GlobalTort

GlobalTort

The Intersection Among Torts, Science, Corporate Law, Insurance & Bankruptcy

Illumina Introduces the Sequencing Machine It Says Will Take Us to the $100 Genome

Posted in Asbestos, Cancer, Litigation Industry

The first genome cost $3-4 billion, and took over a decade; one can debate the specifics.  Times change. Last week, the world leader in gene sequencing (Illumina) announced a new sequencing machine that it says will yield a $100 genome within a decade, as described in articles everywhere. For example, see this January 9, 2017 article in Forbes.  Imagine the impacts for studying diseases, and making claims about the “causes” of disease.

The press release from Illumina explains:
“January 09, 2017 05:30 PM Eastern Standard Time

SAN DIEGO–(BUSINESS WIRE)–Illumina, Inc. (NASDAQ: ILMN), the global leader in next-generation sequencing technology, today introduced the NovaSeqTM Series, a new and scalable sequencing architecture expected one day to enable a $100 genome. Unveiled at the J.P. Morgan Healthcare Conference, this platform redefines high throughput sequencing with unrivaled throughput, ease of use, low per sample costs, and unmatched flexibility.

NovaSeq is the most powerful sequencer Illumina has ever launched and will open new horizons for more highly powered experiments at the depth required to discover rare genetic variants. It was designed from the ground up to allow a broad set of researchers to access next-generation sequencing technology and more easily conduct large-scale genomics projects with greater sample volumes, or more breadth and depth in the genome. In addition to a single instrument capable of sequencing from three to 48 human whole genomes per run, the NovaSeq Systems will open up new markets by making routine a wide range of applications from ultra-deep sequencing of matched tumor-normal pairs, to large-scale variant discovery studies associated with complex diseases, and low-pass sequencing of seed banks to select for specific traits.

“We are excited to be among the first to incorporate Illumina’s new NovaSeq System into the HLI sequencing center to complement our existing HiSeq X® Systems,” said J. Craig Venter, PhD, Co-founder and Executive Chairman of Human Longevity Inc. “Faster, inexpensive and innovative sequencing technology is a key component driving breakthroughs in precision medicine. This technology is also enabling HLI to expand the HLI database, the world’s most comprehensive database of genomic, phenotypic, and clinical data.”

“NovaSeq is a key development for clinical research,” said Richard Gibbs, Founder of the Baylor College of Medicine Human Genome Sequencing Center. “We are looking forward to generating tens of thousands of human whole genomes as we begin genome translation in earnest.”

“The Regeneron Genetics Center has sequenced more than 150,000 exomes in the last few years and we anticipate that moving to the NovaSeq platform will further increase our efficiency and output,” said Aris Baras, MD, Head, Regeneron Genetics Center. “We believe that genetic insight is critical to informing and advancing new treatments and are committed to expediting these advances for patients.”

“The introduction of NovaSeq marks one of the most important inflection points of innovation in Illumina’s history. In the same way that HiSeq X enabled the $1,000 genome with the HiSeq® architecture first announced in 2010, we believe that future systems derived from the NovaSeq architecture we are launching today one day will enable the $100 genome and propel discoveries that will enable a deeper understanding and better treatments for complex disease,” said Francis deSouza, President and CEO of Illumina. “The NovaSeq Systems enable the study of genetic links between health and disease at an unprecedented scale by making it possible to sequence more samples at greater depth and take on projects that would otherwise be cost-prohibitive. By accelerating the trajectory of genomics with these systems, Illumina is making it possible to envision a future in which all people can benefit from precision medicine.”

The NovaSeq Series includes the NovaSeq 5000 and 6000 Systems. These instruments offer ease of use features similar to those found in Illumina’s desktop sequencing portfolio, including automated onboard cluster generation, cartridge-based reagents, and streamlined workflows. With scalable throughput, users will have the flexibility to perform sequencing applications requiring different levels of output by simultaneously running one or two flow cells from up to four different flow cell types.

The NovaSeq 5000 and 6000 Systems are priced at $850,000 and $985,000 respectively. Compared with other Illumina sequencing systems, both have lower per sample consumable costs for most sequencing applications. They provide laboratories that cannot afford the capital cost of a HiSeq X Five or HiSeq X Ten System with a roadmap to completing human whole-genome sequencing projects at a cost of $1,000 per genome.

