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The Wrong-Headedness of Hindsight Standards — Michelle Yeary | Drug & Device Law Blog

May 27th, 2019|Categories: HB Risk Notes|Tags: , , , , , , , , , , , , |

Dechert LLP attorney Michelle Yeary cautions against applying perfect hindsight to drug liability. "We all know hindsight is 20/20.  And, it’s easy.  There are dozens of television and radio programs that thrive on Monday morning quarterbacking.  There’s no risk in saying the coach should have called for a pass when you already know the run didn’t work.  It’s also dangerous because it’s easy.  People are often too quick to point out that you should have taken path B after everyone learns path A is full of potholes.  Pointing it out is one thing, holding you liable for it is another." Yeary takes a look at what happened in Holley v. Gilead Science, Inc., 2019 WL 2077845 (N.D. Cal. May 10, 2019). The case involves two of the main active ingredients in AIDS drugs: TDF and TAF. The plaintiff alleges that the defendant should be responsible for allegedly knowingly using TDF over TAF (allegedly a safer alternative). TDF was FDA approved first and TAF second.  Unfortunately, Yeary wrote, hindsight "can be used to demand perfection," allowing  plaintiffs to "proceed on what is essentially a stop-selling theory," that first-generation drugs should not be submitted to the FDA because, in hindsight, "later approved treatments were safer." That's what happened in Holley, she said. Read the complete post by Michelle Yeary on the Drug and Device [...]

J&J Hit with $120 Million Verdict at Mesh Trial

May 13th, 2019|Categories: HB Risk Notes|Tags: , , |

A Philadelphia jury returned a $120 million verdict against Johnson & Johnson after finding that a negligently designed pelvic mesh implant caused chronic pain and suffering, which left plaintiff Susan McFarland incontinent and unable to have sex for the last 10 years. McFarland alleged the implant she received in 2008 caused the product to saw through the soft tissue in her pelvis and become exposed in her vagina. She had to undergo a second surgery to remove a portion of the implant (Susan McFarland,et al. v. Ethicon Inc., et al., No. 130701577, Phila. Comm. Pls. Ct.). This is the second of two trials. The jury in the first trial was deadlocked, unable to agree on the extent of negligence of the design of the Ethicon product. Tracie Palmer, McFarland’s attorney, added in the second trial that the vaginal mesh was on market prior to clinical studies determining its safety and efficacy.  Defense attorney Adam Spicer maintained that the chronic pain McFarland experienced could be due to other causes, including her age. He said the product had been used for years prior.  McFarland’s case is one of more than 100,000 cases brought together in the MDL, down from nearly 105,000 cases against seven manufacturers.  The MDL will be closing and there will be two more waves of trial, with next wave comprising 150 [...]

Suits Allege Apple Concealed Knowledge of iPhone 7 Defect

May 10th, 2019|Categories: HB Risk Notes|Tags: , , , , , , , , , , , , |

Apple Inc. has been sued in federal courts in Illinois and California for allegedly knowingly selling iPhone 7 and 7 plus models with an audio chip defect, called the “Audio IC Defect” or “Loop Disease” by consumers, which causes an array of operational issues. The bug gums up handset audio functions, grays out speaker buttons during calls, and degrades microphone fidelity.  And if that's not enough it can kill Siri's voice command capabilities. The plaintiffs accuse Apple of actively concealing the Audio IC Defect while advertising the iPhone 7 as “the best iPhone we ever made.” The plaintiffs claim that when they first experienced operational problems Apple didn't offer complimentary repairs. The suits allege breach of warranty and violation of California and Illinois consumer protection laws. Plaintiffs seek class certification, damages, attorneys' fees, and injunctive relief. In Illinois, the plaintiffs may also try to force Apple to repair, recall, and/or replace current defective iPhone 7s in the United States and notify all purchasers of the Loop Disease. Evidence shows “Apple’s internal acknowledgement and subsequent discontinuation of their out-of-warranty repairs without public announcement of the Audio IC Defect amounts to misrepresentation and concealment of the Audio IC Defect,”  the California complaint in Casillas v. Apple reads.  Complaints available on Scribd.com. Casillas v. Apple, N.D. Calif., No. 3:19-cv-2455 Castelli v. Apple, N.D. Ill., Eastern [...]

Artificial Intelligence: DeepMind on Debugging Learned Predictive Models

May 9th, 2019|Categories: HB Risk Notes|

DeepMind, an artificial intelligence research company, in a recent blog post discusses three ways to eliminate bugs in learned predictive models. The company was founded in London in 2010. Google acquired it in 2014. In addition to London they have research centers in Edmonton and Montreal, Canada, and a DeepMind Applied team in Mountain View, California. "Bugs and software have gone hand in hand since the beginning of computer programming," the post reads. "Over time, software developers have established a set of best practices for testing and debugging before deployment, but these practices are not suited for modern deep learning systems. Today, the prevailing practice in machine learning is to train a system on a training data set, and then test it on another set. While this reveals the average-case performance of models, it is also crucial to ensure robustness, or acceptably high performance even in the worst case. In this article, we describe three approaches for rigorously identifying and eliminating bugs in learned predictive models: adversarial testing, robust learning, and formal verification." Read the complete post here! 

