SSRN roundup: health law

The 5 top-downloaded health law articles on SSRN:

1. Safe Storage Gun Laws: Accidental Deaths, Suicides, and Crime
   Yale Law School, Law & Economics Working Paper No. 237
   John R. Lott Jr. and John E. Whitley
   American Enterprise Institute (AEI) and University of Adelaide - School of Economics
   Date Posted:May 22, 2000
   Last Revised:June 10, 2002
   Working Paper Series 8966 downloads
2. Abortion and Crime: Unwanted Children and Out-of-Wedlock Births
   Yale Law & Economics Research Paper No. 254
   John R. Lott Jr. and John E. Whitley
   American Enterprise Institute (AEI) and University of Adelaide - School of Economics
   Date Posted:May 16, 2001
   Last Revised:June 5, 2001
   Working Paper Series 5758 downloads
3. Stability, Not Crisis: Medical Malpractice Claim Outcomes in Texas, 1988-2002
   Columbia Law and Economics Working Paper No. 287
   U Illinois Law & Economics Research Paper No. LE05-002
   U of Texas law, Law and Econ Research Paper No. 030
   Journal of Empirical Legal Studies, Vol. 2, pp. 207-259, 2005
   Bernard S. Black , Charles Silver , David A. Hyman and William M. Sage
   University of Texas at Austin - School of Law , University of Texas Law School , University of Illinois College of Law and Columbia Law School
   Date Posted:October 25, 2005
   Last Revised:January 23, 2006
   Accepted Paper Series
   1624 downloads
4. What the Publisher Can Teach the Patient: Intellectual Property and Privacy in an Era of Trusted Privication
   Stanford Law Review, Vol. 52
   Jonathan Zittrain
   Oxford Internet Institute
   Date Posted:March 9, 2000
   Last Revised:June 30, 2000
   Accepted Paper Series
   1248 downloads
5. TRIPs, Pharmaceuticals, Developing Countries, and the Doha 'Solution'
   U Chicago Law & Economics, Olin Working Paper No. 140
   Alan O. Sykes
   University of Chicago Law School
   Date Posted:February 19, 2002
   Last Revised:March 7, 2002
   Working Paper Series
   1026 downloads

Twenty-five thousand downloads. Whew!

Capital punishment and organized medicine: still a no-go in Mo.

As reported in this morning's New York Times, U.S. District Judge Fernando J. Gaitan, Jr., previously "had demanded an overhaul of the system after the doctor who now mixes the drugs for the state described an improvised process that Judge Gaitan found so chilling that he temporarily barred executions in Missouri."

In a sworn deposition, the Missouri doctor, whose name is being withheld by the state, acknowledged that he had sometimes given the condemned a smaller dose of anesthesia — used to reduce the pain of the lethal drugs to come — than the state had said was its policy.

The doctor said he was solely responsible for counting out dosage amounts of the three drugs administered in sequence, knew of no written protocol by the state for carrying out executions and was at times “improvising.”

He also said he is dyslexic, sometimes mixing up phone numbers or cable bill account numbers. “So it’s not unusual for me to make mistakes,” the doctor, identified in court records as John Doe I, said.

He indicated in his testimony, however, that he had made no mistakes in his death chamber work and that the mistakes elsewhere were “not medically crucial.”

Judge Gaitan said he was “gravely concerned” about the doctor’s dyslexia and criticized the lack of “checks and balances,” ruling on June 26 that the state was subjecting the condemned to “an unnecessary risk that they will be subject to unconstitutional pain and suffering when the lethal injection drugs are administered.”

The judge ordered Missouri to hire a board-certified anesthesiologist (John Doe I is a surgeon), and gave the state until today to submit a formal, written set of procedures, including increased monitoring of inmates and an assurance of sufficient anesthetic drugs.

But in the state’s filing last night, officials said they had sent letters to 298 certified anesthesiologists who reside anywhere near the state’s death chamber in Bonne Terre, and were turned down by all of them.

