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Green light to expunge? Can records of fraudulently obtained 209A Restraining Orders finally be expunged in Massachusetts?

Records of 209A orders live long and are unforgiving. Even an ex parte order that lasts a mere 10 days and is not renewed creates a record that will haunt the Defendant if there is ever another 209A case against him or in bail proceedings, just to name a few instances. Two recent decisions by Massachusetts courts may well have paved the road to expunge s

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

ome of these records. These cases and their implications are discussed below.

In March of 2006 the Massachusetts Appeals Court ruled on a case that's been dragging for four years, and the ruling shed light on an issue that's been dragging on the minds of falsely accused 209A Defendants for much longer: does a District Court judge have the inherent power to expunge a 209A Restraining Order from the statewide domestic violence registry when the order was obtained through fraud on the Court. In

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

short, perhaps surprising but much welcomed: YES. The case was Commissioner of Probation v. Adams, 65 Mass. App. Ct. 725 (2006).

The case commenced when a couple (for reference, court designated pseudonyms of Jones and Adams will be used) obtained mutual 209A Restraining Orders against one another, which were later extended for one year. Sometime during this time period, after Jones was charged with violations of the 209A Order and criminal harassment in two different courts, Adams f

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

iled a motion to vacate the 209A Order against her and to expunge all records of the order. Here ensued the typical game of judicial ping pong. The judge granted the motion to vacate after finding 19 statements made by Jones to be false, but denied the motion to expunge. Adams filed a second motion to expunge the now vacated 209A Order, which the Commissioner of Probation (the office maintaining these records) opposed. The judge granted Adams' motion to expunge, but the Commissioner filed a

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

otion to reconsider. The judge denied the Commissioner's motion, and the Commissioner appealed claiming that the judge had no authority to allow the expungement. The Commissioner argued that, while the Legislature specifically authorized and directed the development and implementation of a system containing records of all issuances and violations of 209A orders in Massachusetts, there was no provision for expungement of data because, according to the Commissioner, the purpose of the system wa

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

s to preserve "complete information about a Defendant."

The Commissioner was correct in that the 209A Law did not contain any provisions allowing for expungement of even incorrectly issued orders. While it is no surprise and no secret that the 209A statute is a poorly written and overly broad piece of legislation, short of the legislature specifically saying that no expungements are allowed, this vagueness left a

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

hole and an opportunity for judges to make some good law on top of bad, for a change. This is exactly what the Appeals Court decided to do by returning to the lower court judges the power that was never expressly taken away by the Chapter 209A, but which the judges were timid to exercise in 209A settings: the power to fix judicial errors and to attempt "to secure the full and effective administration of justice" when there has been a finding of fraud on the court. In such instances, said the

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ppeals Court quoting various earlier cases, "lack of statutory authorization is immaterial," moreover, such power "cannot be restricted or abolished by the legislature."

In this case, vacating the 209A Order against Adams is insufficient to protect the integrity of the courts and does not send an appropriate message to the public. Vacating the order leaves a record of the order in the system. Not only does this leave a permanent mark against Adams, but it also leaves, in perpetuity

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

, a record of a fraudulently obtained court order. Although labels such as "dismissed" or "closed" are applied to records in the system, no explanation is provided as to why the order was dismissed or the case closed. Many vacated 209A orders are vacated because of the victim's failure to prosecute. Law enforcement officials will not be notified that the order was vacated because it was obtained by fraud on the court. Rather, they may presume it was vacated because of the victim's failure to pr

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

osecute or because of insufficient evidence. The perpetuation of a fraud amounts to a defiling of the court itself when law enforcement officials rely on inaccurate information produced by the court. Just as vacating the order is an insufficient remedy in those circumstances, sealing the record of the order is equally inadequate. When records are sealed, they do not disappear. While sealed records become unavailable to the public, the raw data continues to be available to law enforcement officia

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

s (police, probation officers, and courts). Law enforcement officials would retain access to information that is inaccurate and misleading and was obtained through fraud on the court. Therefore, sealing would not remedy the defiling of the court. Id. at 731-732 (citations omitted).

