Editor’s note: This article is the fourth in an ongoing series.
As drug and medical device manufacturers interact more directly with customers through social media and direct advertising, lawyers in pharmaceutical and medical device litigation and regulation are struggling to ascertain how the new reality of direct-to-consumer marketing will alter liability.
At the same time, products liability attorneys are also continuing to struggle with what state-law pharmaceutical and medical device claims are likely to survive federal pre-emption.
Direct to Consumers
Plaintiffs attorney Clifford A. Rieders of Rieders, Travis, Humphrey, Harris, Waters & Waffenschmidt in Williamsport, Pa., said the vanguard in pharmaceutical and medical device litigation is how much protection is going to be afforded consumers through the tort system as they are given more information directly.
“That’s an area of the law that is ripe for development,” Rieders said. “Should direct advertising change the question as between the manufacturer of the drug and the [federal Food and Drug Administration]? Now you’re bypassing the FDA and going directly to the public. Now you’re bypassing the learned intermediary and going directly to the public.”
Some plaintiffs lawyers argue that the learned intermediary doctrine is an obsolete anachronism because of the rise of direct advertising by pharmaceutical companies to consumers.
“There is an antiquated concept in the law … in order to bring a claim against a drug company for its pharmaceutical for causing an injury, you have to prove they didn’t properly alert the so-called learned intermediary, the physician, about the risk and if the doctor had been properly warned he would not have prescribed the pharmaceutical,” said Shanin Specter, a plaintiffs attorney with Kline & Specter in Philadelphia.
But Specter argued that the state Supreme Court should change the common law to reduce the role of the learned intermediary doctrine in failure-to-warn cases because consumers are now making their own decisions about what pharmaceuticals they want to take because of direct advertising.
“Today, with direct-to-consumer advertising, people are making their own decisions about what pharmaceuticals they want,” Specter said. “The question is really whether the products are safe or they aren’t.”
Doctors are hostile to personal injury suits and are not willing to help plaintiffs even though they are their patients, and doctors assume they know everything that is relevant about prescribing drugs even though they may not be in a position to evaluate what information is kept from them about pharmaceuticals, Specter said.
“It’s a … nightmare,” Specter said. “You have a client who’s been badly injured. You have to hope her doctor will support her case. The doctors are often hostile to even discussing it.”
Defense attorney James M. Beck, counsel with Reed Smith’s life sciences health industries group in Philadelphia, said it’s a “triumph of hope over reason” to think that the learned intermediary doctrine is going anywhere.
The doctrine that pharmaceutical companies must warn prescribers, rather than consumers, has been adopted in 48 states, Beck said.
Only New Jersey has adopted an exception from the learned intermediary doctrine because of evidence of direct advertising to consumers, said Beck and John J. Sullivan, a partner with Dechert’s Princeton, N.J., office whose practice includes products liability and mass torts.
Except for a very “grotesque situation” in which “some doctor basically said, ‘OK, you’re an obnoxious patient. You can have it and get out of my room’ and basically abdicated his prescribing authority,” plaintiffs cannot make an argument of failure to warn based on direct consumer advertising, Beck said.
“Sometimes the doctor-patient relationship needs to be respected,” said Raymond M. Williams, a partner with DLA Piper’s products liability and toxic tort practice group in Philadelphia. “The doctor is always going to be in the best position, regardless of the direct-to-consumer advertising … to determine what drug, what product, what prescription their patient should have.”
Just like plaintiffs attorneys want to get rid of the learned intermediary doctrine, Williams said he’d like to get rid of lay juries deciding, on a scientific basis, if drug companies did enough to get drugs approved.
On the regulatory front, lawyers say the FDA has not said very much about social media even though drug companies want to interact with consumers on YouTube channels, Facebook pages, blogs, apps and Twitter.
In 1996, the FDA started talking about laying down some rules regarding marketing through the Internet either through regulations, which in their final version are promulgated in the Code of Federal Regulations, or guidance, which does not impose legally enforceable responsibility but spells out regulators’ thinking, said Kevin M. Madagan, an associate with Reed Smith’s life sciences health industry group in Washington, D.C.
