Is Johnson & Johnson Pumping Funds into Women-Targeted Medical Device Fraud Again? Willow Breast Pump
January 3, 2019
Part 2 below part 1
Frequent readers of this site will know that Johnson & Johnson has a pathological history of unethical and illegal behavior that’s harmed employees, harmed or killed consumers and patients while costing taxpayers billions.
Johnson & Johnson finally in 2018 was in the national news for all the right reasons: Johnson & Johnson knew for decades that asbestos lurked in its Baby Powder. This website reported on this story in 2014 even pointing out that not only did Johnson & Johnson know about the asbestos link to ovarian cancer in their Baby Powder, they knowingly & willingly targeting lower-income minority women their marketing campaigns.
This beautiful sweet lady was murder by #Johnson&Johnson say no to #medicalmesh #CrimeAgainstHumanity #CleanUpYourMesh #FDA #510K #killers #twosons #youngmother #DonaldTrump #ElizabethWarren pic.twitter.com/4N5asYfPJK
— Marcie Ann Stewart (@marcie_stewart) December 1, 2017
Baby Powder would not be the first or last time Johnson & Johnson targeted women in an unethical and illegal fashion causing injury or death. Johnson & Johnson subsidiary Gynecare makers of transvaginal mesh, with at one point over 60,000 cases in federal court against the company, were found by the court to have improperly destroyed files about vaginal mesh implants.
Innovation is used as a manipulation to evade regulatory & compliance laws in many venture capital-funded medical device startups. What many unsuspecting patients contemplating the use of the latest medical device do not know is:
Most medical devices are not FDA approved, they are FDA cleared
The goal of a startup is either to be acquired by a conglomerate or IPO. On average, venture capitalists (VCs) want eight to ten times their original in ROI (return on investment) back in three to five years. As a result, sales quotas for companies aren’t based on what the medical device market can bear, but rather unethically on the investor ROI.
The confusion around medical device clearance is that they are not studied like pharmaceuticals which have clinical trials. A term often used in startups is beta testing. In the case of medical devices and in the cases of self-driving (autonomous) cars, the beta testing is being done on humans without their true understanding and or consent with the high cost of injury or loss of life.
What this means to potential medical device patients is that medical device companies do not see you as patients, they see you as sales quotas to get the company sold quickly or to IPO. Frequent readers of this site will also know that I’m the federal whistleblower who exposed venture capital-funded startup medical device fraud at Johnson & Johnson’s Acclarent. Helping the United States Department of Justice (DOJ) recover $18 million for taxpayers, remove a dangerous medical device from the world-wide market and helped convict two Silicon Valley executives, William (Bill) Facteau and Patrick (Pat) Fabian.
Acclarent was an ExploraMed incubated startup co-founded by Josh Makower & John Chang; and in-part funded by NEA (New Enterprise Associates) the world’s largest venture capital firm and Johnson & Johnson Development Corporation (JJDC), Johnson & Johnson’s venture capital arm. While Makower & Chang were not charged in the federal case against the company they both co-founded and both were patent holders on the medical device linked to healthcare fraud, they should never be far off the government or public’s radar. As explained to me by FBI agent, there’s what you know and what you can prove in court.
Johnson & Johnson cut a deal with DOJ, kicked the Acclarent executives to the feds to be charged criminally, as they should have been; but, Johnson & Johnson was knowingly & willingly complicit with Acclarent’s fraud when they in 2010 purchased the company for $785 million reduced from $820 million over concerns of fraud. Johnson & Johnson’s fraud continued from 2010 until 2013 when they negotiated behind closed doors with DOJ to remove the medical device from the world-wide market and in 2016 agreed to pay $18 million to the government in damages.
I fought very hard to prevent Johnson & Johnson’s JJDC from ever funding or working Makower & NEA again. I failed; and, more importantly, the DOJ failed. As a result Johnson & Johnson (JJDC) is still able to work with and fund Josh Makower’s ExploraMed* incubated startups & NEA. One would think that because Makower’s company caused a five-year federal investigation, costing Johnson & Johnson tens-of-millions, they would no longer want to work with him in any capacity. Sadly, I knew that Makower’s “small subtle changes” to the FDA clearance process and tossing his executives to take the #FedFall made him more desirable to a company like Johnson & Johnson.
