We’ve had an unusual number of plaintiffs’ side blogs link to our Riegel posts over the past several days. While we’re flattered that the other side thinks we’re worth noticing, the traffic from these links has produced quite a few comments trashing either the Supreme Court (especially Justice Scalia), the FDA, or both. We’ve returned

We told you when we posted about it last week (here and here) that the FDA’s new proposed CBE regulation would create a firestorm.

The organization formerly known as ATLA was the first to react, but the Democrats in Congress were not far behind.

Today’s Star-Ledger reported on a letter several leading Democrats

The Wyeth v. Levine case is such a big deal that you can bet we’ll be discussing it a lot. For one thing, it has the potential to obliterate entire mass tort litigations at a stroke. Since we’re mass tort kind of guys, we’re keeping a mental hit list of where we’d strike first after

The FDA posted on its website today a regulatory initiative that will affect many prescription drug/implied preemption arguments. It’s an agency’s proposal to change amend its “Changes Being Effected” regulations for drugs, devices and biologics rule to restrict the ability of manufacturers to make label changes that add/strengthen warnings prior to FDA approval.

We’re both

Implied preemption in prescription drug cases basically comes down to how a judge feels about whether a manufacturer can unilaterally change its label to “strengthen” warnings under 21 C.F.R. §314.70(c) – the so-called “Changes Being Effected” (CBE) regulation. Our side claims that the CBE regulation doesn’t change anything fundamentally, because the FDA still has to

When you argue implied preemption as much as we do in prescription drug product liability litigation cases, you get to know the plaintiffs’ come back arguments in your sleep. Chief among them is that because the FDA’s so-called “changes being effected” (“CBE”) regulation, 21 C.F.R. §314.70(c), allows drug manufacturers to strengthen safety language without