Obesity Drug Risks prompts new Drug Disclosure Rule
The increase of computer-centered professions and extended working hours has led to a decrease of physical activity and many missed exercise times. As government-sponsored initiatives have placed childhood and adult obesity into the spotlights, it stands to reason that consumers want to shed the excess weight – quickly. Diet pills hold the most promise, but there is a danger that lurks behind the ease of popping just a few pills.
For starters, Bloomberg reports that the (now defunct) European drug “Acomplia” actually cam with a suicide risk. American drugs haven’t fared much better and if Abbott Laboratories’ “Meridia” is any indication, the pill-induced increase in heart rate for those whose hearts may already be adversely impacted by excessive weight gain makes for a dangerous combination. Even “Xenical” has its detractors, even if their criticism is only associated with loose bowl movements that the consumer may be incapable of controlling.
Adding insult to injury, there are some rumblings that drug makers have been aware of the problems associated with their drugs but failed to inform the consumer of the extent that they may experience them. Even as drug manufacturers are completely honest with drug regulators, their consumer disclosure practices leave something to be desired.
There is a fine line between divulging trade secrets, which would adversely impact the manufacturers’ ability to realize a commercial gain from their drugs, and disclosing the full depth and breadth of possible side effects, which would enable consumers to do their own benefit analysis. Even as drug makers are eyeing this level of disclosure with apprehension, there is the realization that playing their cards close to the vest is no longer fiscally wise.
Continue Reading...
For starters, Bloomberg reports that the (now defunct) European drug “Acomplia” actually cam with a suicide risk. American drugs haven’t fared much better and if Abbott Laboratories’ “Meridia” is any indication, the pill-induced increase in heart rate for those whose hearts may already be adversely impacted by excessive weight gain makes for a dangerous combination. Even “Xenical” has its detractors, even if their criticism is only associated with loose bowl movements that the consumer may be incapable of controlling.
Adding insult to injury, there are some rumblings that drug makers have been aware of the problems associated with their drugs but failed to inform the consumer of the extent that they may experience them. Even as drug manufacturers are completely honest with drug regulators, their consumer disclosure practices leave something to be desired.
There is a fine line between divulging trade secrets, which would adversely impact the manufacturers’ ability to realize a commercial gain from their drugs, and disclosing the full depth and breadth of possible side effects, which would enable consumers to do their own benefit analysis. Even as drug makers are eyeing this level of disclosure with apprehension, there is the realization that playing their cards close to the vest is no longer fiscally wise.
Pre term Labor Drug, Makena: Spikes in Price for Pregnant Women
Preterm labor is a dangerous risk for any pregnant mom. Each year, it is estimated that one in eight babies is born prematurely, putting the infants at risk for a number of development difficulties. Fortunately, modern medicine has taken great strides to reduce the number of preterm births, with better screening procedures and more aggressive treatments for women who start labor before their 37th week.
One of the most promising developments for women who are at risk for preterm labor is the drug Makena. The drug has been in circulation for a number of years, with a variety of pharmaceutical companies offering variations of the drug. Makena has been shown effective in preventing preterm labor when women receive consistent injections throughout the last half of their pregnancy.
In the past, the drug has been made available to women at risk for about ten to twenty dollars per injection. Some women have received the injection as early as their sixteenth week of pregnancy in order to put off the likelihood of going into labor. To do this, Makena relies on progesterone, which is believed to help relax the walls of the uterus, thereby staving off early labor symptoms. Statistics show that women on progesterone see their risk of premature birth decrease from 55 percent to 36 percent.
Continue Reading...
One of the most promising developments for women who are at risk for preterm labor is the drug Makena. The drug has been in circulation for a number of years, with a variety of pharmaceutical companies offering variations of the drug. Makena has been shown effective in preventing preterm labor when women receive consistent injections throughout the last half of their pregnancy.
In the past, the drug has been made available to women at risk for about ten to twenty dollars per injection. Some women have received the injection as early as their sixteenth week of pregnancy in order to put off the likelihood of going into labor. To do this, Makena relies on progesterone, which is believed to help relax the walls of the uterus, thereby staving off early labor symptoms. Statistics show that women on progesterone see their risk of premature birth decrease from 55 percent to 36 percent.
Bad Drugs need to taken off the shelf
Bad Drugs need to taken off the shelf: Acutane, Yaz, Yasmin, Ocella
It is incredible that young women are still taking Yaz or Yasmin or Ocella. All we hear about these drugs are bad, bad, bad. Given all of the issues, I do not understand why they are still on the market. The power of the drug industry amazes me, that despite all of the serious and life altering side effects which can occur while taking the Yaz trio, doctors are still prescribing these drugs and young women still take them.
We have cases from all over the country. There are no geographical boundaries to taking a drug tort case. Most of our cases are either blood clot/DVT (deep vein thrombosis)/PE (pulmonary embolism), Heart Attack or Stroke.
How in the world other than taking a poison like the Yaz trio could a young woman have a heart attack or stroke? We have not had many death cases due to these injuries because the victims are young and strong. But this only means that, in the long run, these young woman will suffer with the effects of their injury for the rest of their lives. We have interviewed hundreds of prospective clients and it is amazing how many have claims. Between the Yaz trio and Accutane I don’t know which is a worse scourge in the young adult community.
Just for the record, Accutane is every bit as bad as the Yaz trio. The injuries and long term affects of this anti acne drug so far outweigh the relative health benefit that it also amazes me that Doctors can, in good faith, prescribe this drug to their patients. So many of the people we interview simply should never have qualified for taking this drug. It cannot be a causal solution to acne.
The number of young people who have developed bowel trouble after taking Accutane is incredibly high. The bowel trouble comes in many forms, Crohn's Disease, Ulcerative Colitis or Inflammatory Bowel Disease. Some of the lesser known side effects of using Accutane include pancreatitis and hypertension, hair loss and hepatitis.
If you are taking either Yaz or Accutane please go back to your doctor and ask for an alternative treatment for either birth control or acne. You will never die from bad acne and you can control getting pregnant in other formats beyond these drugs. Your life is literally at risk.
Reglan Linked to Tardive Dyskinesia - FDA Issues Black Box Warning
Reglan (metoclopramide), a prescription medication used to treat gastroesophageal reflux (GER) and gastroesophageal reflux disease (GERD) in children and adults has been linked with Tardive Dyskinesia, a potentially permanent movement disorder.
The FDA approved Reglan for short term use in 1995. However, approximately, one-third of patients taking Reglan including the generic form, metoclopramide, are on the drug for 12 months or longer. In 27 to 29 percent of the patients, there is a prevalence of Tardive Dyskinesia.
Tardive Dyskinesia is a neurological disorder that consists of potentially irreversible, involuntary movements of the face, lips, mouth, tongue, and sometimes the legs, arms, and trunk. Both the risk of developing the syndrome and the likelihood that it will become irreversible are believed to increase with the duration of Reglan use and the total cumulative dose..
On February 26, 2009, the U.S. Food and Drug Administration (FDA) announced that manufacturers of metoclopramide must add a black box warning to their drug labels to warn about the risks associated with its long-term or high-dose use.
Tardive Dyskinesia is characterized by repetitive, involuntary movements. These symptoms range from being very mild to very severe, which may be irreversible. Some of these symptoms include:
Jerking movements of the tongue,face, mouth, and jaw Involuntary movement of the hands and fingers Uncontrolled movement of the arms, legs, and trunk.
If you or a loved one has developed Tardive Dyskinesia as a result of taking Reglan, see your doctor immediately for an evaluation.
FDA Requires Boxed Warning and Risk Mitigation Strategy for Metoclopramide/ Reglan
Children's Tylenol Recall prompts Congressional Committee Investigation
In response to the circumstances surrounding McNeil Consumer Healthcare’s (McNeil) voluntary recall of multiple well-known pediatric medicines including Children’s Tylenol, the House of Representatives Committee on Oversight and Government Reform opened an investigation into the matter. Reuters reports that the Congressional committee is looking into whether McNeil, a unit of Johnson & Johnson, “failed to investigate consumer complaints that could have identified the contamination problems.”
The committee also plans to scrutinize the adequacy and performance of the U.S. Food and Drug Administration’s (FDA) inspection process following a routine inspection of McNeil’s Fort Washington, Pa. facility in April in which federal health officials found contamination, grime, thick dust and quality control violations.
