Tuesday, October 22, 2013

Yet Another Reason (If One Were Needed) For Amending Rule 26

We posted recently – and enthusiastically − about the proposed changes to the federal rules governing discovery:   how they would largely end the ediscovery gotcha games, how they would make anticipatory preservation of evidence simpler and more predictable, how they require discovery be proportional to the needs of the case.  But we identified the “root cause” of the current problems as “the overbroad scope of discovery defined by current Rule 26(b)(1).”  In particular, we stated:

[T]he committee’s proposed amendment also seeks to eliminate another well-known phrase, and overused phrase, “[r]elevant information need not be admissible at the trial if the discovery appears reasonably calculated to lead to the discovery of admissible evidence.”  We’ve all seen this language misused to create a very onerous scope of discovery. . . .  This amendment targets such abuses as discovery concerning other products and dissimilar complaints and adverse events, as well as huge data sets relating to clinical studies of aspects of a drug or device other than the injuries claimed by the plaintiff(s).

That post was from late last month.  We again urge the defense side to submit comments.  Why?  Here’s a good example.  Less than two weeks later, yet another poster child for discovery overreach was handed down.  Relying on the rightly-maligned “reasonably calculated” language in current Rule 26(b)(1), the magistrate’s opinion in McLane v. Ethicon Endo-Surgery, Inc., 2013 WL 5556147 (Mag. M.D. Fla. Oct. 8, 2013), required almost exactly what we had decried:  “discovery concerning other products and dissimilar complaints and adverse events.”

If allowed to stand, McLane potentially could expand discovery to other products and their adverse events in every case involving a §510k-cleared medical device (that’s the FDA process through which about 99% of all medical devices historically have reached the market).  In this particular case, the devices at issue were a certain stapler and staple reloads, allegedly “defective” for reasons unclear, beyond the allegation that a surgical incision in the plaintiff’s colon didn’t stay closed.

If the magistrate in McLane had only ordered production of Corrective and Preventive Action (‘CAPA’) documents,” “Failure Mode Effects Analysis (‘FMEA’) documents, and “Inquiry Verification Reports (‘PIVRs’) related to” the devices used on the plaintiff, 2013 WL 5556147, at *1, we might have grumbled about the review/redaction expense (for privacy reasons the FDA requires redaction of adverse event reports, see 21 C.F.R. §20.63(f)), but probably not found it bloggable.  Blanket production of internal documentation and adverse event reports for a product – even without limitation to similarity of the adverse event – is distressingly common these days, even if (in our view) wholly improper under a proper reading of even the present version of Rule 26.

But that’s not what McLane is about.  In plaintiff’s’ eighth – yes, that’ right, eighth – request for production of documents, item 139 (again, that’s not a typo (the briefs are available on PACER)) plaintiff sought adverse event documents for, not the product itself, but for every “predicate device” as to which the product in question was cleared by the FDA as “substantially equivalent.  Id.  Not only that, plaintiff’s counsel used the defendant’s attempt at cooperation against the defendant.  Because the plaintiff’s numerous requests could be viewed as encompassing hundreds of thousands of documents, the defendant had invited the plaintiff’s counsel to visit its depository and make designations.  Plaintiff’s counsel turned around and sought to change cooperation into waiver:

Plaintiff argues the [adverse event reports] are relevant because they refer to predicate devices, and because Defendant waived any objections to producing these documents when Defendant invited Plaintiff’s counsel to review its database and designate [documents] for production.

Id.  No good deed goes unpunished, it seems.

“Substantial equivalence” is a long-standing FDA term of art for clearing medical devices, going back to the original 1976 Medical Device Amendments.  It does not mean “identical” or anything close to that.  A “substantially equivalent” device can be cleared for labeling and marketing despite significant “technological differences” as long as those differences do not, in the FDA’s view, pose different types of safety (or effectiveness) issues.  “[N]ew devices have been found SE even though [having] a change would affect safety and effectiveness.  This is because the [change] presented the same questions of safety and effectiveness as posed by the predicate device.”  FDA, Guidance on the CDRH Premarket Notification Review Program, at “Devices with New Technological Features” available on FDA website here.  Thus, a device can be “substantially equivalent” for FDA purposes even though its technology is very different:

Technological differences may include modifications in design, materials, or energy sources. . . .  [T]he [FDA] focuses on the technological differences that are medically and scientifically significant and avoids the difficulties that would arise from a mechanistic application of rigid formal criteria to the wide variety of substantial equivalence questions posed by new devices proposed for marketing under a 510(k).  Substantial equivalence determinations of necessity require the [FDA] to exercise reasonable scientific judgment. . . .  Thus, from a scientific perspective, to determine which technological changes are consequential, the [FDA] considers whether:

·                     the new device poses the same type of questions about safety or effectiveness as a predicate device.;

·                     there are accepted scientific methods for evaluating whether safety or effectiveness has been adversely affected as a result of the use of new technological characteristics; and

·                     there are data to demonstrate that new technological characteristics have not diminished safety or effectiveness.

Id. (examples omitted).  The FDA thus demands “comparability of performance” in its substantial equivalence determinations, not that they possess the same type of technology.  Id.

