Defective medical devices in Charlotte, North Carolina

If you have been the victim of a defective medical device or have fallen victim to the consumption of a mislabeled or dangerous prescription medication, it is imperative that you consult with an Attorney soon after your injury to preserve your case. Defective Medical Device cases can become some of the most complex injury cases due to the complexity of a the design and operation of a Medical Device.

At the Law Offices of David P. Sheehan, we understand the necessity to spend additional time with clients and experts in an effort to bring a Defective Medical Device case to trial. Sheehan at (704) 222-4752 and speak with an Attorney today.

In North Carolina a claim against a device maker is a Chapter 99B claim, not a malpractice claim

In North Carolina a defective medical device claim against the manufacturer is a product liability action under G.S. 99B-1, which defines the term to reach any action for personal injury, death or property damage caused by or resulting from the manufacture, construction, design, formulation, development of standards, preparation, processing, assembly, testing, listing, certifying, warning, instructing, marketing, selling, advertising, packaging or labeling of a product. Chapter 99B is not a strict liability regime. G.S. 99B-1.1 states flatly that there is no strict liability in tort in product liability actions, so the claim has to be built on negligence, breach of warranty or misrepresentation rather than on the bare fact that the device failed.

It is not a medical malpractice action. G.S. 90-21.11(2) defines that term in two limbs: a civil action for damages for personal injury or death arising out of the furnishing or failure to furnish professional services in the performance of medical, dental or other health care by a health care provider, and a civil action against a hospital, a licensed nursing home or an adult care home alleging breach of administrative or corporate duties to the patient that arises from the same facts. A device manufacturer is not a health care provider as G.S. 90-21.11(1) defines that term, and the surgeon who implanted the device is not the manufacturer.

The distinction is not cosmetic. Rule 9(j) of the North Carolina Rules of Civil Procedure provides that a complaint alleging malpractice by a health care provider under G.S. 90-21.11(2)a. shall be dismissed unless it does one of three things: asserts that the medical care and all available records pertaining to the alleged negligence have been reviewed by a person reasonably expected to qualify as an expert under Rule 702 who is willing to testify that the care did not comply with the applicable standard of care; asserts the same as to a person the claimant will move to have qualified as an expert; or pleads facts establishing negligence under the existing common law doctrine of res ipsa loquitur. That third route exists, but it is narrow, and the Court of Appeals has cautioned against extending it beyond the settings where it has already been approved. The noneconomic damages limit in G.S. 90-21.19 likewise reaches only malpractice defendants. Neither provision touches the device manufacturer.

Federal pre-emption decides which device claims can be brought at all

Before North Carolina law is reached, the regulatory pathway the device took through the Food and Drug Administration has to be identified. Under 21 U.S.C. 360k(a) a state may not establish or continue in effect a requirement relating to the safety or effectiveness of a device that differs from, or adds to, an applicable federal requirement. In Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the Supreme Court held that common law tort duties count as requirements for this purpose, and so most design, warning and manufacturing claims about a Class III device that went through premarket approval are barred.

The bar is neither universal nor automatic. Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), treated clearance under section 510(k) differently, because that route establishes substantial equivalence to a device already on the market rather than device-specific federal requirements. A claim premised on a violation of the FDA's own requirements may survive as a parallel claim, because the state duty mirrors the federal one instead of adding to it. The space is narrow at both ends: Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001), held that a claim owing its existence solely to the federal scheme, such as fraud on the agency, is impliedly pre-empted. Which pathway the device took, and whether a genuine parallel duty can be pleaded, usually determines whether there is a claim at all, which is why the question is settled first rather than last.

The manufacturer's warning duty runs to the prescriber, and the statute says so only for drugs

G.S. 99B-5(c) provides that, notwithstanding the general inadequate-warning rule in G.S. 99B-5(a), no manufacturer or seller of a prescription drug is liable in a product liability action for failing to provide a warning or instruction directly to a consumer where an adequate warning or instruction has been provided to the physician or other legally authorized person who prescribes or dispenses that drug for the claimant, unless the Food and Drug Administration requires that direct consumer warning to accompany the product. That is the learned intermediary doctrine in statutory form.

