Tuesday, November 20, 2012

Riegel v. Medtronic, Inc

I wonder why I have never heard of this case before?  Pretty amazing statute and process re medical devices... a story to write a book about in terms of how we make laws to protect patients and then proceed to allow loopholes to get around the laws!

I can't quite characterize this story but it is worth reading.

Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), is a United States Supreme Court case in which the Court held that the pre-emption clause of the Medical Device Amendment bars state common-law claims that challenges the effectiveness or safety of a medical device marketed in a form that received premarket approval from the Food and Drug Administration.

It modified the rule in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).


Testing Manufacturer Liability in FDA-Approved Device Malfunction

The Supreme Court’s ruling in Riegel v. Medtronic, Inc., may prevent consumers injured by medical devices that have FDA premarket approval from receiving compensation.

Ryan Bailey and Kristin E. Schleiter, JD, LLM

In 1996, an Evergreen Balloon Catheter, marketed by Medtronic, Inc., burst during Charles Riegel’s angioplasty [1]. The catheter had been granted premarket approval (PMA) from the Food and Drug Administration (FDA) in 1994. While the manufacturer’s instructions recommended that physicians inflate the catheter to only 8 atmospheres, the treating physician in Riegel’s case inflated the catheter to 10 atmospheres before it burst. As a result, Riegel developed a heart block, was placed on life support, and underwent emergency coronary bypass surgery.

Riegel and his wife filed a product liability complaint against Medtronic. A federal district court dismissed the complaint, holding that federal legislation—the Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act [2] preempted the state negligence and liability claims the Riegels cited in their case against Medtronic. The case eventually made its way to the U.S. Supreme Court.

Riegel v. Medtronic, Inc. brings to light a conflict between manufacturers who have obtained FDA approval and injured patients who want to retain the option of seeking restitution for damages resulting from defective medical devices [3]. Patients who believe defective devices caused their injuries take little comfort in knowing that the devices had FDA approval. Conversely, device manufacturers who received FDA approval after extensive review want to avoid repeating the review process in the courts. In Riegel, the Supreme Court addressed whether the preemption clause of the Medical Device Amendments bars state law claims that challenge the safety and effectiveness of a medical device given premarket approval by the FDA.

Summary of the Medical Device Amendments of 1976

The Medical Device Amendments (MDA) of 1976 established three regulatory classes of medical devices. Class I medical devices, which include elastic bandages and examination gloves, are subject to “general controls,” such as labeling requirements [4]. Class II medical devices, which include powered wheelchairs and surgical drapes, are subject to “special controls,” such as performance standards [4].

The most regulated medical devices are those in Class III, which the amendments define as devices that support or sustain human life, are “of substantial importance in preventing impairment of human health” or “present a potential, unreasonable risk of illness or injury” [4]. Class III medical devices include replacement heart valves and the catheter used on Charles Riegel. These devices are subject to a rigorous premarket approval (PMA) process that includes:
  • full reports of all studies and investigations of the device’s safety;
  • a complete statement of the device’s components, ingredients, and properties;
  • a detailed description of the methods used in, and the facilities and controls used for, the manufacture and processing of the device;
  • samples of device components required by the FDA; and
  • a specimen of the proposed labeling [1].
The FDA grants premarket approval to Class III devices only after determining that there is reasonable assurance of their safety and effectiveness [5]. In making this determination, the FDA weighs any probable benefit to health from the use of the device against any probable risk of injury in light of available alternatives. For example, a ventricular assist device for children with heart failure was approved, despite a survival rate of less than 50 percent in children using the device, because no other device had a higher survival rate [1]. However, a Class III device that fails to meet PMA requirements is considered unmarketable [4].

At issue in Riegel was the Medical Device Amendments’ preemption clause. In general, preemption clauses provide that federal laws that conflict with state laws will trump, or “preempt” them [6]. The preemption clause in the Medical Device Amendments prohibits states from establishing a requirement with regard to any device intended for human use that is different from, or in addition to, any federal requirement applicable to the device [5]. The preemption clause also forbids states from establishing any requirement that relates to the safety or effectiveness of a device intended for human use [5].

