Hysenlika Law Firm PLLC
Se Habla Espanol • Flasim Shqip • Parliamo Italiano

Speak To The Attorney: (813) 803-0733

Hysenlika Law Firm PLLC


Personalized legal advocacy and care for personal injury and property insurance claims.

Product Liability and Preemption

by | Sep 24, 2013 | Firm News

It is unfortunate how many patients in the United States and all over the world have received defective knee and hip implants. Those found to be the most defective are DePuy , Zimmer, Biomet, Stryker, Wright, Smith and Nephew.

Patients complain of continuous pain and many of them have had to undergo through revision surgery. Although the components of these devices or the device all together have been found to be defective, the manufacturers have found ways to avoid liability. The manufacturers have used USC Section 360 to their advantage to throw these cases out by using preemption against almost all state causes of action. However, USC Section 360 does not indicate nor was it created with the intent to preempt all state causes of action.

Preemption is a doctrine that derives from the Supremacy Clause of the Constitution. The Constitution states that the “Constitution and the laws of the United States shall be the supreme law of the land, and anything in the constitutions or laws of any State to the contrary notwithstanding.” Therefore, any state law that is in conflict or that makes a Federal law impossible to follow will be cancelled out.

There is no right and wrong argument to overcome preemption and many courts have not recognized any. However, below are some arguments that could be plausible.

Klodiana Hysenlika, Personal Injury Attorney, Tampa Bay

(L to R). Klodiana Hysenlika with a client

Congress did not intend to preempt any state causes of action. Judge Stevens in Medtronic Inv.v. Lohr states:“There is, to the best of our knowledge, nothing in the hearings, the Committee Reports, or the debates suggesting that any proponent of the legislation intended a sweeping pre-emption of traditional common-law remedies against manufacturers and distributors of defective devices. If Congress intended such a result, its failure to even hint at it is spectacularly odd, particularly since Members of both Houses were acutely aware of ongoing product liability litigation. Along with the less-than precise language of § 360k(a), that silence surely indicates that at least some common law claims against medical device manufacturers may be maintained after the enactment of the MDA

Claim of preemption is contrary to congressional intent and public safety. According to Medtronic v. Lohr: we start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress. Throughout our history the several States have exercised their police powers to protect the health and safety of their citizens. Because these are ‘primarily, and historically, matters of local concern, the ‘States traditionally have had great latitude under their police powers to legislate as to the protection of the lives, limbs, health, comfort, and quiet of all persons.”

Post Market Surveillance.

Manufacturer should have notified FDA of the dangers of the medical device after hundreds of patients filed lawsuits.

Mandated Post-market Studies by the FDA

FDA currently has two authorities with which to require manufacturers to conduct postmarket studies: post-approval study (PAS) authority under section 515 of the Act, and PMS authority under section 522 of the Act. PAS authority allows FDA to ask a device manufacturer to conduct a study (or studies) of a PMA device, as a condition of its approval, to address product performance in the post-market period (e.g., long-term safety). Consistent with the Agency’s transparency initiative, overall study status, including study results for completed studies, are posted on FDA’s website. Authority under section 522 allows FDA to require post-market surveillance studies for certain Class II or Class III devices, for example to address significant public health issues that arise in the post market period.

A recent Ninth Circuit Court of Appeals en banc decision marks a less than desirable shift in preemption law for medical device manufacturers. In Stengel v. Medtronic Inc. (Jan. 10, 2013) the Ninth Circuit granted rehearing en banc and unanimously reversed the decision of the district court in a product liability case by holding that the Medical Device Amendments (“MDA”) of the Federal Food, Drug and Cosmetic Act (“FDCA”) did not preempt the plaintiffs’ state-law failure-to-warn claim, which was contained in the plaintiffs’ proposed amended complaint.

For more information on product liability and preemption please contact Hysenlika Law Firm PLLC at (813)803-0733.