The nub of the problem, of course, is that "[t]he American Society of Anesthesiologists and the American Medical Association [Op. E-2.06] say physicians should not take part in executions, and Orin F. Guidry, the president of the A.S.A., recently issued a letter to members reiterating that position in light of the Missouri ruling." Dr. Guidry's description of the ASA position on physician participation is a little more nuanced than The Times lets on, but the ASA apparently comes out the same place as the AMA: "ASA does not have a detailed position on anesthesiologist participation in lethal injection but the 2001 House of Delegates 'Approved a recommendation that ASA support the American Medical Association’s position regarding physician nonparticipation in executions.' . . . . Clearly an anesthesiologist complying with the Missouri ruling – and despite this court’s position on ethical obligations - would be violating the AMA position which ASA has adopted. It is my belief that the court cannot modify physicians’ ethical principles to meet its needs."

Guidry ends his letter with some blunt observations:

We are being reluctantly placed on a slippery slope. If the courts demand that inmates be sufficiently anesthetized, then I would have to agree with the court that the only way to assure that would be to have an anesthesiologist prepare and administer the drugs, carefully observe the inmate and all pertinent monitors, and finally to integrate all this information. I don’t think that any of us would want to say that untrained individuals under current death chamber conditions can reliably produce a satisfactory level of unconsciousness. Our core skill is that we can induce an appropriate level of anesthesia. Are we willing to say that untrained individuals can also do so with a reasonable degree of success?

However if the only way to accomplish this appropriate level of anesthesia is with an anesthesiologist using all of our tools AND anesthesiologists will not participate, then are anesthesiologists stopping capital punishment and making public policy?

Not in my opinion. Lethal injection was not anesthesiology’s idea. American society decided to have capital punishment as part of our legal system and to carry it out with lethal injection. The fact that problems are surfacing is not our dilemma. The legal system has painted itself into this corner and it is not our obligation to get it out.

Has the Texas legislature made performing abortions a capital offense?

That's the question raised by a recent request for an Attorney General's Opinion (RQ-0501-GA). The literal question posed by David Swinford (R) (chair of the House Committee on State Affairs) is a bit more technical than that, of course:

Does a physician’s failure to comply with the requirements of either § 164.052(a)(18) (restricting third-trimester abortions performed on viable unborn children) or § 164.052(a)(19) (requiring parental consent for abortions performed on unemancipated minors) of the Texas Occupations Code, as provided by § 1.42 of S.B. 419 (2005 TEX. GEN. LAWS ch 269, § 1.42) subject the physician to liability under the criminal homicide provisions of ch. 19 of the Penal Code?

As reported in this morning's Kaiser Daily Women's Health Report, which drew heavily from a story in yesterday's Austin Statesman-American, Swinford wants to test an interpretation of the new law by the Texas District and County Attorneys Association:

The analysis says that because it is illegal both for abortions to be performed on a minor without the consent of a parent or guardian and for a physician to perform a third-trimester abortion, doctors who perform them could be prosecuted for murder. The analysis -- written by Shannon Edmonds, the group's director of governmental relations -- says, "This was undoubtedly an unintended consequence but one that law enforcement authorities should be aware of." Edmonds, who said he is unaware of any such prosecutions, said, "After every (legislative) session, there are changes in the law that are real head-scratchers, some intentional and some are unintentional. ... This is just a way to illustrate how unintentional consequences can result in something extreme" (Embry, Austin American-Statesman, 7/13). Swinford, who disagrees with the interpretation of the law by the TDCAA, said the law is intended to provide
criminal penalties for the failure of physicians to obtain parental consent or to comply with restrictions on abortions conducted at or after 28 weeks' gestation, but "certainly not to subject a physician to prosecution for capital murder."

Both the Kaiser report and the news story missed a crucial part of the story. Shannon Edmonds' analysis turns on a little-discussed amendment to the Penal Code in 2003 that expanded the definition of "individual" in the homicide portion of the Penal Code to include an unborn child at any stage of development starting at conception. Although the Penal Code exempts physicians who perform lawful abortions, that exemption wouldn't apply to physicians who perform unlawful abortions. And since the 2005 amendments to the Occupations Code make it unlawful for a physician to perform most late-term abortions or abortions on minors without parental consent (subject to a judicial-bypass provision), the argument would be that physicians who violate the new provisions would fall outside the 2003 law's exception for lawful abortions.

