Drug Safety

Generic Drugs: A Closely Watched Case

by Phillips Law Offices on 5/8/2013

In 2005, Karen Bartlett visited her doctor complaining of shoulder pain. Her doctor prescribed Sulindac, a nonsteroidal anti-inflammatory drug used to relieve pain and address symptoms of arthritis. Ms. Bartlett was dispensed...more

Ongoing Fungal Meningitis Outbreak Investigation

by Phillips Law Offices on 4/30/2013

According to the Centers for Disease Control and Prevention (CDC), as of March 11 of 2013 the number of reported cases of injury from contaminated steroids produced by the now-defunct Massachusetts company New England...more

Bayer Healthcare Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc. (Fed. Cir. 2013)

by Michael Greenfield | McDonnell Boehnen Hulbert & Berghoff LLP on 4/25/2013

Contraceptives were the subject of the Federal Circuit's recent decision in Bayer Healthcare Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc. But, unfortunately, it's a rather fact-specific case with nothing of prurient...more

Bleeding Deaths Linked to Pradaxa [Video]

by Lawyers.com on 4/23/2013

Watch this news video if you or anyone you know is on a blood thinner. It could provide life saving information. Pradaxa, an anticoagulant medication, helps prevent blood clots and strokes. It’s often used with people who...more

GranuFlo Lawsuit Consolidation Concentrates Litigation in Massachusetts Federal Court

by Audet & Partners, LLP on 4/23/2013

On March 29, 2013, the United States Judicial Panel on Multidistrict Litigation ("JPML"), consolidated eleven pending federal actions alleging injuries related to GranuFlo and/of NaturaLyte administration during dialysis...more

FDA Grapples with Social Media

by Audet & Partners, LLP on 4/18/2013

As businesses continue to capitalize on social media as an inexpensive and effective advertising tool, pharmaceutical companies are struggling to find ways to embrace this trend while abiding by FDA regulations, “…fear of...more

Compounding Animal Drugs from Bulk Ingredients

by Duane Morris LLP on 4/17/2013

Recent public discussion about the federal role in regulating compounding pharmacies has focused on compounded drugs for human use. Compounded drugs are also vital to companion animal health (like pets). In the world of...more

You Should Know - April 2013

by Patrick Malone & Associates P.C. | DC Injury... on 4/17/2013

In This Issue: - Ask Congress to Hold Generic Drug Makers Accountable - Ruling May Leave You Vulnerable to Unsafe Generic Drugs - By the Numbers - Bookmark Favorites - What's Your Drug Safety IQ? -...more

Quitting Smoking? How Chantix May or May Not Be Able to Help

by The Rothenberg Law Firm LLP on 4/16/2013

Individuals looking to quit smoking may turn to popular smoking-cessation drugs like Chantix (varenicline). Almost everyone has seen the commercials for Chantix, where a handful of people indicate that the drug has helped...more

Beware Of Topamax — It Can Be A Dangerous Drug

by Tate Law Group, LLC on 4/2/2013

Topamax (topiramate) was first approved by the United States Food and Drug Administration (FDA) in 1996 as an anti-convulsant for the treatment of seizures. Topamax was widely used to treat epilepsy in children and adults....more

Filing A Lawsuit For Damages Caused By A Dangerous Drug

by Tate Law Group, LLC on 3/18/2013

Pharmaceutical companies manufacture, test and introduce new drugs regularly. Despite rigorous testing by the drug companies and monitoring by the United States Food & Drug Administration (FDA), lawsuits are an inevitable...more

China Amended Good Supply Practices for Pharmaceuticals

by Katherine Wang | Ropes & Gray LLP on 2/21/2013

The Chinese Ministry of Health (“MOH”) published the long-awaited amendment of Good Supply Practices for Pharmaceuticals (the “Amended GSP”) on January 22, 2013, to be effective as of June 1, 2013. After three rounds of...more

Approving Too Quickly? Drug Safety and the FDA

by Phillips Law Offices on 2/12/2013

In October, 2010, the U.S. Food and Drug Administration (FDA) approved the drug dabigatran to reduce the risk of blood clots and stroke in patients with atrial fibrillation. Marketed as the twice-daily miracle drug Pradaxa,...more

Zoloft Use During First Trimester of Pregnancy Can Increase Risk of Birth Defects

by Hissey Kientz LLP on 1/8/2013

Use of the selective serotonin reuptake inhibitor (SSRI) antidepressant Zoloft during the first trimester of pregnancy can increase a child’s risk of being born with serious heart defects or other birth defects. ...more

Use of Depakote During Pregnancy Can Lead to Birth Defects

by Hissey Kientz LLP on 9/13/2012

The Food and Drug Administration has warned that women who use the seizure and migraine drug Depakote while pregnant are more likely to give birth to a child with major birth defects than those who use other seizure drugs. ...more

