Kibler Fowler & Cave LLP’s Post

KF&C appellate win! When you win big at the trial court level, adversaries are motivated to appeal. This is why it's important to have a sharp appellate practice as part of your overall strategy.

How to developers 21CFR case Defanging the dogs Yesterday I posted a short post in 21CFR litigation instead of a fools case, commercial trade secret litigation, defendant or plaintiff. So how do you developers 21CFR case? Use discovery to explore all FDA files for the devices you are the plaintiff or defendant in the suit. Start out with the initial and all supplemental FDA filings. As was found in the Philips Texas case according to the FDA Philips filed all 3663 information in Philips 510k filings, initial reports. Sure enough there were references to all requirements of the 3663 for the Ingenia MRI. So where’s the commercial trade secrets Philips claims? Subpoena, MAUDE, 483 inspections, recalls, corrective actions, enforcement reports, 510k, PMA, CAPA, foreign agencies filings similar to the FDA’s correspondence and all other FDA correspondence. Subpoena consent decrees, DOJ, State investigations other lawsuits involving the devices you are being sued for or suing on. Foreign standards, VA, DOD, other Federal and State bids or contract awards including sales bids (this sets it up for debarment in government contracting). FCC, OSHA, HHS, HIPPA files, NIST correspondence and other non FDA correspondence related to the device. Depose the registered agent, the person on the 510k filing and the executive in charge of compliance. Depose outside consultants who performed audits and CAPA’s. Forget FDA officials. They have a shield law to protect them. This has never been done in ISO litigation. Why? A number of tactics are used including the tacit threats by big companies that dissuade lawyers from exposing their firms to big company dogs. Going after FDA issues as a plaintiff or defendant levels the field and gets to the truth in litigation. Exposing an OEM’s FDA patterns and practices makes OEM’s threats like this “tell Quinn to get the FDA off our ass or we’ll be in his face the rest of his life” Picker lawyer James Ditmar made that threat to me through my attorney. That threat didn’t work out to well for Picker. 21CFR cases not only get to the truth in litigation patient safety is protected when the truth prevails. Unlike commercial trade secrets, 21CFR trade secrets on medical devices cannot begin until adequate information instructions are provided by the OEM’s and any disputes are resolved by the FDA, as the Philips letter from the FDA states in the TEC litigation. So what does a lay person need under 21CFR? As the saying goes TBD, to be determined in each lay persons adequate request. That’s why commercial trade secret cases fail to get to the heart of litigation and why OEM’s will run from 21CFR litigation. The simple words adequate and lay persons or owners, or others as 21CFR states . Is there any OEM crazy enough to risk the liability in 21CFR litigation just to sue, settle and seal? Well maybe a few. Try it if needed as a defendant or plaintiff and hire good lawyers.

One last item in defanging the dogs Subpoena all sales records, agreements, information provided, and other information for customers buying non medical devices, especially RF devices like MRI’s. And especially veterinary, testing labs, QC testing, industrial operations and gov MRI scanners used in non medical applications, MRI installations. This ties into FCC records and the FCC requirements for ISM information similar to the FDA 3663. All of the above requires schematics, maintenance, testing and more information considered to be trade secret in medical RF devices, like MRI. Outside of 21CFR there’s 47CFR. Is an OEM crazy enough to defy the FDA and FCC? Government contracts will have double jeopardy so to speak. Again, there are a few,

Why Is Arbitration Ideal for Resolving Cannabis Disputes? Today’s (September 13th) panel discussion on cannabis arbitration, skillfully moderated by AAA-ICDR's Lance Tanaka, highlighted the unique benefits of ADR for the cannabis industry. With speakers like Tom Downey, Kyle-Beth Hilfer, and Gary Michael Smith, we gained insightful perspectives on how arbitration can help cannabis companies resolve disputes efficiently while avoiding the uncertainties of litigation. Key takeaways: · Arbitration offers confidentiality, avoiding publicity of disputes · The process is expedited compared to crowded court systems · Arbitrators can be chosen for their expertise in cannabis issues · Relief can be tailored to companies' specific needs Kudos to Lance and the panelists for an illuminating discussion. As co-chair of the New York State Bar Association Commercial & Federal Litigation Section's Arbitration and ADR Committee with Charlie Moxley, I'm proud we hosted this valuable program. More companies are recognizing arbitration as the ideal solution for cannabis disputes. For the recording of this CLE, see the following link: https://lnkd.in/df_pKgC Anne Sekel, Ignatius Grande , Daniel K. Wiig, J.D, M.B.A. , Mansi Karol , Lisa Romeo, Jennifer Rego , Svetlana Gitman , Aaron Gothelf, Esq. , Iman H. , Angela Romero-Valedón, Esq. , Michelle Skipper , Rafael Carlos del Rosal Carmona , Nerissa Diaz Moisan, Luis Martinez , May Li, Esq. , Sarah Clayton , Usher Winslett, FCIArb , Bryan Corbett

