Greatbatch Sues Competitor Over False Statements

Medical device component manufacturer Greatbatch Ltd. is suing Pressure Products Medical Supplies Inc., contending the rival firm made false claims about the company and its products in a news release.

In its lawsuit, Greatbatch accuses Pressure Products of issuing a “false and misleading” news release on June 11 about a patent infringement case pending in U.S. District Court for the Eastern District of Texas. Greatbatch claims the news release was intentionally written to confuse consumers about two of its introducer devices, the OptiSeal and the FlowGuard.

Introducer devices allow surgeons to place and remove catheters or pacemaker leads into blood vessels during surgery. An introducer has a sheath that usually includes a hemostatic valve that remains in the vein and facilitates the regulation of blood flow during surgery. After the lead is inserted, the surgeon must remove the sheath and leave something in its place (a pacemaker lead, for example).

Greatbatch received 510(k) clearance from the U.S. Food and Drug Administration in March for its OptiSeal valved peelable introducer device. The product is approved in Canada and also has been cleared for distribution in Europe. According to product literature from the Clarence, N.Y.-based firm, the FlowGuard valved peelable introducer reduces air embolism by 99 percent over pinched sheath techniques.

Greatbatch, in the lawsuit it filed in U.S. District Court for the Western District of New York, charges Pressure Products with distorting the facts and waging a public relations campaign based on bogus data. “Pressure Products has distorted both the facts and the law as to Greatbatch’s introducer products, and is now waging a public relations campaign based on false statements and innuendos,” the complaint read. “Greatbatch’s customers and the patients whose lives are protected through use of its introducers deserve to have the record set straight and to know that they have access to the medical devices that best serve their needs.”

Greatbatch and Pressure Products executives, of course, both claim their respective companies’ introducer products best serves patients’ needs. Pressure Products officials, however, believe the OptiSeal, FlowGuard and ViaSeal introducer devices infringe upon the company’s patents and have asked a federal court judge for a trial date on the patent infringement claim.

The news release that triggered the outrage from Greatbatch officials announced a trial date for the patent infringement dispute—Sept. 7. The release also said the federal court ruled that Greatbatch cannot challenge the legitimacy of Pressure Products’ patents because a federal appeals court already has confirmed they are valid. “We have taken steps to protect the results of our development and put an end to the continued unlawful use of Pressure Products’ innovation,” Dr. Paul Kurth, Pressure Products president, said in the news release.

Pressure Products holds an exclusive license of the Lee patents for introducers. The company licensed the Lee patents from H. L. Medical Inventions, Inc., owned by Hongpyo Henry Lee, M.D., a California cardiologist.