Zoloft Birth Defects Studies

by Hissey Kientz LLP on 8/31/2012

Several leading medical journal have published studies about the risk of birth defects associated with taking antidepressant such as Zoloft during pregnancy. ...more

Zoloft Birth Defect Lawsuits Consolidated into MDL

by Schmidt & Clark, LLP on 7/20/2012

Manufactured and marketed by pharmaceutical giant Pfizer, Zoloft (generic: sertraline) is a widely-prescribed antidepressant medication from the selective serotonin reuptake inhibitor (SSRI) class. Zoloft is generally...more

Zoloft Birth Defects Lawsuit FAQ

by Hissey Kientz LLP on 3/28/2012

Answers to frequently asked questions about birth defects lawsuits filed concerning the antidepressant Zoloft....more

Can the use of SSRI’s (anti-depressants) cause a child’s birth defect?

by Jonathan Rosenfeld - Chicago Personal Injury... on 3/3/2012

Yes. The extremely popular family of anti-depressant drugs known as serotonin reuptake inhibitors (SSRI’s) have been causally connected with the development of birth defects in children who’s mother’s have taken the drugs...more

FDA Warns Of Birth Defects Risk with Diflucan

by TorHoerman Law, LLC on 8/3/2011

The FDA is warning the public that treatment with chronic, high doses of Diflucan (fluconazole) during the first trimester of pregnancy may be associated with a rare and distinct set of birth defects in infants. Diflucan is...more

More Evidence That Topamax Manufacturer Is Responsible For Birth Defects

by Jonathan Rosenfeld - Chicago Personal Injury... on 4/28/2011

I've written a lot about the serious problems associated with use of Topamax during pregnancy. After all, the FDA ordered Topamax to be re-labelled and re-classified in March, 2011 in response to data suggesting a conclusive...more

New FDA Warnings Suggest Correlation Between Topomax And Birth Defects Including: Cleft Lip & Cleft Palate

by Jonathan Rosenfeld - Chicago Personal Injury... on 3/14/2011

A new FDA warning was recently published which warns women of childbearing age that their use of Topomax (and other generic variations known as topiramate) significantly increases their chances of giving birth to a child with...more

Topamax During Pregnancy Increases Risk Of Cleft Lip And/Or Cleft Palate Birth Defects

by Thomas J. Lamb on 3/10/2011

Topamax During Pregnancy Increases Risk Of Cleft Lip And/Or Cleft Palate Birth Defects Oral Clefts In Babies Are 20 Times More Likely With Women Who Used Topamax (topiramate) After Getting...more

FDA Seeks Information About Topamax-Related Oral Cleft Birth Defect Cases

by Thomas J. Lamb on 2/1/2011

FDA Seeks Information About Topamax-Related Oral Cleft Birth Defect Cases Request For Historical Incidence Data Made In Connection With NDA For New Obesity...more

Glaxo to Pay $1 Billion to Children with Birth Defects from Mothers who took Paxil

by Regan, Zambri & Long, PLLC on 8/3/2010

Bloomberg News reported that GlaxoSmithKline P.L.C. has agreed to pay $1 billion to injured consumers to resolve more than 800 cases involving the antidepressant Paxil. The medication has been in use in the U.S. since 1992....more

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Generic Drugs: A Closely Watched Case

Ongoing Fungal Meningitis Outbreak Investigation

Bayer Healthcare Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc. (Fed. Cir. 2013)

Bleeding Deaths Linked to Pradaxa [Video]

GranuFlo Lawsuit Consolidation Concentrates Litigation in Massachusetts Federal Court

FDA Grapples with Social Media

Compounding Animal Drugs from Bulk Ingredients

You Should Know - April 2013

Quitting Smoking? How Chantix May or May Not Be Able to Help

Beware Of Topamax — It Can Be A Dangerous Drug

Filing A Lawsuit For Damages Caused By A Dangerous Drug

China Amended Good Supply Practices for Pharmaceuticals

Approving Too Quickly? Drug Safety and the FDA

Zoloft Use During First Trimester of Pregnancy Can Increase Risk of Birth Defects

Use of Depakote During Pregnancy Can Lead to Birth Defects

Zoloft Birth Defects Studies

Zoloft Birth Defect Lawsuits Consolidated into MDL

Zoloft Birth Defects Lawsuit FAQ

Can the use of SSRI’s (anti-depressants) cause a child’s birth defect?

FDA Warns Of Birth Defects Risk with Diflucan

More Evidence That Topamax Manufacturer Is Responsible For Birth Defects

New FDA Warnings Suggest Correlation Between Topomax And Birth Defects Including: Cleft Lip & Cleft Palate

Topamax During Pregnancy Increases Risk Of Cleft Lip And/Or Cleft Palate Birth Defects

FDA Seeks Information About Topamax-Related Oral Cleft Birth Defect Cases

Glaxo to Pay $1 Billion to Children with Birth Defects from Mothers who took Paxil

Bleeding Deaths Linked to Pradaxa [Video]

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