January 2012

Co-authored by Brian Gross 


Earlier today we published an article discussing the SOPA Blackout and outlining the major considerations and impact of both SOPA and PIPA. We have just learned that House Judiciary Committee Chairman Lamar Smith, (R-Texas) has issued a press release announcing the Senate’s decision to postpone consideration of this legislation until there is a wider agreement on a solution.

In the release Chairman Smith declared:

 “I have heard from the critics and I take seriously their concerns regarding proposed legislation to address the problem of online piracy. It is clear that we need to revisit the approach on how best to address the problem of foreign thieves that steal and sell American inventions and products.

So for now at least, it appears that the people have spoken. We will continue to monitor and report with updates of interest to our readers.

SOPA Bill H.R. 3261.IH 

Protect IP Act (PIPA) 

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Co-authored by Brian Gross 

Wikipedia SOPA BlackoutIf you’re like me (and 375 million others), then you use Google as your primary search engine, and like most Google users, we are accustomed to seeing the occasional “Doodle” in place of the familiar Google logo. In case you didn’t know, Doodles are the spontaneous and fun changes that Google makes to its logo to celebrate holidays, anniversaries and other historic milestones. But on January 18th, Google users did not find a colorful Doodle, instead the familiar Google logo was shrouded in black. The reason? Well, there are two actually; SOPA (Stop Online Piracy Act) and PIPA (Protect IP Act, Senate Bill 968). These twin bills are currently before the House and Senate, and if passed would provide prosecutors of the Justice Department greater powers to combat foreign-based websites that facilitate pirated content to users in the United States. On its face, this goal appears righteous enough. However, opponents of the these bills, including internet powerhouses like Wikipedia, Twitter, Facebook, WordPress and Google claim that if passed these laws will “jeopardize freedom and shift power of the independent web into the hands of corporations.” 

Wednesday’s internet SOPA Black Out, which included not only Google’s grim logo but a complete block of the Wikipedia website was the first coordinated effort by the aforementioned opponents in an effort to promote public awareness and understanding of exactly what these bills will do to inhibit people’s access to online information; and it may have actually worked to some degree, on Wednesday United States Senator Ron Wyden (D-OR) tweeted “Anti- #PIPA, #SOPA traffic has temporarily shut down our website.” That wasn’t the only fallout from the blackout, it appears that many of the politicians who originally supported these bills are now publically announcing their opposition. A recent article posted by Time Magazine’s online blog Techland reported that after the blackout

at least 10 senators and nearly twice that many House members have announced their opposition.

However, proponents of the bills still remain, and while there are already laws in place to help combat online piracy such as the Digital Millennium Copyright Act (DCMA) of 1998, these proponents are claiming that these new bills will target the “rogue” websites that avoid US copyright law and are currently out of DCMA’s reach.  So what does all this mean for law abiding citizens who don’t engage in online pirating? Plenty actually.

Consider the following:

  • Because the wording contained in these bills is vague and the penalties steep for any site accused of “enabling or facilitating piracy”, there exists the very real potential for abuse – even being associated with a “rogue” site may be enough to land you in trouble with Uncle Sam.
  • Taken one step further, it is possible that blogs or sites where you can post ideas – even kitchen recipes – could land you in jail for a maximum of 5 years under the current versions of these laws!
  • SOPA and PIPA build a framework for future restrictions and suppression,

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Co-authored by Brian Gross 

Generic Drugs

In June of 2011, the United States Supreme Court ruled that makers of generic drugs cannot be sued for failing to warn consumers of the possible side effects of their products if they copy the exact warnings used by their brand-name equivalents.  See Pliva, Inc., et al. v. Mensing, 131 S.Ct. 2567 (2011).  In Mensing, the plaintiffs took a generic form of the drug Reglan for several years, and alleged that the manufacturers were liable under state tort law for failing to provide adequate warning labels, despite mounting evidence that long term use carries a risk of tardive dyskinesia far greater than what was indicated on the label.

 The majority of the Court found that, although State law placed a duty directly on all drug manufacturers to adequately and safely label their products, federal drug regulations prevent generic manufacturers from independently changing safety labels which would add or strengthen a contraindication, warning, or precaution.

Where it is impossible to comply with state and federal law, the Supremacy Clause of the United States Constitution controls, and pursuant to the doctrine of preemption, state law must give way.  The majority distinguished the Court’s holding in Wyeth v. Levine, 129 S.Ct. 1187 (2009).  In that case, the federal law in question permitted a brand-name drug manufacturer to unilaterally strengthen its warning without prior FDA approval.

Now, for the first time, a Massachusettsjudge has applied Mensing to bar failure to warn claims arising out of the distribution of generic drugs.  See Stevens v. Community Health Care, Inc., 2011 WL 6379298 (Mass.Super.).  In Stevens, the plaintiff alleged that DAVA Pharmaceuticals, Inc., (“DAVA”) failed to adequately warn, in accordance with Massachusetts law, of the harmful interaction between the generic drug Clarithromycin and Methadone. Relying on the Mensing decision, DAVA moved for summary judgment.  Superior Court Judge Thomas R. Murtagh granted the motion, and held that, although DAVA was a distributor of the generic drug in question and not the manufacturer, it too had no ability to change labeling or warnings.  As a result, like a generic manufacturer, DAVA could not be subject to liability in connection with a state law claim premised on failure to warn theories.  In a related ruling, Judge Murtagh also rejected Stevens’ motion for leave to add Abbott Laboratories, Inc., the brand manufacturer, to the suit due to the earlier plaintiff’s strategic decision to not do so.

We predict that the Mensing decision will continue to have significant ramifications on pharmaceutical litigation in state courts throughout the United States, as only 25% of all prescription drugs dispensed in this country are brand name drugs.  If you would like to discuss these cases and their potential impact upon future litigation, please visit the Product Liability Defense page for contact information.

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