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These days, when the subject turns to victorious Philadelphia sports teams, most people think green, and “fly” and “Philly Special.” But we are not most people.  We live firmly and fondly in the past, 2008 to be exact.  So we relished every moment of our beloved Phillies’ Alumni Weekend this past weekend.  We cheered ourselves hoarse as a beloved former centerfielder, under a one-day contract, “retired as a Phillie.”  (Mahalo, “Flyin’ Hawaiian.”) And we, along with 35,000 of our closest friends, wept as the widow of our 2008 ace spoke to the crowd on the occasion of her late husband’s enshrinement on the Phillies’ “Wall of Fame.”   (R.I.P., “Doc.”)  And finally, as the members of the 2008 World Champion Phillies marched out to be honored, we allowed ourselves to be transported back to the ecstatic aftermath of our closer’s final slider in a perfect save season.  For sure, victory is sweet.

As it has been, six times now, in post-BMS personal jurisdiction decisions out of the Essure litigation.  In Hinton v. Bayer Corp., 2018 WL 3725776 (E.D. Mo. July 27, 2018), ninety-four plaintiffs from thirty different states filed a joint complaint in a Missouri state court, alleging that they were injured by the defendant’s birth control device.  The defendant removed the case to the Eastern District of Missouri on the basis of diversity jurisdiction.  Of the ninety-four plaintiffs, only thirteen were Missouri residents.  Some of the non-Missouri residents were not diverse to the defendant; however, the defendant moved to dismiss and sever the claims of the non-Missouri plaintiffs before the court ruled on subject matter jurisdiction (and remanded for lack of complete diversity).   The plaintiffs moved to stay determination of the motions to dismiss pending determination of subject matter jurisdiction, but the court declined, explaining that “addressing [the defendant’s] challenge to personal jurisdiction over the claims of the non-Missouri plaintiffs presents the more straightforward inquiry” under recent precedent, justifying a decision to deviate from the usual course of deciding subject matter jurisdiction ahead of personal jurisdiction. Hinton, 2018 WL 3725776 at *2.   As the court emphasized, “Remanding this case for lack of complete diversity only to have the case removed again later once the non-Missouri plaintiffs are dismissed would be a waste of judicial resources.  Ruling [on] personal jurisdiction first is in the interests of judicial economy and expeditiousness.” Id. (citation omitted).

And so the court proceeded to address the defendant’s motion to dismiss the claims of the non-Missouri plaintiffs for lack of personal jurisdiction. The defendant conceded that the court had specific jurisdiction over it regarding the thirteen Missouri plaintiffs, but argued that the court did not have general jurisdiction over it and did not have specific jurisdiction over it with regard to the non-Missouri plaintiffs.  The plaintiffs did not argue that the court had general jurisdiction over the defendant; instead, they argued that the court had specific jurisdiction over the defendant with regard to the claims of all of the plaintiffs because the defendant had conducted “a number of clinical trials” in Missouri and had worked on regulatory approval for the product in Missouri, and because “St. Louis was one of eight cities targeted as part of a broader marketing plan to increase sales and revenue.” Id. at *3.

The court explained that, under BMS, specific jurisdiction depends on “an affiliation between the forum and the underlying controversy, principally [an] activity or an occurrence that takes place in the forum State and is therefore subject to the State’s regulation.” Id. (citation to BMS omitted).  In this case, the plaintiffs did not see marketing in Missouri, did not purchase the product in Missouri, were not prescribed the product in Missouri, did not purchase the product in Missouri, and were not injured by the product in Missouri.  “Furthermore, none of the plaintiffs alleged that she participated in a Missouri clinical study or reviewed or relied on” such studies in deciding to use the product. Id. at *4.  As such, the court held, “Even assuming that discovery would prove exactly what Plaintiffs contend happened in Missouri with respect to . . . marketing and clinical trials, the individual plaintiffs’ claims are too attenuated from those activities to provide specific ‘case-linked’ personal jurisdiction.” Id. (citation omitted).   With no “connection between the forum and the specific claims at issue,” id. (citation to BMS omitted), the court held that it did not have jurisdiction over the claims of the eighty-one non-Missouri plaintiffs and dismissed all of those claims.

And so the defendant hit a figurative home run, expanding its already-prominent role in the elimination of litigation tourism in Missouri. We love this string of decisions, we love BMS, and we will keep you posted as its family of progeny continues to grow.

A couple of weeks ago, the Drug and Device Law Dog Walker texted us midday to report that a coyote had been spotted in our suburban neighborhood and that we should be vigilant when the Drug and Device Law Little Rescue Dogs were out in the yard. We scoffed, insisting that it must have been the neighborhood fox, known to all for years (we live right next to Valley Forge National Park).  The conversation went back and forth for a while, eventually including descriptions of larger size, different coloration, and much longer legs than the fox’s.  We remained unconvinced.  Eventually, our neighborhood e-mail chain came alive with close-up photos of what was undeniably a coyote, taken a scant hundred yards away in a neighbor’s back yard.   Because we are law nerds, it occurred to us that coyotes are just like causation:  an expert can assert a causal link, and assert it again, but, ultimately, there has to be evidence to support the assertion.

As the court agreed in today’s case, a nice (albeit unreported) affirmance of a HUMIRA summary judgment victory out of Maryland’s Court of Special Appeals. In Larson v. Abbott Labs., Inc., 2018 WL 3479236 (Md. Ct. Spec. App. July 19, 2018), the plaintiff, a highly-educated space engineer who had been diagnosed as HIV-positive years before, alleged that the defendant’s psoriasis medication caused him to become sufficiently immunocompromised that he contracted progressive multifocal leukoencephaly (PML).  PML is an often-fatal viral brain disease that left the plaintiff physically disabled and cognitively impaired, and unable to care for himself.  PML is caused by a virus that that is present in the bodies of most adults in the United States but that generally remains inactive except in severely immunocompromised people. HUMIRA’s prescribing information warned that medications of its class had the potential to affect defenses against infection, and that the safety and efficacy of the medication in immunosuppressed patients had not been evaluated.  The warnings did not specifically mention HIV patients.

The plaintiff had been diagnosed as HIV-positive five years before he took HUMIRA. During that time, he treated his plaque psoriasis with home remedies.  When it worsened, he asked his treater about treatment with HUMIRA.  She sought information from the defendant, then referred the plaintiff to a physician who concluded from the information that, because the plaintiff’s HIV was well controlled and that he was not severely immunocompromised (and because a tuberculosis skin test came back negative), he was an appropriate candidate for the medication.  What was unknown to the doctor – and apparently to the plaintiff – was that recent lab results revealed progression of his HIV disease.   (The plaintiff’s infectious disease specialist had attempted to contact him with the results, but he hadn’t responded by the time he began his HUMIRA treatment.) Within three months after beginning his treatment, he began exhibiting headaches and extreme fatigue.  His condition worsened, and he was diagnosed with PML shortly thereafter.

The plaintiff filed suit, asserting the usual product liability claims. His primary causation expert was a “highly-regarded infections disease specialist with significant experience” treating HIV-positive patients. Larson, 2018 WL 3479236 at *7.  The defendant moved to exclude the expert’s opinion.  The trial court granted the motion, and, because the plaintiff was left without expert causation testimony, the court granted summary judgment for the defendant.  The plaintiff appealed.

