Medical device litigation often involves defective product claims against device manufacturers and distributors as well as professional liability claims against hospitals and physicians. These claims might include a failure to warn of device dangers, breaches of medical device warranties, defective design and manufacture, and violation of consumer protection statutes. In device malfunction situations, the court might order the device maker to perform costly long-term medical monitoring. Litigation against manufacturers might be complicated by the “learned intermediary rule,” which suggests that a manufacturer is not normally required to warn a patient of the dangers of the use of a prescription drug or device; rather, the physician has this responsibility. This rule has been applied where the manufacturer has provided adequate warning to the medical community with the expectation that the patient will receive this information from the doctor. Four cases of interest are described below.
Rosenberg v C.R. Bard Inc
The Rosenberg v. C.R. Bard Inc (2019) case sets to determine in Pennsylvania law whether medical devices will be subject to strict liability. Strict liability determines that even in the absence of negligence or intent to harm, a company can still be liable for any damages. Goods like prescription drugs are already considered to be exempt from strict liability given the fact that they are considered inherently dangerous. Rosenberg v. C.R. Bard Inc will decide if medical devices fall under the same category as perception drugs in PA law. This case results from the need for the Plaintiff to receive additional surgeries after she experienced complications from a medical device used in her original procedure. Though the strict liability claims were dismissed by the court for this case, a decision on the overall question of whether medical devices should be considered strict liability is still needed. As of September 2019, a decision has yet to be made.
Johnson & Johnson
Johnson & Johnson (J&J), a multi-national manufacturer of medical devices, pharmaceuticals, and consumer goods, has found itself involved in several lawsuits over defects in their medical devices. The medical devices division of J&J is split into several units, two of which are DePuy and Ethicon. In 2013, the DePuy unit of J&J was ordered to pay over $4 billion to resolve more than 7,500 over defective hip replacement implants. In another case, a federal jury in West Virginia awarded one woman $3.27 million after over 33,000 lawsuits were filed against the Ethicon unit of J&J for defective transvaginal mesh devices. Both cases addressed corporate negligence, strict liability, and product liability issues.
Riegel v. Medtronic
In 1996, patient Charles Riegel underwent angioplasty when a Medtronic heart catheter burst during the procedure, forcing him to undergo emergency bypass surgery as a result. Reigel sued Medtronic, alleging negligence in the design, manufacture and labeling of the catheter, strict liability, and breach of express and implied warranties. Medtronic sought summary judgment on the basis that the claims were preempted since the FDA had approved use of the catheter under the premarket approval process. The district court granted summary judgment for most of Riegel’s claims and the Second Circuit affirmed the district court decision. Medtronic and other medical device manufacturers, backed by the federal government, also argued that the federal system should bar state law claims. Reigel contended that the FDA’s approval process had been sloppy and inadequate. In 2008, the Supreme Court, in an 8-1 decision, held in favor of the manufacturer, finding that Congress intended that the pre-market approval process at issue in Riegel would bar the filing of suits.
Medmarc Casualty Insurance Company v. Angeion Corporation
Angeion Corporation, now known as MGC Diagnostics Corporation, discovered in 2002 that the batteries of their implantable cardioverter defibrillators were wearing out prematurely, so they withdrew these devices from the marketplace. Device distributors sought reimbursement from Angeion for incurred costs related to withdrawal of the defibrillators. Angeion and the distributors settled for $1.4 million. When Angeion sought coverage from its insurer Medmarc under a commercial general liability policy, Medmarc denied coverage and filed a declaratory judgement action. The court had previously held that Medmarc had a duty to defend and that they had breached the duty, but in this action the duty to indemnify was the issue and the applicability of exclusions in the CGL policy was a critical concern. Ultimately the court held that certain exclusions applied to some of the claims involving the failure of the product while in use, but not to claims where the defibrillators did not fail while in use. Specifically, the defibrillators that met the voltage level requiring recall failed while in use and were thus not subject to the exclusion, whereas the units that did not have a voltage level that warranted recall were subject to the exclusion and not covered by the policy. Other issues addressed in the decision included what constituted medical expenses, the reasonableness of the settlement, and the recovery of defense fees.
Suter v. General Accident Insurance Company
The decision in Suter v. General Accident Insurance Company, 2006 U.S. Dist. LEXIS 48209 (D. N.J. 2006), is a decision that was vacated after the parties settled, but provides a thorough analysis of important medical device insurance and reinsurance coverage issues. This case involved claims brought against Pfizer Inc. in connection with allegedly faulty Shiley heart valves. Pfizer paid hundreds of millions of dollars to claimants whose valves had not yet failed, but who contended that they suffered from anxiety about possible failure. Issues considered by the court included not only whether the anxiety claims should be allowed at all, but also how to set the date of injury trigger for all the claims, a determination critical to assessing whether the injuries occurred within the policy period.