Why they might be giving you a parting x-ray whether or not anyone thinks you strictly need one (Dr. Val, Apr. 2).
Posts Tagged ‘medical’
May 21 at AEI: Off-Label Uses of Approved Drugs: Medicine, Law, and Policy
An important all-day conference at AEI next week:
In the last several years, nearly every major pharmaceutical company has paid hundreds of millions of dollars to settle allegations of illegal “off-label” marketing of drugs. There has been a growing trend of actions by federal prosecutors, state attorneys general, and cooperating trial lawyers to litigate against pharmaceutical manufacturers for allegedly doing too much to promote off-label use of prescription products. Citing recent legal changes mandating exclusion from federal programs after a conviction, many manufacturers say they are forced to settle rather than risk defending themselves–even as prosecutions against individual executives have foundered in front of juries.
At this AEI Legal Center event, experts on both law and health care will present papers on the law, economics, medicine, and public policy of off-label marketing, discussing everything from the abuse of class action mechanisms to implications for the First Amendment and medical malpractice. Speakers include former Food and Drug Administration chief counsel Daniel Troy; former Cephalon general counsel John Osborn; former deputy attorney general George Terwilliger; principal deputy assistant attorney general and acting assistant attorney general for the Civil Division Jeffrey Bucholtz; attorneys Brian Anderson, James Beck, Mark Herrmann, Richard Samp, and Kyle Sampson; law professor Margaret Johns; and AEI scholars John E. Calfee, Theodore H. Frank, and Scott Gottlieb.
Panel I: Off-Label Marketing, R&D, and Medical Practice
Panel II: The Legal Environment from Federal Regulation and Enforcement
Panel III: Distortions from State and Private Enforcement
Panel IV: Legal Implications for Commercial Speech and Medical Practice
Register here. Earlier discussion on POL: Feb. 1; Feb. 19; Mar. 24; Dec. 17; Aug. 31; Aug. 22 (Richard Epstein); Aug. 1, 2006 (state AGs); Mar. 19 (InterMune indictment).
Villarreal v. Rio Grande Regional Hospital Inc.
41-year-old South Texas personal injury solo practitioner Hermes Villarreal was admitted to a McAllen hospital on April 16, 2005, reporting that his heart was racing. The hospital put him on a 24-hour EKG. Villarreal reported being under stress, but refused a psychiatric consultation or the recommended medication. At 5 a.m. on April 19, 2005, the day of his scheduled discharge, “Villarreal summoned the nurse on duty and requested a razor, saying that he wanted to take a shower and shave his chest, because the EKG monitor leads attached to his chest were bothering him.” The nurse complied with his wishes, and Villarreal locked himself in the bathroom and committed suicide with the razor.
This was, said Villareal’s family, the hospital’s fault; since it’s South Texas, a Hildalgo County jury, after a three-week trial, awarded $9 million in March (which looks to be reduced at least to $1.64 million under Texas law capping damages). Ironically, the opening line of the Texas Lawyer story says “It was a suicide no one saw coming,” but doesn’t question the resulting jury verdict.
Somehow, the trial lawyer, Raymond L. Thomas, a close friend of Villarreal’s, interjected himself into the closing argument, telling an emotional story of a Rolex Villarreal had given him as a gift that left the jury in tears; the press coverage doesn’t acknowledge the blatant violation of ethical rules (see also Texas Rule 3.04(c)(3)), much less indicate whether he got away with it because of the failure of the defense to object or a judge’s failure to oversee her courtroom. (Jenny B. Davis, “Attorney, Interrupted: Seeking Meaning, Recovery for a Legal Life Lost,” May 5 via ABA Journal).
Response re Terry v. Lindell
In June 2004, we wrote:
In the complicated surgery to correct scoliosis, screws and rods are inserted and bone added into the spine. The risk of nerve damage or paralysis is such that there is something called the Stagnara wake up test, whereby the patient is woken during surgery to ensure she can move her feet. In 1999, however, Joshua Terry was one of the unfortunate 0.1% who was paralyzed during surgery. And, according to the newspaper account, his lawyer, Jay Kelley, found four surgeons to testify against defendant Dr. Ernest Lindell that “paralysis was not a potential complication” from surgery on the spine to correct scoliosis. A Lucas County, Ohio jury awarded $8.4 million to Mr. Terry and another million to his parents. And Dr. Lindell will no longer perform spinal surgery. (“Paralyzed area man wins $10M judgment”, Toledo Blade, Jun. 16; P. Stagnara, et al., “Functional monitoring of spinal cord activity during spinal surgery”, Clin. Orthop., 1973; 93: 173-78).
