A really nice Bloomberg article on whistleblowers “hit the stands” today. The authors, David Voreacos and Margaret Cronin Fisk did an excellent job of tracing the payouts and controversy surrounding corporate employees of drug companies who alert the DOJ to bad pharmaceutical practices. Essentially, the act of telling the DOJ gives the federal government the ability to recoup millions of dollars, a portion of which is given to the whistleblowers as an incentive payment. Without that payment, few whistleblowers would risk their jobs and peer ostracization to bring these bad practices to light. Some think the payments to whistleblowers are too high. I don’t have any problem with it–it may encourage others to report bad practices (and remember–not all whistleblowing cases are accepted, or result in multi-million dollar settlements).
See our prior Seroquel/Whistleblowing blog post.
Here are the stories we’re following this week:
- Infusion pumps: The FDA is tightening regulation of infusion pumps, which have reportedly caused 710 deaths in the past five years, and have been subject to 79 recalls since 2005 (news links to The New York Times, The Wall Street Journal, Associated Press, Reuters).
- Guidant: Brian Nash’s perspective on the defective Guidant defibrillator settlement proposal.
Two contrasting Accutane lawsuit updates in the news today:
First, Some Background: Accutane is used to treat severe acne, and has been associated with a host of problems: birth defects, inflammatory bowel disease, injuries to the liver, kidneys, nervous system and pancreas, dermatological reactions, and even suicide. Roche stopped selling it last year after a 27-year run, citing competition from generics and the 5,000 pending Accutane lawsuits.
Plaintiff’s Verdict: $25.16 Million: In May 2007, Andrew McCarrell emerged victorious in a New Jersey Superior Court Accutane lawsuit against Roche Holding AG. Mr. McCarrell developed inflammatory bowel disease, caused by the Accutane. (View the entire original trial on video, purchase required). That victory was short-lived, as the verdict was appealed and overturned (opinion here, courtesy Drug and Device Law Blog) because the trial judge should have allowed the defendants to present statistical evidence—that there were five million users of the drug.
The Lancet has retracted [free subscription required] the 12-year old article connecting autism to MMR (measles, mumps and rubella) vaccinations. The Lancet stated:
Following the judgment of the UK General Medical Council’s Fitness to Practise Panel on Jan 28, 2010, it has become clear that several elements of the 1998 paper by Wakefield et al1 are incorrect, contrary to the findings of an earlier investigation. In particular, the claims in the original paper that children were “consecutively referred” and that investigations were “approved” by the local ethics committee have been proven to be false. Therefore we fully retract this paper from the published record.
Click here for the original article, “Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and
pervasive developmental disorder in children” (emblazoned with a bold, red typeface “RETRACTED”).
Here’s a summary of the posts on the internet and blogosphere:
We’ve been fielding questions lately about the cardiac stents that have been all over the news here in Baltimore. One of the inevitable questions is whether the stent is defective. There’s no indication that the stents implanted at St. Joseph Medical Center are defective—in fact, there is no evidence that the stents are of any particular brand or manufacturer. A few years back there was discussion about defective Johnson & Johnson Cypher Stents, which one Cleveland Clinic study showed to be four to five times more likely to cause blood clotting. The issue here is not one of defective stents, but rather medical malpractice.
Though it is outside the scope of this blog, it does touch close to home, happening here in Maryland. And, we’ve been fielding questions about these stents, so this is as good a forum as any. So, a little discussion.
Back in June (Statistics, Part I), we reported on the U.S. Department of Justice’s Civil Justice Survey of State Courts, covering 2005 state court trials. Though official statistics have not been released by the DOJ for 2006 to 2009, a recent Bloomberg article, Jurors Turned Against Companies in 2009 Product-Defect Cases, analyzes last year’s product liability verdicts through the lens of the recession and general consumer distrust of Big Business.
The reporter, Margaret Cronin Fisk, notes the following for 2009 product liability lawsuits (which were not limited to just state courts):
- The top 5 product defect verdicts were 52% larger in 2009 (at $620 million), as compared to 2008
On the last day of December, Plaintiff Merle Simon received a stunning present. The Superior Court of Pennsylvania (Pennsylvania’s first level appellate court) decided in Simon v. Wyeth Pharmaceuticals, et al. that the trial judges grant of judgment notwithstanding the verdict in 2007 was erroneous. The trial judge’s opinion was based on statute of limitations grounds and, alternatively, proximate causation. Here are the important dates:
It’s going to be a great year. If one of your new year’s resolutions is to follow industry news more closely, here’s some required reading:
- Hormone Therapy: Bloomberg reports on the latest Plaintiff’s Prempro victory (actually, the drug at issue here was Provera, later combined with Premarin by Wyeth to make Prempro)—a Pennsylvania appeals court ruled that the trial court wrongly granted judgment for defendants, notwithstanding a jury verdict for Plaintiff. We’ll report more on this later in the week.
- Conflicts of Interest: The New York Times notes that two Harvard Hospitals (Massachusetts General and Brigham and Women’s) have issued new guidelines on outside pay for senior officials. They can now only accept a maximum of $5,000 per day of actual work—and no stock. Importantly, speaker’s fees from drug companies are prohibited for all employees. The momentum is good—let’s hope these attitudes spread.
We haven’t written much about the Digitek cases. I looked at them in the beginning (and they looked very promising) but in the end could not find any clients who actually had the legendary “double-dose” pill that was the root of all the evil. Certainly there were some patients who died and had blood tests revealing digoxin toxicity, but that’s still an uphill battle without compelling evidence to show the plaintiff took the pills as directed. The allegations are that, among patients with impaired renal function, digitek toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, bradycardia and death.
So, I cannot say that I know much about the status of these cases. One blog, MassTortDefense, commented today about the status of the MDL. Five bellweather trials have been selected for the federal litigation in the Southern District of West Virginia.
Any plaintiff lawyers out there want to comment on the state of the litigation, from their perspective? Do we believe plaintiffs have a shot on this one?
Bloomberg has a nice article on a 2007 case against Pfizer over its drug Prempro (the drug was manufactured by Wyeth, but Pfizer recently purchased Wyeth). The plaintiff in that Philadelphia state court case, Mary Daniel, took the drug for 16 months and argued that it caused her to develop breast cancer.
The jury in the Daniel case awarded $1.5 million in compensatory damages. Though the trial judge believed punitive damages were not warranted, the jury was allowed to deliberate on the issue in case the trial judge’s decision on punitive damages was overruled on appeal. According to the Bloomberg article, the jury awarded over $8 million in punitive damages. That number was sealed pending appeal; then, the trial judge died and new judge granted Pfizer a new trial on compensatory damages. That decision is also being appealed.
This recent news on the 2007 verdict fuels the outrage against Pfizer/Wyeth for the injuries it has caused. Pfizer continues to toe the Wyeth party line, claiming that 24 cases have been resolved in their favor by juries or judges. This overlooks the reality that six of nine jury verdicts have been for plaintiffs, and any plaintiffs’ victory indicates that the drug can reasonably be responsible for the injury; whereas a defense verdict only means that the drug did not cause injuries in a specific case.