The plaintiff presented several questions for the appellate court’s determination, including questions related to the trial court’s holdings about the adequacy of the product’s warnings. The appellate court found that it needed to consider only one question – whether the trial court erred in barring the testimony of the plaintiff’s general and specific causation experts and granting summary judgment – because a negative answer to that question obviated the need to consider any of the others.  In the process, the court rejected the plaintiff’s argument that the it needed to address the adequacy of the warnings whether or not the plaintiff could establish medical causation.  As the court explained,

Generally, the “proximate causation element” in a failure to warn case against a pharmaceutical manufacturer is established by proof that the allegedly inadequate warning was a substantial contributing factor to the plaintiff’s injury. . . . In certain product liability cases, however, such as the case before us, the parties disagree over whether sufficient evidence exists to show that the product, itself, can cause the specific injury alleged and, therefore, whether the manufacturer had a duty to provide different or additional warning to prevent the injury. . . . . What is often termed “general causation” is present “when a substance is capable of causing a given disease. . . . General causation, therefore, relates to the element of duty — i.e., whether the risk of the type of injury the plaintiff suffered was reasonably foreseeable, and therefore, whether the manufacturer had a duty to warn the prescribing physician in the first place. . . . Evidence demonstrating [medical] causation . . . must exist independent of whether the manufacturer’s allegedly defective warning label was a proximate cause of the injury. In other words, evidence of general and specific causation was necessary in this case to establish [the defendant’s] duty to warn . . . .

Id., at *9-10. And so the court proceeded to determine whether the trial court had erred in excluding the plaintiff’s causation experts. The plaintiff’s causation theory was that “the immunosuppressant effect of HUMIRA permitted the ‘unmasking’ of [the virus that causes PML], despite the fact that” the plaintiff was not as immunosuppressed as HIV-positive patients who develop PML” even in light of his most recent lab results.  Id.  Maryland is a Frye state.  Under that standard, as the court explained, an expert’s opinion is admissible only if the basis of the opinion is “shown to be generally accepted as reliable within the expert’s particular scientific field.” Id. at *12 (internal punctuation and citations omitted). The standard applies equally to new scientific techniques and to accepted methods applied to support novel theories.

With respect to plaintiff’s main causation expert, the trial court had held that his causation conclusions “[had] not been sufficiently tested and proven to qualify as reliable forensic conclusions rather than scientific hypothesis.” Id. at *13.   The expert’s primary contention was that, “in addition to general HIV disease progression, some additional functional immune deficit must be present for PML to occur,” and that HUMIRA caused that deficit in the plaintiff. Id.   The trial court held that the expert had not considered other potential contributing factors, and that he could not provide a sufficient factual basis for his opinion that HUMIRA was “the missing link.” Id. at *14.

The appellate court stated that, “to constitute a sufficient basis for his general causation opinion, Dr. Jacobson needed to provide support for his contention that” the class of drugs was “known to be associated with an increased risk of PML” at the time the plaintiff took the drug. Id. The plaintiff contended that this support was to be found in the expert’s reference to the drug’s black-box warning about opportunistic pathogens coupled with “well-documented reports of PML occurring in patients who had received” this class of drugs.” Id. But, the court pointed out, the expert did not discuss the “well-documented reports of PML” or explain how the reports helped form the basis of his opinion.   The plaintiff also asserted that the expert relied on “peer reviewed studies, reviews of other biologicals, and FDA Adverse Event Reporting data,” but, the court found, he did not explain how the existence of case reports demonstrated a causal connection, and, the one article he cited related to a drug with a different mechanism of action than HUMIRA’s.

The court echoed the trial court’s holding that there “is sound scientific reasoning to suggest that [the drug’s immunosuppressive effect] could be a factor, but it falls short of showing with any degree of reliability that it is a factor, much less a substantial contributing cause” of the plaintiff’s PML. Id. at *15 (emphasis in original).   The court also reviewed the depositions of the plaintiff’s other experts, and held that, although they “believed that [the plaintiff’s] use of HUMIRA likely contributed to his immunological decline, none could provide a sufficient factual basis for that conclusion. . . . Indeed, [one] conceded that a scientifically reliable causal association” had not been established, id., and another stated “more unequivocally that he believed that [the plaintiff’s increased immunosuppression]” occurred “independent of HUMIRA, representing progression of his HIV disease.”  The same expert discussed an article establishing “the theoretical possibility” that the class of drugs was associated with PML, but explained that “it [didn’t] necessarily establish causation . . . .” Id.

The court commented that it agreed with the trial court that “it may well be that additional research will confirm some or all of [the expert’s] hypotheses. What is determinative in this case, however, is that those causal theories have not been established now nor were they established” when the plaintiff took the drug.  The court also acknowledged that there were ethical obstacles to conducting controlled studies on HIV-positive individuals, and that, because PML is a rare disease, “the amount of epidemiological data that could be useful is limited.”  But this didn’t excuse the experts’ theoretical causation opinions.  The court concluded, “We hold that [the plaintiff’s] experts’ opinions were not grounded on an adequate supply of data, and, therefore, the circuit court properly excluded their testimony.” Id. at *16,

We love a good expert exclusion. BTW, the coyote pictures are really cool.  E-mail us, and we will send them to you.

 

 

We spent yesterday in New York City, helping the Drug and Device Law Rock Climber (now the “Drug and Device Law Software Engineer” – yes, we are kvelling) move from one sublet to another as she continues her quest for the perfect apartment. The day was challenging, as these things tend to be. We lost count of the times we heard, “Why didn’t you tell me?” (That it was going to rain, that we would have to use the freight elevator, that we would be forced to keep moving the borrowed van because here was no legal place to leave it, that the refrigerator would bear the detritus of multiple unintentional science experiments – you get the idea. ) Each time, we responded with, “What difference would it have made?’

The plaintiff in today’s case, a tidy appellate decision in a medical malpractice case out of New Jersey Superior Court, asked the same question, and got the same answer. In Hopper v. Progressive Motion Med. Prod. Solutions, 2018 WL 2270839 (N.J. Super. Unpub. July 18, 2018), the defendant doctor performed arthroscopic knee surgery on the plaintiff. Following surgery, the doctor prescribed a cryotherapy device for the plaintiff to use at home to help control pain and swelling. The device worked by creating a flow of cold water across the plaintiff’s bandaged knee. The doctor and his staff instructed the plaintiff to use the device continuously for the first seventy-two hours after surgery and as needed thereafter, and to contact the doctor with any “issues” involving “drainage, redness, [or] warmth.” Hopper, 2018 WL 2270839 at *2.

The plaintiff used the device for seventy-two hours and intermittently for the next several days. On the fifth day, he saw the defendant doctor for complaints of swelling and bleeding. The doctor reassured the plaintiff that fluid buildup was common after surgery, aspirated the fluid from the knee, and instructed the plaintiff to return in a week. When the plaintiff returned, fluid had accumulated again, and the knee was painful. The doctor drained the fluid, but, he testified, was not “overly concerned.” He instructed the plaintiff to continue to use the device as needed.

Over the next several weeks, the plaintiff developed increased pain and swelling along with black skin and blisters on the knee. About five weeks after surgery, the plaintiff went to the emergency room complaining of nausea and increased knee pain. He was admitted, and ended up remaining in the hospital for a number of weeks. At the time of admission, the plaintiff had “eschar” – dead, necrotic tissue – over a wound in his knee. The eschar was surgically debrided, but it returned. Ultimately, the plaintiff was diagnosed with osteomyelitis, an infection of the bones in his knee. He was in danger of losing his leg, though doctors were able to save the leg by fusing the plaintiff’s knee.

