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Is Johnson & Johnson Pumping Funds into Women-Targeted Medical Device Fraud Again? Willow Breast Pump

Is Johnson & Johnson Pumping Funds into Women-Targeted Medical Device Fraud Again? Willow Breast Pump

January 3, 2019

Part 1

Part 2 below part 1

Part 3 below part 2

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. 

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

Most medical devices start out as a venture capital-funded startups

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.

‘Willow is a game changer’-CNBC What’s not disclosed in this quote is that Johnson & Johnson spends on average $2 billion in advertising annually, has a financial relationship with NBC and subsidiaries CNBC & MSNBC, and sponsored Mika Brzesinsk’s #KnowYourValue tour.  Oh and Johnson & Johnson  in-part funds startup Willow via Johnson & Johnson Development Corporation (JJDC), their venture capital arm.

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.

 

There is a medical device war on women and it’s funded by men: Josh Makower & Robert Croce and their link to funding startup medical device fraud continues in Part 2

 

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.

The Sociopathic Business Model™ Fraud Formula:

False Projections

(based on investor ROI not what the market can bear)

+

Give the Appearance of Hypergrowth

(underreporting & ignoring regulatory & compliance issues)

=

Overvaluation = Fraud

 

Translation breakdown:

False Projections

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

April 8, 2019

What many in media (ahem Bad Blood by John Carreyrou) are getting wrong about venture capital funded startups is they think VCs and boards were shockingly unaware of the fraud perpetrated, for instance, by Theranos CEO Elizabeth Holmes or CEO William Facteau in the Acclarent (Johnson & Johnson). Nothing could be further from the truth. Silicon Valley VCs are the architects of the fraud looking for first time, eager to prove their worth, easily manipulated into breaking the law for investor ROI, CEOs. Or what I call CEnOs (as in there’s no way in hell this person is actually qualified to be a CEO.) VCs do this because it allows them to hide behind innovation as a manipulation to evade the law while their hands remain clean; and, startup CEOs are too stupid and blinded by the billions to realize they’re being groomed to take the #FedFall when the DOJ comes a’knocking. And trust it’s going to be a rough decade for the Silicon Valley #GodsOfFrauds.

The Johnson & Johnson Acclarent fraud case made it almost impossible for VCs to get away with fraud the way they once did. Sure the CEO William “Bill” Facteau & VP of Sales Patrick “Pat” Fabian went down for the fraud the VCs funded; but, the VCs felt no financial punishment for knowingly & willingly funding startup fraud that could harm or kill consumers or patients. What the JNJ Acclarent case did though was already make it tougher for the VCs to recover their money. Theranos is the next generation of that fraud recovery. Normally, Theranos would have IPO’d leaving unsuspecting long-term shareholders holding the bag. This time though not only will Theranos CEO Elizabeth Holmes and President Ramesh “Sunny” Balwani face jail time stemming from DOJ criminal charges the added bonus is that the VCs lost all the money they invested and the hopes of getting 8-10 times their original investment back. Sadly, that progress.

Think this is just a little coincidence? Follow the recent IPO of Lyft, who is already blaming short- sellers for their use of false projections to give the appearance of hypergrowth for an overvvaluation, which is fraud. The only type of company that should be fearful of short-sellers (ahem Tesla) is one that’s built fraud into their business model, almost for inception. Or in the case of Acclarent purchased by Johnson & Johnson, fraud was built into the business model well (2004) before the product hit the market (2008), via the co-founders Josh Makower & John Chang.

Ugh those two pesky guys again? Yep the same Josh Makower & John Chang, who did not hit the learn button after barely escaping the Johnson & Johnson Acclarent fraud conviction, are back together again with some familiar faces funding breast pump startup Willow®.

So, let’s take a look at who has the most to lose if, Willow® breast pump, pardon the expression, goes tits up, like Theranos did before the IPO. Hopefully the DOJ & FBI are learning more from Acclarent & Theranos as they go; and, Silicon Valley VC investors are also met with #ForcedAccountability, or lose their original investment, future earnings from an acquisition or IPO and also see the inside of a federal prison. (Fingers crossed)

Willow CEO & President Naomi Kelman and Board Director.  C’mon, take a wild guess who Kelman used to work for?  Oh, need a little hint?

That’s right, Kelman worked for Johnson & Johnson for 10 years per her LinkedIn profile (what we in the medical device industry called a JNJ lifer-a lazy manager, who overlooks pathological fraud that harms or kills consumers or patients, and stays for the pension and discounts in the company store-no thanks!)  Maybe that’s confirmed by only 1 year at Novartis before she quickly shuffled off to her first, yes first, Josh Makower startup, a sex toy company Nuelle, on the Board of Directors.

2014 Johnson & Johnson suspiciously sold off KY Jelly because they didn’t want to fill out paperwork. Weird, it’s the same paperwork, 510(k) that was fraudulently filed with FDA in the Acclarent case, which was under seal at the time.

Wow, NEA Venture Capital Partner, Josh Makower is in bed so often with Johnson & Johnson, I bet JNJ regrets selling off the KY division, because they keep taking it up the ass from Makower, without any lube.

Note: The Willow website is missing The Meet Our Leadership including Board page. That’s a HUGE #RedFlag to consumers. If they don’t want you to know who runs the company or who’s on the board, ask yourself, why?

Reminder: Josh Makower through VC firm NEA funded transvaginal mesh startup Gynecare which sold to Johnson & Johnson; and, harmed almost 100,000 women per federal court case filings. That’s right, Makower profited from harming women’s vaginas, then came up for a sexual solution for women whose vaginas were ripping of the heads of their husband’s penises due to the Gynecare mesh perforating the vaginal wall. Think I’m kidding? Nope, please watch the amazing documentary The Bleeding Edge on Netflix (full disclosure I was interviewed for the documentary and thankfully ended up on the cutting room floor).

“Chat With a Mom,” is nothing but straight up manipulation and playing on the emotions of women who are vulnerable. I recognize women would want to speak to women but have all these Moms used the Willow breast pump?

As I’ve been writing about the fraud-tastic duo of Josh Makower & John Chang publicly since 2014, it’s become more challenging to find an executive or Board of Directors list. Hey Silicon Valley VCs, if you’re embarrassed to be seen on a company website with these, maybe that’s clue you should be in bed with them either.

Kristy Ardell Burns is the VP of Marketing at Willow according to her LinkedIn Page.

Hey Namoi and Kristy you should ask your counterparts at Josh Makower & John Chang co-founded Acclarent, William “Bill” Facteau & Patrick “Pat”Fabian, how that worked out for them? And, why Makower and Chang are inexplicably, despite being the architects of the fraud,  able to evade federal prosecution?

(P.S. I know the answer and you should find it out!)

One of many things should be clear, but the most obvious and glaring is that Josh Makower should never design or fund medical devices targeted to women. Ever. What woman hurt this sick fuck, that he pathologically and perversely makes money off of harming women?

What a shocker, NEA, who helped fund fraud at Gynecare & Acclarent are back together with Makower & Robert Croce, I thought that corpse was *retiring* during the Acclarent federal investigation, guess not.

The Willow™ Wearable Breast Pump is a complete re-imagining of the breast pump. It is the only all-in-one breast pump that fits in a bra and is mobile, discreet and hands-free, so moms can stay plugged into life, not the wall.

I’ll update with more Executives linked to Willow and a full list of Board of Directors as soon as I find time to dig through all the VC websites.

 

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