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Posts Tagged ‘FDA’

New Medical Devices and Performance Criteria

Posted on: February 12th, 2019

By: Koty Newman

The Food and Drug Administration (“FDA”) recently issued final guidance (the “Guidance”), providing a framework for its new Safety and Performance Based Pathway for its updated 510(k) process. Section 510(k) of the Food, Drug and Cosmetic Act requires medical device manufacturers to notify the FDA of their intent to market a medical device. Notification enables the FDA to determine if the product is equivalent to a device already on the market, which by extension, helps the FDA determine if the device is at least as safe and effective as the already marketed device.

The FDA’s Safety and Performance Based Pathway evidences the FDA’s recognition that it may be less burdensome for device manufacturers to show a new device’s substantial equivalence to a predicate device by demonstrating that the new device meets certain performance criteria, rather than directly testing the new device against a predicate device. Thus, “[i]nstead of reviewing data from direct comparison testing between the two devices, FDA could support a finding of substantial equivalence based on data showing the new device meets the level of performance of appropriate predicate device(s),” the Guidance states. In order to discern the requisite performance criteria, manufacturers should look to descriptions in FDA guidance, FDA-recognized consensus standards, and special controls.

The Guidance states that the “FDA believes that use of performance criteria is only appropriate when FDA has determined that (1) the new device has indications for use and technological characteristics that do not raise different questions of safety and effectiveness than the identified predicate, (2) the performance criteria align with the performance of one or more legally marketed devices of the same type as the new device, and (3) the new device meets all of the performance criteria.” Further, a manufacturer may use this program only if the manufacturer can rely entirely on performance criteria to demonstrate substantial equivalence. The FDA will still require that a manufacturer identify a predicate device in order for the FDA to determine the relevant intended use and technological characteristics decision points.

The FDA will maintain a list of device types that are appropriate for the Safety and Performance Based Pathway on its website, along with other information that will be helpful for manufacturers intending on navigating this particular Pathway, such as “guidances that identify the performance criteria and testing methods recommended for each device type.”

This policy represents an expansion of the long-applied approach by the FDA, giving device manufacturers an additional pathway to demonstrate substantial equivalence. For the manufacturers who cannot, or prefer not to, rely on this Safety and Performance Based Pathway, direct comparison with a predicate device will remain available to determine whether the new device is substantially equivalent to a predicate device.

The FDA is also seeking public comment on questions such as whether it should make public a list of devices or manufacturers who make products that rely on older predicates, such as predicates that have been on the market for ten-or-so years, and whether there are actions the FDA could pursue to promote the use of more current predicates. The public will have until April 22, 2019 to comment.

If you have any questions or would like more information, please contact Koty Newman at (678) 996-9122 or [email protected].

Eleventh Circuit Rules Florida Strict Liability and Negligence Claims Not Preempted by the MDA

Posted on: February 12th, 2018

By: Robyn Flegal

A panel of the Eleventh Circuit determined in a February 8, 2018 published decision that a Florida district court erred when it ruled that a husband’s claims, brought against a medical device manufacturer after its Life Vest defibrillator failed to shock his wife’s heart, were preempted by federal law.

A defibrillator is worn by patients at risk of sudden cardiac arrest. It delivers a dose of electric current to the heart, depolarizing the heart muscle and ending dysrhythmia. The lower court dismissed the action in January 2017, ruling that the claims against the manufacturer were preempted by the Medical Device Amendment of the Food, Drug and Cosmetic Act. The FDA previously determined the Life Vest device was safe, and the district court agreed with the manufacturer that the allegations improperly contradicted the FDA’s prior approval of the product.

The Eleventh Circuit disagreed with the lower court’s ruling, deciding that the claims were not preempted. The court reasoned that the strict liability and negligence claims were not preempted by the federal regulations because the plaintiff alleged the defect was due to the manufacturer’s purported failure to comply with these regulations—which then caused a violation of Florida’s laws. The Court considered that a 2014 FDA warning letter put the manufacturer on notice that it was in violation of certain regulations. That letter can, now, serve as a basis for the plaintiff’s claims—even though the letter referred to shocks being delivered to patients who did not need them, as opposed to the failure to deliver shock to patients who needed them (as allegedly experienced by the plaintiff’s wife). The Court determined that the complaint’s references to the letter sufficiently stated a claim that was plausible on its face despite this disconnect between the warning letter and facts relating to the plaintiff’s wife’s use of the product.

Medical device manufacturers should be aware of the Eleventh Circuit’s ruling that claims of strict liability and negligence may not be preempted by the Medical Device Amendment. Such manufacturers should be particularly cognizant of this Eleventh Circuit decision where they have received an FDA warning letter.

For more information, please contact Robyn Flegal at [email protected].

11th Circuit Does Not Mesh Around and Upholds $27M Judgment

Posted on: November 13th, 2017

By Samantha Skolnick

In a recent decision by the U.S. Court of Appeals for the Eleventh Circuit, the Court upheld almost $27 million in judgments against Boston Scientific Corporation (BSC). The consolidated cases stemmed from women who claimed to have had complications from their surgeries using BSC’s Pinnacle Pelvic Floor Repair Kit to correct pelvic organ prolapse. The complications included exposure of pieces of mesh requiring further surgical procedures, loss of vaginal sensitivity, pelvic pain and pressure, incontinence and painful intercourse.