Perhaps there was malpractice in this case; paralysis is relatively rare, and one can’t tell the merits one way or the other from cursory press coverage. (Terry claims that Lindell “lost control” of an instrument during surgery, and it’s unclear whether that claim is the result of concrete evidence or a wishful inference.)
If the press account is correct, the plaintiffs’ attorney put a finger on the scale through expert testimony claiming that paralysis doesn’t happen except through negligence. Even a relatively well-educated lay jury isn’t well situated to resolve which expert is telling the truth. It’s another example of why the current litigation system is poorly situated to resolve disputes of this sort.
Jay Kelley writes us:
“4% of doctors responsible for 50% of payouts”
Trial lawyers like to repeat statistics similar to this (Bizarro-Overlawyered just did so this week) as an argument for medical malpractice being a problem of the doctors, rather than the lawyers. The problem is, as I noted three years ago, that the statistic is fallacious.
Some small X% of doctors responsible for large Y% of payouts is always going to be true simply by random chance. It’s going to be true over any time period: the problem is that if you take that time period and divide by two, the X% in the first half of the time period are going to be almost entirely different than the X% in the second half of the time period. Even if you were to fire every single one of those doctors in the tail in the first time period, all you have is X% fewer doctors; the very next year, it’s going to be a different small A% of doctors responsible for large B% of payouts, and you’ve solved nothing. With very rare exceptions medical malpractice payouts have absolutely nothing to do with the quality of the doctor, and everything to do with the risk profile of their practice.
It’s worth noting Eugene Volokh’s excellent explication of the issue:
From a reader: Home albumin therapy
Lacking specialized knowledge in this area I’m not well situated to evaluate the contents of this letter from reader J.W., but perspectives and advice from medically knowledgeable readers would be more than welcome:
One of our friends apparently has focal segmental glomerulosclerosis, which has a substantial risk for progression to end-stage renal disease.
Apparently, getting a nurse to come and administer albumin, which is a blood product, is a real problem. About three years ago, liability laws stopped the companies that produce albumin from allowing it to be used at home. There is a real possibility she will have to go to “Day Hospital” every day for five hours and perhaps have to be readmitted every weekend.
Given the likelihood that she will die from her disease, I’m sure she is comforted by the fact that she’ll spend so much time in the hospital for legal reasons.
But I feel safer, so that’s nice.
Unintended consequences in health law
Mandatory lunch breaks for unhungry nurses, hurdles to get over in prescribing pain medication, and more. (Toni Brayer, EverythingHealth, Jan. 27).
We were counting on you for favorable testimony!
A Utah federal court will consider the Pace family’s lawsuit against California anesthesiologist Barry Swerdlow, whom they had earlier hired as an expert witness as part of their medical liability suit against another anesthesiologist, Stephen Shuput, whom they blamed for their late daughter’s death. After agreeing to come on board as an expert for the Paces, Swerdlow examined Shuput’s deposition and concluded that Shuput had met the standard of care; he proceeded to inform Shuput’s lawyers of this, and they quickly got the case dismissed. The Paces then sued Swerdlow for “malpractice, fraud, negligent misrepresentation, breach of fiduciary duty, breach of contract, breach of the implied covenant of good faith and fair dealing, and negligent infliction of emotional distress,” to quote AMNews’s catalogue. Swerdlow conceded that he was new at the expert witness game and that it would probably have been a good idea for him to have read Shuput’s deposition earlier. The EleventhTenth Circuit ruled that a lower court should consider the Paces’s contention that they had suffered legally actionable damages from Swerdlow’s actions. (Bonnie Booth, “Expert who changed mind claims immunity, but plaintiffs still sue”, American Medical News, Apr. 14).
Judge Gorsuch, dissenting from the EleventhTenth Circuit’s ruling, wrote:
Parties already exert substantial influence over expert witnesses, often paying them handsomely for their time, and expert witnesses are, unfortunately and all too frequently, already regarded in some quarters as little more than hired guns. When expert witnesses can be forced to defend themselves in federal court beyond the pleading stage simply for changing their opinions – with no factual allegation to suggest anything other than an honest change in view based on a review of new information – we add fuel to this fire. We make candor an expensive option and risk incenting experts to dissemble rather than change their views in the face of compelling new information. The loser in all this is, of course, the truth-finding function and cause of justice our legal system is designed to serve.
(Decision of the Day, Mar. 5; Karen Franklin, Forensic Psychologist, Mar. 7; The Briefcase, Mar. 7).
17 doctors sued, all but one dismissed before trial
National Practitioner Data Bank
When money is paid out on a medical liability claim, the doctor’s name is automatically entered on this federal database — and that may have more serious consequences for the doctor’s career than the payout itself. (Vicki T. Brenthall, Medical Economics, Feb. 15).