October 2012 Archives
510(k) Process Comes Under Renewed Scrutiny by Legislators, Awaiting FDA Response as Proposed Legislation Remains Stagnant| Permalink
by Ashley Zborowsky, UMN Law Student, MJLST Notes & Comments Editor
Several months ago, Representative Edward J. Markey (D-Mass.) and Senator Jeff Merkley (D-Ore.) wrote a letter to Jeffrey Shuren, Director of the Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration, calling for an overhaul of the 510(k) pre-market notification database. The legislators cite reports of defective medical devices cleared via the 510(k) process in recent years, such as the DePuy® artificial hip, that have caused "grievous and irrevocabl[e]" harm to patients.
The issue? Most devices subject to premarket review are cleared through FDA's 510(k) process which provides expedited approval for products that are deemed "substantially equivalent" to an existing predicate device. While the 510(k) process allows patients earlier access to devices, the system is inherently flawed. Referred to as "predicate creep," the 510(k) process clears generations of devices--none of which have been subject to the exacting scrutiny of pre-market approval (the PMA process). As Markey and Merkley cite in their letter to Shuren, many predicate devices upon which new products rely for 510(k) clearance themselves have been recalled by manufacturers due to "fundamental design flaw[s]."
by Bryan Dooley, UMN Law Student, MJLST Staff
Most voters who use the internet frequently are probably aware of "tracking cookies," used to monitor online activity and target ads and other materials specifically to individual users. Many may not be aware, however, of the increasing sophistication of such measures and the increasing extent of their use, in combination with other "data-mining" techniques, in the political arena. In "It's the Autonomy, Stupid: Political Data-Mining and Voter Privacy in the Information Age," published in the Spring 2012 volume of the Minnesota Journal of Law, Science, & Technology, Chris Evans discusses the practice and its implications for personal privacy and voter autonomy.
by Jeremy So, UMN Law Student, MJLSTManaging Editor
On October 28, Australian researchers published new information about the genetic basis for endometriosis, a condition where the cells lining the uterus flourish in other areas of the body. The researchers, instead of recruiting their own research subjects, analyzed samples stored in biobanks in Australia, Japan, and Europe. Because of their approach, the researchers were able to identify common markers that appeared across the ethnically-diverse study population. The Australian team's findings highlight the increasing importance of biobanks--repositories for biological research samples--which have become a valuable resource in the fields of genomics and personalized medicine
by Caroline Marsili, UMN Law Student, MJLST Staff
The candidates aren't talking about patents (with the exception of a brief quip about IP piracy in last Tuesday's debate). But if it's "all about the economy," they should be talking patent policy.
In the presidential and vice-presidential debates of recent weeks, the candidates have exchanged vitriol and "gotchas," and have established a contrast in both policy and character for voters. Notably absent from the debates has been discussion of innovation, and more specifically, the role of IP policy in innovation. IP policy would seem an attractive platform for discussing job creation, as IP industries account for a vast portion of the Nation's jobs and GDP ("IP-intensive industries" accounted for 27.7 of all jobs in the economy in 2010). It's possible that the candidates find common ground on this issue. Alternatively, the topic is, for the time-being, moot in the wake of the America Invents Act, the full effects of which are yet to be seen.
by George Kidd, UMN Law Student, MJLST Staff
The recent multi-billion dollar loss as a result of the 5th worst drought ever recorded in U.S. history adds fuel to an already raging debate over genetically modified organisms ("GMOs"). Amanda Welters, in "Striking a Balance: Revising USDA Regulations to Promote Competition Without Stifling Innovation," delivers a fantastic overview of key issues in the GMO debate while also introducing novel legislative ideas garnered from the pharmaceutical industry. Ms. Welters' article provides important insights into the continuing struggle to provide society with an optimal outcome.
by Bryan Morben, UMN Law Student, MJLST Staff
What happened to the days when kids would get together to play a game of football in the neighborhood? Or what about playing with Barbie dolls, cabbage patch kids, or a slumber party? Children today are just not entertaining themselves like this anymore. I have three younger brothers, and all I ever see them doing is sitting on the computer, playing videogames, or watching TV.
by Johanna Smith, UMN Law Student, MJLSTStaff
Looking at the packaging on a food item can be very overwhelming. Not only does the product contain required nutritional information and an ingredients list, many products also contain health claims or statements on the front of the package to grab the customer's attention. Common terms to see include organic, low-fat, high fiber, and low-carb. In "How Can Better Food Labels Contribute to True Choice?," recently published in the Minnesota Journal of Law, Science & Technology, J.C. Horvath discusses the evolution of the regulation of claims made on food packaging. In addition to regulatory pressure, the other major source of pressure that determines what shows up on food packaging is consumer preference.
