From the Bradenton Herald
Bradenton psychologist charged with smuggling drugs into Sarasota jail
Herald Staff Report
Jan. 09, 2012
SARASOTA — The Sarasota County Sheriff’s Office has arrested a licensed psychologist from Bradenton for illegally providing controlled substances to an inmate at the Sarasota County jail.
A corrections sergeant developed intelligence information that Holli Bodner, 51, of the 7300 block of Kensington Court, Bradenton, agreed to supply an inmate with Oxycodone and Lorazepam during prearranged visits at the jail, according to a news release.
Sheriff’s office detectives monitored four occasions in the month of December during which Bodner met with and supplied an inmate with narcotics. Detectives recovered the drugs from the inmate immediately after each meeting, according to the report.
Bodner was arrested Friday afternoon as she arrived at the jail for another scheduled appointment with the inmate.
She was charged with four counts of delivery of a controlled substance and four counts of introduction of a controlled substance into a correctional facility, all felonies.
She was released Saturday evening after posting $4,000 bond.
Monday, January 16, 2012
Tuesday, January 3, 2012
The Song “Pumped Up Kicks” by the Band Foster the People Helps Bring to Light the Issue of Kids Shootings in Schools
“Pumped Up Kicks" is a song about a kid preparing to shoot his classmates at school. Part of the chorus says you’d better run, out run my gun. Pump of kick simply means expensive shoes.
It is refreshing to hear a band will write and perform music that doesn’t involve love or partying, but an unfortunate form of life in US schools.
Our take on it is not just that guns seem to be so handy to teenagers. Apparently, families leave guns and bullets around for kids to get at them. What is going on in these households? How do parents manage homes these days: No more potato chips before dinner and only two hours of T.V., but here is how you remove the safety on the pistol and can you get me the bullets in the pantry? If you take the gun out of the equation you would simply get a fight, or a stabbing at worst. But to us the real reasons behind these continual school shootings are antidepressants. The media will never talk about the effects of the antidepressants if a gun is involved. The government and media jump on the gun story, while the real ailment is psychotropic drugs. Parents seem to have little problem sanctioning a doctors prescription of antidepressants for their children.
The song “Pumped Up Kicks” has been moving up the charts all this past summer illuminating the violence that schools have become. Two decade ago the worst you got was a bruise or bloody nose, what will the next ten years bring?
Thursday, December 1, 2011
Merck to Pay $950 Million in Settlement Over Vioxx Health Care Fraud
(imagefreeimages.co.uk)
Vioxx is not an antidepressant, but we wanted to continue to enlighten readers of the unethical actions of Pharmaceutical Companies. Merck will pay $950 million and was forced to plead guilty to a criminal misdemeanor in their illegal promotion of Vioxx and their deception of the government and consumers. This court action is part fine ($320 million) and in part to settle civil penalties ($630 million). This came about from a 2004 study showed that Vioxx increased the risk of heart attacks and strokes. Vioxx was initially approved as a pain killer in 1999. This ruling is based on Merck promoting via marketing and pharmaceutical representatives unauthorized “off label” marketing. According to the Wall Street Journal a Merck spokesman Ronald Rogers indicated that some sales representatives promoted Vioxx as a treatment to rheumatoid arthritis before FDA approval. The government indicated that its representatives didn’t inform medical practitioners regarding Vioxx’s issue with cardiovascular safety.
Other pharmaceutical companies have recently been fined for misrepresentations such as GlaxoSmithKline $3 billion settlement for improper drug marketing. Dey Inc. Dey Pharma L.P. agreed to pay $280 million to settle False Claims Act allegations. The Justice department indicated that the Dey Pharma inflated government payments when they charge the Medicare and Medicaid a higher amount over actual price paid by health care providers. That discovery was related by Ven-A-Care. Elli-Lilly, Pfizer, and AstraZeneca have also been fined heavily in the past few years.
Pharmaceutical companies have shown a pattern in promoting their products for other reasons then FDA approval. This misrepresentation and unethical behavior must be from top management to the sale representatives. Why would a sale rep inform medical practitioners of the uses of drugs unless they were told to indicate so by management? This also brings up another issue as doctors are allowed to prescribe drugs for “off label” uses. Shouldn’t a drug be only allowed to be used for the reason it was approved by all involved in the drugs distribution? It looks like a Congressional law is needed here.
