Georgia’s Medical-Malpractice Reform Bill

By Alex Stein

Georgia’s Senate is considering a far-reaching medical malpractice reform: see here. If implemented, this reform would substitute the conventional malpractice regime by a no-fault compensation scheme for patients sustaining medical injuries. This scheme will be modeled on the extant workers’ compensation regime. An injured patient will submit her claim to a special administrative tribunal—the Patient Compensation Board—that will determine her eligibility for compensation promptly and expediently.

Will this reform succeed? Read More

Action of Ohio Controlling Board on Medicaid Expansion

According to Professor Wilson R. Huhn of the University of Akron School of Law, the Ohio governor’s action expanding Medicaid in Ohio is valid. He writes:

On Monday, October 22, at the urging of Governor Kasich, the  Controlling Board of the Ohio Legislature voted 5-2 to accept $2.5  billion in federal funding to expand Medicaid in the State of Ohio.  Under the laws of Ohio this action was valid.

The Controlling Board is a state agency created by statute. The agency  has two principal powers: it can transfer funds and authorize purchases  by state agencies, and it can decide to accept federal funding on behalf of these agencies. Section 131.35(A)(5) of the Ohio Revised Code  states: “Controlling board authorization for a state agency to make an expenditure of  federal funds constitutes authority for the agency to participate in the federal program providing the funds ….”

Two advocacy organizations (the Buckeye Institute and the 1851 Center  for Constitutional Law) as well as several Ohio lawmakers have announced that they intend to challenge the legality of the action of the  Controlling Board. They contend that the action of the Board violates  Section 127.17 of the Ohio Revised Code, which provides that the Board  is bound by the intent of the Ohio General Assembly. The challengers  quite correctly point out that both houses of the General Assembly voted not to accept federal funding to expand Medicaid. Governor Kasich  vetoed this bill, but the challengers argue that despite the Governor’s  veto it’s clear that the General Assembly did not want the Controlling  Board to accept federal funding to expand Medicaid.

Read More

Disruptive Innovation and the Rise of the Retail Clinic

By Michael Young

The Association of American Medical Colleges (AAMC) projects that by 2025 the United States will face a shortage of 130,600 physicians, representing a near 18-fold increase from the deficit of 7,400 physicians in 2008.  The widening gap between physician supply and demand has grown out of a complex interplay of legal, political, and social factors, including a progressively aging population, Congressionally mandated caps on the number of Medicare-funded residency slots and funding for graduate medical education, and waning interest among medical school graduates in pursuing careers in primary care.

These issues generate unprecedented opportunities for healthcare innovators and entrepreneurs to design solutions that can effectively address widening disparities between healthcare supply and demand, particularly within vulnerable and underserved areas.

Read More

Kaiser v. Pfizer and the Question of Who Pays When Fraudulent Pharmaceutical Promotion Has Its Intended Effect

By Kate Greenwood

Cross-Posted at Health Reform Watch

On April 3, 2013, the First Circuit issued decisions in three cases in which third-party payers sought compensation from Pfizer for damages sustained as a result of fraudulent pharmaceutical promotion.  The decisions were noteworthy because in them the First Circuit lent its imprimatur to a causal chain of injury running from a pharmaceutical company’s fraudulent promotion, through the prescribing decisions of thousands of individual physicians, to the prescriptions for which a third-party payer paid.  In the lead case, brought by Kaiser Foundation Health Plan and Kaiser Foundation Hospitals, the  appellate court upheld a jury verdict that, after trebling, came to $142 million.

Not surprisingly, Pfizer has petitioned for certiorari, arguing that the First Circuit’s decisions “warrant review because they…raise important and recurring questions concerning the proper test for proximate cause under RICO and the permissibility of aggregate statistical proof in collective fraud cases.”  Amici briefs filed by BIO, PhRMA, and the Washington Legal Foundation echo these arguments, leaning heavily on the spectre of a “staggering” increase in suits founded on “pharmaceutical companies’ alleged off-label promotion.”  In addition to the financial burden posed by the “likely surge”, amici argue that it would chill their “truthful and constitutionally protected speech concerning beneficial off-label uses of FDA-approved drugs.”

Civil RICO claims cannot be predicated on “off-label promotion”, however.  To state a claim, a plaintiff has to allege that the defendant pharmaceutical company engaged in one of the predicate acts enumerated in the RICO statute, typically mail or wire fraud.  In this case, the jury found that Pfizer promoted the anti-seizure drug Neurontin as a safe and effective treatment for indications for which Pfizer knew it was no more effective than a placebo.  On appeal, Pfizer did not contest the jury’s finding that it committed fraud.  This distinguishes this case from those decided by other circuits and suggests that the First Circuit’s decisions may not open the floodgates quite as wide as Pfizer and its amici claim.

There is also reason to question the claim that the First Circuit adopted a new, more “relaxed” standard of causation in the case. Read More

Introducing Student Contributor Aditya Gupta

Aditya Gupta is an LL.M. student at Harvard Law School interested in issues involving the intersection of health care and intellectual property law and policy and the need for health care and patent law reform in both developed and developing countries. Aditya has practiced as a litigator at an intellectual property law firm in India for three years. During that time, he was part of some of India’s high profile pharmaceutical patent litigation including the Novartis case decided by the Indian Supreme Court.

 A few of Aditya’s recent publications include:

Read More

Avoiding the Crash: New research on fatality rates for cyclists and pedestrians in distracted driving crashes

By Jacqueline Jefferson, BS (’14), Temple University Department of Public Health

Today it seems impossible for drivers to keep both hands on the steering wheel and eyes on the road, with all the technology that is available to us, temptation is at its best. Somewhere along the road our eyes look down at a text message or our hands wander to program the GPS — both distract us from the task at hand: driving. There are laws being enacted all over the country to curb distracted driving (such as the one just recently passed in Maryland) but, there are other factors in this issue. The question also becomes about whether our roads and communities are protecting pedestrians and bicyclists — in other words, how are we protecting the people who do not have four sides of steel protecting them from injury?

Let’s take a closer look at the problem. A study published this week in Public Health Reports by PHLR grantee Fernando Wilson, PhD, examines victims of fatal distracted driving crashes and shows that fatality rates of motorist victims of distracted driving crashes are falling while fatalities of pedestrian and bicyclist distracted driving crashes substantially increased from 2005 to 2010. Read More

Why the Administration Will Think Twice Before Delaying the Individual Mandate

It has been widely reported that people are having trouble buying healthcare through the online exchanges due to technical difficulties, a situation President Obama addressed from the Rose Garden on Monday, saying “no one is madder than me” and encouraging people to try to sign up by telephone rather than online.  Ezra Klein calls the rollout, so far, a “failure” but says the real question is how long it takes for the exchanges to get running smoothly.

Klein is right about that: it would seem unfair to impose a tax on someone for failing to obtain insurance if they tried but were unable to do so due to problems with the government-run website.  Yet that is what the well-known individual mandate codified at 26 U.S.C. § 5000A(b)(1) says: a taxpayer who goes a month (or more) without health insurance after the effective date must pay a tax penalty.  There is no exception for taxpayers who tried and failed to get health insurance through the exchanges.  Or is there?

Read More