Courts Grapple with Concept of “Harm” in Online Privacy Suits

Cross-posted by Forbes.com at WLF Contributor Site

The fundamental legal principle that only those who have been “harmed” can sue in U.S. courts is being put to the test by the ever-evolving, subjective concept of “privacy” in the equally organic online world.

U.S. Supreme Court rulings on so-called Article III standing reflect that a harm must be 1) concrete, particularized, actual, and imminent; 2) fairly traceable to defendant’s actions; and 3) likely redressed by a favorable decision. If a party fails to meet this test, the court will dismiss the suit for lack of jurisdiction. 

Plaintiffs’ lawyers, eager to add online privacy “violations” to their lucrative book of business, have been advancing broad theories of injury through class action lawsuits. Their claims of harm routinely center around either emotional or economic injury. Those efforts so far, with a few exceptions, have met resistance from federal judges. Continue reading “Courts Grapple with Concept of “Harm” in Online Privacy Suits”

Will Supreme Court Add Another Alien Tort Statute Case to its Docket?

Cross-posted by Forbes.com at WLF’s Contributor Site

This spring, the U.S. Supreme Court will address whether to impose significant limits on the scope of lawsuits filed under the Alien Tort Statute (ATS).  For the past several decades, the ATS has served as the favorite vehicle of human rights activists and plaintiffs’ lawyers seeking to challenge the overseas business practices of U.S. corporations. The Court’s decision in Kiobel v. Royal Dutch Petroleum will determine whether ATS suits can be filed against corporations, or whether individuals are the only proper defendants.  Perhaps more importantly, the Court may agree to hear a second ATS case that raises even more fundamental issues under the ATS, including whether the ATS applies at all to overseas activities. Continue reading “Will Supreme Court Add Another Alien Tort Statute Case to its Docket?”

With Par Pharmaceutical Suit, Courts Should Put an End to FDA’s Lawless Behavior on Off-Label Speech

Cross-posted by Forbes.com on WLF Contributor Site

The Food and Drug Administration has been largely successful in avoiding judicial review of claims that its regulation of drug promotion activities runs afoul of First Amendment constraints.  But FDA may well be unable to avoid a merits-based review of First Amendment claims raised in a lawsuit recently filed by Par Pharmaceutical, Inc.  Par complains that FDA is chilling its speech rights by threatening to crack down on truthful speech about on-label uses for its FDA-approved products.

Although FDA has long suppressed even truthful manufacturer speech about FDA-approved drugs, the dearth of challenges to such restrictions is understandable.  For one thing, most drug manufacturers are quite reluctant to file lawsuits against an agency which reviews new drug applications.  Moreover, FDA generally issues “guidance” documents (rather than more formal regulations) to announce to its new policies, and courts have been hesitant to entertain challenges to such documents because they arguably do not represent binding agency policy.  In response to past First Amendment challenges, FDA invariably has argued that the lawsuits are not “ripe” for judicial review because they do not arise in the context of specific speech but rather are mere “hypothetical” disputes about the plaintiffs’ anticipated speech. Continue reading “With Par Pharmaceutical Suit, Courts Should Put an End to FDA’s Lawless Behavior on Off-Label Speech”

Finger on the Pulse: From Our Blogroll and Beyond

  • Federal agency jurisdictional throwdown impending between FTC and CFPB? (Blog of Legal Times)
  • And a throwdown between FTC Chairman and a Commissioner over “pay-for-delay” settlement bill in Congress (FDA Law Blog)
  • Huge risks arise when corporate counsel conduct internal investigations (Corruption, Crime & Compliance)
  • SEC’s first report on Commission’s whistleblowing program offers interesting clues (D&O Diary)
  • Sanity in E-discovery? Judge in hip implant case imposes some on plaintiffs (Drug & Device Law)
  • Shockingly, Ninth Circuit working to curtail Supreme Court ruling on general jurisdiction in liability cases (Product Liability Monitor)
  • The food police take their ideological crusade to a new level (Food Politics)

SCOTUS to hear Obamacare: How the 5.5 hours of oral argument will be divided

In a relatively unsurprising move, the U.S. Supreme Court this morning granted discretionary review of the Eleventh Circuit’s opinion invalidating the individual insurance mandate contained in the Affordable Care Act.  What was surprising, however, is that the Court allotted a whopping 5.5 hours of oral argument for all the questions under consideration:

  • DEPT. OF H&HS v. FLORIDA, No. 11-398:  “Whether Congress had the power under Article I of the Constitution to enact the minimum coverage provision.”  The Court granted two hours of argument on this question.

U.S. Medical Devices Travel Overseas to the Detriment of Economy, Patients

Guest Commentary

Elizabeth Green, WLF Fellow*

The largest survey to date on the effectiveness of the “510(k)” medical device review process at the U.S. Food and Drug Administration (FDA), released this month, reported that within the past three years, 76 percent of companies surveyed chose to bring a specific device to market first outside of the United States and that their reasons for doing so included high costs, time, and general difficulties in coordinating with the FDA.  The survey, funded by the Institute for Health Technology Studies (InHealth), demonstrates the continued difficulties the FDA approval process poses for medical device manufacturers. Additionally, the findings call into question a recent report by the Institute of Medicine (IOM) which had stated that the 510(k) process was “more economical, faster and less burdensome to industry than the premarket approval application.”  Industry respondents, however, found that the two processes have effectively the same average time from submission to approval.  Continue reading “U.S. Medical Devices Travel Overseas to the Detriment of Economy, Patients”

Finger on the Pulse: From Our Blogroll and Beyond

  • Forthcoming DOJ guidance on Foreign Corrupt Practices Act: too little, too late? (FCPA Professor)
  • Bipartisan group of Members of Congress urge FDA to improve medical device review process (Mass Device)
  • Justice Department’s Civil Division bangs the comply or be prosecuted war drums on health care (Food & Drug Law Blog)
  • Both parties in cell phone health warning case in San Francisco to appeal judge’s temporary injunction ruling (S.F. Chronicle)
  • Patent troll wins one at the U.S. Court of Appeals for the Federal Circuit (Patently-O)
  • EPA head directs invective at those criticizing the agency’s work (Law & The Environment)
  • FDA concerns over user-generated content is likely delaying agency’s guidance on regulated industries’ use of social media (Med Ad News Insider)