FDA Moves on Device Safety as Promised

The FDA’s safety push is a matter of public record, but the agency has moved decisively on this area on several occasions in the month of April. Some of the moves were entirely expected, but one arose with little warning, making clear that while the agency has a definite safety agenda, that agenda can be modified at a moment’s notice.

The FDA advised industry in January it would be more active in the area of device safety via the medical device safety action plan, but the agency’s guidance agenda for the current fiscal year also lists a number of items that can be attributed to the push for safety. In mid-April, the FDA said it would pull the marketing authorizations for all surgical meshes for pelvic organ prolapse, a move that followed the agency’s 2016 up-classification of these devices/indications from class II to class III. The FDA notice indicated that the two sponsors that had decided to submit PMA filings had failed to demonstrate a reasonable assurance that those devices presented an acceptable benefit-risk profile, although devices that have been the subjects of Section 522 postmarket surveillance studies will have to complete those studies.

More recently, the agency posted a draft guidance for the use of nitinol used in medical devices, which was driven at least in part by contraceptive devices, although devices for the circulatory system are also caught up in this issue. Former FDA commissioner Scott Gottlieb and Jeff Shuren, director of the Center for Devices and Radiological Health, said in a statement that nitinol is not the only material of immediate concern at the agency as graphene, too, is on the agency’s safety agenda.

The impact of any moves on nitinol will be keenly felt in the cardiovascular space, thanks to widespread use in items such as aortic valve replacement devices. The draft guidance for nitinol in implanted devices is product agnostic, but the FDA makes reference to standards that have emerged for material characterization as a resource for ensuring device performance. One of the considerations is the material’s susceptibility to corrosion, but while the draft does not suggest any impending regulatory action, device makers may have to include more detail in their regulatory filings going forward.

The draft states that product labels may have to include warnings about allergic reactions to nitinol, although it is not clear whether a test for such sensitivities is routinely offered to patients. Among the entries in the literature on this point is an article in the March 6, 2017, issue of the Journal of Vascular Surgery Cases and Innovative Techniques, which describes a patient who experienced “a full-body, desquamating macular-papular pruritic rash” after implant of a stent in the popliteal artery for acute limb ischemia. The patient’s condition improved after the device was removed, although he continued to experience less severe episodes out to two years, which were blamed on exposure to other products that contain nickel, including occupational exposure and bottled alcoholic beverage containers.

Surgical staples, staplers also on the list

Surgical staplers and staples also fell under the FDA’s watchful eye, as demonstrated by several related announcements. In one instance, the agency proposed to reclassify some staplers from class I to class II, and an accompanying announcement lists a May 30 advisory committee to take up this question, but the issue is significant enough to warrant a statement from CDRH chief Jeff Shuren. Shuren said the agency has received in excess of 41,000 medical device reports for surgical staplers and staples for internal use, which includes more than 32,000 malfunctions and 366 patient deaths between January 2011 and the end of March 2018.

The agency also issued a draft guidance for labeling for staplers and internal-use staples, the scope of which captures four products codes. The draft would require that labels reflect a number of advisories, such as not to use a staple on large blood vessels, including the aorta. The agency is taking comment through June 23, but it seems plausible this draft will undergo more than the usual amount of revision before reaching final form, given that the advisory hearing will take place prior to the end of the comment period.

Supreme Court Cases to Watch This Term

Courtney Young, Esq. | Senior Attorney, Medmarc Risk Management

This term (which began last month), the Supreme Court will hear a number of cases that may affect the life sciences industry. Here are a few we will be watching.

Air and Liquid Systems Corp. v. DeVries

The issue in this case is whether defendants in a products liability case can be held liable under maritime law for injuries caused by products they did not make, sell, or distribute. The Court heard argument in this case on October 10. The case involves equipment sold by various manufacturers and installed several years ago on Navy ships. To function properly, the equipment required asbestos insulation, which was installed shortly after equipment. The plaintiffs are a group of individuals who worked on the ships at the time and were allegedly injured by the asbestos.

Merck Sharp & Dohme Corp. v. Albrecht

This is another preemption case, and an important one for makers of drugs and, potentially, PMA devices. The issue here is whether a plaintiff’s state-law-based failure-to-warn claim is preempted if the FDA rejected the drug manufacturer’s proposal to warn about the specific risk the state-law claim alleges should have been warned about. Argument has not been scheduled in this case yet.

Two Tales of Preemption

FDA preemption for medical devices is never out of the spotlight for long, even if the story usually seems unchanged by the latest retelling. One recent case confirms that success is sometimes measured in large part by the adversary’s miscues, but the other seems to break new ground in this area by posing the question of how preemption works when a PMA and a 510(k) device are joined. Perhaps as important, however, is that this second case portends a growing split in the courts on a central point in the preemption debate.

Alphatec Prevails in Sixth Circuit

Some preemption cases are a trial in more ways than one, but Alphatec Spine, Inc. prevailed fairly handily in a hearing of Agee v. Alphatec Spine in the U.S. Court of Appeals for the Sixth Circuit. The district court had dismissed the charges with prejudice despite allowing the plaintiff to amend the complaint, describing the plaintiff’s arguments as “a rambling, disorganized mess,” which consisted primarily of conclusory arguments that came up short of pleading standards under the Federal Rules of Civil Procedure 8 and 9.