The plaintiff sued the doctor for medical malpractice, alleging that the doctor deviated from the accepted standard of care during the postoperative period and that the deviations proximately caused his injuries. At trial, the plaintiff’s experts testified that the cryotherapy device caused “freezer burn” – a thermal injury – to the plaintiff’s skin, which the doctor did not recognize. According to the plaintiff’s experts, the untreated thermal injury destroyed the skin on the plaintiff’s knee. When the knee was debrided, the plaintiff’s experts testified, bacteria in the hospital environment infected the knee and eventually the bones, necessitating the fusion. The plaintiff’s experts testified that the doctor deviated from the standard of care by, inter alia, failing to warn the plaintiff of the risk of thermal injury and failing to personally instruct the plaintiff on how to use the cryotherapy device instead of allowing his staff to perform this task.

The defendant’s infectious disease expert opined, based on testing performed on tissue removed from the plaintiff’s knee, that the plaintiff was suffering from bullous cellulitis, blistering caused by a staph infection of the knee – not a thermal injury – when he presented to the emergency room, and that the infection would have occurred whether or not the plaintiff used the cryotherapy device. The defendant’s “standard of care” expert conceded that the doctor deviated from the accepted standard of care when he failed to warn the plaintiff of the risk of thermal injury. He testified that it was more likely than not that the plaintiff had sustained a thermal injury, but he did not opine that such injury was the proximate cause of the plaintiff’s damages.

The jury agreed, finding that the defendant had deviated from the applicable standard of care but that the deviations were not the proximate cause of the plaintiff’s injuries. On appeal, the plaintiff argued, inter alia, that, because it was ruled that the learned intermediary doctrine applied (the medical device manufacturer was no longer in the case when it was tried) and because there was sufficient evidence that thermal injury was a risk, the trial court committed error by failing to charge the jury about informed consent. The plaintiff argued that this error was “clearly prejudicial [because] defendant admitted he did not warn plaintiff of the risk of thermal injury.” Id. at *16.

The court disagreed, distinguishing between the product liability concept of “learned intermediary” and the medical monitoring theory of informed consent, explaining that “to prove a physician was negligent premised upon a theory of lack of informed consent, a plaintiff must show (1) the physician failed to comply with the applicable standard for disclosure; (2) the undisclosed risk occurred and harmed the plaintiff; (3) a reasonable person under the circumstances would not have consented and submitted to the [procedure] had he . . . been so informed; and (4) the [procedure] was a proximate cause of plaintiff’s injuries. Id. at *17 (citation omitted).

In any event, the court concluded that, because the jury had found that the doctor’s deviations from the standard of care were not the proximate cause of the plaintiff’s damages, the court’s failure to charge the jury on informed consent was harmless error. Verdict affirmed, and doctor off the hook for failing to warn. Wish it were that easy for the mother of a certain software engineer.

We love the unexpected. We loved standing up after what we thought was the finale of the fireworks show last night only to be left breathless by a stunning and unexpected encore.  We loved walking in to a “quiet family dinner” for our recent advanced birthday to find the room filled with dear relatives and friends shouting “surprise.”  But sometimes it is nice when things happen just as they are supposed to (which, in the jurisprudential world, may actually be unexpected!), like they did in today’s case, a terrific summary judgment decision out of the Eastern District of New York.  (A shout out to Tom Kurland of Patterson, Belknap for the victory and for sending us the decision before it was available online.)

In Chandler v. Janssen Pharms. Inc., et al., — F.Supp. 3d —,  2018 WL 3212422 (E.D.N.Y June 29,  2018), the plaintiff, placed in foster care in 1996 when he was six years old,  began taking Risperdal the next year after displaying aggression at school.  He continued to have serious psychiatric and behavioral problems and to take Risperdal in gradually increasing doses, until 2009.  That year, during a visit with his psychiatrist, the plaintiff complained that his breasts were enlarged.  The psychiatrist recommended that the plaintiff stop taking Risperdal, which he observed was “probably responsible for the breast enlargement,” and noted that he had been aware of the correlation between the drug and breast enlargement for several years. The plaintiff continued to see psychiatrists, and to take antipsychotic medications, until late 2012.   In April 2014, he underwent bilateral mastectomies to remove his enlarged breast tissue.  In March 2015, he filed suit alleging that the defendants failed adequately to wan about rate of incidence of gynecomastia (breast enlargement) in pediatric users of Risperdal.  Specifically, although the label at all relevant times, had always included a Precaution about gynecomastia, the plaintiff alleged that gynecomastia should have been listed in the “Warnings” or “Adverse Reaction” section, and that gynecomastia rates were two to five times higher than the 2.3% rate listed in the label after October 2006, when Risperdal was approved for pediatric use.  He alleged that his doctor would not have prescribed Risperdal if he had known about the higher incidence rate.

The defendants moved for summary judgment, arguing that the plaintiff had not produced admissible evidence that the Risperdal gynecomastia warning was inadequate.   The defendants argued that the only “evidence” supporting the plaintiff’s warnings claim was the two cherry-picked clinical studies that ostensibly demonstrated the higher incidence rate, a “contention that [was] inadmissible without expert testimony.” Chandler, 2018 WL 3212422 at *6.

The court explained that, under the learned intermediary doctrine, a drug warning is “adequate as a matter of law if it clearly and unambiguously notifies the prescribing physician of the particular adverse reaction that forms the basis of the plaintiff’s complaint.” Id. (citations omitted).  Because the Risperdal label always warned that the product could cause gynecomastia, the plaintiff could not prove that the label was inadequate.   The court also rejected the argument that the label should have included an incidence rate for gynecomastia before the drug was approved for use in children, noting that the defendants “were clearly keeping abreast of knowledge” of the drug through available methods and were “taking steps to bring that knowledge to the attention of the medical profession.”   Id. (internal punctuation and citation omitted).  Finally, the court held that the plaintiff had not produced admissible evidence that the gynecomastia incidence rate in the 2006 and 2007 labels was inadequate.  The plaintiff relied on two studies (of eighteen conducted around the same time)  that allegedly showed higher incidence rates, but the plaintiff “introduce[d] no  expert testimony on the validity of [those]  studies, either standing alone or  compared to the other sixteen studies, or [on]  the regulatory requirements of labeling.” Id, at *8.  Without an expert, the court held, the plaintiff could not opine on the “statistical or methodological differences between the studies or why the two studies he cited were correctly decided in comparison to the other sixteen.” Id.  Concluding, “To be clear, while the two studies could be evidence of higher incidence rates, the absence of an expert to interpret and validate them precludes their admission,” id, the court held that Risperdal’s gynecomastia warnings were adequate as a matter of law at all relevant times.

