Life Sciences

  • November 22, 2017

    What Attorneys Get Wrong About Native American Law

    Allergan Inc.’s recent deal seeking to shield several patents behind a New York tribe’s sovereign immunity highlights the reality that attorneys who focus on other practice areas may at some point find themselves in need of a crash course on Native American law. Here, Law360 takes a look at some fundamental misconceptions practitioners in the field say they've encountered among their colleagues.

  • November 22, 2017

    How Associate Bonuses May Highlight BigLaw's Profit Gap

    In past years, many BigLaw firms have played follow-the-leader in matching associate bonuses to those set by the most profitable firms, but as law firm profit gaps grow, experts say it's likely that bonuses at less profitable firms will remain on trend with past years even as their counterparts up the ante for a select few associates.

  • November 21, 2017

    Akorn Reaches $24M Deal To End Investors' Accounting Suit

    Specialty drugmaker Akorn Inc. has reached a $24 million deal to settle a proposed investor class action alleging that the company’s failure to fix widespread accounting problems and weak internal controls led it to report inflated revenue figures to the market, according to papers filed in Illinois federal court on Monday.

  • November 21, 2017

    Dialysis Patients Face Undoing By Experts In Fresenius MDL

    Attorneys for about a dozen dialysis patients argued in Boston on Tuesday that, although their own experts say otherwise, they should be allowed to seek a jury's opinion on claims that they were gravely injured on the watch of leading kidney clinician Fresenius Medical Care.

  • November 21, 2017

    Sanofi Wins Fees After Ditching 'Clearly Frivolous' FCA Suit

    Amphastar Pharmaceuticals Inc. must pay Sanofi-Aventis' attorneys' fees for filing a “clearly frivolous” False Claims Act suit against the company's predecessor alleging the blood thinner Lovenox was improperly patented, as Amphastar knew it wasn’t eligible to bring such a suit, a California federal judge ruled Monday.

  • November 21, 2017

    Ex-Galleon Trader Says He Didn't Report Shkreli To Feds

    A former Galleon Group trader turned Deutsche Bank project manager on Tuesday told jurors that he never reached out to federal prosecutors about his suspicions that Martin Shkreli was engaged in a market manipulation scheme with Retrophin Inc. stock despite having dropped the dime on his old boss at Galleon.

  • November 21, 2017

    DOJ Cleared To Split Up $350M Shire Deal For Whistleblowers

    A Florida federal judge signed off Monday on the U.S. Department of Justice’s apportionment plans for payouts from a $350 million False Claims Act settlement with biotech company Shire, with two of six whistleblower suits getting more than 95 percent of the proceeds, which must still be tabulated.

  • November 21, 2017

    FDA Warning Wire: Insomnia Drug Promo Omits Risk Info

    The U.S. Food and Drug Administration voiced concerns about promotions for an insomnia spray that left out risk information, scolded an online retailer of disposable cigarette filters for making unapproved claims, and upbraided a nutritional supplement maker for labeling claims and other issues.

  • November 21, 2017

    Pharma Groups Pressure FDA On Drug Innovation, Access

    In response to a U.S. Food and Drug Administration solicitation, leading pharmaceutical trade groups are jousting over how the agency should recalibrate the delicate balance between innovation and affordability, newly released letters show.

  • November 21, 2017

    Fla. Hospitals Launch Wide-Ranging Opioid Liability Suit

    Two Florida hospitals on Monday sued a group of pharmacies, drug manufacturers and drug distributors for allegedly contributing to the nation’s opioid crisis by filling suspicious orders or prescriptions and downplaying the risks of the painkillers.

  • November 21, 2017

    'Willfulness' In Civil FBAR Cases Comes Down To The Facts

    A judge’s recent decision to let a pharmaceutical CEO escape civil penalties for failing to report his Swiss bank account doesn’t necessarily signal that courts could be a reliable counterweight against the IRS’ dwindling sympathy, tax specialists say, but instead highlights the fact-dependent approach for determining willful nondisclosure.

  • November 21, 2017

    Pepper Hamilton Regains Life Sciences Duo In Philly

    Pepper Hamilton LLP announced Tuesday that it had lured back two Philadelphia attorneys who focus on transactional work in the life sciences industry from Hogan Lovells as partners, with one to take a leadership role in the firm’s growing health sciences department.

  • November 20, 2017

    Ex-Galleon Trader Details Shkreli Vendetta At Ex-Katten Atty Trial

    A Deutsche Bank project manager and former Galleon Group trader on Monday told the jury weighing the fate of Martin Shkreli’s former Katten Muchin attorney of how the now-incarcerated former pharmaceutical executive harassed his family over a stock ownership dispute, but came under fire on cross-examination over a trade he made on inside information while at Galleon.

  • November 20, 2017

    Globus Says Ex-Engineer Took Trade Secrets To Stryker

    Globus Medical Inc. on Friday filed a lawsuit in New Jersey federal court alleging that a former project engineer defected for Stryker Corp. with the spinal implant maker’s trade secrets, in violation of a former employee’s noncompete and nondisclosure agreements.

  • November 20, 2017

    DOD Slow To Target Rising Rx Costs, Fraud Risks: Watchdog

    The U.S. Department of Defense’s health care arm had been too slow to respond to risks of fraud posed by drugs with rapidly rising costs, only recently updating its rules to cut down on those risks, according to a watchdog report Monday.

  • November 20, 2017

    Abbvie Says Medical Mutual Being 'Cagey' In Androgel MDL

    Medical Mutual of Ohio is refusing to answer AbbVie Inc.'s request for more detail on the basic premise behind its potential class action accusing AbbVie of fraudulently marketing its testosterone replacement therapy drug Androgel, the drugmaker told an Illinois federal court Monday.

