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Photomedex, Inc. v. Irwin

September 27, 2010

PHOTOMEDEX, INC., PLAINTIFF,
v.
DEAN STEWART IRWIN; RA MEDICAL SYSTEMS, INC., DEFENDANTS.
RA MEDICAL SYSTEMS, INC., PLAINTIFF,
v.
PHOTOMEDEX INC., ET AL., DEFENDANTS.



The opinion of the court was delivered by: Honorable Janis L. Sammartino United States District Judge

ORDER: DENYING PHOTOMEDEX INC.'S MOTIONS FOR RECONSIDERATION

(04-CV-24 Doc. No. 182) (06-CV-1479 Doc. No. 66)

Presently before the Court are PhotoMedex, Inc.'s motion for reconsideration in PhotoMedex Inc. v. Dean Stewart Irwin (PhotoMedex I), 04-CV-24 JLS (CAB), (Doc. No. 182) and PhotoMedex Inc.'s motion for reconsideration in RA Medical Systems, Inc. v. Photomedex, Inc. (RA Med. I), 06-CV-1479 JLS (CAB), (Doc. No. 66.). Also before the Court are opposition briefs from RA Medical Systems, Inc. and Dean Stewart Irwin and reply briefs from PhotoMedex. The motion, opposition, and reply brief are identical in both cases and therefore treated in aggregate here. After full consideration of this matter, the Court DENIES PhotoMedex's motions.*fn1

BACKGROUND

The parties in this case are well aware of the background of this matter. Moreover, this Court and the Ninth Circuit have both provided a full description of the underlying facts. (See PhotoMedex I, Doc. No. 145 (PhotoMedex I MSJ Order) at 1--2; RA Med. I, Doc. No. 31 (RA Med. I MTD Order) at 1--2; PhotoMedex, Inc. v. Irwin (PhotoMedex II), 601 F.3d 919, 922--23 (9th Cir. 2010); see also RA Med. Sys., Inc. v. PhotoMedex, Inc. (RA Med. II), 2010 WL 1417890 (9th Cir. Apr. 9, 2010).) Those factual summaries are incorporated by reference here.

However, this Order will quote the 9th Circuit's description of the relevant facts from PhotoMedex II.

PhotoMedex directly competes with Ra Medical in the production and sale of lasers for use in dermatological treatments. These dermatological lasers are regulated by the FDA and must pass what is known as the "510(k)" clearance process... before being placed on the market. PhotoMedex's product is the "XTRAC Excimer Laser System" (XTRAC), the first excimer laser the FDA cleared for the treatment of the skin disorders psoriasis and vitiligo.

Irwin served on the development team for the XTRAC system during his employment with PhotoMedex from February 1998 to July 2002. Following his departure from PhotoMedex, Irwin co-founded Ra Medical in September 2002.

Ra Medical entered into a licensing agreement for a competing laser product with SurgiLight, Inc. on March 13, 2003. SurgiLight had received FDA 510(k) clearance in March 2002 for its "EX-308" excimer laser for the treatment of psoriasis and vitiligo, though at the time of the agreement it had not actually manufactured or marketed the cleared laser. In exchange for royalties, SurgiLight gave Ra Medical the "exclusive manufacturing rights and exclusive marketing rights for [the FDA-cleared EX-308 device], including any derivative devices, substantially conforming to the specifications[,] as well as the exclusive right to use its mark EX-308 on devices [Ra Medical] intends to manufacture and market."

After securing the license from SurgiLight, Irwin appeared on Ra Medical's behalf at a trade show held by the American Academy of Dermatology in March 2003. At the show, Defendants distributed a brochure which proclaimed that Ra Medical's "Pharos EX-308 Excimer Laser" (Pharos) was "FDA Approved for Psoriasis & Vitiligo." This brochure also described Irwin as "inventor of the first FDA approved excimer laser for phototherapy," i.e., PhotoMedex's XTRAC laser. Defendants' subsequent marketing materials made similar promotional claims.

Word spread that the Pharos would be available for purchase within a few months. The record includes evidence that a person attending the trade show heard that the Pharos was scheduled for sale in August 2003. SurgiLight issued a press release, also in March 2003, announcing that "Ra Medical anticipates the introduction of its PHAROS EX-308, Excimer laser system for treatment by dermatologists of psoriasis and vitiligo (pigmentation loss) this summer." Defendants did not actually ship the first Pharos laser until September 2004, more than a year after the projected introduction date. The Pharos laser differed in some respects from SurgiLight's already-cleared EX-308 laser.

PhotoMedex filed the present action against Defendants, asserting violations of the Lanham Act and California laws prohibiting untrue and misleading advertising and unfair competition. The district court granted summary judgment in favor of Defendants on each of these claims. The court held PhotoMedex lacked standing to challenge whether Defendants improperly promoted their laser as "FDA approved" because the FDA retains exclusive jurisdiction over FDCA enforcement. The court determined Defendants' predicted release date for its laser was a non-actionable forward-looking statement. Defendants' assertion that Irwin invented PhotoMedex's laser was held to be a matter of opinion and not misleading. PhotoMedex timely appealed.

PhotoMedex II, 601 F.3d at 922--23.

The Ninth Circuit held that this Court erred in granting summary judgment in PhotoMedex I on the issues of (1) Defendants' representations regarding the release date of the Pharos laser and (2) Defendants' representations regarding Defendant Irwin's status as the "inventor" of the XTRAC. Id. at 931--33. However, it affirmed this Court's grant of summary judgment ...


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