As a defective medical device lawyer, I was very interested to see a medical device lawsuit brought by people who claimed their doctors failed to disclose important FDA approval information before surgery. In Perez et al. v. Nidek Co. et al, Robert Perez and a few other plaintiffs brought claims on behalf of a putative class of LASIK surgery patients who were not told that LASIK is not approved to correct farsightedness—only nearsightedness. Perez and the other proposed lead plaintiffs did not allege any injury. As a result, the district court dismissed their claims under the California Consumers Legal Remedies Act and the state’s Protection of Human Subjects in Medical Experimentation Act for failure to state a claim. Their common-law fraud claim was dismissed as preempted by federal medical device regulations.
Perez and the other proposed lead plaintiffs got LASIK surgery to correct farsightedness. They claim they were not told that the FDA has not approved LASIK for farsightedness, and argued that if they had known, they would not have consented to the surgeries. Their lawsuit proposes a class of people who had LASIK for farsightedness between 1996 and 2006, regardless of injuries. During that period, the device was being investigated in FDA trials for use in farsighted patients. In addition to the statutory and fraud allegations, they alleged civil conspiracy and aiding and abetting, against various doctors and corporate entities related to Nidek Co., the owner of the LASIK patent, saying the defendants conspired to use LASIK devices for off-label purposes without disclosing this to patients. The district court dismissed the lawsuit for failure to state a claim and preemption.
The Ninth Circuit upheld those decisions. It first ruled that plaintiffs had no standing to sue a class of doctors that did not perform surgery on any named plaintiffs, but were accused of conspiracy. These claims are conclusory and unsupported by facts, the Ninth said, and cannot support standing. Furthermore, the court said, plaintiffs have no standing under the Consumers Legal Remedies Act, because they are requesting an injunction but can identify no harmful conduct that the injunction would block. The Ninth struck down the Human Subjects Act claim because none of the claims in this case fit the statute’s definition of a medical experiment; it found unpersuasive an argument that off-label use of a device is an experiment. Finally, the court found that the Medical Device Amendments to the Food, Drugs and Cosmetics Act expressly preempt the common-law fraud claims, citing Riegel v. Medtronic, and would also be impliedly preempted as a private attempt to enforce FDA regulations.
Riegel disturbed many pharmaceutical liability attorneys like me because it appeared to relieve medical device manufacturers of any accountability for clearly dangerous behaviors. This is another case whose merits were not considered because of the finding that the lawsuit is preempted. The reasoning that this is the FDA’s area of enforcement would comfort me more if the FDA had a reputation for thorough investigations of new drugs and devices, and quick, decisive action against devices found to be dangerous. But as a dangerous medical device lawyer, I know the agency has often been faulted for being very slow to recall devices with safety problems. For that reason, I would prefer to see appeals courts err on the side of generosity to patients when patient safety is at issue.
If a dangerous medical device caused an injury or illness in your family, you should talk to Carey, Danis & Lowe about your rights and your legal options. You can send us an email or call toll-free at 1-877-678-3400.
Similar blog posts:
Oklahoma Supreme Court Permits Negligence Claim in Medical Device Injury – Howard v. Zimmer, Inc.
Ninth Circuit Rules Medtronic Pain Pump Claims Expressly or Impliedly Preempted – Stengel v. Medtronic
Fifth Circuit Resurrects Defective Medical Device Claim Involving Hip Replacement – Bass v. Stryker Corp. et al.