This is almost undoubtedly not what the legislature intended. With the Texas Legislature, though, you can never be quite sure. And by providing specific, lesser penalties for violations of the Occupations Code, the Legislature could be understood to have intended these penalties as an alternative to the Penal Code's death penalty. But when it comes to harsh penalties and the Texas Legislature, you can never be quite sure.

Pain control and end-of-life care are not simply their own reward

Excellence in end-of-life care and pain management are also sometimes rewarded by others, in this case by the AHA, which recently gave nurse practitioner Peg Nelson and St. Joseph Mercy Hospital in Pontiac, MI, its Circle of Life Award (which includes $10,000). This article from the Detroit Free Press has the details of their approach to end-of-life care.

Senate votes to allow drug reimportation by individuals

On Tuesday, the Senate approved (68-32) S. Amdmt. 4548 to H.R. 5441 (Department of Homeland Security Appropriations Act, 2007): "To prohibit the United States Customs and Border Protection from preventing an individual not in the business of importing a prescription drug from importing an FDA-approved prescription drug." As reported by The New York Times on Wednesday, the House is unlikely to get a chance to vote on the Senate's amendment: "[A]ides said that as in past years, the provision was likely to be removed when the legislation got to a conference committee of House and Senate lawmakers who will negotiate the final version."

Drug reimportation is extremely popular with voters, but Sen. Judd Gregg (R-N.H.) had his own reasons for opposing reimportation: "Referring to a leading cholesterol-lowering drug, . . . Gregg . . . said, 'If I were a creative terrorist, I would say to myself, "Hey, listen, all I’ve got to do is produce a can here that says ‘Lipitor’ on it, make it look like the original Lipitor bottle, which isn’t too hard to do, fill it with anthrax."'" But, hey, who needs to be a creative terrorist when our senators are dreaming up doomsday scenarios and sharing them with the national press corps?! And in any event, what's to stop that terrorist from doing the same thing with a bottle of Tylenol right here in the U.S.? Sorry, Senator, your argument doesn't persuade me that the Administration's (and your) opposition to reimportation is about anything more than keeping profits up for Big Pharma. Sure, there are a handful of drugs for which special handling (such as refrigeration) is required to avoid a loss in potency, but those can be excluded from the rule that allows reimportation, or special requirements can be added to try to ensure drug safety.

NYC unveils pandemic preparedness plan

From today's CDC Public Health Law News:

"City unveils a plan to identify, and contain, a flu pandemic" -- The New York Times (07/11/06) Diane Cardwell [link]

New York City Mayor Michael R. Bloomberg and city health commissioner Thomas R. Frieden this week announced a new plan to address avian influenza preparedness. The plan details the steps for identifying and containing an outbreak and distributing scarce resources such as antiviral medications. "The fact that New York is a major gateway to the nation and one of the world's most densely populated cities means the possibility of pandemic flu, however remote, is one that we must take extremely seriously," said Bloomberg. The plan stresses early detection to help contain the pandemic, so health officials have taken steps to strengthen communication with doctors and to monitor information about ambulance runs, pharmacy sales, and emergency room visits. In the event of an outbreak, in which the city estimates more than 2.5 million New Yorkers could be infected, officials said they would use traditional methods of containing the virus by encouraging certain behaviors among the public. "It's low technology, but it works: covering your mouth when you cough or sneeze; not going out if you have fever and cough. These are very important things people can do to reduce the spread of infection, and if there were a pandemic, they would be our first line of defense," said Frieden.

[Editor's note: To read the New York City Pandemic Influenza Preparedness and Response Plan, click here.]

Senate stem-cell vote set for next Tuesday

Laurie Kellman of The Washington Post has the story on the upcoming Senate vote on three stem-cell research bills, which were first discussed here two weeks ago:

The Senate will vote next week on three bills related to stem-cell research, including a measure that would expand federal funding for a procedure that uses and destroys human embryos in the drive to cure diseases that afflict millions of Americans [H.R. 810].

The Senate is expected to pass that bill, which would send it to the White House for President Bush's signature. Bush has promised to veto the measure, effectively killing it because neither chamber of Congress has displayed the two-thirds majority needed to override it.

That would be the end of the story, a victory for social conservatives, but for two issues: The Senate debate set to open Monday occurs late in a year of midterm elections, and polls show 70 percent of Americans support the embryonic stem cell bill.