Vioxx is not an antidepressant, but we wanted to continue to enlighten readers of the unethical actions of Pharmaceutical Companies. Merck will pay $950 million and was forced to plead guilty to a criminal misdemeanor in their illegal promotion of Vioxx and their deception of the government and consumers. This court action is part fine ($320 million) and in part to settle civil penalties ($630 million). This came about from a 2004 study showed that Vioxx increased the risk of heart attacks and strokes. Vioxx was initially approved as a pain killer in 1999. This ruling is based on Merck promoting via marketing and pharmaceutical representatives unauthorized “off label” marketing. According to the Wall Street Journal a Merck spokesman Ronald Rogers indicated that some sales representatives promoted Vioxx as a treatment to rheumatoid arthritis before FDA approval. The government indicated that its representatives didn’t inform medical practitioners regarding Vioxx’s issue with cardiovascular safety.
Other pharmaceutical companies have recently been fined for misrepresentations such as GlaxoSmithKline $3 billion settlement for improper drug marketing. Dey Inc. Dey Pharma L.P. agreed to pay $280 million to settle False Claims Act allegations. The Justice department indicated that the Dey Pharma inflated government payments when they charge the Medicare and Medicaid a higher amount over actual price paid by health care providers. That discovery was related by Ven-A-Care. Elli-Lilly, Pfizer, and AstraZeneca have also been fined heavily in the past few years.
Pharmaceutical companies have shown a pattern in promoting their products for other reasons then FDA approval. This misrepresentation and unethical behavior must be from top management to the sale representatives. Why would a sale rep inform medical practitioners of the uses of drugs unless they were told to indicate so by management? This also brings up another issue as doctors are allowed to prescribe drugs for “off label” uses. Shouldn’t a drug be only allowed to be used for the reason it was approved by all involved in the drugs distribution? It looks like a Congressional law is needed here.
Thursday, November 17, 2011
Please Keep Us Afloat and Make a 2011 Donation
We are sure you are aware of the important role we can all play in helping people whose lives are impacted by Antidepressants. Our important work is supported largely by the support of generous donors who contribute to our annual capital campaign. This year’s goal is $20,000 which will allow Stoprx.org to continue providing much needed information and assistance to those in around the world who are in need of the real information on pharmacuetical drugs, and to be aware of the deathly effects of psychotropic drugs. Without the continued support of generous donors like you, these needs will likely not be met.
In order to continue making a difference in the lives of individuals affected by the work of Stop Foundation Inc. it is vital for this year's capital campaign to be a success. Can we count on you to make a donation to this important cause? By making a tax deductible donation to our campaign, you'll be directly contributing to helping people struggling to cope with thoughts of suicide, and BigPharma drug induced aggressive behavior.
Stop Foundation Inc. (stoprx.org) is depending on your assistance and generosity. Please visit www.stoprx.org to pledge your support by using the Paypal Donate button on the contact us donate page, or mail a check to Stop Foundation Inc. 1450 Sutter Street San Francisco, Ca. 94109. Your donation is fully tax deductable in the US as we are a 501(C) 3. We are happy to accept even small donations of $10, $15, $20 and more, which helps our mailing campaigns. Larger donations will help us expand and spread the word about the true effects of antidepressants.
Thank you for your consideration and continued support.
Stop Foundation Inc
Tuesday, November 1, 2011
Are Vitamins Really Bad for You? Or Are Their Other Forces at Work?
(imageVitamin-supplements.com)
The recent Archive of Internal Medicine study widely published claims that older women who take dietary supplements die sooner than those who don't. Another Recent Study in the Journal of the American Medical Association claims that men with prostate cancer who take vitamin E supplements are more likely to die than those who don’t.
The Archive of Internal Medicine study collected information from nearly 40,000 women several times over 22 years. They collected more data than supplements, but in their supplement data they indicated several supplements that they say increases mortality, vitamin B6, folic acid, iron, magnesium, zinc, copper, and the innocent multivitamin. The increase in mortality rate ranged from 2.2 percent (multivitamins) to as much as 18 percent (copper).
