But they were TOLD by both the Brits AND the FDA that and infant only study would not pass muster. They still went ahead and what happened? The Brits said fine, you can sell it here but we won't pay. Great business decision by NVD.
Novartis milestones be proud ! Management take a bow !
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But they were TOLD by both the Brits AND the FDA that and infant only study would not pass muster. They still went ahead and what happened? The Brits said fine, you can sell it here but we won't pay. Great business decision by NVD.
Larry Husten
7/30/2013 @ 11:16AM |2,511 views
More Bad News For Novartis Blood Pressure Drug
In the last few days more bad news about valsartan (Diovan, Novartis NVS -0.28%) has emerged in Japan. Another major study conducted in Japan– the Jikei Heart Study– will be retracted and Japanese health authorities said they were investigating severe skin reactions associated with use of the drug.
The new events are only the latest problems for the drug and Novartis. As reported previously, the current scandal first began to unfold in late 2011 when a Japanese blogger pointed to a number of apparent errors in publications authored by Matsubara. This ultimately led to a series of retractions of Matsubara papers and the retraction of the main paper of the Kyoto Heart Study itself. In February Matsubara resigned his position at Kyoto Prefectural University of Medicine. Earlier this month the Japanese health minister and officials at Kyoto Prefectural University of Medicine said that data from the Kyoto Heart Study had been fabricated.
Now a second large trial, the Jikei Heart Trial, will also be retracted. Questions had been raised earlier about this trial when it became known that Novartis employees had worked on both the Kyoto and the Jikei trials. The relationship of the employees to the company was not disclosed in the trial publications. Now, as reported in Pharmaceutical Processing, the first author of the Jikei Heart Trial, Seibu Mochizuki, has said that the trial, originally published in the Lancet in 2007, will be retracted.
Diovan Data Was Fabricated, Say Japanese Health Minister And University Officials
Novartis said that an independent investigation found no evidence that its employee who worked on the trial manipulated or altered the data. An official at Jikei University School of Medicine said that its own investigation had not ruled out such misconduct on the part of the former Novartis employee. The employee has denied such wrongdoing.
The Jikei investigation found that the blood pressure data used in the Lancet paper was different from the actual medical records.
In a separate development, the Japan Times reported that the Japanese health ministry was investigating reports of severe skin reactions linked to the use of valsartan.
7/30/2013 @ 11:16AM |2,511 views
More Bad News For Novartis Blood Pressure Drug
In the last few days more bad news about valsartan (Diovan, Novartis NVS -0.28%) has emerged in Japan. Another major study conducted in Japan– the Jikei Heart Study– will be retracted and Japanese health authorities said they were investigating severe skin reactions associated with use of the drug.
The new events are only the latest problems for the drug and Novartis. As reported previously, the current scandal first began to unfold in late 2011 when a Japanese blogger pointed to a number of apparent errors in publications authored by Matsubara. This ultimately led to a series of retractions of Matsubara papers and the retraction of the main paper of the Kyoto Heart Study itself. In February Matsubara resigned his position at Kyoto Prefectural University of Medicine. Earlier this month the Japanese health minister and officials at Kyoto Prefectural University of Medicine said that data from the Kyoto Heart Study had been fabricated.
Now a second large trial, the Jikei Heart Trial, will also be retracted. Questions had been raised earlier about this trial when it became known that Novartis employees had worked on both the Kyoto and the Jikei trials. The relationship of the employees to the company was not disclosed in the trial publications. Now, as reported in Pharmaceutical Processing, the first author of the Jikei Heart Trial, Seibu Mochizuki, has said that the trial, originally published in the Lancet in 2007, will be retracted.
Diovan Data Was Fabricated, Say Japanese Health Minister And University Officials
Novartis said that an independent investigation found no evidence that its employee who worked on the trial manipulated or altered the data. An official at Jikei University School of Medicine said that its own investigation had not ruled out such misconduct on the part of the former Novartis employee. The employee has denied such wrongdoing.
The Jikei investigation found that the blood pressure data used in the Lancet paper was different from the actual medical records.
In a separate development, the Japan Times reported that the Japanese health ministry was investigating reports of severe skin reactions linked to the use of valsartan.
National / Science & Health
Novartis ordered to state skin disorders as Diovan side effects
Aug 7, 2013
The health ministry has instructed Novartis Pharma K.K. to state in an attached note for its Diovan blood pressure-lowering drug that the medicine may cause serious skin disorders.
Diovan, whose generic name is valsartan, has been cited in a recent suspected case of clinical data manipulation, but the ministry said the instruction issued Tuesday is unrelated to it.
The drug’s possible side effects include five skin diseases — toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, pemphigus, and pemphigoid. All are serious drug rashes that may cause skin over the entire body to turn red, blister or develop sores.
The Health, Labor and Welfare Ministry said it decided on the move because there have been three cases in which a causal relationship between such skin disorders and the drug could not be ruled out from fiscal 2010 to 2012. It said there had also been an unspecified number of side effect cases before fiscal 2010.
Novartis ordered to state skin disorders as Diovan side effects
Aug 7, 2013
The health ministry has instructed Novartis Pharma K.K. to state in an attached note for its Diovan blood pressure-lowering drug that the medicine may cause serious skin disorders.