Warnings Causation

Though the defendants were entitled to summary judgment based on the adequacy of the warning, the court went on to consider the issue of warnings causation; in other words, whether a different warning would have changed the plaintiff’s doctors’ decisions to prescribe the drug. The court added, “if the treating physician is aware of the risks of a drug, independent of any warning by the manufacturer, such knowledge constitutes an intervening event relieving the manufacturer of any liability to a patient under a failure to warn theory.” Id. at *10 (internal punctuation and citations omitted).   In this case, both of the plaintiff’s prescribing physicians knew of the possible correlation between Risperdal and gynecomastia “both before and during the time that they prescribed the drug” for the plaintiff. Id.  One of the doctors testified that he wasn’t sure he would have changed his prescribing decisions even if he knew the risk was higher.  The other  testified that, although he knew of the gynecomastia risk from other  sources, he didn’t read the label or advise the plaintiff of the risk, both of which constituted intervening causes, “severing the causal connection between Defendants’ alleged failure  to warn and Plaintiffs’ injury.” Id. (citation omitted).  Finally, the court disregarded the plaintiff’s guardian’s affirmation to the effect that she would not have consented to the Risperdal prescription if the plaintiff’s doctor had advised her of the gynecomastia risk.  The court explained, “A failure to obtain informed consent might be a viable theory of liability against [a] physician or … hospital,” but neither was a party to the lawsuit.  Because the plaintiff could not establish specific (warnings) causation, the court held that the defendants were entitled to summary judgment on that basis as well.

We love a good warnings decision, and we are delighted that we had the chance to bring this one to you.   We hope you all had a great holiday.

Permit us to recount a recent travel misadventure, though whatever eventual connection we draw to today’s case will be specious at best. Last Friday, we traveled from Philadelphia to Hartford, Connecticut for a deposition.  We were fresh off of a long flight home from Europe and were hesitant to take on a couple hundred miles of driving at each end of the day, so we investigated our options.  In the morning, direct flights from PHL to BDL abound.  But after 6 p.m., when our deposition was scheduled to end, there are no direct flights home. Nor are there Amtrak trains leaving Hartford after that hour.  So we threw up our hands and reserved a connecting flight home, reasoning that sleeping, reading, and eating Biscoff cookies would be more relaxing than driving.  This even though, to get from Hartford to Philadelphia, we had a totally illogical connection at Dulles, many miles out of the way.

Our originating flight landed at Dulles early.  And our 9:30 pm connection was showing “on time” on the board.  At 9:15 pm, the following announcement came over the loudspeaker: “We are very sorry, but your first officer is coming in on a flight that is delayed, so we need to delay your 9:30 pm flight until 11:30 pm.”  We were not pleased, but the new schedule would still get us home, crucial because we were leaving at noon on Saturday for an overnight trip.  At 11:20, the gate agent announced, “Your first officer’s flight has landed.  Give us a few minutes and we’ll get you boarded.”  At 11:30, we heard the following, dripping with contrition: “We are SO SORRY, but we are unable to put together a crew for your flight tonight, so we are delaying this flight until NOON TOMORROW.” [Emphasis added.]  Turns out that the long-awaited first officer had now exceeded his maximum hours for the day.

We did not react politely to this. We asked, “You mean to tell us that nothing in your computer could have told you this before we sat here for two hours and lost all other options??”  We did not receive a satisfactory response.  Ultimately, we took a 45-minute cab ride to Union Station (cavernous, pitch-black, and empty) and caught a 3:10 a.m. (!!) Amtrak train to Philadelphia.  When all was said and done, that was all that was left.

“Not much left” also describes (we warned you) today’s case, an excellent PMA and Buckman preemption decision out of the Northern District of Illinois.  In Gravitt v. Mentor Worldwide, 2018 WL 2933609 (N.D. Ill. June 12, 2008), the plaintiff alleged that she was injured by the defendant’s silicone breast implant.  Her complaint asserted claims under Illinois law, alleging design and manufacturing defects, failure to warn, and the defendant’s alleged failure to comply with the FDA’s pre-market approval (“PMA”) process for Class III medical devices, including numerous allegations of deficiencies in the defendant’s design and execution of post-PMA studies ordered by the FDA.

In earlier motion practice, the court dismissed most of the plaintiff’s claims without prejudice.  (We published a guest post on the first dismissals here.)  The plaintiff filed an amended complaint, which the court commented “strongly resemble[d] the original complaint.” Gravitt, 2018 WL 2933609 at *1.  The defendant again moved to dismiss, arguing that the plaintiff’s claims were expressly preempted under the Medical Device Amendments (“MDA”) to the FDCA or impliedly preempted under Buckman.

Express Preemption

The defendant argued that the plaintiff’s claims were expressly preempted to the extent that they were based on alleged methodological defects in the defendant’s post-PMA studies. The Court explained that under SCOTUS’s Lohr decision, as construed by the Seventh Circuit in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), as well as SCOTUS’s Riegel decision, state law tort claims related to Class III medical devices granted PMA are allowed to proceed if they: 1) allege violations of common-law duties that parallel federal requirements; or 2) claim violations of federal law.  Conversely, state law claims that “would impose on [the defendant] a requirement that is in addition to federal requirements” – in other words, claims that the defendant “violated state tort law notwithstanding compliance with the relevant federal requirements” – are preempted. Gravitt, 2018 WL 2933609 at *4 (internal punctuation and citations omitted).

The court held that, while the complaint alleged numerous deficiencies in the defendant’s post-PMA studies and alleged that each deficiency amounted to an “independent failure to comply with the FDA’s post-approval requirements” and thus a ground for withdrawal of PMA, the plaintiffs “simply assume[d], without legal or other support, that those deficiencies amount[ed] to violations of the FDA’s conditions for PMA.” Id. at *6 (citations omitted).   The court concluded that “such an assumption may not ground a viable claim,” id., and held that certain categories of the plaintiff’s allegations were expressly preempted.

Implied Preemption

But the court held that other categories of the plaintiff’s allegations were not expressly preempted. Specifically, the court held that “the complaint plausibly alleged that [the defendant] violated federal law” by failing to satisfy several categories of requirements related to, inter alia, follow-up of study participants, collecting and reporting of data at required intervals and related updates to labeling, warning of newly-discovered risks of the device, and failing to comply with requirements for manufacturing facilities.  Because the plaintiff “plausibly alleged” that these “shortcomings in [the defendant]’s post-PMA testing and manufacturing processes violated federal law,” section 360(a) of the MDA did not preempt those claims. Id. But the court emphasized, “Plaintiffs may proceed with those claims, however, only if they pass through a second legal filter” – the “filter” of implied Buckman preemption of “fraud on the FDA claims.” Id. at *7.

The court explained that, under Buckman, “federal law preempts claims to the extent they seek to deploy state law in the service of policing fraud against federal agencies based on statements that federal  law required the defendant to make to the agency, id. (internal punctuation and citation omitted), but doesn’t preempt traditional tort law claims involving breach of a duty to the plaintiff.  The court held:

Here, several of the claims that survive express preemption – for example, claims that the defendant reported results of the core study for fewer than the required number of years and recruited fewer than the required number of patients for a large post-approval study – are impliedly preempted under Buckman because those shortcomings breached no . . .  [tort duty to the plaintiff].  Rather, as in Buckman, those claims are unconnected to any traditional state tort duty, meaning that the existence of the relevant federal enactments is a critical element of those claims.

Id. (internal punctuation and citation omitted).  The court noted that the plaintiff attempted to tie the defendant’s alleged misconduct to her state tort claims, alleging that, if the defendant had more fully complied with the PMA process, its “disclosures would have led to much wider knowledge of the risks associated with its product.” Id. (internal punctuation and citations omitted).  But, it emphasized, “the Buckman analysis centers on the nature of the asserted claim and the source of the violation, not on the violation’s effects . . . . A claim arising entirely out of a violation of [the defendant’s] compliance with the FDA’s requirements in granting PMA is . . . . preempted under Buckman. Id.

