Michael Goetz is the head of the Mass Tort Section of Morgan & Morgan, one of the largest exclusively plaintiffs’ law firms in the nation.
Goetz represents clients in mass tort matters throughout the United States, including clients with filed cases in most of the currently active pharmaceutical and medical device litigations. He has been appointed to a number of multidistrict litigation steering committees, most recently to those in Transvaginal Mesh and Pradaxa.
Goetz earned his B.A. degree magna cum laude from Emory University in 1989, and then attended the University of Florida College of Law, where he graduated with honors in 1992. He is "AV - Preeminent" rated by Martindale-Hubbell and was designated in successive years by Florida Trend's Magazine as a "Florida Legal Elite" and by Law & Politics Magazine as a Florida "Super Lawyer" in the field of Class Action/Mass Torts.
Drugwatch.com recently spoke with Goetz.
Drugwatch: How did you become involved in diabetes drug litigation?
Michael Goetz: I’ve been handling pharmaceutical cases for many years, but my first involvement with diabetes drug litigation was in representing hundreds of Type 2 diabetes patients with injuries related to their use of Avandia. More recently, I’ve been pursuing claims by users of Actos. And since early 2013, I’ve been investigating claims by users of a number of the 14 incretin-based drugs, such as Januvia, Janumet, Byetta and Victoza, all of which are used to treat Type 2 diabetics.
DW: What is your role in the litigation?
Goetz: My primary role is counselor and advocate for the many clients I represent. Secondarily, I am working alongside lawyers across the country for the common benefit of all claimants in an effort to hold drug manufacturers accountable for avoidable injuries and deaths caused by their products.
DW: We’ve noticed that some plaintiffs sue over two drugs at the same time – like Januvia and Byetta. Is it true that there is one MDL for all of these drugs?
Goetz: Yes, the Judicial Panel on Multidistrict Litigation has established one MDL (No. 2452) covering four incretin-based medications: Januvia, Janumet, Byetta and Victoza. While there are 14 incretin-based drugs, it remains to be seen whether the MDL will be expanded to include any of the other drugs in the class (Bydureon, Janumet XR, Juvisync, Onglyza, Kombiglyze XR, Nesina, Kazano, Oseni, Tradjenta, Jentadueto).
DW: It sounds like Byetta, Januvia and Victoza can help people manage Type 2 diabetes. What are the problems with them?
Goetz: Like all drugs, there is a laundry list of potential side effects associated with incretin-based drugs. The most serious problem with Januvia, Janumet, Byetta, Victoza and the others, is the concern over pancreatic cancer. In the case of Byetta, there is also a risk of thyroid cancer that has not been warned about by the drug manufacturer.
DW: Why did the FDA approve these drugs if they have dangerous side effects?
Goetz: The FDA relies heavily on drug manufacturers to supply critical scientific and other data that is used in deciding whether to approve a drug. One of the key aspects in this litigation will be to determine what the manufacturers knew about the risk of pancreatic cancer, when they knew it, and what efforts, if any, they took to inform the FDA either before or after the drugs were approved.
DW: How are these side effects different from those associated with Actos and Avandia, two other dangerous diabetes drugs?
Goetz: While all these drugs are used to treat the same condition, the dangers associated with them are quite different. Patients who stay on Actos longer than a year may be at significantly greater risk for developing bladder cancer than those not taking Actos. Avandia, by contrast, has been associated with a higher than expected risk of heart failure. These conditions are obviously quite different than pancreatic and thyroid cancer, but similar in that they are all life-threatening medical conditions that may not have been properly warned against by the drug manufacturers.
DW: What should consumers do if their doctor has prescribed one of these drugs for them?
Goetz: That’s a difficult question and one best left between an informed doctor and his or her informed patient. There are many factors that go into deciding the best treatment option for any given medical condition. My best advice is to choose a doctor who is open to a thoughtful and candid conversation about the risks and benefits of these drugs as compared to the numerous other treatment options for Type 2 diabetes.
Screening for pancreatic cancer is very difficult because of the location of the pancreas in the body, so patients who use these drugs should at the very least confirm that their doctors are actively looking for any warning signs of changes in the pancreas.
DW: What do you say to consumers who have been injured by one of these drugs?
Goetz: Sadly, I rarely have the opportunity to speak with those directly injured by Januvia, Janumet, Byetta or Victoza. Pancreatic cancer is one of the deadliest forms of cancer. The disease is usually detected only in its latest stages, when it is almost always fatal. An incredible 73 percent of patients die within the first year after diagnosis.
DW: Should these medications be recalled?
Goetz: My personal belief is that they should be recalled. All drugs carry certain risks. But there are many treatment options for Type 2 diabetes that do not pose a risk for disease as deadly as pancreatic cancer.
DW: Why are people suing the manufacturers of these drugs?
Goetz: The manufacturer of a drug is typically in the very best position to understand its risks and warn about them. Users of Januvia, Janumet, Byetta and Victoza who developed pancreatic cancer are claiming that the manufacturers knew or should have known of the risk of pancreatic cancer and failed to adequately warn doctors and patients of such risk. They also contend that the risks of the drugs far outweigh any benefit.
These patients, had they been given the choice between a drug that could cause a deadly cancer and another safer and equally effective alternative, would surely have chosen the safer alternative. As such, lawsuits are being filed to obtain compensation for those who have needlessly suffered and died because of these drugs.
DW: How much does it cost to file a lawsuit related to a diabetes drug?
Goetz: It costs our clients absolutely nothing to investigate a claim and, if appropriate, file a lawsuit. My firm advances all such costs, which are reimbursed only in the event we are successful. Similarly, our clients do not owe any fee for legal services unless we obtain a recovery for them.
DW: Why should people consider filing a diabetes drug lawsuit?
Goetz: Lawsuits against drug companies that engaged in dangerous or negligent behavior are a vital check and balance against corporate misconduct and greed. History shows that drug companies often put their own profits over patient safety. We can rely on the government to police these activities only so far. Beyond that, it’s up to the people to stand up and hold bad corporate actors accountable for the harm they cause innocent consumers.
DW: When will these lawsuits go to trial?
Goetz: At this point, no trial has been set anywhere in the country. Given the speed by which pancreatic cancer claims its victims, we intend to encourage a very aggressive trial schedule with the hope of getting a case to a jury as quickly as possible.
Most of the cases in the country have been filed in the Southern District of California, the selected forum for the recently formed multidistrict litigation. Now that the MDL has been established, all cases filed in federal court anywhere in the country will be transferred to the Southern District of California for coordinated pretrial proceedings.