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.

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

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.
 

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.

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.

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...

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.)

This case illustrates that tragic facts make bad law. The Court holds that a state tort jury, rather than the Food and Drug Administration (FDA), is ultimately responsible for regulating warning labels for prescription drugs. That result cannot be reconciled with Geier v. American Honda Motor Co., 529 U. S. 861 (2000), or general principles of conflict pre-emption.

Alito goes on to pose the hypothetical question:  "is it the FDA or a jury in Vermont— that has the authority and responsibility for determining the “adequacy” of Phenergan’s warnings?"

There is so much to discuss in this 80 page decision.   Over the next few days we will go into the decision more on this blog, to highlight more important points in this opinion. As Civil Justice Prosecutors, we are pleased with the Court's decision in Wyeth v. Levine.

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.

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.

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.

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.
 

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.

Although the study was presented as an abstract and at a conference, the results of this analysis should not be embraced fully until the full article has been published in a scientific journal and examined by other scientists. Also, the mechanism by which bisphosphonates lead to this increased risk of fibrillation of the atria is not known; all that has been concluded thus far is that there is a link between the two events.

In response, the FDA has begun a safety review to study these results further, and has recommended that physicians to be watchful when prescribing this medication to patients who are already at risk for cardiovascular conditions. Patients taking this drug should consult with their Doctors and should not  alter their prescription patterns, unless ordered by their Doctor.

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.

 

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.

Click here to read more on this Vytorin Study dispute from the Wallstreet Journal. (Note: Subscription required)

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.

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...

"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.

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.

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.