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Critics have been known to accuse us of being too hard on product liability plaintiffs and too forgiving of defendants who develop medical products.  We all have our biases, especially after many collective decades of representing the latter group, but we do think the table is often tilted in favor of the former group.  One area where plaintiffs and defendants tend to get very different treatment is written discovery.  Plaintiffs often get lots of extra time to respond to simple discovery, whereas defendants have to go to great lengths to produce voluminous and sometimes ancient documents in rapid fashion at the risk of sanctions.  (See here, here, and here for a sampling.)  Another is MDLs.  Plaintiff lawyers often get to park bad cases at the back of the line, with minimal look into their weaknesses, while their better cases are at the front and the defendants are kept busy with one-sided discovery.  And don’t get us started on how the MDL bellwether process can favor the bad guys.  In fairness—and we do strive to be fair—there is an area where we think plaintiffs have a tougher go of it than defendants:  pleadings.

Mind you, we do not think it is unfair, just that it is harder to offer detailed pleadings as a product liability plaintiff than as a defendant.  Rule 8 uses the phrase “short and plain” to apply to both claims and defenses and this proviso applies to all pleadings:  “Each allegation must be simple, concise, and direct. No technical form is required.”  The “special matters” in Rule 9 can apply to plaintiffs and defendants.  Yet, there tends to be much more litigation on whether a claim withstands a 12(b)(6) challenge than whether a defense should be stricken under 12(f), which provides no particular standard for when an “insufficient defense” should be stricken.  Our experience is that some courts apply the 12(b)(6) standards for striking insufficient pleaded “claims” to 12(f), complete with the requirements from Twombly and Iqbal.  Within certain districts, it seems to depend on the particular judge, but it is certainly a minority position to require defendants to plead defenses with the same factual underpinnings as plaintiffs must plead claims.  We think the logic of requiring more for claims than for defenses is compelling, but we do appreciate that the scrutiny paid to the pleading of defenses tends to be less.  (Although MDLs can be lax in evaluating the pleading of claims.)

That brings us to Crumpton v. Octapharma Plasma, Inc., No. 19 C 8402, 2021 U.S. Dist. LEXIS 9520 (N.D. Ill. Jan. 19, 2021).  The Northern District of Illinois is apparently one of the districts that applies the TwIqbal standards to defenses and Illinois has a somewhat unusual privacy statute that creates another vehicle to bring class actions over intangible harms.  Illinois has a Biometric Information Privacy Act (“BIPA”) that prohibits gathering biometric information like fingerprints without first giving certain disclosures and obtaining written consent.  There is apparently something of a cottage industry emerging in Illinois state and federal courts over BIPA class actions.  In Crumpton, the defendant runs centers where people can donate plasma (for money); according to the interwebs, the defendant’s foreign parent company manufacturers plasma products.  The defendant utilizes various medical devices in its collection of plasma, but does not make any medical product or sell anything to the public.  Plaintiff claims that the defendant requires donors to scan fingerprints without providing the BIPA disclosures and getting informed consent.  Id. at **2-3.  The defendant included in its answer “affirmative defenses” based on preemption due to FDA requirements and a statutory exemption due to HIPAA requirements.  Plaintiff moved to strike both of them.  We focus on the former.

As noted above, this district is one that applies the TwIqbal standards to 12(f) motions to strike, so the focus was whether the answer included factual assertions that, if true, would entitle the defendant to relief (i.e., a defense).  Somewhat surprisingly, the Crumpton court did not include much of a discussion of what the answer actually said about FDA and preemption.  This could have been because it did not include factual assertions along with its denials and defenses, as an answer in a jurisdiction that did not engraft TwIqbal and 12(b)(6) onto 12(f) would typically not do.  Then again, the court also did not give the defendant leave to amend its preemption defense like it did with the parts of its HIPAA exemption defense that was stricken.  I suppose we have now given away the result here, but it is quite unusual for plaintiffs to not get a chance to re-plead after failing to offer sufficient facts to state a claim upon which relief can be granted.  When the defendant is found to fail a similar test on a motion to strike, one might expect a chance at a second strike.

In any event, the analysis of preemption was largely a legal inquiry.  We cannot say it was wrong, especially without the complaint and answer to review, but it seems to us that the real test will be when an entity more directly under FDA’s regulatory authority is sued.  As we noted, this defendant uses devices to collect blood; it does not manufacture them.  Thus, a claim based on alleged express preemption under the Medical Device Amendments did not fit, at least to the court on the pleadings here.

BIPA imposes no requirements upon Octapharma’s [devices used in its business], only upon Octapharma itself.  Moreover, BIPA’s requirements are only triggered by the collection of biometric identifiers, which the MDA does not mandate.

Id. at **7-8.  No state law requirements that were different than or in addition to requirements imposed on the devices.

Impossibility and obstacle theories of implied conflict preemption were next, although with more than a bit of blurring the standards and no citation of the pleadings.

Octapharma points to no federal statute or regulation incompatible with simultaneous compliance with BIPA.  BIPA applies only when an entity collects biometric information; the FDCA does not require Octapharma to collect or use biometric information.  Although the FDCA does require screening procedures for identity, it does not prescribe an exclusive or preferred method.

Id. at *8 (citations omitted).  No conflict of any sort.

Field preemption was even easier on this record.  The Supreme Court had said in the Hillsborough case in 1985 that FDA’s regulations on plasma donation were not intended to preempt the field.  Id. at *9 (citations omitted).

For our clients who might get sued in BIPA cases and increase their chance of a better result on a motion to strike we had items of unsolicited advice beyond the obvious need to comply with local privacy law.  First, consider including detailed factual assertions in your answer should you get sued.  Second, if you think the FDCA or its regulations should preempt claims against you, then consider developing the obstacle preemption argument.  Part of the problem with a patchwork of state-by-state requirements for a national business is that they do undercut the authority of federal regulators.  The “purposes and objectives of Congress” in enacting laws that give regulatory authority to some federal agency will run into obstacles not just from what one state does but when each state does something different in the same space.  Then again, we tend to like informed consent in our product liability case, especially when they create the complete defense of assumption of the risk.