Barry Cadden Gets 9 Years Behind Bars

SENTENCED Barry Cadden, former president of New England Compounding Center, must report to federal prison on Aug. 7.

Barry Cadden, the co-founder and former head of the compounding pharmacy responsible for a meningitis outbreak that killed 76 people and sickened nearly 800 more, was sentenced yesterday to 9 years in prison.

Mr. Cadden was charged in connection with a 2012 fungal meningitis outbreak, linked to contaminated steroid injections manufactured by the New England Compounding Center (NECC) in Framingham, Mass. Prosecutors said Mr. Cadden had run NECC as a criminal enterprise and directed the production of drugs in unsanitary and dangerous ways in the drive to boost profits. Although acquitted of 25 counts of second-degree murder charges, he was convicted in March on 57 counts of racketeering conspiracy and mail fraud.

"I am so sorry for your extraordinary loss," Mr. Cadden told the victims. He also said he would carry the burden of what he'd done for the rest of his life. He must report to federal prison on Aug. 7 but remains free on bond till then.

Prior to sentencing, prosecutors had asked U.S. District Judge Richard G. Stearns to sentence Mr. Cadden to at least 35 years in prison, while Mr. Cadden's lawyer said the sentence should have been 2½ to 3 years.

Last week Judge Stearns rejected Mr. Cadden's request for a new trial. In his decision, Judge Stearns rejected Mr. Cadden's claims that he did not know of the poor conditions in the clean rooms where the medications were prepared. Judge Stearns added there was "considerable evidence" Mr. Cadden was aware of serious problems. Judge Stearns also concluded there was ample evidence of a conspiracy between Mr. Cadden and others at NECC. Mr. Cadden was one of 14 people tied to the outbreak, but 1 of only 2 people to face second-degree murder charges.

The Centers for Disease Control and Prevention traced the outbreak of fungal meningitis and other infections in 20 states to contaminated injections of medical steroids. As of October 2013, the CDC placed the death toll at 64, though prosecutors said 12 more people have died since as a result. In all, an estimated 778 people were sickened, with Indiana, Michigan and Tennessee being the hardest-hit states.

Bill Donahue

Did Short-Staffed Hospital Put Patients in Jeopardy?

STRETCHED THIN A single OR team was reportedly asked to handle all emergent surgeries performed between 5 p.m. and 7 a.m.

Leadership at Tulare (Calif.) Regional Medical Center has promised to add resources to its surgical department after inadequate staffing levels reportedly contributed to 2 patient deaths.

The hospital routinely staffed 1 OR team consisting of a nurse, surgical tech and anesthesia provider to handle all emergency, lengthy and high-risk surgeries performed between 5 p.m. and 7 a.m., according to a report compiled by inspectors from the California Department of Public Health. The report cited specific examples of how the staffing model contributed to the patient deaths. In one instance, a backlog of emergency cases delayed surgery by 12 hours for a patient with bleeding in the lower bowel. In the second case, a patient who needed urgent surgery to remove a bowel blockage underwent surgery 9 hours later than expected.

The staffing issues did not go unnoticed among members of the surgical team. The hospital's operating room director told health inspectors she had expressed concerns about patient safety for 2 years and said the strain on OR resources was discussed repeatedly at weekly staff gatherings and monthly leadership meetings. One of the hospital's anesthesiologists and the former chair of its monthly steering committee claimed he asked administrators to address how resources were being allocated in the surgical department, but said nothing was done to address his concerns.

Tulare Regional submitted a corrective action plan. Among the process improvements outlined in the plan: a policy to define high-risk procedures and establish how quickly those procedures must be performed; surgical steering committee review of all surgeries performed after 5 p.m.; review of the daily surgical schedule by the director of surgery; and the hiring of backup surgeons, a CRNA, a physician assistant and a surgical tech to help the short-staffed surgical team.

In a statement, Tulare Regional and Healthcare Conglomerate Associates (HCCA), which owns the hospital, say they do not agree with the state's survey report. According to the statement, the hospital offered a plan of correction, which it says is "hardly" an admission of wrongdoing, because it is always seeking to improve its procedures and practices. The statement also says it is "ridiculous" to suggest that the hospital's administration would ever delay implementation of a safety or quality measure, especially if there was any concern by any staff member.

"State inspectors have found the hospital to be fully compliant with all [of the plan's] requirements and the matter is closed," says Kathleen Johnson, vice president of marketing for HCCA.

Daniel Cook

Study: Docs Choose Phone Calls Over In-Person Consultations with Caregivers

QUESTIONABLE CALL Nearly two-thirds of post-surgical conversations with caregivers were handled over the phone.

When the surgery's finished and the patient's in PACU, where and how do your surgeons talk to their patients' caregivers? A recent study suggests that the vast majority fail to take full advantage of what may be the best chance to convey critical information and instructions to those caregivers.

The study, which involved nearly 16,000 such interactions across 19 surgical specialties, found that only 34% were carried out in person. The other roughly two-thirds of post-surgical conversations took place via a phone call, either to the lobby or to a consult room.

The study, which was presented at the 2017 Southeastern Surgical Congress, also found that more than 70% of the face-to-face conversations took place in lobbies or waiting rooms, where caregivers might not have felt as relaxed or free to ask questions. Overall, only about 9% of interactions involved face-to-face discussions in private rooms.

Of the 4,700 outpatient procedures included in the study, 36% were followed by face-to-face meetings with surgeons and caregivers.

Overall percentages were similar across the board, regardless of patients' races, insurance status or admission type (elective or emergent).

Jim Burger

InstaPoll: Have Your Surgeons Changed Their Opioid Prescribing Habits?

Health officials who believe that surgeons are unwittingly fueling the nation's opioid epidemic by overprescribing opioids have urged doctors to cut back on the number of painkillers they prescribe to patients after surgery. Tell us in this week's InstaPoll if your surgeons are prescribing fewer opioids.

If a surveyor walked through their doors right now for a surprise on-site inspection, 8% of the 337 respondents to last week's InstaPoll would be afraid of what the surveyor might discover. The results:

If a surveyor walked through our doors right now for a surprise on-site inspection, we'd _____ .

  • pass with flying colors 41%
  • be cited for a few deficiencies 51%
  • be in a world of trouble 8%

Dan O'Connor

News & Notes

  • Nationwide recall of succinylcholine Three lots of succinylcholine manufactured by Hospira, repackaged by Fagron Sterile Services and distributed nationwide to hospitals and clinics, are being recalled, in addition to the more than 50 lots of injectable solutions Hospira recalled last week. The recalls were prompted by the detection of microbial growth during a routine simulation of Hospira's manufacturing process. Call Stericycle at (888) 628-0728 to arrange a return.
  • Standardize antibiotics after appendectomy Administering a standardized antibiotic protocol involving 5 days of cefuroxime and metronidazole does not increase risk of SSIs in patients who undergo laparoscopic surgery for complicated appendicitis, compared with 10 days of non-standardized antibiotic treatment, according to new research. The shorter duration and standardized antibiotic protocol did contribute to lower medical costs, notes the study.
  • Same-day penile implants on the rise Inflatable penile prosthesis (IPP) surgery in outpatient settings is on the rise, having increased from 54.3% of all IPP surgery (outpatient and inpatient) in 2005 to 83.2% in 2015, according to recent research. Of 40,488 IPP surgeries studied during the 10-year period studied, 75% were virgin implants, 22.2% revisions and 2.8% were device removals.