Note what the subsection covers. By its terms it speaks of a prescription drug, not of a device. Courts applying North Carolina law have reasoned along the same lines about prescription devices, but a device maker's warning defense rests on that case law rather than on the words of G.S. 99B-5(c), and the point is argued rather than assumed. The practical consequence for a patient is the same either way: the adequacy of what the surgeon was told, not what the patient was told, is usually the contested issue, so the instructions for use, the surgical technique guide and the field safety notices in force on the date of implantation matter more than the consumer-facing literature.

G.S. 99B-6(d) is drawn the same way. It provides that no manufacturer of a prescription drug is liable in a product liability action on account of an aspect of the drug that is unavoidably unsafe, where an adequate warning and instruction has been provided under G.S. 99B-5(c); unavoidably unsafe means that, in the state of technical, scientific and medical knowledge generally prevailing when the product left the manufacturer's control, the aspect that caused the harm was not reasonably capable of being made safe. Again the named subject is a prescription drug. Where the product is a generic medication rather than a device, federal law narrows things further: PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), held failure-to-warn claims against generic manufacturers pre-empted because the generic label must match the brand label, and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), extended that reasoning to design claims that turn on the adequacy of a warning.

G.S. 99B-4 and G.S. 99B-3 supply the defenses a device maker will raise

North Carolina remains one of a small number of states in which a claimant whose own want of care contributed to the injury may recover nothing, and in product cases the rule is codified. G.S. 99B-4 provides that no manufacturer or seller shall be held liable in a product liability action if any one of three things is established. The first is that the use of the product was contrary to express and adequate instructions or warnings delivered with, appearing on or attached to the product or its original container or wrapping, where the user knew or with the exercise of reasonable and diligent care should have known of those instructions or warnings. The third is that the claimant failed to exercise reasonable care under the circumstances in the use of the product and that failure was a proximate cause of the occurrence complained of.

The second bar deserves care, because it is narrower than it is usually described. G.S. 99B-4(2) applies where the user knew of or discovered a defect or dangerous condition of the product that was inconsistent with the safe use of the product, and then unreasonably and voluntarily exposed himself or herself to the danger, and was injured by that product. Every element carries weight. Knowledge on its own is not enough; the condition must be inconsistent with safe use, the exposure must be voluntary, and it must be unreasonable. That matters in implant cases, where a patient routinely learns that a device is the subject of a recall and then goes on living with it for months while a revision is scheduled, or because removing it early carries its own surgical risk. Continuing under medical advice, or because no safer alternative is available, is not the unreasonable and voluntary exposure the subdivision describes, and it should not be conceded as though it were.

G.S. 99B-3 is a separate defense with its own limits. It bars a claim where a proximate cause of the injury was an alteration or modification of the product by a party other than the manufacturer or seller, occurring after the product left that manufacturer's or seller's control, unless the alteration or modification was made in accordance with the manufacturer's or seller's instructions or specifications or with its express consent. The exclusion of changes made by the maker itself is part of the rule rather than a gloss on it. G.S. 99B-3(b) defines alteration or modification to include changes in the design, formula, function or use of the product from what was originally designed, tested or intended by the manufacturer, and to include failure to observe routine care and maintenance, while expressly excluding ordinary wear and tear. That definition does real work for reprocessed instruments, and for implanted pumps, leads and monitors that are serviced or interrogated on a schedule.

