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Posts Tagged ‘FDA’

Coverage for unclean hands? Plaintiffs Say Manufacturer Misrepresented Sanitizer’s Effect on Coronavirus

Posted on: March 25th, 2020

By: Renata Hoddinott and Barry Miller

On March 23 FMG presented the webinar Navigating Coverage Issues Arising from COVID-19. Presenters Marc Shrake, Erin Lamb, and Barry Miller discussed four lawsuits that already have been filed alleging claims related to coronavirus.
A few additional cases bear mentioning, and there will be many more to come.

In class action David v. Vi-Jon, Inc.¸ 20-CV0424, S.D. Cal. March 5, 2020 , a putative class alleges that Germ-X, a Vi-Jon product, is “advertised, marketed and sold as a Product that will prevent or reduce infection from the flu and other viruses, including the coronavirus.”

The David Complaint notes that on January 17, 2020, the Food and Drug Administration issued a warning letter to Purell regarding advertising that its hand sanitizer could prevent infection from flu and other viruses. The FDA letter says nothing about coronavirus, which given its date is not surprising. But it does chastise the maker of Purell for its advertising and social media posts that “clearly indicate your suggestion that PURELL® Healthcare Advanced Hand Sanitizers are intended for reducing or preventing disease from the Ebola virus, norovirus, and influenza.” Because Germ-X’s formula is nearly identical to Purell, the David Complaint states that the FDA letter applies equally to Vi-Jon.

Vi-Jon was already the subject of a class action suit filed a month earlier alleging similar promises that its product would prevent the transmission of flu also were misleading. The putative class in Sibley et al v. Vi-Jon, Inc., Case No. 20-cv951, N.D. Cal., February 7, 2020 also alleges the FDA letter to Purell should apply to Vi-Jon.

David alleges (¶ 50) that—by stating that Germ-X kills 99.9 percent of germs—Vi-Jon implies that Germ-X kills 99.9 percent of viruses and bacteria, preventing and reducing illness. Sibley, in turn, alleges that consumers were misled about the effectiveness of alcohol-based hand sanitizer and that Vi-Jon duped consumers into thinking their product (Germ-X) would fight the flu virus despite no clinical studies showing alcohol-based sanitizers reducing instances of the flu. Similarly, the January 17 FDA letter states that the agency “is currently not aware of any adequate and well-controlled studies demonstrating that killing or decreasing the number of bacteria or viruses on the skin by a certain magnitude produces a corresponding clinical reduction in infection or disease caused by such bacteria or virus.”

Both lawsuits allege claims under California consumer protection laws prohibiting false advertising and unfair competition. The David lawsuit adds common law claims for negligent misrepresentation and intentional misrepresentation.

False advertising may raise issues under Coverage B (“Personal and Advertising Injury”) under the standard Commercial General Liability Policy. Under the CGL definitions “Personal and Advertising Injury” only occurs if an enumerated “offense” is alleged or proved. In the ISO form those offenses are:

  • False arrest, detention or imprisonment;
  • Malicious prosecution;
  • The wrongful eviction from, wrongful entry into, or invasion of the right of private occupancy of a  room,  dwelling  or  premises  that  a  person occupies,  committed  by  or  on  behalf  of  its owner, landlord or lessor;
  • Oral or  written  publication,  in  any  manner, of material  that  slanders  or  libels  a  person  or organization   or   disparages a person’s  or organization’s goods, products or services;
  • Oral or  written  publication, in any manner, of material that violates a person’s right of privacy;
  • The use  of  another’s  advertising  idea  in  your “advertisement”; or
  • Infringing upon another’s copyright, trade dress or slogan in your “advertisement”.

None of these enumerated offenses expressly include false advertising or misrepresentations to consumers.

Coverage A is triggered by allegations of “Bodily Injury” to a third person or “Property Damage” suffered by a third person. The Complaints do not appear to allege bodily injury. In fact, the only specific damage claimed is that the class would not have bought Germ-X but for the advertising or representations of Vi-Jon. Thus, they allege, Vi-Jon holds money that should belong to the class. But the taking of money without right does not constitute “property damage” in many states, including California.

Another case worth reading is Welch Foods, Inc. v. Nat’l Union Fire Ins. Co., No. 09-12087-RWZ, 2010 U.S. Dist. LEXIS 110004 (D. Mass. Oct. 1, 2010) where a competitor alleged that Welch’s pomegranate juice was made mostly from apples. The court found no coverage for false and misleading advertising under three different policies and four different coverages:

  • There was no coverage under the GL for advertising injury.
  • A “Media Wrongful Act” coverage did not apply because (among other reasons) it covered “errors or omissions” in publications or broadcasts, and the complaint alleged intentionally false advertising.
  • “Professional Services Wrongful Act” coverage did not apply because there were no allegations that the advertiser was engaged in professional services, or that such coverage applies to claims from competitors.
  • A policy providing coverage for claims arising from an alleged “Wrongful Act” defined wrongful act to include a “misleading statement.” While the allegations may have fallen within that insuring agreement, the policy contained an exclusion for claims arising out of unfair competition or deceptive trade practices, among other business practices. Because the Complaint alleged such practices the exclusion applied.

Both Germ-X lawsuits, as well as any further actions that may be filed in the coming weeks and months, merit continued monitoring to see if coverage issues arise under these kinds of policies or others.

Additional information: 

The FMG Coronavirus Task Team will be conducting a series of webinars on Coronavirus issues every day for the next week. We will discuss the impact of Coronavirus for companies in general, but also for business in insurance, healthcare, California specific issues, cybersecurity, and tort. Click here to register.

FMG has formed a Coronavirus Task Force to provide up-to-the-minute information, strategic advice, and practical solutions for our clients. Our group is an interdisciplinary team of attorneys who can address the multitude of legal issues arising out of the Coronavirus pandemic, including issues related to Healthcare, Product Liability, Tort Liability, Data Privacy, and Cyber and Local Governments. For more information about the Task Force, click here.

You can also contact your FMG relationship partner or email the team with any questions at [email protected].

**DISCLAIMER: The attorneys at Freeman Mathis & Gary, LLP (“FMG”) have been working hard to produce educational content to address issues arising from the concern over COVID-19. The webinars and our written material have produced many questions. Some we have been able to answer, but many we cannot without a specific legal engagement. We can only give legal advice to clients. Please be aware that your attendance at one of our webinars or receipt of our written material does not establish an attorney-client relationship between you and FMG. An attorney-client relationship will not exist unless and until an FMG partner expressly and explicitly states IN WRITING that FMG will undertake an attorney-client relationship with you, after ascertaining that the firm does not have any legal conflicts of interest. As a result, you should not transmit any personal or confidential information to FMG unless we have entered into a formal written agreement with you.  We will continue to produce education content for the public, but we must point out that none of our webinars, articles, blog posts, or other similar material constitutes legal advice, does not create an attorney client relationship and you cannot rely on it as such. We hope you will continue to take advantage of the conferences and materials that may pertain to your work or interests.** 

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.