Digitek maker Actavis Has New Legal Issues Looming

Pharmaceutical giant Actavis, the company responsible for theĀ  Digoxin recall, is no stranger to plaintiff lawsuits over its drugs, and this year is no exception. You may recall that Actavis first attracted attention for its Digitek-branded Digoxin, which was the subject of hundreds of lawsuits. The FDA hammered the company over safety and reporting violations that culminated in a federal recall of Digitek tablets (used to treat heart failure and arrhythmia) that were mistakenly manufactured at double the expected thickness. These tablets also contained double the expected dosage printed on packaging and prescribed, leading to hundreds of customers suffering serious cardiovascular side effects, in particular digitalis toxicity, from the double-dosage of the drug’s active components. The 2008 recall removed Digitek from the market, but the lawsuits continued through a Multi-District Litigation in West Virginia (involving approximately 2,190 victims) into mid-2010. Eventually, a private Digitek settlement agreement was reached in late 2010 between the pharmaceutical companies and plaintiff’s attorneys.

The terms of the settlement with Digitek victims were never disclosed, and most of the pending issues in that case are largely wrapped up by now, with many victims reporting payments in the $4,000 range if they didn’t suffer significant health effects from the mislabeled dosages. While Actavis’s settlement agreement in the Digitek litigation gives the company closure on their liability to those claimants (at an estimated $12 million in payments to victims), an even larger legal threat looms from one of their newest drugs, Androderm, that may make $12 million look like a bargain. Androderm has the potential to have much greater cardiovascular effects on a much larger demographic group, and the legal wrangling is just beginning.

Androderm is one of the much-hyped “Low-T” drugs to hit the market in the last two years. While not an actual recognized medical condition, this hasn’t prevented it from becoming one of the most highly-advertised “fixes” for everything from decreased libido, to mental sharpness, to strength, and just about every other ailment associated with getting older. The target demographic for these ads, men over the age of 30, have been quick to buy-in to the promised “fountain of youth” benefits these low-T products are pitching. Low-T products (also called testosterone replacement therapy, or TRT) brought in an estimated $2 billion in revenue to pharmaceutical companies like Actavis, on an estimated $80 million in direct-to-consumer marketing, according to a recent NY Times article.

The problem with these Low-T prescriptions (besides there being no such disease as “low-t”) is that these advertisements are not revealing the true cardiovascular risks of using synthetic testosterone, especially among the older male demographic that is the primary consumer. Topical creams, gels, and transdermal patches (of which Androderm is the leader) are the convenient delivery methods used by low-T products that don’t require a doctor to administer, but they also represent the potential for incorrect dosing of a drug that’s long-term health risks are only recently being studied. The FDA has already issued 3 separate warnings about the connection between increased risks of heart attack, stroke, and deep-vein thrombosis among TRT users over the age of 55. Already, thousands of low-T lawsuits are cropping up from men who have suffered heart attack or strokes within 6 months of using TRT products, and who had no previous history of heart disease. Some of these claims are now being processed through a class action case involving over 200 victims in the Northern District Court of Illinois, while hundreds of individual low-T plaintiff lawyers are bringing private lawsuit claims against the manufacturers for defective product design and failure to warn claims in various state and federal courts. For the pharmaceutical companies who created an entire market and associated demand for low-testosterone treatment, the party may finally be coming to a close as the lawsuits mount.