Earlier

In what is becoming commonplace, a judge or federal agency official blasts a pharmaceutical company for not revealing a drug’s dangerous side effects earlier. This time, expert witness Dr. John Gueriguian has testified that Eli Lilly should have told the public about Zyprexa’s dangerous side effects as early as 1998. Instead, Lilly chose to hide the findings from the public and health officials. According to his testimony in the Alaska Zyprexa trial, Eli Lilly put “profit over concern of the consumer.” Zyprexa’s side effects include weight gain and the onset of diabetes. The drug, manufactured by Eli Lilly, is prescribed to treat schizophrenia. Of course, Eli Lilly denies any culpability and says it fully disclosed everything it knew about Zyprexa to the FDA. However, in this trial in which the state of Alaska is suing Eli Lilly in order to recover costs associated with Medicaid patients who developed diabetes as a result of taking Zyprexa, the witness is an expert in diabetes and was an FDA reviewer for 20 years prior to his retirement. Eli Lilly will have to do more than its usual public relations spin to put one over on this expert.

Rotexmedica Issues World Wide Heparin Recall

German Heparin Manufacturer Rotexmedica recalled heparin after allergic reactions were reported in Germany. Apparently, the ingredients from the German heparin came from Chinese plants. Baxter International in the U.S.A. also recalled heparin because of possibly contaminated or counterfeit ingredients from China. Currently, both U.S. and German authorities are investigating what might be counterfeit ingredients in heparin from China. Rotexmedica exports most of its heparin outside of Germany. Heparin is an injectable blood thinner. It is frequently used in kidney dialysis and open heart surgery. It can also be used to treat blood clots. Persons sickened or killed by counterfeit or contaminated heparin made by Baxter International may have legal claims in the U.S. It is unclear what rights Europeans may have against the German Manufacturer.

New Priest Abuse Allegations on the Rise

In stark contrast to what the United States bishops have been saying in their public relations’ campaign, new, credible allegations of priest sexual abuse are on the rise. This news comes surprisingly from the bishop’s own report concerning the audit for which they hired the Gavin Group. Unfortunately, as long as the bishops continue to try to spin the story rather than fix the problem, priest sex abuse will remain a scourge on the church and society. The church’s self-audit is filled with self-congratulatory language that ignores or glosses over the issue of how the church is really doing to help victims of priest abuse as well as prevent abuse in the future. For instance, priests accused of sexual abuse don’t have to report or submit themselves to monitoring, several lay review boards didn’t even meet in 2007, the auditors who wrote the report didn’t have access to personnel files, and 56 US religious orders refused to participate in the report and are not in compliance with the Dallas Charter. David Clohessy, SNAP’ Executive Director stated that, “It’s tempting but irresponsible to assume progress has been made at this very premature stage. There always has been and always will be a lag time in reporting abuse.” The dioceses in the US still refuse to make their finances as well as their history of handling abusers transparent. They continue to refuse to make public the files containing information about the priests who’ve abused. Reform is still a buzzword but not a practice.

Medical Devices and Consumer Safety

Imagine a country where air travelers, cell phone users, and cable tv customers are safer than patients who receive potentially life-saving medical devices. According to Dr. William Maisel, a prominent cardiologist, that country is the United States of America. In an article published in the New England Journal of Medicine, Maisel faults the FDA’s regulatory measures and zeroes in on Medtronic’s Sprint Fidelis heart defibrillator lead to illustrate his point. Maisel is particularly critical of FDA’s 2004 approval of Sprint Fidelis without adequate human testing. Medtronic’s lack of post-marketing data concerning Sprint Fidelis’ effectiveness and safety only exacerbated the problem. These factors coupled with the huge popularity of Sprint Fidelis among doctors meant that 90% of Medtronic defibrillators implanted since 2004 were Sprint Fidelis defibrillators. While Maisel focuses his attention on the Sprint Fidelis defibrillaor problem, the same problems exist with other medical devices such as the Kugel Mesh hernia patch whose recoil ring collapses and fails as well as Stryker Corporation’s Trident hemispherical and Trident PSL Shells hip replacement devices. These faulty medical devices cause untold human suffering because the companies don’t spend the time nor the money to test them adequately and the FDA has not been able to properly regulate them. In the end, consumer safety suffers.

Resurgence in Bed Bugs?

I came across an interesting article in the NY Times yesterday about a resurgence in bed bugs or Cimex lectularius, the common bedbug. Businesses employing bed bug detecting dogs are thriving and, according to the article, are receiving so many inquiries from hotels and motels, they are not able to keep pace with the demand. Bed bugs are small, wingless insects that burrow themselves into mattresses and even luggage. The most common manner in detecting bed bugs is specks of blood on the mattress and/or tiny bites on your skin after you awaken from a night’s sleep. Hopefully, the surge in bed bugs will be short lived and dogs can return to being man’s best friend rather than bed bug detectives.