“Our Godot is the FDA’s policy on Internet and social media,” said Madagan, referencing the Samuel Beckett play Waiting for Godot.
But Godot may be arriving, because the FDA Safety and Innovation Act, which was signed into law by President Obama earlier this summer, requires the FDA to issue guidance regarding promotional advertising on social media within two years.
The FDA has issued one guidance document that discusses how a company should respond to unsolicited questions through social media and online about off-label uses, Madagan said.
Unlike print ads, there is not the real estate in online ads to put all of the potential side effects, as well as providing a reference point on where to get more information, Sullivan said.
“Is it enough on Internet advertising to have all the information the FDA wants you to have to warn one click away?” Sullivan asked.
Another issue is if, through social media, a consumer seems to be reporting an adverse event from using a drug, it’s an open question on whether that has to be reported to the FDA, Sullivan said.
What is said on social media is going to become increasingly important in litigation, Williams and Sullivan said.
“Plaintiffs can’t keep their mouths shut,” Williams said. “Sometimes that’s true with defendants too. Some corporate defendants, their employees can’t keep their mouths shut either.”
If Pennsylvania adopted the Restatement (Third) of Torts, it would be helpful regarding promotional advertising because that Restatement leaves open the question of whether a claim can be premised upon advertising to the public that misrepresents the utility of the drug, Rieders said.
Some areas of pharmaceutical and medical device litigation are now clearly pre-empted by federal law, but it’s an open question for other sorts of litigation.
Both Rieders and Beck said it is an open question in Pennsylvania if the state will adopt claims for negligence in the design of pharmaceutical drugs and whether they would be pre-empted.
The state Supreme Court heard argument almost a year ago in a case in which the state Superior Court said there should be a viable cause of action for negligent design defect while not requiring that plaintiffs show an alternative design.
Design defect cases are difficult to get over the pre-emption hurdle, Rieders said.
Products liability design defect cases typically require plaintiffs demonstrate an alternative design, but Beck said alternative designs are not possible for pharmaceutical products.
“Most of these drugs are chemical substances of one size or another and if you change the design you’re changing them from one drug to another and you would have to go through the FDA process all over again,” Beck said.
In the medical device realm, all but two types of claims regarding Class III medical devices, which support or sustain human life and which must get pre-market approval by the FDA, are pre-empted, Beck said.
But the current fight is whether parallel state law claims, which are based upon a state law parallel to and the same as the federal Food, Drug and Cosmetic Act, can be prosecuted, Beck and Sullivan said.
“Parallel violation claims: the courts are really struggling with them and plaintiffs attorneys are very good at trying to find those,” Sullivan said.
Class III medical device manufacturers can be sued in Pennsylvania if they also made an express warranty beyond that required by the FDA, Beck said.
Medical device litigation is alive and well regarding medical devices that are not as heavily regulated as Class III devices, but some courts are finding pre-emption against fraud theories because of implied pre-emption, Sullivan said. The theory is that the FDA can fight against fraud on its own, he said.
Lawyers also are litigating the questions of how many and what types of lawsuits over generic pharmaceuticals are pre-empted.
The U.S. Supreme Court ruled in June 2011 in Pliva v. Mensing that claims against generic drugmakers on the basis that they failed to warn plaintiffs adequately are pre-empted because generic manufacturers are required to use the same warning labels as their brand-name counterparts.
The FDCA expressly pre-empts state law requiring something different from federal law in the area of medical devices, but the FDCA does not do so in the area of brand-name pharmaceuticals, Beck said.
In the wake of the Supreme Court’s generic-drug decision, plaintiffs are now suing on a misrepresentation theory, Beck said.
“Plaintiffs in these generic [drug] cases don’t have anywhere else to go,” Beck said.
Publishers of educational materials, which publish information given out to consumers at the pharmacy, are now also being sued, Williams said.
Williams said plaintiffs attorneys also are now pursuing “innovator liability” against the original makers, designers and testers of products.
“The question for me and other pharma lawyers: Will the innovator liability envelope get pushed by various state courts around the country given that [Mensing] does not arguably allow you to bring a claim against a generic manufacturer?” Williams asked.