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Teaching Hospital Update - October 11-15, 2010

 
 
By Allison Cohen and Leah Voigt*

Justices Split on Childhood-Vaccine Case

The Supreme Court seemed divided Tuesday on whether allowing lawsuits by people allegedly harmed by the side effects of childhood vaccines would hurt the general public by exposing drug companies to so much risk that they would leave the business. The justices agreed that Congress has gone to great lengths to shield vaccine-makers from suits by the few who have had an adverse reaction to a vaccine approved by the U.S. Food and Drug Administration (FDA). The issue is whether those hurt by vaccines have a right to sue manufacturers if they can prove that a safer version was available.

"We are talking about trying to eliminate some of the most horrifying and horrible incidents of injury to vaccines that we compel children to take," said a Washington lawyer. He represents the parents of Hannah Bruesewitz, age eighteen, who began to have seizures as an infant after receiving the third of five scheduled doses of Wyeth's Tri-Immunol diphtheria-pertussis-tetanus vaccine. The company, now owned by Pfizer, has taken the drug off the market.

The National Childhood Vaccine Injury Act of 1986 said all such claims must first go to a special tribunal commonly called the "Vaccine Court." The tribunal ruled against the Bruesewitzes, saying they had not proved that the vaccine caused Hannah's problems. The couple then sued under Pennsylvania tort law. But federal courts said the suit could not proceed, because federal law prohibits claims against "design defects" in vaccines. The question before the Supreme Court is whether that is correct, or whether Congress left some remedy for those who say injury or death could have been avoided if the manufacturer had offered a safer vaccine.

The attorney representing Wyeth told the Court that Congress's intent was clear and that it acted "against the backdrop of a wave of tort litigation that threatened to drive manufacturers out of the business of providing the vaccine." She said the ruling will be important for the future as well. "There are 5,000 claimants in vaccine court now who claim there is a relationship between the mumps, measles and rubella vaccine and autism," she said. "They have lost all six test cases, and when the individual cases are resolved, that is 5,000 potential claimants in state court."

But Wyeth’s attorney faced tough and repeated questioning from Justices Sonia Sotomayor and Ruth Bader Ginsburg. Without the prospect of a lawsuit, Sotomayor asked, "what is the motivation for manufacturers to voluntarily remove a drug that is causing harm to the public before the FDA acts?" Sotomayor's repeated questioning indicated that she did not think Sullivan produced an answer. Ginsburg said that if Congress had meant to exempt vaccine manufacturers from all suits, it could have simply done that. "Congress didn't make that statement," she said.

Hannah Bruesewitz’s attorney’s tough questions came from Chief Justice John G. Roberts Jr., and Justices Antonin Scalia and Samuel A. Alito Jr. When the attorney told the Court that the industry was protected by Congress in 99% of the cases, Roberts wondered what the payouts might be in the one percent not covered and whether that would convince the vaccine makers that it was not worth their investments. "It doesn't take too many $60 million verdicts to make you come out on the other side of your calculus," he said.

Justice Elena Kagan was recused from the case because of her past work on it when she was solicitor general. Roberts sold his holdings in Pfizer in August so that the case would not be heard by only seven Justices. The lack of a full Court makes it harder for the Bruesewitzes. The justice Kagan replaced, John Paul Stevens, was one of the court's strongest believers in consumers' ability to sue in state courts. And the Bruesewitzes’ attorney must persuade five of the eight to overturn the U.S. Court of Appeals for the Third Circuit to allow the suit to proceed. If the justices are evenly split, the judgment of the lower court is upheld, but it does not set a national precedent.

Robert Barnes, Justices Split on Childhood-Vaccine Case, Wash. Post, (Oct. 13, 2010).

Physician Shortage Projected to Soar to More than 91,000 in a Decade

Nationwide physician shortages are expected to balloon to 62,900 doctors in five years and 91,500 by 2020, according to new Association of American Medical Colleges (AAMC) workforce projections. That's up more than 50% from previous estimates.

AAMC officials attribute the widening gap to increased demands from the aging baby boomer generation and expansion of coverage by 2019 to thirty-two million uninsured Americans under the healthcare system reform law. "As you get more people put in the ranks of the insured, that is going to make the shortage get worse a lot more quickly," said AAMC chief advocacy officer. "We have much less time to address these issues." To counter shortages, AAMC is urging federal officials to lift limits on Medicare funding for residency positions, which have been capped at 100,000 slots since 1997.

The U.S. Department of Health and Human Services estimates that the physician supply will increase by just 7% in the next decade and decrease in specialties such as urology and thoracic surgery. During the same period, one-third of practicing physicians are expected to retire and the number of Americans sixty-five and older is projected to grow 36%, according to figures released September 30, 2010, by AAMC Center for Workforce Studies.

Carolyn Krupa, Physician Shortage Projected to Soar to More than 91,000 in a Decade, Am. Med. News (Oct. 11, 2010).

Medical Scribes in High Demand

Two years ago a Florida International University (FIU) pre-med student from Kendall, FL, found out about a program run by Baptist's emergency physicians. The doctors hire college students and recent graduates interested in becoming physicians, and train them as medical scribes. The scribes follow the doctors around and enter their notes on patients into electronic medical records (EMRs).

The student applied and was hired on a part-time basis, thirty hours a week, for a little more than minimum wage. He has worked day and night shifts in Baptist's emergency department, wheeling around a computer and typing the emergency doctors' observations, diagnoses, and orders into the EMR. A year ago he was promoted to chief scribe, and next year he plans to take his medical college admissions test.

"This is pretty much a ticket not just into medical school but into the mindset of physicians," said the student, now an FIU senior. "I can get medical knowledge from a book, but when someone talks to me about congestive heart failure, I can draw from my own experience with thousands of patients with that condition."

