Foreign Corrupt Practices Act pharmaceutical investigation expands – International Law Office

Enforcement of the Foreign Corrupt Practices Act,(1) including the number of investigations and the size of settlements, has increased significantly over the past several years. Against this backdrop of increased enforcement, in November 2009 the Department of Justice announced that it planned to investigate the pharmaceutical and medical device industries for suspected violations of the act.(2) The department recently backed up these warnings when a small number of pharmaceutical companies received notice that they were under investigation to determine whether they had made improper payments to foreign physicians and health officials in various countries.

The investigation has expanded to include at least 12 major drug and medical device companies that are under investigation by federal prosecutors and securities regulators for possible act violations.(3) The focus of the department’s recent inquiry appears to include concerns as to whether these companies have made payments or other improper inducements to non-US physicians to influence the results of clinical trials of drugs and devices that might find their way into the US market.

The effect of the alleged conduct could be significant considering that it is “estimated that between 40 percent and 65 percent of clinical trials investigating [Food and Drug Administration]-regulated products are conducted outside the United States”.(4) Indeed, 80% of the drugs approved for sale in 2008 underwent clinical trials in foreign countries, and over half of all clinical trial subjects and sites were located abroad.(5) Prosecutors are now investigating payments made to physicians who manage these clinical trials for pharmaceutical and device companies.

via Foreign Corrupt Practices Act pharmaceutical investigation expands – International Law Office.

Improving legal records management: harness the DNA of data | CPA Global

Data discovery has played a key role in US litigation for two generations, during which time nearly all forms of information have migrated to the digital realm. Yet, according to Texas-based trial lawyer and e-discovery expert, Craig Ball, few legal departments are addressing this reality. He says that, despite the central role of electronic information in our lives, e-discovery efforts are either overlooked altogether or pursued in such epic proportions that discovery dethrones the merits as the focal point of the case.

Ball believes that, at each extreme, lawyers must bear some responsibility for the failure. ‘Few have devoted sufficient effort to understanding their clients’ information architecture or mastering tools and techniques to manage data,’ he argues. ‘We didn’t know how good we had it when discovery meant only paper. Paper is tangible. It has to be stored somewhere physically accessible, and systems have developed over time to store and retrieve it. Paper holds power of place, whereas electronic data accumulates invisibly.

‘Even if employees label electronic data accurately, they rarely file it consistently,’ continues Ball. ‘Thousands of emails sit ignored in inboxes; their subject lines offering no clue as to their contents. Documents are saved in cryptically named folders on desktops and portable storage media or replicated between work and home computers. There is still plenty of paper around, too, but filing systems, like filing clerks, have all but disappeared.’

Ball adds that there is a standard misconception that evidence can be retrieved simply by running a Googlelike search across a company’s electronic files. ‘That’s rarely feasible, even in high-tech enterprises,’ he emphasises. Similarly, he is frustrated by the attempts by many lawyers to try to convert e-data into paper form. ‘Such is the volume of electronic information that it would be impossible to convert it all to hard copy,’ he says, ‘and yet lawyers seem to overwhelmingly favour this expensive, inferior path over learning to deal with electronic data differently.’

via Improving legal records management: harness the DNA of data.

Google Street View Car Inspected by French Regulator – BusinessWeek

A car used by Google Inc. to collect data for its Street View mapping service was inspected yesterday, less than a week after France’s privacy regulator criticized the program’s resumption.

The inspection was a result of Google’s decision to begin photographing French streets before officials decided whether the company complied with orders to limit Street View’s data collection, said Yann Padova, secretary general of the National Commission for Computing and Civil Liberties.

The inspection “was done especially to verify that they stopped collecting Wi-Fi data,” Padova, 43, said in an interview today.

via Google Street View Car Inspected by French Regulator – BusinessWeek.

Court Finds No Spoliation as to Documents Produced from Backup Tapes because “Documents Were Never in Fact Destroyed” : Electronic Discovery Law

Pitney Bowes Gov. Solutions, Inc. v. United States, 2010 WL 3278402 (Fed. Cl. Aug. 19, 2010)

In this post-award bid protest, plaintiff sought spoliation sanctions for defendant’s destruction of relevant documents.  Although most of the documents were deleted and/or destroyed by their original custodians upon the order of the contracting officer, the documents were available for production from backup tapes.  The restored documents, however, all reflected the same author in their metadata, causing plaintiff to doubt their veracity and persist in its request for spoliation sanctions.

via Court Finds No Spoliation as to Documents Produced from Backup Tapes because “Documents Were Never in Fact Destroyed” : Electronic Discovery Law.

Litigation: Avoiding the Arbitration Trap | Inside Counsel

Courts, bar associations, alternative dispute resolution organizations and private attorneys who serve as arbitrators all frequently laud the benefits of contractual arbitration. Obviously, each has his own financial or institutional bias for encouraging alternative dispute resolutions (ADR); therefore, they frequently describe arbitration as less costly, more efficient and ideally suited for a prompt resolution of disputes with guaranteed finality—a preferable alternative to formal litigation. Unless the contractual arbitration clause is drafted clearly and thoughtfully, however, the risks of arbitration for most corporate clients outweigh the rewards.

I offer no statistical proof for the following hypothesis, only anecdotal experience from more than 20 years of practicing in complex civil litigation in state and federal court systems and in all types of arbitration proceedings: Arbitrations are almost invariably more expensive for parties; less certain and far more contentious than judge-supervised litigation; and, of course, the results are almost never reviewable.  Rules (to the extent that any are actually intended to apply) are often flouted, delays are the norm, arbitrator and ADR-facilitator billing is virtually unreviewable, and the results are unpredictable and often based on erroneous and uncorrectable interpretations of law and fact.

via Litigation: Avoiding the Arbitration Trap.