Diovan, whose generic name is valsartan, has been cited in a recent suspected case of clinical data manipulation, but the ministry said the instruction issued Tuesday is unrelated to it.
The drug’s possible side effects include five skin diseases — toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, pemphigus, and pemphigoid. All are serious drug rashes that may cause skin over the entire body to turn red, blister or develop sores.
The Health, Labor and Welfare Ministry said it decided on the move because there have been three cases in which a causal relationship between such skin disorders and the drug could not be ruled out from fiscal 2010 to 2012. It said there had also been an unspecified number of side effect cases before fiscal 2010.
Novartis drug shows no survival benefit in liver cancer
ZURICH | Wed Aug 7, 2013 3:30am EDT
(Reuters) - Swiss drugmaker Novartis said on Wednesday its drug Afinitor did not show a survival benefit in patients with advanced liver cancer.
Data from a late-stage trial found that Afinitor did not extend overall survival compared with placebo in patients with locally advanced or metastatic hepatocellular carcinoma (HCC), the most common type of liver cancer.
The study was examining the efficacy and safety of Afinitor, which is also known as everolimus, in patients whose disease had progressed after treatment with or were intolerant to Onyx and Bayer's drug Nexavar.
"While we are disappointed with these results, Novartis remains committed to studying everolimus through a robust research and development program to address unmet needs in different types of cancer," said Alessandro Riva, Global Head of Oncology Development & Medical Affairs at Novartis Oncology.
ZURICH | Wed Aug 7, 2013 3:30am EDT
(Reuters) - Swiss drugmaker Novartis said on Wednesday its drug Afinitor did not show a survival benefit in patients with advanced liver cancer.
Data from a late-stage trial found that Afinitor did not extend overall survival compared with placebo in patients with locally advanced or metastatic hepatocellular carcinoma (HCC), the most common type of liver cancer.
The study was examining the efficacy and safety of Afinitor, which is also known as everolimus, in patients whose disease had progressed after treatment with or were intolerant to Onyx and Bayer's drug Nexavar.
"While we are disappointed with these results, Novartis remains committed to studying everolimus through a robust research and development program to address unmet needs in different types of cancer," said Alessandro Riva, Global Head of Oncology Development & Medical Affairs at Novartis Oncology.
http://www.bloomberg.com/news/2013-...ying-china-doctors-kickbacks-herald-says.html
Sandostatin
http://www.fiercepharma.com/story/novartis-under-us-scrutiny-gilenya-marketing-tactics/2013-07-18
Gilenya
The story should be what drug does Novartis promote without kickbacks ????
Sandostatin
http://www.fiercepharma.com/story/novartis-under-us-scrutiny-gilenya-marketing-tactics/2013-07-18
Gilenya
The story should be what drug does Novartis promote without kickbacks ????
Thu Aug 29, 2013 4:38pm BST
(Reuters) - The U.S. Food and Drug Administration said it was investigating a case of a rare and serious brain infection that developed in a patient in Europe, who was being treated with Novartis's multiple sclerosis drug, Gilenya.
The FDA said this was the first instance of the infection, called progressive multifocal leukoencephalopathy (PML), being reported in a Gilenya patient, who had not previously received Biogen Idec's Tysabri. (r.reuters.com/xuc72v)
Tysabri is another multiple sclerosis (MS) drug associated with a high risk of PML. Demand for the drug has slowed due to concerns over the potentially fatal infection.
(Reuters) - The U.S. Food and Drug Administration said it was investigating a case of a rare and serious brain infection that developed in a patient in Europe, who was being treated with Novartis's multiple sclerosis drug, Gilenya.
The FDA said this was the first instance of the infection, called progressive multifocal leukoencephalopathy (PML), being reported in a Gilenya patient, who had not previously received Biogen Idec's Tysabri. (r.reuters.com/xuc72v)
Tysabri is another multiple sclerosis (MS) drug associated with a high risk of PML. Demand for the drug has slowed due to concerns over the potentially fatal infection.
FDA issues warning on Multiple Sclerosis drug
Gilenya after PML case emerges
Brie Zeltner, The Plain Dealer By Brie Zeltner, The Plain Dealer
on August 30, 2013 at 12:00 PM, updated August 30, 2013 at 12:14 PM
CLEVELAND, Ohio-- The Food and Drug Administration (FDA) has issued a warning for patients who take the multiple sclerosis drug fingolimod, sold under the brand name Gilenya by the Swiss pharmaceutical company Novartis after a patient taking the drug developed a rare but serious brain infection.
The FDA’s alert, posted Aug. 29, refers to a single patient in Europe who took Gilenya for eight months and was diagnosed with progressive multifocal leukoencephalopathy, or PML. PML is an infection caused by a virus (called JC) that damages the fatty protective covering of the nerves in the brain. This protective covering, called myelin, acts as insulation around the nerve fibers and is essential for the rapid and efficient relay of nerve signals
Anyone who has experienced a potential adverse event associated with the drug Gilenya is urged to report it to the FDA’s MedWatch program online, by mail at MedWatch, 5600 Fishers Lane, Rockville, MD 20857, or by calling 1-800-332-1088.
