Sometimes, personal responsibility is hard to come by. The same can be true of corporate responsibility, which is another version of personal responsibility (under the law, corporations are entities capable of suing and being sued, and doing many of the same things that people do).
Guidant, a former medical device manufacturer, faced charges from both the FDA and DOJ over its handling of medical devices.
In 2005, Guidant faced a series of recalls related to its implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The recalls were related to a defect in the devices’ wiring that could cause the devices to malfunction or fail to deliver a life-saving shock to the heart.
In 2010, Guidant pleaded guilty to two federal criminal charges related to its handling of the ICD and CRT-D defects. The company was charged with submitting a false and misleading report to the FDA about one of the device malfunctions and failing to notify the FDA about a safety issue with one of the devices. The DOJ alleged that Guidant knew about the defects for several years before taking action and that the company continued to sell the devices even after discovering the problems.
As part of the settlement, Guidant agreed to pay $296 million in criminal fines and forfeitures. The company also entered into a deferred prosecution agreement with the DOJ, which required the company to implement certain compliance measures and to cooperate with ongoing investigations.
The FDA also took action against Guidant related to the device defects, issuing a warning letter to the company in 2005 and fining the company $2.25 million in 2007 for failing to report certain device malfunctions to the agency. The FDA’s actions against Guidant underscored the importance of rigorous quality control and testing procedures in the production and distribution of medical devices, as well as the need for timely and accurate reporting of safety issues to regulators.
Exhibit A is Guidant’s plea in federal court on Monday. Guidant (recently acquired by Boston Scientific) pleaded guilty to criminal violations of the Federal Food, Drug, and Cosmetic Act. Specifically, it pleaded guilty to two violations:
- making a materially false statement in a required submission to the FDA (Ventak Prizm 2DR)
- Failing to notify the FDA of a “correction” made to reduce a health risk caused by defibrillators (Contak Renewal)
As part of the plea, Guidant agrees to pay over $296 million in criminal penalties, the largest criminal penalty ever imposed on a device manufacturer. Judge Donovan Frank is reviewing the plea agreement.
The defibrillators are devices implanted near the heart, designed to provide life-saving electrical jolts to patients with heart defects. Because of the defective devices, people have died when the devices did not function as they were expected to. Prosecutors allege that the manufacturer, which had notice of the problems, tried to cover up the fact that those deaths were caused by the defibrillators.
Money to the Government, Not Families
More Guidant Recall Information
It is important to remember that none of the $296 million will go to Guidant’s victims or their families. The company is being held criminally responsible, but civil responsibility is elusive here. Even though Guidant admitted its wrongdoing, the U.S. Supreme Court decision in Riegel v. Medtronic holds that medical device manufacturers cannot be held civilly responsible for devices approved by the FDA’s pre-market approval process.
How Did Preemption Stop Victims from Bringing Lawsuits?
Preemption is a legal doctrine that can limit the ability of plaintiffs to bring state law claims against manufacturers of medical devices that have been approved by the FDA.
In the case of Guidant Corporation and its implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), the issue of preemption played a prominent role in limiting its liability.
The doctrine of preemption was established by the U.S. Supreme Court in the case of Riegel v. Medtronic, Inc., which involved a medical device that had been approved by the FDA through the premarket approval (PMA) process. The Court held that state law claims were preempted by federal law in cases where a medical device had been approved by the FDA through the PMA process, and the manufacturer had complied with all FDA requirements.
Guidant argued that preemption applied to some of the claims brought by plaintiffs in the defibrillator lawsuits, on the grounds that the devices had been approved by the FDA through the PMA process, and the company had complied with all FDA requirements. Guidant argued that the FDA’s approval of the devices meant that the company was shielded from state law claims, including claims related to design defects and failure to warn.
Medical Safety Device Act
So, there’s only limited responsibility here. The Medical Device Safety Act (introduced in Congress as S. 540 and H.R. 1346) is designed to remedy that situation.
If a rich man clubs a child with a baseball bat, shouldn’t he be sent to jail and subject to paying for the child’s injuries? The same thing should hold true for corporations.
Where Is Guidant in 2023?
Guidant Corporation, which was a major – albeit much maligned – medical device manufacturer, was acquired by Boston Scientific Corporation in 2006. Boston Scientific acquired Guidant for approximately $27 billion in cash and stock, making it one of the largest acquisitions in the medical device industry.
Following the acquisition, Boston Scientific continued to produce and sell medical devices under the Guidant name, including implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). However, Boston Scientific later phased out the Guidant brand name and began selling these products under its own name.
In 2023, Boston Scientific is still in business and is one of the world’s largest medical device manufacturers, with a wide range of products in areas such as cardiovascular health, urology and pelvic health, endoscopy, and neuromodulation. This buried the taint of the Guidant name.