The Supreme Court should grant the review of an appeals court decision that could block millions of surgery patients from needed relief, all based on the testimony of “experts” who themselves conducted no experiments, epidemiological studies, or lab work.
The background of the lawsuit at issue is bizarre. It involves a patient-warming system, called the Bair Hugger, which for more than three decades has been the industry standard for keeping people comfortable during surgeries. The suit against the Bair Hugger was filed — get this — by the very doctor who invented it.
Inventor Scott Augustine lost his rights to the Bair Hugger when he was convicted of Medicare fraud. So he invented a new competing warming device called the Hot Dog. He suddenly began spurring lawsuits claiming that the Bair Hugger, his own creation, caused infections by blowing airborne bacteria into hip- and knee-surgery areas even though the warming device is used only on the upper body, not on the body parts being operated on.
The Food and Drug Administration has repeatedly dismissed Augustine’s claims and reaffirmed that the Bair Hugger is not only safe but “demonstrated to result in less bleeding, faster recovery times, and decreased risk of infection for patients [emphasis added].” Every major independent study has found such systems safe, including one by 400 physicians from 52 countries reaching a “strong consensus” that “no studies” show they increased surgical-site infections. A German court even forbade Augustine from repeating what it called false claims against the Bair Hugger.
And so Augustine himself sponsored a series of bogus “studies” purporting to show otherwise. Based partly on those efforts and on an engineer’s computer simulation, three “medical experts” would testify that the Bair Hugger was unsafe.
Of course, most of us aren’t scientists. We aren’t well versed in adjudging who is or isn’t a valid medical “expert.” That’s why the Supreme Court in 1993 laid down what is known as the Daubert standard — by which trial court judges can determine, using neutral and consistent criteria, whether someone qualifies as a medical expert for the purposes of courtroom testimony. In this case, the trial court judge originally decided to be lenient and allow the testimony to proceed, but later, based on Daubert, decided the purported expertise was not “reliable” enough to be admissible. The Bair Hugger’s current owner, 3M, therefore won the suit.
But the 8th U.S. Circuit Court of Appeals overruled the district judge even though it acknowledged that the judge was right about significant flaws in the “expert” opinions. It said the testimony should be readmitted, in large part by using its own permissive standard for review that it had applied before the Supreme Court’s Daubert ruling and before the nation’s Judicial Conference amended official rules of evidence to comply with Daubert.
On Feb. 7, 3M filed a petition for the Supreme Court to review the 8th Circuit’s decision. Daubert, after all, is important. It amounted to a successful legal pushback against “junk science,” whereby lawyers would gin up fake experts to fool juries in big-money lawsuits. Oftentimes, the purveyors of junk science itself victimize far more people than the class of sufferers they purport to help. Such would be the situation here if the FDA is right: A series of successful lawsuits against the Bair Hugger could result in the elimination of a key respected tool for patient comfort and safety, one that has been used successfully 300 million times (!) and is now used worldwide in 50,000 surgeries daily.
The Supreme Court should grant review here to George Amador v. 3M Company so as to ensure that, henceforth, all lower courts apply the Daubert standard faithfully and consistently. Otherwise, junk science again will rule, generating lawsuit abuse galore and perhaps denying patients, in numerous fields, of otherwise safe and tremendously helpful treatments for their ailments.
