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Drugs & Medical Devices

Blocked Expert Testimony Isn’t Necessarily the End of Mirena MDL

— March 29, 2016

On March 8, U.S. District Judge Cathy Seibel barred four of the plaintiffs’ expert witnesses and limited the scope of testimony of the other two. Bayer, maker of the Mirena IUD, called the ruling a victory and began preparing a motion for summary judgment which would end any chance of recovery for the women injured by this product. However, blocked expert testimony isn’t necessarily the end of Mirena MDL, especially if the plaintiffs’ steering committee has its way.

On March 8, U.S. District Judge Cathy Seibel barred four of the plaintiffs’ expert witnesses and limited the scope of testimony of the other two. Bayer, maker of the Mirena IUD, called the ruling a victory and began preparing a motion for summary judgment which would end any chance of recovery for the women injured by this product. However, blocked expert testimony isn’t necessarily the end of Mirena MDL, especially if the plaintiffs’ steering committee has its way.

Bayer’s counsel issued a letter to Judge Seibel on March 22 paving the way for their planned motion for summary judgment. According to the letter, “the Court excluded the testimony of Dr. Susan Wray and Dr. Roger Young in its entirety. These were the only experts remaining in the litigation that Plaintiffs claimed were offering general causation opinions – i.e., that Mirena is generally capable of causing perforation unrelated to the insertion procedure (what Plaintiffs call “secondary perforation”).  In addition, the Court excluded the only specific causation opinions tendered in the two Initial Disposition Pool (“IDP”) trial cases, given by Dr. Roger Young (in the Danley action) and Dr. Richard Strassberg (in the Hayes action).

Because the Court excluded all of Plaintiffs’ causation testimony, Plaintiffs can establish neither the existence of the very injury at the center of this MDL, nor that any Plaintiff actually experienced that claimed injury.  As a result, all cases in this MDL, including IDP trial cases Danley and Hayes, should be dismissed. The Danley and Hayes summary judgment motions are fully briefed, and Defendants respectfully request leave to file an MDL-wide summary judgment motion based on lack of causation.”

In pharmaceutical product liability suits such as these, causation is a very big deal. There are two types: general and specific and both must be proven if plaintiffs are to succeed. General causation is the ability of a certain product to cause an injury. Specific causation is verification that the product caused the actual injury suffered by the plaintiff. Attorneys rely on expert testimony in many instances to prove both types of causation. Bayer argues that without their expert witnesses, plaintiffs cannot prove either general or specific causation: in this particular MDL, that Mirena has the ability to perforate uterine tissue after insertion and that the injured plaintiffs’ actually suffered a post-insertion perforation.

Since Judge Seibel barred the plaintiffs’ experts, Bayer is certain the MDL cannot survive its motion. Sadly, for two of the cases in the MDL, those of Jennifer Danley and Christie Hayes, Bayer is correct. In fact, in a letter also dated March 22, the Plaintiffs’ Steering Committee (PSC) (the group of attorneys overseeing the plaintiffs’ cases) announced their willingness to “execute voluntary dismissals with prejudice and without costs in both cases, based on the unique facts of each case regarding specific causation as detailed in the Court’s Opinion.” Dismissal with prejudice means these suits can never be brought again.

In furtherance of its argument that the entire MDL must be dismissed Bayer’s letter states, “Plaintiffs cannot credibly argue that they can prove causation by methods other than expert testimony. In their oppositions to summary judgment, Plaintiffs point to internal company documents and documents related to foreign regulatory actions to claim that Bayer has admitted to the existence of secondary perforation.”

The PSC’s letter points out that “Bayer had previously touted a preemption defense, but its current litigation strategy is to assert that Mirena perforates the uterus only during insertion, and to deny that perforation occurs after insertion. E.g., Bayer’s Summary Judgment Memorandum in the Danley case (ECF No. 2758), at 4 (Part II(A)(3)) (“Perforation Occurs During Insertion But May Not Be Detected Until Later”) (emphasis added). In 2010, however, Bayer had publicly stated that “[u]terine perforation may occur with MIRENA at the time of insertion or after the insertion with limited clinical symptoms.”

While Bayer would argue that this does not fall within acceptable evidence for causation, the PSC believes “Bayer’s Health Canada letter constitutes an admission under Fed. R. Evid. 801(d)(2). Such corporate statements made in public documents or submitted to regulatory agencies are not hearsay… and are routinely offered in evidence against their corporate authors to prove the truth of the matters asserted in the statements” in many other cases (citations omitted).

