Ethics: February 2008 Archives

In its continuing coverage of the criminal case against transplant surgeon Hootan Roozrokh, MD, the San Luis Obispo Tribune reports on the second day of testimony from Laura Lubarsky, MD, at a preliminary hearing. Lubarsky is the critical-care specialist who served as Ruben Navarro's attending physician at the Sierra Vista Medical Center on the night of February 3, 2006, when Navarro's organs were to be harvested during cardiac-death donation.

Lubarsky, who has received immunity from prosecution, reportedly described her role on the night in question in conflicting terms: although an "independent observer" of the organ-donation process, she admitted to also having "an ethical and legal obligation to protect [Navarro] from harm." The reported facts of the case suggest that Lubarsky acted more consistently (and regrettably) as a spectator in Navarro's end-of-life care, while the patient was given massive doses of morphine and lorazepam, which were ordered by Roozrokh.

Lubarsky admitted yesterday on the stand that Navarro, once his mechanical ventilation was removed, did not exhibit the signs of pain or distress that would warrant such large doses of analgesic or sedating medication. Lubarsky also implied either ignorance or confusion regarding her role as attending physician in the process of cardiac-death donation.

Information to date suggests that the final events of Ruben Navarro's life are a consequence of the unhappy meeting of extreme passivity and aggressiveness in Lubarsky and Roozrokh, respectively.

Printing its first non-AP blurb on the subject, the NYT today features the criminal proceedings against California transplant surgeon Hootan Roozrokh, MD—a story that has heretofore received considerable attention in the West Coast press and elsewhere. Prompting the NYT's attention now is evidently the fact that a preliminary hearing in the case begins today in the San Luis Obispo County Superior Court. Roozrokh is charged with three felony counts related to the 2006 death of potential organ donor Ruben Navarro at the Sierra Vista Regional Medical Center.

Some of the best coverage to date on this story (and available through the oh-so-terrific Google News archive feature) can be found in a-little-paper-that-could, the San Luis Obispo Tribune, with the bulk of its reporting on this story by Sarah Arnquist. Particularly informative are reports of unsealed court documents from the AP, by way of the Tribune. These documents, coupled with complementary news stories, enable the construction of the following rough timeline of the attempt to harvest Navarro's organs during his unfortunate last hours and the ensuing events.

• 01/29/06: Navarro, a 25-year-old man debilitated by adrenoleukodystrophy, is found in respiratory arrest at the Casa de Vida adult-care facility and is taken to Sierra Vista (which, according to Google Maps, is right across the street), where he is revived but remains comatose and on life support.

• 01/29/06-02/03/06: At some time during this period, Navarro's family agrees to remove the patient from mechanical ventilation and to donate his organs (however, this claim is challenged later by the patient's mother, Rosa Navarro, who says her consent was not informed). Navarro reportedly has minimal brain function but is not brain dead, and at least one of his Sierra Vista physicians allegedly writes in medical records that Navarro would not make a good candidate for a procedure known as cardiac-death donation—which requires organ harvesting within 30 minutes of death—because Navarro's "drive to breathe was still intact."

• Friday, 02/03/06, evening: A dispatched team from the California Transplant Donor Network, which includes Roozrokh, another surgeon Arturo Martinez, and nurse coordinator Carla Albright, arrive at Sierra Vista. Roozrokh and Martinez examine Navarro in the ICU, a clear violation of organ-donation law, which prohibits contact between transplant surgeons and potential donors during life. This contact is also in violation of Sierra Vista policy.

