SCULPTRA MEDICAL DEVICE TREATS LOSS OF FACIAL FAT AND WRINKLES
PATIENT SUES MANUFACTURER, CLAIMING DEFECT INJURED HER.
Sculptra is a substance that is injected into a patient. It is considered a “Class III” medical device. It was approved by the Food and Drug Administration (“FDA”) in 2004. The approval followed a nine-month review. Sculptra was initially approved for the restoration and correction of lipoatrophy. (Lipoatrophy is commonly known as facial fat loss.) The device was only approved for use in people with human immunodeficiency virus (“HIV”).
In 2006, the manufacturer filed a supplemental application. The application asked the FDA to allow the device to be used for purely cosmetic purposes.
In 2009, the FDA approved the use of Sculptra for non-HIV patients. The device was approved “as a single regimen for correction of … facial wrinkles.” The cosmetic product was marketed under a different name — “Sculptra Aesthetic.” But Sculptra Aesthetic is apparently identical to the original. The FDA has never revoked, suspended, or otherwise interrupted its approval of Sculptra.
In 2014, a woman we’ll give the fictitious name of Sophronia Rogers sued the manufacturer. Rogers claimed she sustained injuries following cosmetic Sculptra treatment in 2007. Rogers charged that Sculptra was defective. She complained that, when she received the treatment, it hadn’t yet been approved for cosmetic use. She further claimed that the manufacturer made specific promises about the product that were false.
The lawsuit wound up in federal court. The judge recently ruled that Rogers’ court papers were defective. In large part, the judge’s ruling was based on a lack of specifics in her court papers. In a federal lawsuit, a claimant’s court papers must contain specific factual allegations. These allegations must demonstrate that the claim is plausible on its face.
Roger’s court papers failed to meet this standard. The papers also suffered from various other defects. The judge ruled that these defects merited the case being dismissed from court.
The judge, though, did give Ms. Rogers’ 30 days to amend her court papers. If the deficiencies are corrected, the case can continue.
Call Marc S. Berman, Esq., (888) 316-8288 if you’ve been injured by a defective product. FREE CONSULTATION. No attorney fee unless you get compensation.
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