Industry has been warned: US Food and Drug Administration (FDA) approval is no shield against failure-to-warn or product-liability suits.
A recent ruling by the US Supreme Court likely signals the beginning of the end for 'preemption'—a legal principle that drug manufacturers have argued protects them from state lawsuits challenging the safety, efficacy or labeling of FDA-approved products. The Supreme Court has now clarified that FDA oversight matters not one jot in terms of a drug maker's protection from liability at the state level. And although federal preemption does still apply to certain types of medical devices, it seems US political momentum is building to pass new legislation that would nix that as well.
Nine years ago, Diana Levine lost her arm to gangrene after a physician's assistant improperly injected Wyeth's anti-nausea drug Phenergan (promethazine hydrocholoride), causing the drug to come into contact with arterial blood. Over two times the dose recommended on the label was administered, and the medical personnel persisted with the procedure despite Levine's protestations of pain. Levine sued the physician and physician's assistant, settling the suit out of court.
She then went after Wyeth (p. 399), alleging that the company had failed to provide sufficient warnings in Phenergan's labeling to indicate that the drug was “not reasonably safe for intravenous administration.” Her attorney argued Wyeth was negligent because the drug label should have warned physicians not to use the intravenous (IV)-push method at all. The jury agreed, awarding Levine $7.4 million, which was subsequently reduced to $6.7 million.
Phenergan's label includes six statements (two in all capital letters and boldface type) explicitly warning that injecting the drug into arterial blood poses a high risk of tissue damage. In 1988, Wyeth had suggested to FDA a strengthening of Phenergan's label to warn about inadvertent administration into the artery via the IV-push method—exactly the issue targeted in the Levine suit. Ironically, though, FDA declined the labeling change presumably because the benefits of retaining IV-push injection as a treatment option for patients outweighed the risks. Thus, the regulator discouraged the manufacturer from making the label change that it was subsequently sued for not making.
When the Wyeth v. Levine appeal reached the United States' highest court last year, the drug company argued that FDA's oversight of Phenergan's label preempted Levine's claims of negligence on the basis of Article IV of the US Constitution. But in a 6–3 split decision this March, the Supreme Court disagreed with this interpretation, ruling that there is no preemptive language in the statutes governing drug regulation. Thus, any doubt over the invalidity of FDA preemption for drugs is now at an end.
Not surprisingly, the ruling has sent shock waves through industry. FDA preemption had been gaining ground in recent years, particularly with the former Bush administration pushing tort law reform. What's more, several prominent cases, including Riegel v. Medtronic heard in the Supreme Court last year, have upheld the FDA's supremacy over state law. Just this January, a judge in the US District Court in Minnesota used FDA preemption as the basis for dismissing >1,000 lawsuits filed against Medtronic after the company's Sprint Fidelis implantable defibrillator lead was withdrawn from the market.
But Wyeth v. Levine differs from most of the previous case law in that it concerns a drug rather than a device. This is important because devices that receive premarketing approval are covered by a special piece of legislation—the Medical Device Amendments of 1976—containing a preemption clause that specifically bars US states from imposing “any requirement” related to a medical device that is “different from, or in addition to” a federal (FDA) requirement. There is, however, no such language in US law governing drugs, as the Supreme Court has now clarified.
Even for device companies, the days of FDA preemption may be numbered. Shortly after the Wyeth v. Levine decision, Congressmen Henry Waxman (D-CA) and Frank Pallone (D-NJ) introduced the Medical Device Safety Act of 2009, which explicitly states that the Medical Device Amendments do not preempt lawsuits against device companies. With a similar bill being prepared for the Senate, and a Democratic majority in both houses, the legislation has a good chance of passing.
Thus, in all likelihood, the biotech and pharmaceutical industries will soon be among not only the most regulated sectors in the world, but also the most sued.
As a result, companies and investors will almost certainly shy away from funding programs for innovative products with a higher element of litigation risk (e.g., pediatrics). The budget for corporate legal departments will mushroom as more dollars are spent fighting litigation.
At the FDA, staff will spend more time on labeling issues as companies insist on clearer records about agency labeling decisions. And labels will balloon to Dostoyevskian proportions, expanding on the one hand to cover every possible liability and becoming more restrictive on the other so that liability is placed squarely on the shoulders of the prescribing physician or surgeon. The emphasis will change from providing professionals with succinct information on best practice to the compilation of long lists of side effects and warnings that simply serve to shield manufacturers from litigation.
The result will be denser, less-intelligible product labels, which will be read less closely by medical professionals, which will result in a greater number of accidents and adverse events and injury, which in turn will result in even more lawsuits.
All of which doesn't bode particularly well for companies, for physicians or for patients. In the 1980s, an increasingly litigious environment hastened the flight of drug manufacturers from child vaccines. The concern is that the Wyeth v. Levine decision will prompt a similar flight by drug manufacturers away from innovative products in high-risk indications.