The threat of malpractice suits might be a strong catalyst encouraging physicians to adopt pharmacogenetic strategies in treating patients, according to PGx veteran George Poste.
“Legal pressures [are] starting to invade personalized medicine,” Poste, a professor at the Biodesign Institute at Arizona State University, said at a conference hosted by the Personalized Medicine Coalition last month in Washington, DC. “In my opinion, this is an inevitable train, and much as I’m saddened to say this, I think [it will be] one of the catalysts” driving the adoption of PGx strategies in healthcare.
“What is the basis of medical jurisprudence? It is not just the delusional belief propagated by tort lawyers and legislators that you can have zero risk,” Poste continued. “It is the question of ‘How do you emotionally engage the jury?’”
Poste gave a hypothetical example of a court case in which a prosecutor is cross-examining a doctor regarding a fictional patient whose death was allegedly the result of being given a drug that did not fit her genetic profile.
“Would you please tell the jury the nature of the molecular profile you ran on Mrs. Jones – I’m so sorry, the late Mrs. Jones – with respect to the fact that do I interpret correctly, Doctor, that in fact you assaulted – I withdraw the term, Your Honor – treated – treated the late Mrs. Jones with a combination of cytotoxic napalms for her – I again withdraw, Your Honor – a treatment regimen that was totally irrelevant relative to her genetic profile,” Poste quipped.
While Poste’s example elicited laughter among the conference participants, industry observers have long expressed concern that increasing acceptance of pharmacogenomic technologies could potentially increase malpractice litigation.
Legal experts point often to the growing prevalence of so-called “wrongful birth” lawsuits in which parents sue healthcare professionals for failing to adequately inform them of the risk of a genetic abnormality in an unborn child, as a harbinger for the types of ethically complex legal wranglings that could come in the era of personalized medicine.
For instance, a jury in July awarded $23.5 million to a Florida couple after determining that a geneticist at the University of South Florida failed to diagnose Smith-Lemli-Opitz syndrome in their first son and assured the couple there was no risk of the disorder in future children.
Heeding this advice, the couple had a second son who was born with the disorder, which keeps the body from synthesizing cholesterol. The couple argued in court that if their first son had been correctly diagnosed and the risk of them passing on the genetic abnormality to future children had been identified, they would not have had their second son.
Cases run the other way, too. Last year, for instance, the New Hampshire Supreme Court reversed a $2.3 million jury award to a couple whose son was born with a rare chromosomal disorder, trisomy 18. By overturning a superior court’s decision, the high court found that Dartmouth Hitchcock Medical Center in Lebanon, NH, had sufficiently informed the couple about the risk that their unborn child would have significant birth defects.
“What is clear is that courts are split on when and whether to hold physicians liable for negligent genetic testing with regard to claims of ‘wrongful birth’ and ‘wrongful life,’ but some states do impose liability, particularly for negligent testing and negligent counseling regarding genetic test results,” Heidi Li Feldman, a law professor at Georgetown University Law Center, told Pharmacogenomics Reporter this week. “I would expect these cases to be a departure point for courts asked to consider physician liability for injuries caused by faulty genetic testing and counseling outside the pregnancy context.”
However, according to another Georgetown University law professor, the belief that increased acceptance of personalized medicine will bring with it a slew of malpractice suits is “pretty speculative.”
“The greatest predictor of whether you will be sued as a doctor is how well or badly you get along with your patients,” said Maxwell Gregg Bloche, co-director of the Georgetown-Johns Hopkins Joint Program in Law and Public Health and a law professor at Georgetown University.
“Malpractice suits are neither tentative nor specific as a measure of actual malpractice. Insofar as medicine is not evidence-based it is more likely that there will be multiple ways of treating any given illness,” he added. “In the absence of data that decides what you should do, it is more likely that there’ll be variations in practice styles, which creates a kind of Russian roulette possibility for the doctor.”
