Nelson v. Anika Therapeutics, Inc.

28 Mass. L. Rptr. 613
CourtMassachusetts Superior Court
DecidedAugust 15, 2011
DocketNo. 20093231
StatusPublished

This text of 28 Mass. L. Rptr. 613 (Nelson v. Anika Therapeutics, Inc.) is published on Counsel Stack Legal Research, covering Massachusetts Superior Court primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Nelson v. Anika Therapeutics, Inc., 28 Mass. L. Rptr. 613 (Mass. Ct. App. 2011).

Opinion

Leibensperger, Edward P., J.

Plaintiff, Alana Nelson, claims that she was wrongfully discharged from employment by defendants, Anika Therapeutics, Inc. and Anika’s Chief Executive Officer and President, Charles H. Sherwood. In Count One of her complaint she asserts that she was fired because she communicated to superiors at Anika certain “Bad Practices” and that she is entitled to common-law whistle-blower protection. Thus, she contends, her firing was wrongful because it was a violation of the public policy exception to the employment at-will doctrine. Defendants move for summary judgment dismissing Nelson’s sole remaining count of the complaint.2 For the reasons stated below, defendants’ motion is ALLOWED.

FACTS

The following facts are taken from the parties’ Consolidated Statement of Undisputed Facts (“SOF”) and the materials submitted therewith, including affidavits and deposition transcripts. The SOF were reviewed by the Court keeping in mind that at the summary judgment stage the undisputed facts should be viewed in the light most favorable to the nonmoving party, Nelson. The Court notes, however, that affidavits and depositions “shall be made on personal knowledge [and] shall set forth facts as would be admissible [614]*614in evidence ...” Mass.R.Civ.P. 56(e). To the extent that Nelson’s affidavit and testimony contain hearsay, speculation, rumor and opinion, such ruminations are not “facts” and are not considered. Moreover, the Court notes that the 174 paragraphs of the SOF include numerous instances of plaintiff inserting argument and unsupported conclusions in response to a statement of fact, in violation of both the letter and the spirit of Superior Court Rule 9A(b) (5).3 Where such counters constitute the only response by plaintiff to a statement of fact, then the statement of fact is deemed admitted. Superior Court Rule 9A(b)(5)(ii).

1. Nelson’s Employment History

Anika is a medical device company that invents, develops, manufactures and commercializes therapeutic products for tissue protection, healing and repair. As such, it is regulated by the federal Food and Drug Administration (“FDA”). Sherwood has been the Chief Executive Officer and President of Anika since 2002.

Anika hired Nelson in 1997 as a part-time analytical chemist in the Quality Control (“QC”) department. In December 1998, Nelson was hired on anon-temporary basis in the same position. As a QC Analytical Chemist, her duties included routine testing, validation development, troubleshooting, and testing associated with manufacturing investigations.

In October 2006, Nelson was promoted to the position of QC Lead Analyst. Her duties in this role included leading investigations into out-of-specification (“OOS”) results and managing the laboratoiy. An OOS result is a result in the laboratoiy that does not meet specifications set by Anika’s standard operating procedures (“SOP”). Managing the laboratoiy included testing of raw material, in-process production material, finished product, and production development samples. She was also responsible for environmental monitoring, sampling and testing critical utilities, and for ensuring the laboratoiy was operating within established good manufacturing processes and within Anika’s SOP. Later that same month, the QC Manager (Nelson’s supervisor) resigned from her employment with Anika and Nelson began functioning as the Interim QC Manager until a replacement was found. As Interim QC Manager, Nelson began reporting to Timothy Mayhew, Anika’s Director of Quality. In August 2007, Nelson was promoted to the QC Manager role. In her role as QC Manager, Nelson was responsible for the QC department, consisting of analytical and microbiology laboratories. As QC Manager, Nelson was expected to ensure compliance by the QC department with Anika’s SOP, FDA regulations, and good manufacturing and documentation practices. Duties of the QC Manager also included developing staff budgets, monitoring equipment and supply expenditures, and managing personnel in the QC department.

While not specifically stated in the parties’ SOF, it appears uncontested that Nelson was, at all relevant times, an at-will employee.

2. FDA Review and Criticism

In March 2008, the FDA conducted a routine inspection of Anika. There is no evidence that Nelson, as a whistle-blower or otherwise, initiated the FDA inspection. Likewise, Nelson does not allege, nor is there evidence in the record, that she communicated with the FDA in aid of its inspection or that she reported any alleged wrongdoing or poor practices to the FDA. There is no evidence to suggest that Anika did anything other than encourage its employees to cooperate with the FDA inspection.

On March 21, 2008, the FDA issued a Form 483 to Anika after the inspection of Anika’s facilities. A Form 483 is issued when the FDA finds that a company may not be in full compliance with FDA regulations. The Form 483 indicated that it contains “observations made by FDA representatives during the inspection . . . and [such observations] do not represent a final agency determination regarding your compliance.” The Form 483 contained seven categories of “observations” with subsidiaiy findings regarding each category. Among other things, the Form 483 raised several specific concerns about the QC Department. For example, the FDA observed that “[m]anagement with executive responsibility has not ensured that an adequate and effective quality assurance system has been fully implemented and maintained at all levels of the organization. The responsibilities and procedures applicable to the quality control unit are not fully followed.” At the time the Form 483 was issued, it was Nelson’s responsibility to ensure that the QC department was complying with FDA regulations and the company’s SOP.

On July 2, 2008, the FDA sent a “Warning Letter” to Anika. The Warning Letter, also based upon the March inspection, repeated the concerns raised in the Form 483 and sought corrective action. The FDA stated that Anika’s products were deemed to be “adulterated within the meaning of section 510(h) of the Act, 21 U.S.C. §351(h), in that the methods used in, or the facilities or controls used for, their manufacturing, packing, storage or installation are not in conformiiy with the current Good Manufacturing Practice (cGMP) requirements of the Quality System (QS) regulations ...” The FDA detailed more than eight “violations” and stated that Anika is “responsible for investigating and determining the causes of the violations . . . and for preventing their recurrence or the occurrence of other violations.” The FDA demanded prompt action by the company, warning that failure to act might result in civil action by the FDA to seize or enjoin the products or to seek a civil money penalty. The FDA did not, however, take any action to stop Anika from continuing to market and sell any of its products on the ground that there existed a specific and imminent threat to public safety.

Anika was concerned about the receipt of the Warning Letter. The company had not, during the entire [615]*615tenure of Sherwood as CEO, previously received such a letter. Because most of the deficiencies in the Warning Letter were in the QC department, Sherwood believed that the Executive Director of Quality, Mayhew, was responsible for poor management of the department. Mayhew was terminated from employment on August 11, 2008.

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28 Mass. L. Rptr. 613, Counsel Stack Legal Research, https://law.counselstack.com/opinion/nelson-v-anika-therapeutics-inc-masssuperct-2011.