In re Bard Ivc Filters Prods. Liab. Litig.
| Decision Date | 22 November 2017 |
| Docket Number | No. MDL 15-02641-PHX DGC,MDL 15-02641-PHX DGC |
| Parties | IN RE: Bard IVC Filters Products Liability Litigation |
| Court | U.S. District Court — District of Arizona |
This multidistrict litigation ("MDL") involves more than 3,000 personal injury cases brought against Defendants C. R. Bard, Inc. and Bard Peripheral Vascular, Inc. (collectively, "Bard"). Bard manufactures and markets medical devices, including inferior vena cava ("IVC") filters. Each Plaintiff received a Bard IVC filter implant and claims that the filter is defective and has caused Plaintiff to suffer serious injury or death. Plaintiffs assert various state law claims and seek both compensatory and punitive damages.
In this motion, Bard seeks summary judgment on the ground that Plaintiffs' state claims are expressly preempted by the Medical Device Amendments of 1976 ("MDA"), 21 U.S.C. § 360 et seq., and impliedly preempted by the MDA under the Supreme Court's conflict preemption principles. Doc. 5396. The motion is fully briefed, and the Court heard oral arguments on November 17, 2017. The Court will deny Bard's motion.
The Court will begin by describing IVC filters and their uses, the history of the MDA, the relevant regulatory process, and the claims asserted by Plaintiffs.
The IVC is a large vein that carries de-oxygenated blood from the lower body to the heart. IVC filters are small metal devices implanted in the upper portion of the IVC to stop blood clots from travelling to the heart and lungs. Blood clots often develop in the legs from a condition called deep vein thrombosis or "DVT." Once blood clots reach the lungs, they are deemed pulmonary emboli or "PE." Pulmonary emboli and other thromboembolic events, such as strokes, can cause serious injury or death.
People at risk for DVT and PE may be prescribed blood thinners such as Heparin or Warfarin to help prevent blood clots. But these medications do not prevent blood clotting for certain people at high risk for DVT or PE, and blood thinners may not be an option for bariatric and trauma patients who could experience thromboembolic events during surgery. In those situations, physicians may recommend implanting an IVC filter to catch any blood clots before they reach a vital organ.
IVC filters originally were designed to be implanted permanently. Because some patients need only temporary filters, however, medical device manufacturers such as Bard developed retrievable filters. Bard first obtained Food and Drug Administration ("FDA") clearance to market a retrievable IVC filter in 2003. Seven different versions of Bard filters are at issue in this MDL - the Recovery, G2, G2 Express, G2X, Eclipse, Meridian, and Denali. They are spider-shaped devices with multiple struts fanning out from a cone-shaped head. The struts consist of legs with hooks that attach to the IVC wall, and shorter curved arms that serve to catch or break up blood clots. Each of these filters is a variation of its predecessor. The last-generation Denali filter received FDA clearance in May 2013. The filters are designed to be retrievable using Bard's Recovery Cone Removal System.
Throughout our history, states have exercised police powers to protect the health and safety of their residents. The federal government first entered this field more than a century ago with passage of the Food and Drug Act of 1906, 34 Stat. 768, whichprohibited the manufacture of adulterated or misbranded food and drugs. Congress broadened the coverage of the statute to include misbranded or adulterated cosmetics and medical devices in the Food, Drug, and Cosmetic Act of 1938 ("FDCA"), 52 Stat. 1040, as amended, 21 U.S.C. § 301 et seq.
The FDCA required premarket approval for new drugs, but not new medical devices. As technology advanced and reliance on medical devices grew, policymakers and the public became concerned about the increasing number of injuries resulting from device failures. Notable in this regard were injuries women suffered from the Dalkon Shield contraceptive device in the 1960s and early 1970s. Other devices, including catheters, artificial heart valves, and pacemakers, also created possible health risks. Several states responded with regulatory measures, such as California's 1970 law requiring premarket approval of medical devices. 1970 Cal. Stats. ch. 1573, §§ 26670-26693.
In 1976, Congress passed the MDA "to provide for the safety and effectiveness of medical device[s] intended for human use[.]" Pub. L. No. 94-295, 90 Stat. 539 (1976). The MDA extends coverage of the FDCA to medical devices through federal oversight measures implemented by the FDA. It also curtails state regulation of medical devices through a provision that preempts state requirements that differ from or add to federal requirements. 21 U.S.C. § 360k.