And that was the case here.  The defendant went through in its brief (Document 46 on PACER) and listed the major ways in which the technological characteristics of the device in question differed from the two predicate devices as to which plaintiff sought discovery.  These included:  articulability (ability to bend), method of closing the wound, re-loadability, staple configuration, tissue cutting, trigger and handle design, and staple formation.  Br. at 5-6 (tables).  Since the device is a stapler, these are hardly minor differences.

However, the magistrate in McLane didn’t seem to care about the FDA’s approach the substantial equivalence.  The magistrate completely ignored the devices’ many different technological differences.  Instead, the opinion doesn’t bother looking past the “substantial equivalence” label used in the statute:

Defendant has not met its burden of specifically showing how the requested documents are irrelevant. . . .  Defendant identified the predicate devices as “substantially equivalent” in representations to the Food and Drug Administration.  While the [device] is distinctive from its predicate devices, this Court understands that “substantial equivalency between a product and its predicate devices] can be established by comparing materials, design considerations, energy expected to be used or delivered by the device, and operational principles, as well as device functions, scientific bases, and performance characteristics.”  It is likely that documents pertaining to the [device’s] predicate devices are relevant insofar as discovery of the documents is reasonably calculated to lead to admissible evidence.

McLane, 2013 WL 5556147, at *2 (citations omitted).

The jaw drops.  There is no mention of the element(s) of the plaintiff’s claim to which this discovery might possibly pertain.  There is no discussion of what the FDA’s §510k “comparisons” involve or how FDA review could possibly correspond to the “substantial similarity” standard customarily used in evaluating the admissibility of other incidents.  There is no discussion of any different, or for that matter similar, design feature among these products.  Yes, one (or more properly the FDA) might “compare” all those things listed in the opinion – but what that means is that all those things may be different, not that they’re necessarily the same.

The McLane opinion cites two cases in support of authorizing broad discovery into predicate devices.  Neither have anything to do with the discovery being compelled, as neither involved discovery of predicate devices – or even of the same device.  Healey v. I-Flow, LLC, 853 F. Supp.2d 868, 877 (D. Minn. 2012), which the McLane magistrate quoted, is not even about discovery, but rather about amending a complaint.  Davenport v. State Farm Mutual Automobile Insurance Co., 2012 WL 555759, at *2 (M.D. Fla. Feb. 21, 2012), involved discovery, but only of photographs of a plaintiff.  From the opinion (and the papers) we can’t tell if discovery solely into predicate devices has ever been allowed before.

The only other “justification” for this discovery – if it can be called that – is the use of the defendant’s effort at informal cooperation against it.  2013 WL 5556147, at *2 (“Defendant invited Plaintiff to view and designate for production [some of the] documents in question” and “allowed Plaintiff’s counsel access to its database and did not place restrictions or parameters on documents Plaintiff’s counsel was permitted to review and request”).  The magistrate even had the nerve to “remind” the defendant that discovery “should be practiced with a spirit of cooperation.”  Id.  Well gee whiz, what exactly was the “invitation” just mentioned, if not an effort at cooperation?

Amazingly, or perhaps appallingly, neither the magistrate’s opinion in McLane, nor the plaintiff’s brief seeking to compel discovery (document 45, if you go PACER fishing), cited a single case permitting discovery concerning mere predicate devices in any context.  The only ground for allowing broad discovery into:  (1) corrective change; (2) internal failure analysis; and (3) adverse events involving different products was as just recited, that being the statute’s “substantial equivalence” label and invocation of the current “reasonably calculated” scope of discovery.

Beware all manufacturers of §510k devices – and their predicates.  In this particular instance, the defendant’s predicate devices appear also to have been manufactured by the same defendant, but that’s often not the case.  Nothing the FDA’s regulations requires that a manufacturer limit itself to its own products in asserting substantial equivalence to a predicate device.  Thus, not only are device manufacturers themselves potentially subject to extensive and intrusive discovery about devices that a plaintiff did not use, but under the same rationale that was applied in McLane, other manufacturers, not party to litigation, could be hit with similar discovery demands, simply because someone else cited their device as “substantially equivalent” in an FDA premarket notification.

Thus McLane epitomizes why discovery is out of control and why Rule 26 needs to be amended to consign the overbroad (and misinterpreted) “reasonably calculated to lead to the discovery of admissible evidence” standard to the dustbin of history.  Eight sets of demands for document production!  At least 139 different categories of documents!  And not even a pretense in the McLane opinion at determining whether the relevant technological characteristics of the other devices as to which discovery is compelled either:  (1) have anything to do with any aspect of the product in question that the plaintiff claims is defective, or (2) are in any way similar to that allegedly defective aspect.

The broad discovery into other products allowed in McLane, with nothing more than a regulatory label and an incantation of “reasonably calculated” as justification, is only the latest example of how discovery under the current Federal Rules is running amok.  Right now, we have a literally once in a generation opportunity to change this for the better.  As detailed in our prior post, defendants and their counsel have until February 15, 2014 to submit comments supporting the proposed changes.  Testimony on horror stories such as McLane is still being accepted for two public hearings in January and February of 2014.  If we don’t support these changes, we will have only ourselves to blame if they fail.

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