In a contrarian view, Dr Alan Gaby (Author of a leading nutritional textbook) says “Dietary supplements have been clearly shown to decrease the severity of many diseases in people who are not deficient by any standard laboratory measurement” (PRWeb)
As for the study on vitamin E and prostate cancer, Dr Gaby suggested that both vitamin E supplements, and vitamin E research, are often misunderstood. “There are four types of vitamin E that occur naturally in food. Two of them, alpha- and gamma-tocopherol, have been shown to slow the growth of prostate cancer cells (in a test tube study) and to be associated with lower risk of developing prostate cancer (based on blood levels.) In both cases, gamma-tocopherol was more effective than the alpha form."
There is, however, an important shortcoming in vitamin E studies, as well as in most vitamin E supplements.
“It’s important to understand that isolated alpha-tocopherol is the form present in most vitamin E supplements, and is the form of vitamin E used in almost all clinical research. But we know that large doses of the alpha form deplete the body of the gamma form, and this upsets the natural balance of vitamin E derived from food. Because of this, it appears that large doses of isolated alpha-tocopherol may be harmful. However, natural vitamin E in the form of mixed tocopherols contains all four types of naturally-occurring vitamin E, and may prevent prostate cancer. Alpha-tocopherol may only be protective when it is supplied with gamma-tocopherol in the proper natural balance.” (PRWeb)
Also, Wen-Bin Chiou, Ph.D., a professor at National Sun Yat-Sen University told Men's Health. “Taking dietary supplements increases perceived invulnerability,” In other words: It’s not the vitamins that are harmful; it’s the life choices people make while taking vitamins. Do people take vitamins to substitute bad life choices?
We also looked at the source of the study which is the American Medical Association, which has become and arm of the Pharmaceutical industry.
Archive of Internal Medicine and Journal of the American Medical Association (JAMA) are published by the American Medical Association (AMA) which is heavily influence by the Pharmaceutical industry. BigPharma uses its financial resources to help shape the continuing medical education of physicians in order to server its marketing purposes. Physicians and medical educational institutions aid and abet this influence by accepting, sometimes even soliciting, financial help and other favors from the industry, thus relinquishing what should be their professional responsibility for self-education, and the uninfluenced patient doctor relationship. The medical profession is being educated by BigPharma to sell the drugs physicians prescribe and thus surrenders its ethical commitment to serve as the independent fiduciary for its patients.
In our opinion, a study that diminishes the effect and use of vitamins will in turn increase the use and prescription of pharmaceuticals. We also don’t believe that all vitamins are the same, as many supplements have “fillers” or additives, so you are not taking the full vitamin. Consumers need to research to locate the best vitamin sources, so you ensure you get the full effect of the supplement.
The recent Archive of Internal Medicine study widely published claims that older women who take dietary supplements die sooner than those who don't. Another Recent Study in the Journal of the American Medical Association claims that men with prostate cancer who take vitamin E supplements are more likely to die than those who don’t.
The Archive of Internal Medicine study collected information from nearly 40,000 women several times over 22 years. They collected more data than supplements, but in their supplement data they indicated several supplements that they say increases mortality, vitamin B6, folic acid, iron, magnesium, zinc, copper, and the innocent multivitamin. The increase in mortality rate ranged from 2.2 percent (multivitamins) to as much as 18 percent (copper).
In a contrarian view, Dr Alan Gaby (Author of a leading nutritional textbook) says “Dietary supplements have been clearly shown to decrease the severity of many diseases in people who are not deficient by any standard laboratory measurement” (PRWeb)
As for the study on vitamin E and prostate cancer, Dr Gaby suggested that both vitamin E supplements, and vitamin E research, are often misunderstood. “There are four types of vitamin E that occur naturally in food. Two of them, alpha- and gamma-tocopherol, have been shown to slow the growth of prostate cancer cells (in a test tube study) and to be associated with lower risk of developing prostate cancer (based on blood levels.) In both cases, gamma-tocopherol was more effective than the alpha form."
There is, however, an important shortcoming in vitamin E studies, as well as in most vitamin E supplements.
