Lawsuit Update Center

As you remember, Fosamax, Merck’s osteoporosis drug, is the subject of much litigation. The question presented is whether the drug causes osteonecrosis of the jaw, which is the death of jawbone tissue.

Judge Keenan, ruling over the federal Fosamax cases from his bench in the U.S. District Court for the Southern District of New York (Manhattan), decided that Merck was not entitled to dismissal of the Louise Maley case on the issue of specific causation (essentially, Merck argued that plaintiff could not prove that Fosamax caused her injury. This is different from general causation, which is the argument that Fosamax can cause injuries of this type). The plaintiff did not argue against the dismissal of her strict liability and warranty claims, however. Her case will proceed on a failure to warn claim. See the Order (hat tip: Shearlings Got Plowed). The Maley case will go to trial on April 19, 2010.

So, Plaintiff Maley survived where Bessie Flemings could not—Judge Keenan dismissed her case (set for trial this month) last November on specific causation grounds.

Remember Wyeth v. Levine, U.S. Supreme Court decision that held federal approval of labels drug warning labels does not preclude lawsuits under state law claiming inadequate warnings? Well, the government, through the FDA, has now added a final chapter to that story.

Facts of Wyeth v. Levine

Wyeth v. Levine was a landmark U.S. Supreme Court case that involved a Vermont musician named Diana Levine who had her right hand amputated after being injected with Phenergan, an anti-nausea medication made by Wyeth, a pharmaceutical company that was later acquired by Pfizer.

Kugel hernia mesh lawsuits are settling, thanks in part to a change in defense counsel. The products, manufactured by Davol, are defective because the plastic ring can break off, causing perforation and infections. Left untreated, these injuries can be fatal. Davol has since eliminated the use of the plastic rings, in favor of a bio-absorbable ring.

Now represented by the New York firm Reed Smith, Davol has signaled a change in thinking to a more reasonable approach—these can be very meritorious cases worthy of settlement, and the expense of litigation is unnecessary. There are about 1,000 cases in the Rhode Island United States District Court MDL, and about 1,200 cases in Providence state court (the manufacturer, Davol, is a Rhode Island company). Right now, 4 federal suits have been settled, and one state claim has been settled. This looks to be the tip of the iceberg, as the parties move toward the first scheduled federal court trial in March 2010. That will be followed shortly thereafter by the first state court case in June 2010. The settlements will probably come in rapid numbers, now that discovery is coming to a close and the trials quickly approach.

For more on Kugel Mesh lawsuits and settlements, see our prior blog post.

The FDA is now requiring the makers of two prescription topical testosterone gel products to include a boxed warning on the labels. The move comes after reports of inadvertent exposure to eight children, aged nine months to five years. The drug is topically applied on the shoulders, arms, or abdomen. When transferred to children through secondary exposure (for example, children touching skin covered in the gel), the drug can cause enlargement of the genitalia, premature development of pubic hair, advanced bone age, and aggressive behavior.

The manufacturers of these products, Solvay Pharmaceuticals (AndroGel 1%) and Auxilium Pharmaceuticals (Testim 1%), already warn against exposure to the drug by children; however, the black box warning will enhance the visibility of the warning on the package inserts. Black box warnings are among the strongest safety measures the FDA can take, being reserved for medications with serious or life-threatening dangers.

There’s nothing to indicate that the companies did anything wrong—the dangers of secondary exposure are clearly noted in PDR guides, which warn against allowing others to come into contact with gel-covered skin. And of course, doctors who prescribe the medication should warn their patients about these risks.