How Safe is Safe Enough?

The dispute in Riegel centered on the amount of regulation necessary to ensure the safety and effectiveness of medical devices. Medtronic argued that letting state claims proceed against devices that had passed the premarket approval process would usurp the power of the FDA, because the PMA process was designed to assure the safety and effectiveness of medical devices [7]. The Riegels countered that Congress never intended the FDA’s power to regulate medical devices to negate the right of private citizens to sue negligent manufacturers [8].

The Riegels also contended that FDA regulations alone were not enough to protect consumers, since no amount of rigor in the premarket approval process could predict all possible outcomes or problems with a device and its use. Without the threat of litigation, the Riegels argued, manufacturers could attempt to hide safety flaws from the FDA [9].

Medtronic challenged the plaintiffs’ assertion that the threat of litigation would improve product safety. Instead, it argued, state restrictions would reduce innovation in the development and availability of beneficial medical devices [7]. Moreover, Medtronic argued, because manufacturers factor the cost of potential litigation into product prices, increasing the threat of litigation would increase the cost of health insurance and put some devices out of reach of potential consumers [10].

Interpreting the Medical Device Amendments and Applicable Precedent

To settle this dispute, the Supreme Court turned to judicial precedent and the plain text of the Medical Device Amendments’ preemption clause. In particular, the Court relied on its 1996 decision in Medtronic v. Lohr. In Lohr, the Supreme Court had ruled that the Medical Device Amendments preempt state requirements only when the FDA has established “specific counterpart regulations or there are specific requirements applicable to a particular device” [11]—in other words, only when the FDA has a regulation that covers the same safety aspect or the same device that the state requirement covers. The Court rejected the Medtronic contention that general labeling requirements for all medical devices fall under this “specific counterpart” description [10].

Unlike general labeling requirements, premarket approval entails an in-depth review of a specific medical device. Writing for the majority, Justice Scalia stressed that the premarket approval process for medical devices is one that is rigorous and highly individualized [1]. The Court held that because “premarket approval is specific to individual devices” it constitutes “federal safety review” which, under the Medical Device Amendments, preempts state law [1]. Because the Medtronic catheter that burst during Charles Riegel’s angioplasty had premarket approval from the FDA, state claims against its manufacturer were invalid under the Medical Device Amendment and Lohr [1]. In support of this holding, Justice Kennedy emphasized during oral arguments that, if state law damage claims were not preempted by federal regulations, state juries would be asked to repeat the demanding review process already completed by the FDA for any potentially hazardous device [3].

The Effect of the Ruling

By ruling against the Riegels, the Supreme Court refused to allow injured patients to sue device manufacturers whose products pass the FDA’s findings of adequate safety. This ruling prevents courts from enforcing state regulations on medical devices with premarket approval unless those restrictions are identical to corresponding FDA restrictions. Going forward, this may prevent consumers injured by such devices from receiving adequate compensation [8]. Though consumers are not completely without legal recourse—they can still bring suit against negligent manufacturers under state laws identical to FDA requirements or against negligent physicians—the Supreme Court has immunized PMA medical devices from many product liability suits founded in state law, leaving some injured consumers without a common source of judicial remedy [1, 10].


Medical device classification

The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. The three classes and the requirements which apply to them are:

Device Class and Regulatory Controls

  1. Class I General Controls
    • With Exemptions
    • Without Exemptions
  2. Class II General Controls and Special Controls
    • With Exemptions
    • Without Exemptions
  3. Class III General Controls and Premarket Approval

The class to which your device is assigned determines, among other things, the type of premarketing submission/application required for FDA clearance to market. If your device is classified as Class I or II, and if it is not exempt, a 510k will be required for marketing. All devices classified as exempt are subject to the limitations on exemptions. Limitations of device exemptions are covered under 21 CFR xxx.9, where xxx refers to Parts 862-892. For Class III devices, a premarket approval application (PMA) will be required unless your device is a preamendments device (on the market prior to the passage of the medical device amendments in 1976, or substantially equivalent to such a device) and PMA's have not been called for. In that case, a 510k will be the route to market.

