Liability • Medical Device Amendments • Federal Preemption • FDA Approval

Starks v. Coloplast Corp., PICS Case No. 14-0253 (E.D. Pa. Feb. 13, 2014) McLaughlin, J. (21 pages).

Plaintiff’s state law tort claims based on malfunction of medical device approved by FDA were preempted by federal law. Negligence, strict liability and implied warranty claims dismissed with prejudice; breach of express warranty and breach of contract claims dismissed without prejudice.

Plaintiff sued defendant for negligence, strict products liability, breach of warranties and breach of contract after its product, a penile implant, malfunctioned. Plaintiff alleged that, two years after the product was surgically implanted, it malfunctioned due to a fluid leak in one of the tubing cylinders. As a result, plaintiff was forced to undergo additional surgery to remove the implant and have a new one put in. He sought damages for medical bills, post-surgical pain and related causes.

Defendant moved to dismiss the complaint for failure to state a claim upon which relief can be granted. The U.S. District Court for the Eastern District of Pennsylvania dismissed the action.

The implant manufactured and sold by defendant is a Class III medical device approved by the FDA. Class III devices receive the most oversight from the FDA, and must undergo a rigorous process known as premarket approval. Premarket approval includes an in-depth review of scientific and clinical data. The FDA spends an average of 1200 hours reviewing each application and is required to weigh probable health benefits against probable risks of injury or illness. After a device has been approved, the manufacturer cannot change design specifications that affect safety or effectiveness without FDA permission.

The Medical Device Amendments of 1976 (21 U.S.C. §§360c et seq.) expressly preempt state law requirements that are “different from, or in addition to, any requirement applicable under” the amendments to the device and which related to the safety or effectiveness of the device. Id. §360k(a). To determine whether a claim is preempted, a court must determine: (1) whether the federal government has established requirements applicable to the medical device; and (2) whether the state common law claims impose requirements that are “different from, or in addition to” those imposed by federal law.

Here, defendant’s product received premarket approval. Therefore, the federal government has imposed device-specific “requirements” on the implant, thereby satisfying the first prong of the two-part test of express preemption under §360(k).

All of plaintiff’s claims, except for express warranty and breach of contract, were preempted as claims relating to safety or effectiveness that are “different from, or in addition to” federal requirements.

However, the breach of express warranty and breach of contract claims were not preempted by federal law. Express warranties do not independently arise by operation of state law, and the parties, not the state, define the obligations of the contract and therefore any express warranties. However, plaintiff failed to allege any affirmation of fact or promise made by defendant relating to the implant that would amount to an express warranty. Moreover, plaintiff failed to adequately allege the elements of a cause of action for breach of contract.