Drug & Device News

Citing Choice-of-Law Issues, Appeals Court Reverses Plaintiff Verdict in Accutane Case

An appeals court has reversed a $25 million verdict against Hoffmann-La Roche Inc. and Roche Laboratories in the case of a man who alleged he developed Crohn's disease after using the company's acne drug, Accutane. New Jersey's Appellate Division ruled Aug. 11 in McCarrell v. Hoffmann-La Roche that the filing of the suit was untimely because the trial court erred in applying New Jersey's statute of limitations to the case rather than the law of the plaintiff's home state, Alabama. This is the second reversal in this case; the first plaintiff verdict was rendered in 2007, but it was also thrown out on appeal.

David Buchanan of Seeger Weiss in New York is representing plaintiff McCarrell. Following the appellate decision, he said, “Mr. McCarrell has litigated against Roche for 12 years concerning the permanent and devastating injuries he developed from his use of Accutane, and has proven Roche's responsibility for those injuries in two separate trials. Today's result is very disappointing. On behalf of Mr. McCarrell, we will be seeking further review of today's decision by the New Jersey Supreme Court.”

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FDA Warns Morning Sickness Drug Maker

When celebrity Kim Kardashian West touted a morning sickness medication to her followers on Instagram in August, the federal Food and Drug Administration (FDA) quickly responded with a warning letter to the drug's manufacturer, Duchesnay Inc.

Kardashian's post stated: “OMG. Have you heard about this? As you guys know my #morningsickness has been pretty bad. I tried changing things about my lifestyle, like my diet, but nothing helped, so I talked to my doctor. He prescribed me #Diclegis, and I felt a lot better and most importantly, it's been studied and there was no increased risk to the baby. I'm so excited and happy with my results that I'm partnering with Duchesnay USA to raise awareness about treating morning sickness. If you have morning sickness, be safe and sure to ask your doctor about the pill with the pregnant woman on it and find out more www.diclegis.com; www.DiclegisImportantSafetyInfo.com.”

The FDA noted in its letter to the company that advertisements for FDA-approved drugs may not promote those products without also including warnings and information about contraindications for taking them. In the case of the Kardashian post, no risk information of any kind was provided. And although readers were told they could find further information at Duchesnay's Diclegis web sites, the FDA was not placated. It ordered the company either to cease publishing claims such as Kardashian's or cease distributing Diclegis through interstate commerce.

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Citing Choice-of-Law Issues, Appeals Court Reverses Plaintiff Verdict in Accutane Case

An appeals court has reversed a $25 million verdict against Hoffmann-La Roche Inc. and Roche Laboratories in the case of a man who alleged he developed Crohn's disease after using the company's acne drug, Accutane. New Jersey's Appellate Division ruled Aug. 11 in McCarrell v. Hoffmann-La Roche that the filing of the suit was untimely because the trial court erred in applying New Jersey's statute of limitations to the case rather than the law of the plaintiff's home state, Alabama. This is the second reversal in this case; the first plaintiff verdict was rendered in 2007, but it was also thrown out on appeal.

David Buchanan of Seeger Weiss in New York is representing plaintiff McCarrell. Following the appellate decision, he said, “Mr. McCarrell has litigated against Roche for 12 years concerning the permanent and devastating injuries he developed from his use of Accutane, and has proven Roche's responsibility for those injuries in two separate trials. Today's result is very disappointing. On behalf of Mr. McCarrell, we will be seeking further review of today's decision by the New Jersey Supreme Court.”

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FDA Warns Morning Sickness Drug Maker

When celebrity Kim Kardashian West touted a morning sickness medication to her followers on Instagram in August, the federal Food and Drug Administration (FDA) quickly responded with a warning letter to the drug's manufacturer, Duchesnay Inc.

Kardashian's post stated: “OMG. Have you heard about this? As you guys know my #morningsickness has been pretty bad. I tried changing things about my lifestyle, like my diet, but nothing helped, so I talked to my doctor. He prescribed me #Diclegis, and I felt a lot better and most importantly, it's been studied and there was no increased risk to the baby. I'm so excited and happy with my results that I'm partnering with Duchesnay USA to raise awareness about treating morning sickness. If you have morning sickness, be safe and sure to ask your doctor about the pill with the pregnant woman on it and find out more www.diclegis.com; www.DiclegisImportantSafetyInfo.com.”

The FDA noted in its letter to the company that advertisements for FDA-approved drugs may not promote those products without also including warnings and information about contraindications for taking them. In the case of the Kardashian post, no risk information of any kind was provided. And although readers were told they could find further information at Duchesnay's Diclegis web sites, the FDA was not placated. It ordered the company either to cease publishing claims such as Kardashian's or cease distributing Diclegis through interstate commerce.

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