The NovaSeq 6000 will begin shipping in March 2017 and NovaSeq 5000 will begin shipping mid-2017. For more information, visit www.illumina.com/novaseq.”

DNA Folding Defects and Limb Malformation: It’s Not Just About DNA Sequences

Posted in Cancer, Science

How does/can a product “cause” an undesired outcome in the formation of limbs or diseases such as cancer, and how can/does one test to try to better assess opportunities and risks related to products that may have cellular level impacts? One older line answer involved the Ames test, and others, which are mainly about mutations to DNA sequences. The Ames test dates back to 1970s science.

For persons concerned about risks and opportunities related to products with cellular impacts, it’s useful to recognize the reality of the ongoing molecular biology revolution and more recent discoveries and ongoing inquiries. A cogent example of new molecular science is illustrated by a family with a “curse” of webbed fingers in some of its members, as described in a January 9, 2017 NYT article. The big picture point is that defects in folding of DNA appear to “cause” undesirable conditions and cancers. One of the related medical articles is in Nature and is open access.

Set out below is part of the text from the NYT article on the family with webbed fingers:

“The family, under promise of anonymity, is taking part in a study by Dr. Mundlos and his colleagues of the origin and development of limb malformations. And while the researchers cannot yet offer a way to prevent syndactyly, or to entirely correct it through surgery, Dr. Mundlos has sought to replace the notion of a family curse with “a rational answer for their condition,” he said — and maybe a touch of pioneers’ pride.

The scientists have traced the family’s limb anomaly to a novel class of genetic defects unlike any seen before, a finding with profound implications for understanding a raft of heretofore mysterious diseases.

The mutations affect a newly discovered design feature of the DNA molecule called topologically associating domains, or TADs. It turns out that the vast informational expanse of the genome is divvied up into a series of manageable, parochial and law-abiding neighborhoods with strict nucleic partitions between them — each one a TAD.”

Finding Cancer Very Early: Grail and Illumina Start Another Year with Another Notable Step Forward

Posted in Asbestos, Cancer, Litigation Industry, Science

One year ago, Illumina announced a stunning goal: find all cancers very early (stage 1 or 2) through use of massive computing power and artificial intelligence to find mutated cells circulating in a small blood sample. The lead backers of the effort are the world leader in gene sequencing (Illumina), Bill Gates and Jeff Bezos (and others). To that end, they created a new company with a fitting name: Grail. Last year’s news caused me to ask, rhetorically, if people felt the earth move.

Yesterday, a year later, the progress is strong enough they announced yesterday that Grail is to receive $1+ billion in a private placement. That level of investment puts Grail up in the ranks with Uber. The January 5, 2017 press release is online here, and pasted below. A Forbes article is here.

Because I bleed a bit of Illini orange and blue after growing up there and going to the U of I for undergrad, I’ll toss in a friendly reminder the CEO of Grail is a University of Illinois computer science grad who led the teams that created Google Maps and Google Earth. He is Jeff Huber. He is especially highly motivated because his wife died in her 40s because of a colon cancer no one saw coming. He spoke this past spring to the graduating class at the U of I, and had a simple but powerful theme: Find a Better Way. Who would want to bet against him and the rest of the team?

Now imagine the consequences for tort litigation if in fact the Grail team meets its goals.  Among other goals, they seek to have the test approved and on the market in 2019. Clinical trials are to begin this year, and are to scale up to massive numbers. Imagine the possible consequences for litigation when there is a relatively simple to administer screening test to find any cancer at stage 2 or 1, for (they hope) less than $2,000.

______________________________________________________________________________

“Illumina, Inc. has issued a new press release.

Title: GRAIL Plans to Raise in Excess of $1B in Series B Funding

Date(s): 5-Jan-2017 4:05 PM

For a complete listing of our news releases, please click here

Investment by Strategic Industry Partners Would Enable GRAIL to Expand Clinical Validation of Blood Test for Early-Stage Cancer Detection

SAN DIEGO–(BUSINESS WIRE)–Jan. 5, 2017– Illumina, Inc. (NASDAQ: ILMN), today announced that GRAIL has received indications of interest to invest approximately $1B for its Series B financing, primarily from undisclosed private and strategic investors. GRAIL intends to raise additional capital in the Series B financing from other investors and has engaged Goldman Sachs as a placement agent in connection with the contemplated additional financing. GRAIL intends to close the Series B prior to the end of the first quarter.