Gilenya after PML case emerges
Brie Zeltner, The Plain Dealer By Brie Zeltner, The Plain Dealer
on August 30, 2013 at 12:00 PM, updated August 30, 2013 at 12:14 PM
CLEVELAND, Ohio-- The Food and Drug Administration (FDA) has issued a warning for patients who take the multiple sclerosis drug fingolimod, sold under the brand name Gilenya by the Swiss pharmaceutical company Novartis after a patient taking the drug developed a rare but serious brain infection.
The FDA’s alert, posted Aug. 29, refers to a single patient in Europe who took Gilenya for eight months and was diagnosed with progressive multifocal leukoencephalopathy, or PML. PML is an infection caused by a virus (called JC) that damages the fatty protective covering of the nerves in the brain. This protective covering, called myelin, acts as insulation around the nerve fibers and is essential for the rapid and efficient relay of nerve signals
Anyone who has experienced a potential adverse event associated with the drug Gilenya is urged to report it to the FDA’s MedWatch program online, by mail at MedWatch, 5600 Fishers Lane, Rockville, MD 20857, or by calling 1-800-332-1088.
Novartis Downgraded by Barclays Capital to Underweight (NVS)
Posted by John Perry on Sep 16th, 2013
Novartis (NYSE:NVS) was downgraded by investment analysts at Barclays Capital to an “underweight” rating in a note issued to investors on Monday, American Banking News reports.
Posted by John Perry on Sep 16th, 2013
Novartis (NYSE:NVS) was downgraded by investment analysts at Barclays Capital to an “underweight” rating in a note issued to investors on Monday, American Banking News reports.
September 17, 2013 11:30 am
Novartis’s Alcon embroiled in Chinese corruption allegations
By Patti Waldmeir in Shanghai
Alcon Contact Lens Products©Bloomberg
Alcon, the eyecare division of Novartis, said it would investigate claims it used fake clinical trials to bribe doctors in China, the latest in what has become a steady stream of corruption allegations against mostly foreign pharmaceutical groups in the country. ...
Novartis’s Alcon embroiled in Chinese corruption allegations
By Patti Waldmeir in Shanghai
Alcon Contact Lens Products©Bloomberg
Alcon, the eyecare division of Novartis, said it would investigate claims it used fake clinical trials to bribe doctors in China, the latest in what has become a steady stream of corruption allegations against mostly foreign pharmaceutical groups in the country. ...
Off label promotion is the mother of Novartis' (and bigpharmafia's) criminal activity. Fake clinical & other trials is another big one they have used for decades. These done in China may be as same as those done in Canada under the name Diovantage and Destination during the hight of criminal promotion of Diovan. These were fake Post Marketing Trials in which the doctors were paid off to Rx Diovan to anyone with even trace of increased BP. No paper work was needed only the Rx of Diovan. By conservative esimate Novartis Canada Inc has stolen at least $400 million( equal to $4 billion in USA) from their public health care via these two fake trials. Finally after 8 years of doing this crime, someone from another Co complained to Rx&D ( their pharma biz self governing body/club) and Novartis was ordered to stop shit and paid grand total of $10.000 in fine. Yes not 10, 100 or 1000 millions as it would happen in USA but only $10.000. So you can imagine that they continue to do the same crimes with impunity in Canada. This Co is such a criminal entity that no mafia can even come close to them. They do it all over the World and the fines they pay are just another cost of doing their evil biz. Even in USA where they already paid over 1/2 Billion in fines they did not stop use of illegal/criminal practices. WHY? It is too profiitable and too addictive for them to EVER stop. Only if they start serving some long time in jails or get shot in China ( there they execute criminals for financial crimes) they may consider giving it up.
As the man used to say, do not let these criminal bastards go on with their crime. Do something. At least if you have the evidence blow the whistle, do the right thing and get rewarded for it. It's the right thing to do.
BWAHAHAHAHAH like BP after the Gulf Spill , We're Sowwy 
do like southpark & have Epstein naked on a bear rug saying we're sowwy
Novartis says "deep regret" over Japan drug trials scandal
By Sophie Knight
TOKYO, Sept 26 | Thu Sep 26, 2013 12:43pm BST
(Reuters) - The pharmaceutical head at Swiss firm Novartis AG apologised to the Japanese public for alleged manipulation of data in trials of its best-selling blood pressure drug Diovan, saying an employee had acted inappropriately.
Divisional head David Epstein made the comments after meeting with Japanese health minister Norihisa Tamura in Tokyo. He agreed to cooperate with the ministry to resolve the issue.
"We express our deep regret for the concern that the issue has brought to patients, to the medical society as well as the ministry," Epstein said.
"We are very willing to work with them and take additional actions and potential sanctions in order to bring the issue to a good conclusion," he added, but said he could not specify the type of sanctions ahead of the release of the ministry's findings at the end of this month.
Several Japanese hospitals have stopped offering Diovan after two universities retracted papers printed in foreign medical journals on the drug's efficacy for preventing strokes and heart disease. The other three universities that published research on Diovan are still investigating the matter.
Epstein said that a former Novartis employee who assisted in all five trials had acted "way beyond what we consider appropriate" and that the company had responded by strengthening its training and oversight procedures at Novartis Pharma, its Japanese arm, under new head Yoshiyasu Ninomiya.
Japan is an important market for Novartis, accounting for around a quarter of Diovan's global sales before the scandal. Novartis Pharma declined to disclose the impact on sales of the drug, whose patent is due to end in Japan later this year, allowing competition from generic copycats.
