$105 Million Settlement in Paxil Lawsuit Alleging GlaxoSmithKline Improperly Marketed Paxil and Other Drugs
Columbus, OH (PRWEB) June 23, 2014 -- The Paxil birth defect lawyers at Wright & Schulte LLC note that GlaxoSmithKline has agreed to pay $105 million to resolve criminal and civil charges that it purportedly improperly marketed Paxil and other drugs. According to a report from Bloomberg News, the agreement, which resolves claims levied against the company by dozens of state attorneys general, prevents GlaxoSmithKline from paying incentives to its drug reps that encourage those individuals to promote unapproved indications for the medications, and from using doctors to promote its drugs. In agreeing to settle the claims against it, GlaxoSmithKline did not admit to any wrongdoing.
[bloomberg.com/news/2014-06-04/glaxo-
to-pay-105-million-to-settle-promotion-
claims.html, June 4, 2014]
According to Wright & Schulte LLC, once a medication is approved by the U.S. Food & Drug Administration (FDA), doctors are free to use it off-label for any indication they see fit. However, drug companies are barred by law from marketing a medication for off-label uses. According to a report from the Associated Press, attorneys general from more than 40 states had accused GlaxoSmithKline of violating state consumer protection laws by misrepresenting the uses and qualities of drugs and marketing them for purposes unapproved by the FDA. Medications covered by the accord include the antidepressants Paxil and Wellbutrin, as well as an asthma drug called Advair.
(bigstory.ap.org/article/glaxosmithkline-agrees-105-million-settlement, Associated Press, June 5, 2014)
Paxil is a selective serotonin reuptake inhibitor (SSRI), a class of antidepressants that increases the amount of serotonin in the brain. In 2005, the U.S. Food & Drug Administration (FDA) moved Paxil from Pregnancy Category C to Category D, after studies involving pregnant women indicated Paxil posed a risk to the fetus.
[fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm051731.htm]
In 2006, a study published in the New England Journal of Medicine (NEJM) suggested that infants born to women who had been treated with an SSRI during the third trimester of their pregnancy faced a six-fold increased risk of being born with persistent pulmonary hypertension of the newborn (PPHN). As a result of the study’s findings, the FDA asked the manufacturers of several SSRI antidepressants, including Paxil, to add information to their labels describing the potential risk of PPHN.
[fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150749.htm]
In 2007, the NEJM published another study that indicated infants whose mothers had used SSRI’s during the first trimester of pregnancy were twice as likely to suffer heart-related birth defects. The most common heart defects seen in that study were ventricular outflow defects and septal defects.
[nejm.org/doi/full/10.1056/NEJMoa067407]
Wright & Schulte LLC offers free Paxil lawsuit evaluations to alleged victims of Paxil birth defects. If your child suffered a heart malformation or some other birth defect that could be connected to Paxil, please visit yourlegalhelp.com, or call toll-FREE 1-800-399-0795 to learn more about your options for legal recourse.
If you believe that taking Paxil may have played a role in causing your child’s birth defect, the experienced Paxil lawyers at Wright & Schulte, LLC strongly encourage you to learn more about your rights and to contact Wright & Schulte LLC to receive a thorough evaluation of your case. Our Paxil attorneys are committed to standing up for victims’ rights, and to help those who have been injured receive the compensation they deserve. To learn more about what you can do to hold GlaxoSmithKline accountable, simply fill out the online form on the right, or give Wright & Schulte LLC a call, toll-free, at 1-800-399-0795 or visit http://www.yourlegalhelp.com
About Wright & Schulte LLC
Wright & Schulte LLC, a leading personal injury firm, is dedicated to the belief that America’s legal system should work for the people. Every day, the attorneys of Wright & Schulte LLC stand up for the rights of people who have been injured or wronged, and fight tirelessly to ensure that even the world’s most powerful corporations take responsibility for their actions. If you’re looking for a law firm that will guarantee the aggressive and personal representation you deserve, please do not hesitate to contact Wright & Schulte LLC today. Free case evaluations are available through yourlegalhelp.com, or call 1-800-399-0795.
Contact:
Wright & Schulte LLC
812 East National Road
Vandalia, Ohio 45377
1-800-399-0795
http://www.yourlegalhelp.com
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Richard Schulte, Wright & Schulte LLC, http://www.yourlegalhelp.com, +1 1-800-399-0795, [email protected]
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