“It’s important to understand that isolated alpha-tocopherol is the form present in most vitamin E supplements, and is the form of vitamin E used in almost all clinical research. But we know that large doses of the alpha form deplete the body of the gamma form, and this upsets the natural balance of vitamin E derived from food. Because of this, it appears that large doses of isolated alpha-tocopherol may be harmful. However, natural vitamin E in the form of mixed tocopherols contains all four types of naturally-occurring vitamin E, and may prevent prostate cancer. Alpha-tocopherol may only be protective when it is supplied with gamma-tocopherol in the proper natural balance.” (PRWeb)
Also, Wen-Bin Chiou, Ph.D., a professor at National Sun Yat-Sen University told Men's Health. “Taking dietary supplements increases perceived invulnerability,” In other words: It’s not the vitamins that are harmful; it’s the life choices people make while taking vitamins. Do people take vitamins to substitute bad life choices?
We also looked at the source of the study which is the American Medical Association, which has become and arm of the Pharmaceutical industry.
Archive of Internal Medicine and Journal of the American Medical Association (JAMA) are published by the American Medical Association (AMA) which is heavily influence by the Pharmaceutical industry. BigPharma uses its financial resources to help shape the continuing medical education of physicians in order to server its marketing purposes. Physicians and medical educational institutions aid and abet this influence by accepting, sometimes even soliciting, financial help and other favors from the industry, thus relinquishing what should be their professional responsibility for self-education, and the uninfluenced patient doctor relationship. The medical profession is being educated by BigPharma to sell the drugs physicians prescribe and thus surrenders its ethical commitment to serve as the independent fiduciary for its patients.
In our opinion, a study that diminishes the effect and use of vitamins will in turn increase the use and prescription of pharmaceuticals. We also don’t believe that all vitamins are the same, as many supplements have “fillers” or additives, so you are not taking the full vitamin. Consumers need to research to locate the best vitamin sources, so you ensure you get the full effect of the supplement.
Saturday, October 22, 2011
CBS News Interview-$760 million Paid to Doctors By Pharma Past Two Years
http://www.cbsnews.com/8301-500188_162-20124165/mega-bucks-flow-from-drug-cos-to-doctors/
(CBS News)
A dozen pharmaceutical companies have given doctors and other healthcare providers more than $760 million over the past two years - and those companies' sales comprise 40 percent of the U.S. market.
The numbers come from the non-profit journalism organization Pro Publica, which assembled and continues to update a database on the payments.
The payments, says Pro Publica, are for consulting, speaking, research and expenses on the part of the providers.
Drug companies have traditionally been very tight-lipped about those payments, Pro Publica notes, but, "Over the past two years, companies have begun posting this information on their websites, some as the result of legal settlements with the federal government."
What's more, Pro Publica points out, "Federal law requires that all companies publicly report this data beginning in 2013. That information will be posted on a government website."
With bucks that big flying around, is the quality of care offered by providers accepting them compromised? "Absolutely," said Dr. John Santa, head of the Consumer Reports Health Ratings Center.
"Money works," Santa told "Early Show on Saturday Morning" co-anchor Russ Mitchell. "Doctors are human. Doctors who take money from drug companies are more likely to give you an expensive drug or more likely to give you a drug you may not need."
A recent Consumer Reports survey had 72 percent of respondents saying they believe pharmaceutical companies have too much influence on the drugs that doctors prescribe; 85 percent saying they were concerned about drug companies rewarding doctors who write a lot of prescriptions for their drugs; and 76 percent saying they were concerned about doctors providing testimonials or serving as a spokesperson for a drug.
Santa says he'd be reluctant to advise someone to go to a doctor who has that sort of relationship: "The issue is, who are you working for? Me, as the patient? Or the drug company you're taking money from?"
Do the payments result in doctors not giving patients the least expensive drugs in some cases?
"Absolutely," Santa replied. "We know from our studies and others that there are still many opportunities for doctors to prescribe generic drugs and they're not doing it, and one of the reasons is these financial relationships."
Santa pointed to three signs that could tip off patients that their doctor is getting drug company money.
First off - seeing drug company salespeople in a doctor's office. "The last time I was in a medical office," Santa says, "there were three drug representatives in the waiting room. I haven't been back."