• 02/03/06, 11 pm and after: In preparation for a cardiac-death donation (reportedly the first ever performed at Sierra Vista), Navarro is transferred from the ICU to an operating room, where mechanical ventilation is to be disconnected and his organs harvested within a 30-minute window of time after death. The transplant physicians are evidently in the OR at this time, another clear violation of transplant law and hospital policy. Also allegedly present are at least six staff members, including critical-care specialist Laura Lubarsky, MD, a respiratory therapist, and several nurses. According to reports of unsealed records, at 11:10 pm, a transplant surgeon (presumably Roozrokh) orders 100 mg of morphine and 40 mg of lorazepam (Ativan) to be given to Navarro, despite the fact that the doctor does not have hospital privileges at Sierra Vista. Shortly thereafter, Roozrokh allegedly directs the respiratory therapist to remove Navarro’s ventilatory assistance, and Lubarsky tacitly agrees (per the respiratory therapist). However, once off the respirator, Navarro does not die. What apparently follows is a disagreement between Roozrokh and nurse coordinator Albright as to whether Navarro has a pulse: Roozrokh believes there is none, while Albright claims that she can see Navarro’s heartbeat through his emaciated chest (Navarro apparently weighed about 80 pounds; also, there is confusion in the press reports as to whether Navarro is hooked up to a heart monitor at this time). Allegedly frustrated with Albright, Roozrokh orders another large dose of morphine and lorazepam to be given to Navarro and is quoted as uttering the unfortunate phrase, "Let's just give him some more candy." (Reports indicate that astonishing doses of both medications are ultimately given to Navarro—200 mg of morphine and 80 mg of lorazepam.) Also at some point in time, Roozrokh suggests that the neuromuscular blocker vecuronium be given to Navarro; however, Albright objects. Roozrokh does administer Betadine through Navarro's feeding tube, presumably as a sterilization maneuver—which should be performed after death but before organ harvesting. From reports, it can be concluded that Roozrokh (possibly along with the rest of the transplant team) leaves Sierra Vista at approximately midnight. Navarro, still alive, is transferred back to the ICU at Sierra Vista.

• 02/04/06, ~8 am: Ruben Navarro dies at Sierra Vista, and his death certificate is reportedly signed by Lubarsky. Navarro's cause of death is originally listed as cerebral anoxia with the contributing factor of respiratory arrest. Navarro’s organs are never harvested, there is no autopsy, and his body is cremated. Sometime later, Navarro’s cause of death is revised to "pending investigation."

• Monday, 2/06/06: A Sierra Vista employee informs hospital administrators of the transplant-policy violation, and they contact the San Luis Obispo county coroner, the Medical Board of California, the California Department of Health Services, and the Joint Commission (the hospital-accrediting association). The medical board and county law enforcement officials begin their investigations.

• 05/18/06: Roozrokh is placed on administrative leave from Kaiser Permanente, after learning of allegations against the physician.

• 01/07: Roozrokh is reinstated by Kaiser Permanente, after "no new developments" in the investigations.

• 03/07: The San Luis Obispo police turn their investigation of the Navarro case over to the county DA's office.

• 06/29/07: Rosa Navarro, the patient's mother, files a civil suit against Sierra Vista, the California Transplant Donor Network, physicians Roozrokh and Martinez, and their employer, Kaiser Permanente Medical Group for assault, battery, fraud, civil conspiracy, negligence, medical malpractice, and intentional infliction of emotional distress. Reports also indicate that Ms. Navarro is suing her son's "primary care doctors" (naming Lubarsky, among others), as well as ResCare (a provider of disability services) and Casa de Vida. 

• 07/30/07: San Luis Obispo county prosecutors charge Roozrokh with three felony counts: dependent-adult abuse, administering a harmful substance (Betadine), and the unlawful prescription of a controlled substance. If convicted, Roozrokh could face up to 8 years in jail and $20,000 in fines. Roozrokh is again placed on administrative leave from Kaiser Permanente.

• 07/31/07: Roozrokh is booked at the San Luis Obispo county jail and is freed after posting a $10,000 bond.

• 09/12/07: Roozrokh pleads not guilty to two counts, and his lawyer, M. Gerald Schwartzbach (who successfully defended actor Robert Blake), requests that the second count (administering a harmful substance) be dismissed.

• 11/07: Ms. Navarro's civil suit against Sierra Vista and its parent company is settled for $250,000. Sierra Vista acknowledges no wrongdoing in the settlement, which covers all hospital employees who cared for Ruben Navarro on the night in question. (A disclaimer at Sierra Vista's website indicates, "Physicians performing services at Sierra Vista Regional Medical Center are independent contractors and not employees, agents or representatives of Sierra Vista Regional Medical Center," suggesting that physicians who cared for Navarro at Sierra Vista are still defendants in Ms. Navarro's civil suit.)

