Birth Defects

News & Analysis as of

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

Superior Court Affirms Dismissal of Paxil Birth Defect Case Lacking Proximate Causation

In its March 4, 2013 non-precedential decision in Pettit v. GlaxoSmithKline, LLC, No. 850 EDA 2012, the Pennsylvania Superior Court (applying Ohio law) affirmed an order of Philadelphia Court of Common Pleas Judge Sandra...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

FDA Warns Of Birth Defects Risk with Diflucan

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

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

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

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