Posts Tagged ‘pharmaceuticals’

Liability roundup

  • Hoping to blame Pacific Gas & Electric power lines for Northern California fires, lawyers from coast to coast descend on wine country [Paul Payne, Santa Rosa Press-Democrat]
  • Courts should police lawyers’ handling of class actions, including temptation to sweep additional members with doubtful claims into class so as to boost fees [Ilya Shapiro, Trevor Burrus, and Reilly Stephens on Cato certiorari amicus in case of Yang v. Wortman]
  • “Seventh Circuit Curtails RICO Application to Third-Party Payor Off-Label Suits” [Stephen McConnell, D&DL] “Here Is Why The False Claims Act Is An ‘Awkward Vehicle’ In Pharma Cases” [Steven Boranian]
  • Litigation finance moves into car crash business [Denise Johnson, Insurance Journal]
  • Slain NYC sanitation worker’s “frequent advice to Sanitation colleagues about how to save for the future helped persuade the jury that Frosch had a viable career ahead of him in financial planning,” contributing large future earnings component to $41 million award [Stephen Rex Brown, New York Daily News]
  • “Ninth Circuit Overturns State Licensing Scheme Forcing Businesses to Incorporate in California” [Cory Andrews, WLF]

Transferring drug patents to Indian tribes, cont’d

More on the controversy that erupted in September: By ruling the patent invalid due to obviousness, a federal judge may have mooted Allergan’s innovative move to transfer its patent over a successful dry-eye drug, Restasis, to the St. Regis Mohawk tribe. “The Restasis patents are at the center of a novel legal strategy that involves using Native American sovereignty rights to avoid certain types of patent reviews, called inter partes reviews, or IPRs….But this ruling won’t be the last time sovereign immunity is used to defend patents.” [Joe Mullin, ArsTechnica] And for something contrarian, Joanna Shepherd at Truth on the Market offers context on the bypassing of inter partes reviews, saying IPR is a process itself unbalanced in favor of patent challengers.

Tales of discovery: document request in qui tam case

And speaking of discovery, reader W.C. writes to say:

This is a False Claims Act case. I am not terribly interested in the substance (relators claim that a drug was recommended for off-label use and that Medicaid shouldn’t have paid for it; they complained and were fired).

What is interesting is taxable costs. Fifth Circuit affirmed (finding no abuse of discretion for an award of) $232,809.92.

Money quotes for me: “The district court acknowledged that [Defendant]’s invoices were not detailed but explained that, given nearly three million pages of copies [Defendant] produced for its defense in this case, it would have been impossible for [Defendant] to explain each page’s usefulness.” (emphasis added). The Court also allowed for “costs relating to (1) TIFF image conversion, (2) scanning, (3) formatting electronic documents, and (4) PDF conversion – per [28 U.S.C.] § 1920(4), which allows recovery for ‘exemplification’ and ‘making copies’ of case materials,” and confirmed that the district “allow[s] a prevailing party to recover the costs of complying with an opposing party’s request to reformat electronic documents or scan hard copies of documents” under 28 USDC s 1920.

Lessons: (i) You might want to more narrowly tailor those discovery request; (ii) Defendants had asked for $961,380.52, so maybe the back up the truck strategy was not 100% effective.

Medical roundup

  • “Oral Contraceptives Should be Free (From the Third-Party Trap)” [Jeffrey Singer, Cato]
  • Arbitrator awards $17.5 million after hospital fires neurosurgeon: in retaliation, or because he didn’t disclose problems with the law unrelated to practice? [Mike Baker, Seattle Times]
  • Idea of empowering government to rewrite recipes for packaged food has gotten more traction in British public health sector than here [Sean Poulter, Daily Mail]
  • Encyclopedia time: you can look up a variety of health topics in the now-online Encyclopedia of Libertarianism including Michael Cannon on health care generally, Gene Healy and Bruce Benson on illegal drugs, Jeffrey Schaler on psychiatry. And the Routledge Encyclopedia of Libertarianism includes Jessica Flanigan on libertarianism and medicine;
  • If treatment deviating from the standard of care is the standard for malpractice, then some patients in pursuit of unconventional therapy choose it, and the law of waivers and of assumption of risk should respect their autonomy [Nadia Sawicki via TortsProf]
  • About the Washington Post’s big opioid-legislation exposé, a few questions [Robert VerBruggen]