Bravo? Can we run and request that all vacated 209A orders now be expunged? Not quite. First, the court made it clear that only orders procured through fraud on the court are subject to exp

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ungement. As an example of the type of orders NOT to be expunged the court cited the Vaccaro v. Vaccaro case, where a 209A order was vacated because there was not enough evidence to extend it, as opposed to an order initially obtained by fraud. 425 Mass 153 (1997). The court said that, in the case of a merely vacated order or a dismissal for failure to prosecute, but where there is no finding of fraud, there exists "value" to law enforcement officials in retaining records of its issu

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ance.

Second, the court set out a rather stern definition of what it considers fraud, namely "where it can be demonstrated, clearly and convincingly, that a party has sentiently set in motion some unconscionable scheme calculated to interfere with the judicial system's ability impartially to adjudicate a matter by improperly influencing the trier or unfairly hampering the presentation of the opposing party's claim or defense." Adams, at 729-730 (citations omitted).

T

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

hird, the court spoke of the timing for a motion to expunge, ruling that 209A defendants "have adequate opportunity to assert [the fraud] argument" at the 10 day and the extension hearings. "If the judge does not make a finding of fraud on the court, the defendant will have no basis for a subsequent motion to expunge the record of the order from the system. Nothing in G. L. c. 209A, or in this opinion, requires a hearing on a defendant's motion for expungement. Furthermore, the 'clear and conv

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ncing evidence' standard of proof required for demonstrating a fraud on the court finding will necessarily limit the number of instances when expungement may even be considered as an appropriate remedy." Id. at 736-737.

Far short of an open floodgate, the Adams case seems to offer an ever so slight crack in the door for expunging certain 209A orders when backed by strong evidence of fraud and brought at the precisely right time.

Less than six months after the Appeals Court d

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ecided Adams, much closer to the daily reality of 209A Orders, Judge Gregory Flynn in the Waltham District Court rendered a decision applying the new standards from Adams. The case was Chamberlain v. Khanlian, Waltham District Court Docket No. 0651-RO-99. Here the Plaintiff failed to appear at the 10 day hearing and the 209A Order against the Defendant expired on that day. Another 11 days after that, the Defendant brought a motion to expunge the record alleging frau

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

d on behalf of the Plaintiff. The Defendant supported his motion with several affidavits that set out facts in support of the fraud. The Plaintiff failed to appear at the hearing on the motion to expunge, but the Commissioner of Probation appeared and opposed the expungement in this case as well, though this time claiming that its sole purpose in opposing the motion was to make sure that the standards set out in Adams are followed.

"In light of the allegations made in the relevant pl

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

adings, the factual support presented by the accompanying affidavits, the failure of the petitioner to appear to be heard on the allegations of fraud, the court is clearly convinced that the original restraining order was granted only upon a fraudulent set of facts presented to the Court," wrote Judge Flynn. "Accordingly, in conformity with the standards set forth in Commissioner of Probation v. Adams, the motion to expunge was allowed."

This being an "unpublished" District Court case

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

, no further light into Judge Flynn's reasoning or rationale is shed from his brief decision. It is interesting to note, however, that seemingly the timing standards set in Adams by the Appeals Court were not met here. In Adams, the Appeals Court noted that the Defendant's only opportunities to raise allegations of fraud would be at the 10 day hearing or any further extension hearings. Here the 10 day hearing came and went without a motion to expunge. Yet, Judge Flynn still

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

allowed the expungement when the motion was brought 11 days later. It is also interesting to note that both defendants in the two cases discussed above were women, and both had career motivated reasons for seeking expungements: one was an attorney while the other was a licensed pharmacist.

Whether other judges will see Adams as Judge Flynn did, and whether dozens of the falsely accused men in Massachusetts will be able to obtain relief from this turn in the law -- only time will tell

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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