Another sign? Free drug samples. "People think a free sample is a good thing," Santa observes. "Well, the expensive prescription that follows it, if it works, is not a good thing. It can be, again, a much more expensive drug than you may need."
Also: Marketing materials in the physician's office. "Doctors who have relationships with drug companies will often have promotional materials, will have information that they give patients that come from the drug company. You should be wary of that," Santa cautioned.
And what if you spot any of those signs?
"First of all," Santa suggested, "you shouldn't hesitate to ask, 'Do you have a relationship with a drug company? Is it your policy and your practice to take money from drug companies?' More and more, I think, it's good for consumers to ask those kinds of questions.
"What you should especially ask, though, is, 'What are my other options?'"
(CBS News)
A dozen pharmaceutical companies have given doctors and other healthcare providers more than $760 million over the past two years - and those companies' sales comprise 40 percent of the U.S. market.
The numbers come from the non-profit journalism organization Pro Publica, which assembled and continues to update a database on the payments.
The payments, says Pro Publica, are for consulting, speaking, research and expenses on the part of the providers.
Drug companies have traditionally been very tight-lipped about those payments, Pro Publica notes, but, "Over the past two years, companies have begun posting this information on their websites, some as the result of legal settlements with the federal government."
What's more, Pro Publica points out, "Federal law requires that all companies publicly report this data beginning in 2013. That information will be posted on a government website."
With bucks that big flying around, is the quality of care offered by providers accepting them compromised? "Absolutely," said Dr. John Santa, head of the Consumer Reports Health Ratings Center.
"Money works," Santa told "Early Show on Saturday Morning" co-anchor Russ Mitchell. "Doctors are human. Doctors who take money from drug companies are more likely to give you an expensive drug or more likely to give you a drug you may not need."
A recent Consumer Reports survey had 72 percent of respondents saying they believe pharmaceutical companies have too much influence on the drugs that doctors prescribe; 85 percent saying they were concerned about drug companies rewarding doctors who write a lot of prescriptions for their drugs; and 76 percent saying they were concerned about doctors providing testimonials or serving as a spokesperson for a drug.
Santa says he'd be reluctant to advise someone to go to a doctor who has that sort of relationship: "The issue is, who are you working for? Me, as the patient? Or the drug company you're taking money from?"
Do the payments result in doctors not giving patients the least expensive drugs in some cases?
"Absolutely," Santa replied. "We know from our studies and others that there are still many opportunities for doctors to prescribe generic drugs and they're not doing it, and one of the reasons is these financial relationships."
Santa pointed to three signs that could tip off patients that their doctor is getting drug company money.
First off - seeing drug company salespeople in a doctor's office. "The last time I was in a medical office," Santa says, "there were three drug representatives in the waiting room. I haven't been back."
Another sign? Free drug samples. "People think a free sample is a good thing," Santa observes. "Well, the expensive prescription that follows it, if it works, is not a good thing. It can be, again, a much more expensive drug than you may need."
Also: Marketing materials in the physician's office. "Doctors who have relationships with drug companies will often have promotional materials, will have information that they give patients that come from the drug company. You should be wary of that," Santa cautioned.
And what if you spot any of those signs?
"First of all," Santa suggested, "you shouldn't hesitate to ask, 'Do you have a relationship with a drug company? Is it your policy and your practice to take money from drug companies?' More and more, I think, it's good for consumers to ask those kinds of questions.
"What you should especially ask, though, is, 'What are my other options?'"
Wednesday, October 12, 2011
US Supreme Court Rules in Favor of Pharma on Vaccines, Data Mining and Generics. Who is Looking Out for You?
United States: Supreme Court Rules In IMS Data Mining Case
by Maria Buckley
On June 23, 2011, the Supreme Court in Sorrell, Attorney General of Vermont, et al. v. IMS Health Inc. et al1, struck down a Vermont law2 that bans the sale of physicians' prescribing information to pharmaceutical companies and further bans pharmaceutical companies from using such data to market their products. The Supreme Court's 6-3 opinion by Justice Kennedy found that the Vermont law unconstitutionally restricted the pharmaceutical companies' right to free speech.
Vermont's Prescription Confidentiality Law provides that absent the prescriber's consent, pharmacies and other related entities are prohibited from selling prescriber identifiable information for marketing purposes and that such information cannot be used by pharmaceutical manufacturers to market their products. The statue permits other uses of the data, e.g., healthcare research.
