Tuesday, March 24, 2015

Supreme Court of New Hampshire Reminds Us How Facebook Works

So, it’s 2015, so we’re not sure that a court needs to dedicate a section of an opinion to “Explanation of Facebook Technology Relevant to this Case.”

In February, the Supreme Court of New Hampshire did just that in an appeal arising from the defendant’s convictions for stalking and witness tampering.

In its opinion, the court noted as follows:

Facebook is a widely-used social media website, available for free to anyone with an e-mail account, whose stated mission is to give people the power to share and make the world more open and connected. Facebook and other social media sites are becoming the dominant mode of communicating directly with others, exceeding e-mail usage in 2009. With over one billion active users, Facebook is revolutionizing the way people behave and interact with one another in their everyday lives through site functions that facilitate sharing information, such as a user’s “profile page,” the ability to send personal messages to other users, and by allowing users to become “Facebook friends” with other users.

A profile page is a webpage that is intended to convey information about the user. By default, Facebook profile pages are public. When a user shares something publicly, anyone including people off of Facebook can see it. Alternatively, Facebook users can restrict access to their Facebook content using Facebook’s customizable privacy settings. Access can be limited to the user’s Facebook friends, to particular groups or individuals, or to just the user.

State v. Craig, No. 2013-229 (N.H. Feb. 12, 2015) (quotations and citations omitted).

We’ve deleted the citations, but we note that the court cited to law review articles and quoted from Facebooks pages directly.

But are these basic principles really so novel that they need to be stated and then supported with citations? If the authority the court is citing indicates that Facebook has one billion active users and that social media usage has surpassed email as a communications medium, isn’t it a familiar enough phenomena in society to go without saying? Can’t the court simply jump to the discussion of the relevant Facebook usage facts without pausing to remind us how it works? Do the terms profile page and Facebook friends really need to be in quotation marks at this point?

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Monday, August 16, 2010

Failure to Survey Medical Literature may be Negligence Per Se

One issue in a recent decision by the District Court of New Hampshire was whether a generic manufacturer’s failure to comply with Food an Drug Administration (“FDA”) regulations constitutes a per se violation of its duty of care under New Hampshire law. Bartlett v. Mutual Pharm. Co., No. 08-CV-358-JL, 2010 WL 2765358 (D.N.H. Jul. 12, 2010). Judge Joseph N. Laplante answered in the negative, holding that the jury could consider the violation as evidence of a breach but it was not a per se breach of duty.

In Bartlett, Karen Bartlett sought medical treatment for right shoulder pain. Her physician prescribed a non-steroidal anti-inflammatory (“NSAID”) drug called Clinoril. Bartlett’s pharmacist filled per prescription with Sulindac, the generic version of Clinoril, manufactured by Mutual Pharmaceutical Company (“Mutual”). Two weeks after taking Sulindac, Bartlett was diagnosed with Stevens-Johnson Syndrome (“SJS”) progressing to toxic epidemal necrolysis (“TEN”), a serious and potentially fatal condition characterized by necrosis of the skin and mucous membranes.

As a result, Bartlett filed suit against Mutual asserting state law claims for strict products liability – failure to warn, strict products liability – defective design, fraud, and negligence. During discovery, it was found that the year prior to Bartlett’s physician prescribing Clinoril to her, an international medical journal found a link between NSAIDs and the conditions that Bartlett suffered from. It found 89 reported cases of SJS/TEN over a 17 year period in patients taking Clinoril, more than any other NSAID on the market. Also during discovery, Mutual admitted not being aware of the study and not monitoring medical literature for information on Sulindac’s safety risks. According to Mutual, the manufacturer of the brand named drug was responsible for monitoring safety risks.

On cross-motions for summary judgement, Bartlett argued that she was entitled to summary judgement on her negligence claim based on Mutual’s failure to survey medical literature for adverse events associated with Sulindac. Bartlett based this argument on the FDA requirement that generic manufacturers “develop written procedures for the surveillance . . . of post-marketing adverse drug experiences to the FDA.” 21 C.F.R. Section 314.80(b).

The Court interpreted this regulation to require generic manufacturers to develop procedures for surveying medical literature for information and studies on safety risks. Therefore, the question became whether Mutual’s admitted violation of this safety regulation versus violation of a statute could be a per se violation of its duty of care. The Court found that courts were split over whether plaintiffs could seek to enforce a FDA violation through a negligence per se action even thought the FDCA does not provide for a private right of action. Judge Laplante found no clear answer in New Hampshire but held that the New Hampshire Supreme Court would likely not treat the violation as negligence per se. Therefore, the court denied Bartlett’s motion for summary judgment and ruled that the jury could consider the violation as evidence of breach.

Drug manufacturers, generic and named-brand, must be aware of these FDA regulations governing surveillance of medical literature. Compliance with these regulations will be especially relevant in states that consider violations as negligence per se and not merely evidence of breach for the jury to consider.
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