Two categories of claims remained. The court dismissed the plaintiff’s claims alleging that the defendant’s manufacturing facilities failed to comply with applicable law and regulations, holding that the complaint had not adequately alleged a true manufacturing defect claim.  In addition, the plaintiff had failed to respond to the defendant’s arguments against these claims.  The last claim alleged that the defendant learned, but did not disclose, that its device had a higher likelihood of rupture than had been reported.  The court acknowledged that these claims were not fully developed in the complaint, but held that Rule 9(b)’s particularity requirement did not apply to the claims.  Holding that the plaintiff’s pleading “cross[ed] the line from conceivable to plausible,” satisfying Twiqbal, the court allowed the claims to proceed.

But that was all that was left.  The claims that were preempted – expressly and impliedly – were dismissed with prejudice, in an infrequent and laudable turn of events.   We would wax on at greater length, but today’s flight is boarding in a few minutes.  At least that’s what the board says.  We’ll keep you posted.

We have an adorable, pigtailed, toddler grand-niece. We play a game with her that involves placing one building block on the table and asking her how many blocks there are.  She answers, “One.”  We take that block away and replace it with another.  Again, the answer is “one.”  Then we place both blocks on the table and ask, “How much is one plus one?”  As brilliant as she is beautiful, she answers, “Two!”   Simple, right?  But those of us who practice in the mass tort space are far too accustomed to reading opinions laying out the building blocks of an obvious holding then failing to conclude that one plus one equals two.

Not so the lovely opinion on which we report today. In Young v. Mentor Worldwide LLC, 2018 WL 2054591, — F. Supp. 3d — (E.D. Ark. May 1, 2018), the plaintiff was implanted with the defendant’s sub-urethral sling in 2003 to address her stress urinary incontinence.  In two subsequent surgeries, in 2006 and 2008, portions of the sling were removed.   In 2013, more than five years after the last revision surgery, the plaintiff filed suit, asserting all of the usual claims and alleging permanent injury from the defendant’s product.

Because Arkansas law, which governs the plaintiff’s claims, imposes a three-year statute of limitations on product liability lawsuits, the defendant moved for summary judgment, alleging that the plaintiff’s claims were time-barred. The court denied the motion, finding a question of fact as to when the plaintiff’s cause of action accrued under the applicable discovery rule.

Motion to Bifurcate Trial

Flash forward to the eve of trial. Arguing that resolution of the statute of limitations defense would require only a few witnesses and would likely take only two days, the defendant asked the court to bifurcate the proceedings in a novel manner, holding a preliminary trial on the statute of limitations and moving on to a full trial on the merits of the plaintiff’s claims only if necessary.  The plaintiff opposed the motion, arguing that resolution of the statute of limitations issue would require admission of evidence of the defendant’s alleged fraudulent concealment and that a single jury should resolve all of the issues at the same time.

The court disagreed, holding,

Regardless of whether the [plaintiff is] entitled to pursue a fraudulent concealment claim, [the defendant’s] statute of limitations defense is potentially dispositive, and preliminary trial will not consume the time and expense necessary for a trial on the merits.  The Court finds that a separate, initial trial on the statute of limitations question is especially warranted in this case, as it will promote judicial economy, avoid confusion of the issues, and prevent possible undue prejudice.

Young, 2018 WL 2054591 at *2.

Motions to Exclude Expert Testimony

The defendant also moved to exclude the testimony of two of the plaintiff’s experts, a biomedical engineer and a pathologist.

Biomedical Engineer

The biomedical engineer sought to testify about the mechanical structure of the defendant’s product “and to offer his opinion that the design and testing of [the product] was inadequate, that the product was defective for its intended use, and that [the defendant] failed to warn about the significant risk of complications and adverse events from the use of the product.” Id. at *3.  The defendant moved to exclude the expert’s testimony about the adequacy of the warnings, arguing that the expert was not qualified to offer such opinions.  The court agreed, holding, “The record is void of information indicating that [the expert’s] expertise in the area of biomedical engineering and product design qualifies him to opine as to the adequacy of warnings at issue or that his opinion on this ultimate issue of fact would be helpful to the jury.” Id.

The expert’s report also included statements to the effect that the defendant was “fully aware” of a high rate of complications associated with the product. The defendant moved to exclude these statements on the ground that they were inadmissible expressions of “corporate intent and legal conclusions.”  Again, the court agreed, holding, “The Court finds that a jury is capable of making its own determinations as to [the defendant’s] intent, motive, or state of mind, and that [the expert’s] opinion on these subjects does not meet the helpfulness criteria of Rule 702.” Id. (citation omitted).

Pathologist

The pathologist’s report stated that his general causation opinions were “based on his review of over 300 explanted mesh samples, which include[d] hernia meshes, pelvic organ prolapse meshes, and slings used to treat urinary incontinence.” Id. at *4.  He acknowledged that only ten of the 300 samples he examined were manufactured by the defendant, and those were samples he received from plaintiffs’ attorneys.

The defendant argued that the expert’s opinions about other types of mesh and other manufacturers’ products were irrelevant and unreliable. In deposition, the expert testified that “all of this background” was necessary to “interpret accurately case-specific material.”  The court disagreed, holding, “The Court finds that neither [the expert’s ] explanation nor [the plaintiff’s] arguments demonstrate that information about various types of polypropylene mesh products . . . is relevant in this case, which deals with a specific mesh product, used for a specific purpose.” Id. Further, the expert “admit[ted] that he [had] no knowledge as to how the mesh implants he has examined were selected, thus there is no assurance that they were randomly selected and no way of projecting the potential rate of error.” Id. The court concluded, “After careful review, the Court cannot find that [the expert’s] proposed opinion testimony is the product of reliable principles and methods, and [the defendant’s] motion to exclude will be granted.

We love this opinion – logical, correct, and elegant in its simplicity. We hope that others follow suit, and we will keep you posted.

We are back in the trenches today after spending a wonderful day in New York with our lifelong best friend, in yet another of the blissfully endless celebrations of the milestone birthday we marked in December. We saw “The Band’s Visit,” a new musical based on a 2007 movie about eight members of an Egyptian police orchestra stranded overnight in a remote Israeli town.  The band members accept a local resident’s invitation to bunk overnight in her café, setting the stage for lovely intersections of hearts, minds, and cultures.  It is short, sweet, and very satisfying.

As is today’s case, for those of us who defend prescription drug and device manufacturers. In Kwasniewski v. Sanofi-Aventis, LLC, 2018 WL 1567851 (D. Nev. Mar. 30, 2018), the plaintiffs alleged that the defendant’s prescription sleep medication caused their decedent to commit suicide.  The opinion includes the judge’s decisions on objections to several earlier rulings by the magistrate judge and her decision on the defendant’s motion to dismiss the plaintiffs’ design defect claims.

Objections to Magistrate’s Rulings

First, the plaintiffs objected to the magistrate’s refusal to stay discovery – and relieve the plaintiffs of their obligation to respond to the defendant’s pending discovery requests – while the defendant’s Motion to Dismiss was pending. The court agreed with the magistrate, emphasizing that “[t]he Federal Rules of Civil Procedure do not provide for automatic or blanket stays of discovery when a potentially dispositive motion is pending.” Kwasniewski, 2018 WL 1567851 at *2.