Device classification depends on the intended use of the device and also upon indications for use. For example, a scalpel's intended use is to cut tissue. A subset of intended use arises when a more specialized indication is added in the device's labeling such as, "for making incisions in the cornea". Indications for use can be found in the device's labeling, but may also be conveyed orally during sale of the product. A discussion of the meaning of intended use is contained in Premarket Notification Review Program K86-33.


xxx [from connie]


I think the hip device was  a class three  device and it did go through the 501K process which I believe essentially  was a "fast track" to the market. Not sure if it was a class two device as it was in Europe for a long time.




Medtronic Vs Lohr


Facts of the Case


The Medical Device Amendments of 1976 (MDA) provides for "the safety and effectiveness of medical devices intended for human use," and classifies such devices based on their level of risk. Class III devices pose the greatest risk and, thus, are subject to a rigorous premarket approval (PMA) process. However, two statutory exceptions to this process exist. Because Medtronic, Inc.'s pacemaker is a Class III device found substantially equivalent to a pre-existing device, it can avoid the PMA process. In 1990, Lora Lohr's Medtronic pacemaker failed, allegedly according to a defect. Lohr and her spouse filed a Florida state-court suit, alleging both negligence and strict- liability claims. Medtronic removed the case to federal district court. The court then dismissed the case as pre-empted by 21 USC section 360k(a), which provides that "no State...may establish or continue in effect with respect to a device intended for human use any requirement (1) which is different from, or in addition to, any requirement applicable under [the MDA] to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under [the Act]." Reversing and affirming in part, the Court of Appeals concluded that the Lohrs' negligent design claims were not pre-empted, but that their negligent manufacturing and failure to warn claims were. (This case was decided together with 95-886, Lohr et vir v. Medtronic, Inc.)

Do the Medical Device Amendments of 1976 pre-empt a state common-law negligence action against the manufacturer of an allegedly defective medical device


Decision: 5 votes for Lohr, 4 vote(s) against

Legal provision: Federal Food, Drug, and Cosmetic, and related statutes
No. In an opinion delivered by Justice John Paul Stevens, the Court held that the Court of Appeals decision was reversed insofar as it held that any of the claims were pre-empted and affirmed insofar as it rejected any pre-emption defense. In a 9-0 vote, the Court allowed the lawsuit based on alleged defects in the pacemaker's design to proceed. In a 5-4 vote, the Court allowed the lawsuit to proceed on its claims of alleged defects in its manufacturing and failure to warn. Justice Stevens reasoned that the MDA was not intended to pre-empt "traditional common-law remedies against manufacturers and distributors of defective devices," as long as they paralleled federal requirements


Reclassification of Hip devices in Europe from Class 2b to class 3.

Directive 2005/50/EC on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices was issued in August 2005, at the behest of France and the United Kingdom. The Directive altered the classification of those devices from Class IIb to Class III for several reasons: the hip, knee, and shoulder are complex joints, the hip and knee are weight bearing joints, the hip and knee are extremely sophisticated implants, shoulder implants are a more recent technique, and hip, knee, and shoulder replacement surgery is increasing in younger patients. Member states were required to transpose the directive into national law by 1 March 2007 and apply its provisions by 1 September 2007.

US  Classification of Hips in the US now:


Tuesday, May 24, 2011

WASHINGTON – Today, U.S. Senator Herb Kohl, Chairman of the Special Committee on Aging, wrote Dr. Margaret Hamburg, Commissioner of the Food and Drug Administration (FDA) commending her Agency’s recent decision to require medical device manufacturers to conduct post-market surveillance for high-risk, metal-on-metal hip implants. In his letter to Hamburg, Kohl suggests that more surveillance of high-risk devices is still necessary, particularly for devices that were approved through the FDA’s fast-track review process.