So Senate Majority Leader Bill Frist, R-Tenn., who supports the bill and has spent a year trying to bring it to the floor, succeeded last week by promising opponents to also hold votes on two other stem cell measures they could support and Bush could sign [S.2754 and S.3504].

In a delicate election-year balancing act, Frist also will bring up a measure that would ban so-called "fetal farming," described as growing fetuses for the sole purpose of harvesting tissue. The other would fund research for stem cells derived from adults.

The House would then act quickly to pass the two non-controversial bills and all three would be sent to Bush for his signature. Bush would veto the embryonic bill and sign one or both of the others, giving him and social conservatives in Congress fresh evidence to present to voters this fall that they support stem cell research.

The current issue of Health Affairs is dedicated to public health. There are some terrific articles, but I particularly commend these:

• Can Public Health And Medicine Partner In The Public Interest? [link]
  J. Michael McGinnis
  Abstract: The dominant issues for health and health care today can be effectively engaged only if public health and medicine work together as better partners. Yet historical, professional, organizational, operational, and financial barriers exist to closer relationships. Fostering the necessary collaboration will require changes for both public health and medicine in leadership styles, professional education, practice incentives, accountability measures, and financing structures.

• What Does Social Justice Require For The Public’s Health? Public Health Ethics And Policy Imperatives [link]
  Lawrence O. Gostin and Madison Powers
  Abstract: Justice is so central to the mission of public health that it has been described as the field’s core value. This account of justice stresses the fair disbursement of common advantages and the sharing of common burdens. It captures the twin moral impulses that animate public health: to advance human well-being by improving health and to do so particularly by focusing on the needs of the most disadvantaged. This Commentary explores how social justice sheds light on major ongoing controversies in the field, and it provides examples of the kinds of policies that public health agencies, guided by a robust conception of justice, would adopt.

NH court: Doc has 1st Amendment right to be a jerk

As reported by the Associated Press, New Hampshire judge Edward Fitzgerald "has ordered the state Board of Medicine to stop disciplinary proceedings against a doctor accused of telling a patient she was so obese she might only be attractive to black men and advising another to shoot herself following brain surgery." The article reports that Terry Bennett, M.D., says "he planned to sue everyone involved for 'malicious prosecution.'

"'I am not inclined to be forgiving about it,' he said. 'It's been devastating and infuriating.'"

New Hampshire Public Radio aired a good piece on the matter, including comments by medical ethicist Larry McCullough (tough love -- and tough speech -- may be what the doctor ordered and is within the bounds of standard medical practice) and Vermont medical professor Virginia Hood (offensive speech can cause harm).

There are a few excerpts from the judge's opinion in an article in the Manchester Union-Leader.

This case raises some interesting issues. First, can it possibly be true that a medical board can't decide that certain speech constitutes unprofessional conduct and punish a licensee for engaging in such conduct, even if the speech is otherwise protected by the First Amendment? And second, the First Amendment cuts both ways. Recall the 2002 Ninth Circuit decision that First Amendment rights of physicians meant the federal government couldn't revoke the drug licenses of California physicians who recommended marijuana to their patients (Conant v. Walters).

Many hospice patients live longer than expected

Terrific story (via Kaiser Family Foundation's Daily Health Policy Report) about hospice:

McClatchy Newspapers/St. Paul Pioneer Press on Wednesday examined how some patients who check into hospices believing they are near death later go on to recover and leave hospice care. For Medicaid and Medicare beneficiaries to cover hospice care, the patient's doctor and the hospice's doctor must agree that the patient will die within six months. About two-thirds of hospice patients die within 30 days, according to the National Center for Health Statistics at CDC. If a patient does survive six months but is not likely to survive another six months, the patient remains in hospice. Patients who survive six months are discharged if their condition has improved and stabilized enough that they are likely to live another six months. According to CDC data, an estimated 100,000 hospice patients will leave hospice care this year. One study estimates that about one-third of those who leave hospice die within six months of their release. About 5,000 to 20,000 hospice survivors annually "live on with evident satisfaction," while the remainder is transferred to nursing homes, according to McClatchy/Pioneer Press.

