Tuesday, October 19, 2010

Many doctors on drug company payrolls have tainted record, media report alleges.

ProPublica (10/19, Ornstein et al.) reports that despite drug companies saying "they hire the most-respected doctors in their fields for the critical task of teaching about the benefits and risks of their drug," an investigation by ProPublica "uncovered hundreds of doctors on company payrolls who had been accused of professional misconduct, were disciplined by state boards or lacked credentials as researchers or specialists." A "review of physician licensing records in the 15 most-populous states and three others found sanctions against" more than "250 speakers, including some of the highest paid." Their "misconduct included inappropriately prescribing drugs, providing poor care or having sex with patients," and "some of the doctors had even lost their licenses."
In Georgia, a state appeals court in 2004 upheld a hospital’s decision to kick Dr. Donald Ray Taylor off its staff. The anesthesiologist had admitted giving young female patients rectal and vaginal exams without documenting why. He’d also been accused of exposing women’s breasts during medical procedures. When confronted by a hospital official, Taylor said, “Maybe I am a pervert, I honestly don’t know,” according to the appellate court ruling.

Last year, Taylor was Cephalon's third-highest-paid speaker out of more than 900. He received $142,050 in 2009 and another $52,400 through June.

        The Chicago Tribune (10/19, Graham) reports that "doctors are drawing an extra paycheck...for speaking to other medical professionals about pharmaceutical products at company-sponsored, company-scripted events in Illinois and across the country."

"Let's be honest: The purpose of these talks is to influence doctors to buy a company's drugs," said Eric Campbell, an associate professor of health policy at Harvard Medical School.
The Tribune adds that drug companies have started "publicly releasing data about their relationships with physicians, information that until now has been a closely guarded secret." While most doctors received small payments, "pharmaceutical data show that 11 Illinois physicians each earned more than $100,000 between January 2009 and June 2010 from seven companies," and an "additional 13 medical providers earned between $75,000 and $100,000, primarily for participating in speakers' bureaus and educational forums." The Tribune goes on to detail views on both sides of the "medical moonlighting" practice.

Dr. Catherine DeAngelis, editor of the Journal of the American Medical Association, criticized the speaking arrangements, saying they posed "a conflict of interest" and threatened to put doctors' "own financial benefit before that of the patients who trust them."

        The Boston Globe (10/19, A1, Kowalczyk) reports on its front page, "The Harvard brand, unrivaled in education, is also prized by the pharmaceutical industry as a powerful tool in promoting drugs," and "its allure is evident in a new analysis of all publicly reported industry payments to physicians." Data show that "doctors and researchers affiliated with Harvard Medical School collected 45 percent of the $6.3 million given to Massachusetts doctors in 2009 and 2010 by seven pharmaceutical companies that disclosed their payments for parts of those years. The money was mostly for talking to other physicians about the companies' drugs and the diseases they treat, but also for consulting on research and marketing." Notably, "doctors said they created their own presentations" initially, but "now, companies generally make them, and they are reviewed by" the FDA.

Thursday, October 14, 2010

Bellwether Order Amended

Following the status conference this week, Judge Herndon amended the bellwether order, as follows:
12 cases will be selected by each side, for a total of 24.
8 of these cases will be VTE cases, and 4 will be gallbladder cases, leaving the following pools:
8 cases for the first trial (PE case), 8 cases for the second trial (a gallbladder (GB) case), and 8 cases for the third trial trial (a VTE case).

The first case tried will be a Pulmonary Embolism case (this is not a change, just a clarification of my previous blog).
The trial dates and deadlines will stay the same.
Basically this amendment reduces the number of cases which will be subjected to discovery from 50 to 24.
The end result will still be pretty much the same.
There will be a slightly different strike system, with each party getting 2 strikes, one VTE/PE strike and one GB strike.  The Court will then select a lead case and two back up cases from the remaining pool for each of the three trial dates.
This means that the Court will have 6 cases from which to choose a gallbladder case and 14 cases from which to choose the PE and VTE cases.

One other important change.  All Plaintiffs MUST waive Lexicon.  That means that every case selected by either side must waive venue and agree to have their case tried before Judge Herndon.  If ANY Plaintiff refuses to waive Lexicon, then the Judge can (and probably will) totally withdraw the trial bellwether plan.

Tuesday, October 12, 2010

Trial Dates set for Bellwethers in MDL

Judge Herndon has set the initial trial schedules for the first three cases to be tried in federal court in East St. Louis, Illinois.  The first trial will be a VTE case (venous thrombotic event, such as a pulmonary embolism).  The second case will be a gall bladder case, and the third case will be another VTE case.

The first trial is set for September 12, 2011, the second January 9, 2012, and the third case April 20, 2012.  This will require an extraordinary level of work to get the cases prepared.  Bayer still has not produce many documents, and many that were produced were improperly redacted, requiring duplication of effort and delay.

Selection of these bellwether cases is to be made by October 27, 2010. Each side will submit 25 cases, 13 VTE cases and 12 gallbladder cases, forming a pool of 50 cases from which the selection of the three will be made.  If a case is selected and there is no completed Plaintiff Fact Sheet, the case may be dismissed without prejudice.

Discovery in the 50 selected cases will begin November 1st, and must be completed by March 14, 2011.  Thereafter the Plaintiffs and Defendants will each pick three cases for each of the three trial dates, and the Court will then select three cases from the proposed group.  So there will be three cases set for each of the three trial dates.  In this way there will be back up cases in case the first scheduled case cannot proceed.

The schedule also contains dates for expert reports and other deadlines.  All in all it is a very thorough and aggressive schedule that will require a tremendous amount of work.