Novartis says the drug is effective for reducing blood pressure and says patients should consult their doctors before they stop taking it. (Editing by Ben Hirschler)
do like southpark & have Epstein naked on a bear rug saying we're sowwy
Novartis says "deep regret" over Japan drug trials scandal
By Sophie Knight
TOKYO, Sept 26 | Thu Sep 26, 2013 12:43pm BST
(Reuters) - The pharmaceutical head at Swiss firm Novartis AG apologised to the Japanese public for alleged manipulation of data in trials of its best-selling blood pressure drug Diovan, saying an employee had acted inappropriately.
Divisional head David Epstein made the comments after meeting with Japanese health minister Norihisa Tamura in Tokyo. He agreed to cooperate with the ministry to resolve the issue.
"We express our deep regret for the concern that the issue has brought to patients, to the medical society as well as the ministry," Epstein said.
"We are very willing to work with them and take additional actions and potential sanctions in order to bring the issue to a good conclusion," he added, but said he could not specify the type of sanctions ahead of the release of the ministry's findings at the end of this month.
Several Japanese hospitals have stopped offering Diovan after two universities retracted papers printed in foreign medical journals on the drug's efficacy for preventing strokes and heart disease. The other three universities that published research on Diovan are still investigating the matter.
Epstein said that a former Novartis employee who assisted in all five trials had acted "way beyond what we consider appropriate" and that the company had responded by strengthening its training and oversight procedures at Novartis Pharma, its Japanese arm, under new head Yoshiyasu Ninomiya.
Japan is an important market for Novartis, accounting for around a quarter of Diovan's global sales before the scandal. Novartis Pharma declined to disclose the impact on sales of the drug, whose patent is due to end in Japan later this year, allowing competition from generic copycats.
Novartis says the drug is effective for reducing blood pressure and says patients should consult their doctors before they stop taking it. (Editing by Ben Hirschler)
Japan to raid Novartis over alleged data fabrication
(Globalpost/GlobalPost)
Japanese authorities are preparing to raid the local arm of Swiss pharmaceutical giant Novartis over data fabrication claims, reports said Friday.
A health ministry panel of experts has concluded that Novartis Pharma KK should be held responsible for studies at various universities that used manipulated data on a popular blood pressure drug, the Asahi Shimbun and other media said.
The studies suggested the drug -- sold under the name Diovan in Japan and licensed for use in more than 100 countries -- had some prophylactic effect on strokes and angina.
The firm used data from the studies to market its drug, playing up its supposed additional benefits.
"The panel is examining the possibility of exaggerated advertisement which is a violation of the Pharmaceutical Affairs Act and will urge the government to take strict actions," against Novartis Pharma KK, the Asahi said.
Upon receipt of the panel's interim report next week, "the health ministry plans to carry out an on-site investigation" into the company, the Asahi said.
The panel's report will also say the company and the universities must be held accountable for the faulty studies, regardless of the degree of their involvement, the Mainichi Shimbun said.
The panel will also urge the authorities to estimate the financial impact of the studies on the nation's health insurance finances, the Mainichi said.
Novartis has maintained that the company had no knowledge of episodes in which a now-former employee allegedly used bogus data in a string of Japanese university studies that exaggerated the drug's effectiveness in preventing strokes and angina.
The worker had hidden his affiliation with Novartis during the studies at various institutions that used incomplete clinical data to demonstrate the effects of the drug, hospitals and media reports have said.
The worker and other researchers involved in studies have denied to the panel that they manipulated the data, the Mainichi previously said.
Novartis Pharmaceuticals chief David Epstein was called to meet with Health Minister Norihisa Tamura and promised Thursday to cooperate with Tokyo's probe into the matter.
Epstein apologised for the concern the incident has caused, but did not admit the company's role in the data fixing allegations, a company spokeswoman said.
Tokyo's Jikei University School of Medicine has retracted research that appeared in respected medical journal The Lancet six years ago due to data fabrication.
Kyoto Prefectural University of Medicine also concluded that its studies on the drug used incomplete clinical data.
(Globalpost/GlobalPost)
Japanese authorities are preparing to raid the local arm of Swiss pharmaceutical giant Novartis over data fabrication claims, reports said Friday.
A health ministry panel of experts has concluded that Novartis Pharma KK should be held responsible for studies at various universities that used manipulated data on a popular blood pressure drug, the Asahi Shimbun and other media said.
The studies suggested the drug -- sold under the name Diovan in Japan and licensed for use in more than 100 countries -- had some prophylactic effect on strokes and angina.
The firm used data from the studies to market its drug, playing up its supposed additional benefits.
"The panel is examining the possibility of exaggerated advertisement which is a violation of the Pharmaceutical Affairs Act and will urge the government to take strict actions," against Novartis Pharma KK, the Asahi said.
Upon receipt of the panel's interim report next week, "the health ministry plans to carry out an on-site investigation" into the company, the Asahi said.
The panel's report will also say the company and the universities must be held accountable for the faulty studies, regardless of the degree of their involvement, the Mainichi Shimbun said.
The panel will also urge the authorities to estimate the financial impact of the studies on the nation's health insurance finances, the Mainichi said.