Committee Chairman Edolphus Towns, a New York Democrat, and the panel's ranking Republican, Darrell Issa of California, had this to say about the committee’s investigation in a jointly filed news release:
“We are deeply concerned about the recall of popular pediatric medications widely used by infants and children across the country. When a recall of this nature occurs, it is our responsibility to bring attention to the issue as a public service and to fulfill our oversight responsibility by asking tough questions about the conditions of the manufacturing plant and controls put in place by the drug company’s management, and about whether FDA’s inspection and recall procedures were sufficient.”
Towns and Issa also noted in the news release that it is important to investigate the circumstances surrounding the recall due to the potentially adverse effects the products could have on children. According to the Washington Post, the recall affects an estimated 70 percent of the market for over-the-counter pediatric liquid medicines.
Towns, Issa Announce Investigation into Recall of Popular Pediatric Medication – Committee on Oversight and Government Reform’s News Release about the Investigation
House committee will look into recall of children's drugs after Tylenol recall – The Washington Post
FDA report indicates McNeil Consumer Healthcare knew of Contamination
A report issued by the U.S. Food and Drug Administration (FDA) states that federal health inspectors found that Johnson & Johnson unit McNeil Consumer Healthcare (McNeil) knowingly used materials contaminated with bacteria to make certain lots of its infant’s and children’s Tylenol products. McNeil issued a voluntary recall on April 30 of more than 40 different sizes and flavors of seven of its most popular products, including Children’s Tylenol and Children’s Motrin. The company has also suspended production at its Fort Washington, Pa facility. For now, FDA officials are saying that no final product batches contain contamination, but that the agency needs to review the inspectors’ assessments further to rule out any such possibilities.
Following a routine FDA inspection of McNeil’s Fort Washington, Pa. facility in April, federal health officials noted the following:
“The Quality Control Unit (QA) authorities most responsible for overseeing daily operations at the Fort Washington facility did not ensure that the responsibilities of the Analytical, Microbiological, Compliance, and Quality Assurance departments were enforced for rejection and withholding from approval any raw material component that contained known contamination of gram negative organisms. Raw material…lots…had known contamination with gram negative organisms and were approved for use to manufacture several finished lots of Children's and Infant's Tylenol drug products, which remain within expiration date(s) on the market.”
The FDA’s report also indicated that its inspectors found grime and thick dust covering certain types of equipment at McNeil’s Fort Washington, Pa. facility. In addition, the report, dated April 30, notes that the company handled consumer complaints poorly. Reuters reports that consumers filed 46 complaints between June 2009 and April 2010 involving “dark material in the liquid products.” The FDA is urging consumers to use generic over-the-counter medicines in place of the recalled products.
FDA: Drug maker McNeil knew of contamination – USA Today
FDA finds grime at J&J plant, urges use of generics – Reuters
FDA Inspection Report of McNeil’s Fort Washington, Pa. Facility
Johnson & Johnson unit McNeil issues Recall of Children's Tylenol and other well-known pediatric Medicines
McNeil Consumer Healthcare, a division of McNEIL-PPC, Inc. (McNeil) issued a voluntary recall of some of its most popular children’s medicines on Friday, including multiple varieties of the popular Children’s Tylenol and Children’s Motrin. The Johnson & Johnson unit issued the voluntary recall in consultation with the U.S. Food and Drug Administration (FDA) due to “manufacturing deficiencies” and because the products “may not meet required quality standards.” The FDA is urging consumers to stop using the affected products immediately.
According to the FDA, the manufacturing deficiencies have the potential to affect the purity, quality and even potency of the recalled over-the-counter children’s medicines. The New York Times reports that certain lots of the products may contain a larger amount of the active drug ingredient than specified, and that other recalled products could contain ingredients or foreign particles that may not meet McNeil’s testing requirements.
The recall involves more than 40 different sizes and flavors of seven well-known products, including:
• TYLENOL® INFANTS’ DROPS
• CHILDREN’S TYLENOL® SUSPENSIONS
• MOTRIN® INFANTS’ DROPS
• CHILDREN’S MOTRIN® SUSPENSIONS
• CHILDREN’S ZYRTEC® LIQUIDS IN BOTTLES
• CHILDREN'S BENADRYL® ALLERGY LIQUIDS IN BOTTLES
McNeil’s voluntary recall comes in response to a routine inspection of the company’s Fort Washington, P.a. facility on Friday in which federal health inspectors found multiple manufacturing violations. According to the New York Times, this is McNeil’s second major recall of 2010, the other taking place in January involving over-the-counter adult and children’s medicines manufactured at a plant in Puerto Rico.
Children’s Tylenol and Other Drugs Recalled – New York Times
McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants’ and Children’s Products – McNeil Press Release (includes list of recalled products)
FDA issues warning on popular cholesterol medication Zocor
The U.S. Food and Drug Administration has issued a warning to patients and healthcare providers about the potential for increased risk of muscle injury from the cholesterol-lowering medication Zocor (simvastatin) 80 mg.
Zocor, manufactured by Merck & Co, is sold in combination with ezetimibe as Vytorin, and in combination with niacin as Abbott Laboratories Simcor. Simvastatin also is available as a single-ingredient generic medication.
Myopathy, a muscle injury, is a commonly known side effect with all statins. However, the recent FDA warning highlights the greater risk of developing muscle injury, including rhabdomyolysis, for patients when they are prescribed and use higher doses of this drug.
Rhabdomyolysis is the most serious form of myopathy and can lead to severe kidney damage, kidney failure, and sometimes death.
Eric Colman, M.D., Deputy Director of FDA’s Division of Metabolism and Endocrinology Products (DMEP) stated the following:
“Review of simvastatin is part of an ongoing FDA effort to evaluate the risk of statin-associated muscle injury and to provide that information to the public as it becomes available. It’s important for patients and healthcare professionals to consider all the potential risks and known benefits of any drug before deciding on any one therapy or dose of therapy.”
Merck stock closed at $38.06.
Click on the following links to read more on the FDA warning on Zocor and potential increased risk of muscle injury.
FDA issues warning for high doses of Zocor - Reuters
FDA warning on cholesterol drug Zocor - ABC News
Merck falls on Zocor warning - Investors.com
Online advertising for Yaz causes headaches for Bayer with the FDA
The U.S. Food and Drug Administration (FDA) has given Bayer HealthCare Pharmaceuticals, Inc. (Bayer) multiple warnings regarding the marketing of its birth control YAZ (Yasmin). One of the most recent warnings came in April of 2009, in which the FDA warned Bayer that its Internet search engine sponsored links of YAZ and other drugs were in violation of federal regulations.
According to the FDA’s warning letter on Yaz, the sponsored links were:
“Misleading because they make representations and/or suggestions about the efficacy of YAZ [and other drugs made or marketed by Bayer], but fail to communicate any risk information associated with the use of these drugs.”
The letter went on to state that the sponsored links for YAZ did not adequately communicate Yaz side effects, and failed to use the required established name of the drug. Because of the aforementioned reasons, the FDA found Bayer’s Internet marketing of YAZ to be in violation of the Federal Food, Drug, and Cosmetic Act in addition to FDA regulations.
It is important to note that the risk information associated with using YAZ excluded by Bayer in the sponsored links includes the possibility of:
- Blood Clots
- Deep Vein Thrombosis
- Hypertension
- Gallbladder Disease
- Stroke
- Heart Attack
- Other Ailments
The FDA’s warning letter stated that Bayer’s omission of YAZ’s risk information is “particularly concerning” because the oral contraceptive has a Boxed Warning. According to the FDA:
“Drugs that have special problems, particularly ones that may lead to death or serious injury, may have this warning information displayed within a box in the prescribing information. This is often referred to as a ‘boxed’ or ‘black box’ warning.”
This warning from the FDA is just another troubling example of Bayer’s failure to communicate the risks associated with using YAZ. In addition to this warning, the FDA has found other facets of Bayer’s marketing campaign involving YAZ to be misleading, including several broadcast television advertisements released in 2008.
Because the makers of YAZ have repeatedly failed to communicate the risks associated with the oral contraceptive, you may be entitled to file a civil claim. As a YAZ-induced injury victim, you may be able to receive compensation for your medical costs, loss of wages, and more. If you have suffered any serious injuries as a result of taking Yaz, you may want to contact an experienced personal injury attorney to discuss your specific matter.
FDA Announces Class I Recall of Infusion Needles Used in Treatment of Chronically Ill
Huber needles used in implanted ports to withdraw blood, inject medications, and other solutions
The U.S. Food and Drug Administration (FDA) announced a Class I recall of certain infusion set needles used in the treatment of chronically ill patients and others. Products included in the recall are the following all manufactured by the Japan-based Nipro Medical Corporation for Exelint International Corporation.