The Court found that speech in the process of pharmaceutical marketing is a form of expression protected by the free speech clause of the first amendment. Therefore, the Vermont statue must be subjected to heightened judicial scrutiny of the reasons for the restrictions on speech.
Vermont's justification was that the law was necessary to protect medical privacy, avoid physician harassment by drug company representatives, and to preserve the integrity of the doctor-patient relationship. Vermont further argued that the statute is integral to its efforts to control healthcare costs and improve public health.
HEALTH News
Supreme Court Rules in Favor of Vaccine Manufacturers
SCOTUS makes it more difficult to sue manufacturers in autism cases.
By Meghan McCarthy
The Supreme Court Feb 22, 2011 ruled that vaccine companies cannot be sued for design defects, handing the pharmaceutical industry a victory and making it more difficult to bring cases against vaccine manufacturers for allegedly causing autism.
A 1986 law established a federal system for compensating patients injured by "unavoidable" side effects after being given a vaccine. The law aimed to make collecting damages for children injured by vaccines easier and faster by giving the Health and Human Services Department the authority to hear the cases and hand out compensation, funded by an excise tax on pharmaceutical companies making vaccines. President Obama’s fiscal 2012 budget estimated the vaccine fund would have $3 billion. The fund has paid out over $2.5 billion since its inception.
A ruling that allowed suits against the vaccine producers for a "design defect" might have opened up the pharmaceutical industry to thousands of cases alleging that vaccines caused autism in children.
The case heard by the Supreme Court, brought by Russell and Robalee Bruesewitz, alleged that their daughter Hannah was disabled by a diphtheria, tetanus, and pertussis (DTP) vaccine she received as an infant in 1992 manufactured by Lederle Laboratories, now owned by Pfizer Inc.’s Wyeth unit. After the family was denied compensation in the federal vaccine court in 1995, they filed the suit that ultimately reached the Supreme Court, charging that the defective design of the vaccine caused their daughter’s disabilities and that the company could be held liable for negligent design under Pennsylvania law.
Supreme Court Rejects Generic Drug Labeling Suits
Reuters by James Vicini June 23, 2011
(Reuters) - The Supreme Court ruled on Thursday that generic drug companies cannot be sued under state law over allegations that they failed to provide adequate label warnings about potential side effects.
By a 5-4 vote, the justices gave a victory to Israel's Teva Pharmaceutical Industries Ltd, Mylan Inc's UDL Laboratories and Iceland-based Actavis Inc by overturning U.S. appeals court rulings that allowed such lawsuits.
The companies argued that federal law barred such lawsuits because the drug had been approved by the U.S. Food and Drug Administration (FDA). Federal law requires generic drugs to have the same labels as their brand name equivalents.
Justice Clarence Thomas in the court's majority opinion agreed. He said federal drug regulations applicable to generic drug manufacturers directly conflicted with and thus pre-empted state lawsuits.
The Supreme Court decided a related issue in 2009 when it ruled FDA drug regulations do not protect pharmaceutical companies from being sued under state law over drug labeling, a case involving Pfizer Inc's Wyeth unit and its antinausea drug Phenergan.
But in the generic drug cases, the justices reversed separate U.S. appeals court rulings that the lawsuits against the companies could go forward.
The high court agreed with the arguments of the generic drug makers that they had no choice but to use the same drug labels as the brand manufacturer.
Teva, Actavis and the Generic Pharmaceutical Association hailed the ruling.
The court ruled 6-2 to uphold the ruling of the 3rd Circuit appellate court, finding that the federal law preempts all “design-defect claims” made against vaccine manufacturers. Justice Antonin Scalia, writing for the majority, said the statute only holds manufacturers liable for proper manufacturing and labeling, not for the actual design of the drug.
by Maria Buckley
On June 23, 2011, the Supreme Court in Sorrell, Attorney General of Vermont, et al. v. IMS Health Inc. et al1, struck down a Vermont law2 that bans the sale of physicians' prescribing information to pharmaceutical companies and further bans pharmaceutical companies from using such data to market their products. The Supreme Court's 6-3 opinion by Justice Kennedy found that the Vermont law unconstitutionally restricted the pharmaceutical companies' right to free speech.
