Posted On: November 19, 2010

Valcade Recall: Flakes in Vials

I don't have the energy. But someone needs to set up a Johnson & Johnson recall blog. Just expect to stay busy.

J&J and Millennium Pharmaceuticals have issued a recall of the cancer drug Valcade after reports of "white particles" found in the medication. Seven lots of the medication have been recalled. The flakes are apparently a polyester-like material that have come into the product from some manufacturing defect.

I should not be so hard on Johnson & Johnson. In their defense, they are a huge company and the vast majority of these recalls do not seem to implicate patient safety. Still.

Posted On: November 18, 2010

Mark Herrmann Returns!

Mark Herrmann, formerly of our archenemy friend The Drug and Device Law Blog is back online again writing for Above the Law from the perspective of in-house counsel. Here is his first post.

I never agree much with Mark but I always enjoyed his writing. His new column for Above the Law is definitely for in-house counsel and defense lawyers. But I'm sure I will read it anyway.


Posted On: November 15, 2010

Yaz Lawsuits: The Plan

The Yaz/Yasmin MDL lawsuit picture became a little bit clearer as the MDL judge
set forth a plan for the bellwether trials. The first trial will be a pulmonary embolism
case on September 12, 2011. Over plaintiffs' lawyers' objections, the second trial
will be a gallbladder case on January 9, 2012. The third bellwether trial will be a
thromboembolic (VTE) case on April 2, 2012. The court also lays out the scheduling
order in these cases.

The purpose of these bellwether trials is to begin to get an assessment of what the values of these three types of Yaz/Yasmin cases will be in hopes of bringing about a global Yaz/Yasmin settlement. How much is a Yaz/Yasmin case worth? Anyone who thinks they know for sure is kidding themselves. But you can be pretty confident Bayer is going to continue to dig in until either verdicts start coming back against them or Yaz/Yasmin's market share continues to plummet; because it is hard for any drug company to lay off the gas defending lawsuits where the drug remains profitable and on the market. Bayer has set aside almost $70 million to pay for "anticipated defense costs" to defend the Yaz and Yasmin lawsuits which means, at least in the short term, Bayer is hunkering down for a fight.

The court's order setting forth the MDL trial schedule contains some interesting analysis on the MDL judge's thinking on what cases should be included in the bellwether trials.


Posted On: November 4, 2010

Abbott's Appeal of $1.67 Billion Verdict

These runaway juries are unreal. They are constantly finding in favor of plaintiffs who are essentially faking injuries instead of expressing gratitude for the life altering medications pharmaceutical companies make. Abbott Laboratories is now fighting one of these runaway verdicts on appeal after a jury awarded the plaintiff $1.67 billion.

Oh, wait. The Plaintiff was not claiming to be injured. The Plaintiff was pharmaceutical titan Johnson & Johnson who was awarded $1.67 billion for patent infringement regarding the arthritis drug Humira which, ironically is under attack for the side effects it causes and now has a black box warning.

I suggest this defense for Abbott. The FDA approved Humira. If the FDA thought it infringed on a patent, it would have said so. Patent infringement preemption.

Posted On: November 1, 2010

Effient Lawsuit?

There have been no lawsuits filed (of which we are aware) involving Effient, a blood-thinner marketed by Eli Lilly. There could be potential lawsuits on the horizon after news that Effient has been linked to higher rates of cancer than its rival, Plavix, according to data provided in the Archives of Internal Medicine.

Sometimes plaintiffs' lawyers are like the man with a hammer. Everything is a nail. So before demanding a recall and calling this the next class action, here are two good reasons why there may never be any lawsuits associated with Effient:

First, it could be that this data is wrong and there is no high rate of cancer with Effient. Second, it could be that Eli Lily could not have known of the increased cancer rate even with the exercise of reasonable care and diligence (here is a flaw in that theory, however).

Still, smart Effient patients should be talking to their doctors and smart plaintiffs' lawyers will keep abreast of future developments.