Panel Discussion: Product Liability Issues

July 1, 2007

7 Min Read
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PRODUCT LIABILITY

Panelists

Although many of the federal regulations governing companies in the life sciences differ according to sector, companies in the biotech, medical device, and pharma sectors have many common interests when it comes to developing strategies to protect themselves from product liability litigation. In the face of changes in the overall healthcare environment and corresponding changes in company marketing practices, however, even defense doctrines with a long and distinguished history of success could be in jeopardy. Whether doing business in their own sectors or in cross-sector alliances, life sciences companies are increasingly likely to encounter legal challenges that could be difficult, time-consuming, and expensive to overcome.

Panel Discussion Information

Thursday, October 4 2:45–3:30 p.m.

Chair: Genese Kay Dopson Attorney at Law Sedgwick Detert Moran and Arnold LLP

In this session, panel chair Genese Kay Dopson, a product liability attorney with the law firm of Sedgwick Detert Moran and Arnold LLP (San Francisco), will lead a discussion of timely issues affecting life sciences companies that find themselves involved in product liability litigation. Key areas of concern include the following.

  • Both FDA and Congress have expressed concern about widespread off-label use of approved medical products. What are the implications of such activity for defending against product liability claims?

  • Can informed consent during clinical trials influence the outcome of later product liability claims?

  • Does the increasing use of direct-to-consumer advertising by medtech companies affect the availability of the learned intermediary defense in product liability litigation?

  • How can the use of consumer-directed information on a Web site sponsored by a medtech company alter the company's product liability risks?

  • What are industry concerns related to the October 2007 Supreme Court review of Riegel v. Medtronic and the issue of federal preemption of state tort laws in suits involving FDA-approved medical devices?

  • How and when should cross-sector partners consider how their business venture will address product liability issues?

On the issue of direct-to-consumer (DTC) advertising, Dopson observes that companies using a DTC approach could fall victim to the significant erosion of the learned intermediary doctrine that has begun to appear in certain court decisions. Under some circumstances, the doctrine could be called into question even when a company's products are typically selected and used exclusively by healthcare professionals. In such an environment, protecting a company's legal defense options requires significant forethought.

“Intuitive Surgical's product is a surgical robot used in minimally invasive surgeries,” notes panel member Rick Runkel, Intuitive's senior vice president and general counsel. “But since it is a revolutionary technology, doctors aren't always willing to discuss it with their patients. So we're considering ways of providing more information directly to consumers, primarily through the various Web sites that the company maintains.

“With the advent of the Internet, patients are much more educated and inquisitive about potential new treatments,” says Runkel. “We're trying to take advantage of that while also making sure that the information we provide is properly used to arrive at the right decision for each patient.

“In turn, this has raised issues about how the company can provide information with appropriate disclosures, and also maintain the integrity of the learned intermediary doctrine.

“Consequently, we're devoting a good portion of the materials we develop for consumers to emphasize the importance of consultation with the physician,” says Runkel. “The various discussions and disclaimers embodied in our Web sites address these points and continue to put the most important consultation in the hands of the doctor and the patient.

“We're trying not to go beyond that. But it's tough.”

Panelist Kevin Quinley, senior vice president at Medmarc Insurance, agrees that companies using DTC advertising could find it difficult to preserve the learned intermediary defense. “Ingenious plaintiff attorneys are arguing persuasively, and some courts have agreed, that medical product companies can't have this both ways.

“The phrase, ‘Ask your doctor about x,' has become almost an advertising icon,” says Quinley. “But a company cannot go around the doctor to entice the consumer directly, and then expect to hide behind the physician with a defense that claims it's entirely up to the doctor to explain all of a treatment's potential side effects, contraindications, and risks.”

“From a defense attorney's standpoint, I hope we will begin to see companies establishing solid planning before undertaking direct-to-consumer advertising,” says Dopson. “That planning should include ways to raise public awareness about a product or therapy as well as ways to ensure that the medical community understands the medical judgment that needs to be exercised when the product or therapy is used or prescribed.

“It may make doctors feel uncomfortable that some patients will consider them obstacles to getting the therapy that the patient wants,” says Dopson. “But ultimately, it is still going to be the doctor who has to exercise medical judgment about the propriety of a therapy or device, and it will be up to the doctor to explain why a therapy or device is, or isn't, suitable for a particular patient.”

Elona Baum, director of regulatory, quality, and compliance policy at Genentech, says direct-to-consumer advertising, when used appropriately, is a terrific tool to trigger thoughtful discussion between a doctor and patient. “A company's exercise of commercial speech should not serve to limit a doctor's duty and obligation to explain the pluses and minuses of different types of treatments and options,” she says.

“If thoughtful discussion does not occur between the physician and the patient, I would suggest that this would not be the fault of the drug company, and the erosion of the learned intermediary defense would serve only to freeze this type of speech,” Baum adds. “Let's not forget that FDA regulates in this area.”

Maintaining the integrity of a company's planned communications can be difficult when working with partners or customers, notes Runkel. “It's a constant battle to maintain the lines of communication—to ensure that the materials we have carefully crafted with all the legal and liability issues in mind aren't picked up and used inappropriately, and sometimes without the protections that we put in place.

“We request that people seek our review before using our materials, so that we can ensure that what they've done is consistent with our policies and procedures,” says Runkel. “But there is always a danger that a company's collaborators or customers will take the materials to the next step, even without its knowledge or approval. And in doing so, it may eviscerate some of the protections that the company has worked very carefully to put in place.”

Collaborations can also pose insurance and risk management issues, say Quinley. “In the event of a claim or a lawsuit, partnering companies should know which of their insurance companies is required to respond; which company should act as the primary carrier; which firm will take the lead in defending or controlling the claim; or, if the effort is to be collaborative, how the costs and tasks will be apportioned.

“It's easy to overlook these issues when companies are in the throes of fleshing out a partnership deal,” says Quinley. “But these kinds of collaborations present risk management and insurance issues that need to be carefully thought through in terms of possible scenarios. Because almost always, the occurrence of such conflicts isn't a matter of if, but of when.”

Among other topics for this panel will be the status of the federal preemption of state tort laws for medical devices approved through FDA's premarket approval process. Within days of this session, the U.S. Supreme Court is expected to hear the landmark case of Riegel v. Medtronic, which is expected to result in a definitive ruling on the preemption defense. In this panel, participants will review the legal issues in play and outline the potential effects of the court's ruling on medtech companies.

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