Top Five Things to Know if You’re Building Your Cannabis Empire Through M&A — CannaLawBlog

May 7th, 2019|Categories: HB Risk Notes|Tags: , , , , , , , |

Cannabis is associated with calm. Joining the industry is anything but.   Hilary Bricken already has nearly a decade of experience in the field of cannabis law. She founded the Canna Law Blog in 2010, which now has several contributors from the Harris Bricken firm and is easily one of the best out there. Her latest post offers insights on companies who wish to build their cannabis business through mergers and acquisitions. In her May 6 post, titled "Top Five Things to Know if You're Building Your Cannabis Empire Through M&A," she writes:  "It’s no secret that multiple state-by-state operators are building their cannabis empires through aggressive mergers and acquisitions. Last year, our cannabis business attorneys closed more than $100 million in cannabis company acquisitions, and that shows no signs of stopping in 2019. Cannabis M&A is not your run-of-the-mill business dealing though, and working from boilerplate, rote M&A documents is hugely dangerous. In addition, diligence is oftentimes like a regulatory spiderweb laden with liabilities that other businesses do not face. In addition, the barriers to entry in the cannabis industry are increasingly high, tedious, and protectionist, which can really torture business deals." Bricken writes that "if you find yourself turning into a larger multi-state operator though acquiring cannabis businesses," there are at least five things you should know. Read on for what she has to [...]

Moving Your Corporate Data to the Cloud: Top 13 Things to Think About as you Review Your Hosting Agreement — Judy Selby Consulting

May 6th, 2019|Categories: HB Risk Notes|Tags: , , , , , , , , , , , |

Some data migration risks can be mitigated at the cloud contract stage, Allison Bird, Judy Selby’s partner at Clearview Privacy Consulting LLC, explains. Regarding indemnification, Bird says, "If data is lost or exposed by the hosting company, your company as well as any affiliates who use the services will be subject to suits from clients and individuals whose data was impacted.  You may also be subject to regulatory scrutiny which could result in legal costs and regulatory penalties.  To the extent possible, negotiate a full indemnification of third party claims arising out of the hosting services." She says the limitation of liability section of your hosting agreement "may be the single most important" part.  "Your hosting company may make a lot of promises in the agreement.  However, if their liability under the agreement is significantly capped, you won’t receive the monetary compensation necessary to make up for hosting company’s acts and omissions that damage the company. Negotiations for a higher cap will translate into real dollars in the event of a security incident." Of course, insurance is always a good solution if done right. "You can negotiate the perfect contract but unless your hosting company has a deep pocket, it may not have sufficient capital to make good on contractual obligations in the event of a breach or data loss situation, especially one [...]

The Cloud: Selected Benefits, Risks, and Insurance Coverage Issues (Part 1) — Barnes & Thornburg

May 6th, 2019|Categories: HB Risk Notes|Tags: , , , , , , , , , , , , , , , , |

  Cloud Risk: Do You Transfer Liability Along with Data? Many of us were using data clouds before we even knew what they were. Now, while most of us are comfortable with the concept, we may not be comfortable knowing who is liable when data is lost, damaged or breached. It's not a given that your cloud provider absorbs any liabilities, and it's not a given they can even afford the liability should it arise. Below are quotes from an article by Scott Godes, Kara Cleary, and Heidi Fessler of Barnes & Thornburg LLP on the subject, and a link to their complete article.  Godes, Cleary, and Fessler list several cloud-related risks: data breaches, data loss, interruption of access, compromised credentials and broken authentication, and denial of service.  But two other categories for concern are:  #1. BYOC, or Bring Your Own Cloud. Employees may be innocently using productivity applications that store work data on non-company clouds, in effect, "bringing their own clouds" to the workplace. #2. Multi-Tenancy. This involves risks posed when unrelated cloud users are sharing the same computing resources.  "Both the cloud provider and the user must be aware of system and data security to prevent a breach in the security. In addition, when a risk is realized, it may not always be clear who is at fault for the [...]