Explanation
Experts say there are several factors that can lead terminally ill patients to recover enough to leave hospice care. In many cases, doctors inaccurately estimated how long a patient had to live, McClatchy/Pioneer Press reports. According to McClatchy/Pioneer Press, predicting how long a hospice patient will live might be more difficult today than it was in the 1970s and 1980s, when
three-quarters of hospice patients were admitted because of cancer. By contrast, nearly half of current hospice patients have dementia or heart, lung, kidney or liver failure -- which can make the length of a patient's decline less predictable. "Another theory ... is that pending death brings out the curative power of family and friends," McClatchy/Pioneer Press reports. In addition, some experts say patients might improve in hospice because they are receiving better care than before they entered facilities (Greve, McClatchy/St. Paul Pioneer Press, 7/5).

The article doesn't mention the ill-fated trial balloon from CMS a few years back, in which they proposed to recoup hospice benefits paid to Medicare beneficiaries who didn't die within 6 months!

Also: If you have trouble with the link provided above to the news article (I did!), try this one. Free registration may still be required, but at least the article (eventually) appears on your screen. . . .

HPV debate moves to the states

On June 30 Stateline.org published a useful summary of the issues surrounding the recently recommendation from the CDC's Advisory Committee on Immunization Practices that all 11- and 12-year-old girls receive the vaccine for the most dangerous strains of human papillomavirus (HPV), which causes cervical cancer. As a public health matter, the advisory committee's recommendation is pretty straightforward. But the politics of abortion, always lurking just below the surface of any discussion of public policy and sex, promise to alter the debate in many states:

. . . HPV is a sexually transmitted disease. The distinction already is spurring some conservative groups to say states shouldn’t mandate that girls get the vaccine, because the only way to catch the cancer-causing disease is through sexual contact.

Linda Klepacki, an analyst on sexual health for Focus on the Family, which promotes abstinence until marriage, said the reason for inoculating schoolchildren for diseases like measles doesn’t apply to the cervical cancer vaccine.

“HPV cannot be communicated by sitting in a public school classroom. It’s communicated only by sexual behavior. Because of that reason, we believe that parents should be the primary decision makers. . . . It’s not something you can catch, but it’s something you really have to go out and get,” she said.

Klepacki acknowledged that women who remain celibate until marriage still could be at risk, if their husbands contracted the virus earlier.

NEJM Perspective on Roe

There's an excellent (and free) article on Roe and partial-birth abortion in this week's New England Journal of Medicine. The authors leave no room for doubt as to their position on legal abortions, including late-term procedures, but their article is no more polemic: it's reasoned and supported by data and careful argument, ending with these four paragraphs:

Watson Bowes, emeritus professor of obstetrics and gynecology at the University of North Carolina, is among those who argue that Roe v. Wade is a misuse of federal authority: "The Supreme Court used raw judicial power to trump state legislators, and the decision should be overturned on those grounds." Other antiabortion activists advocate incremental changes in state laws to limit the provision of abortion. These changes include parental consent laws, fetal homicide laws (making it two crimes to kill a pregnant woman), strict regulations for abortion clinics, and legislation requiring physicians to offer women fetal ultrasonography before an abortion.

This strategy is already having an effect, argued Katherine Grainger, legislative counsel at the Center for Reproductive Rights. "With each year, more and more restrictions on Roe are being passed." Ultimately, Grainger said, "we'll see it slowly eviscerated to the point where . . . it's hollow."

Many older abortion providers believe that the complacency of younger women and physicians is partially responsible for the current state of affairs. "They don't remember the thousands of women who died from septic abortions," argued Edelin. "They don't realize that this is a battle to save women's lives — not a battle for choice."

As new legislation is passed, the courts will hear more cases that challenge Roe, and physicians may increasingly risk their careers and their lives if they choose to provide abortions. With each new decision to limit abortion, more American women lose their access. Whether the Supreme Court ultimately upholds or overturns the Partial-Birth Abortion Ban Act, one thing is certain: poor women in rural America are bearing the brunt of these decisions, and some may pay with their lives.

Health care costs going up by 9.6%

An article in today's Wall Street Journal (click here - link should be good for about a week) reports that "Americans should expect to pay more for medical costs whether they are employed or retired, according to two new studies. The reports, by Milliman Inc. and Watson Wyatt Worldwide, show that health-care costs are still rising at a fast pace -- despite slowing from double-digit rates in recent years -- and that businesses expect to curtail or limit retiree medical benefits."

