When a product manufacturer wants to market and sell a medical device that presents an unreasonable risk of injury or illness to the public, under federal law 21 USCF § 360 the manufacturer must show to the Food and Drug Administration (“the FDA”) that the effectiveness of the product outweighs any risks of harm. The manufacturer must also provide, under federal law 21 CFR § 860.7, assurance through valid scientific evidence that in a significant portion of the population the device will provide clinically significant results. In such a scenario a product manufacturer will look to biostatistical research companies or contract research organizations (“CROs”) to help it run studies and present evidence to the FDA that the medical device meets the FDA’s requirements.
Can a claim be brought against such a CRO in its role of running studies and presenting evidence to the FDA about a medical device? Lawsuits against the manufacturer alone can be difficult to bring, as claims in state court that the product was defective can be prevented or “preempted” by the fact that the FDA already found the medical device was effective, and its benefits outweigh any risks. However the Thistle Law Firm was one of the first firms to successfully do so in a case where the FDA found it was defrauded when it gave initial approval to market and sell one such medical device.
The manufacturer in the Thistle Law Firm’s case had retained a CRO to run a U.S. study to show the manufacturer’s product was effective. The product was a gel that was supposed to reduce scar tissue following single level back surgeries. The study was run on 360 patients, some who received the gel following back surgery and some who did not. A “blinded” neuroradiologist (one who did not know which patients received the gel) reviewed MRI results of these patients’ backs. The problem with the study? It showed the control and non-control groups had the same scarring scores. In order to work, a product had to demonstrate a P value of less than .05 which means there was a 5% probability that the results of the study were due to chance. In this study the P value was over .5 which means that the study result was totally due to chance.
Despite these results, the Thistle Law Firm claimed the CRO allowed the manufacturer to present data to the FDA on only half of the U.S. study patients, which appeared to demonstrate that the gel worked, in order to get conditional approval to market and sell the gel. The Thistle Law Firm also claimed the CRO then unblinded the study to the manufacturer. The neuroradiologist re-read the MRIs of the remaining half of the patients and re-entered their scar scores in pencil. Two unblinded employees of the manufacturer were present to review the scar scores being entered by the neuroradiologist. These scoring cards had numerous erasures to them. After the re-reads were done and re-recorded, the scar scores changed. Now 91 of the controls had the worse scar score whereas only 74 gel patients had the worse scar score. The P value of the study also went from above .5 to a .002. This data was then submitted by the CRO, which had also requested that the manufacturer not associate the CROs name with any of the work it did with the gel.
Unfortunately, besides not being effective, the gel caused CSF leaks (fluid that surrounds the spinal chord) which interfered with the healing process to the dura (spinal chord) following surgery. This could result in infections to the spinal chord and other serious complications. As a result of the problems with CSF leaks, the FDA conducted an investigation. During the investigation they learned of the improper substitution of data to have the product approved. The manufacturer subsequently pled guilty to a six count indictment including fraud.
How could the Thistle Law Firm bring a claim against the biostatistical research company? The CRO argued that it was just hired to crunch numbers and had no role in manufacturing a defective medical device. Thus, according to the CRO, it had no duty to patients injured by the gel who were not in the scope of the CRO’s contract with the manufacturer.
The attorneys at the Thistle Law Firm relied on §324A of the Restatement (Second) of Torts in support of its claim. §324A applies to a person or company who agrees to render services to another which it should recognize as necessary for protection of third persons. Under §324A that company is liable for harm caused to those third persons for failure to exercise reasonable care in rendering those services if either: (a) the failure to exercise reasonable care increases the risk of such harm, or (b) the company has undertaken to perform a duty owed by the other to the third person, or (c) the harm is suffered because of reliance of the other or the third person on the undertaking.
In this matter the Thistle Law Firm pointed out that the CRO’s contract itself stated that the CRO was required to monitor safety data from the study and alert the manufacturer to any potential safety concerns. The Thistle Law Firm also argued that the CRO did not simply crunch numbers. Instead it took the entire responsibility of the U.S. study which would be the basis for the FDA giving final approval to market and sell the gel. Furthermore the Thistle Law Firm argued that the CRO agreed to maintain clinical data for the study, serve as the direct liaison for collecting data from the neuroradiologist reading the MRIs, and it assumed responsibility for reporting any deviations from protocol to the FDA. This study was for a medical device the CRO knew came with inherent risks of injury to patients using it and that the purpose of the study was to demonstrate the product was sufficiently effective to justify the risks associated with implanting the medical device.
There was still the issue of federal preemption. Under the Supremacy Clause in the Constitution, the law of the United States is the supreme law of the land and overrides conflicting state laws. §360(k) of the Medical Device Amendments, which governed the approval and sale of the gel at issue, prohibits states from imposing requirements different from, or in addition to, the specific requirements imposed on medical devices by FDA regulations. Therefore, a party typically cannot claim a FDA approved device is defective under state law when the FDA has already found its effectiveness outweighs any risks of harm the device may have.
The attorneys at the Thistle Law Firm were able to show that preemption did not apply to their case. This was because the FDA had determined it was defrauded during the approval process for the gel. Relying on the concurring opinion in Buckman Company v. Plaintiffs’ Legal Committee, 531 U.S. 341, 121 S. Ct. 1012, 148 L. Ed. 2d 854 (2001), the Thistle Law Firm pointed out that, because the FDA had already found it was defrauded and removed the gel from the market, its state law claim did not conflict with the findings of the FDA but instead supplemented those findings.
The attorneys at The Thistle Law Firm have the knowledge and skill to take on cases involving difficult and complex legal issues for their clients. If you want to read more about this case, the court’s opinion can be found at: Wawrzynek v. Statprobe, Inc., 2007 U.S. Dist. LEXIS 80155, 2007 WL 3146792.