The filing deadline can start before the operation took place

G.S. 1-46.1(1) provides that no action for the recovery of damages for personal injury, death or damage to property based upon or arising out of any alleged defect or any failure in relation to a product shall be brought more than 12 years after the date of initial purchase for use or consumption. In an implant case that date can precede the surgery, because the hospital bought the device before anyone used it. Since the period runs from purchase rather than from injury, it can extinguish a claim before the device ever fails. The 12-year period applies to causes of action arising on or after 1 October 2009; the shorter repose in the former G.S. 1-50(a)(6), repealed at the same time, continues to govern claims that accrued earlier, so the age of the implant decides which rule is in play.

The three-year limitation in G.S. 1-52 runs alongside the repose. Under G.S. 1-52(16) a personal injury cause of action does not accrue until bodily harm to the claimant becomes apparent or ought reasonably to have become apparent, and no cause of action accrues more than 10 years from the last act or omission of the defendant giving rise to it. That is the provision that matters where a device corrodes, fractures or sheds material silently. A death claim is brought under G.S. 28A-18-2 and must be commenced within two years of death under G.S. 1-53(4), which also provides that where the decedent would have been barred in life by G.S. 1-15(c) or G.S. 1-52(16), no action for the death may be brought at all.

A claim against the surgeon or the hospital runs on a different clock. G.S. 1-15(c) sets three years from the last act of the defendant giving rise to the cause of action, with one year from discovery where the injury was not readily apparent and became apparent two or more years after that last act, and in no event more than four years from the last act. A foreign object left in the body that has no therapeutic or diagnostic purpose carries its own rule, one year from discovery with a 10-year outer limit. Rule 9(j) allows a claimant to move, before the applicable limitation period expires, for an extension of up to 120 days in which to file the complaint and obtain the review the rule requires. The extension is not available for the asking: a resident superior court judge for a district where venue is proper, or a presiding judge if none is available, may allow it only on a determination that good cause exists and that the ends of justice would be served.

Tolling for a person under a disability is not a single rule, and the difference is easy to get wrong. G.S. 1-17(a) allows a person who was under a disability when the cause of action accrued, a minor included, to bring the action within the ordinary period after the disability is removed; that is the provision that bears on a products claim, always subject to the repose in G.S. 1-46.1. Malpractice is carved out of it. G.S. 1-17(b) requires a minor's professional malpractice action to be commenced within the times fixed by G.S. 1-15(c), except that if those times would expire before the minor turns 19, the action may be brought before the minor turns 19. G.S. 1-17(c) then displaces both for a minor's claim against a health care provider: the G.S. 1-15(c) periods apply, with a floor permitting suit before the minor reaches the full age of 10 where those periods would otherwise expire sooner, and further allowances only in defined circumstances involving an adjudication that the minor is an abused or neglected juvenile, or a minor in the legal custody of the State, a county or an approved child placing agency. A parent should not assume that a child's claim against a surgeon waits for adulthood. In most cases it does not.

The explanted device and the regulatory record are the evidence

When a device is removed it is frequently sent back to the manufacturer for analysis and does not come back. North Carolina recognizes a spoliation inference: where a party destroys or fails to preserve evidence that was within its control, the finder of fact may infer that the evidence would have been unfavourable to that party. Red Hill Hosiery Mill, Inc. v. MagneTek, Inc., 138 N.C. App. 70 (2000), states the principle and also its limits, since whether the inference arises at all depends on the record. It is permissive, never compelled, and it cuts against whichever side held the item. A written preservation request sent to the hospital before the revision surgery, together with an agreement about who inspects the device, when, and under what protocol, is worth considerably more than an inference argued after the fact.

The paper record does work the device cannot. Operative and explant reports, the implant record with lot and serial numbers or the unique device identifier, the instructions for use in force on the date of implantation, recall and field safety notices, and the manufacturer's adverse event reporting all bear on what was known and when. Causation opinions come in under North Carolina Rule of Evidence 702, which since State v. McGrady, 368 N.C. 880 (2016), applies the federal reliability standard, so expert work has to be planned from the beginning on the assumption that it will be challenged.