Here's a little more detail:

The average annual medical cost for a family of four participating in a preferred provider organization, or PPO, program is up 9.6% from 2005 to $13,382 in 2006, according to Milliman, a consulting and actuarial firm that released its second annual study Thursday. Unlike other major health-care cost studies, which look at costs in terms of annual premiums or just the employer's share, the Milliman study also factors in employees' costs, including out-of-pocket expenses.

By my reckoning, even though the reported rate of increase is down a bit compared to reent years, it is still about 2.5-3 times the overall rate of inflation. The outlook for retirees is gloomier than for workers:

The vast majority of businesses are planning to curtail medical plans for current and future retirees, according to the Watson Wyatt study. The survey of 164 companies found that 14% plan to eliminate the benefit for future retirees over age 65, and 6% plan to eliminate it for their current retirees over age 65.

While most employers who still provide the coverage plan to continue it, retirees should expect to pay more for their coverage. "The good news is that they're all not jumping out. The majority are still going to provide it," says Cara Jareb, director of retiree medical consulting at Watson Wyatt. "The bad news is they will be paying more for this coverage."

Nearly two-thirds of employers expect to increase the financial contribution for future retirees, and half expect to change the design of their plans. Twenty-four percent plan to tighten eligibility for future retirees. Fidelity Investments has estimated that a 65-year-old couple retiring without employer-provided health benefits will need $200,000 for out-of-pocket health-care expenses during retirement.

Bottom line: more cost pressures on consumers of health-care services. Depending on your politics, this is either a good thing (because it provides an incentive for us to be better, savvier purchasers of health care goods and services) or not (because it pushes increasing numbers of us -- especially those in the worst position to protect themselves (low-income earners and retirees on a fixed income) -- to make tragic choices (drugs vs. food, or Drug A vs. Drug B).

Happy 4th of July

There's something really stirring about listening to the news-readers and commentators on NPR read the Declaration of Independence every 4th of July. If you missed it this morning, click here.
For some Independence Day fun, check out the National Archives' Charter of Freedom exhibit, where you'll find some interesting information about the signers (for example, 24 of the 56 signers were lawyers) [biographical overview], and you can add your signature to the Declaration, remembering that as we do so, "we mutually pledge to each other our Lives, our Fortunes and our sacred Honor." Heady stuff. (Thanks to Rob Robinson for the link to the Stark County Law Library Blog, which got me to the Moritz School of Law's legal information blog site and the National Archives.)

Garry Trudeau on creationism

[click for larger view]

Senate to take up stem cell bills

Sen. Majority Leader Bill Frist announced yesterday that he intends to bring up a three-bill package that would provide federal funding for stem-cell research for a vote before the Senate takes a break for the mid-term elections in October (according to the AP) or July (according to CNN, the Washington Post, and the Wall Street Journal).

• AP (LA Times)
• CNN
• Washington Post
• Wall Street Journal (subscription)

Here's the summary of the Senate's unanimous-consent agreement on Frist's plan (from the Congressional Record's Daily Digest for June 29):

Stem Cell Research Legislation--Agreement: A unanimous-consent agreement was reached providing that at a time determined by the Majority Leader, after consultation with the Democratic Leader, Senate begin consideration en bloc of H.R. 810, to amend the Public Health Service Act to provide for human embryonic stem cell research, and S. 2754, to derive human pluripotent stem cell lines using techniques that do not knowingly harm embryos, and S. 3504, to amend the Public Health Service Act to prohibit the solicitation or acceptance of tissue from fetuses gestated for research purposes, that both bills be discharged from the Committee on Health, Education, Labor, and Pensions; that there be 12 hours of debate equally divided between the Majority and Democratic Leaders, or their designees; that no amendments be in order to any of the bills; that following the use, or yielding back of time, the bills be read a third time, respectively, and the Senate begin three consecutive votes on final passage of the bills in the following order: S. 3504, S. 2754, and H.R. 810; provided further, that any bill that does not receive 60 votes in the affirmative have its votes on passage be vitiated, and that those bills be returned to the calendar or to the Committee on Health, Education, Labor, and Pensions; and that it not be in order for the Senate to consider any bill or amendment relating to stem cell research during the remainder of the 109th Congress.