Source of Heparin Contamination Found

The FDA has found the source of the contamination in the recently recalled Heparin. However, it remains unidentified and is also not known if the contaminant was introduced to the Heparin inadvertently or intentionally. Thus far, 19 deaths have been associated with the contaminated Heparin which originated in China. According to the FDA, the contaminant was found in the active ingredient from Baxter’s supplier, Scientific Protein Laboratories, LLC. The contaminant, whatever it is, was found in large quantities. The 19 deaths have occurred since January 2007 and seem to indicate a failure on the part of nursing homes, hospitals, as well as other healthcare institutions to report a potential problem to the FDA in a timely manner. This is another issue on top of the critical failure of the FDA to inspect, monitor, and supervise the nation’s drug supply, especially the drug supply that is being imported.

MMPI Fake Bad Scale Excluded in Florida Auto Crash Cases

Dr. Paul Lees-Haley, a psychologist, who makes his living primarily helping insurance companes in personal injury cases has designed a “Fake Bad Scale” psychological test to challenge personal injury claimants. An article in the March 5, 2008 Wall Street Journal describes how Dr. Lees-Haley developed the test and convinced the Minnesota Multiphasic Personality Inventory, MMPI, to make the Fake Bad Scale an official subset of the MMPI. This Fake Bad Scale has been used by the KBR unit of Halliburton Inc. to deny disability claims of truck drivers who worked in Iraq by labeling them as malingerers. However, the court in two Tampa, Florida auto personal injury cases has rightly excluded the Fake Bad Scale from the courtroom. The scientific basis of this test has not been properly demonstrated. Furthermore, it has long been the jury’s job to evaluate the credibility of courtroom witnesses. Using a psychological test such as the Fake Bad Scale as evidence in a trial invades the proper province and job of the jury to make that evaluation. The use of a lie detector test is not admissable in court for the same reasons. In essence, Dr. Lees-Haley and the auto insurance companies are attempting to use this Fake Bad Scale as a lie detector test. Our jury system does and should provide justice though jury trials on all the issues, not through a machine or a test designed by an insurance company consultant..
Florida Accident Lawyer

Lilly Faces First Court Battle with Zyprexa

Drug manufacturer Eli Lilly and Co. will face its first court battle over its antipsychotic drug Zyprexa in Alaska. The trial will have important implications for other states considering suing the drug maker for not disclosing that the company knew for years that Zyprexa caused weight gain and diabetes. The courtroom testimony and ultimately the outcome of the trial will factor into whether other states want to pursue claims against Eli Lilly. In the Alaskan trial, the state of Alaska has not only accused Eli Lilly of a failure to warn doctors and patients about weight gain and diabetes but also about what it considers deceptive marketing practices designed to increase sales of Zyprexa. The Alaska state attorney general has alleged that Lilly improperly marketed Zyprexa “off-label” to the state’s Medicaid recipients, costing Alaska more than it should have to reimburse patients. The state’s Medicaid program spent about $40 million on Zyprexa in the past five years, about a third of it for off-label uses.

Florida Pedestrian Accidents

Unfortunately, Florida ranks as one of the worst states in the nation regarding pedestrian safety. According to the Florida Department of Transportation, Florida ranks second only to California in the number of pedestrian fatalities in the nation. Such accident deaths comprise 15.2% of all Florida traffic fatalities. According to the state agency, some of the reasons for Florida’s abysmal rankings stem from its rapid growth as well as its primarily post World War II expansion and urban sprawl. Another factor not mentioned by the agency would seem to be the high senior citizen population residing in the state. Roads designed in the 1950’s can not possibly accomodate the dense population and rapid growth we’ve seen in the past two decades. All of these factors account for greater pedestrian danger and higher fatality rates for Florida pedestrians. In light of this year’s state budget crunch, the situation does not appear to be improving any time soon.
Florida Accident Lawyer

Department of Justice Subpoenas Stryker Documents

Stryker Corporation, the artifical hip manufacturer, has received a subpoena regarding the agency’s probe into Stryker’s sale of medical device prodcuts to foreign countries. Stryker was one of five medical device companies to settle with the federal government and avoid prosecution over kickbacks to doctors in exchange for using their hip implants. Stryker has been in the news recently after it recalled its Trident PSL and Trident Hemispherical Acetabular Cups used in hip replacement surgery. Stryker has known about problems with the hip devices since at least January 2005 when it began receiving complaints from patients who had received the hip replacement devices. The problem with the hip replacement components are two-fold involving manufacturing processes as well as issues regarding defective design.