Exel/Exelint Huber needles
Exel/Exelint Huber Infusion Sets
Exel/Exelint “Suretouch+ [plus.”
The recall comes in response to inspections of Japanese Nipro facilities carried out in October 2009. These inspections found that the needles, used to access under skin ports designed for repeated access to veins, “cored” in approximately 60 to 72 percent of tests. According to the FDA, coring means that the silicone cores (or silvers) of the needles were cutting and dislodging the under skin ports when inserted, causing the ports to leak in certain cases.
In a news release about the recall, the FDA stated that:
“At this time, the FDA has not received any adverse event reports related to silicone foreign bodies released in patients from Huber needle coring. The agency received only reports of port leakage. However, because it may be very difficult for clinicians to associate adverse patient outcomes with the use of defective Huber needles, there may be under-reporting of events.”
Needles involved in the recall were manufactured between January 2007 and August 2009. According to the FDA, this recall includes more than 2 million units in distribution nationwide.
The affected needles have lot numbers beginning with the following, along with a catalogue number of product code:
“07”
“08”
“09”
For more information, please read the following articles on the Class I FDA recall for Needles
FDA’s New Release about Recall: FDA Announces Class I Recall of Certain Infusion Set Needles
CNN Health Article on Recall: FDA recalls more than 2 million needles used in port implants
Cleviprex, popular blood pressure drug, recalled by Medicines Company
The Medicines Company (NASDAQ: MDCO) has issued a voluntarily recall of eleven (11) lots of Cleviprex ® (clevidipine butyrate) injectable emulsion due to the potential presence of visible particulate matter.
The affected Cleviprex lots are 61-978-DW, 61-979-DW, and 61-980-DW, Exp. 01/2010; 68-404-DJ, 68-405-DJ, and 68-406-DJ, Exp. 08/2010; 69-830-DJ, 63-385-DJ, 63-386-DJ, and 63-266-DJ, Exp 03/2011; and 64-453-DJ, Exp. 04/2011. No other lots are affected by this recall.
The Medicines company is cooperating with the U.S. Food and Drug Administration on this recall.
The particulate matter comprises sub-visible inert stainless steel particles of around 2.5 microns.
There are no known complaints or reports of adverse events related to this issue regarding Cleviprex ®
For medical inquiries, adverse event reporting or quality issues related to Cleviprex, please contact The Medicines Company Medical Information at 1-888-977-6326 Monday to Friday 8:00am-5:30pm EST or cleviprexrecall@themedco.com
Consumers with any adverse reactions associated with the use of Cleviprex may also report this to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website.
The stock for MDCO closed at $8.04, down .08 shares from previous trading.
Preemption Victory Against Generic Drug Manufacturers!
Congratulations on the valiant efforts of the legal team of The Public Justice Foundation and the Center for Constitutional Litigation (CCL) for winning a huge victory against generic drug manufacturers in the Mensing v. Wyeth, Inc., case. The U.S. Court of Appeals for the Eighth Circuit ruled that federal preemption can't be used by generic drug manufacturers to avoid liability for failing to warn of their drugs' dangers.
According to this ruling, an FDA approval for a generic drug does not does NOT preempt claims against the drug makers for failing to warn consumers of known risks. Justices in this case, included: Hon. Roger L. Wollman - Sioux Falls, SD, Hon. Diana E. Murphy, Minneapolis, MN and Hon. Kermit E. Bye - Fargo, ND
In Mensing v. Wyeth, the Eighth Circuit's decision concluded with the following:
Mensing has stated a viable claim against the generic metoclopramide manufacturers. Far from prohibiting them from taking steps to warn
their customers of new safety hazards, federal law requires such action. For the
reasons stated we reverse the judgment in favor of the generic manufacturers but
affirm the judgment as to the name brand manufacturers.
Arthur Bryant, Executive Director, Public Justice and the Public Justice Foundation made an excellent point when he recently shared the following message:
The Eighth Circuit emphasized that generic manufacturers, like name-brand drug companies, "bear primary responsibility for their drug labeling at all times." Lawsuits like Ms. Mensing's, the court said, do not "obstruct the purposes and objectives" of federal drug regulation "in any way." Instead, they help achieve the "fundamental" purpose of federal regulation-ensuring that "all marketed drugs remain safe."
Click here to read the Court Opinion on Mensing v. Wyeth, Inc.
We are headed in the right direction of improving drug safety and holding pharma giants, both brand and generic, accountable for their actions.
Time will tell what impact this decision has on the future of generic pharmaceuticals.
Gadolinium NSF raises concerns for patients
Gadolinium-based contrast agent (GBCA) enables medical specialists to get a clearer picture of abnormal body tissues during the course of an MRI. Gadolinium is a type of metallic ion that moves differently from others in a magnetic field, thus making it an excellent diagnostic aid, but it comes with a huge risk for some patients.
Patients with advanced kidney failure who cannot excrete the chelated form of gadolinium fast enough, nephrogenic systemic fibrosis (NSF) may result. An additional risk factor is acidosis, elevated acid levels in body fluids, a condition often found in end-stage renal patients.
Patients who undergo angioscopic diagnostic procedures may be exposed to up to three times the usual amount of gadolinium. Cardiac patients often have renal insufficiencies due to prolonged elevations in blood pressure. Those most at risk of developing gadolinium NSF are those who have acute or chronic renal insufficiency, often part of the pre-operative stages of a liver transplant.
First noticed in 1997, gadolinium NSF is characterized by a thickening and hardening of skin and connective tissues. Thickened and inflexible skin can interfere with the range of movement in extremities, sometimes resulting in an inability to walk. Internal organs and connective tissue can be seriously damaged, impinging on the function of organs or restricting the movement of areas like the diaphragm, key in the breathing mechanism. Damage may begin appearing within two days to 18 months. Extensive organ damage may result in death.
The first strong association between the use of GBCA and NSF was described in a Danish Medicines Agency press release in May 2006.
In 2007, Yale University’s Dr. Phillip Kuo, MD, PhD, a world-renowned expert on NSF, and his colleagues began recommending hemodialysis of kidney patients with a few hours of undergoing a gadolinium-assisted MRI procedure. Kuo recommended at least two sessions of hemodialysis with the first 24 hours of this particular diagnostic test. In subsequent reports, a renal transplant was shown to arrest or even partially reverse the ravages of NSF.
In order to alert physicians to the hazards associated with gadolinium, the U.S. Food and Drug Administration began asking manufacturers in 2009 to include warnings on their gadolinium-based product labels.
Neurontin litigation goes to trial but stalls on first day
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One of the current hot legal topics is the lawsuit against Pfizer and their wonder drug, Neurontin. Neurontin had been marketed by Pfizer as a drug that treated multiple conditions prior to the Food and Drug Administration’s (FDA) approval of the drug to treat these various symptoms and ailments. While the drug was approved to treat epilepsy, it was not approved by the FDA to treat either mood swings or arthritis as its advertising indicated. Presently under investigation is whether or not a side effect of Neurontin is an increase in suicidal thoughts and tendencies of those taking the drug. This issue surfaced after the family of a 39-year old woman that committed suicide while taking Neurontin filed a lawsuit against its maker, Pfizer. The deceased was taking the drug to treat several health issues including epilepsy, mood swings, and arthritis. There are approximately 1200 additional lawsuits pending against Pfizer and their drug, Neurontin.
The first lawsuit against Pfizer, in regard to Neurontin, to be heard before the court was the case of Susan Bulger, the 39-year old woman that committed suicide. After the first day of trial, the lawsuit brought against Pfizer by Ms. Bulger’s family was dropped after an anonymous donor agreed to provide monies to the family with the stipulation that the monies be put into a trust for Ms. Bulger’s daughter. The family determined that this would be in the best interests of the child and chose not to proceed with their lawsuit. The court dismissed the case. The attorneys for Pfizer continue to assert that there is no evidence that Neurontin increases or causes suicidal thought or behaviors. However, no real answer has been provided to this question. With the first lawsuit being so quickly dismissed, the mysteries and unanswered questions regarding Neurontin may have to wait to be discovered and answered until further lawsuits come before the courts.
