ILNews

SCOTUS: Plaintiffs can sue drug companies

Back to TopCommentsE-mailPrintBookmark and Share

The U.S. Supreme Court says pharmaceutical companies can be sued in state court over alleged drug effects, even if the Food and Drug Administration has approved the medication and its warning label.

In what some are describing as a landmark decision Wednesday in Wyeth v. Levine, No. 06-1249, justices voted 6-3 against the drug giant and issued a major defeat to the pharmaceutical industry. The majority determined that the federal regulation and warning label approval doesn't preempt state laws and shield companies from damages as part of liability claims.

The decision is a blow to companies such as Indianapolis-based Eli Lilly, which have long sought to establish federal oversight as a single standard for preempting state law and had support from the Bush administration that pushed to shield pharmaceutical industries from negligence suits.

Critics say this Wyeth ruling could lead to a flood of litigation in state courts, while others contend it simply reinforces what should already be happening.

Indianapolis attorney Irwin Levine, who has no connection to this case but represents multiple plaintiffs against Wyeth in other cases nationally, said the SCOTUS decision makes a lot of sense.

"The FDA, which we all know is overburdened, underfunded, and can't even keep our food supply safe, is not the end all, be all for consumer safety," he said. "Drug companies wanted a free pass, but the court determined that the FDA approval is not a get-out-of-jail-free card."

Justices found in favor of Diana Levine, a once-professional musician who received a $6.8 million jury award in Vermont after she developed gangrene and lost her right forearm because of how Wyeth's anti-nausea drug, Phenergan, was administered. The trial court concluded that Levine's injury would not have occurred if the drug's label had included an adequate warning about the significant risks of delivering it by means of the IV-push method.

The court rejected the drug maker's arguments that the FDA had approved warning labels for the drug and that trumped state law under which the suit was filed.

"State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly," authoring Justice John Paul Stevens wrote. "They also serve a distinct compensatory function that may motivate injured persons to come forward with information."

Justice Stevens wrote a footnote that conceded the FDA has "limited resources to monitor the 11,000 drugs on the market," and he mentioned a series of studies lamenting the federal agency's inability to use its drug-approval authority to ensure that pharmaceutical companies are doing all that they must do to warn doctors and patients about the risks of new drugs and of the methods of administering them to patients.

Writing for the minority, Justice Samuel Alito called the ruling a "frontal assault" on the FDA's regulatory regime for drug labeling and that the warnings in this case sufficiently warned of the possible dangers.

"This case illustrates that tragic facts make bad law," he wrote.

"The unfortunate fact that respondent's healthcare providers ignored Phenergan's labeling may make this an ideal medical malpractice case," he later wrote.

Indianapolis attorney Scott Montross said he finds it refreshing that the court refused to accept the attempts to further extend the preemption limitation, which had come from a ruling last year denying plaintiffs the right to sue medical-device makers because of express language.

Justice Stevens' recognition that Wyeth received notice about 20 similar incidents but didn't attempt to strengthen the warning label shows the dangers of what could have happened in this case had the decision been different.

"(That) demonstrates how dangerous it is to cloak a manufacturer with any immunity, be it for prescription drugs or medical devices," Montross said. "The pre-emption doctrine removes the incentive to the manufacturer to monitor the use of its products and to take reasonable steps to protect innocent patients."

ADVERTISEMENT

Post a comment to this story

COMMENTS POLICY
We reserve the right to remove any post that we feel is obscene, profane, vulgar, racist, sexually explicit, abusive, or hateful.
 
You are legally responsible for what you post and your anonymity is not guaranteed.
 
Posts that insult, defame, threaten, harass or abuse other readers or people mentioned in Indiana Lawyer editorial content are also subject to removal. Please respect the privacy of individuals and refrain from posting personal information.
 
No solicitations, spamming or advertisements are allowed. Readers may post links to other informational websites that are relevant to the topic at hand, but please do not link to objectionable material.
 
We may remove messages that are unrelated to the topic, encourage illegal activity, use all capital letters or are unreadable.
 

Messages that are flagged by readers as objectionable will be reviewed and may or may not be removed. Please do not flag a post simply because you disagree with it.

Sponsored by
2015 Distinguished Barrister &
Up and Coming Lawyer Reception

Tuesday, May 5, 2015 • 4:30 - 7:00 pm
Learn More


ADVERTISEMENT
Subscribe to Indiana Lawyer
  1. OK, now do something about this preverted anacronism

  2. William Hartley prosecutor of Wabash county constantly violates people rights. Withholds statement's, is bias towards certain people. His actions have ruined lives and families. In this county you question him or go out of town for a lawyer,he finds a way to make things worse for you. Unfair,biased and crooked.

  3. why is the State trying to play GOD? Automatic sealing of a record is immoral. People should have the right to decide how to handle a record. the state is playing GOD. I have searched for decades, then you want me to pay someone a huge price to contact my son. THIS is extortion and gestapo control. OPEN THE RECORDS NOW. OPEN THE RECORDS NOW. OPEN THE RECORDS NOW.

  4. I haven't made some of the best choices in the last two years I have been to marion county jail 1 and two on three different occasions each time of release dates I've spent 48 to 72 hours after date of release losing a job being denied my freedom after ordered please help

  5. Out here in Kansas, where I now work as a government attorney, we are nearing the end of a process that could have relevance in this matter: "Senate Bill 45 would allow any adult otherwise able to possess a handgun under state and federal laws to carry that gun concealed as a matter of course without a permit. This move, commonly called constitutional carry, would elevate the state to the same club that Vermont, Arizona, Alaska and Wyoming have joined in the past generation." More reading here: http://www.guns.com/2015/03/18/kansas-house-panel-goes-all-in-on-constitutional-carry-measure/ Time to man up, Hoosiers. (And I do not mean that in a sexist way.)

ADVERTISEMENT