Anderson Kill’s 5th Annual Cyber Insurance Recovery Conference

May 6th, 2019|Categories: HB Risk Notes|Tags: , , , , , , , , , , , , , |

Recent news of "Collection 1", a cache of sensitive data now appearing for sale on the dark web and comprised of an astonishing 773 million records, is a grim reminder of the scope of cyber perils for most.  Last year's staggering tally of serious data breaches and theft coupled with a spate of new legislation for companies gathering, hosting and selling consumer data means policyholders must rise to the challenge.  New state legislation compounds an already daunting federal and international regulatory landscape, and regulatory compliance will be a must to deal with the attendant fines, penalties and consumer claims that non-compliance can trigger.  New technology also continues to drive the evolving conversation about the legal relationships between parties transacting business electronically.  Risks range from anonymity that raises jurisdictional and collection issues to “immutable” record keeping that creates a permanent, public record of transactions. --Anderson Kill   Find out more about this complimentary seminar from Anderson Kill here!

Spotify Tells EU Apple is Hampering Competitors as Apple Music Surpasses Spotify in U.S. — MoginRubin

April 30th, 2019|Categories: HB Risk Notes|

  "Apple Music recently surpassed Spotify in the U.S. market, according to the Wall Street Journal, signing up 28 million subscribers compared to Spotify’s 26 million. Spotify continues to have more total subscribers, however. "Spotify Founder and CEO Daniel Elk took to the company blog to make his case, saying, “Apple operates a platform that, for over a billion people around the world, is the gateway to the internet. Apple is both the owner of the iOS platform and the App Store—and a competitor to services like Spotify. In theory, this is fine. But in Apple’s case, they continue to give themselves an unfair advantage at every turn.” "In a recent statement, Apple says it revolutionized the distribution of music with iTunes, and did the same thing with the App Store, something that has created “many millions of jobs” and, it says, generated more than $120 billion for developers and new industries." Read the complete post on the MoginRubin Blog here!

Top Class Actions: Vaccine Litigation Case Roundup

April 19th, 2019|Categories: HB Risk Notes|

There have been numerous lawsuits filed alleging injuries caused by the shingles vaccine Zostavax. Cases have stated they were not warned of the adverse side effects of the vaccine alleging it caused the diseases it is meant to prevent, among other things. Here is what the CDC says to consumers: “Your risk of shingles and postherpetic neuralgia (PHN) increases as you get older. CDC recommends that people 60 years old and older get shingles vaccine (Zostavax®) to prevent shingles and PHN. Shingrix (recombinant zoster vaccine) is the preferred vaccine, over Zostavax® (zoster vaccine live), a shingles vaccine in use since 2006. Zostavax may still be used to prevent shingles in healthy adults 60 years and older. For example, you could use Zostavax if a person is allergic to Shingrix, prefers Zostavax, or requests immediate vaccination and Shingrix is unavailable. Zostavax (zoster vaccine live) was licensed by the FDA in 2006. This vaccine reduces the risk of developing shingles by 51% and PHN by 67%. It is given in one dose as a shot, and can be given in a doctor’s office or pharmacy.“ Read more: https://www.cdc.gov/vaccines/vpd/shingles/public/zostavax/index.html The vaccine is produced by Merck & Co.  Their product information can be found here: https://www.merckvaccines.com/Products/Zostavax Here is a roundup of the cases filed. 1.Husband and Wife File Zostavax Shingles Vaccine Lawsuit  "A North Carolina husband and [...]

Product Liability in the Internet of Things — Schiff Hardin Product Liability & Mass Torts Blog

April 14th, 2019|Categories: HB Risk Notes|Tags: , , , |

Photo by Markus Spiske on Unsplash "Combining a physical object and an intangible technology also creates a novel issue when it comes to strict product liability principles, which typically hold that a product manufacturer may be strictly liable for a product’s defect. The first task in a strict product liability case is to identify the product. In the context of a device that has no internet connectivity, the answer is straightforward. If a ladder is defective and causes an injury, the ladder’s manufacturer may be held strictly liable because a ladder is the product. But when it comes to IoT devices, the line may be blurred. Almost always, the software part of the IoT device is 'manufactured' by a separate entity from the entity that manufactures the physical object. If the IoT device proves to be defective, the question becomes which entity may be held strictly liable." Read the complete post by Schiff Hardin's  Gregory Dickinson & Jeffrey D. Skinner  here.

National Geographic Disclosed Customer Info, Class Action Says — Top Class Actions Blog

April 14th, 2019|Categories: HB Risk Notes|Tags: , , , |

"The National Geographic class action states that prior to and at the time that he subscribed to the magazine, the company did not notify him that it discloses the personal reading information of its customers. "Markham also claims that he wasn’t provided with any written notice that National Geographic makes a practice of renting, exchanging, or otherwise disclosing personal reading information to third parties, and provides no means of opting out. "However, the National Geographic information disclosure class action lawsuit says that since subscribing to National Geographic and between Mach 26, 2016 andJuly 30, 2016, National Geographic disclosed Markham’s personal reading information to data aggregators, data appenders, and/or data cooperatives." Read the complete post by Top Class Actions Editor Emily Sortor here.

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