Do Medical Device Makers Deserve More Protection than Patent Owners?

Friends of Blawgletter know something about the great swirling myriad of doctrines that can doom a claim of patent infringement.  All sorts of "invalidity" and "unenforceability" slings and arrows await the intrepid patent holder who dares sue to remedy infringement.  The stakes?  Essentially whether the inventor, or her assignee, gets to keep the temporary monopoly that the federal government granted in examining the patent application and issuing the patent.

Medical devices, I think we can all agree, involve a different set of stakes.  A defective balloon catheter that pops during dilation of a coronary artery threatens more than the patient's economic interest in retaining enough function to earn a living.  No.  A defective medical device endangers our very ability to draw breath.

So what kind of monopoly should the makers of medical devices get?  If they held a patent, their own inequitable conduct before the Patent and Trademark Office could, for example, invalidate their right to practice their inventions.  But under the Supreme Court's decision this week in Riegel v. Medtronic, Inc., No. 06-179 (U.S. Feb. 20, 2008), the Food and Drug Administration's blessing of an unsafe, death-dealing device grants a lawsuit-free monopoly to the manufacturer.

Do medical device makers deserve an immunity that patent holders don't get?  Are health and safety less important than coming up with inventions?

Happy Friday to you!

Comments

[Leif]

You read Riegel to foreclose claims of defective manufacture?

Blawgletter: We don't boast expertise in pre-emption of personal injury claims but do read Scalia's opinion as sweeping aside any state law tort claims that impose any requirements "different" from what the applicable federal regulations call for. Do the fed regs require nondefective manufacture? If they do, per Scalia, a tort claim that relies on the federal duty to make nondefective devices would survive pre-emption. If on the other hand the fed regs don't mandate nondefective manufacture, Scalia likely would say state tort law that does require it runs afoul of federal pre-emption.