Second, the plaintiffs objected to the magistrate’s application of Nevada’s learned intermediary doctrine.   In a 30(b)(6) deposition notice, the plaintiffs included topics concerning “information about direct to consumer advertising.”  Because, under the learned intermediary doctrine, the defendant had a duty to warn only “medical experts, not consumers, about the dangers of [its prescription drug],” id. at *4, the magistrate ruled that deposition testimony about direct-to-consumer advertising was irrelevant.  As such, she limited the plaintiffs’ Rule 30(b)(6) deposition topics to the defendant’s “representations to the medical community.”  The plaintiffs argued that the magistrate had “effectively decided a dispositive motion” by applying the learned intermediary doctrine, and that the doctrine was an affirmative defense that had not yet been pled.  The court again affirmed the magistrate and barred the plaintiffs from discovering information  that the defendant had disseminated directly to consumers. We like this ruling and applaud the court’s adherence to the standard imposed by Fed. R. Civ. P. 26, requiring discovery to be “relevant to [a] party’s claim or defense and proportional to the needs of the case,” and its refusal to sanction a meaningless and abusive fishing expedition.

Defendant’s Motion to Dismiss

The defendant moved to dismiss the plaintiffs’ design defect claims sounding in both strict liability and negligence, arguing that “any claim that [the defendant] should have changed the formulation of [the product] or that the product should simply not have been marketed are preempted by Federal Law.” Id. at *5.  In their response, the plaintiffs conceded that they were “not arguing that that [the defendant] should have reformulated the drug – just simply that [the defendant] should have” included adequate warnings of the drugs alleged suicidality risk. Id. As such, the court was able to grant the defendant’s motion, and foreclose the plaintiff’s from alleging a design defect claim at a later date, without addressing the preemption argument.. (Given this court’s clear-headed, correct-leaning rulings, we suspect that its preemption decision would have been fun to read.)

Kwasniewski is a tidy, no-nonsense, defense-friendly opinion.. If, on this beautiful spring day, we are confined to an office and not roaming the Great White Way, we are pleased that this case crossed our desk.

This morning, our commuter train was packed with overjoyed Villanova students headed for the NCAA Championship Victory Parade.   It was the second time in a few months that our fair city has been lifted by a huge sports triumph.  And, though our heads were ringing by the time we reached our stop (“Indoor Voice” is apparently not a course offered at Villanova), we love the infectious joy of these victories.

We also love a good Daubert victory, like today’s decision.  In Tsao v. Ferring Pharms., Inc., 2018 U.S. Dist. LEXIS 49173 (S.D. Tex. Mar. 26, 2018), the defendant manufactured a drug designed to stimulate women’s ovaries to produce eggs to be used for in vitro fertilization (“IVF”).  The plaintiff, an oncologist, underwent fertility treatments using the defendant’s drug.  Alleging that she purchased “defective, adulterated, and misbranded” vials of the drug, she sued the defendant for economic damages for breaches of express and implied warranties and violations of the Texas Deceptive Trade Practices Act.   The defendant had earlier voluntarily recalled certain lots of the drug because routine stability testing indicated that the lots “did not meet potency specifications and were out of specification . . . at the time of testing (twelve months or more into their shelf life.” Tsao, 2018 U.S. Dist. LEXIS 49173 at *1.   The plaintiff “complain[ed] that [the defendant] failed to inform her that [the drug] lacked the potency described in the drug’s Prescribing Information” and that she would not have purchased and used [the drug] had she known it did not meet those product specifications.” Id. at *3.  Claiming that the reduced potency adversely affected her fertility treatments, she sought recovery of money she spent to purchase the drug, money she spent on other medications used in conjunction with the drug, and the costs of her IVF treatments.

Among her designated experts, the plaintiff designated herself to offer a number of opinions, among them opinions related to the alleged “sub-potency” of the drug she purchased, the likelihood that this “sub-potency” would cause her IVF treatments to fail, and multiple issues related to ovarian stimulation, including the “usual” period of stimulation, the “prolonged” period necessary because the drug was “sub-potent,” and the supposed negative effects of this “prolonged stimulation.”  The plaintiff also designated a regulatory expert to testify about causation as well as the defendant’s “alleged lack of compliance with FDA regulations regarding drug recall and misbranded or adulterated drugs.” Id. at *11.  The defendant moved to exclude the plaintiff’s “expert” testimony and the testimony of her regulatory expert.

Motion to Exclude the Plaintiff’s Expert Testimony

The defendant moved to strike the plaintiff’s expert testimony on the grounds that: 1) she was not qualified as a reproductive endocrinologist; and 2) her opinions lacked the indicia of reliability required for medical expert testimony.  The court resoundingly agreed.  First, the court held that the plaintiff had “failed to demonstrate knowledge, skill, experience, training, or education with respect to reproductive endocrinology and drug recalls . . . .” Id. at  *17.   To wit, the plaintiff testified in deposition that “many of her opinions regarding [the drug] and reproductive endocrinology [were] based on internet research that she conducted using Google  and Wikipedia” as well as “the websites of different fertility clinics and online patient forums to research the average stimulation period” for women undergoing this type of therapy. Id. at *17-18.   In addition, the plaintiff testified that her opinions about issues related to the drug’s recall were “based on her general understanding of ow pharmaceutical companies work. Id. at  *19 (internal punctuation omitted).   And so, the court found, the plaintiff had not met her burden to demonstrate that she was qualified to offer her expert opinions.

Because it had excluded the plaintiff’s opinions based on her lack of qualifications, the court emphasized that it didn’t need to reach issues related to the reliability of her opinions. But it stated for the record that the plaintiff’s own opinion that she would have produced more eggs if the drug were “fully potent” was not reliable because: 1) it “did not “fit” with the scientific literature, the data contained in the medical record, or her treating physicians’ testimony,” id. at *21; 2) was not the product of the same rigor the plaintiff would use in her own practice (the court commented that it “[didn’t]  believe that [the plaintiff ] would base her opinions regarding treatment of an oncology patient on Wikipedia research”); id. at *24-25; and 3) her repeated deference to her treating physicians confirmed her lack of expertise in reproductive endocrinology. Id. at *26.

And so, while the plaintiff was obviously permitted to testify about her own experience, she was not permitted to offer her own “expert” opinions.

Motion to Exclude Regulatory Expert

The defendant challenged the testimony of the plaintiff’s designated regulatory expert on three topics: 1) the potency of the drug purchased and used by the plaintiff; 2) FDA labeling requirements; and 3) the recall of the drug.  After recounting the expert’s qualifications at length, the court held that she was generally qualified to testify as an expert, and, specifically, was qualified to testify about FDA regulations and recalls.  But the court held that the expert’s opinions that the drug was “misbranded” and “adulterated” were impermissible legal conclusions and were contrary to FDA regulations.  Specifically, the FDA had set a potency range within which the drug was required to fall – 80%  to 125% of the labeled potency —  and the drug was not “misbranded”  or “adulterated” or “out of specification,” according to FDA regulations, as long as it fell within this  range.  And there was no evidence that any lots of the drug that the plaintiff used were “out of specification” at the time she used them.  As such, the expert’s opinion that certain vials of the drug “may have” fallen out of specification by the time the plaintiff used them was “speculative, contrary to the evidence, and inadmissible ipse dixit.” Id. at *37.   Finally, the court held that the expert’s opinion that the drug’s potency was a key factor affecting the quality of retrieved eggs was unreliable because it was “contrary to the labeled indications for [the drug], her own deposition testimony, and the testimony of Plaintiff’s treating physicians.” Id. at *43.