Vermont's Prescription Confidentiality Law provides that absent the prescriber's consent, pharmacies and other related entities are prohibited from selling prescriber identifiable information for marketing purposes and that such information cannot be used by pharmaceutical manufacturers to market their products. The statue permits other uses of the data, e.g., healthcare research.
The Court found that speech in the process of pharmaceutical marketing is a form of expression protected by the free speech clause of the first amendment. Therefore, the Vermont statue must be subjected to heightened judicial scrutiny of the reasons for the restrictions on speech.
Vermont's justification was that the law was necessary to protect medical privacy, avoid physician harassment by drug company representatives, and to preserve the integrity of the doctor-patient relationship. Vermont further argued that the statute is integral to its efforts to control healthcare costs and improve public health.
HEALTH News
Supreme Court Rules in Favor of Vaccine Manufacturers
SCOTUS makes it more difficult to sue manufacturers in autism cases.
By Meghan McCarthy
The Supreme Court Feb 22, 2011 ruled that vaccine companies cannot be sued for design defects, handing the pharmaceutical industry a victory and making it more difficult to bring cases against vaccine manufacturers for allegedly causing autism.
A 1986 law established a federal system for compensating patients injured by "unavoidable" side effects after being given a vaccine. The law aimed to make collecting damages for children injured by vaccines easier and faster by giving the Health and Human Services Department the authority to hear the cases and hand out compensation, funded by an excise tax on pharmaceutical companies making vaccines. President Obama’s fiscal 2012 budget estimated the vaccine fund would have $3 billion. The fund has paid out over $2.5 billion since its inception.
A ruling that allowed suits against the vaccine producers for a "design defect" might have opened up the pharmaceutical industry to thousands of cases alleging that vaccines caused autism in children.
The case heard by the Supreme Court, brought by Russell and Robalee Bruesewitz, alleged that their daughter Hannah was disabled by a diphtheria, tetanus, and pertussis (DTP) vaccine she received as an infant in 1992 manufactured by Lederle Laboratories, now owned by Pfizer Inc.’s Wyeth unit. After the family was denied compensation in the federal vaccine court in 1995, they filed the suit that ultimately reached the Supreme Court, charging that the defective design of the vaccine caused their daughter’s disabilities and that the company could be held liable for negligent design under Pennsylvania law.
Supreme Court Rejects Generic Drug Labeling Suits
Reuters by James Vicini June 23, 2011
(Reuters) - The Supreme Court ruled on Thursday that generic drug companies cannot be sued under state law over allegations that they failed to provide adequate label warnings about potential side effects.
By a 5-4 vote, the justices gave a victory to Israel's Teva Pharmaceutical Industries Ltd, Mylan Inc's UDL Laboratories and Iceland-based Actavis Inc by overturning U.S. appeals court rulings that allowed such lawsuits.
The companies argued that federal law barred such lawsuits because the drug had been approved by the U.S. Food and Drug Administration (FDA). Federal law requires generic drugs to have the same labels as their brand name equivalents.
Justice Clarence Thomas in the court's majority opinion agreed. He said federal drug regulations applicable to generic drug manufacturers directly conflicted with and thus pre-empted state lawsuits.
The Supreme Court decided a related issue in 2009 when it ruled FDA drug regulations do not protect pharmaceutical companies from being sued under state law over drug labeling, a case involving Pfizer Inc's Wyeth unit and its antinausea drug Phenergan.
But in the generic drug cases, the justices reversed separate U.S. appeals court rulings that the lawsuits against the companies could go forward.
The high court agreed with the arguments of the generic drug makers that they had no choice but to use the same drug labels as the brand manufacturer.
Teva, Actavis and the Generic Pharmaceutical Association hailed the ruling.
The court ruled 6-2 to uphold the ruling of the 3rd Circuit appellate court, finding that the federal law preempts all “design-defect claims” made against vaccine manufacturers. Justice Antonin Scalia, writing for the majority, said the statute only holds manufacturers liable for proper manufacturing and labeling, not for the actual design of the drug.
Subscribe to:
Posts (Atom)




