510(k) Clearance Precludes Punitive Damages in Arizona


We know the plaintiffs’ bar’s feelings about the FDA’s 510(k) clearance process. They tell the jury and the court it is antiquated. They say it does not constitute a finding of safety or efficacy. They do all they can to paint the FDA’s regulatory clearance process as meaningless and not worthy of consideration by a judge or jury. Such arguments may have some vitality in some jurisdictions. But, as we learned twice again in the last month, not in Arizona.

Back in 2012, the Arizona legislature passed a law stating that a manufacturer may not be held liable for exemplary or punitive damages if “[t]he product alleged to have caused the harm was designed, manufactured, packaged, labeled, sold or represented . . . according to the terms of an approval, conditional approval, clearance, license or similar determination of a government agency.” A.R.S. § 12-689(A)(1). The statute broadly defined “manufacturer” to include those engaged in designing, manufacturing, or formulating a product. A.R.S. § 12-689(D)(3). And it further defined “government agency” to mean any federal or Arizona agency with authority “to issue rules, regulations, orders or standards concerning the design, manufacture, packaging, labeling or advertising of a product[.]” A.R.S. § 12-689(D)(2).

Basically, under Arizona law, if a drug or medical device is approved or cleared by the FDA, then punitive damages are not available, unless plaintiffs can show that the manufacturer:

  1. sold the product after it was removed from the market;
  2. made an illegal payment to a government official to obtain product approval;
  3. intentionally, and in violation of applicable regulations, as determined by final action of the government agency, withheld from or misrepresented to the government agency information material to the product’s approval; or
  4. knowingly violated, as determined by a government agency, applicable reporting regulations concerning the product’s risks of harm.

A.R.S. § 12-689(B)

Needless to say, the statute was a game changer. But despite being on the books for nearly a decade, and after multiple cases holding that the statute serves to bar punitive damages claims, involving 510(k)-cleared medical devices, see e.g., Baca v. Johnson & Johnson, No. CV-20-01036-PHX-DJH, 2020 WL 6450294, at *6 (D. Ariz. Nov. 2, 2020); Taylor v. Bos. Sci. Corp., No. CV-19-05499-PHX-DJH, 2020 WL 4592923, at *4-5 (D. Ariz. Aug. 5, 2020); Casey v. Wright Med. Tech., Inc., No. CV-19-05360-PHX-NVW, 2020 WL 736306, at *7 (D. Ariz. Feb. 13, 2020); Hix v. Bos. Sci. Corp., No. CV-19-00422-PHX-DJH, 2019 WL 6003456, at *8 (D. Ariz. Nov. 14, 2019), plaintiffs continue to pursue such claims. Thankfully for pharmaceutical and medical device manufacturers, such efforts remain unavailing.

Within the last month, the District of Arizona has twice held on summary judgment that a plaintiff cannot seek punitive damages when the medical device at issue obtained 510(k) clearance. See Thornton v. Ethicon Inc., No. CV2000460TUCJCHEJM, 2021 WL 4437978, at *10 (D. Ariz. Sept. 28, 2021); Engleka v. Bos. Sci. Corp., No. CV-20-00925-PHX-DLR, 2021 WL 4803562, at *1 (D. Ariz. Oct. 14, 2021). In Thornton and Engleka, each plaintiff filed suit against their respective pelvic mesh manufacturers in multidistrict litigation proceedings in the Southern District of West Virginia. Both plaintiffs sought punitive damages. Upon remand to the District of Arizona, each pelvic mesh manufacturer moved for summary judgment, citing Arizona’s statutory bar on punitive damages. In both cases the court agreed with the manufacturers.

There is no dispute that the FDA cleared Defendants’ TVT-O device to be marketed in the United States. Arizona law bars a claim for punitive damages where the product at issue was designed, manufactured, packaged, labeled, sold, or represented in relevant and material respects according to the terms of an approval, conditional approval, clearance, license, or similar determination of a government agency. This Court finds that Ariz. Rev. Stat. § 12-689 bars Plaintiff’s punitive damages claim.

Thornton, No. CV2000460TUCJCHEJM, 2021 WL 4437978, at *10. Accord Engleka, No. CV-20-00925-PHX-DLR, 2021 WL 4803562, at *1 (“Boston Scientific argues that Engleka cannot recover punitive damages because the Obtryx and Uphold were cleared by the FDA at the time they were implanted. Boston Scientific is correct. . . . the FDA did not determine that Boston Scientific had withheld or misrepresented material information. Engleka therefore cannot recover punitive damages in this case.”).

These rulings add to a growing body of case law in the District of Arizona holding that, in the absence of a government determination of (essentially) fraud on the agency, drug and device manufacturers cannot be subject to punitive damages awards under Arizona law when the product at issue has received FDA approval or 510(k) clearance.

The material contained in this communication is informational, general in nature and does not constitute legal advice. The material contained in this communication should not be relied upon or used without consulting a lawyer to consider your specific circumstances. This communication was published on the date specified and may not include any changes in the topics, laws, rules or regulations covered. Receipt of this communication does not establish an attorney-client relationship. In some jurisdictions, this communication may be considered attorney advertising.

About the Author: Elie Biel

Elie Biel helps clients defend, resolve, prevent and manage medical device and pharmaceutical product liability litigation throughout North America. Drawing upon his on-the-ground litigation experience and intimate understanding of the medical field, Elie works with clients in the medical device, pharmaceutical and health care industries to evaluate the strengths and weaknesses of their cases and helps them manage risk and pursue favorable solutions through arbitration, mediation, settlement or trial.

©2024 Faegre Drinker Biddle & Reath LLP. All Rights Reserved. Attorney Advertising.
Privacy Policy