GRAIL will use the proceeds for continued development and validation of their blood-based test for cancer screening, which will require large-scale clinical trials including the previously announced Circulating Cell-free Genome Atlas study as well as other trials that are expected to sequence hundreds of thousands of patients. Additionally, proceeds will be used to repurchase a portion of Illumina’s stake.

“We founded GRAIL a year ago to enable early cancer detection via a blood-based screening test powered by Illumina sequencing technology,” said Jay Flatley, Executive Chairman of Illumina and current Chairman of GRAIL. “This raise, when completed, will provide GRAIL the resources to develop its first products and embark on the large-scale trials required to demonstrate the stringent performance requirements of a cancer screening test.”

Given the potential success of the Series B, and GRAIL’s plan to aggressively invest that capital, Illumina has decided to accelerate their path to independence, which will result in GRAIL becoming one of Illumina’s largest customers over time. Illumina will modify the supply and commercialization agreement with GRAIL to a market-based agreement and will no longer have representation on the Grail Board of Directors. As part of this transaction Illumina’s ownership will become slightly less than 20 percent and GRAIL will be treated as a cost-method investment.

“We are very excited about the progress the GRAIL team has made in the last year,” said Francis deSouza, President and Chief Executive Officer of Illumina. “This capital allows GRAIL to take on the significant technology, market, and regulatory challenges of developing and validating a blood-based cancer screening test. This outcome maximizes value to Illumina by creating one of our largest customers of sequencing instruments and consumables over time, providing royalties on future GRAIL tests and through appreciation of our ownership interest.”

GRAIL’s Chief Executive Officer, Jeff Huber, added, “We are honored to have world-class investors who support our goal of reducing global cancer mortality through early detection — especially the invaluable support we received from Illumina during our start-up phase – and we look forward to the next phase of our growth.”

About Illumina, Inc.

Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit www.illumina.com and follow @illumina.

About GRAIL

GRAIL is a life sciences company whose mission is to detect cancer early when it can be cured. GRAIL combines the power of high-intensity sequencing (ultra-broad and ultra-deep sequencing), leading-edge computer science, and large population-scale clinical studies to enhance the scientific understanding of cancer biology and develop a blood test for early-stage cancer detection. The company has secured over $100 million in Series A financing from Illumina, Inc. and ARCH Venture Partners, with participating investors including Bezos Expeditions, Bill Gates, Sutter Hill Ventures, and GV (formerly Google Ventures). For more information, please visit www.grail.com.

Forward-Looking Statements

This release contains forward-looking statements that involve risks and uncertainties. Examples of forward-looking statements include, but are not limited to, statements we make regarding the expected availability dates for new products and services and FDA submission dates and intentions for certain products and services. Important factors that could cause actual results to differ materially from those in any forward-looking statements include the risk that GRAIL is not able to raise the amounts contemplated in is its Series B financing to reduce Illumina’s ownership stake below 20% and achieve the planned deconsolidation of GRAIL’s financial results in Illumina’s financials statements, challenges inherent in developing, manufacturing, and launching new products and services, and the other factors that are detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We do not intend to update any forward-looking statements after the date of this release.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170105006393/en/

Source: Illumina, Inc.

Illumina, Inc.
Investors:

Rebecca Chambers, 858-255-5243
rchambers@illumina.com

or
Media:

Eric Endicott, 858-882-6822
pr@illumina.com” 

Swiss Create New Fund to Pay Compensation to Persons with Asbestos Related Diseases

Posted in Asbestos, Asbestos Trusts, International Asbestos, Litigation Industry

As reported by Laurie Kazan Allen at the IBAS web site and in other places, a new fund has been created in Switzerland to pay compensation to persons suffering from asbestos-related diseases. The Swiss Info channel reported the news in a December 19, 2016 online article. The following are excerpts from the article:

“A CHF100 million ($97 million) fund is to be created in Switzerland to offer support for victims of asbestos-related illnesses who are not eligible for accident insurance. The construction industry and insurers will voluntarily contribute to the fund that will run until 2025

….