• 11/07/07: A judge rules that Roozrokh can abstain from Rosa Navarro’s civil suit, for the time being.

Whatever the legal outcome of this unfortunate criminal case, it seems clear that Roozrokh (and Martinez) violated the laws and policies which justifiably dictate that a very large distance should remain between transplant surgeons and a potential, living organ donor. Moreover, Navarro's case reinforces the reasons for adhering strongly to these laws and policies.

My own experience indicates a general, hovering aggressiveness among this particular group of occasionally self-righteous physicians, which can be intimidating and requires some degree of backbone in those who should remain advocates for the still living—even if that living is anticipated to be very short. On more than one occasion, when asked to verify brain death in a potential donor, I've been pushed to the point of saying to this particular surgical breed, Back Off.

On Friday, the WSJ reported that Merck agreed to pay out more than $650 million in its settlement of two qui tam (ie, “whistleblower”) lawsuits. In the suits, Merck allegedly used a historically exploited exception to the 1990 Medicaid Drug Rebate Program, which otherwise requires drug makers to report the lowest prices they charge to any entity not excepted by the law. The law’s exception—originally intended to foster deep drug discounts to charities and certain state-run facilities—specified that drug discounts of 90% or more (ie, "nominal prices") do not have to be disclosed to the government or included in the seller's best-price calculation for Medicaid reimbursement.

The qui tam lawsuits were specifically directed at the widespread practice of loosely applied nominal pricing, in which drug companies offered extreme medication discounts to health care facilities in exchange for formulary preference, and thus a sizeable market share for the drug. According to a 2003 report by the WSJ, the suit brought by qui tam relator and New Orleans geriatrician William LaCorte, MD, alleged that, from 1996 to 2001, Merck sold each tablet of then-prescription famotidine (Pepcid) to some New Orleans hospitals for $0.10, while charging Medicaid approximately $1.65 per tablet.

In its February 7 press release, Merck acknowledged the settlement, while asserting that it did not constitute an admission of guilt. The company also clarified that it believed "its pricing and sales and marketing policies and practices were consistent with all applicable regulations and contracts during the relevant time." The company also claims that it "voluntarily began to put in place substantial compliance initiatives in 2001," which raises the question If Merck’s pricing practices were consistent before 2001, why did it have to initiate compliance initiatives in 2001?

A December 2006 clarification of nominal pricing is provided in a DHHS document to state Medicaid directors, which defines nominal prices as those offered to 1) a covered entity described in section 340B(a)(4) of the Public Health Service Act; 2) intermediate-care facilities for the mentally retarded, and (3) state-owned or -operated nursing facilities. The document further clarifies that "[n]ominal sales to other entities must be included in the drugmaker’s best price."

Seeing nefarious deception where there’s perhaps just silliness and embarrassment, a Congressional committee wants information about the use of a rowing body double for Robert Jarvik, MD, in the overplayed Lipitor TV ads. According to today’s NYT, the committee sent out letters yesterday to 9 advertising firms (IMC2; the Maya Group; Cline, Davis, & Mann; ARS Group; Guideline; Ipsos-ASI; Ipsos-Understanding; the Kaplan Thaler Group; and Unit 7), asking for relevant records and raising the musical question Just how many agencies does it take to create a TV ad campaign?

The committee wants information regarding payment made to a body double, who was revealed yesterday by the NYT to be Seattle rower and Jarvik look-alike Dennis Williams. Thanks to the NYT, the committee members can now locate the remuneration figure by reading the April 2006 newsletter of the Lake Washington Rowing Club, which reveals that member Williams was paid $550 per day for his Lipitor stunt-double stint. (Compare this rate with the $1.35 million that the Pfizer contract provides to Jarvik for 2 years of Lipitor pitching.)

The NYT also reports that the committee wants to know if Jarvik body doubles were used in other versions of the Lipitor ads. The congressional inquiry conjures up the notion that Pfizer has collected a small, specialized army of Robert Jarviks, ready to stand in for the pitchman whether he’s rowing, batting, kicking a field goal, triple jumping, high jumping, ice dancing, or 2-man luging with himself. But I ask Why stop with an athletic body double? Why not just collect your big fat check, while someone much better looking than you impersonates you throughout the entire ad?