It appears that with so many other lawsuits pending against Pfizer regarding Neurontin that this story is long from over. If Neurontin truly is a potentially dangerous drug, the public needs to be made aware of this before more innocent people are affected. Attorneys on both sides of the arena seem ready and willing to share their perspectives and evidence with the courts and their juries. How this legal saga is going to play out is anyone’s guess. At this point, there are still more questions than answers. It is important to note that in 2004, Warner-Lambert paid $430 million in to settle allegations involving Neurontin related to off label marketing, in a case handled by the Justice Department.
Click here to read more on the Neurontin case from Bloomberg.
Pfizer's stock closed at $16.07 today.
Stay tuned...
Supreme Court rejects Pharma giant Wyeth's FDA pre-emption claims in Wyeth v. Levine
Interesting turn of events today in the U.S. Supreme Court. The Supreme Court issued a decision regarding pre-emption in the Wyeth v. Levine, product liability case. This was an overwhelming victory for Americans. The 6-3 decision explicitly upheld the ruling that FDA approvals do not provide a defense to pharmaceutical manufacturer Wyeth in product liability tort claims, in the Wyeth v. Levine, No. 06-1249 (slip op., 03/04/09).
According to the 80 page decision that was delivered by Justice Stevens,
Directly injecting the drug Phenergan into a patient’vein creates a significant risk of catastrophic consequences-quences. A Vermont jury found that petitioner Wyeth, the manufacturer of the drug, had failed to provide an Adequate-quate warning of that risk and awarded damages to re-spondent Diana Levine to compensate her for the amputation of her arm. The warnings on Phenergan’s label had been deemed sufficient by the federal Food and Drug Administration (FDA) when it approved Wyeth’s new drug application in 1955 and when it later approved changes in the drug’s labeling .The question we must decide is whether the FDA’s approvals provide Wyeth with a complete defense to Levine’s tort claims. We conclude that they do not.
The majority decision, authored by Justice Stevens, unequivocally rejected the pharmaceutical defendant’s arguments that the FDA regulatory scheme preempted state law failure-to-warn claims and outlined the real world limitations of FDA powers. This decision will have implications in pharmaceutical product liability claims for decades to come. Also joining Justice Stevens were Supreme Kennedy, Sorter, Ginsberg, Beyer, and Thomas. It was not surprising that the three dissenters included, Chief Justice Roberts, Ali to and Scalar.
It is important to note that this Br yer and Thomas clarified their vote by also writing an opinion in addition to Justice Stevens. This solidified their strong belief in their sentiments that manufacturers can't hide behind the FDA approval and not be vigilant in issuing necessary warnings and safety precautions. The Supreme Court held: (1) the FDA’s regulatory scheme exists in harmony with state law failure-to-warn claims; (2) the controversial 2006 FDA preamble regarding preemption is entitled to no deference; and (3) it is the manufacturer, not the FDA, which has the duty to warn consumers about side effects. As the Supreme Court reasoned, “State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly.” (Slip op., at 23.)
Continue Reading...Darvon painkiller under fire by FDA
Interesting news today on the Pharma front. The FDA has issued orders that the "old faithful" painkiller Darvocet should be withdrawn off the market. This drug is somewhat of a household medicine cabinet staple, with over 20 million prescriptions in 2007 alone. A review panel narrowly approved this measure to withdraw this drug with a vote of 14-12. It makes one wonder after 50 years why is this drug getting the attention of the FDA. The Consumer Watch Dog Group, Public Citizen, may have something to do with this recent interest. Last year, in June 2008, the Public Citizen Group filed a lawsuit against the FDA over Darvon, Darvocet and all drugs containing propoxyphene , since it has been banned in the United Kingdom, since 2005. The group brought this revelation to the FDA's attention as far back as 2006. What took the Agency so long to act?
We are delighted that someone in the FDA is finally paying attention to reports from non-biased organizations, such as the Florida Medical Examiners. There is data from the reporting system of the Florida Medical Examiners that show reports from 85 people out of 341 dying with the Darvon drug in their system. It is important to note that all 341 deaths were classified as drug related causes.
Fierce Pharma states that there were 1,452 deaths associated with propoxyphene from 1957 through September 2008.
Click here to read more from the FDA and the Wallstreet Journal on the Darvocet painkiller.
Pharma companies balance sheets and the consumer safety
Today it was announced that Pfizer was going to take a $2.3 billion earnings hit over government investigations of their drugs Celebrex and Bextra. You can't help but wonder if they are profitable. Look no further, they recentely announced their attempt to make a $64 billion purchase of Wyeth Pharmaceuticals. The combined merger would layoff 18,000 people.
Our interest on the Injury Law Blog is Consumer Safety and making sure that Companies pay for their wrong doings. In fact, everyone celebrated last year when Pfizer announced that it would pay $745 million to settle personal injur suits over Bextra and Celebrex. They also paid $60 million to 33 state Attorney Generals and $89 million for class actions. This is a lot of money for hurting unsuspecting people with a harmful drug,
The disbelief to all of us at the Injury law Blog is that this company still has $68 billion to purchase another pharma company, Wyeth. Are they keeping consumers safe with their drugs? Are the pharma companies taking the necessary steps in doing enough clinical trials to ensure there will be no deaths or loss of limbs or serious impairments from taking their drugs?
The questions remain to be answered. It is nice to see articles such the one from the WSJ Blogs by Sarah Rubenstein discussing all of the money Pfizer stands to make if their merger is successful.
Let's hope that the American public's safety is not an expense to this merger and this pharma giant flexing its muscles that it can afford $68 billion for an acquisition of a competitor.
Epilepsy drug taken while pregnant may increase risk of Autism
According to a new study, women taking the epilepsy drug valproate while pregnant may significantly increase their child's risk of developing autism. Valproate is a generic version of the brand drug, Depacon. Further, according to the FDA this drug has a laundry list of side effects. However, the most glaring one is that some patients taking the drug Valproate have experienced life-threatening liver failure.
The author of the report published in Neurology, December 2, 2008, Professor Gus Baker, of the University of Liverpool, states that women using the drug valproate during pregnancy could lead to a "substantial" risk of children being diagnosed with the condition. Further, they should be aware of this risk and should discuss them with their doctor.
Preliminary results from this on-going study have shown that of the 632 children being followed, nearly half of the mothers took epilepsy drugs during the pregnancy. Seven of the children were exposed to valproate in the womb and five of the seven exposed to the drug, developed autism. It is important to note that the mother of one of the five children with autism took a combination of Valproate and Lamotrigine.
The children in the study had no family histories of autism and were tested at ages one, three and six. Most of the children were six years old when they were diagnosed.
Click here to read more from Science Daily on this Epilepsy drug's risk to pregnant women.
Big Pharma, FDA and Preemption: Who should be held liable?
The Supreme Court Case, Wyeth v. Levine (06-1249), the Supreme Court Justices are sharply divided over whether FDA regulations of labeling can prevent consumers from suing. Wyeth and the FDA presented the case before the Supreme Court involving Diana Levine, an amputee, whose bodily injury resulted from the use of the drug, Phenergan.
The debate among Supreme Court Justices is in the matter of whether consumers have the right to sue drug companies when the FDA has approved a drug for use. The strength of the argument presented by Levine's lawyers is that Wyeth is attempting to use FDA labeling to deny her a Consumer’s right to hold a Pharma company liable.
This is not the first case of involving a Pharma company being sued for harmful and deadly side effects of their drugs. A few notable instances include, Glaxo for their drugs Paxil and Avandia, Purdue Pharma for Oxycontin, Merck & Co. for Vioxx. In some cases, deficient research led to serious risks that was overlooked. In others, misleading advertising that omitted possible risks was the basis of these lawsuits.
The issue of FDA labeling as insurance to preempt lawsuits by consumers is an important aspect of the Wyeth v. Levine case. The issue of preemption is supported by the current Bush Administration in its attempts to reduce lawsuits by consumers against drug companies. Pharmaceutical companies argue that stiffer regulations and standards inhibit their research of newer, more effective drugs.
In the Levine case, Wyeth's argument reduces the lawsuit to a simple case of medical malpractice. Surprisingly, the FDA stands with Wyeth in the argument. The Federal Agency that is supposed to be on the side of Consumers, feels that once the FDA approved the drug for use, extraordinary risks that may appear as a result of use at some later point should not be a consideration for lawsuits against drug companies that have received FDA approval and are labeled as such. This begs the question: Who should be liable and held accountable if the FDA and the pharmaceutical maker fails to catch something in trials or overlooks a deadly side effects, because of the rush to get a drug on the market?
