Birth Defects

News & Analysis as of

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

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

Guest Post - Design Defect Preemption - It’s as Simple as One, Two, Three

Courts are starting to “get” the design defect preemption argument. That makes sense because the argument is simple. Any major changes in the design of a drug or a medical device require the prior approval or permission of...more

New York Court of Appeals Rejects Litigation Science under Frye Standard

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

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

Zofran Morning Sickness Lawsuit and Birth Defects

If you took Zofran to treat the symptoms of morning sickness during your pregnancy and your baby has a serious birth defect, you may be able to file a product liability claim. According to a recent article in Reuters, federal...more

Another Zoloft Daubert Win: How Many Strikes Before The Plaintiffs Are Out?

Everybody knows that it is three strikes and you are out in baseball. (Bexis and Ken Burns could discuss the history of baseball’s rules on balls and strikes in the nineteenth century, but we will stick with the public...more

The Ghost of Bendectin – Exorcized by the FDA?

Not quite two years ago, we posted about how, under Wyeth v. Levine, 555 U.S. 555 (2009), and subsequent Supreme Court cases, private plaintiffs can’t make claims that so-and-so should have warned about such-and-such with...more

Can the California A.G. limit those incessant Prop 65 lawsuits?

The California Attorney General has proposed amendments to California’s Proposition 65 regulations governing enforcement actions brought by a “private person in the public interest.”...more

Plaintiffs Allege GSK Hid Risk of Birth Defects

The Food and Drug Administration approved Zofran in 1991 for use in cancer patients who required chemotherapy or radiation therapy. The two women have sued GlaxoSmithKline (GSK), the maker of Zofran, accusing it of promoting...more

A Frye Opinion By Any Other Name: Zoloft Plaintiffs' Experts Excluded in Philadelphia

We spent the weekend in the Boston area, visiting the Drug and Device Law Rock Climber for “parents’ weekend.” Saturday’s schedule was replete with activities: a keynote speech by the university president, lectures on topics...more

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

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

SDNY Dismisses Manufacturing and Fraud Claims in Fertility Drug Case, But Conflates and Confuses the Rest

By all rights, it should be Sullivan writing about the Sullivan case. But John is taking a well-deserved vacation. We do not know if Sullivan’s travels more closely approximate a Bexis expedition, which involves long hikes...more

Preemption (and Other Things) Defanging Depakote Claims

It wasn’t a complete win, but the summary judgment outcome in Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 4743056 (S.D. Ohio Aug. 10, 2015), has to put a spring in the step of the defendants as they...more

More Lawsuits Filed Against the Makers of Zofran

Zofran (ondansetron) is an anti-nausea medication made by GlaxoSmithKline (“GSK”). In 1991, the Food and Drug Administration (“FDA”) approved it for chemotherapy patients with severe nausea and vomiting. However, it has been...more

GlaxoSmithKline Files Motion To Consolidate Zofran Litigation In Philadelphia

Zofran was developed to prevent nausea and vomiting caused by cancer chemotherapy. However, doctors prescribed it for the treatment of morning sickness in pregnant women. GlaxoSmithKline is the world’s seventh largest...more

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

Lawsuits Allege LinkBetween Zoloft and Birth Defects

Report Suggests Anti-Depressant May Cause Birth Defects - Last year, a Pfizer report included information from a scientist that suggested a “potential link” between birth defects and the manufacturer’s anti-depressant...more

Pfizer Wins First Zoloft Birth Defect Trial in Missouri

A jury trial was wrapped up recently after lasting a little more than a week in state court in St. Louis after the jury found in favor of Pfizer. The lawsuit alleged that Logyn Pesante, an eleven year old boy from California,...more

Result-Driven Affirmance of Birth Defect Verdict

We have said it before – birth defect cases are hard. Juries and judges are sympathetic where the individual whose health is at issue had no say in the matter. We have also said that we do not like it when judges frame the...more

Long Tail Personal Injury Claims – Have the Gates Opened in Western Australia?

In September 2014, we reported on the argument before the Supreme Court of Western Australia Court of Appeal in an appeal against the decision of Dixon v Clarke [2013] WASC 471.  The Court of Appeal delivered its reasons for...more

California Appellate Court Finds Employer Has No Duty to Future Child for Parent-Employee’s Preconception Exposure to Toxins

The preconception tort is essentially any tortious conduct occurring prior to a child’s conception that results in harm to the child. This type of claim, which has been recognized in California since 1982, can cover all...more

Six Hot Opportunities in Genomic Medicine

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

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

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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