Regular readers are familiar with our frustration with the too-frequent admission of expert testimony that should never see the light of day.   While many of the challenges to the Tsao opinions were, dare we say, a slam-dunk, it’s still nice to see an opinion come out the right way.  Let’s hope for more, and, on the day of the Phillies’ 5-0 victory in their home opener, hope springs eternal that they can harness some of the city’s “sports karma” for the long upcoming season.

We write this as key elements of the Drug and Device Law Passover Feast languish in the oven. Tomorrow, the Drug and Device Law Bubbie will force four generations of our family – the devout and the not and everyone in between – to read (aloud) the lengthy prayer service that precedes the meal.  The ritual includes much laughter, enthusiastic (if discordant) singing, and predicable misbehavior from those of us at the “kids’ table” (the 50- and 60-year-olds, as distinguished from our parents) that provokes sharp rebukes from the elders.  And, these days, the gathering is a little bit bittersweet (cue “Sunrise, Sunset”), as time’s toll on the eldest members of the clan is softened by the presence, each year, of more of our babies’ babies.  We complain about the cooking.  We grouse about the most troublesome relatives.  But we wouldn’t miss it for the world, though we should mention that “feast” is something of a misnomer, as many Passover staples are notorious for barely crossing the line into “palatable.”

Speaking of misnomers, earlier this week, one of our co-bloggers termed causation the “MVP” of mass tort practice. While we heartily agree in principle, we have read (and participated in) too many scenarios in which a passive judge “benched” this “player” to allow meritless cases to queue up in settlement inventories. On the flip side, we are heartened by the increase in Lone Pine orders demanding early causation evidence and by judges who refuse to allow plaintiffs lacking proof of causation to escape summary judgment.

Such was the result of today’s case, a Risperdal case out of the Northern District of Alabama. In Drake v. Ortho-McNeil-Janssen Pharms., 2018 U.S. Dist. LEXIS 47164 (N.D. Ala. Mar. 22, 2018), the plaintiff was an obese 36-year-old man who was diagnosed as schizophrenic at age 17.  He was initially prescribed Risperdal but was switched to other drugs several months later.   He was switched back to Risperdal about two years after that and then remained on the drug for about thirteen years before different drugs were again substituted.

Shortly after the plaintiff stopped taking Risperdal, a social worker noticed that he had large breasts and told his mother that he should be tested for gynecomastia, benign enlargement of glandular breast tissue in males. Antipsychotic medications have been associated with gynecomastia, which “is distinct from pseudo-gynecomastia, which is breast enlargement due to fat deposits in overweight males.  The two conditions may be differentiated only with a physical exam.” Drake, 2018 U.S. Dist. LEXIS 47164 at *4.  No exam took place.  The plaintiff was never diagnosed with gynecomastia, though his levels of prolactin were elevated.  Prolactin is a hormone that induces lactation, but it “does not have a direct grown-stimulating effect on the breast glandular tissue.” Id. at *6 (citation omitted).  Many of the drugs prescribed to the plaintiff were known to cause prolactin elevation.

The plaintiff’s complaint, asserting all of the usual causes of action, alleged that Risperdal caused him to develop gynecomastia. The defendant moved for summary judgement, arguing that the plaintiff could not meet his burden of establishing causation.  The judge emphasized that the plaintiff was required to prove both general and specific causation and that expert testimony was required for both.  The plaintiff’s expert was a certain former FDA commissioner who has testified that the risk of gynecomastia in children and adolescents was higher than Risperdal’s labeling represented.  But, as the court pointed out, while the expert’s “report and deposition testimony from other  cases might be sufficient to raise a question of fact regarding general causation, . . . his report and testimony contain[ed] no evidence regarding the cause of [the plaintiff’s] alleged injuries. Id. at *13.  And the plaintiff had no other causation expert.

As such, as the court put it, “the plaintiff’s evidence concerning specific causation [was] threadbare.” Id.  There was no evidence that the plaintiff had even been diagnosed with gynecomastia.  And while the plaintiff argued that, if his elevated prolactin level had caused “testosterone level drops leading to estrogen expression,” then Risperdal could “theoretically [have caused] gynecomastia,” there was “no evidence in the record regarding [the plaintiff’s] testosterone or estrogen levels, and evidence that Risperdal could theoretically cause gynecomastia [was] not sufficient to raise a disputed issue of material fact concerning specific causation.” Id. The court concluded, “In the absence of medical or expert evidence, a fact finder must speculate about the cause of [the plaintiff’s] enlarged breasts, and a verdict may not rest on speculation.” Id.  

In other words, maybes on top of maybes do not proof of causation make. If the plaintiff cannot be bothered to get a diagnosis or an expert, that plaintiff should not be in court.  Unassailable, although we’ve all seen too many such “easy” decisions go wrong.  We like this case.  We will continue to keep you posted on the good and the bad, and we wish happy gatherings to all celebrating any holiday this week.

Here in Philadelphia, less than a week before the first day of Spring, it is sunny and calm, albeit a bit chilly. Not so last week, when we were hit with the second Nor’easter in less than a week.  As much as sixteen inches of snow fell in some suburbs, and thousands of people, some of whom had just regained electric power after the last storm, were knocked into the dark and cold when tree limbs felled by heavy snow took power lines with them.  For the second time in as many storms, we found ourselves in a pocket on the low end of predicted accumulations.  We only got about six inches of snow, and it started melting quickly when temperatures rose in the evening.  And, again, our end of the street did not lose power.  (Assuming cooperation from the technology gods, this no longer affects us, as we happily parted with some retirement savings a few years ago in favor of a whole-house generator, after a four-day outage during which we tested long-held friendships by descending with the Drug and Device Law Menagerie in tow.)  The only “blip” was a scary near-miss.  We were out walking the Drug and Device Law Little Rescue Dogs at the height of the storm when a huge tree limb crashed down on a spot where we had stood ten seconds earlier.  Reminds us not to sweat the small stuff – this could have been tragic.

But save for that significant footnote, it was all pretty good.   And our assessment of today’s decision is similar.  In In re Bard IVC Filters Prods. Liab. Litig., 2018 WL 1109554 (D. Ariz. Mar. 1, 2018), the court ruled on a number of motions in limine in advance of a mid-March trial.  The plaintiff alleged that she was injured when defendant’s filter, inserted in her inferior vena cava (“IVC”) to capture blood clots, migrated and fractured.  The filter that was implanted in the plaintiff, a Class II device, was granted 510(k) clearance by the FDA because of its “substantial equivalence” to an earlier filter model the defendant had marketed.  And that is the source of the most interesting rulings.

Defendants’ Motion to Exclude Evidence of Complications Associated with Predicate Device

Earlier, the plaintiff had moved to exclude evidence of the 510(k) clearance process, a motion that the defendants “vigorously opposed.” In re Bard IVC Filters, 2018 WL 1109554 at *1.  The court agreed with the defendants, “noting that the FDA grants 510(k) clearance only where the device is as safe and effective as a predicate device and does not raise different questions of safety and efficacy than the predicate device.” Id. (internal punctuation and citations omitted).  As such, compliance with the 510(K) clearance process was “certainly probative under Georgia law on the issues of reasonableness of the design, manufacture, and warnings of the [cleared filter]” as well as issues related to the plaintiff’s punitive damages claim. Id. Georgia law, hmmmm…. The Fourth Circuit’s Cisson misstep, going 180° the other way, was also Georgia law, as we discussed here.  Needless to say, we like this one better.