Another valid point of the argument by Levine’s lawyers is that Wyeth did not advise physicians or consumers of the danger of using the "push" method of injection of Phenergan. It is safe to say, that maybe more people would have had second thoughts about using this drug, if they would have known about the additional dangers. Moreover, in another case, Pfizer's anti-nausea drug, Vistrol, caused gangrene when injected into the arteries and Wyeth should therefore have requested an FDA to change the label warning of this on their Phenergan label.
The State of Vermont awarded Levine $6.8 million. In preemption arguments, federal law supersedes state law. Justices Scalia, Alito and Roberts argued in favor of Wyeth while Bader-Ginsberg argued in favor of Levine.
It would be simple to view Wyeth's position as one of preemption vs. adequacy of disclosure. Ultimately, the Supreme Court must address the potential for future lawsuits of this nature. They must also address the issue of what happens if the drug company gives the FDA false or misleading information about a drug that later proves to be harmful to consumers. Consumer advocates everywhere are following this case closely. Let’s see if the Supreme Court can do the right thing and tell Wyeth and the FDA that they do not get a free pass in this case. They are responsible for the safety of drugs that are put on the market, even if the FDA gives the drug a stamp of approval.
Jacob Goldstein, Writer and Blogger for the WSJ Health Blog, shares a few insightful comments from Diana Levine in his blog post "Wyeth v. Levine: The Mother of All Preemption Cases". He also includes a nice candid photo of the woman who Wyeth is going after for fighting for her rights to hold them accountable for taking their migraine drug that caused her to have her arm amputated. All eyes are on the Supreme Court regarding the decision of this case. Let's see if they can get it right and hold the Pharmaceutical companies liable for unreported risks and dangers associated with their drugs.
New study shows increased risk Risk of Atrial Fibrillation from the use of Fosamax and Zometa
If you or someone you know suffers from osteroporosis and takes bisphosphonate medications, Fosamax (alendronate) or Zometa ( zoledronic acid), there is something you should know. Doctor Jennifer Miranda, reported findings from a study at a recent scientific conference, that shows patients taking these medications have an increased risk of 68% for a condition called atrial fibrillation. More specifically these Atrial fibrillation cases can lead to hospitalization or death. Atrial fibrillation is a dangerous condition in which the heart's natural beat and rhythm are disrupted and can lead to severe cardiac malfunction and death. This study was the result of a meta-analysis of more than 16,000 subjects, with a mean age of 69 to 75 years most of whom were female.
Bisphosphonates are a type of drug which inhibit the resorption of bone. They are commonly used to treat osteoporosis and other bone defects because, by reducing the body's natural breakdown of bone, they can help slow the rate at which bones become weak and brittle.
Continue Reading...New study shows increased risk Risk of Atrial Fibrillation from the use of Fosamax and Zometa
If you or someone you know suffers from osteroporosis and takes bisphosphonate medications, Fosamax (alendronate) or Zometa ( zoledronic acid), there is something you should know. Doctor Jennifer Miranda, reported findings from a study at a recent scientific conference, that shows patients taking these medications have an increased risk of 68% for a condition called atrial fibrillation. More specifically these Atrial fibrillation cases can lead to hospitalization or death. Atrial fibrillation is a dangerous condition in which the heart's natural beat and rhythm are disrupted and can lead to severe cardiac malfunction and death. This study was the result of a meta-analysis of more than 16,000 subjects, with a mean age of 69 to 75 years most of whom were female.
Bisphosphonates are a type of drug which inhibit the resorption of bone. They are commonly used to treat osteoporosis and other bone defects because, by reducing the body's natural breakdown of bone, they can help slow the rate at which bones become weak and brittle.
Continue Reading...Use of Spiriva Handihaler may cause heart attacks, strokes or death
According to the research article, “Inhaled Anticholinergics and Risk of Major Adverse Cardiovascular Events in Patients With Chronic Obstructive Pulmonary Disease” written by Sonal Singh, MD; Yoon K. Loke, MD; and Curt D. Furberg, MD, and published in the Journal of the American Medical Association, people using the Spiriva inhaler possibly face the following risks: cardiac death, heart attacks or strokes. Alarmingly, the risks are greater for the Spiriva inhaler users than inhaler users using a placebo or other drugs. This study published in the September 24, 2008 issue of JAMA denotes that although the risks were small, the popular inhalers could lead to potentially life threatening side effects.
The German Manufacturer, Boehringer Ingelheim Pharmaceuticals Inc. makes Spiriva Handihaler (tiotropium) and the generic drug for Atrovent, Ipratropium, approved for treating COPD. In the United States, they have a joint marketing partnership with Pfizer Pharmaceuticals. In 2004, the inhaler was approved for a daily long-term treatment of bronchospasm, which is linked with COPD, chronic obstructive pulmonary disease.
It is important to note that both drugs have been used by approximately 8 million people worldwide. They are both known for helping to open passages and preventing spasms that decrease airways in the lungs to increase effective breathing.
The JAMA article details how authors, Sonal Singh, MD; Yoon K. Loke, MD; and Curt D. Furberg, MD analyzed the data from 17 randomized studies, and compared it to primarily older people on either Spiriva or Ipratropium, to people using placebos or other drugs. Their research found that patients had an increased risk over 50% in developing both fatal and non fatal heart problems, including heart attacks when they used Ipratropium or Spiriva.
Researchers are quick to add that additional studies are required to further evaluate the safety of the drugs. However, they recommended individuals with COPD to take precautionary measure prior to starting drug therapy that includes stop smoking, control blood pressure and cholesterol and the use of oxygen.
There was a statement issued by Boehringer and Pfizer indicating that disagreed with the analysis of the new study. They cited an analysis of 30 clinical trials that confirmed the safety of the Spiriva Handihaler and that showed no increased risk of all-cause death or cardiovascular death to the inhaler users.
However, the Food and Drug Administration, FDA issued an early communication in March 2008, that indicated they are evaluating the potential connection between the side effects of the the Spiriva Handihaler and strokes. The March 2008 FDA communication was quick to point out that their investigation was precautionary and did not mean that Spiriva causes strokes. They encouraged people on the drugs to not stop taking their drug based on the FDA early communication, in March but to wait until they have confirmed conclusions and recommendations.
We can only hope that the FDA’s conclusions will not be too late for some individuals.
Vytorin Study comes under dispute
There seems to be a dispute between two studies on risks involving Vytorin. In recent trials, data provided to the Food and Drug Administration on Thursday showed no increased risk of cancer.
However, a recently published study called Seas, disputes these findings and found an increased risk of cancer and deaths from cancer in patients taking Vytorin, compared with those given a placebo.
According to a WSJ article, the new Seas study, released in July, has surprised investors and the medical community.
Hormone Replacement Therapy cases have major set back due to Product Liability Act
Another win in the column for Drug Makers. They are celebrating the recent dismissal of the first two HRT cases being tried before Superior Court Judge Jamie Happas, the designated judge for all N.J. The Plaintiff's alleged that they developed breast cancer due to taking HRT drugs. The Defense argued the drugs were approved by the FDA and showed no signs of this in all of their research.
New Jersey has a Consumer Fraud Act that is meant to help protect consumers from fraudulent behavior on the part of corporations. Surprisingly, Judge Happas also dismissed the cases pending citing violation of the New Jersey Fraud Act.
The first two HRT cases that were dismissed were, Bailey v. Wyeth Inc., L-9999-06, and DeBoard v. Wyeth Inc..
Heparin Sodium: History and Background
Heparin Sodium, a drug used to prevent blood clots in patients, was first approved for the market by the FDA in 1972. Its primary manufacturer is Baxter International, and its production is handled by the Wisconsin-based group Scientific Protein Laboratories LLC (SPL). Heparin is an anticoagulant used to thin the blood in surgery, dialysis, and to prevent blood clots in bedridden patients.
Recent Reports Find Negative Side Effects for Heparin
The adverse effects of Heparin first came into light towards the end of 2007. In the beginning of 2008, the FDA reported over 350 instances of adverse effects due to Heparin since the end of 2007. Following this report, Baxter International announced its intentions to recall its multi-dose vials of Heparin. In March of 2008, Baxter expanded its recall to all multi-dose, single-dose, and diluted solutions of Heparin.
According to the FDA reports, approximately 500 patients have suffered from the adverse side effects of Heparin, and at least 21 have died as a result of the drug. One widely-publicized instance of Heparin’s dangerous effects was that of actor Dennis Quaid. In this case, the actor’s newborn twins were accidentally given an excessive dosage of Heparin, a mistake which nearly caused the infants’ deaths. Dennis Quaid and his wife have sued the maker's of Heparin, Baxter Healthcare Corp. for not doing enough. The lawsuit also says the company should have recalled the large-dosage vials after overdoses killed three children at an Indianapolis hospital.