What a North Carolina device claim can cover, and what is repaid from it

Recoverable losses include the revision or explant surgery, continuing monitoring, future care, lost earnings and lost earning capacity, pain and suffering, permanent injury and scarring. Rule 414 of the North Carolina Rules of Evidence limits evidence offered to prove past medical expenses to the amounts actually paid to satisfy bills that have been satisfied, regardless of the source of payment, and the amounts actually necessary to satisfy bills incurred but not yet satisfied, so the figure a jury hears is often below the sum billed. Under G.S. 24-5(b), the portion of a money judgment in an action other than contract that the fact finder designates as compensatory damages bears interest from the date the action is commenced until the judgment is satisfied.

Punitive damages are governed by Chapter 1D and are never automatic. G.S. 1D-15 allows them only where the claimant proves that the defendant is liable for compensatory damages and proves, by clear and convincing evidence, one of three aggravating factors related to the injury: fraud, malice, or wilful or wanton conduct. Against a corporation there is a further condition, that its officers, directors or managers participated in or condoned the conduct constituting the aggravating factor. G.S. 1D-25 then provides that an award shall not exceed three times the amount of compensatory damages or $250,000, whichever is greater, and the existence of that limit is not made known to the jury. Out of what is recovered, medical providers may assert liens under G.S. 44-49, and G.S. 44-50 provides that such a lien shall in no case, exclusive of attorneys' fees, exceed 50 per cent of the amount of damages recovered.

Where a surgeon or hospital is a co-defendant, a further limit reaches that defendant alone. G.S. 90-21.19 caps noneconomic damages in a medical malpractice action at a statutory figure, a base of $500,000 that the Office of State Budget and Management resets every third year against the Consumer Price Index, so the operative number in any given year is the current adjusted amount rather than the base. The cap is conditional rather than absolute. Under G.S. 90-21.19(b) it does not apply where the claimant suffered disfigurement, loss of use of part of the body, permanent injury or death and the defendant's conduct was committed in reckless disregard of the rights of others, was grossly negligent, or was fraudulent, intentional or malicious.

Where a Charlotte device case is filed and how it moves

Under G.S. 7A-243 the superior court division is the proper division for the trial of a civil action in which the amount in controversy exceeds $25,000, and G.S. 1-82 lays venue in the county in which the plaintiffs or the defendants, or any of them, reside at the commencement of the action. For a Charlotte claimant that is Mecklenburg County Superior Court. Device manufacturers are almost always incorporated and headquartered elsewhere, so where the parties are completely diverse and the amount in controversy exceeds $75,000 a defendant may remove the case under 28 U.S.C. 1332 and 1441 to the United States District Court for the Western District of North Carolina, Charlotte Division. Removal is common in these cases, but it depends on those conditions being satisfied, and joining a North Carolina surgeon or hospital as a co-defendant will ordinarily defeat diversity.

Where the same device is already the subject of federal multidistrict litigation, the Judicial Panel on Multidistrict Litigation may transfer the case under 28 U.S.C. 1407 for coordinated pretrial proceedings, which is where common discovery, shared expert work and the pre-emption rulings tend to happen. Transfer is for pretrial purposes only; under 28 U.S.C. 1407(a) a case not terminated in the transferee court is remanded to the district it came from for trial. A case that stays in state court may be recommended for designation as exceptional under Rule 2.1 of the General Rules of Practice for the Superior and District Courts, which allows the Chief Justice to assign one superior court judge to it from beginning to end. Mediation depends on a court order rather than on the statute standing alone: G.S. 7A-38.1 provides that the senior resident superior court judge of a participating district may order a mediated settlement conference in a superior court civil action, and may by local rule order all cases not exempted by the Supreme Court's rules to such a conference. Where an order of that kind applies, the parties and their representatives attend before trial.

Common questions

Written for North Carolina law and reviewed by David P. Sheehan, attorney, Charlotte. General information, not legal advice — see the disclaimer.