A round table of politicians, trade unions, industry groups and asbestos victim support organisations came up with the solution to financially support victims who fell ill after 2006. Some CHF30 million has already been pledged to the fund.”

Hartford Closes Out 2016 With $420+ Million Charge for More Asbestos Losses

Posted in Asbestos, Asbestos Bankruptcy, Insurance

As previously predicted by yours truly and other members of a multidisciplinary team, asbestos losses continue to rise for insurance companies. To start 2017, Hartford announced a $423 million charge to expand its coverage from NICO/Resolute.  Note that the price of the coverage is essentially 43 cents on the dollar. That’s notably more expensive than past prices for similar coverage. The press release of January 3, 2016 is online. It states:

“The Hartford Enters Into Reinsurance Agreement Covering Asbestos And Environmental Liability Reserves With National Indemnity CompanyJanuary 03, 2017 08:00 AM Eastern Standard Time

  • Agreement provides aggregate limit of up to $1.5 billion for adverse net loss reserve development on asbestos and environmental exposures
  • Reinsurance premium of $650 million will result in a fourth quarter 2016 charge to net income of $423 million, after-tax

The Hartford to retain control of claims handling for all exposures reinsured under this agreementHARTFORD, Conn.–(BUSINESS WIRE)–The Hartford has entered into a definitive agreement effective Dec. 31, 2016 with National Indemnity Company (NICO), a subsidiary of Berkshire Hathaway Inc., for a $1.5 billion aggregate excess of loss reinsurance agreement covering certain of The Hartford’s asbestos and environmental liability exposures. The reinsurance premium for this agreement is $650 million.

“Our asbestos and environmental exposures have generated adverse loss reserve development over time, creating uncertainty for investors and others about the ultimate cost of these policy liabilities, most of which were underwritten prior to 1985”
Tweet this
The agreement covers potential adverse development on The Hartford’s existing asbestos and environmental reserves as of Dec. 31, 2016, excluding those held by the company’s U.K. Property and Casualty (P&C) run-off subsidiaries, which the company is under contract to sell and currently expects to close in first quarter 2017. The agreement provides up to $1.5 billion of reinsurance for adverse net loss reserve development above estimated net loss reserves of $1.7 billion as of Dec. 31, 2016. The Hartford will continue to handle claims, subject to certain conditions, and will retain the risk of recoveries under third-party reinsurance contracts for these exposures.

“Our asbestos and environmental exposures have generated adverse loss reserve development over time, creating uncertainty for investors and others about the ultimate cost of these policy liabilities, most of which were underwritten prior to 1985,” said Chief Financial Officer Beth Bombara. “The agreement announced today is consistent with our stated objective of evaluating options that had favorable economics, while taking into consideration our expertise in handling these complex claims. NICO is a very strong counterparty and this agreement reduces uncertainty about potential adverse development while allowing us to continue to handle both claims and reinsurance recoveries, which we believe will enable us to achieve the best possible resolution for these long-tail exposures.”

The agreement will be accounted for in The Hartford’s fourth quarter 2016 financial statements as a retroactive reinsurance agreement, resulting in a charge of approximately $423 million, after-tax, against fourth quarter 2016 net income, or a pro forma impact of $1.10 per share to Sept. 30, 2016 book value per diluted share of $48.30. The reinsurance premium is expected to have a slightly negative impact on 2017 P&C net investment income and does not affect the company’s expectation to execute its previously announced 2017 capital management plan including equity repurchases of $1.3 billion.

About The Hartford

The Hartford is a leader in property and casualty insurance, group benefits and mutual funds. With more than 200 years of expertise, The Hartford is widely recognized for its service excellence, sustainability practices, trust and integrity. More information on the company and its financial performance is available at https://www.thehartford.com. Follow us on Twitter at www.twitter.com/TheHartford_PR.

The Hartford Financial Services Group, Inc., (NYSE: HIG) operates through its subsidiaries under the brand name, The Hartford, and is headquartered in Hartford, Conn. For additional details, please read The Hartford’s legal notice.

