- Staff Writer | July 31, 2006 10:37 PM |
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FDA & Prescription DrugsAccording to the AP, the FDA warned July 21, that an unconventional treatment for Lyme disease could cause serious injury and even death. Alternative health physicians and others purporting to be doctors prepare and inject into patients a mixture known as bismacine or chromocine, which contains large amounts of heavy metal bismuth. At least one person died while using this product and others...
- Staff Writer | July 31, 2006 6:39 PM |
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Medical MalpracticeThe US Food and Drug Administration (FDA) and MRL, Inc (a Welch Allyn company), recently notified healthcare professionals about the class 1 recall of 1184 automated external defibrillators ([AEDs] Welch Allyn PIC 50, catalog #97108X) manufactured during February 2002 to October 2004; 673 units were sold within the United States.The recall occured because of an electrical contact problem that...
- Staff Writer | July 30, 2006 10:35 PM |
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MiscellaneousAccording to the AP Wire, BP has halted operations at 12 Alaskan oil wells in order to investigate reports of leaking oil or diesel insulating agents. The wells are located at Prudhoe Bay, North Star and Milne Point and produced over 8,000 barrels of oil daily while in operation. Whistleblowers working with BP in Alaska reported the leaks to officials. Currently a grand jury is hearing testimony...
- Staff Writer | July 22, 2006 6:20 PM |
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Medical MalpracticeThe FDA's prime responsibility is to insure that the public is protected from unsafe drugs and medical devices. Recent studies suggest that the FDA is falling well short of it's goal. Even more surprising, these concerns have been raised from within the FDA itself.Today, the Union of Concerned Scientists released a survey noting that more than a third of FDA scientists said agency officials...
- Staff Writer | July 22, 2006 5:57 PM |
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Medical MalpracticePharmacists and physicians belong to two of the most trusted professions in America. We routinely follow our doctors advice regarding drugs they prescribe and then trust that our pharmacists will correctly fill the order. Unfortunately, many times our trust is misplaced. Today the Institute of Medicine released a report noting that medication errors harm 1.5 million people each year. The...
- Staff Writer | July 21, 2006 6:29 PM |
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Workplace DiscriminationWhen handling a termination or a disciplinary situation, it is critical that the manager or supervisor remain calm and professional, or the employer may have problems explaining the "business reason" for the employer's action when discriminatory motive is claimed. In Zamora v. Elite Logistics, Inc., decided June 5,2006, the 10th Circuit looked to the supervisor's responses, which were rude and...
- Staff Writer | July 21, 2006 5:56 PM |
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FDA & Prescription DrugsAccording to a report by NEWS.com, Roche, a large prescription drug manufacturer, crossed an ethical boundary when it treated hundreds of doctors to expensive meals at some of Australia's most exclusive restaurants. One of these meals cost more than $65,000 USD as Roche paid the bill for over 200 cancer specialists to eat at the Guillaume at Bennelong, and exclusive restaurant inside the famous...
- Staff Writer | July 20, 2006 6:28 PM |
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Workplace DiscriminationAn employer cannot "rubber stamp" the decision of a bigoted manager to terminate an employee, and then claim lack of discriminatory intent when the employee files suit claiming discrimination. In EEOC v. BCI Coca-Cola Bottling Co., decided June 7, 2006, the 10th Circuit recognized that an employer must hear both sides of the story and conduct an independent investigation of the grounds for...
- Staff Writer | July 20, 2006 5:54 PM |
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FDA & Prescription DrugsIn recent weeks, dozens of e-mails between internal FDA officials were turned over to the New York Times. The e-mails show that at least four FDA officials had serious reservations about the safety of the popular antibiotic, Ketek, which was recently forced to change its label to include stronger warnings. Dr. David Graham, part of the FDA's drug safety office, wrote in a message dated June 16...
- Staff Writer | July 19, 2006 7:28 PM |
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FDA & Prescription DrugsAccording to a recent article on Yahoo! News, the producer of Azathioprine, Roxane Laboratories, Inc., on June 13, 2006, announced a recall across the United States and Puerto Rico of Azathioprine tablets, manufacturing lot 558470A. Azathioprine helps to prevent the rejection of kidneys following kidney transplants and in some cases helps treat severe rheumatoid arthritis. The recall is...
- Staff Writer | July 19, 2006 6:26 PM |
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MiscellaneousAccording to a report on MSNBC.com, during the first six months of 2006, commercial real estate continues to boom in the Denver-metro area. According to a market overview by Cushman & Wakefield of Colorado Inc., 2006 has seen $2.3 billion in commercial properties sold in Denver, and record capital inflow and sales.