It came to my attention earlier this week, that Johnson & Johnson’s JJDC , Josh Makower via ExlporaMedNC7 * & NEA, where Makower is also a venture capital partner, are funding the Willow Breast Pump medical device.
It should not shock anyone that I became aware of this most unholy of unions linked to medical device fraud from a victim of the Willow Breast Pump, who wishes to remain anonymous.
Part 2 will continue to explore the financial ties to funding startup medical device fraud and the harm it causes its unsuspecting victims. If you would like to be interviewed (anonymously or on the record) please email me at first and last name at gmail (Melayna Lokosky).
*per The Sociopathic Business Model™ companies linked to fraud often change their names to try and avoid accountability.
Part 2: The Venture Capital Funds Pumping up Willow® Wearable Breast Pump
Silicon Valley Incubator ExploraMed NC7, founded by Josh Makower, received Series A funding on January 21, 2015 for $15 million. Series B funding on December 11, 2017 was for $27.5 million for a total of $42. 5 million. This incubator and the funding behind it supports a woman targeted-medical device, the Willow® Wearable Breast Pump, used by an especially vulnerable group of women who are breast feeding after birth.
The two venture capitalists who funded the $42.5 million for Willow® were previous partners in funding medical devices that harm or kill women and are linked to healthcare fraud: New Enterprise Associates (NEA) and Johnson & Johnson Development Corporation (JJDC).
Working with the United States Department of Justice (DOJ) & FBI as a federal medical device whistleblower, coupled with fact-based evidence over time, has taught me that this combination:
Josh Makower’s ExploraMed incubators, NEA (where Makower is also a venture capital partner) and JJDC startups, are a huge RED FLAG for consumers and or patients.
(based on investor ROI not what the market can bear)
Give the Appearance of Hypergrowth
(underreporting & ignoring regulatory & compliance issues)
Overvaluation = Fraud
The sales numbers & quotas are based on the investors getting 8-10 times their ROI back in 3-5 years*; and, not the realistic number of women breast feeding or the ability to ethically take market share from established breast pump companies. birth.
Let’s do the math using the median numbers at the current funding:
Willow ® has $42.5 million in funding + investors want 7 X’s that back = $297.5 million
Willow® was founded in 2015 and in 4 years or 2019 (which is this year) they want to sell the company for roughly $297.5 million.
Ex: Per CDC 81% of mothers breast feed at the time of their babies birth and only 51.8 are still breastfeeding at six months.
One goal of Willow® based on the Makower formula may be to keep mother’s breast feeding longer, not because it’s better for the mother or child, but solely for the purpose of selling medical devices to ultimately get the ROI for investors. This case study is not an indictment of breast feeding (pumping) v formula, it’s solely for the purposes of explaining how the sales model could potentially cause more harm than good.
*this venture capital ROI calculation was taught to me while working for Josh Makower’s Acclarent, funded in part by NEA and JJDC.
Give Appearance of Hypergrowth:
Watch for predatory and or manipulative sales tactics which can include but are not limited to: underreporting adverse events to governmental regulatory & compliance agencies
management blaming the rep for not training properly
the company blaming/shaming the consumer
getting the run-around on promised returns or refunds
Since 2019 is potentially a critical year for Willow® to either be acquired or IPO at an estimated $297.5 million, sales would the company’s only focus. Remember the goal of a venture capital funded startups is seldom consumer/patient-centric, it’s to show hypergrowth at all costs, even human, to get the investors their ROI. From personal experience with a Josh Makower incubated, NEA & JJDC venture capital-funded startup, I was told by management & executives that medical device problems reported to the government potentially harmed the future of the company either being acquired or IPO’ing . As sales reps, we were strongly discouraged/threatened & intimidated into down-playing or ignore adverse events.
If you’re a current user of Willow® and if some of what’s been written rings true, please consider taking the steps necessary to protect you and your family. Including publicly exposing negative truthful information and or legal intervention for force accountability.
Again, this isn’t a review of the product, it’s a review of the companies funding the product. It’s up to each person reading to make the best decisions for their families.
In full disclosure, I would and will never use any product designed by, incubated by and venture capital-funded by Josh Makower ExploraMed, NEA or JJDC (and that includes all Johnson & Johnson products).
Part 3 Let’s Meet the Willow® Board and Executive Team