Leapfrog names the ABCs of hospital-acquired conditions

Since the 2012 establishment of the Leapfrog Group’s Hospital Safety Grade health care rating system, patient safety has improved across the country, including a 21 percent reduction in hospital-acquired conditions (HACs). However, significant patient safety problems persist. For example, over 1000 people are estimated to die each day from preventable errors—the third leading cause of death in the country.

Rating

The Leapfrog Hospital Safety Grade is the only national health care rating focused on errors, accidents, and infections. The program has assigned letter grades—A, B, C, D, F—to general acute-care hospitals in the U.S. since 2012 based upon national performance measures from CMS, the Leapfrog Hospital Survey, the Agency for Healthcare Research and Quality (AHRQ), the Centers for Disease Control and Prevention (CDC), and the American Hospital Association’s Annual Survey and Health Information Technology Supplement.

Improvement

A significant area of improvement is the 21 percent reduction in HACs between 2010 and 2015. The positive stride is attributable, in part, to Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) provisions designed to reduce HACs (see By any measure, national effort to increase health care safety succeeded, Health Law Daily, December 13, 2016). However, the HAC progress is not without its caveats. Estimates of hospital related patient harms put the number of hospital deaths related to preventable errors at over 400,000 per year.

The Leapfrog Group identified other areas of progress, regarding the reduction of medication errors through increased adoption and functionality of computerized physician order entry systems, as well the development of public and private partnerships to reduce HACs.

Grades 

Five years into the Leapfrog Hospital Safety Grade scoring, 63 out of over 2,600 hospitals have achieved an “A” in every national scoring update. In the most recent rating of 2,369 hospitals, 823 earned an “A,” 706 earned a “B,” 933 earned a “C,” 167 earned a “D” and 10 earned an “F”. The five states with the highest percentage of “A” hospitals were Maine, Hawaii, Oregon, Wisconsin and Idaho.

Too much ‘noise’ in system at root of device recall delays

Postmarket surveillance of medical devices, which includes device manufacturers’ investigations of complaints about their devices, are generally not logged in the FDA’s adverse event report system. In a study sponsored by the University of Minnesota and published in the journal Production and Operations Management, the researchers found that the more adverse event reports there are for a ­particular device, the more likely it was a company would have “under-reaction” bias in deciding whether a recall was appropriate.  In other words, device manufacturers, when presented with multiple adverse event reports for a specific device, actually took longer to react on the recall decision.

Each year, the FDA receives several hundred thousand medical device reports (MDRs) of suspected device-associated deaths, serious injuries, and malfunctions. The FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. A Manufacturer and User Facility Device Experience (MAUDE) database houses these MDRs submitted to the FDA by mandatory reporters (manufacturers, importers, and device user facilities) and voluntary reporters, such as health care professionals, patients and consumers.

Although MDRs are a valuable source of information, they provide only a passive surveillance system. Limitations include the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use. Because of this, MDRs comprise only one of the FDA’s several important postmarket surveillance data sources. As the researchers applied digital analytics to millions of medical device product reports and recall records for their study, they found a high “signal to noise” ratio correlated with the delays. Not only did these indicators create detection issues, older and widely used devices tended to have multiple adverse event reports in MAUDE, making safety-signal detection difficult.

In 2012, the FDA announced plans to develop a National Evaluation System for Health Technology (NEST) to generate better evidence for regulation and agency decisions throughout the lifespan of a device. Whether the system will provide a better way for both the agency and industry to monitor postmarket safety of medical devices is indeterminate, but the FDA is counting on the system providing more collaboration than the current one.

GNC agrees to reform and pays $2.25M over illegal supplements

GNC Holdings Inc. (GNC), the world’s largest dietary supplement retailer, agreed to pay $2.25 million under a non-prosecution agreement to resolves the retailer’s liability for selling dietary supplements produced by a firm under indictment. GNC also agreed to reform its practices related to potentially unlawful dietary ingredients and pledged to undertake voluntary initiatives designed to improve the quality and purity of dietary supplements.

Investigation

The FDA, the U.S. Attorney’s Office for the Northern District of Texas, and the Consumer Protection Branch of the Department of Justice’s (DOJ’s) Civil Division conducted an investigation which revealed the inadequacy of GNC’s practices regarding the legality of the products on its shelves. The investigation found, in 2013, GNC sold, nationwide, OxyElite Pro™ Advanced Formula, a product of Dallas-based USPlabs LLC (USP Labs). GNC sold the product based upon representations from USP Labs that the product and its ingredients complied with the law. However, GNC did not undertake additional testing or require additional certifications to confirm those representations.