The Blame Game
It is suspected that during the production of Heparin in one of SPL’s Chinese factories, a contaminant was put into the drug’s active ingredient. Additionally, it has been discovered that the production factories in China were not up to sanitation code. The blame for this lack of inspection falls not only on SPL and Baxter International, but also on the FDA, who admitted to breaking its own policy by not inspecting these locations.
Recent Reports Find Negative Side Effects for Heparin
The adverse effects of Heparin first came into light towards the end of 2007. In the beginning of 2008, the FDA reported over 350 instances of adverse effects due to Heparin since the end of 2007. Following this report, Baxter International announced its intentions to recall its multi-dose vials of Heparin. In March of 2008, Baxter expanded its recall to all multi-dose, single-dose, and diluted solutions of Heparin.
According to the FDA reports, approximately 500 patients have suffered from the adverse side effects of Heparin, and at least 21 have died as a result of the drug. One widely-publicized instance of Heparin’s dangerous effects was that of actor Dennis Quaid. In this case, the actor’s newborn twins were accidentally given an excessive dosage of Heparin, a mistake which nearly caused the infants’ deaths. Dennis Quaid and his wife have sued the maker's of Heparin, Baxter Healthcare Corp. for not doing enough. The lawsuit also says the company should have recalled the large-dosage vials after overdoses killed three children at an Indianapolis hospital.
The Blame Game
It is suspected that during the production of Heparin in one of SPL’s Chinese factories, a contaminant was put into the drug’s active ingredient. Additionally, it has been discovered that the production factories in China were not up to sanitation code. The blame for this lack of inspection falls not only on SPL and Baxter International, but also on the FDA, who admitted to breaking its own policy by not inspecting these locations.
Medtronic recalls Heparin CardiopulmonaryProducts
Medtronic, Inc. voluntarily recalled several Heparin products, According to the U.S. Food and Drug Administration (FDA). One can only wonder what took them so long to get this conviction. On April 8, 2008, the U.S. Food and Drug Administration's recommended that heparin supplies be checked with newly-developed tests, and that affected products be evaluated for possible field corrective action. The Medtronic recalled products include disposables used for heart surgeries and the cardiopulmonary bypass, including reservoirs, blood oxygenators, tubing packs, and pumps. It is unclear if exposure to Heparin Carmeda-coated medical devices could cause adverse events similar to those observed with injectable heparin formulations.
In a separate action, Medtronic is advising customers that selected lots of Trillium-coated products were also manufactured with heparin containing OSCS. Trillium is another biosurface used on CPB products. The ultimate goal is to remove all contaminated products from the market.
The Medtronic recall is a precautionary one. Let's all hope the company continues to take measures regarding their products that will help save lives and not threaten them.
Zyprexa Lawsuit to be scaled back per Judge
In a widely discussed article on Bloomberg.com, Judge Jack Weinstein, an outspoken U.S. District Judge from New York, has stated that he does not want to allow patients and insurers who paid for Zyprexa for uses approved by the U.S. Food and Drug Administration, including schizophrenia and bipolar disorder, to sue as a group. Further he does not feel that the purchasers of the Zyprexa drug are entitled to claim punitive damages. The case ``ought to be settled,'' said the judge to both Plaintiff and Defense lawyers. "I really think that we're not dealing with very much money.''
In a blog post on the Pharmaceutical Blog Pharmalot, the author mentions that a lawyer for Zyprexa purchasers, is pushing for Judge Weinstein to certify classes of individual Zyprexa users and third-party payers, such as insurers. He believes that Zyprexa maker, Eli Lilly exaggerated the effectiveness of the drug; failed to adequately warn about side effects including weight gain, diabetes and other illnesses; and promoted Zyprexa for off-label use, including for treating elderly dementia patients and children.
Drug manufacturer, Eli Lilly has paid over $1billion to settle over 30,000 claims brought by patients stating they were not given adequate warning about the side effects of Zyprexa.
Judge Weinstein is supposed to issue a ruling sometime soon.. Everyone is waiting to see if justice will be served for the purchasers. Stay tuned...
Bloggers for the Drug and Device Law Blog have some interesting comments on the subject. It is nice to see a healthy discussion between bloggers and readers...
FDA seeks comments on the new guidelines for unapproved uses of Medical Products
Concerned Citizens, Health Care Personnel, the FDA wants your opinion on the new FDA Proposed Guidance for Dissemination of Information on Unapproved Uses of Medical Products. Public Comments will be accepted for 60 days.
"Articles that discuss unapproved uses of FDA-approved drugs and devices can contribute to the practice of medicine and may even constitute a medically recognized standard of care," said Randall Lutter, FDA deputy commissioner for policy. "This guidance also safeguards against off-label promotion."
Previously, Section 401 of the Food and Drug Administration Modernization Act set out guidelines that allowed the dissemination of information on unapproved uses of FDA-approved products. As long as the guidelines were met by the manufacturers, the dissemination of such materials was not viewed by the FDA as evidence of an intent to promote the product for an "off-label" use. However, Section 401 expired on Sept. 30, 2006.
Comments via the Internet: go to Docket Number FDA-2008-D-0053 on the Regulations.gov Web site.
Comments via mail:
Submit comments to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
All comments should be identified with the docket number, FDA-2008-D-0053. For single copies of the draft guidance, call 301-827-3360 or contact: Office of Policy, Food and Drug Administration, 5600 Fishers Lane, Room 14-101, HF-11, Rockville, MD 20857.
MS drug natalizumab linked to liver injury per FDA
A recent report by the FDA links the multiple sclerosis drug natalizumab (Tysabri) to liver injury. It can occur as early as six days after the initial dose, per reports from the FDA.
The drug's marketers, Biogen Idec and Elan,issued a letter to clinicians, stating a warning about liver toxicity has been added to the natalizumab label.
The new warning informs the user that signs of liver injury "including markedly elevated serum hepatic enzymes and elevated total bilirubin" not only occurred within six days of initial doses, but also had "been reported for the first time after multiple doses."
One can only wonder how someone can feel safe taking this drug after reading such a warning. I applaud the manufacturer for at least including the warning on the label now, so that the consumer can be fully aware of risks and side effects of this drug.
Click here to read more from Medpage Today on this new warning for natalizumab or click here to read more on Tysabri.
Recent deaths halt intense drug therapy to lower blood sugar
There is a recent report that 257 patients have died after receiving intense therapy to lower their blood sugar. As a result, the National Institutes of Health has discontinued a portion of major study on diabetes and heart disease. The study was aimed at reducing to normal levels the blood sugar of type 2 diabetics at especially high risk of heart attack and stroke.
It is important to note that NHLBI officials stressed that they have been unable to link the increased deaths in the study to any drug, including Avandia. There are over 18 million Americans that have been diagnosed as having diabetes, with type 2 the most common form.
Click here to read more from the Associated Press and MSNBC on the recent deaths from dug intense therapy to lower blood sugar.
Vytorin and Zetia come under attack for misleading consumers
Merck and Schering plough are being sued for misleading consumers into believing their drugs were more effective than generic ones. According to an Associated Press article, Four lawsuits have been filed in New Jersey, New York, Florida and Washington state. They were filed on behalf of patients and medical insurers who paid for the expensive cholesterol drugs.
In the Florida Lawsuit, the plaintiff seeks to recoup the difference in cost between generic cholesterol drugs that cost about one-third as much Vytorin or Zetia. According to the Plaintiff's Attorney, Tim Howard, "The cost of those drugs is two-thirds more than the generics, which has the same benefit." Lead Plaintiff in the Florida lawsuit, Marion Greene, stated that she felt misled by using a drug that cost three times as much as a generic without additional benefits.
Earlier this month, Merck/Schering Plough released a study named Ehance (Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia) Trial. Merck/Schering-Plough have requested permission to present findings from the ENHANCE trial at the American College of Cardiology meeting, which will be held in March 2008. In wake of the new developments and lawsuits surrounding Vytorin, since the abstract was released, time will tell, if their request will be granted.
Merck and Schering Plough is also under fire with a Congressional inquiry led by Rep. John D. Dingell (D-MI), Chairman of the Committee on Energy and Commerce, and Rep. Bart Stupak (D-MI), Chairman of the Subcommittee on Oversight and Investigations. After the Merck and Schering-Plough’s release of the ENHANCE study results the Congressmen issued a statement to the fact that their investigation into the ENHANCE trial would continue.
