Class II Medical Devices

A myth that has regrettably gained some traction lately is that the FDA’s clearance of a medical device under the 510(k) substantial equivalence process is unrelated to safety and efficacy. One notably unfair manifestation of this myth is the entry of orders in limine in a number of recent medical device cases excluding evidence of the devices’ 510(k) regulatory pathway.  Most or all of these orders rely on the Supreme Court’s 1996 opinion in Medtronic, Inc. v. Lohr, where the Court held that federal law did not preempt certain medical device warnings claims involving 510(k) devices.  In so holding, the Court distinguished the pre-1990 510(k) clearance process from the more involved and “rigorous” premarket approval (“PMA”) process and observed that the old 510(k) process was “focused on equivalence, not safety.”  518 U.S. 470, 493 (1996).

The Supreme Court did not hold that 510(k) clearance has no bearing on safety and efficacy, but the language quoted above provides a foothold for those inclined to marginalize the FDA’s role.  Indeed, we believe the Supreme Court’s view of the 510(k) process was already outdated in 1996.  As we have explained multiple times (including here), the 510(k) clearance process is keyed directly to safety and efficacy, and the Supreme Court has been retreating from Medtronic v. Lohr almost since the day the opinion was filed.

A district judge in Los Angeles recently provided what we think is the correct perspective. The case is Otero v. Zeltiq Aesthetics, Inc., No. CV 17-3994, 2018 WL 3012942 (C.D. Cal. June 11, 2018), and it is not a preemption case, or even a product liability case.  Instead, patients sued the manufacturer of a non-invasive fat-reducing system under California’s permissive consumer fraud statutes, claiming that the company made partial statements that were misleading and failed to disclose material information about the product. Id. at **1-2.

What were the misleading partial statements and omitted facts? The plaintiffs alleged that the manufacturer stated (truthfully) that the product was “FDA-cleared” and “FDA-cleared as safe and effective.” Id. at *1.  And the manufacturer failed to explain the difference between “FDA clearance” on the one hand and “FDA approval” on the other.  That’s the omission.

We have unending sympathy for individuals who fight weight gain and for whom the condescending admonition to exercise more and eat less is not helpful. Be that as it may, these claims have no arguable merit, and the district court correctly dismissed them.  With regard to the alleged “partial” representation that the device was “FDA cleared,” the district court ruled that “Plaintiffs fail to explain how that true representation—on its own—could cause reasonable consumers to erroneously believe that the system received FDA approval.” Id. at *2.  The court continued:

Plaintiffs simply point out that under California law, true statements may mislead reasonable consumers if other relevant information is omitted. Although that is an accurate legal proposition, it does not establish that “FDA-Cleared” gives rise to viable [California statutory] claims, especially because the “mere possibility” that some consumers acting unreasonably will conflate FDA-clearance and FDA-approval is insufficient.

Id. So can a true statement ever support a claim?  Under some circumstances not presented here, it appears that one could, although that would be truly exceptional case.  Can a true statement support a claim where it is merely possible that a consumer will unreasonably misconstrue it?  This court ruled that it cannot.

There is more. The plaintiffs also argued that adding the words “safe and effective” to “FDA-cleared” was misleading because that claim can only be made in connection with FDA approval, citing Medtronic v. Lohr.  (See, we were going to get back to Medtronic v. Lohr eventually, and here we are).  In the part of the order that we like the most, the district court convincingly debunked the myth that “safe and effective” is unique to the PMA process:

It appears that this argument relies on Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), which allegedly establishes that “‘[t]he § 510(k) notification process is by no means comparable to the PMA process’ and in no way warrants that the device is safe and effective.”  [quoting Plaintiffs’ brief.]  Although Medtronic observed that obtaining Section 510(k) clearance is not as onerous as the “rigorous” PMA process, the Supreme Court did not find that the former has no bearing on a device’s safety and effectiveness. In fact, Medtronic acknowledged that “the FDA may well examine § 510(k) applications . . . with a concern for the safety and effectiveness of the device . . .”  The Supreme Court later clarified “the FDA simultaneously maintains the exhaustive MPA and the more limited § 510(k) process in order to ensure . . . that the medical devices are reasonably safe and effective.

Id. at *3 (first emphasis added, second in original).  In other words, the plaintiffs (and others before them) were relying on a snippet to misread Medtronic and overstate its holding.  The district court went on to state that the FDA’s regulations connect 510(k) clearance to safety and effectiveness, too:

Indeed, the FDA regulations provide that if the agency has found that a device is substantially equivalent to—but has “technological characteristics” that are different from—a predicate device, then that means the agency has concluded that “[t]he data submitted . . . contains information, including clinical data if deemed necessary by the Commissioner, that demonstrates that the device is as safe and as effective as a legally marketed device.”

Id. (emphasis in original).  Finally, the district court noted that compliance with general and special controls, which Class II medical devices must do, further provides “reasonable assurance of the safety and effectiveness of the device.” Id. There was no deceptive, no misleading statement.  Only true representations of a medical device’s regulatory pathway.  That is not the basis for a consumer fraud claim.

Nor is it consumer fraud when a manufacturer does not explain the difference between FDA clearance and FDA approval. The district court ruled that a manufacturer’s duty to consumers is limited to warranty obligations, absent an affirmative misrepresentation or a “safety issue.” Id. at *4.  We are not sure this is an accurate statement of a medical device manufacturer’s duty to consumers, especially considering the presence of prescribing physicians (i.e., the learned intermediaries) for many devices.  We also can’t imagine a situation where a medical device manufacturer would be under a legal obligation to explain FDA regulations to consumers.  But even taking the rule at face value, the plaintiffs alleged no safety risk. Id. at *5.  Maybe they were unsatisfied with the results (i.e., effectiveness) and wanted their money back.  Whatever their beef was, it was not about safety.

The plaintiffs walked away with their core claims dismissed without leave to amend. The district court gave them another chance to plead that they actually observed other statements that they claimed were misleading, based on counsel’s representations at argument that their clients might have seen them. Id. at **5-6.  We don’t know.  It seems to us that if those facts existed, the plaintiffs would already have pleaded them.  The takeaway for us is the reality that the 510(k) process does tie into safety and efficacy.  Don’t let anyone tell you otherwise.

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.