One example of possible ambiguity in treatment options can be found in the warfarin testing market. This summer, the FDA required manufacturers of warfarin to include genetic testing information in the product’s label. Around that time the agency also approved the first genetic test designed to help physicians dose warfarin. However, the agency stressed that it was not requiring doctors to use diagnostics to find a safe dose for warfarin, but rather it was informing them that the option exists.
According to the FDA, more outcomes data is needed before it will suggest a stronger recommendation. Agency officials have further emphasized that genetic testing should not be a stand-alone method for dosing the drug, but should be used along with clinical evaluation and International Normalized Ratio data.
In Bloche’s view, the absence of definitive data pointing to the superiority of a particular treatment can create problems for the patient/physician dynamic. “The doctor does treatment A, but in the absence of evidence, some doctors do B, some do C, and some do D. … If a doctor does A and it turns out badly then the relationship breaks down and patients get a lawyer and sue,” he said.
“In the absence of data that decides what you should do, it is more likely that there’ll be variations in practice styles, which creates a kind of Russian roulette possibility for the doctor.”
“It will become easy then for the lawyer to find doctors who would have done B, C, or D. Whereas if evidence decisively says that only treatment B is the right treatment, because A, C, and D all have bad side effects, then probably the vast majority of doctors will be doing B. … So, it’s going to be much harder to bring suits.”
In addition to evidence-based medicine, helping patients better understand what they are getting into when genetic tests are performed on them can also help to preserve the physician/patient relationship. “The best way to minimize malpractice in this area is to not commit any malpractice … and get true informed consent from patients” that goes beyond a single leaflet that glosses over genetic testing information, said Li Feldman.
“Doctors need to impress upon patients that genetic testing is neither good nor bad, but complicated,” she added.
This discussion, however, is difficult to have in the current managed healthcare structure, where profits are tied to the number of patients doctors can see. Although managed care organizations are increasingly recognizing that implementing genetic tests can reduce healthcare costs, granting doctors the time to appropriately explain the risks and benefits of genetic testing would reduce the rate at which they can see patients and, therefore, lower profits in the short term, Li Feldman pointed out.
“It’s not only the tsunami of information coming at them that’s being referenced, it is the unit pressure of the 7- to 15-minute consultation,” Poste said.
In the rapidly evolving genetic testing environment, industry experts have suggested that the reimbursement structure needs to be redesigned to account for genetic counseling [see PGx Reporter 10-03-2007]. In addition, physicians will need to develop protocols for giving patients the results of their genetic tests, Li Feldman said.
Genetic testing poses numerous ethical challenges for doctors and patients, requires a specific type of medical expertise and counseling training, and may cause anxiety among patients if they find out that they are at a greater risk for developing a disease for which there is no cure.
Myriad Genetics last month launched a promotional campaign for BRCAnalysis, which has been criticized for glossing over some of these complexities [see PGx Reporter 09-12-2007].
Following the launch of its four-city advertising campaign for BRCAnalysis in September, healthcare professionals expressed concern that the promotional blitz would increase requests for BRCA1 and BRCA2 genetic testing to an unmanageable volume and that they wouldn’t have enough time or expertise to appropriately counsel these women.
According to reports, health officials also feared that the ads may encourage women at low risk for developing breast and ovarian cancer to take unnecessary medical measures.
Furthermore, Connecticut Attorney General Richard Blumenthal has been cited in the press saying his office has received reports from healthcare professionals that BRCAnalysis has a potential for “misinterpretation and overreaction” and is investigating the accuracy of Myriad’s claims in its ads for the test.
While the availability of cancer diagnostics like HerceptTest and BRCAnalysis have been at the forefront of raising the public’s awareness of pharmacogenetics and personalized medicine, this area may also be the first to see malpractice suits. “I believe that just as oncology is on the vanguard of this with respect to the science [of genetic testing], I also believe it will be in the vanguard of court cases to come,” Poste said.