by Jeremy So, UMN Law Student, MJLST Managing Editor
As China's Communist party prepares for its once-a-decade leadership transition, the news has instead been dominated by the fall from power of Bo Xilai, the former head of the Chongching Communist Party and formerly one of the party's potential leaders. While such a fall itself is unusual, the dialogue surrounding Bo's fall is also remarkable--Chinese commentators have been able to express their views while facing only light censorship.
by Ryan J. Connell, UMN Law Student, Joint Degree Program Fellow, MJLST Staff
As genetic research continues to develop, researchers are more apt to make incidental discoveries in the course of the research on a subjects DNA. Susan Wolf, Founding Chair of the University of Minnesota's s Consortium on Law and Values in Health, Environment & the Life Sciences, points out in her article "The Role of Law in the Debate over Return of Research Results and Incidental Findings: The Challenge of Developing Law for Translational Science," that, with this development, there is a serious question that must be asked, but that the law does not really answer: do researchers have to report these incidental findings to the subject?
by Eric Friske, UMN Law Student, MJLST Managing Editor
From one mouse click to the next, internet users knowingly and unknowingly leave a vast array of online data points that reveal something about those users' identities and preferences. These digital footprints are collected and exploited by websites, advertisers, researchers, and other parties for a multitude of commercial and non-commercial purposes. Despite growing awareness by users that their online activities do not simply evaporate into the ether, many people are unaware of the extent to which their actions may be visible, collected, or used without their knowledge.
by Benjamin Hamborg, UMN Law Student, MJLST Articles Editor
Later this month, the U.S. Supreme Court is scheduled to hear oral arguments in Kirtsaeng v. John Wiley & Sons, Inc., a case which should decide once and for all whether the first-sale doctrine applies to works manufactured outside of the United States. As I described last spring in volume 13 of the Minnesota Journal of Law, Science & Technology, the case arises from Supap Kirtsaeng's attempt to take advantage of the disparity in pricing between textbooks manufactured for sale in the United States and those manufactured and sold internationally. Kirtsaeng's plan involved purchasing textbooks published by John Wiley & Sons, Inc.'s wholly-owned subsidiary John Wiley & Sons (Asia) Pte Ltd., then reselling the textbooks online to consumers within the United States.
Wasted Places Report Elucidates Key Problem in Current Environmental Legal and Regulatory Infrastructure| Permalink
by David Hanna, MJLST Lead Article Editor, UMN J.D./M.S. in Chemistry Joint Degree Candidate
During a time when environmental issues flood the headlines of newspapers, magazine covers, and television broadcasts, it is hard not to come across sustainable efforts by concerned companies and institutions trying to proactively tackle these environmental issues. While these pointed campaigns and programs deserve some recognition, there is plenty of room for improvement and this improvement needs immediate legal and regulatory acknowledgment.
by Mike Borchardt, UMN Law Student, MJLST Managing Editor
Recent announcements from Microsoft have helped to underscore the current conflict between internet privacy advocates and businesses which rely on online tracking and advertising to generate revenues. Microsoft recently announced that "Do Not Track" settings will be enabled by default in the next version of their web browser, Internet Explorer 10 (IE 10).
As explained by Omer Tene and Jules Polonetsky in their article in the Minnesota Journal of Law, Science & Technology 13.1, "To Track or 'Do not Track': Advancing Transparency and Individual Control in Online Behavioral Advertising," the amount and type of data web services and advertisers collect on users has developed as quickly as the internet itself. (For an excellent overview of various technologies used to track online behavior, and the variety of information they can obtain, see section II of their article). The success and ability of online services to supply their products free to users is heavily dependent on this data tracking and the advertising revenue it generates. Though many online services are dependent on this data collection in order to generate revenue, users and privacy advocates are suspicious about the amount of data being collected, how it is being used, and who has access.
by Eric Maloney, UMN Law Student, MJLST Staff
Apparently, Bridgeport Music has never seen the episode of Chappelle's Show declaring that "Wu-Tang Clan ain't nothing to [mess] with." The record label has decided to sue the group, specifically artists Raekwon, Ghostface Killah, Method Man, and producer RZA, for reportedly using a sample of a 1970's recording originally by the Magictones on a 2009 Raekwon album track. The portion of the recording allegedly utilized in production of the song was sped up to change the sample's key from E minor to F# minor, and constituted four measures of the original tune. The sample was only ten seconds long.
by Bobbi Leal, UMN Law Student, MJLST Articles Editor
A recent study, published in Agricultural Economics, found that the average body mass index for consumers that read nutrition labels is lower than those that do not read the labels. This finding implies that understanding and utilizing food and nutrition labels provides consumers with the information needed to make informed decisions about what they eat. However, a recent article by J.C. Horvath published in the Minnesota Journal of Law, Science & Technology, "How Can Better Food Labels Contribute to True Choice?" makes evident that food labeling has a long way to go before it truly gives consumers the information necessary to make informed decisions.