Novartis has maintained that the company had no knowledge of episodes in which a now-former employee allegedly used bogus data in a string of Japanese university studies that exaggerated the drug's effectiveness in preventing strokes and angina.
The worker had hidden his affiliation with Novartis during the studies at various institutions that used incomplete clinical data to demonstrate the effects of the drug, hospitals and media reports have said.
The worker and other researchers involved in studies have denied to the panel that they manipulated the data, the Mainichi previously said.
Novartis Pharmaceuticals chief David Epstein was called to meet with Health Minister Norihisa Tamura and promised Thursday to cooperate with Tokyo's probe into the matter.
Epstein apologised for the concern the incident has caused, but did not admit the company's role in the data fixing allegations, a company spokeswoman said.
Tokyo's Jikei University School of Medicine has retracted research that appeared in respected medical journal The Lancet six years ago due to data fabrication.
Kyoto Prefectural University of Medicine also concluded that its studies on the drug used incomplete clinical data.
The big money question, "The ministry’s panel, which is probing the drugmaker’s involvement and how data manipulation occurred, also said it found a conflict of interest regarding funds given by Novartis to Jikei and Kyoto Prefectural universities."
If the panel finds that Novartis actively manipulated the data then used it to promote the drug - nuclear meltdown levels of risk to fines. Not only did they make money off of conrived data they caused harm to millions who paid for this drug as treatment which is a fraud when they could have been seeking other treatments that might have been more successful - full on harm!
Japan confirms Novartis clinical trial data fabrication
1 October 2013 Emma Stoye
Japan’s ministry of health has concluded that studies based on clinical trials for Novartis’s blood pressure drug Diovan contain manipulated data. It is now investigating whether the company has broken Japanese law by citing these studies to promote the product.
Diovan was approved for use in Japan in 2000, but recently two universities who hosted and analysed trials for Novartis – the Kyoto Prefectural University of Medicine and Jikei University School of Medicine – reported finding evidence of data fabrication. In August, the ministry of health launched an investigation, which has led to the retraction of several papers relating to Diovan’s ability to prevent angina and stroke. Some hospitals have stopped offering the drug, and investigations are now underway at three other universities that hosted Diovan clinical trials.
It is not yet clear who is responsible. As the investigation continues, officials at both Novartis HQ in Switzerland and Novartis Pharma KK, the Japanese subsidiary, have pledged their cooperation.
1 October 2013 Emma Stoye
Japan’s ministry of health has concluded that studies based on clinical trials for Novartis’s blood pressure drug Diovan contain manipulated data. It is now investigating whether the company has broken Japanese law by citing these studies to promote the product.
Diovan was approved for use in Japan in 2000, but recently two universities who hosted and analysed trials for Novartis – the Kyoto Prefectural University of Medicine and Jikei University School of Medicine – reported finding evidence of data fabrication. In August, the ministry of health launched an investigation, which has led to the retraction of several papers relating to Diovan’s ability to prevent angina and stroke. Some hospitals have stopped offering the drug, and investigations are now underway at three other universities that hosted Diovan clinical trials.
It is not yet clear who is responsible. As the investigation continues, officials at both Novartis HQ in Switzerland and Novartis Pharma KK, the Japanese subsidiary, have pledged their cooperation.
Wow the fraud merry go round never stops, even to take a breath at Novartis.
Bernstein Liebhard LLP Announces That A Class Action Has Been Filed Against BioScrip, Inc.
By Bernstein Liebhard LLP
Published: Friday, Oct. 4, 2013 - 7:11 am
NEW YORK, Oct. 4, 2013 -- /PRNewswire/ -- Bernstein Liebhard LLP today announced that a class action has been commenced in the United States District Court for the Southern District of New York on behalf of all those who purchased securities of BioScrip, Inc. (NASDAQ: BIOS) ("BioScrip" or the "Company") between August 8, 2011 through September 20, 2013, inclusive (the "Class Period").
BioScrip is a pharmacy benefit management and specialty pharmaceutical organization that partners with managed care organizations and healthcare providers to control prescription drug costs. The Company provides pharmacy benefit products and services and mail order pharmacy services, and is the fulfillment center for online retailers offering prescription and OTC products.
The Complaint alleges that throughout the Class Period, Defendants made false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (1) the Company improperly distributed the product Exjade through its specialty pharmacy operations; (2) the Company was in violation of certain federal and state laws and regulations; and (3) as a result of the foregoing, the Company's statements were materially false and misleading at all relevant times.
On September 23, 2013, the Company announced in a Form 8-K, that it received a civil investigative demand issued by the United States Attorney's Office for the Southern District of New York and a subpoena from the New York State Attorney General's Medicaid Fraud Control Unit, regarding the distribution of the Novartis Pharmaceuticals Corporation product Exjade by the Company's legacy specialty pharmacy division.
Read more here: http://www.sacbee.com/2013/10/04/5793959/bernstein-liebhard-llp-announces.html#storylink=cpy
Bernstein Liebhard LLP Announces That A Class Action Has Been Filed Against BioScrip, Inc.