According to a Forbes.com article, Congressman, Bart Stupak of Michigan made the following statement "You bring in an independent advisory panel to 'put the lipstick on the pig' to salvage Vytorin, and you can't do that right."
Merck stock closed at $49.56 yesterday. Schering Plough stock closed at $20.17 yesterday.
We will keep our eye on the developments surrounding Vytorin and report them to our readers on the LaBovick Injury Law Blog.
To read more on the information in this post, Click here for Forbes.com, US News, ABC News, CNNMoney
Bayer's Liquid formulation of Leukine is withdrawn from market
Bayer's liquid formulation of Leukine, a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function has been withdrawn from the market. The product was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with a change in the formulation of liquid Leukine to include edetate disodium (EDTA). The upward trend in adverse reaction reporting rates has not been observed with the use of lyophilized Leukine. The product should not be used by anyone and all unused vials must be returned to the manufacturer.
Bayer letter regarding withdrawal of Leukine
Bayer letter regarding withdrawal of Leukine
Trial by Jury and Personal Injury
One of our favorite Bloggers, Blawgletter wrote a post about Tort Reform and the rights of trial by jury. Although his post is re: a securities fraud case against University of Phoenix, it also rings true that jury trials are important for personal injury cases. Without them, who would be held accountable? Ted Frank at Points of Law.com, chimed into the jury trial discussion by adding "trials remain a risky business for both plaintiffs and defendants", in a recent post.
Pointsoflaw.com, provided an excellent summation of the Vioxx litigation in their vioxx roundup yesterday. They cited several cases pending trials and gave updates on Merck. All eyes are on Merck. Let's see if their proposed vioxx settlement of $4.85 billion will make the jury trials go away. In a newswire release, Merck indicated that there are 50,000 Vioxx claimants.
Only time will tell how this saga will end. Stay tuned...
Merck settles Vioxx Product Liability suits for $4.85 billion
Merck has agreed to pay a fixed amount of $4.85 billion into a settlement fund for qualifying Vioxx claims that enter into the resolution process. This is not a class-action settlement. Claims will be evaluated on an individual basis. According to Richard T. Clark, chairman, president and chief executive officer of Merck, "This is a good and responsible agreement that will allow the Company to concentrate even more fully on its mission of discovering, developing and delivering novel medicines and vaccines."
The conditions in the agreement, is open only to those cases filed or tolled on or before
November 8, 2007.
Click here to read full release from Merck re: Vioxx settlement.
Click here to read Merck Final Vioxx Agreement Signed for outstanding product liability claims.
House Gives U.S. FDA More Power to Police Drug Safety
This week, The House of Representatives approved legislation that gives the FDA more power to police the safety of prescription drugs, sending the measure to the Senate for final approval.
What if the the Food and Drug Administration required drugmakers to study the safety of their products after they go on the market? Would that be so terrible? Would it be a bad thing for regulators to order warnings added to prescribing information? If these measures can help save lives and prevent more illnesses, I think not.
This new legislation may be able to prevent future repeats of what happened with Vioxx, the Merck & Co. painkiller, allegedly linked to heart attacks and strokes, and Avandia, GlaxoSmithKline Plc's diabetes pill linked in some studies to a risk of heart attacks.
I hope that Representative Henry Waxman, a California Democrat, is correct in his assessment that the legislation ``provides FDA with critical tools the agency has been desperately lacking in its efforts to protect the American public from unsafe drugs". Now let's see if the Senate agrees.
Click here to read more on this new FDA legislation from Bloomberg News.
Is Nexium and Prilosec the New Avandia?
This week there were two major articles discussing the safety of AstraZeneca's Prilosec and Nexium, one in Forbes written by Matthew Harper, "Averting another Avandia" and on the Star-Ledger of New Jersey's Pharmalot.com written by Ed Silverman, " Will Nexium become the new Avandia"?
The articles were discussing the newly released public notice from the FDA on the "Early Communication About an Ongoing Safety Review Omeprazole (Prilosec) and Esomeprazole (Nexium)"
In the FDA public notice there is an alarming statement as to increased heart attacks and heart failure. An excerpt from the FDA public notice states "The results from the study of Prilosec and analyses from an ongoing study of Nexium raised concerns that long-term use of Prilosec or Nexium may have increased the risk of heart attacks, heart failure, and heart-related sudden death in those patients taking either one of the drugs compared to patients who received surgery."
However, on the other hand, Paul Seligman, an associate director in the FDA’s Center for Drug Evaluation and Research, tells reporters “It’s hard to know how this process will play out” and that “this is something of a moving target." This public notice was released to make the pubic aware the FDA is looking into this and will have results from more tests in about three months.
Should the public be alarmed? Is the FDA trying to prevent another Avandia? Time will tell.
On a positive note, it is good that the FDA released this public information rather than an independent source. The FDA communicated this new information in a somewhat timely manner. On May 29, 2007, AstraZeneca, the manufacturer of Prilosec and Nexium sent FDA their preliminary review of new data from two studies about the potential heart risks. Since that time, the FDA has been going over the data.
FDA "thank you" for making a bold step in sharing this information about Nexium and Prilosec to the public. We remain hopeful that you will honor your obligations to the public and find out if these two drugs are safe for the public or are they detrimental to increasing a patient's heart risks.
Let's all hope that Neium and Prilosec do not become the new Avandia.
Click Here to read more on Prilosec or Nexium from Forbes and from the Star-Ledger of New Jersey's Pharmalot.com.
Avandia get reprieve and receives FDA Warning not Ban
The Executives at GlaxoSmithKline must be breathing a huge sigh of relief. They only received a mere minor setback with the new Food and Drug Administration decision. Yesterday, The FDA advisory panels called for new warnings for the widely used diabetes drug Avandia. New evidence has shown that it significantly raises the risk of heart attack, however, they stopped short of recommending that the drug be pulled from the market, as some FDA officials had urged. I wonder why and how they managed to get a 22 to 1 vote to allow continued sales of Avandia?
There has been controversy among regulators, drug company officials, physicians and advocates for patients, who have offered dueling interpretations of contradictory safety studies. Maybe it is because it is a "Billion Dollar Baby" for the North Carolina Drug Maker, GlaxoSmithKline. Last year, Avandia produced $3 billion in sales for the company. Today, stock for GlaxoSmithKline closed at $51.08, an increase of $1.64 per share. I think that shareholders must be happy with the news of the new FDA warning.
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The company that produces Tums and other well known brands have been given another chance to make a difference in the lives of millions of people around the world. Let's hope that this miracle they received, will keep them in check and make them proactively share critical information to unsuspecting consumers before they take a GSK drug or product, instead of after the fact. Good corporate citizenship requires as much, if not more.Click Here to read more from the Washington Post on the Avandia FDA Warning.
The LaBovick Injury Law Blog is presented as a service of the Private Law Firm, LaBovick & LaBovick, P.A., Civil Justice Prosecutors.
Avandia has more bad news: new report finds increased Risks
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Avandia, a popular diabetes drug, has just been dealt another strike. A new report from the FDA on Wednesday, finds that patients who take Avandia, face an increased risk of heart attacks over those who take Actos, a similar drug. According to a recent New York Times article, one review in the study included the following statement: "Patients with heart disease and those taking insulin should not take Avandia".
Avandia increases the risks of heart attacks by as much as 40 percent in most diabetes patients. In those taking insulin or nitrates, the risks are higher, according to the drug agency’s analysis. Most diabetics die of heart disease. This news is unsettling, given that the drug was created to save lives, not help cause greater risks.
The FDA is stepping up and diligently trying to ensure the safety of Avandia patients. After the harsh but necessary criticism from Iowa Republican Senator Charles E. Grassley. Mr. Grassley said. “If F.D.A. leaders are asleep at the switch, it’s a dereliction of duty. But if they’re knowingly suppressing information about risks to public safety, then it’s morally corrupt.” We need more lawmakers to stand up and hold agencies in charge with protecting the public accountable. This should be a bi-partisan issue. It affects everyone.
