[Drug and Device Law] Three Strikes and Out of Court for Breast Implant Opt-Out
Over the weekend, we watched one of our favorite “chick flicks,” a holiday-themed montage entitled “Love, Actually.” One of our favorite characters, played by the ever-brilliant Bill Nighy, is an over-the-hill former pop star who resorts to superimposing cheesy holiday lyrics on a familiar melody in an (ultimately successful) attempt to manufacture one last comeback. A disc jockey, hearing this effort for the first time, exclaims, “How the mighty have fallen!” This crossed our mind as we read today’s case, a decision on Daubert motions in a leftover breast implant case.
Twenty-some years ago, we cut our Drug and Device teeth on breast implant litigation, arguing motions in the infant Mass Tort Program in Philadelphia Back then, the high-profile litigation, involving claims that breast implants caused serious auto-immune diseases in recipients, commanded high levels of attention and resources and produced some landmark verdicts. Now, with the vast bulk of the litigation long settled, key defendants in bankruptcy, and many of plaintiff’s claims resoundingly debunked, all that remains are isolated opt-outs, like In re Dow Corning, Corp., Ezra v. DCC Litigation Facility, Inc., 2015 WL 5737997 ( E.D. Mich. Sept. 30, 2015), a primer on Daubert’s raison d’etre.
Plaintiff in Ezra claimed that her silicone gel implants caused
muscle aches and pains all over her body; metallic taste in the mouth; chronic problems with diarrhea; dizziness/vertigo problems; chronic low-grade fevers; frequent yeast infections; chronic fatigue; severe headaches; loss of taste and smell; memory loss and loss of concentration; frequent gastrointestinal problems; sinus problems with ear aches; difficulty swallowing; problems with choking; easily bruised with slow healing of bruises and cuts; spider veins on legs and feet; coldness of hands, fingers, feet, toes and face; muscle spasms; problems with rashes; tingling and numbness in extremities; difficulty breathing; unexplained dental problems; excessive hair loss; as well as emotional, physical and financial losses.
Ezra, 2015 WL 5737997, at *1. She proffered the testimony of three causation experts, and defendant moved to exclude all three.
The first, retained one week before the expert deadline “only after a plaintiff in a companion case located him through Internet searches,” id. at *3, was according to Defendant, “a part-time internal medicine doctor who has divided his workload into four roughly equal parts: internal medicine practice; prescribing the synthetic opiate Suboxene to drug users; conducting social security exams and drafting reports; and testifying as a paid expert witness in a wide range of cases, many involving drug and alcohol intoxication issues.” Id. Thus, according to Defendant, the expert was not qualified to render opinions on breast implants or autoimmune diseases. Moreover, Defendant argued, the expert’s opinion that “silicone could cause disease in certain genetically predisposed persons,” id., was pure ipse dixit and was not the result of any reliable methodology. Defendant pointed out that the expert’s report contained “no discussion of autoimmune disease, no independent analysis regarding how or why plaintiff's conditions constitute autoimmune diseases and no reference to any texts, treatises, or authorities regarding autoimmune diseases, . . . [and that he admitted] to performing no research on the issues of whether silicones are capable of causing rheumatoid arthritis or any other type of autoimmune disease or symptoms and has not published any papers on the topic.” Id.
In opposition, Plaintiff argued that the expert had “extensive 35-year-experience as a physician,” id., and, though he had “conducted no research studies on the issue of silicone and autoimmune disease,” this did not bar him from testifying at trial. Id.
The court agreed – resoundingly – with the defendant, holding that the expert: 1) was not qualified to offer his opinions (“Other than his deposition testimony that he has diagnosed people with autoimmune diseases, he has not established his knowledge or training as to autoimmune disease, specifically whether breast implants or silicone gel causes such diseases.”); 2) employed no reliable methodology (“There was no causation analysis in [the expert’s] report, other than a summary of [plaintiff’s ] medical history.”); and 3) would not assist the trier of fact, since, again, it lacked any causation analysis. Id. at 4. As such, the court excluded the expert’s testimony in its entirety.
Plaintiff’s other experts fared no better. Her rheumatologist submitted a “one-page report, competed within two hours,” in which, defendant argued, he rendered opinions that were “contrary to the scientific evidence widely endorsed by the medical and scientific communities [and] based on possibilities, not probabilities.” Id. Moreover, as defendant pointed out, the expert “merely assumed, without more, that [the plaintiff] was exposed to silicone gel manufactured by Dow Corning.” Accordingly, defendant argued, the expert’s opinions lacked reliable methodology and were based on a theory that was pure speculation.” Id. at *5. The court agreed, holding that the expert lacked any specialized knowledge in the relevant area of rheumatology, that he “admitted that his report does not set forth any methodology or any analysis or reasoning” and that he simply read the medical records and provided his conclusions, that his opinion could not help the trier of fact “since he cites no support for his opinion.” Id. at *5-6. Two down, one to go.
Plaintiff’s third expert, apparently a chemist or “materials science” type (the opinion doesn’t specify) whom courts had “routinely excluded . . . in breast implant litigation,” testified that breast implants “have injurious potential and they degrade and injure.” Id. at *6. The court found that, while the expert was “specialized in the field related to chemical properties of silicone gel,” he could not testify about medical causation because, with no medical training, “he would be merely speculating.” Id. Strike three. And, with all of plaintiff’s causation experts excluded, the court granted summary judgment for the defendant.
For a plaintiff considering opting out of a global settlement, Ezra should serve as a cautionary tale. Those of us who spend our days representing defendants in mass tort litigation are all too aware that bottom-feeding plaintiffs’ lawyers fill court dockets with cases that lack all merit then wait patiently to be swept along on the settlement train. But there is safety in numbers. And “lone holdout” status increases the odds that a court will slam the gates on experts who blatantly fail to meet Daubert’s admissibility standards. A good (if obvious) decision, and now onto weekend movie time!
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Posted By Rachel B. Weil to Drug and Device Law at 10/09/2015 04:43:00 PM --
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