By Bernstein Liebhard LLP
Published: Friday, Oct. 4, 2013 - 7:11 am
NEW YORK, Oct. 4, 2013 -- /PRNewswire/ -- Bernstein Liebhard LLP today announced that a class action has been commenced in the United States District Court for the Southern District of New York on behalf of all those who purchased securities of BioScrip, Inc. (NASDAQ: BIOS) ("BioScrip" or the "Company") between August 8, 2011 through September 20, 2013, inclusive (the "Class Period").
BioScrip is a pharmacy benefit management and specialty pharmaceutical organization that partners with managed care organizations and healthcare providers to control prescription drug costs. The Company provides pharmacy benefit products and services and mail order pharmacy services, and is the fulfillment center for online retailers offering prescription and OTC products.
The Complaint alleges that throughout the Class Period, Defendants made false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (1) the Company improperly distributed the product Exjade through its specialty pharmacy operations; (2) the Company was in violation of certain federal and state laws and regulations; and (3) as a result of the foregoing, the Company's statements were materially false and misleading at all relevant times.
On September 23, 2013, the Company announced in a Form 8-K, that it received a civil investigative demand issued by the United States Attorney's Office for the Southern District of New York and a subpoena from the New York State Attorney General's Medicaid Fraud Control Unit, regarding the distribution of the Novartis Pharmaceuticals Corporation product Exjade by the Company's legacy specialty pharmacy division.
Read more here: http://www.sacbee.com/2013/10/04/5793959/bernstein-liebhard-llp-announces.html#storylink=cpy
Pharma & Healthcare 10/05/2013 @ 7:38AM |416 views
Should Drugmakers Pay Punitive Damages? Novartis Says No
Should a drugmaker not have to pay punitive damages for product liability because such penalties encroach on the ability of the FDA to enforce its authority? This is the question that Novartis hopes the US Supreme Court will answer in its upcoming session, although whether the justices will agree to review the issue is unclear. A decision may be known this coming week.
In arguing for a review, Novartis cites a 2009 ruling by the Supreme Court that a Vermont woman named Diana Levine had the right to sue Wyeth, which is now owned by Pfizer, in state court after alleging damage caused by one if its drugs. The drugmaker unsuccessfully cited preemption, which is the notion that FDA approval of a drug supersedes state law claims challenging safety, efficacy or labeling (some background).
The ruling marked a watershed in the pharmaceutical industry, but Novartis maintains the decision does not apply to punitive damages, because the Levine case only involved compensatory damages. And Novartis is raising the issue following a 2010 case in which a North Carolina jury awarded a family $12.6 million for alleged misconduct in punitive damages, although that was later reduced to $867,00 under state law caps.
In that case, the jury decided that Novartis failed to adequately warn about the risks of its Zometa and Aredia bone-strengthening medications taken by Rita Fussman, who died four years ago of breast cancer. And a federal court judge later upheld punitive damages after reviewing evidence that suggested the drugmaker engaged in a high-level cover up concerning side effects.
“Based on the evidence presented, the court concludes that sufficient evidence was presented to support a finding by the jury, by clear and convincing evidence, that Novartis managers intentionally concealed the risk of ONJ (osteonecrosis of the jaw) and attempted to subvert the medical inquiry regarding the risks of ONJ, all with the knowledge and approval of high-ranking officials within the company,” US District Court Judge James Beaty wrote two years ago (back story).
Novartis subsequently lost an appeal, but now hopes that the Supreme Court will agree that allowing punitive damages undermines the Food, Drug & Cosmetic Act and calls into question the ability of the FDA to enforce product labeling and wayward behavior committed by drugmakers. Novartis, meanwhile, maintains that private citizens may participate in agency enforcement by filing a citizen’s petition.
“The FDA retains complete discretion to decide how and whether to proceed against a drug company for alleged misconduct,” the drugmaker writes in its brief. “…Punitive damages awards impermissibly conflict with this federal scheme by placing enforcement discretion in the hands of tort plaintiffs who act as a private attorney general under the law.” Novartis also goes on to argue that punitive damages awards can greatly exceed the fines that the FDA can levy (this is the Novartis court filing).
In response, the Fussman family legal team argues that “the punitive damages here were not awarded to punish Novartis for violating FDA requirements. They were awarded to punish Novartis for deception and disregard that caused significant pain and injury to Mrs. Fussman and to deter such conduct in the future,” they write in their own brief to the court. An award in these circumstances is fully consistent with the FDA’s goal of protecting patients from harmful drugs and its objective that a drug’s labeling disclose adverse events associated with it” (this is the complete reply).
They also note that the appeals courts have not been divided on the issue, suggesting that there is no judicial disagreement over whether punitive damages awards should be preempted. Meanwhile, Novartis has support from the Pharmaceutical Research and Manufacturers of America, the industry trade group, which filed a friend-of-the-court brief.
Should Drugmakers Pay Punitive Damages? Novartis Says No
Should a drugmaker not have to pay punitive damages for product liability because such penalties encroach on the ability of the FDA to enforce its authority? This is the question that Novartis hopes the US Supreme Court will answer in its upcoming session, although whether the justices will agree to review the issue is unclear. A decision may be known this coming week.
In arguing for a review, Novartis cites a 2009 ruling by the Supreme Court that a Vermont woman named Diana Levine had the right to sue Wyeth, which is now owned by Pfizer, in state court after alleging damage caused by one if its drugs. The drugmaker unsuccessfully cited preemption, which is the notion that FDA approval of a drug supersedes state law claims challenging safety, efficacy or labeling (some background).
