Pharmaceutical News
2012/2011 | 2010 | 2009 | 2008 | 2007
April 10, 2012
Feds Will Participate in Whistleblower's False Claims Act Appeal
The First Circuit ruled on Tuesday that the Justice Department will be permitted to participate in an appeal to resurrect a whistleblower lawsuit filed against Pfizer, Inc., Law360 reports. The original lawsuit, filed in 2003 by former Pfizer Vice President Peter Rost, alleged the drugmaker paid kickbacks to physicians who prescribed Genotropin, a human growth hormone made by Pfizer. Rost argued the kickbacks resulted in pharmacies submitting false claims in order to receive reimbursement from Medicaid programs for Genotropin. But, a Massachusetts district court judge concluded in 2010 that, because the claims were submitted by innocent third-party pharmacies, they were not necessarily fraudulent, even though the kickbacks were in violation of the Anti-Kickback Statute. The U.S. argues the Massachusetts court ruling is inconsistent with recent decisions by the First Circuit in New York v. Amgen Inc. and U.S. ex rel. Hutcheson v. Blackstone Medical Inc., which ruled that claims submitted to Medicaid by innocent third parties can be false if kickbacks are involved. The U.S. will participate in arguments, along with the “Relator” Peter Rost in the beginning of May.
March 30, 2012
Medtronic to Pay $85 Million to Settle Class Action Lawsuit
Medical device company Medtronic has agreed to settle a class action lawsuit filed by the company's shareholders for $85 million. The class action suit alleges that Medtronic suppressed information and made misleading statements regarding its Infuse bone growth product. Medtronic shareholders filed the lawsuit after discovering the company was relying heavily on off-label uses for Infuse not approved by the U.S. Food and Drug Administration (FDA). Medtronic failed to inform shareholders that roughly 85 percent of sales for Infuse were based on off-label uses such as cervical fusions, which can cause life-threatening complications. The Minneapolis Firefighter's Relief Association filed the investor lawsuit in 2008, stating that Medtronic's stock price was artificially inflated due to the underreporting of Infuse's off label marketing. The $85 million settlement will go to investors who owned Medtronic stock between November 20, 2006 and November 17, 2008. Medtronic denies any wrongdoing in the settlement.
Baum Hedlund represents patients injured as a result of off-label use of Infuse. They accuse the medical device manufacturer of illegally promoting the product, amongst other allegations.
Read more here.
March 28, 2012
FDA Issues Updated Heart Warning on Celexa Use
The US Food and Drug Administration (FDA) has issued an updated Drug Safety Communication regarding the use of the antidepressant Celexa, and its association with the potential risk of a rare and sometimes fatal abnormality of the heart’s electrical system. A previous FDA Drug Safety Communication warned that Celexa and its generic version citalopram should not be taken at daily doses greater than 40 mg “because it could cause potentially dangerous abnormalities in the electrical activity of the heart,” specifically an abnormal and potentially fatal heart rhythm called Torsade de Pointes. Changes have now been made to the drug label, which includes an announcement that the maximum recommended dose of Celexa for patients older than 60 years of age is 20 mg per day.
Celexa (citalopram) is a selective serotonin reuptake inhibitor (SSRI) antidepressant manufactured, marketed and sold by Forest Laboratories Inc. The drug has also been associated with numerous birth defects, including Persistent Pulmonary Hypertension of the Newborn (PPHN).
Read the FDA Drug Safety Communication
March 26, 2012
Senator Leahy (D-VT) Introducing Bill to Protect Consumers of Generic Drugs
Senator Patrick Leahy (D-VT) will soon introduce new legislation meant to reverse a 2011 Supreme Court decision that frees generic drug companies from liability for failing to warn consumers of known risks of their generic drugs. The Supreme Court decision maintains that "state law tort claims against generic manufacturers are preempted by federal law, which requires generic drug manufacturers to use the same label as a brand name drug, even when the generic pharmaceutical company knows that the warning on the label is inadequate." The decision creates an inconsistency between what name brand manufacturers and generic manufacturers must do in order to protect consumers from adverse drug reactions, Leahy argues.
If someone takes a brand-name drug, they have the recourse to sue the manufacturer if they suffer any prescription drug injury. According to the Supreme Court decision, however, when it comes to generic drugs, consumers are not able to sue the generic drug company if they sustain injury as a result of taking the drug. The decision has wide-ranging implications because some state laws and insurance plans mandate that generic drugs be given to patients whenever they are available, thus, many people do not have any control over the drugs they are prescribed. "I will introduce legislation to address this contradiction so that consumers are fully protected from harm and receive adequate warnings," said Senator Leahy.
In 2010, 75 percent of drug prescriptions were filled using generic drugs. The Leahy legislation would permit generic drug companies to change the labeling information on their products, the same as brand-name manufacturers, if they believe the label is lacking or inadequate or when they become aware of previously unknown risks not contained in the label.
Read more here.
March 8, 2012
60 Minutes Report: Antidepressants -- The Emperor Has No Clothes
For many people, particularly those who have taken or are currently taking antidepressants, the 60 Minutes segment that aired on Sunday, February 19, was a hard pill to swallow. Consumers are shocked, flabbergasted, and have been left in stunned disbelief – how could this be? Despite the billions of prescriptions filled and multi-billions of dollars spent on antidepressants, the benefits of antidepressants do not outweigh placebo?
The 60 Minutes (CBS) program about antidepressant efficacy was riveting. Irving Kirsch, an associate director of the Placebo Studies Program at Harvard Medical School, who has been studying placebos for 36 years, told 60 Minutes that the difference between the perceived benefit of a placebo compared with the benefit of an antidepressant is minimal for most people.