The action is set out at pp. S7169-S7173 of the Congressional Record for June 29.

Is it legal to buy off manufacturers of generic equivalents?

The FTC thinks it's unlawful for the manufacturer of a patented drug or device to include in the settlement of its suit against the manufacturer of a generic equivalent a cash payment in return for the generic manufacturer's pledge to withhold its product from market. [In the Matter of Schering-Plough Corporation, Upsher-Smith Laboratories, and American Home Products Corporation, Docket No 9297] The 11th Circuit disagreed. [Schering-Plough Corp. v. FTC, No. 04-10688, March 8, 2005] On Monday, the Supreme Court denied cert. [order list; Docket No. 05-273], at least in part because the Solicitor General told the Court that this wasn't a particularly good case to tee up the issue (according to observers like SCOTUSBlog and the AP), in part because a similar case is cooking over in the Second Circuit [from the SG's brief at 16: "Indeed, only a district court thus far has examined, and rejected, the view that a patent gives the holder merely a potential right to exclude infringing competitors from the market. In re Ciprofloxacin Hydrochloride Antitrust Litig. (Cipro-floxacin), 363 F. Supp. 2d 514, 531-533 (E.D.N.Y. 2005), appeal docketed, No. 05-2851 (2d Cir. June 7, 2005). The Second Circuit may address the validity of that theory in its consideration of that case. That prospect further counsels against plenary review at this juncture."]

Meanwhile, as reported by Modern Healthcare, four members of the Senate Judiciary Committee (Republican Chuck Grassley (press release) and Democrats Leahy (press release), Kohl (press release), and Schumer) have introduced "[a] bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market." See Cong. Rec. S6560 (June 27, 2006); see also S.3582 (referred to the Committee on Commerce, Science, and Transportation).

This issue bears close watching. It is a terrific combination of cost-quality-access issues, as well as a good introduction to the tactics of the drug and device industries.

Words of One Syllable Department

[click image for larger view]

Drug & device manufacturers and docs: a new twist on an old tale

Drug and medical device manufacturers have long struggled to devise ways to get tight with physicians who can promote, recommend, prescribe, or use their products. In recent years, PhRMA and the FDA have published guidelines to rein in marketing abuses. All that effort, and the reams of adverse news stories and other publicity, seems only to have intensified the industry's efforts to continue the remuneration to doctors, albeit in a manner that might escape detection or, once discovered, provide the industry with a better cover story than was possible when the emoluments took the form of all-expenses-paid trips to Hawaii.

Judging from an article in today's N.Y. Times ("Charities Tied to Doctors Get Drug Industry Gifts," by Reed Abelson), the latest ploy seems not to have worked exactly as planned:

The Midwest Heart Foundation, and the way it has become quietly interwoven into its doctors' professional lives, is far from unique. Around the country, doctors in private practice have set up tax-exempt charities into which drug companies and medical device makers are, with little fanfare, pouring donations — money that adds up to millions of dollars a year. And some medical experts see that as a big problem.

The charities are typically set up to engage in medical research or education, and the doctors involved defend those efforts as legitimate charitable activities that benefit the public. But because they operate mainly under the radar, the tax-exempt organizations represent what some other doctors, as well as regulators and industry consultants, say is a growing conduit for industry money. The payments, they say, can bias the treatment decisions of physicians, may lead to suspect research findings and at times may even risk running afoul of anti-kickback laws.

Federal officials are starting to take notice of such tax-exempt charities, which critics say are becoming increasingly popular as other forms of industry support to physicians — like lucrative consulting agreements that involve little actual work — have come under scrutiny from regulators and others worried about the potential conflicts.

HealthLawBlog is back

It's been an interesting, fun, and rewarding trip along the HealthLawProf superhighway, but it's time to return to the meandering blogpath I started down almost exactly three years ago. I wish über-blogger Paul Caron and my HLP co-blogger Betsy Malloy nothing but success. For my part, I will probably blog a little less often than every day, will focus on matters of interest to me without worrying over-much about the relevance to teachers who teach health law or practitioners who practice health law, and will try to have some fun along the way.