The ruling marked a watershed in the pharmaceutical industry, but Novartis maintains the decision does not apply to punitive damages, because the Levine case only involved compensatory damages. And Novartis is raising the issue following a 2010 case in which a North Carolina jury awarded a family $12.6 million for alleged misconduct in punitive damages, although that was later reduced to $867,00 under state law caps.
In that case, the jury decided that Novartis failed to adequately warn about the risks of its Zometa and Aredia bone-strengthening medications taken by Rita Fussman, who died four years ago of breast cancer. And a federal court judge later upheld punitive damages after reviewing evidence that suggested the drugmaker engaged in a high-level cover up concerning side effects.
“Based on the evidence presented, the court concludes that sufficient evidence was presented to support a finding by the jury, by clear and convincing evidence, that Novartis managers intentionally concealed the risk of ONJ (osteonecrosis of the jaw) and attempted to subvert the medical inquiry regarding the risks of ONJ, all with the knowledge and approval of high-ranking officials within the company,” US District Court Judge James Beaty wrote two years ago (back story).
Novartis subsequently lost an appeal, but now hopes that the Supreme Court will agree that allowing punitive damages undermines the Food, Drug & Cosmetic Act and calls into question the ability of the FDA to enforce product labeling and wayward behavior committed by drugmakers. Novartis, meanwhile, maintains that private citizens may participate in agency enforcement by filing a citizen’s petition.
“The FDA retains complete discretion to decide how and whether to proceed against a drug company for alleged misconduct,” the drugmaker writes in its brief. “…Punitive damages awards impermissibly conflict with this federal scheme by placing enforcement discretion in the hands of tort plaintiffs who act as a private attorney general under the law.” Novartis also goes on to argue that punitive damages awards can greatly exceed the fines that the FDA can levy (this is the Novartis court filing).
In response, the Fussman family legal team argues that “the punitive damages here were not awarded to punish Novartis for violating FDA requirements. They were awarded to punish Novartis for deception and disregard that caused significant pain and injury to Mrs. Fussman and to deter such conduct in the future,” they write in their own brief to the court. An award in these circumstances is fully consistent with the FDA’s goal of protecting patients from harmful drugs and its objective that a drug’s labeling disclose adverse events associated with it” (this is the complete reply).
They also note that the appeals courts have not been divided on the issue, suggesting that there is no judicial disagreement over whether punitive damages awards should be preempted. Meanwhile, Novartis has support from the Pharmaceutical Research and Manufacturers of America, the industry trade group, which filed a friend-of-the-court brief.
"Mind boggling twisted logic": what can one expect from company that has invented use of crime as business practice. Novartis is a leading bigpharmafia company that invented and implemented the so called commbination model of modus operandi that includes both legal and illegal practices. They have known for decades that by using both legal/acceptable biz practices and illegal/criminal ones in their appoach of doing biz, is much more effective and profitable than using either approach alone. When commbined these two ingredients make one plus one three.(1+1=3) Vasella was behind this 1100% and it will be one of his legacies of crime and plunder of the company and health care systems everywhere, be they private or public.To read more go to: Whisteleblowers, BPO and even Canadian board.
Nothing is suprising what this Co did or does. The crime continues inspite of fines they paid and will pay. It is simply a company culture that can be changed only if and when the current protagonists are sent ot jails around the world and those replacing them get scared of same blowback.
Novartis' Sandoz Infringed On Pfizer Eye Drug Patents: Judge
Law360, Los Angeles (October 04, 2013, 9:07 PM ET) -- A New Jersey federal judge ruled Friday that Sandoz Inc. violated four patents owned by Pfizer Inc. and InSite Vision Inc. when it tried to bring to market a generic version of AzaSite azithromycin eye drops, which are used as a bacterial conjunctivitis treatment.
Judge Cooper said Friday that Sandoz, which is owned by Novartis AG, infringed two claims of U.S. Patent Number 6,861,411; four claims of U.S. Patent Number 6,239,113; two claims of U.S. Patent Number 6,569,443; and 10 claims of U.S. Patent Number 7,056,893....
Law360, Los Angeles (October 04, 2013, 9:07 PM ET) -- A New Jersey federal judge ruled Friday that Sandoz Inc. violated four patents owned by Pfizer Inc. and InSite Vision Inc. when it tried to bring to market a generic version of AzaSite azithromycin eye drops, which are used as a bacterial conjunctivitis treatment.
Judge Cooper said Friday that Sandoz, which is owned by Novartis AG, infringed two claims of U.S. Patent Number 6,861,411; four claims of U.S. Patent Number 6,239,113; two claims of U.S. Patent Number 6,569,443; and 10 claims of U.S. Patent Number 7,056,893....
In a setback to Novartis, the US Supreme Court has decided not to review a case in which the drugmaker argued that punitive damages should not be awarded by juries in product liability lawsuits. Why? Novartis hoped to convince the court that such penalties purportedly encroach on the ability of the FDA to enforce its authority.
As we wrote last week, Novartis cited a 2009 ruling by the Supreme Court that a Vermont woman named Diana Levine had the right to sue Wyeth, which is now owned by Pfizer (PFE), in state court after alleging damage caused by one if its drugs. The drugmaker unsuccessfully cited preemption, which is the notion that FDA approval of a drug supersedes state law claims challenging safety, efficacy or labeling (more here).