After a jury trial in 2014, each woman was awarded more than $6 million dollars. On appeal, the Eleventh Circuit held that the district court exercised the appropriate amount of discretion when it consolidated the actions and when it disallowed certain FDA evidence. The FDA evidence was related to the regulatory scheme and clearance of the Pinnacle for sale pursuant to the 510 (k) “substantial equivalence” process. The Court excluded this evidence under Fed. R. Evid. 402 and 403 on the basis that it was irrelevant and prejudicial. In so doing, the Court found that positive completion of the Section 510(k) process was immaterial to the product’s safety. The Court cited to the district court’s explanation that “[i]f 510(k) does not go to a product’s safety and efficacy — the very subjects of the plaintiffs’ products liability claims — then evidence of BSC’s with 510(k) has no relevance to the state law claims in this case.” The Court found that the concern with prejudice and confusion substantially outweighed the probative value of the evidence, which separated from any clear showing of safety review for the device or a device of a similar nature was minimal. The evidence had diminished probative value because 510(k) “operate[s] to exempt devices from rigorous safety review procedures.”

The key take away: the Federal Rules of Evidence and the ever-present 403 balancing test must always be in the back of your mind, especially in products liability cases.  An entire case can fall apart at the stitches (or sutures) when evidence is deemed inadmissible when the probative value does not outweigh the prejudice.

If you have any questions or would like more information, please contact Samantha Skolnick at [email protected]

FDA Continues to Fight the First Amendment But Facteau Deals Another Blow

Posted on: August 18th, 2016

By: Kristian Smith

Last month, a federal jury in Massachusetts acquitted two executives of medical device company Acclarent, Inc. of 14 felony counts of fraud related to off-label promotion of Acclarent’s “Stratus” device. United States v. Facteau, et al. stemmed from the distribution of Acclarent’s Relieva Stratus Microflow Spacer (“Stratus”) for off-label use. Although Stratus was cleared by the FDA as a medical device intended to maintain an opening to a patient’s sinus and provide moisture by using a saline solution, Acclarent’s CEO, William Facteau, and Vice President of Sales, Patrick Fabian, promoted the product off-label, as a steroid delivery device. The FDA claimed that Facteau and Fabian had misbranded the device and had committed fraud on the FDA by intending to use the device in a way other than its cleared use.

Although Facteau and Fabian were convicted on 10 misdemeanor counts relating to the same charges, the jury still accepted that it is not a crime for device manufacturers to make truthful, non-misleading statements about off-label use. The jury instead convicted Facteau and Fabian based on their conduct, mainly because of a violation of the Park Doctrine, which provides that responsible corporate officers can be liable for misdemeanor violations of the Federal Food, Drug and Cosmetic Act (“FDCA”) even if the corporate officer had no intent to commit, or even knowledge of, the offense.

This is only one of many recent victories for medical device companies in the off-label promotion realm.

In February, a Texas jury acquitted medical-device manufacturer Vascular Solutions and its CEO of all counts in a criminal case that alleged the company illegally promoted Vari-Lase, a device to treat varicose veins, off-label. The Vascular Solutions case was particularly memorable for the trial judge’s jury instruction that it is not a crime for a device company to provide doctors with truthful, non-misleading information about off-label product uses. This was a significant blow to the FDA’s long-standing practice of discouraging (and prosecuting) off-label promotion.
In 2015, in Amarin Pharma, Inc. v. FDA, a federal judge in New York found that Amarin, a drug manufacturer, was entitled to engage in truthful and non-misleading speech promoting the off-label use of its medical device, and such speech could not form the basis of a prosecution for misbranding. This decision was based in large part on the Second Circuit’s 2012 watershed decision in U.S. v. Caronia, where the Court held that to avoid infringing on the First Amendment, misbranding provisions of the FDCA could not be construed to prohibit and criminalize truthful off-label promotion of FDA-approved drugs.

Even with more and more federal courts embracing Caronia, the FDA continues to prosecute drug and device manufacturers (and their corporate officers) for off-label promotion. With the decisions in Facteau and Vascular Solutions, though, it looks like the FDA will have a more difficult path to prosecution than ever before.

FDA Approves First Drug Made by 3D Printing

Posted on: September 1st, 2015

By: Mike Bruyere

Additive manufacturing, or 3D printing, reached a significant milestone this month when the FDA approved the production of an epilepsy medication that will be marketed under the name Spritam.  The new drug, developed by Aprecia, controls seizures brought on by epilepsy, and is the first drug produced by a 3D printer to receive the FDA’s imprimatur.

3D printing was invented over thirty years ago by a brilliant engineer, Chuck Hull. At its most fundamental level, 3D printing began as the modification of an ink printer to utilize various materials as the “ink” or powder to build vertical levels of a design. In successive passes of the build process, the printing jet is slightly raised and the printed material is added onto the previous layers.

3D printing enables medical providers to rapidly produce devices like customized artificial limbs, dental devices, and exterior bracing (such as braces used to treat scoliosis).  Accordingly, the availability of high-quality and low-cost devices is spreading geographically and throughout the health care industry. 3D printing applications are currently in use or development for pumps, stents, coils, surgical guides and a host of orthopedic applications.

As with myriad other applications in the life sciences industry, 3D printing of medicines brings the manufacturing process much closer to the patient, but it also raises potential issues concerning who is considered the actual manufacturer of the drug from a products liability standpoint.  For example, is Aprecia considered the manufacturer, or are other entities involved in the design, testing, manufacturing (such as the manufacture of the 3D printer), and distribution of the drug also at risk?  Additionally, while life sciences advances such as Spritam hold the promise of lower health care costs and more readily available drugs, the implications for misuse of this technology, particularly in the area of illegal designer drugs, cannot be understated.