  • November 20, 2017

    Fed. Circ. Urged To Not Review Defense In $200M Patent Suit

    Boston Scientific urged the Federal Circuit on Friday not to rethink a holding that the company is shielded from liability by the rarely invoked ensnarement defense in a cardiologist’s contract suit seeking more than $200 million in royalties on his stent patents, saying its use of the defense didn't come as a surprise.

  • November 20, 2017

    J&J Says Applicant Must Arbitrate Background Check Claims

    A Johnson & Johnson subsidiary urged a Pennsylvania federal judge Monday to order that a would-be employee must arbitrate claims that he unfairly lost his job offer due to a background check, noting she has already ordered the man to arbitrate his closely intertwined allegations against the staffing company that facilitated the hiring process.

  • November 20, 2017

    EU Drug Agency Packs Bags For Amsterdam Amid Brexit

    In a razor-thin decision, the European Union on Monday selected Amsterdam as the new headquarters of the bloc’s prescription drug regulator, starting the clock on a relocation from London prompted by Brexit.

  • November 20, 2017

    SEC Judge Refuses To Bar Shkreli Without Tie To Adviser

    A U.S. Securities and Exchange Commission administrative law judge on Friday denied the agency's request to bar Martin Shkreli from the securities industry, saying the agency needs to show whether the so-called pharma bro was associated with an investment adviser at the time he allegedly committed fraud.

Expert Analysis

  • BPCIA At Fed. Circ.: Awaiting Guidance On Patent Dance

    Tasha Francis

    The Federal Circuit heard arguments last week in Amgen v. Apotex, a case that has the potential to shape Biologics Price Competition and Innovation Act litigation and factor into a biosimilar manufacturer’s decision to engage in the patent dance, say Tasha Francis and Jenny Shmuel of Fish & Richardson PC.

  • Gorilla Glue Case Shows Cannabis IP Is Not Sticking

    Thomas McMahon

    Last week's trademark settlement between adhesives company Gorilla Glue and cannabis company GG Strains is the latest in a string of settlements that show there is marketplace precedent but no reliable legal precedent for cannabis brands registering and enforcing their own trademarks, say Thomas McMahon and Lauren Estevez of Margolin & Lawrence.

  • How Bristol-Myers Squibb May Transform Class Actions

    Richard Dean

    In her dissent from the U.S. Supreme Court's holding in Bristol-Myers Squibb, Justice Sonia Sotomayor foresaw several major implications of the verdict. Now her prediction of plaintiffs having to sue defendants in multiple jurisdictions to recover for a single injury seems not only possible, but probable, say Richard Dean and Michael Ruttinger of Tucker Ellis LLP.

  • Good And Bad News For Massachusetts Life Sci, Health Cos.

    Caroline Bullerjahn

    Life sciences and health care companies nationwide are being sued by shareholders far more frequently this year, but the good news for such companies in Massachusetts is that after several years of issuing no significant decisions in securities class actions, the First Circuit has now issued several favorable dismissals, say Caroline Bullerjahn and Deborah Birnbach of Goodwin Procter LLP.

  • What Duties Do Lead Lawyers Owe MDL Plaintiffs?

    Elizabeth Burch.jpg

    Do lead lawyers have fiduciary obligations to individual plaintiffs in multidistrict litigation who have no direct attorney-client relationship with them? That’s the question at the heart of a recent opinion by U.S. District Judge David Herndon in the Yazmin/Yaz litigation, says Elizabeth Chamblee Burch of the University of Georgia School of Law.

  • Strategies For Protecting Biotechnology In Brazil And China

    Deborah Sterling

    Brazil and China have taken important steps to become significant contributors to the future success of the bioeconomy. Understanding options for quickly procuring and challenging patents in Brazil and China can be key for companies looking to expand their bioeconomy investments outside the U.S. and Europe, say attorneys with Sterne Kessler Goldstein & Fox PLLC.

  • A New Strain Of Inequitable Conduct Litigation

    Aron Fischer

    The Federal Circuit’s recent decision in Regeneron v. Merus opens new tactical opportunities for defendants asserting inequitable conduct defenses in patent cases, and may incrementally expand the use of a doctrine that the Federal Circuit has repeatedly tried to rein in, say Aron Fischer and Rachel Schwartz of Patterson Belknap Webb & Tyler LLP.

  • When Plaintiff Conduct Matters: Part 3

    James Beck

    Where supported by sufficient evidence, defenses based on plaintiff conduct are sometimes available in pharmaceutical product liability litigation. Situations where plaintiffs failed to disclose critical medical information, or did not comply with medical instructions, may present such opportunities, and other plaintiff conduct can be relevant as well, says James Beck of Reed Smith LLP.

  • The Future Of Value-Based Care After Repeal And Replace

    Tom Bulleit

    In light of skepticism expressed by the now-former U.S. Department of Health and Human Services Secretary Tom Price toward much of the Obama administration’s approach to mandatory bundled payment initiatives, many have wondered whether his resignation might lead to a change in direction. Tom Bulleit and Jessica Band of Ropes & Gray LLP summarize Price’s approach to some of these key initiatives and look to what might be ahead.

  • When Plaintiff Conduct Matters: Part 2

    James Beck

    There are a number of situations in which a plaintiff's actions can make a difference in medical product liability. When plaintiffs read but disregard warnings, sign forms indicating their informed consent or fail to testify that a different warning would have changed the outcome, liability is affected, says James Beck of Reed Smith LLP.