Major Legal Victory! For those who are unaware: 1. Elliot Lewis (CEO of Catalyst Cannabis Co. ) used basic arithmetic and publically available data to demonstrate how Glass House maybe one of the largest sources of diverted cannabis in the Country by employing the burner distribution system. 2. Glass House files a defamation case against Elliot Lewis and Catalyst Cannabis Co. claiming the statements false and malicious. 3. After a year, the trial court ordered Glass House to produce discovery, including details of its distribution partners and network (evidence that would likely make or break the defamation case). 4. However, Glass House refused to produce the documents and resisted every attempt to comply with a court ordered production. 5. Now, instead of complying with the discovery order, Glass House elects to drop the defamation claim in its entirety without notice and without settlement. I’ll let the community decide what Glass House is “saying” by dropping the defamation claim. A huge thank you to our counsel, Jeff Augustini. You never fail to deliver for Catalyst Cannabis Co.

Partners Allyson A. Avila and Justin Puleo and Senior Counsel Jason C. Kalkirtz, Esq. presented "Why Legal Guidance is Imperative Before Opening an IV Hydration Therapy Business" for a live webinar hosted by the American IV Association on August 22, 2023. This presentation covered the IV hydration therapy industry, current regulations in various states, and workplace training best practices to protect your business, customers, and employees. They also answered IV providers' most frequently asked questions. Learn more below. #healthcarelaw #ivtherapy #law #lawfirm #litigation #legal #lawyer #grsm #gordonrees #your50statepartner

MRI information access and defeating Philips litigation strategy While the FDA’s release of Philips Ingenia MRI records on file in the 510k filings was useful, another filing that will open the door to defeat claims of proprietary trade secrets is a FOIA to the FCC for the MRI technical reports on file with the FCC which requires the actual manuals to be filed. All of this is independent of the FDA but these manuals should be on file with the FDA form 3663 If a manufacturer of MRI’s does not file these documents with the FCC that’s a completely independent action that the FDA cannot interfere with. With the massive litigation efforts by Phillips and Philips litigation strategy you might want to, for pre litigation, FOIA the technical reports at the FCC for the information that’s available to you as a litigation deterrent, stop it before it begins, and to request adequate information instructions from OEM’s that are filed with the FCC. These manuals are also available through another FOIA. What Phillips told and supplied to the VA, DOD other federal and state medical facilities biddings. From my experience Phillips plays a catch us if you can strategy, relying on self interpretation, with Philips requirements to exempt the information instructions in the CFR’s for manuals and software from litigation and if Philips is exposed during litigation it’s just a cost of litigation for you. Stop that tactic before it starts and deter lawsuits from Philips Sue settle and seal is a costly experience for you Just my opinion and experience. I hope it helps you. Always remember adequate manuals and software at a lay persons level, as required, in dealing with OEM’s.

On May 15, 2024, the Georgian Parliament passed the law "On Patent Attorneys of Georgia" during its third reading. This new legislation will regulate patent attorneys' qualification, registration, and professional activities, as well as establish and oversee the Association of Patent Attorneys. The adoption of this law has led to amendments in both the "Patent Law of Georgia" and the Law of Georgia "On Entrepreneurs." These changes aim to harmonize existing laws with the new regulations stipulated in the "On Patent Attorneys of Georgia" law. A significant aspect of this reform is the introduction of a new qualification examination standard for patent attorneys, along with a mandatory requirement for professional liability insurance. The legislative process was notably influenced by the active involvement of patent attorneys, whose contributions and recommendations were crucial in shaping the final draft of the law. Their input ensured that the legislation addressed the practical needs and concerns of the profession. The legislative package was presented to Parliament by Vakhtang Bachiashvili, the parliamentary secretary of the government. The implementation of this law is expected to create a modern and dynamic institution focused on professional development and innovation. This will enhance the protection of intellectual property in Georgia and support the overall growth and development of the field. For any inquiries regarding intellectual property matters in Georgia, please contact us at mail@so-ipr.com. #IntellectualProperty #Georgia #SOIP

Thanks to the opportunities and innovations our clients trust us with, Foley is proud to once again be ranked as a top firm in total U.S. utility patents issued. Click the article below to learn more. #IntellectualProperty #PatentLaw #HappyAtFoley

Thanks to the opportunities and innovations our clients trust us with, Foley is proud to once again be ranked as a top firm in total U.S. utility patents issued. Click the article below to learn more. #IntellectualProperty #PatentLaw #HappyAtFoley