The plaintiff seems to have compounded the problem by failing to directly respond to Alphatec’s argument regarding implied preemption during district court proceedings, taking up the subject only from the standpoint of doctrine. The plaintiff attacked express preemption at the district court stage, but Alphatec never raised express preemption. Also apparently unchallenged by the plaintiff was Alphatec’s argument that state law in Ohio bars common-law negligence claims.

The Sixth Circuit allowed the plaintiff to return to the district court to revisit the issue of whether the complaint met federal pleading standards, a move attributed to what is said to have been an abuse of discretion on the part of the district court judge. Nonetheless, the Sixth Circuit made clear it was unimpressed with more or less the entirety of the plaintiff’s handling of the matter, stating that the plaintiff’s failure to challenge the district court’s conclusions regarding preemption “fully determines this appeal inasmuch as the forfeited arguments encompass all of the plaintiffs’ causes of action.”

Preemption, PMAs and Predicate Devices

Express preemption might seem a largely settled matter thanks to Reigel v. Medtronic, but the recently decided case of Shuker v. Smith & Nephew took up the relatively novel predicament of a combination of both PMA and 510(k) devices. The outcome in this case in the U.S. Court of Appeals for the Third Circuit affirmed preemption for PMA devices, but seems to have created a schism with respect to the presumption against express preemption.

Shuker addresses a combination of devices that were not approved by the FDA in the configuration used by the implanting physician, and the plaintiff alleged the company’s literature had violated the law when it discussed the use of Smith & Nephew’s R3 acetabular cup in this configuration. The court received an amicus brief from the Department of Justice, which affirmed preemption for PMA devices even when attached to one or more 510(k) devices, but the Third Circuit seems to have sustained the possibility that Smith & Nephew’s printed material regarding the R3 could support a claim of misrepresentation. The Third Circuit sent that discussion back to the district court, which had dismissed that claim with prejudice.

While Shuker is a win for preemption, this appears to be the first instance in which an appeals court has undertaken the question of a device system bearing both 510(k) and PMA components. There is a novel source of tension in the decision, however, in that the court declared that the presumption against express preemption is still alive. The U.S. Court of Appeals for the Eight Circuit arrived at a different conclusion last year in Accord Watson v. Air Methods Corp., but the outcome in Shuker is based in part on the notion that what some believe is pertinent a Supreme Court precedent – that of Puerto Rico v. Franklin California Tax-Free Trust – is not applicable to the areas of the economy regulated by the FDA because Puerto Rico v. Franklin was directed toward bankruptcy law.

Consequently, the Third Circuit argued that the presumption against federal preemption is still a functioning legal theory, but attorneys for Medtronic might differ. The company won a case in the Arizona Supreme Court in October 2017, Conklin v. Medtronic, in which Judge Lori Bustamante declared that even though federal laws are not typically presumed to preempt state laws, the courts “do not invoke that presumption when the federal statute contains an express preemption clause.” Bustamante cited Puerto Rico v. Franklin in support of that conclusion.

It is predictably difficult to forecast how the presumption dilemma will unfold if only because a device maker will have to suffer an adverse outcome in a circuit court before the question is brought to the Supreme Court. On the other hand, there is clearly a growing trend toward differential outcomes on this point, which at the very least suggests the Supreme Court may find this a compelling problem should a device maker apply for cert.

What Scalia’s Passing Means to Life Sciences Companies

Courtney A. Stevens | Senior Attorney, Loss Control | Medmarc Insurance Group

The recent passing of Justice Antonin Scalia, the Court’s longest-serving justice, means more than just political scuttlebutt over who will get to appoint his replacement. For life sciences companies, it means the loss of a real ally in matters of tort liability and a powerful force in intellectual property.

Preemption

Scalia authored the 8-1 majority opinion in Riegel v. Medtronic, 552 U.S. 312 (2008), a pivotal decision in preemption jurisprudence that held that the Medical Device Amendments to the Food, Drug and Cosmetic Act (FDCA) preempted state-law claims relating to the safety and effectiveness of pre-market approval (PMA) devices. This effectively shields makers of PMA devices from products liability claims.

In Wyeth v. Levine, 555 U.S. 555 (2009), which undermined preemption in holding that FDA approval of a medication does not preempt state law failure-to-warn claims, Scalia joined the dissent (authored by Justice Samuel Alito). The dissent argued that this holding was inconsistent with their previously-adopted “conflict preemption” analysis.

Continue reading “What Scalia’s Passing Means to Life Sciences Companies”

Regulatory Roundup: FDA Reports and Guidances in August

Courtney A. Stevens, Esq. | Senior Attorney, Medmarc Loss Control

Recommendations for a National Medical Device Evaluation System

On August 20, the FDA released, for public comment, a report from the Medical Device Registry Task Force and the Medical Devices FDA logo.jpgEpidemiology Network. The report described the inadequacies in the existing framework for medical device evaluation, what a more effective system would look like, what devices would be particularly ripe for evaluation via such a system, and how the system could be implemented. The full report can be found here.

FDA Issued Several New Drug and Device Guidances

The Agency issued several new guidance documents in August, including the following. Continue reading “Regulatory Roundup: FDA Reports and Guidances in August”