- Staff Writer | July 18, 2006 5:52 PM |
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MiscellaneousMicrosoft has filed federal lawsuits against two Colorado companies who allegedly sold pirated Windows and Office software. Microcomp Solutions Inc. of Denver and Computers Plus USA of Grand Junction are accused of pirating software or installing the software on computers. Microsoft was made aware of the problem from system builders who are going out of business because they can't compete with...
- Staff Writer | July 18, 2006 10:13 AM |
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MiscellaneousAccording to newratings.com, Merrill Lynch agreed to a settlement in which it will pay $29.5 million to Enron in order to resolve allegations of fraud. Enron has settled lawsuits against many financial institutions including Merrill Lynch, Lehman Brothers Holdings, CIBC and Credit Suisse after accusing them of involvement in Enron's accounting scandal.
- Staff Writer | July 17, 2006 10:10 AM |
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MiscellaneousIn a recent Bloomberg.com article hedge-fund fraud was identified as a growing concern for investors. A taskforce designated by the President Bush to investigate corporate crime is meeting in July to discuss this threat. Hedge funds are lightly regulated and according to the head of the taskfoce, Deputy Attorney General Paul McNulty, hedge funds are "a good example of an emerging threat that we...
- Staff Writer | July 16, 2006 10:08 AM |
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MiscellaneousAn extremely troubling report in-Pharma Technologist.com indicated that government investigators are looking into the release of 25 gallons of chemicals containing cyanide from a Merck production plant in Pennsylvania into the sewer. It is likely that after the chemicals left the wastewater treatment plant it affected between two and eight miles of the Wissahickon Creek. While the incident...
- Staff Writer | July 16, 2006 10:02 AM |
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FDA & Prescription DrugsAccording to The Doctor's Guide News, officials in Singapore have reported a dramatic increase in the reported cases of Fusarium Keratitis, a severe fungal eye infection possible linked to Bausch and Lomb ReNu with MoisureLoc. A study by the Singapore Eye Research Institute examined contact lens wearers rate of Fusarium keratitis during a 15-month period. Of the contact lens wearers diagnosed...
- Staff Writer | July 11, 2006 9:11 PM |
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FDA & Prescription DrugsAs a regulatory agency, the authority of the FDA is limited to the creation of regulations which implement the responsibilities delegated to FDA by Congress. Since Congress did not expressly preempt state law tort claims, FDA has no authority to establish express preemption.FDA has no authority to interpret the law. The doctrines of conflict preemption are judicially created and judicially...
- Staff Writer | July 10, 2006 9:09 PM |
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FDA & Prescription DrugsFDA recognizes that FDA's regulation of drug labeling will not preempt all State law actions. The Supreme Court has held that certain State law requirements that parallel FDA requirements may not be preempted (Medtronic, Inc. v. Lohr, 518 U.S. 4790, 495 (1996)) (holding that the presence of a State law damages remedy for violations of FDA requirements does not impose an additional requirement...
- Staff Writer | July 10, 2006 11:00 AM |
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MiscellaneousThe 9th Circuit Court of Appeals [Federal] has recently affirmed a lower court's determination that if a client settles a case based on erroneous legal advice the settlement will still stand. The client may be able to sue the lawyer for malpractice, but the settlement will be enforced. A client alleged that the was given bad advice by her lawyer, and even deceived by her lawyer. She found this...
- Staff Writer | July 09, 2006 9:02 PM |
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FDA & Prescription DrugsConsistent with its court submissions and existing preemption principles, FDA believes that at least the following claims would be preempted by its regulation of prescription drug labeling:1. Claims that a drug sponsor breached an obligation to warn by failing to put in Highlights or otherwise emphasize any information the substanc4e of which appears anywhere in the labeling;2. Claims that a...
- Staff Writer | July 08, 2006 9:00 PM |
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FDA & Prescription DrugsState law actions also threaten FDA's statutorily prescribed role as the expert federal agency responsible for evaluating and regulating drugs. State actions are not characterized by centralized expert evaluation of drug regulatory issues. Instead, they encourage, and in fact require, lay judges and juries to second-guess the assessment of benefits versus risks of a specific drug to the...
