They say the smartest people are the ones who are always learning something new. Those who are open to new ideas and concepts. People who are eager to acquire new information. That’s a great way to live. Long live enlightenment. However, when it comes to federal preemption of a failure to warn claim involving a
Recently, largely related to the dubious pleasure of home ownership, we have had multiple occasions on which we were forced to shrug our shoulders and proclaim, “Nothing’s perfect.” To wit, we recently noticed a small wet spot on our bedroom ceiling. The roofing company discovered that the corresponding section of the roof was too shallow
Well, at least that’s true when we are blogging about defense wins. And this week, we have another good gadolinium case. This time from New York.
Just a quick reminder – gadolinium is a contrast agent that is injected into a patient before undergoing an MRI. The gadolinium is intended to pass through the body,
The last baseball player to reach a .400 batting average for a season was Ted Williams in 1941. In a sport that probably keeps more stats than any other, baseball sees records broken and milestones reached all the time. Some marks, however, appear to be set in stone. One of these is Ted Williams’s 1941
This post is from the non-Reed Smith side of the blog.
When we say Nebraska, what comes to mind? Cornhusker football? Warren Buffet, the Wizard of Omaha? Buffalo Bill’s Wild West Show? Mutual of Omaha’s Wild Kingdom? An amazingly haunting album by Bruce Springsteen? As the Jersey Girl blogger on this site, it should be
And it’s the start of another season of too much eating, drinking, shopping, and socializing. Sometimes it feels like a year’s worth cramped into a little over a month. And, for some of us (OK, me), we’re entering this week still a little groggy and foggy. So, we’ll admit to looking for something fairly straightforward
Can you recall what you were doing back in March of this year? To be more precise the day before St. Patty’s Day and the day after the Ides. No? Well, apparently the defendants in the Risperdal and Invega Products Liability Cases pending in California state court were celebrating but they forgot to invite us
We’ve got a copy of the Reply Brief filed by defendant Wyeth in the Wyeth v. Levine case. Here are the highlights as we see them (we’re trying to stay away from the Phenergan or Wyeth specific stuff):
We’ve now had a chance to review the new “change being effected” (or “CBE”) rule finalized by the FDA last week. Here are the cites: 73 FR 49603, 2008 WL 3874230. For drugs, the rule is 21 C.F.R. Sec. 314.70(c)(6).
This is what we found.
First, the FDA made one change from the draft rule
The FDA has finalized the new CBE rule. (That’s the so-called “Change Being Effected” rule at 21 C.F.R. Sec. 314.70(c)(6) for drugs.)
Here was our post on that subject when the FDA proposed the rule in January. (We explain there why this change is a big deal.)