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The blog Drug and Device Law posted today on the Bausch & Lomb cases. The lawyers working the keyboards, Jim Beck and Mark Herrmann, do a good job with their blog, and it’s always interesting to read. That said, they are clearly defense lawyers, and have the accompanying defense biases (note to readers—I’m a plaintiff’s lawyer and have my own set of biases). And Beck’s firm defends Bausch & Lomb. So, I’d like to supplement their post.

Drug and Device Law discusses the Daubert/Frye hearing that a federal and state judge will conduct for a few days in New York to determine whether the Plaintiffs have sufficient causation evidence to link the contact lens solution to non-Fusarium infections. This is, of course, an appropriate way to handle those cases (and kudos to the judges involved for conserving resources and tag-teaming the hearing). The judges will decide if the scientific link is strong enough to permit the cases to go forward—this is just one way the system works to make sure only meritorious cases get to juries.

However, there were also lawsuits filed on behalf of people who suffered from the eye infection known as Fusarium keratitis. That’s a nasty little bug that can damage the cornea, and may require corneal transplants or even eye removal. The Drug and Device Law blog gives cursory mention of those lawsuits, noting that “Some of the MoistureLoc lawsuits were naturally filed on behalf of people who actually suffered from Fusarium keratitis.”

With well over 100 cases filed in at least 21 states, the shoulder pain pump litigation is gaining steam. Pain pumps are small devices used to control post-operative pain. However, pump catheters placed near cartilage (usually the shoulder, but sometimes the knee or even toe) can cause the progressive deterioration of those cartilage cells, leading to painful and permanent bone-on-bone contact.

Defendants typically include the manufacturers and distributors of the pain pumps. However, some lawyers are adding anesthetic drug manufacturers. These are companies like AstraZeneca, Hospira, APP Pharmaceuticals Abbott Labs, who all supply local anesthetic (bupivacaine, marcaine, lidocaine, sensorcaine, ropivacaine, etc…) often selected for use in the pumps by doctors.

The case against the anesthetic manufacturers is indeed harder to prove than the case against the device manufacturers. However, inclusion may be important for a couple of reasons. First (though not a good reason to bring in a defendant by itself), the majority of the pain pump market share is owned by I-Flow. Discovery conducted to date indicates that I-Flow may have limited insurance to cover the flood of verdicts that may be coming.

Reglan (generic: metoclopramide) is a drug used to treat heartburn and slow gastric emptying in diabetes patients. The drug is commonly used to treat gastroesophageal reflux disease (GERD), gastroparesis, and other conditions affecting the digestive system.

The danger that Reglan lawyers are investigating is tardive dyskinesia (also known as TD), a neurological disorder that manifests as repeated involuntary movements. Injured patients may experience grimacing, protrusion of the tongue, lip-smacking, rapid eye blinking, and movement of the extremities. There is no treatment for tardive dyskinesia.

Not to say that heartburn isn’t painful, but how many of us would risk contracting tardive dyskinesia just to compensate for bad eating habits? Reglan lawyers have discovered that the label, unfortunately, minimized that risk, implying that there wasn’t much danger. The original label said it “may produce extrapyramidal reactions, although these are comparatively rare.” Other sections of the label likewise indicate that tardive dyskinesia is a low risk.

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.