This FIU student is among several thousand young people across the country working in the rapidly growing medical scribe field. Scribes—typically pre-med students paid $8 to $10 an hour with no benefits—save doctors time and money, enable them to spend more quality minutes with patients, and help them bill more fully for services they provide. Scribes are needed to help doctors navigate the tough transition from paper charts to electronic records, which are supposed to make them more efficient and ensure better care for patients. In return, the scribes get invaluable medical experience and recommendations that enable a high percentage of them to get into medical school.

Still, some physicians question whether college students can handle the complicated task of charting patients. Others wonder why it's necessary to hire additional staff to fill out computerized records that were supposed to be simpler and more efficient than paper. “It will be interesting to watch whether the need for scribes goes away as the next generation of physicians who grew up with computers and electronic medical records comes in,'' said a senior researcher at the Center for Studying Health System Change in Washington, DC, who has studied physicians' experiences with EMRs.

Harris Meyer, Medical Scribes in High Demand, The Miami Herald (Oct. 11, 2010).

Hospitals Lure Doctors Away from Private Practice

Last year, half of new doctors were hired by hospitals, according to the Medical Group Management Association (MGMA), a professional organization for physician practices. According to a 2009 report by the American Medical Association (AMA), one in six doctors works for a hospital, and the number is quickly growing. Several factors are driving the trend. For some doctors, the recession is making it more difficult to run a small business, with fewer patients coming in for care and others unable to pay their bills. And many physicians who are just starting out don’t want the long hours and administrative headaches that come with private practice.

For Rex Healthcare and many other hospitals, hiring doctors is crucial to their strategies. Having more doctors in the fold guarantees a steady stream of patient referrals. They also emphasize the impact of the new health overhaul law: it rewards creation of more efficient, integrated models of care. Some experts worry, however, that hiring doctors and forming the “accountable care organizations” envisioned under the law could give hospitals much more negotiating clout with health insurers—and drive up insurance prices paid by employers and consumers.

The senior vice president in charge of physician employment at Rex, part of the University of North Carolina’s health care system, has hired about thirty physicians over the past few years and is in talks with another fifty-five. He has to act quickly because Raleigh is a highly competitive market and each of the major systems—among them Duke Medicine, WakeMed Health & Hospitals and Novant Health—wants to grow and attract patients with private insurance, which typically pay more than the Medicare and Medicaid programs for the elderly, poor and disabled.

For a hospital, says the Rex vice president, anything that disrupts the stream of patient referrals, including losing the loyalty of local physicians, "can have a really big impact on your ability to make money. Just a 3% change in any of that can really wipe out your whole bottom line." He estimates there are only about sixty-seven doctor practices left in the Raleigh area that are not yet affiliated with a hospital. In the next five years, he says, the vast majority will be scooped up by local hospital systems. The doctors have some leverage: "If we don't accommodate the needs they have,” he says, “they're going to look to someone else."

Jenny Gold, Hospitals Lure Doctors Away from Private Practice, Kaiser Health News (Oct. 13, 2010).

House Members Tell FDA That Changes to Device Clearances Could Be Disruptive

A bipartisan group of House Energy and Commerce Committee members said this week that five of the proposed changes to the U.S. Food and Drug Administration's (FDA) clearance process for certain medical devices could prove disruptive and should be considered controversial. The lawmakers commented on FDA's August release of recommendations from an agency working group on strengthening the 510(k) premarket notification program for clearing low- and moderate-risk medical devices for marketing. The bipartisan House group said more details are needed on the key proposals, as well as an analysis of the economic impact and an explanation of whether FDA would seek revisions to 510(k) through guidance document, rules, or statutory changes.

Depending on how they are implemented, the five key provisions could “prevent companies from using important evidence in product applications, delay the introduction of innovative new therapies, increase the cost and time associated with new product development, and potentially upset the delicate balance that exists between providing information to the public and protecting intellectual property,” the six Democrats and six Republicans said in a letter to FDA Commissioner Margaret A. Hamburg.

Specifically, the lawmakers are concerned about proposals that involve potential FDA rescission authority, changes to the use of split and multiple predicates, and mandatory premarket inspection and mandatory clinical information for a subset of Class II devices. FDA's August report said that predicate devices, as largely Class II devices, generally are those “for which there is a reasonable assurance of safety and effectiveness with general and applicable special controls.” Class III devices go through premarket approval. The FDA report's recommendations include the possibility of developing a subset of Class II devices called Class IIb devices, for which “clinical information, manufacturing information, or, potentially, additional evaluation in the postmarket setting, would typically be necessary to support a substantial equivalence determination.”

While the lawmakers do not necessarily oppose the recommendations, greater transparency about the proposals and their implementation is needed from FDA, they said. They asked that FDA provide a detailed work schedule for implementing the provisions; explain how they will be implemented, such as by guidance, rulemaking, or statutory changes; provide further details on each proposal and allow for public comment; and analyze the economic impact of the recommendations on the domestic medical device industry.

House Members Tell FDA That Changes To Device Clearances Could Be Disruptive, BNA's Healthcare Daily Report (Oct. 14, 2010) (note: registration is required to view this content).

AHLA Teaching Hospital Updates are intended to provide quick summaries of cutting-edge issues of interest to teaching hospitals and their counsel. Additional information and more in-depth coverage on these topics may be available from AHLA Health Lawyers weekly and appropriate AHLA Practice Groups.

*We would like to thank Allison Cohen, Esquire (Washington, DC), and Leah Voigt, Esquire (Squire Sanders & Dempsey LLP, Washington, DC), for providing this week's update.

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