In one such case, “public documents filed with regulatory agencies or released to press by defendants are admissions of party opponent and thus not excludable from summary judgment affidavit. The rule applies when corporate documents are submitted to  a  governmental agency, whether the agency is foreign or domestic.”

In another, “The rule binding a corporation to its public statements also applies in product liability cases, including mass tort MDLs. E.g., In re Meridia Prods. Liab. Litig., 328 F. Supp. 2d 791, 810 (N.D. Ohio 2004) (statements in manufacturer’s drug label regarding drug’s capacity to cause harm were admissions sufficient to show genuine issue of material fact on general causation.”

The PSC believes that the general causation requirement is met due to showing “sufficient evidence that the substance in question has the capacity to cause harm.”

Further, “Accordingly, Bayer’s 2010 admissions will be offered at trial as evidence that what Bayer and its expert witnesses now say is ‘impossible’ is, instead, quite possible: Mirena can perforate the uterus after insertion. As the Court stated:  ‘Should the jury be convinced that secondary perforation is possible, it will discount the experts’ opinions about the label accordingly.’”

In terms of possibly admissible statements, “Bayer’s own label, though, acknowledges that Mirena has the capacity to perforate the uterus after insertion. For example, the perforation warning in the current Mirena label states:

Perforation (total or partial, including penetration/embedment of Mirena in the uterine wall or cervix) may occur most often during insertion, although the perforation may not be detected until sometime later.

This language, while veiled and indirect, admits that Mirena can cause “total or partial” perforation after insertion, although it will cause perforation ‘most often’ during insertion. The Mirena labels therefore provide another Rule 801(d)(2) admission that Mirena has the requisite ‘capacity to cause harm.’”

The PSC’s letter cites several internal Bayer documents (details redacted from publicly available sources) that show that “the company has long been aware of the risk of seconda1y perforation and potential mechanisms for causing it. This dates back at least to 2000, when Mirena entered the U.S. market.”

Addressing the issue of specific causation, the PSC’s letter said what I have been thinking for some time now:

“Although Bayer may suggest otherwise, this is not a complex chemical injury or cancer causation case presenting a host of potential confounding factors, each of which must be separately analyzed in great detail. Rather, despite the mechanism of secondary perforation remaining in dispute, perforation itself is a relatively straightforward mechanical act. If a Mirena has perforated a woman’s uterus, there are only two possibilities: either the perforation occurred during insertion or it occurred after insertion.” [Emphasis added by author]

Secondary perforation of Mirena IUD. Image courtesy of
Secondary perforation of Mirena IUD. Image courtesy of

In support of this theory of specific causation (one which this author applauds, simply based on the pure logic of it), the PSC writes:

“Plaintiffs ‘ treating medical providers are charged with correctly inserting the Mirena device in their patients – inserting it without perforating the uterus. From the standpoint of Mirena insertion, these are akin to ‘soft tissue’ personal injury cases. As with any soft tissue case, the medical providers are able to testify to a reasonable degree of medical certainty regarding the medical services they provided.

If a plaintiff’ s inserting medical provider testifies to a reasonable degree of medical certainty, based on the factors typically evaluated by practitioners in his or her field (feel, patient reaction, string check, ultrasound, etc.), that the uterus was not perforated during the Mirena’s insertion, the plaintiff will have provided admissible specific causation testimony. Bayer will have the right to challenge the treater’s opinion and try to convince the jury that perforation occurred at insertion, but if the jury believes the treating provider, there is only one remaining alternative:  perforation occurred after insertion.”

The judge will allow the parties to respond to each other’s positional letters by March 30, though that has yet to appear in the MDL docket.

Interestingly, the PSC also points out that:

“It is not surprising that the parties dispute the mechanism at play when Mirena perforates the uterus after insertion. Modern science still does not fully understand how Mirena interacts with the uterus in any respect – even including how it prevents pregnancy. See, e.g., Mirena label (copy annexed hereto as Exhibit 2), § 12.1 (Mechanism of Action) (“The local mechanism by which continuously released LNG enhances contraceptive effectiveness of Mirena has not been conclusively demonstrated. Studies of Mirena and similar LNG IUS prototypes have suggested several mechanisms that prevent pregnancy[.]”). [Emphasis added by author]

In other words, Bayer is grasping at straws. They don’t even understand their own product, yet they try to defend against injuries it’s causing to innocent women. And they’re attempting to do so with arguments so illogical that they could be defeated by a fifth grader.

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