Introducing Student Contributor Aditya Gupta

The Petrie-Flom Center Staff Leave a comment

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:

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

Temple University Center for Public Health Law Research 1 Comment

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

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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?

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Twitter Round-up 10/22

The Petrie-Flom Center Staff Leave a comment

By Sara Providence

This week, our contributors tweeted quite a bit about the Affordable Care Act, but also about vaccination, the cost of extending life, and the budgetary impact of preventive health policy.

Amitabh Chandra (@AmitabhChandra2) tweeted the piece “The Cost of Living,” a New York Magazine article about the dilemma posed by very expensive cancer drugs that extend life only by a few dozen days. His opinion on the article: “If there is only one article that you read on healthcare this year, make it this one.” (10/22)

Frank Pasquale (@FrankPasquale) tweeted Paul Krugman’s blog post, “Maybe Economics is a Science, but Many Economists are not Scientists.” Krugman raises the question of whether economists are actually using the evidence garnered in their studies to inform policy debates, using healthcare as an example. (10/21)

Adrian Gropper (@agropper), our newest contributor, tweeted his own blog post: “State Surveillance Endangers the Affordable Care Act: A Case Study.” He uses Massachusetts as a lens to discuss the issues caused by state monitoring of individual health information. (10/18)

Art Caplan (@ArthurCaplan) tweeted a BBC report that a judge in the UK ordered two sisters to receive the MMR vaccine. The ruling represents the latest perspective on the benefits of the vaccine versus its risks. (10/17)

Amitabh Chandra (@AmitabhChandra2) tweeted a report by the New England Journal of Medicine on the effect of cigarette taxes on the Federal budget. The analysis, performed by the Congressional Budget Office, highlights the complexity of determining the effects of health policy on the deficit. In Chandra’s opinion, it “exposes [the] sloppiness of prevention arguments.” (10/17)

Richard Epstein (@RichardAEpstein) tweeted his blog post, “The Obamacare Train Wreck,” about his take on how to improve the Affordable Care Act. In the post, he touches on ideas to “fix” the exchanges, the employer mandate, the coverage structure, etc. (10/14)

Caveat Veterans: Limitations and Repose in Medical Malpractice Actions under FTCA

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By Alex Stein

To be able to sue the government under the Federal Tort Claims Act (FTCA), an aggrieved person must first present his claim to the appropriate agency within two years of the claim’s accrual. 28 U.S.C. § 2401(b). When the agency fails to make a final disposition within six months, the claim is deemed denied and the person may sue the government in federal court. 28 U.S.C. § 2675(a). Alternatively, he may continue the process with the agency. If the agency ultimately denies the claim, he would have another six months to file a suit. 28 U.S.C. § 2401(b).

Augutis v. United States — F.3d —-, 2013 WL 5553084 (7th Cir. 2013), features a medical patient that did exactly this. Alas, when he sued the government for medical malpractice, allegedly committed by his doctors at the Veterans Affairs Hospital in Illinois, it was too late. His suit was blocked by the Illinois statute of repose (735 ILCS 5/13–212(a)) that nullifies an aggrieved patient’s right to sue his doctor within four years of the date of the alleged malpractice. The patient argued that this statute was preempted by the abovementioned provisions of FTCA, but the Seventh Circuit disagreed.  Here is why: Read More

HHIP: Jaan Tallinn, co-founder of Skype, talks on responsible technology development

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So You Want to be a Technology Developer…

The roots of Skype go back to one email. If that email hadn’t been sent, the world today might be different. In general, technology development is not something that “just happens” — instead, it’s a result of particular actions by individual people. Moreover, the responsibility of technology developers must increase proportionally to the power of their creations. The talk sketches out a vision of what it means to be a responsible technology developer, using behind the scenes stories and videos from the early days of Skype development.

 Jaan Tallinn, co-founder of Skype

Wednesday, October 30th

5:30 – 6:30 PM

Science Center A

RSVP to this event

The event is organized by Harvard HIP (High Impact Philanthropy).

Expanding Access to Clinical Trial Data Responsibly

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[Ed. Note: This report stems from the “Issues in Clinical Data Sharing Conference” co-sponsored by MRCT and Petrie-Flom last May.]

Press Release: A new report by researchers from Harvard University and others in a working group convened by the Multi-Regional Clinical Trials Center (MRCT) at Harvard proposes recommendations for addressing a problem that has vexed drug regulators: how to expand public access to data from clinical trials while protecting patients’ privacy and weighing pharmaceutical companies’ business interests. Recently, the European Medicines Agency (EMA) announced it will provide public access to participant-level data submitted in applications for marketing approval in Europe, prompting questions about whether the U.S. Food and Drug Administration should follow suit. Data releases by the EMA have spurred litigation by drug companies and heated debate about whether clinical trial data should be protected as proprietary information or widely shared.

The report, published online October 21, 2013 in The New England Journal of Medicine, was released to coincide with the first meeting of the Institute of Medicine’s Committee on Strategies for Responsible Sharing of Clinical Trial Data on October 23. The Institute of Medicine convened the committee on an accelerated timetable to develop a framework for expanded public access to clinical trial data. An initial report is expected in January 2014.

“Our experiences with Vioxx, Avandia, and other widely prescribed drugs that were revealed to have serious safety risks show how important it is to give independent scientists access to clinical trial data,” said Michelle Mello, professor of law and public health at the Harvard School of Public Health and lead author of the report. “The question is, how can we achieve the powerful public health benefits of data sharing while protecting research participants’ privacy, avoiding ‘junk science,’ and minimizing burdens on trial sponsors?”

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Medical Malpractice and Wrongful Death under Maryland’s Statutes of Limitations and Repose

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By Alex Stein

On October 18, Maryland’s Court of Appeals has delivered a precedential ruling on the applicability of the state’s limitation and repose statutes to suits for wrongful death that allegedly resulted from medical malpractice.  Mummert v. Alizadeh— A.3d —-, 2013 WL 5663105 (Md. 2013).

This ruling dealt with the following set of facts:

A family doctor failed to address his patient’s cancer symptoms between 1997 and 2004. In 2004, the patient was diagnosed with cancer that could not be treated successfully. The patient died of cancer on March 14, 2008. On March 8, 2011, her surviving family members filed a wrongful death action against the doctor, who claimed in response that the action was time-barred. The doctor relied on the 3-year limitations period set for wrongful death actions generally and on Maryland’s Health Care Malpractice Claims Act that sets two alternative expiration dates for suits against physicians: “(1) Five years of the time the injury was committed; or (2) Three years of the date the injury was discovered.” (§ 5–109 of the Courts and Judicial Proceedings Article of the Maryland Code).

The Court dismissed both defenses and allowed the plaintiffs to proceed with their suit. Read More