But, as we noted, Novartis maintained the decision did not apply to punitive damages, because the Levine case only involved compensatory damages. And Novartis raised the issue following a 2010 case in which a North Carolina jury awarded a family $12.6 million for alleged misconduct in punitive damages, although that was later reduced to $867,00 under state law caps.
In that case, the jury decided that Novartis failed to adequately warn about the risks of its Zometa and Aredia bone-strengthening medications taken by Rita Fussman, who died four years ago of breast cancer. And a federal court judge later upheld punitive damages after reviewing evidence that suggested the drugmaker engaged in a high-level cover up concerning side effects.
Novartis subsequently lost an appeal, but had hoped that the Supreme Court would agree that allowing punitive damages undermines the Food, Drug & Cosmetic Act and calls into question the ability of the FDA to enforce product labeling and wayward behavior committed by drugmakers. Novartis, meanwhile, maintained that private citizens may participate in agency enforcement by filing a citizen’s petition (this is the argument that Novartis filed with the Supreme Court).
But no such luck. The court denied its petition without comment (see page 12). A Novartis (NVS) spokeswoman sent us a note say the drugmaker petitioned the court “because the case poses an important issue not previously addressed by the court… The key issue is that the jury awarded the plaintiff punitive damages despite the fact that the company was consistently in compliance with the FDA-approved prescription drug labeling.”
“…We are disappointed that the (court) has denied the Novartis petition and that we won’t have the opportunity to present our case to the court at this time… The ability for juries to impose punitive damages against FDA-compliant manufacturers of prescription drugs threatens the availability of necessary and often life-saving medications for patients around the world. Novartis believes that the Fussman petition took an important first step in raising this issue with the court, and we anticipate that the court will address the arguments raised in the petition in the future.”
As for the Fussman legal team, John Vecchione sent us this: “The proposition that mere federal regulation immunizes a company from punitive damages apparently did not even attract four votes for review of the issue. Another plus for plaintiffs from Novartis's certiorari petition is the federal district courts now have a blue print for approaching these cases as (US District Court) Judge Beaty did, with firm confidence that they will be upheld upon review even to the highest court in the land.”
He adds that the decision is also significant for another reason - there are verdicts and judgments “larger than that at issue in Fussman pending against Novartis, from California, to New York to Florida.” The suggestion? More punitive payouts on the horizon.
Naughty Naughty! LOL
As we wrote last week, Novartis cited a 2009 ruling by the Supreme Court that a Vermont woman named Diana Levine had the right to sue Wyeth, which is now owned by Pfizer (PFE), in state court after alleging damage caused by one if its drugs. The drugmaker unsuccessfully cited preemption, which is the notion that FDA approval of a drug supersedes state law claims challenging safety, efficacy or labeling (more here).
But, as we noted, Novartis maintained the decision did not apply to punitive damages, because the Levine case only involved compensatory damages. And Novartis raised the issue following a 2010 case in which a North Carolina jury awarded a family $12.6 million for alleged misconduct in punitive damages, although that was later reduced to $867,00 under state law caps.
In that case, the jury decided that Novartis failed to adequately warn about the risks of its Zometa and Aredia bone-strengthening medications taken by Rita Fussman, who died four years ago of breast cancer. And a federal court judge later upheld punitive damages after reviewing evidence that suggested the drugmaker engaged in a high-level cover up concerning side effects.
Novartis subsequently lost an appeal, but had hoped that the Supreme Court would agree that allowing punitive damages undermines the Food, Drug & Cosmetic Act and calls into question the ability of the FDA to enforce product labeling and wayward behavior committed by drugmakers. Novartis, meanwhile, maintained that private citizens may participate in agency enforcement by filing a citizen’s petition (this is the argument that Novartis filed with the Supreme Court).
But no such luck. The court denied its petition without comment (see page 12). A Novartis (NVS) spokeswoman sent us a note say the drugmaker petitioned the court “because the case poses an important issue not previously addressed by the court… The key issue is that the jury awarded the plaintiff punitive damages despite the fact that the company was consistently in compliance with the FDA-approved prescription drug labeling.”
“…We are disappointed that the (court) has denied the Novartis petition and that we won’t have the opportunity to present our case to the court at this time… The ability for juries to impose punitive damages against FDA-compliant manufacturers of prescription drugs threatens the availability of necessary and often life-saving medications for patients around the world. Novartis believes that the Fussman petition took an important first step in raising this issue with the court, and we anticipate that the court will address the arguments raised in the petition in the future.”
As for the Fussman legal team, John Vecchione sent us this: “The proposition that mere federal regulation immunizes a company from punitive damages apparently did not even attract four votes for review of the issue. Another plus for plaintiffs from Novartis's certiorari petition is the federal district courts now have a blue print for approaching these cases as (US District Court) Judge Beaty did, with firm confidence that they will be upheld upon review even to the highest court in the land.”
He adds that the decision is also significant for another reason - there are verdicts and judgments “larger than that at issue in Fussman pending against Novartis, from California, to New York to Florida.” The suggestion? More punitive payouts on the horizon.
Naughty Naughty! LOL