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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.