HIG-F

Some of the statements in this release may be considered forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. We caution investors that these forward-looking statements are not guarantees of future performance, and actual results may differ materially. Investors should consider the important risks and uncertainties that may cause actual results to differ. These important risks and uncertainties include those discussed in our 2015 Annual Report on Form 10-K, subsequent Quarterly Reports on Forms 10-Q, and the other filings we make with the Securities and Exchange Commission. We assume no obligation to update this release, which speaks as of the date issued.

From time to time, The Hartford may use its website to disseminate material company information. Financial and other important information regarding The Hartford is routinely accessible through and posted on our website at https://ir.thehartford.com. In addition, you may automatically receive email alerts and other information about The Hartford when you enroll your email address by visiting the “Email Alerts” section at https://ir.thehartford.com.

Contacts
The Hartford
Media Contact:
Michelle Loxton, 860-547-7413
michelle.loxton@thehartford.com
or
Investor Contact:
Sabra Purtill, 860-547-8691
sabra.purtill@thehartford.com”

Exotic Bats on the Moon: A Coda on the Hearsay Rule and Ancient Documents Exception

Posted in Evidence, Litigation Industry, Science

Nathan Schactman added a coda to his prior post on the probable demise of the ancient document exception to the rule against hearsay. Hint: the post focuses on exotic forms of bats living on the moon. See his December 30, 2016 post at http://schachtmanlaw.com/more-ancient-document-epistemic-nihilism/.

2017 May Bring an End to the US Federal Version of the Ancient Document Hearsay Exception

Posted in Asbestos, Comparative Law, Evidence, Litigation Industry, Mass Tort Issues, Science

2016 has been quite the year, and it looks as if 2017 could be quite the year. To close out this year, a link to Nathan Schactman’s December 28, 2016 blog article regarding the likelihood that 2017 will bring an end to the federal rule for the ancient document exception to the hearsay rule. The article covers much ground and is quite helpful when thinking about various aspects of the future for the litigation industry.

On to 2017; best wishes to all!

Large Problems: Pfizer Goes Past $3.5 Billion in Payments of Fines and Settlements for Celebrex and Bextra

Posted in Litigation Industry, Mass Tort Issues

Some product liability losses are massive due to wide spread use and distribution of the products. For example, asbestos litigation is now predicted to cost insurers over $100 billion. Other large losses can arise from widely distributed drugs. For example, a  new settlement by Pfizer is for over $465 million, according to a December 21, 2016 article in LAW360.  “The underlying suit alleged that the company and its executives, including CEO Henry McKinnell, knew that drug safety studies conducted between 1998 and 2004 showed Celebrex and Bextra posed serious cardiovascular risks but hid the information from the public.” In addition, Pfizer previously paid  “$894 million to settle product liability and consumer fraud suits brought by drug users and state attorneys general, $1 billion to settle civil allegations it fraudulently promoted and marketed Bextra, and a $1.3 billion criminal fine — at the time the largest ever imposed in the U.S. — for the same fraudulent misbranding.” Thus, total payments over $3.5 billion, to say nothing of professional fees paid to defense lawyers and others.

“The Future is Now:” New Opportunities and Risks from New Science and Technology

Posted in Product Liability, Science

This week brings another example of how quickly science and technology are providing new opportunities and risks related to new products and/or liability risks.  Specifically, here’s a December 21, 2016 article from Weil explaining where things are going – quickly – on vehicles and technology as NHTSA tosses out proposed tules on vehicles being able to “talk” to each other to avoid crashes, etc. The title explains: The Future is Now: NHTSA Proposes Rule Requiring Cars to “Talk” to Each OtherThe Future is Now: NHTSA Proposes Rule Requiring Cars to “Talk” to Each Other .

Canada Announces Asbestos Ban

Posted in Asbestos, Asbestos Bankruptcy, Litigation Industry

The Canadian government announced on Thursday its plan to move forward to ban future uses of asbestos, and to more tightly regulate the workplace, not later than 2018.  The basic news is provided in a Globe and Mail story of December 15, 2016.  The government’s press release is pasted below and provides some further specifics:

“Government-wide strategy will lead to a comprehensive ban to protect the health and safety of Canadians

OTTAWA, Dec. 15, 2016 /CNW/ – Today, the Honourable Kirsty Duncan, Minister of Science, along with the Honourable Jane Philpott, Minister of Health, the Honourable Catherine McKenna, Minister of Environment and Climate Change, and the Honourable Judy M. Foote, Minister of Public Services and Procurement, announced that the Government of Canada will move forward with a whole-of-government approach to fulfill its commitment to ban asbestos and asbestos-containing products by 2018.

