News & Analysis as of

Birth Defects

Faegre Drinker Biddle & Reath LLP

Amended FRE 702 Arrives in MDL Practice: S.D.N.Y. Excludes Plaintiffs’ Experts in Acetaminophen MDL

The Committee Notes to the newly implemented amendments to Federal Rule of Evidence 702 make clear that the “[j]udicial gatekeeping” of expert evidence is “essential.” Federal courts in New York have played an important role...more

Faegre Drinker Biddle & Reath LLP

Lack of “Newly Acquired Information” Defeats Plaintiffs’ Claims in Zofran MDL

Zofran (ondansetron) has often been used to combat nausea during pregnancy. It has never been approved by the FDA for that indication, but clinical experience has not supported an association with pregnancy-related risks –...more

Faegre Drinker Biddle & Reath LLP

Experts’ Disagreement with Medical Literature Leads to Exclusion

Peer-reviewed literature can be a powerful tool in attacking an opposing expert’s opinions. A solid, on-point article can do more than merely satisfy several of the so-called Daubert factors for assessing reliability – by...more

Console and Associates, P.C.

The Use of Depakote by Pregnancy Women Linked to Serious Birth Defects

Over ten years ago, the Food and Drug Administration (FDA) determined that pregnant women who take Depakote (valproate) have a much higher chance of giving birth to a baby who suffers low IQ or a birth defect. In response,...more

Foley Hoag LLP

Product Liability Update: July 2019

Foley Hoag LLP on

Massachusetts Federal Court Dismisses Suit By Japanese Plaintiffs Against Massachusetts Reactor Designer For Japanese Disaster Based On Forum Non Conveniens, Citing Japanese Compensation System That Provided Alternative Forum...more

Steptoe & Johnson PLLC

WV Supreme Court Kicks Failure to Warn Case Under Michigan Law

The West Virginia Supreme Court of Appeals recently upheld the Mass Litigation Panel’s grant of summary judgment against a class of Plaintiffs alleging birth defects resulting from the use of prescription medicine in...more

Shook, Hardy & Bacon L.L.P.

Tenth Circuit Finds Citizen Petition Denial to be "Clear Evidence" of Conflict Preemption

A U.S. Court of Appeals has held that a Food and Drug Administration (FDA) denial of a citizen petition can be “clear evidence” of conflict preemption under the test set forth by the Supreme Court in Wyeth v. Levine, 555 U.S....more

Morrison & Foerster LLP

Another Step Toward Reasonable Preemption Case Law

Last month, the Sixth Circuit affirmed a complete defense verdict for Abbott Laboratories Inc. which was based in part on branded drug preemption. Rheinfrank v. Abbott Laboratories Inc., Case No. 16-3347, 2017 WL 680349 (6th...more

Morrison & Foerster LLP - Class Dismissed

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

Morrison & Foerster LLP - Class Dismissed

Federal Preemption Claims: Clear Evidence and an Unclear Standard

Last week, a federal court in Utah granted Aventis Inc.’s motion for summary judgment based on federal preemption of failure-to-warn claims. Cerveny v. Aventis, Inc., 2016 U.S. Dist. LEXIS 34182 (D. Utah Mar. 16, 2016). The...more

Cozen O'Connor

New York Court of Appeals Rejects Litigation Science under Frye Standard

Cozen O'Connor on

Put quotes around the phrase “litigation science” and Google it. Go ahead, we’ll wait. . . . . What did you find? Not good, right. You found a lot. Too much. The first Google page alone shows how controversial this...more

Mintz - Employment, Labor & Benefits...

Zika Virus: Appropriate Workplace Responses

The Zika virus has been the topic of much discussion and anxiety for many weeks. The United States Centers for Disease Control and Prevention (CDC) has now issued travel warnings for more than two dozen countries in the...more

Searcy Denney Scarola Barnhart & Shipley

Ohio Couple Says Zofran Caused Infant’s Death

In 1991, the Food and Drug Administration (FDA) approved Zofran, which is manufactured by GlaxoSmithKline LLC (GSK) for use in cancer patients who require chemotherapy or radiation therapy. An Ohio couple has sued GSK, the...more

Morrison & Foerster LLP

Another Major Earthquake: California Creates Big Fissures in Proposition 65 Regulations – Proposals Could Shatter Defenses

In the midst of making Proposition 65’s longstanding warning regulations far more onerous, and vexatious litigation far more likely, California’s Office of Environmental Health Hazard Assessment (OEHHA) has unveiled still...more

Mintz - Consumer Product Safety Viewpoints

Hidden Costs of Common Beauty Treatments?

The “toxic trio” is a foreboding name some associate with common and seemingly innocuous manicures and pedicures. Salon workers suffer higher-than-average rates of birth defects, miscarriages, cancers, and skin afflictions...more

Foley & Lardner LLP

Six Hot Opportunities in Genomic Medicine

Foley & Lardner LLP on

Advances in DNA sequencing technology and the interpretation of the acquired data have fueled advances in genomics and its application in the delivery of personalized healthcare. Illumina recently announced a new milestone...more

Foley & Lardner LLP

Supreme Court Asked for Further Clarity on Patent-Eligibility of Diagnostic Claims

Foley & Lardner LLP on

Did the Federal Circuit incorrectly interpret and apply the holding of the U.S. Supreme Court’s decision regarding patent-eligibility of medical methods as set forth in Mayo Collaborative Services v. Prometheus Laboratories,...more

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