Medical roundup

  • New Mercatus report on certificate-of-need laws, which operate to suppress competition in health care;
  • “Hospitals don’t dispense perfectly safe but expired drugs because that may expose them to regulatory penalties or lawsuits.” [Mike Riggs, Reason]
  • California unions push law setting minimum staffing requirements for dialysis centers [L.A. Times]
  • Glaxo neither made nor sold the pill he took, jury tells it to pay $3 million anyway [Roni Caryn Rabin, New York Times]
  • Maryland and Michigan suits seek to characterize patient falls as non-medical negligence; Kentucky suit aims to avoid medical review panel requirement [Andis Robeznieks, AMA Wire]
  • “Ohio Drug Price Initiative Gives Taxpayer Money to Unnecessary Lawyers” [Hans Bader, CEI]

Philly workers’ comp lawyers and their special pharmacy

“Three partners at the [law] firm and its chief financial officer are majority owners of a mail-order pharmacy in the Philadelphia suburbs that has teamed up with a secretive network of doctors that prescribes unproven and exorbitantly priced pain creams to injured workers — some creams costing more than $4,000 per tube…. These sorts of doctor- and lawyer-owned pharmacies are largely unknown outside of the local workers’ comp industry and are not fully understood even within legal and medical communities, because the lawyers and physicians behind them have kept a low profile or sought to conceal their ownership….Clients who click through to the pharmacy’s website are told: ‘Focus on your recovery. Let us handle the fine print.'” [William Bender, Philadelphia Daily News]

Drug company hands patents over to Indian tribe

Allergan: we’ve transferred the patents for our dry-eye drug Restasis to the St. Regis Mohawk tribe, so now the Patent Trial and Appeal Board and our competitors can just go take a hike. The move follows a January decision by the PTAB to drop “a case against the University of Florida citing its sovereign immunity as a state institution. After that ruling, Michael Shore, a lawyer at Shore Chan DePumpo LLP in Dallas that represented the university, said the firm began looking for an Indian tribe that was interested in taking advantage of the ‘arbitrage opportunity.'” Rivals can still challenge the patents’ continuing validity in federal court, but that is a more cumbersome process. [Jonathan D. Rockoff, WSJ]

Medical roundup

  • Bill advancing in California legislature would authorize jail for nursing home staff who “willfully and repeatedly fail to use a resident’s preferred name or pronouns” [Eugene Volokh, SB 219]
  • “The FDA cannot get out of its own way on the issue of off-label communications.” [Stephen McConnell, Drug and Device Law Blog first and second posts]
  • Public health covets territory of other studies and disciplines, part CLXXII [British Medical Journal on American College of Physicians’ resolution declaring “hate crimes” and “legislation with discriminatory intent” to be public health issues]
  • Podcast on battle between Vascular Solutions and the FDA [Federalist Society with Howard Root and Devon Westhill]
  • Policy U-turns needed: “Deregulation and Market Forces Can Lower Pharmaceutical Prices” [Marc Joffe, Reason]
  • Florida Supreme Court ignored market history in striking down noneconomic damages limits in medical malpractice awards [Robert E. White, Jr., Insurance Journal and Andrew S. Bolin, WLF on North Broward Hospital District, et al v. Kalitan]

Pharmaceutical roundup

  • What if law firms advertising about drugs had to live with the same set of rules as drug firms advertising about drugs? [Beck, Drug and Device Law]
  • Jury: no injury damages for testosterone-gel plaintiff, but lawyer got us upset at AbbVie so here’s $150 million anyway [Lisa Schencker, Chicago Tribune]
  • “Plaintiff’s design defect claim was that the defendant shouldn’t have used ibuprofen at all, but rather [an alternative compound] even though the FDA has not approved [that compound] for sale in the United States.” That won’t fly even in California [Beck]
  • Sky-high prices: “The pharmaceutical market is anything but free at present” [Marc Joffe, Reason]
  • Opioids epidemic poses a policy challenge but no time to panic [Jeffrey Singer/Cato, related podcast, op-ed, panel; an ACA angle?]
  • “Gene editing isn’t about designer babies, it’s about hope for people like me” [Alex Lee, Guardian]

Vicarious criminal liability for managers: how we got there

In Dotterweich v. U.S., a 1943 case that established a persistent and troublesome doctrine in criminal law, the U.S. Supreme Court agreed that a pharmaceutical company manager could appropriately be convicted over the misdeeds of an underling without having to show that he knew of the violation, participated in it, intended it, or was negligent in failing to prevent it. My new Cato post summarizes new research by Craig Lerner on Dotterweich’s trial, in which the court seemed to struggle with the idea of imposing vicarious guilt without mens rea (a guilty state of mind). I also link to the chapter I wrote on white-collar prosecution in this year’s new edition of the Cato Handbook for Policymakers.