Unfortunately, this news does not bode well for the drug maker, Glaxo Smith Kline, since the drug is billion dollar producer for the company. Last year Avandia had sales over $3.4 billion. Upon news of this new report, the shares of stock fell $1.40, closing at $51.23. I am sure the company executives and shareholders are nervous. If the full report that comes out on Monday, and shows more risks for Avandia patients, the drug could be in more danger. All eyes are on Avandia and the FDA report that comes out on Monday. Should GSK be nervous? Is there really a reason for this alarm? Time will tell if GSK will hit a base hit or a sacrificed fly and score a run with this billion dollar drug? I don't really see how they can hit a home run with this one. The other side seems to have scored a few good runs, with these new findings. Time will tell... Stay tuned....
Click Here to read more on Avandia from the New York Times article
Merck's Vioxx is making headlines after a new study from NEJM
Merck's former billion dollar baby, Vioxx, arthritis Medicine, is still making headlines, despite having been pulled off the market for several years. A recent 2,434-patient study, published on Wednesday in the New England Journal of Medicine, finds that increased heart risk begins much earlier than after 18 months of use, as previously indicated by the drug maker. Of course, Merck is denying the relevancy of this study. According to Merck, the study is not conclusive.
There are over 27,000 lawsuits against Merck from people who claim to have been harmed by the drug. I wonder if this new study will impact these lawsuits or not. A few months ago, a jury awarded a man $47.5 million verdict against Merck for Vioxx, finding it responsible for his heart attack. The replacement for Vioxx, ARCOXIA, was not approved by the Food and Drug Administration's (FDA) Arthritis Advisory Committee. They voted against recommending approval of ARCOXIA® (etoricoxib) for the symptomatic treatment of osteoarthritis in the United States. ARCOXIA has been under review by the FDA as an investigational selective COX-2 inhibitor since the New Drug Application (NDA) was submitted in December 2003 and is currently available in 63 countries. On a more positive note, Merck's stock is doing great.The stock closed at $53.38, this is an increase over prior trading. There must be promising new drugs in the pipeline that are keeping everyone optimistic and hopeful.
Time will tell. Let's see if if the former billion dollar baby, Vioxx, will continue to make headlines.
Click here to read more on Vioxx from Reuters or the New York Times.
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Avandia Maker Sued Over Heart Attack
The widow and son of a Beaumont man are suing the maker of the popular diabetes drug Avandia, GlaxoSmithKline PLC, challenging it contributed to the man's death from a heart attack.
Larry Alan Stanford, 60, died in May, which was around the same time a scientific analysis was published in the New England Journal of Medicine saying that Avandia was linked to a greater risk of heart.
The deceased victim had taken Avandamet, a form of Avandia mixed with another diabetes drug, since early 2005.
Click Here to read more about the case in a recent AP article.
Larry Alan Stanford, 60, died in May, which was around the same time a scientific analysis was published in the New England Journal of Medicine saying that Avandia was linked to a greater risk of heart.
The deceased victim had taken Avandamet, a form of Avandia mixed with another diabetes drug, since early 2005.
Click Here to read more about the case in a recent AP article.
Wyeth Loses Pondimin Lawsuit
Drug developer Wyeth lost a lawsuit alleging damage from the diet drug Pondimin, which the company previously marketed.
The jury awarded the plaintiff Virginia Cavender $75,000 in the case, tried in the U.S. District Court for the Eastern District of Missouri in St Louis. She alleged heart valve injury from use of the drug.
Click Here to read more about this Wyeth lawsuit.
Wisconsin Lawyer seeks new Vioxx trial
A Wisconsin Attorney requested Madison County Circuit Judge Daniel Stack to give his client a new trial, alleging the judge did not weigh all evidence when granting a directed verdict for Merck on one count of defective design during the county's first Vioxx trial.
At trial, lawyers for the Plaintiff alleged that Vioxx was defectively designed, inadequately tested, dangerous to human health, and lacked proper warnings, which subjected users to risks of heart attacks, strokes and other illnesses.
Merck argued that the Plaintiff''s preexisting risk factors -- a family history of heart disease, morbid obesity, diabetes, high blood pressure and sedentary lifestyle -- were responsible for her tragic unfortunate, sudden cardiac death
The trial ended in favor of Merck on March 27 after a seven-woman, five-man jury rejected the Plaintiff's claim that his wife's sudden heart attack at age 52 was caused by taking Vioxx.
Click Here to read more about this request for a new Vioxx trial in the Madison Record.
Pharmaceutical Fraud and Sicko
I am feeling Sick-O. After being an attorney for the Department of Justice and always feeling like I was in the right, I moved over to the private sector to help people in civil areas of law. After a few years of general practice, I realized that I enjoyed personal injury law the most, so we (my wife and I) started to concentrate on handling only personal injury related cases. This was about the time that the Corporatist Party of American (formerly known as Republicans) came to power and began a campaign of hate and lies against personal injury plaintiffs and their lawyers. Certainly they had some ripe fruit to pick from. This area of the law is fraught with fraud. As a loyal Republican the attack on injured individuals and Plaintiff’s attorneys was a bit of a disconnect. Why are the perssonal injury attorneys so bad? Why are they hurting American business so greatly. Being in the industry, I just did not see it.
Of course everyone wants to rid the world of fraudulent personal injury cases. Those cases are the ones that make helping a truly injured person so difficult today. But the solutions being offered by the Corporatist Party of America were not aimed at stopping fraud. They were aimed at stopping lawsuits of value and significance. Fraudulent injury cases almost always settle for small sums of money. It is virtually impossible to sell a fraudulent injury case to a jury today. How, therefore, will “capping damages” help to cure fraud? It only caps the recovery for the most injured people! The real cases get hurt while the fraud cases go unpunished.
Meanwhile, under our noses, corporate America began an attack on the American stock shareholder and the American citizen taxpayer, which is unprecedented in our history. After working with hundreds of injured people and sifting through many hypochondriac jokers and having to kick some cases to the curb, I have come to the absolute conclusion that the true harm to the average American today is squarely in corporate fraud against our own government and against our own people. The worst thing about this is that our government is in on the plan. Our legislators and administrators are in bed with the corporate big wigs that cheat the little guy out of health and retirement plans, stock ownership or even savings.
The level of fraud in America today is sickening. There is no comparison between the fraud of corporate America and the fraud of fake injury “victims”. I guarantee you the damage done to the American economy, the American ideal and the American tax system from corporate fraud is 1000 times greater than all of the insurance scams put together. The fraud is so disturbing that it is actually hard to believe.
Coming this summer is a movie called Sicko. It is a documentary about the health and drug industry. I am almost certain it will document the conspiracy going on between doctors, drug manufacturers and the FDA.
As we speak (or rather, as you read) the drug lobby and their corporatist party lackeys are trying to make the FDA the final oversight of the drug industry and take away a injured victims right to sue if they are hurt by a drug. It is my prayer that this movie spurs politicians NOT to permit the drug lobby to have the FDA be there ONLY oversight. We must keep the drug companies honest and the only way they will be an honest broker is if they are held accountable through civil lawsuits. Is the system perfect? Certainly not. But it is far better than any other system out there. It is only through the power of the pocketbook that we can control the moral-less corporate beast.
So, you ask, why am I so “up in arms” about the FDA issue right now?
OxyContin Maker, Pays $634.5 Million to settle lawsuit
The maker of the powerful painkiller OxyContin and three of its current and former executives pleaded guilty to misleading the public about the drug's risk of addiction, and agreed to pay $634.5 million to settle lawsuit.
The Purdue Pharma L.P company will have help in paying this fine, the president, top lawyer and former chief medical officer, will also share in paying the $634.5 million in fines for claiming the drug was less addictive and less subject to abuse than other pain medications, according to U.S. Attorney John Brownlee.
"With its OxyContin, Purdue unleashed a highly abusable, addictive and potentially dangerous drug on an unsuspecting and unknowing public," Brownlee said. "For these misrepresentations and crimes, Purdue and its executives have been brought to justice."
Ken Jost of the Justice Department's Office of Consumer Litigation said "this case should put pharmaceutical companies on notice that they won't be able to get away with breaking the law to make a profit".
Click here to read more on this story from Associated Press and Law.com
Suits Surge Against Makers of Anti-Psych Drug Seroquel
AstraZeneca was hit with over 350 products Liability cases from Plaintiff's in Delaware state court for their anti-psychotic drug Seroquel. This is more than the total number of cases filed in AstraZeneca's home state in the last two years. A defense observer thinks that plaintiffs counsel may be trying to force the company into an early settlement of the Delaware cases and to avoid the federal multidistrict litigation. But a defense attorney says AstraZeneca has no plans to settle.
Click here to read full text from National Law Journal (subscription required)
