Showing all posts written by Michael Christensen
Mr. Christensen also has extensive experience conducting patent due diligence for leading Venture Capital firms and other investors. He has also performed several IP audits to help companies identify ways to improve their patent portfolio. One of Mr. Christensen’s areas of expertise is developing strategies for expediting patent prosecution both in the United States and abroad. Prior to joining the firm, Mr. Christensen clerked with firms in Seattle, Salt Lake City and Irvine. While pursuing his undergraduate degree in electrical engineering, Mr. Christensen served as a Teaching Assistant in a semiconductor device fabrication lab in addition to taking courses focusing on digital system design and digital communication theory.
Mr. Christensen was a summer associate with the firm in 2007 and he joined the firm as an associate in 2008.
In a move that may substantially increase healthtech companies’ exposure to monetary damages, the U.S. Supreme Court agreed to weigh in on the key standard for fraud lawsuits under the False Claims Act (“FCA”). On January 13, 2023, the Supreme Court granted petitions for writs of certiorari in two now-combined 7th Circuit Court whistleblower fraud lawsuits that address the fraud standard– Schutte v. Supervalu Inc. and Proctor v. Safeway.
The FCA imposes monetary damages on persons and companies that defraud the government by “knowingly” submitting to the government false claims for payment, or “knowingly” making false statements in support of such claims. Lawsuits under the FCA may be filed by the government or by a private party, such as a whistleblower.
In the underlying cases, the 7th Circuit held that a company can shield itself from fraud lawsuits if the company’s lawyers can show that the company’s conduct was consistent with an erroneous but “objectively reasonable” interpretation of the law, regardless of the company’s subjective beliefs. However, some judges and commentators have opined that “subjective bad faith” can establish the necessary intent.
The Supreme Court will now hopefully resolve this issue of whether and when a defendant’s contemporaneous subjective understanding or beliefs about the lawfulness of its conduct are relevant to whether it “knowingly” violated the FCA.
The total annual amount of recovery under the FCA is substantial and may likely to continue to increase, especially if the Supreme Court removes the “objectively reasonable” shield. According to the Department of Justice (“DOJ”) website, the DOJ obtained more than $5.6 billion in settlements and judgments from civil cases involving fraud and false claims against the government in the fiscal year ending Sept. 30, 2021, which was the second largest annual total in history. Numbers for the 2022 fiscal year should be released shortly.
Of the $5.6 billion in recovery in the 2021 fiscal year, over $5 billion relates to matters that involved the health care industry. For example, as recently reported in a prior Knobbe Medical blog post, a medical device developer Advanced Bionics LLC stated that it will pay about $12 million to resolve allegations that it misled federal health care programs.
Medtronic plc and DaVita Inc. are joining forces to form a new, independent medical device company to provide enhanced kidney health care. The new company will focus on making different dialysis treatments more accessible to patients, especially at-home patients.
According to the joint press release on May 26, 2022, the new co-owned company “will focus on developing a broad suite of novel kidney care products and solutions, including future home-based products, to make different dialysis treatments more accessible to patients.”
During a May 26, 2022 earnings call, Medtronic CEO, Geoff Martha, stated that this joint venture had “been under consideration for a while” and that both Medtronic and DaVita will get to “participate in the expected upside.”
Medtronic will spin out its existing renal care product portfolio into the new company, as well as its product pipeline, global manufacturing, and R&D teams and facilities in the renal care solutions sector. As one of the largest providers of kidney care services in the U.S., DaVita will contribute its depth of knowledge and expertise in providing kidney care to patients in hospitals, outpatient dialysis centers, and at home. Medtronic and DaVita will each contribute approximately $200 million in cash to launch the new company, according to a regulatory filing submitted to the Securities and Exchange Commission.
The CEO of the new company will be Ven Manda, who is currently the president of Medtronic’s Renal Care Solutions business and who has worked for Medtronic for more than 20 years. In the press release announcing the proposed joint venture, Ven Manda emphasized:
Our singular focus on end-to-end kidney health solutions will position this new company to make a measurable difference in the lives of more than three million patients with kidney failure globally-a figure expected to double over the next decade.
