Medical Devices Today

When Corporate Integrity Agreements Multiply, Firms Know What To Expect

From the June 25, 2007, issue of "The Gray Sheet"

Orthopedic companies will likely be among the next device firms subject to corporate integrity agreements with the HHS Office of Inspector General, and stakeholders say there are clues as to what they should expect.

Several large hip and knee implant manufacturers reportedly could reach a settlement with the U.S. Department of Justice related to anti-kickback violations as early as this summer.

Biomet, Johnson & Johnson/DePuy, Smith & Nephew, Stryker and Zimmer received subpoenas from DoJ in 2005 as part of a major investigation into the industry's financial relationships with physicians.

Unique-Device-Identification Language Might Be Tacked Onto User Fee Bill

From the June 18, 2007 issue of "The Gray Sheet"

Language requiring a unique identification system for implantable devices could be added to a House device user fee reauthorization bill scheduled for committee markup this week.

"As we move toward markup, I hope this committee will be able to take sensible and prudent steps to improve patient notification [during product recalls]," Rep. Darlene Hooley, D-Ore. said June 12 at a House Energy and Commerce Health Subcommittee hearing on several draft FDA bills, including user fee reauthorization. "Our first step in that process is to allow the FDA to conclude its work on a unique device identification, or UDI."

FDA has stated its intention to establish a universal UDI coding system and regulations to improve the device recall process and generally make it easier to track individual products.

Federal Preemption Defense Under Fire In Draft House Bills

From the June 11, 2007, issue of "The Gray Sheet"

A one-sentence provision tucked into draft legislation circulating in a House subcommittee seeks to weaken device and drug manufacturers' ability to claim FDA approval as a defense in state product liability lawsuits.

On June 6, the House Energy & Commerce Health Subcommittee released "discussion drafts" for nine FDA-related bills, including the reauthorization of medical device and drug user fee programs, and legislation relating to pediatric product development, drug safety, clinical trial registries and FDA advisory panel conflicts of interest.

Each of the drafts includes an identical section, entitled "Rule of Construction Regarding Federal Preemption." The section reads, "Nothing in this Act or the amendments made by this Act may be construed as having any legal effect on any cause of action for damages under the law of any State (including statutes, regulations, and common law)."

Device Industry Intensifies Efforts To Protect IP, Modify Patent Reform Bills

From the June 4, 2007, issue of "The Gray Sheet"

With legislation moving quickly in Congress, the device industry is stepping up its efforts to be heard in the long-running debate on reforming the U.S. patent system.

According to medical technology stakeholders, controversial provisions in the Patent Reform Act of 2007 - including limitations on damages that can be awarded for infringement and a new channel by which patents can be challenged long after they are granted - could weaken the value of patents and jeopardize firms' access to venture capital.

Identical bills introduced in the House and Senate April 18 (HR 1908 and S 1145) are backed by software giants like Microsoft, Cisco Systems and Intel. Sponsors say the legislation will prevent litigation abuses and increase patent quality.