LawyersandSettlements (LAS): What types of testosterone side effects are you investigating?
Michael Hingle (MH): We are accepting testosterone injury claims involving deep vein thrombosis, or DVT, heart attack and pulmonary embolism - a blockage in a lung artery.
Pulmonary embolism, or emboli, appears to be the biggest problem, but all three “signature injuries” are life-threatening. Pulmonary embolism is most often a complication of DVT, which is usually caused by a blood clot from a vein in the leg.
LAS: So you aren’t looking at stroke or prostate cancer complaints?
MH: Not at this time. And stroke cases are very difficult to deal with; in other words, it is hard to associate stroke with testosterone injury.
LAS: Testosterone side effects have seemingly emerged in the past year or so. Why now?
MH: Recent medical reports and FDA warnings have caused lots of reaction. The FDA report found a higher percentage of people experiencing heart attacks with testosterone therapy, and in the wake of that report, we have people calling us.
LAS: Who is mainly calling you?
MH: We have people on testosterone therapy calling who have suffered blood clot issues and heart attacks. Or a loved one or someone they know has suffered a heart attack.
As well, men call with concerns and questions. They want more information, and of course, they want to know whether they have a claim. Some men want to know what is wrong with the product and whether they should stop taking it - those are questions for their doctor.
LAS: Has negligence been proven on the part of the manufacturer(s)?
MH: Negligence has to be determined after the discovery stage.
In our experience, generally the drug or medical device manufacturer rushes to get its product on the market and often doesn't use an adequate amount of people in clinical trials before it is put on the market. Human studies are limited. As well, drug research and development costs a lot to reach the consumer. The manufacturer may not evaluate all the issues before market, but at this point it is impossible to say whether the clinical trials are inadequate.
LAS: Could the manufacturer be accused of failure to warn?
MH: There is a strong possibility of failure to warn consumers of potential testosterone side effects such as heart attack.
LAS: Is there any potential for a whistleblower situation where studies were hidden or not revealed?
MH: There is always the possibility of someone working with the manufacturer who comes forward with information that would indicate wrongdoing. For instance, a pharmacist or chemist or scientist says they talked to the manufacturer about risk but the maker decided to do nothing about it. That person would be a whistleblower. But someone from within the FDA with an adverse report is not necessarily a whistleblower.
LAS: What about inappropriate off-label marketing or false advertising?
MH: Many people use many drugs off-label. For instance, Viagra was first marketed to lower blood pressure; Chantix was first prescribed as an antidepressant. Until discovery is complete, we are unsure about testosterone.
LAS: Will litigation apply to both generic and brand testosterone therapy drugs?
MH: We are concentrating just on brand-name testosterone now because we know of a battle going on in the Supreme Court where generic drugs don’t have to give full warnings and we don’t have the generic information.
LAS: Are you focusing on Androgel or all testosterone medications?
MH: We are accepting all claims but mostly seeing lots of Androgel complaints.
LAS: What is currently happening with the litigation?
MH: Court claims are being filed in various jurisdictions on behalf of people who believe they have been affected. And we would expect the case filings to grow quickly as awareness increases, particularly with the increase in television ads.
LAS: Does it matter to the claimant whether they file a claim with one of these TV ads that represent national firms or should they try to find a local law firm?
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LAS: Have any deaths been reported?
MH: Yes, we have talked with one lady whose husband had a heart attack and died.
LAS: Can you gaze into your litigation crystal ball?
MH: There is going to be a meeting with attorneys and a discussion with the Plaintiffs Bar in early April, which will somewhat determine how this litigation will proceed. There has not yet been a move to form a multidistrict litigation or MDL. We would presume that in the next few months or earlier there will be a petition filed in court requesting an MDL and one judge. I think this testosterone litigation will wind up as an MDL for initial discovery and possibly bellwether trials somewhere down the line.