Drug Safety

News & Analysis as of

Defendants Secure Rare Summary Judgment in Zoloft MDL

In an unusual turn of events, U.S. District Judge Cynthia Rufe recently granted defendants’ motion for summary judgment as to over 300 cases in the Zoloft MDL. These cases were consolidated in 2012 and involved allegations...more

Lawsuits Involving Fluoroquinolones Piling Up Against Manufacturers

Google “fluoroquinolones,” and page after page of search results come up about the dangers, risks and side effects of the antibiotic. Articles appear citing arrhythmia, nerve damage and type 2 diabetes all being associated...more

Big Pharma Should Take Reporting Adverse Events to FDA More Seriously

The U.S. Food and Drug Administration’s requirement that pharmaceutical companies report dangerous side effects cause by medicines they manufacture is being flouted by a few bad actors. Such violations of the federal law are...more

Xarelto’s Approval by the FDA

The controversy over Xarelto’s approval by the FDA and alleged irregularities in the conduct of the ROCKET-AF clinical trial continue to hang over the heads of Bayer and Janssen (a division of Johnson & Johnson), the...more

So Long Zoloft MDL

The Zoloft MDL has finally collapsed. We started to see the writing on the wall in June 2014, when the MDL judge ruled that none of the plaintiffs’ experts could testify that taking Zoloft while pregnant could cause birth...more

Xarelto Litigation – February Updates

There have been a number of recent noteworthy developments in the national litigation involving Xarelto. Currently, there are approximately 5,000 individual lawsuits pending in state and federal courts against the...more

Washington Healthcare Update

This Week: The House is not in session this week... The Senate returns today... Committees in the Senate will hold hearings on co-ops and mental health... Vice President Biden will attend the World Economic Forum in...more

Congress Clears Controlled Substances Act Scheduling Legislation

On November 16, 2015, the House of Representatives approved HR 639, the Improving Regulatory Transparency for New Medical Therapies Act, clearing it for the President. The legislation would amend the Controlled Substances...more

Pro Te: Solutio Vol. 8 No. 2

Summer is in full swing and certain topics are (staying) hot—especially regulatory issues, from new proposed rules to challenges to case law to strategic considerations. Generic preemption remains a hot topic. In Storm...more

Arizona Supreme Court Poised to Consider “Learned Intermediary” Doctrine

The Arizona Supreme Court will soon decide whether to grant or deny review of the Court of Appeals’ January 2015 decision regarding the longstanding “learned intermediary” doctrine. In January, the lower court held that the...more

FDA Releases Long-Awaited Biological Naming Draft Guidance and Proposed Rule

On August 27, 2015, the U.S. Food and Drug Administration (FDA) released long-awaited and highly anticipated draft guidance regarding the non-proprietary naming of biological products, including biosimilars. The draft...more

Central District of California "Discontinues" Much of Plaintiffs' Experts' Testimony in Cymbalta "Discontinuation Symptoms" Case

“I’m not a doctor, but I play one on TV” – shorthand for “I am pretending to know what I’m talking about, but I really don’t.” We have blogged frequently about experts inclined to such pretense and about courts’ varying...more

FDA Investigates Children’s Cough and Cold Medication With Codeine Amid Safety Concerns

In the wake of the European Medicines Agency’s (EMA) recently announced warning against giving codeine to children under 12 years old, the FDA announced its own safety investigation of the drug for use in children. The FDA’s...more

House Easily Passes 21st Century Cures Legislation, Includes Significant FDA Reforms

On July 10, 2015, the U.S. House of Representatives passed with an overwhelming majority (344-77), the 21st Century Cures bill (H.R. 6), a high-profile bipartisan bill intended to speed up and improve the process for...more

Wrap-Up of Federal and State Chemical Regulatory Developments, June 2015

EPA Denies Petition To Ban Triclosan: On May 13, 2015, the U.S. Environmental Protection Agency (EPA) denied a petition submitted in January 2010 by Food & Water Watch and Beyond Pesticides seeking to ban triclosan, an...more

Health Alert (Australia) - June 15, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgements: New South Wales. O'Sullivan v Medical Council of New South Wales [2015] NSWCATAD 113 The New South Wales Civil and...more

Makena Drug Compounding Lawsuit Against FDA Gets New Life

On January 7, 2014, a three-judge panel of the United States Circuit Court for the District of Columbia unanimously vacated the dismissal of claims against the U.S. Food and Drug Administration (“FDA”) and others by K-V...more

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

You Should Know - April 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

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

China Amended Good Supply Practices for Pharmaceuticals

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

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

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

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

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 Defects Lawsuit FAQ

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

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