Last month Kohl held a hearing examining the FDA’s role in protecting patient safety as part of the medical device approval process. The hearing featured testimony from Ms. Katie Korgaokar, a Denver resident who received a DePuy ASR hip implant to treat a congenital condition called Perthes disease. In 2010, the DePuy hip was recalled and Korgaokar endured a second hip-replacement surgery in early 2011. Korgaokar was one of 96,000 patients affected by the DePuy hip recall.
Kohl writes: “As stated in the hearing, it is unacceptable that so many high risk, Class III devices continue to be approved through the 510(k) process.

However, it is encouraging that, during our hearing, FDA pledged to finish either reclassifying the devices or requiring Premarket Approvals (PMAs) for Class III devices currently considered through the 510(k) process. Completing this review is essential to protect the public health.”

The April 13th Aging Committee hearing is archived online at: http://aging.senate.gov/hearing_detail.cfm?id=332473&

Full text of the letter copied below.

May 24, 2011
Dr. Margaret Hamburg
The Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

Dear Commissioner Hamburg:

I applaud your decision to require medical device manufacturers to conduct post-market surveillance for high-risk, metal-on-metal hip implants. The Food and Drug Administration’s (FDA) use of its 522 regulatory authority will help improve our understanding of the health risks metal-on-metal implants pose to patients. FDA should continue to advance its surveillance of high-risk devices, especially those that have been approved through the fast-track, 510(k) process.

As you know, last month, the Special Committee on Aging held a hearing entitled, “A Delicate Balance: FDA and the Reform of the Medical Device Approval Process,” in which Dr. William Maisel of FDA participated. The hearing highlighted the problems with metal-on-metal hip implants. A victim of the DePuy ASR hip implant recall, Katie Korgaokar, testified to the distress she experienced with revision hip surgery as a result of the faulty hip implant.
As stated in the hearing, it is unacceptable that so many high risk, Class III devices continue to be approved through the 510(k) process. However, it is encouraging that, during our hearing, FDA pledged to finish either reclassifying the devices or requiring Premarket Approvals (PMAs) for Class III devices currently considered through the 510(k) process. Completing this review is essential to protect the public health.

Metal-on-metal hip implants are an example of these Class III devices being cleared through 510(k). It is imperative for patient safety that Class III devices like metal-on-metal hip implants have appropriate review before being marketed to patients, and rigorous oversight once the devices are marketed.

Again, I applaud and support FDA’s efforts to protect the public health through more vigorous post-market surveillance. I look forward to continue working with FDA to improve post-market device oversight, specifically to ensure that there is adequate post-market surveillance of high-risk devices, like the metal-on-metal hip implants.

Herb Kohl
United States Senator

[from connie]

Remarkable if you think about all of this went into a full circle:

1) Hips are classified as a type 3 device  which is a device  that requires premarket approval
2)  However....the 501 K process allows a fast track to market  if the hip is similar to others on the market so many went through this fast track to get onto the market.
3) Now in 2011, this Senator wants to ensure premarket approval  of these hips which, if you go back to the beginning of this post was a statute put into  effect  in 1976 which facilitated companies like Medtronics to  have a "get out of jail free card" re liability for manufacturers through this very PMA process ! 
4) While this law was clarified in 1996, (so it was in effect for 20 years), to ensure that after 20 years, this PMA process was not really  enacted to provide shelter for manufacturers against liability claims, it seems as though we have come full circle with all of these shenanigans!  So from 1976-2013 (37 years) we attempted to deal with the problem of "how do you protect patients safety"...and then proceeded to provide all of the loopholes to work around any of the patient safety legislation.

If this story doesn't send you into hysterical laughter, you may just want to cry!


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