The new company is expected to be formed in 2023.
The announcement of this new joint venture comes concurrently with Medtronic’s announcement during a recent earnings call that it experienced a 2021 Q4 shortfall relative to its expected revenue . Medtronic stated that the shortfall was primarily due to COVID lockdowns in China and global supply chain challenges.
On December 13, Baxter International Inc. (“Baxter”) announced the completion of one of the biggest medtech acquisitions of 2021, acquiring Hillrom (a global medical equipment maker headquartered in Chicago) for a purchase price of ~$10.5 billion. The deal had originally been announced by Baxter in September 2021.
According to a statement on Baxter’s website, “Baxter’s acquisition of Hillrom has formed one of the world’s leading medical technology companies, centered around a shared vision to transform healthcare.”
Baxter’s product portfolio includes diagnostic, critical care, kidney care, nutrition, and surgical products used in hospitals, physician offices, and patient homes. According to Baxter, the addition of Hillrom’s product lines, including legacy Welch Allyn products that were acquired by Hillrom in 2015, will help Baxter improve care outcomes and broaden access to care. Hillrom’s products include the MacroView® Plus Otoscope, the Volara™ Oscillation & Lung Expansion Therapy System, the PST 500 Precision Surgical Table, and the Centrella® Smart+ Bed.
In a press release, Baxter’s chairman Jose E. Almeida stated:
The Baxter-Hillrom combination unlocks the next phase of our transformation, presenting a new wave of potential to drive greater impact for patients, clinicians, employees, shareholders and other communities we serve worldwide. Integrating our complementary capabilities introduces additional opportunities for growth across our broad geographic footprint and also creates remarkable new possibilities for connectivity with leading-edge digital health innovation focused on enhancing care, lowering costs and increasing workflow efficiency.
According to the press release, Baxter expects the combination to result in ~$250 million of annual pre-tax cost synergies within 3 years.
Medical Device Trade Secret Not Publicly Disclosed via Patenting, Displaying, and Selling Covered Product, 7th Cir. Affirms
Can certain specific medical device details remain company know-how or protected trade secrets even if patents are pursued on the medical device? Consider the Seventh Circuit’s commentary in its August 9, 2021 decision upholding a preliminary injunction in the Life Spine, Inc. v. Aegis Spine, Inc. case. The preliminary injunction prohibits Aegis from selling or marketing its competing AccelFix product (shown below, right) until the case is resolved on the merits.
Aegis argued in appealing the preliminary injunction that the district court erred in concluding that information about the ProLift device could remain a protected trade secret after Life Spine patented, displayed, and sold the device to hospitals and surgeons. However, the Seventh Circuit held that “Aegis does not come close to showing that [the district court’s] finding was clear error.” The Seventh Circuit stated that Aegis had not proven that Life Spine’s patent materials disclose the “exact dimensions and measurements of every ProLift component.” In addition, the Seventh Circuit stated that “those who attend ProLift displays do not have unfettered access to the device” and that “the only purchasers of the ProLift are hospitals and surgeons, who purchase the device for use in scheduled surgeries.”
Regarding the patent materials, a figure of which is shown below, the Seventh Circuit noted that “Life Spine’s patent did not disclose the precise specifications of the ProLift” devices. The Seventh Circuit recognized that such dimensions could only be learned by someone who has access to the device and sophisticated measurement technology. As for public displays, the Seventh Circuit noted that Life Spine representatives supervise those who attend ProLift displays as they handle the devices.
Regarding sales of the ProLift device, the Seventh Circuit noted that Life Spine or its distributors ship the ProLift in sealed boxes and that the surgeries are overseen by Life Spine representatives or distributors. The Seventh Circuit further noted that “it seems doubtful that the hospitals or surgeons purchasing the device . . . would secretly unpackage the device [and] measure all its components with specialized measurement technology” and that it “seems even more unlikely that a device would be removed from a patient’s body and then reverse engineered.”
Following this decision, the case will return to the United States District Court for the Northern District of Illinois to continue on the merits.