March 5, 2012
Archives of General Psychiatry: Delayed Fetal Head Growth
in Maternal Use of SSRI's, Study Finds
Mothers using selective serotonin reuptake inhibitor (SSRI) antidepressants during pregnancy risk their child being born with serious birth defects, a new study suggests.
The study, published in the online journal Archives of General Psychiatry, assessed 7,696 pregnant mothers and ultra scans were performed during each of the trimesters. Results showed that babies in mothers who took SSRIs were more likely to suffer from delayed head growth. The study also showed that mothers treated with SSRI antidepressants were more likely to give birth earlier (preterm) than those untreated.
"Fetal body growth is a marker of fetal health and fetal head growth is a marker for brain development," said the study’s lead author Hanan El Marroun of the department of child and adolescent psychiatry at Sophia Children's Hospital and Erasmus Medical Center in Rotterdam, the Netherlands. "We found prenatal exposure to SSRIs was associated with decreased growth of the head, but not decreased growth of the body."
Although further investigation is needed, researchers say, these results raise concerns of whether or not SSRI treatment during pregnancy carries more risk than benefits to the fetus. Combine this latest study with data collected since 2005 and the risk of SSRI use during pregnancy seems higher than the benefits.
Click here for more information
January 24, 2012
PLOS Medicine: Key Opinion Leaders Who Lend Their Names to Ghostwritten Medical Articles Should Be Held Legally Liable, Article States
The authors of an article published on January 24, 2012 in the medical journal PLoS (Public Library of Science) suggest that prominent physicians (also known as Key Opinion Leaders or “KOLs”) who lend their names to ghostwritten, industry-financed medical articles that convey fraudulent misinformation resulting in harm to patients should be held legally liable.
The article, entitled "Challenging Medical Ghostwriting in the US Courts," was co-written by Baum Hedlund attorney Bijan Esfandiari along with Dr. Xavier Bosch from the University of Barcelona and Dr. Leemon McHenry from California State University, Northridge.
September 30, 2011
Reason Magazine Perpetuates False Information
About Safety and Efficacy of Antidepressant
 Baum Hedlund lawyer sets the record straight about “new working paper” on antidepressants and teen suicide and responds to Reason Magazine’s recycled and unwarranted conclusions about the rise in teen suicides, declining grades, etc., by pharma-funded academics which have been debunked by other scientists and by the authors themselves.
September 22, 2011
Actos Bladder Cancer Lawsuits Continue to Increase
Over 25 Actos bladder cancer complaints have been filed since the first Actos lawsuit was filed in early August. Actos (pioglitazone) is a drug approved by the US Food and Drug Administration (FDA) to treat type 2 diabetes. The lawsuits are continuing to pile up against Takeda Pharmaceuticals, the manufacturer of Actos, over allegations the drug company failed to properly research the medication or warn patients taking Actos about the increased risk of bladder cancer when the drug is taken for more than one year. Complaints were filed only weeks after the FDA issued warnings about the dangers of Actos. France and Germany called for an Actos to be taken off the shelves due to the high occurrence of bladder cancer amongst patients taking the medication. Actos is still on the market in the United States.
A petition was filed last month to consolidate Actos bladder cancer litigation to avoid conflicting rulings from different judges in different parts of the United States. Arguments are not expected to be heard until a hearing scheduled in December of this year.
August 24, 2011
FDA Warns High Doses of Celexa May Increase Risk of Fatal Heart Side Effects
The U.S. Food and Drug Administration (FDA) said in an online posting that high doses of the antidepressant Celexa can lead to an increased risk of fatal heart complications. Celexa is in a category of antidepressant drugs called selective serotonin reuptake inhibitors (SSRI). Federal health regulators have informed doctors that Celexa dosages above 40 milligrams can affect the heart's electrical activity.
Celexa labels at one point stated that some patients should be given as much as 60 milligram doses, but the FDA changed the language on labels due to the increased risk of heart complications. New language on Celexa labels will state that patients with congestive heart failure and conditions that affect the pumping action of the heart should avoid using the drug. Forest Laboratories, the company that markets and sells Celexa, agreed to pay over $300 million in 2010 to resolve civil and criminal allegations that the company illegally promoted Celexa off-label to treat depression in children and adolescents.
Click here for more information
July 4, 2011
Antidepressants Linked to Autism, Research Finds
 SSRI antidepressants (selective serotonin reuptake inhibitors) including Celexa, Lexapro, Prozac, and Zoloft have been linked to an increased risk of autism. A report published in Archives of General Psychiatry reveals new research that links the use of SSRI antidepressants during pregnancy with autism spectrum disorders (ASDs) in children.
After examining medical records, researchers found a “2-fold increased risk of ASD associated with treatment with selective serotonin reuptake inhibitors by the mother during the year before delivery, with the strongest effect associated with treatment during the first trimester.” The medical records came from the Childhood Autism Perinatal Study, which was conducted by Kaiser Permanente Medical Care program in Northern California.
“Results suggest that exposure, especially during the first trimester, may modestly increase the risk of ASD,” researchers concluded, adding that further studies will be needed to replicate and extend their findings.
Click here to read the article
May 19, 2011
Avandia to be Pulled From U.S. Shelves, Government Officials Say
The U.S. government announced on Tuesday that beginning in November this year, controversial diabetes drug Avandia (rosiglitazone) will be pulled from pharmacy shelves throughout the country. Starting in November 18, 2011, Avandia will be removed from local pharmacies and only certified doctors will be allowed to prescribe the medication to patients who are educated of the risks involved with the diabetes drug. Avandia, approved in 1999 to decrease blood-sugar levels in patients with type 2 diabetes, has been shrouded in controversy since scientific data in 2007 linked its use with a 40 percent increased risk of heart attack.
2012/2011 | 2010 | 2009 | 2008 | 2007
|