USP Labs

In 2015, USP Labs was indicted and is currently awaiting trial. The indictment alleges that USP Labs conspired to import ingredients from China using false certificates of analysis and false labeling. USP Labs subsequently lied about the source and nature of those ingredients after it put them in its products. Additionally, the indictment alleges that USP Labs told retailers it used natural plant extracts in some of its products, when, in fact, it was using synthetic stimulants manufactured in a Chinese chemical factory.

Agreement

Under GNC’s non-prosecution agreement, the retailer has agreed to:

  • Immediately suspend the sale of a product upon learning that the FDA has issued a public written notice that a purported dietary supplement or an ingredient contained in a purported dietary supplement is not legal and/or not safe;
  • establish two lists—a “restricted list” containing ingredients that are not to be used in dietary supplements and a “positive list” containing ingredients that are approved for sale;
  • substantially revise its internal approach to dealing with the vendors whose products GNC sells, including requiring more explicit guarantees from its vendors that their products do not contain ingredients on the “restricted list”;
  • voluntarily work to develop an industry-wide quality seal program; and
  • update its adverse event reporting policy to ensure that its employees understand the proper procedures to employ if a customer complains of injuries associated with a dietary supplement bought at GNC.

Wright Medical agrees to pay $240 M to settle metal-on-metal hip revision claims

Wright Medical Technology, Inc. (WMT), a wholly owned subsidiary of Wright Medical Group N.V., has entered into a Master Settlement Agreement (MSA) on November 1, 2016, pursuant to which the medical device manufacturer will pay $240 million to settle claims brought by patients as part of a metal-on-metal hip revision multi-district litigation known as In re: Wright Medical Technology, Inc., CONSERVE® Hip Implant Products Liability Litigation, MDL No. 2329 (MDL) and the consolidated proceeding pending in state court in California known as In re: Wright Hip System Cases, Judicial Council Coordination Proceeding No. 4710 (JCCP). In addition, on October 28, 2016, the medical device manufacturer entered into a Settlement Agreement with three of its insurance carriers. Of the $240 million, approximately $180 million will be funded from cash on hand and $60 million will be funded from insurance recoveries (Wright Press Release, November 2, 2016).

Under the terms of the MSA, the parties have agreed to settle 1,292 specifically identified CONSERVE, DYNASTY or LINEAGE revision claims which meet the eligibility requirements of the MSA and are either pending in the MDL or JCCP, or are subject to tolling agreements approved in the MDL or JCCP. Eligibility requirements of the MSA include that the claimant has a pending or tolled case in the MDL or JCCP, has undergone a revision surgery within eight years of the original implantation surgery, and that the claim has not been identified by WMT as having possible statute of limitation issues. Claimants who have had bilateral revision surgeries will be counted as two claims but only to the extent both claims separately satisfy all eligibility criteria.

The MSA, which includes a 95 percent opt-in requirement, may be terminated by WMT prior to any settlement disbursement if claimants holding greater than five percent of eligible claims in the Final Settlement Pool elect to “opt-out” of the settlement. No funding of any individual plaintiff settlement will occur until the 95 percent opt-in requirement has been satisfied or waived.

Although the MSA will help bring to a close significant metal-on-metal litigation activity in the United States, WMT has declared its intention to continue to defend vigorously all metal-on-metal hip claims not settled pursuant to the MSA. As of September 25, 2016, the company estimated that there were close to 600 outstanding metal-on-metal hip revision claims that would not be included in the MSA settlement, including approximately:

  • 200 claims with an implant duration of more than eight years,
  • 300 claims subject to possible statute of limitations preclusion,
  • 30 claims pending in U.S. courts other than the MDL and JCCP,
  • 50 claims pending in non-U.S. courts, and
  • 20 claims that would be eligible for inclusion in the settlement but for the participation limitations contained in the MSA.

The company also estimated that there were nearly 700 outstanding metal-on-metal hip non-revision claims, which are excluded from the MSA, as of September 25, 2016.

In announcing the company’s third quarter earnings, WMT disclosed the loss range applicable to a substantial portion of revision cases of $150 million to $198 million and, in accordance with U.S. generally accepted accounting practices (US GAAP), the company recognized $150 million as a charge within discontinued operations in the second quarter of 2016. This second-quarter loss represented the low end of the range of probable loss for these cases. During the third quarter of 2016, the company recorded charges of roughly $39 million in order to increase its accrual from the low end of probable loss range that had been recognized during the second quarter to amounts more in line with the final agreements and to record accruals for certain other revision cases.