We wish everyone a nice Martin Luther King Day. Today not only honors a great American, it has also evolved into a day of service. That says something profound and wonderful about the honoree. We’ll do our best to observe the spirit of the day. There are all sorts of service. A friend in SoCal is helping to paint a lifeguard station. That makes us wildly jealous, given that we are staring outside at sheets of ice and awaiting the next visit of “Wintery Mix.”
Frankly, we were a little worried about whether this blog could render any real service today. There’s been a Monday curse of late, as we’ve opened the last couple of weeks with kvetch-fests on truly dreadful opinions (Bausch, Stevens, and Bartlett). But recently the Middle District of Tennessee rode to the rescue and delivered a useful opinion in a pain pump case, Rodriguez v. Stryker Corp., 2011 U.S. Dist. LEXIS 1252 (Jan. 5, 2011). It grants summary judgment to the defendants and supports its ruling with common sense and clear thinking.
The plaintiff in Rodriguez underwent shoulder surgery in 2004, including installation of a pain pump. A follow-up procedure in 2008 showed that the cartilage in the plaintiff’s shoulder had been destroyed. The plaintiff filed a lawsuit claiming that the pain pump had caused chondrolysis (a condition marked by destruction of the articular cartilage). The plaintiff alleged causes of action for strict liability, negligence, and breach of implied warranty.
The court applied Comment K to the strict liability claim, concluding that with “unavoidably unsafe products” such as a prescription medical device, the only issue was whether the manufacturer had failed to supply appropriate warnings. Rodriguez, 2011 U.S. Dist. LEXIS 1252, * 19. See how straightforward that was? Unlike the Bartlett case, the court didn’t conflate design defect and failure-to-warn theories.Continue Reading Helpful Pain Pump Case on Comment K and Warning Causation

We’ve complained before about MDL “master” or “consolidated” complaints being used to deprive defendants of the ability to pursue their rights to seek dismissal on TwIqbal and other pleading-related grounds.  In individual actions, defendants have the right to put the plaintiffs’ pleadings to the test required by Rules 8 and 12.  That has not necessarily

The FDA cannot get out of its own way on the issue of off-label communications. Its power to punish off-label promotion comes from an odd regulatory two-step, whereby off-label promotions are said to prove an indicated use not included in the label and, thus, not accompanied by adequate directions for use – making the product

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

There must be some problem with our comment function, because we received an email from a reader that the comment quoted below wouldn’t post. We apologize for that, but (being Luddites) all we know how to do is put it up as a post. Here’s the comment:

Wouldn’t such a request be objectionable and properly

A few folks have contacted us complaining about either (1) the need to provide a Google password to post a comment on this blog or (2) the delay in seeing a comment posted, because the comments are “moderated” and your two hosts don’t check sufficiently frequently to moderate (and post) the comments soon after they’re

As you know, we’ve chosen to host the Drug and Device Law Blog on “Blogger.”

Blogger permits folks to publish “comments” reacting to what we’ve written, although Blogger automatically (so far as we can tell) postpones publishing a comment until one of the co-hosts of the blog “moderates” it. (We’re given the choice of either

Abuse of substantive law as a weapon to force settlement occurs so frequently in multidistrict litigation (“MDL”), that we’ve given it a name – “the MDL treatment.”  The linchpin of the MDL treatment is that plaintiffs are allowed to take way more liberties with state law than the Erie doctrine allows.  Readers can recall from our prior posts that both the Supreme Court and Third Circuit (to take the relevant example), view expansive federal court “predictions” of state law – and state tort law in particular – usurp the prerogatives of the states and are an abuse of power. Continue Reading CPAP MDL Overinflates Plaintiffs’ Claims

Beginning – at least − with the awful decision in Schrecengost v. Coloplast Corp., 425 F. Supp.3d 448, 465 (W.D. Pa. 2019) (discussed here), plaintiffs seeking to overturn the longstanding Pennsylvania (since the 1940s) prohibition against strict liability in prescription medical product liability litigation have been systematically attacking the precedential weight