Janice L. Weiner
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 51, Room 6304
Silver Spring, MD 20993-0002

Dear Ms. Weiner,

We are grateful for the opportunity to submit comments in support of the Food and Drug Administration’s (FDA) proposed rule entitled, Supplemental Applications Proposing Labeling Changes

Here’s a little more in-depth analysis of the generic drug argument before SCOTUS:

Andre Mura, litigation counsel at the Center for Constitutional Litigation in Washington, D.C., said the government’s argument was troubling. “There were suggestions that the FDA shouldn’t be second-guessed, but as the Court said in Wyeth v. Levine, the FDA approval process

More on generic liability:

During a one-hour oral argument justices questioned whether federal law, in this case the requirement that generics have same design as the name-brand version, prevents plaintiffs from making such claims under state law.


Some justices signaled concern about juries making sweeping judgments about the effectiveness of drugs while others

Longtime readers of this (or any drug-related blog) know that the U.S. Supreme Court ruled that manufacturers of generic drugs cannot be sued for failure-to-warn claims.  The ruling created a legal injustice for those injured by generic drugs.

While every plaintiff’s lawyer has secretly hoped that Congress would fix the law, we’re all savvy enough

In a study published in a 2007 edition of the New England Journal of Medicine, Sura Alwan et al. evaluates the effect of maternal use of selective serotonin reuptake inhibitor medications (SSRIs) during pregnancy on the likelihood of bearing children with congenital malformations.  The study, titled “Use of Selective Serotonin Reuptake Inhibitors in Pregnancy

I’ve been engrossed in a mesothelioma trial and have fallen behind in blogging. Frequent readers will snarkily note that this is not an uncommon occurrence. However, there has been a major development in generic pharmaceutical litigation. The Supreme Court has granted certiorari (that means accepted) in three Reglan lawsuits. If the Supreme Court rules in

A common but unfounded criticism of product liability lawyers is that they keep needed drugs off the market.  Actually, it’s the drug companies who do so by engaging in pay-to-delay.  Here’s how that works: Big pharmaceutical companies pay generic manufacturers not to sell generic versions of brand-name drugs.  And unfortunately, this practice has now been