The MDA gives the FDA broad powers to classify and regulate medical devices. The FDA assigns medical devices to Class I, Class II, or Class III based on their risk levels. Class I devices, which include products such as bandages and tongue depressors, are low-risk and subject to oversight only through "general controls" such as labeling requirements. 21 U.S.C. § 360c(a)(1)(A). Class II devices pose moderate health risks. The original MDA definition of a Class II device identified performance standards as the means by which the FDA could reasonably ensure safety and effectiveness. The Safe Medical Devices Act of 1990 ("SMDA"), Pub. L. 101-629, added various "specialcontrols" for this purpose. The special controls may include FDA guidance documents, premarket data requirements, performance standards, postmarket surveillance measures, and patient registries. 21 U.S.C. § 360c(a)(1)(B). Class III includes devices used to support human life, such as pacemakers and hearts valves, and devices that pose a high risk of injury. 21 U.S.C. § 360c(a)(1)(C). They receive the highest level of regulatory control.1 IVC filters originally were designated as Class III devices, but were moved to Class II, along with many other pre-MDA devices, in 2000. See 65 Fed. Reg. 17138, 17144 (Mar. 31, 2000); 21 C.F.R. § 870.3375.
The FDA applies different levels of scrutiny to medical devices before approving or clearing them for market, and the level of scrutiny can affect whether state laws are preempted. The most rigorous level of scrutiny is known as "premarket approval," often referred to as the "PMA process." 21 U.S.C. § 360e(a). To comply, a manufacturer must file an application that provides a wide range of detailed information to the FDA in order to demonstrate that the device is safe and effective. See 21 U.S.C. § 360e(c). If the FDA finds the device safe and effective, it approves the device for marketing.2
Others medical devices can be cleared for market through a less rigorous process known as section "510(k)" review after the original statutory provision describing the review. A manufacture can satisfy this level of review, and be exempt from the PMA process, by providing premarket notice to the FDA that its device is "substantially equivalent" to a predicate device already on the market.3 § 360c(f)(1)(A). This 510(k)review is more streamlined than the PMA process and focuses primarily on equivalence rather than safety and effectiveness. If a 510(k) notice results in an FDA finding of substantial equivalence, the device is cleared for marketing.
The FDA maintains a bright line between devices "approved" through the PMA process and devices "cleared" through 510(k) review. PMA approval results in a finding of safety and effectiveness, while 510(k) clearance results only in a finding of substantial equivalence. FDA regulations require manufacturers to maintain this distinction:
Submission of a [510(k) notice] in accordance with this subpart, and a subsequent determination by the Commissioner that the device intended for introduction into commercial distribution is substantially equivalent to a device in commercial distribution . . . does not in any way denote official approval of the device. Any representation that creates an impression of official approval of a device because of complying with [510(k) notification] is misleading and constitutes misbranding.
21 C.F.R § 807.97.
The Bard IVC filters at issue in this case, like most medical devices on the market today, received FDA clearance through 510(k) review. Each Bard filter was deemed to be substantially equivalent to a predicate filter already on the market. No Bard filter has received FDA approval through the PMA process.
Plaintiffs allege that Bard IVC filters are defective. Plaintiffs contend that the filters tilt, perforate the IVC, and fracture and migrate to neighboring organs such as the heart and lungs. Plaintiffs claim that Bard filters are more dangerous than other kinds of IVC filters, and that Bard concealed adverse information and otherwise failed to warn the medical community and the public about the risks posed by its filters. Bard vigorously disputes Plaintiffs' allegations of high risk levels, contending that overall complication rates associated with Bard filters are low and comparable to those of other IVC filters.
Plaintiffs' master complaint asserts 17 causes of action under various state laws: strict product liability claims for manufacturing, information, and design defects (Counts I-III); negligence claims for design, manufacturing, failure to recall or retrofit, failure to warn, misrepresentation, and per se negligence (Counts IV-IX); breach of warranties (Counts X-XI); fraudulent misrepresentation and concealment (Counts XII-XIII); consumer fraud and unfair trade practices (Count XIV); loss of consortium (Count XV); wrongful death (Count XVI); and survival claims (Count XVII). Doc. 303-1.4
Bard seeks summary judgment on each cause of action, arguing that the MDA preempts them all. Doc. 5396 at 14-34.5 For reasons explained below, the Court finds that...
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