Best-practice planning for e-discovery

Some US litigators saw the problem coming, but not that many did much about it. Old paper-based discovery regulations and practices just aren’t equipped to deal with the growing mass of digital files and email correspondence that is generated in corporate offices every day. Correspondence with external counsel is generally privileged, of course, but everything else that could be relevant to a case has to be gathered, sorted and offered up, should the worst occur and a discovery request hits the legal department’s desk.

But e-discovery expert Jonathan Redgrave believes that many lawyers are making it worse on themselves by sticking their heads in the sand about the whole issue. As with much of law, he says, preparation is key.

A thirst for information

Redgrave started his career working on civil trial and appellate matters at Minneapolis-based law firm Gray Plant Mooty, before making his name in high-profile litigation work at international law firm Jones Day. He says it was his experiences of managing discovery requirements on major international tobacco cases that first drew him to e-discovery – that and a love for technology itself. ‘Data privacy, discovery records management… it’s the space where technology and law meet that I find so fascinating,’ he explains.

Redgrave’s next role, as head of Nixon Peabody LLP’s information-law practice, gave him ample access to that space. He believes that few companies have been afforded the advice they need to create robust programmes for records management and disposal. ‘The parameters as to what to preserve, collect and disclose are not fully clear,’ he says. ‘And while courtrooms and corporate law departments are playing catch-up, technology is continuing to evolve.

‘For example, social media and cloud computing technologies are having a major impact on the ways in which we work. But, while employees profit from the freedom that these services afford, businesses and even the government are left scratching their heads when it comes to recording, storing or producing conversations or files that were shared on those systems.’

But Redgrave emphasises that e-discovery isn’t just about sifting through electronic correspondence to get a handle on what’s been said and to whom. ‘Companies also need to know, for example, what it will mean if data is accidentally lost or destroyed,’ he says. ‘Or what content they can safely delete from their systems without having to worry about facing repercussions down the line.’

To do this, Redgrave believes that you need to look forward as well as back: ‘Ask yourself “What will the workplace look like in 10 years’ time?” and “How will we be communicating and sharing data?” I think that current working practices are going to be almost unrecognisable in a decade, and legal departments need to start thinking about the impact of that on their e-discovery requirements now.’

The legal industry is hardly celebrated for being an early adopter of technology, and Redgrave says that this lack of understanding about current systems and future trends is also hampering some corporation’s e-discovery efforts. It was partly this that led him to work with others to set up the e-discovery working group of The Sedona Conference think-tank, a not-for-profit research and educational institute that pulls together leading lawyers, judges, academics and other legal professionals to discuss, study and help establish guidelines and standards in key areas of US law.

via Best-practice planning for e-discovery.

Podcast: An Inside Look at the 2010 Civil Litigation Conference at Duke Law School | Legal Talk Network

The 2010 Civil Litigation Conference at Duke Law School inspired a lot of chatter on the e-discovery wires. On this edition of Digital Detectives, co-hosts Sharon D. Nelson, Esq.,President of Sensei Enterprises, Inc. and John W. Simek, Vice President of Sensei Enterprises, welcome Magistrate Judge David J. Waxse from Kansas, to reflect on the conference. They look at conference highlights including: the future of the Federal Rules of Civil Procedure, clarifying the standards regarding governing the preservation of electronically stored information and next steps for the Federal Rules Advisory Committee.

via An Inside Look at the 2010 Civil Litigation Conference at Duke Law School | Legal Talk Network.

India: Hand over your data Google, Skype – Communications – News

India has instructed Google and Skype to allow its government to monitor their customer data or face being banned from operating in the world’s second-most populated nation, according to a new report.

An AFP article Tuesday confirmed previous reports that the U.S.-based search giant and voice over Internet Protocol (VoIP) service provider were next in line, after Research In Motion, to face scrutiny from the Indian government. AFP said the request to monitor the companies’ data will extend to virtual private networks as these services allow remote users to access their corporate network.

According to the newswire, notices will be sent out to the U.S. service providers starting Tuesday, where the companies will have to comply with the government’s directive or risk being shut down

via India: Hand over your data Google, Skype – Communications – News.

India: Hand over your data Google, Skype – Communications – News

India has instructed Google and Skype to allow its government to monitor their customer data or face being banned from operating in the world’s second-most populated nation, according to a new report.

An AFP article Tuesday confirmed previous reports that the U.S.-based search giant and voice over Internet Protocol (VoIP) service provider were next in line, after Research In Motion, to face scrutiny from the Indian government. AFP said the request to monitor the companies’ data will extend to virtual private networks as these services allow remote users to access their corporate network.

According to the newswire, notices will be sent out to the U.S. service providers starting Tuesday, where the companies will have to comply with the government’s directive or risk being shut down

via India: Hand over your data Google, Skype – Communications – News.

Cisco Moves to Acquire Skype for US$ 5 Billion

Reportedly, Cisco has made an offer to acquire Skype before they complete their initial public offering process (filed August 9th, 2010). If the rumor pans out to be true, the deal will sport an estimated US$ 5 billion dollar price tag.

Rumors are rumors, but Cisco has been making bold moves as of late. The company attracted a ton of attention with the release of Cisco Quad, a collaboration platform for the enterprise designed to give Microsoft and Google a bit of competition. Following Quad, Cisco kicked out Cius, a tablet poised to rival the iPad, and more interestingly given today’s news, a hosted collaboration platform that zeros in on unified communications and collaboration.

Tacking Skype onto their offerings would catapult Cisco into the mass market of video communications, positioning them as both the world’s largest Internet calling service and heavy competition for the likes of AT&T and Verizon.

via Cisco Moves to Acquire Skype for US$ 5 Billion.