J.C. McElveen, of Jones Day, submitted the following guest post, for which we thank him. As is always true of guest posts, our guest gets all the credit for what follows:
Relatively few legal cases have discussed the newly emergent field of genomics, but there is no shortage of discussion on the subject. In
Is there anything in product liability litigation as boring as Medicare liens? Putting aside document privilege reviews, or drafting answers to form complaints, that is. Some substantive area of the law?
Substantively, we’d be hard-pressed to think of anything. Back in the day – when such arguments were still possible – we got a bit
That headline is correct, except for the exclamation point.
The Third Circuit just issued its decision in Colacicco v. Apotex, on remand from the Supreme Court for reconsideration in light of Wyeth v. Levine.
The Third Circuit decided not to issue a new decision immediately, but instead remanded the cases to the two relevant trial
The Solicitor General just submitted a letter to the Third Circuit in Colacicco v. Apotex giving the government’s position on the preemption question in light of the Supreme Court’s decision in Wyeth v. Levine.
The SG says that the FDA “has not yet conducted the sort of reexamination of various preemption issues following the Supreme
We’re so sad: Now that Riegel v. Medtronic and Wyeth v. Levine have been decided, we can no longer bill ourselves as “all preemption, all the time!”
We’re forced to write about other stuff.
Not so fast!
One of us was giving a talk a few weeks ago, and an audience member posed a good
We’ve recently been thinking about Lexecon waivers.
(Yeah, yeah: We were thinking about sex, drugs, and Lexecon waivers.)
You know the story: Lexecon v. Milberg Weiss, 523 U.S. 26 (1998), holds that MDL transferee judges lack authority to try cases that originated outside of the transferee court. Thus: The MDL Panel coordinates a bunch
This post is about product liability but not particularly about prescription medical products. But since this subject is something Bexis has labored over for so long, we’re invoking the McFadden exception to deviate from drugs and devices for the moment.
But if you’ve got a product liability case of any sort in Pennsylvania or involving
We’re not surprised that physicians invest in medical devices companies.
Legendary investor Peter Lynch said, “Buy what you know.” Surgeons who implant medical devices know . . . medical devices.
Sometimes those surgeons invent the devices. Sometimes the surgeons simply learn about the devices and believe they’re good products.
Not surprisingly, surgeons sometimes choose to
Off-label use — using a drug or medical device for an indication other than that set forth in the FDA-approved label — poses tricky legal issues.
Off-label use is entirely legal: The FDA doesn’t regulate the practice of medicine, so physicians can use drugs or devices for any appropriate purpose, approved by the FDA or
About ten days ago, the FDA Law Blog reported on the FDA’s order requiring manufacturers of 25 types of Class III “preamendments” devices to submit to the FDA information about those devices, including adverse safety and effectiveness data not already submitted to the Agency. The data is due by August 7, 2009, and is a