But having fought for admission of evidence of the 510(k) clearance process, the defendants were faced with the plaintiff’s intention to introduce evidence of complications with the predicate device. The defendant moved to exclude this evidence, arguing that the complications were not “substantially similar” to the issues the plaintiff experienced with her device.  The defendant argued that, ‘[b]ased on clinical experience with the [predicate] filter, [it] made several significant changes to the [new] filter.” Id. Because the plaintiff received the new filter, which had been “changed significantly” from the predicate device, the defendants argued that problems with the predicate device  had no relevance to the plaintiff’s case.

The court denied the motion, noting that the defendant had “avowed to the FDA that the design, material, components, fundamental technology, . . . and intended use featured with the [new filter] are substantially equivalent to those featured with the predecessor [filter].” Id. The defendants further asserted that “one of [the] goals in developing the [new] filter was to reduce the number of incidents of filter fracture and migration that [it] had observed with the [predecessor].” Id. The court concluded, “Given these facts, . . . [the defendant’s] knowledge of problems with the [predecessor filter] is relevant to central issues in this case” – whether the defendant properly designed the new filter to correct the problems, whether it failed to properly warn about the problems, and whether its conduct justified an award of punitive damages. Id. at *2.

This ruling presents a quandary. We have spent many years defending manufacturers of Class 2 medical devices and advocating for admission of evidence of 510(k) clearance. We can appreciate the tension and the difficulty of drawing appropriate evidentiary lines.  But evidentiary lines and regulatory requirements are different.  This is a variant of the same fallacy underlying the 510(k) admissibility point discussed above.  FDA regulatory requirements and admission of evidence in civil litigation are two different things, created for different purposes, and often don’t mix well.

That is true here. For one thing, there is more to 510(k) than just substantial equivalence (“SE”).  The entire relevant part of the FDCA allows for an SE finding where the device being considered:

(ii)(I) has different technological characteristics and the information submitted that the device is substantially equivalent to the predicate device contains information, including appropriate clinical or scientific data if deemed necessary by [FDA] that demonstrates that the device is as safe and effective as a legally marketed device, and (II) does not raise different questions of safety and effectiveness than the predicate device.

FDCA §513(i)(1)(A) (emphasis added), So a substantial equivalence finding by the FDA does not mean that the predicate device is technologically the same – or necessarily even close – as long as it “does not different questions of safety and effectiveness.”  That’s a lot different from the “substantially similar” standard generally used for admission of other occurrence evidence.

Admission of evidence of 510(k) clearance should not automatically open the floodgates to evidence of problems a plaintiff didn’t’ experience with a device she didn’t receive. The other occurrence could well arise from a “different technological characteristic.”  That would require a deeper dive into the regulatory pedigree of the device than occurred here.  We are thinking about this issue for a future post. Meanwhile, here are some highlights of the court’s less complicated rulings:

Defendants’ Motion to Exclude FDA Warning Letter

The defendants moved to exclude an FDA warning letter because: 1) it was an “informal advisory statement” by FDA; 2) it was issued more than seven years after the plaintiff received her IVC filter; and 3) the specific topics in it were not related to the filter the plaintiff received or to any issue in the case. Id. at *3.  The plaintiff countered that the letter was evidence to counter the defendant’s assertion that the FDA had never expressed concern about the defendant’s filters or taken any action against the defendant.   The court held that several sections of the warning letter lacked probative value because they addressed topics that were not at issue in the litigation.   Others addressed a generation of filter that was developed after the filter the plaintiff received.  The court granted the motion in limine with respect to those topics, but reserved for trial the question of the admissibility of topics related to the defendant’s handling and reporting of filter failures.  The court did conclude that, if the letter should become relevant at trial, it would be admissible under the public records exception to the hearsay rule.  Whatever happens later, the defendant’s first point about warning letters being “informal” and “advisory” was spot on.  We examined that issue in great detail here and here.

Plaintiffs’ Motion to Exclude References to IVC Filters as “Lifesaving” Devices.

The plaintiff sought to preclude the defendants from “putting on a ‘filters save lives’ defense” or from describing the filters as “lifesaving” or “life-extending.” Id. at *4.  The court denied the motion, holding that, under Georgia’s risk-utility analysis, “evidence concerning the benefits of IVC filters is directly relevant. . . .”

Plaintiffs’ Motion to Exclude “Standard of Care” Evidence

The plaintiffs sought to exclude the defendants from presenting evidence that IVC filters are “within the standard of care for medical treatment of pulmonary embolisms.” Id. at 5 (citations omitted).   The court denied the motion, agreeing with the defendants that “evidence regarding the use and benefits of IVC filters, and when they are called for, will be relevant to the jury’s risk-utility analysis, as well as evaluation of the failure to warn claims and [the surgeon’s] decision to implant” the defendant’s filter in the plaintiff. Id. In response to the plaintiffs’ concern that the jury could be confused about the standard of care to apply, the court conceded that “the standard of care for . . . design and marketing of IVC filters is entirely different from the medical standard of care for when filters should be used to treat patients.” Id. As such, the court held, the parties should refer to the “medical standard of care” when referring to the standard for implanting the filters, and should seek a clarifying instruction if warranted.

Plaintiffs’ Motions: “Nonparty at Fault” and “Intervening Cause”

Under Georgia law, a defendant may identify a “non-party at fault” and present evidence of that party’s fault to the jury. The jury may then include the non-party in its apportionment of fault and damages.  In this case, the defendant identified a diagnostic radiologist as the only “nonparty at fault,” alleging that the radiologist’s failure to report the condition of the filter to the plaintiff’s physicians was a cause of the plaintiff’s injuries.  While this was the only non-party whose fault the defendants intended to prove to the jury, the defendants argued that they should be permitted to introduce other doctors’ conduct, under a separate legal doctrine, as “intervening causes” of the plaintiff’s injuries, breaking the chain of causation between the defendant and the plaintiff and relieving the defendant of liability under Georgia law.  The plaintiffs moved to exclude evidence that  doctors not identified as “nonparties at fault” were “intervening causes” of the plaintiff’s injuries.  The court denied the motion, holding “. . . [A]lthough Defendants will be precluded from arguing that [other doctors] were negligent or at fault for purposes of apportioning liability, the Court cannot say that they should be precluded from asserting the fault of these nonparties as an intervening cause” of the plaintiff’s injuries.  The court emphasized that it would be careful to instruct the jury about the distinction between the two doctrines.

Plaintiffs’ Motion to Exclude Statements from Professional Associations

The plaintiffs sought to exclude evidence of statements of professional associations, trade groups, societies of physicians, and the like, arguing that the statements were hearsay, and, introduced through non-experts, would “evade Daubert scrutiny and would violate Rule 403.”  The court reserved its rulings for trial, holding that it could not grant the motion because the plaintiffs did not identify particular statements.  But it held that, on the present record, it could not conclude that the probative value of certain statements was outweighed by the potential for prejudice or that testimony about the absence of certain statements constituted inadmissible hearsay.  We see an analogy to how the federal rules treat learned treatises for hearsay purposes.

All in all, a pretty good day, with the exception of the quandary created by the rulings related to the admissibility of 510(k) evidence. That one isn’t as black and white as the ruling that was made.  We will keep you posted.