- Staff Writer | July 07, 2006 8:57 PM |
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FDA & Prescription DrugsState law requirements can undermine safe and effective drug use in other ways and over-warning, just like under-warning, can similarly have a negative effect on patient safety and public health.State law actions can rely on and propagate interpretations of the act and FDA regulations that conflict with the agency's own interpretations and frustrate the agency's implementation of its statutory...
- Staff Writer | July 07, 2006 11:12 AM |
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Automobile Accidents
- Staff Writer | July 07, 2006 10:58 AM |
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Workplace DiscriminationThe Court first explained that in making a reverse discrimination claim, an employee must show that the employer is actually discriminating against the majority - a fairly unusual occurrence. The Court concluded that Argo could not establish reverse discrimination in this case. Instead, Blue Cross showed that it hired many men for the same position and that it had employed Argo in the...
- Staff Writer | July 07, 2006 10:49 AM |
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FDA & Prescription DrugsAn interesting report on the Ivanhoe Newswire reports that patients at the University of Rochester Center in New York who have taken Clozapine have drastically greater rates of metabolic syndrome, which increases their chance of getting diabetes, stroke and heart diseases. Clozapine is the only product that the Food and Drug Administration approves for treatment of suicidal behavior.
- Staff Writer | July 06, 2006 8:49 PM |
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FDA & Prescription DrugsNew Rules on Prescription Drug Preemption and Preemption PrinciplesFDA believes that under existing preemption principles, FDA approval of labeling under the act, whether it be in the old, or new format, preempts conflicting or contrary State law. Indeed, the Department of Justice (DOJ), on behalf of FDA, has filed a number of amicus briefs making this very point. In order to more fully...
- Staff Writer | July 06, 2006 7:04 PM |
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FDA & Prescription DrugsWe'd like to alert you to recent developments concerning Ketek, a popular antibiotic marketed by Sanofi-Aventis SA. Ketek has been associated with severe liver damage and death. In April 2004, Ketek was approved for upper respiratory infections in patients 18 years and older. The FDA had rejected the drug in 2001 and 2003, asking for more safety information. Although Sanofi's clinical...
- Staff Writer | July 06, 2006 10:55 AM |
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Workplace DiscriminationSometimes, it really is all about performance. Or, in the words of Judge McConnell of the Tenth Circuit, "This case presents an especially weak Title VII sex discrimination claim."The Plaintiff, Griff G. Argo, worked as an Individual Enrollment Specialist ("IES") for the Defendant Blue Cross Blue Shield of Kansas, Inc. ("Blue Cross"). Although he was an effective worker for several years, his...
- Staff Writer | July 06, 2006 10:48 AM |
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FDA & Prescription DrugsAccording to the Philadelphia Inquirer, dentists are asking patients whether they have used bone-density medications such as Fosamax before treatment or diagnosis. These drugs, known as bisphosphonates, are linking in numerous studies to a condition known as osteoncrosis of the jaw, or a rotting of the jawbone. Osteoncrosis is causing substantial injuries to victims that in some cases many cases...
- Staff Writer | July 05, 2006 8:47 PM |
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FDA & Prescription DrugsComment 12: Some manufacturers expressed concerns that, by highlighting selected information from the FPI to the exclusion of information not highlighted, they make themselves more vulnerable to product liability claims. some of these comments also stated that the highlights limitation statement, which states that highlights do not contain all the information needed to prescribe a drug safely...
- Staff Writer | July 04, 2006 8:44 PM |
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FDA & Prescription DrugsNew FDA labeling regulations were effective June 30, 2006. Announced January 18, 2006, these regulations, 21 CFR 201, 314 and 601, have the claimed purpose of providing new labeling guidelines for prescription drugs, to make drug labeling easier to read and understand and to include requirements to highlight certain information and to promote minor changes in graphics and content of drug...
- Staff Writer | July 03, 2006 11:19 AM |
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MiscellaneousAs we celebrate the 4th of July and our constitutional form of government built on checks and balances, it is trendy to complain that the legal system is broken by pointing to selected "facts" about it. Upon closer examination, those "facts" are often demonstrably inaccurate or taken out of context. The fact of the matter is that our liberties and our prosperity are protected by the legal...
- Staff Writer | July 01, 2006 6:38 PM |
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FDA & Prescription DrugsAccording to the Associated Press, Merck failed to report to authorities about tests in which users of Vioxx were at greater risk for death then people given placebo. This is according to Dr. Edward Scolnick, the former head of Merck's research laboratories. Dr. Scolnick also testified that in two clinical trials people on Vioxx death was more than two times as likely for those on Vioxx. Merck...