The approach will be guided by science-based decision making and will be implemented in consultation with our partners. Canadians can be confident that the Government of Canada is making every effort to protect their health and safety, along with the health and safety of their families, co-workers and communities.

The comprehensive ban on asbestos will include:

  • creating new regulations that ban the manufacture, use, import and export of asbestos under the Canadian Environmental Protection Act, 1999, the legislative framework that protects people from the risks associated with hazardous substances such as asbestos;
  • establishing new federal workplace health and safety rules that will drastically limit the risk of people coming into contact with asbestos on the job;
  • expanding the current online list of asbestos-containing buildings owned or leased by the Government of Canada;
  • working in collaboration with our provincial and territorial partners to change the national, provincial and territorial building codes to prohibit the use of asbestos in new construction and renovation projects across Canada;
  • updating our international position regarding the listing of asbestos as a hazardous material based on Canada’s domestic ban before next year’s meeting of parties to the Rotterdam Convention, an international treaty involving more than 150 countries that support listing asbestos as a hazard; and
  • raising awareness of the health impacts of asbestos to help reduce the incidence of lung cancer and other asbestos-related diseases.

The Government of Canada will work with the health, labour, trade and commercial sectors, among others, to fulfill its commitment to ban asbestos by 2018. The regulatory process will be open and inclusive and will allow for consultations with multiple stakeholders—including provinces, territories, communities, industry, scientists and health professionals—in advance of the ban being implemented. The result of the government’s coordinated and comprehensive actions will ensure that the health and safety of Canadians is protected at home, at work and in their communities.

Quotes

“Protecting the health and safety of Canadians is of utmost importance to the government. There is irrefutable evidence that has led us to take concrete action to ban asbestos. Canadians can be confident my colleagues and I will continue to work hard to ensure their families, co-workers and communities will be protected from the harmful impacts of asbestos exposure so they may lead healthy, secure lives.”
– The Honourable Kirsty Duncan, Minister of Science

“Across Canada and around the world, asbestos-related cancers continue to hurt Canadian families and pose a significant burden for our health care systems. Our government is taking action to protect Canadians from substances such as asbestos that can be harmful to their health and safety.”
 – The Honourable Jane Philpott, Minister of Health

“The Prime Minister made a commitment to move forward on a ban on asbestos and asbestos-containing products in Canada. Today, we are delivering on that promise. We will put in place the best regulatory measures to protect the health and safety of Canadians as we move forward towards a complete ban on asbestos.”
– The Honourable Catherine McKenna, Minister of Environment and Climate Change

“Our government took early action against asbestos by prohibiting its use in new Public Services and Procurement Canada buildings and creating a public inventory of buildings that contain asbestos that are owned or leased by PSPC. I am proud that we are building on these important first steps to prohibit the broader use of asbestos and taking a leadership role in extending our inventory to include all federal government buildings. We are committed to providing employees and the occupants and visitors of our buildings with safe and healthy environments.”
– The Honourable Judy M. Foote, Minister of Public Services and Procurement

Quick facts

  • Asbestos was declared a human carcinogen by the World Health Organization’s International Agency for Research on Cancer in 1987.
  • At the height of its use, asbestos was found in more than 3,000 applications worldwide; however, production and use have declined since the 1970s.
  • Effective April 1, 2016, the Government of Canada introduced a ban on the use of asbestos-containing materials in all new construction and renovation projects under the purview of Public Services and Procurement Canada (PSPC).
  • PSPC has published a National Asbestos Inventory of federal buildings containing asbestos that it owns or leases.
  • There are no significant health risks if materials containing asbestos in homes are tightly bound and left undisturbed.
  • The government participates in the Rotterdam Convention, whose objective is to protect human health and the environment by promoting informed decisions about the import and management of certain hazardous chemicals.”