Moria suit against Surgin dismissed; Surgin receives 510(k) clearance for blades

The court and regulatory decisions came within days of each other. The upshot: Surgin receives the right to market its replacement microkeratome blades.

Issue: December 15, 2001

ALEXANDRIA, Va. — Instrument maker Surgin Inc. has been granted the right to market replacement blades for Moria microkeratomes. A suit filed against Surgin by Moria for false advertising was dismissed just days before specific 510(k) clearance was given.

For several months Moria and Surgin have been wrangling over Surgin’s claim that its microkeratome blades can be used as replacements for Moria equipment. The issue came to a head when Moria filed suit against Surgin alleging false advertising.

After hearing oral arguments Oct. 29, Judge Gerald Bruce Lee of the U.S. District Court for the Eastern District of Virginia, Alexandria Division, dismissed with prejudice a complaint filed by Moria SA and Moria Inc. against Surgin Surgical Instrumentation Inc.

Days later, the Food and Drug Administration granted clearance for Surgin to sell its blades as replacements for Moria’s microkeratome.

The trail to approval

In 2000, Surgin obtained 510(k) clearance for its Accublade LASIK blades for the ACS and Hansatome microkeratome (Bausch & Lomb). In April 2001, the FDA sent a letter to Surgin, which stated that Surgin did not have approval for use of the Prizm blades in Moria’s microkeratomes. In July, Surgin wrote the FDA and said it would discontinue the promotion of the Prizm blades.

Moria claimed in its lawsuit that Surgin’s statement on its Web site that all of the company’s blades were 510(k) cleared was false and misleading. Surgin moved to dismiss the complaint on the basis that whether a product has 510(k) clearance or needs a second 510(k) clearance are questions for the FDA to decide, not for the courts.

When the case was dismissed in November, Judge Lee said it was not the court’s place to interpret FDA regulations and guidance documents on the scope of a 510(k) clearance prior to the agency issuing a final determination. He also noted that no private right of action exists under the Federal Food, Drug, and Cosmetic Act, and that the complaint filed by Moria was an attempt to enforce that act through litigation between private parties.

The decision states, “Moria’s false advertising claim must be dismissed because it is asking the Court to step into the shoes of the FDA and enforce that agency’s regulations … Moria is in effect requesting the Court to determine whether Surgin was required to have obtained new 510(k) clearance for its blades before it advertised FDA approval on its Web site. Under the system adopted by the FDA, it is the manufacturer who makes the initial decision as to whether a new 510(k) application is necessary after it has altered its product. In this case, Surgin did not believe that it was required to do so.”

On Nov. 5, Surgin received specific 510(k) clearance from the FDA to sell its Prizm LASIK blades for Moria’s microkeratome.

Companies interpret results

Armand Maaskamp, president of Surgin, said in a Nov. 2 statement that the company was vindicated by the decision of the court.

“This is a case that should never have been brought, and we are pleased that the Court agreed. Surgin has always been committed to complying with all applicable legal requirements and we are particularly pleased that the Court rejected Moria’s attempt to drag both Food and Drug Administration officials and Surgin into court,” he said.

In an interview with Ocular Surgery News, Mr. Maaskamp said, “The FDA gave us clearance be cause they found that our blades were safe and effective.”

Moria said that the FDA’s letters to Surgin emphasized that selling blades that do not have separate FDA approval for use with a particular microkeratome raises a patient safety issue.

“We strongly disagree with the court’s decision,” the Moria press release concluded. “The court dismissed our lawsuit on a procedural technicality — namely, that the FDA has not taken final action in this matter.”

Michael Bartell, CEO of Moria Inc., told Ocular Surgery News that he is concerned about another company’s blades are being used with Moria’s equipment. “We can’t be responsible for what goes wrong with someone else’s blade in our equipment. Without controlling the blade, you can’t control the microkeratome ... It’s not just the blade that’s important; you’re talking about a complete surgical system,” Mr. Bartell said.

Competition or safety?

Surgin has stated several times that the lawsuit and press releases by Moria were designed to keep customers from purchasing Surgin’s replacement blades instead of Moria’s. On the company’s Web site, Surgin explained that customers do not have to purchase disposable products from the original manufacturer and pointed to the 1995 U.S. Circuit Court case of Datagate Inc. vs. Hewlett-Packard Co.

“We have always believed that the action taken by Moria was more about keeping competitors out of the marketplace than about patient safety.”

He continued, “Competition continues to be the backbone of our free enterprise system and with both rulings, we believe the consumer wins.”

For Your Information:
Armand Maaskamp is president of Surgin Surgical instrumentation Inc. He can be reached at 14762 Bentley Circle, Tustin, CA 92780; (714) 832-6300; fax: (714) 832-2020; e-mail: amaaskamp@surgin.com; Web site: www.surgin.com.
Michael Bartell is CEO of Moria, Inc. He can be reached at 1050 Cross Keys Drive, Doylestown, PA 18901; (215) 230-7662; fax( 215) 230-7670; e-mail: moriausa@moriausa.com; Web site:www.moria-surgical.com.