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

facebook - twitter on Facebook & Twitter

Indiana State Bar Association

Indianapolis Bar Association

Evansville Bar Association

Allen County Bar Association

Indiana Lawyer on Facebook

facebook
ADVERTISEMENT
Subscribe to Indiana Lawyer
  1. My daughter was taken from my home at the end of June/2014. I said I would sign the safety plan but my husband would not. My husband said he would leave the house so my daughter could stay with me but the case worker said no her mind is made up she is taking my daughter. My daughter went to a friends and then the friend filed a restraining order which she was told by dcs if she did not then they would take my daughter away from her. The restraining order was not in effect until we were to go to court. Eventually it was dropped but for 2 months DCS refused to allow me to have any contact and was using the restraining order as the reason but it was not in effect. This was Dcs violating my rights. Please help me I don't have the money for an attorney. Can anyone take this case Pro Bono?

  2. If justice is not found in a court room, it's time to clean house!!! Even judges are accountable to a higher Judge!!!

  3. The small claims system, based on my recent and current usage of it, is not exactly a shining example of justice prevailing. The system appears slow and clunky and people involved seem uninterested in actually serving justice within a reasonable time frame. Any improvement in accountability and performance would gain a vote from me. Speaking of voting, what do the people know about judges and justice from the bench perspective. I think they have a tendency to "vote" for judges based on party affiliation or name coolness factor (like Stoner, for example!). I don't know what to do in my current situation other than grin and bear it, but my case is an example of things working neither smoothly, effectively nor expeditiously. After this experience I'd pay more to have the higher courts hear the case -- if I had the money. Oh the conundrum.

  4. My dear Smith, I was beginning to fear, from your absense, that some Obrien of the Nanny State had you in Room 101. So glad to see you back and speaking truth to power, old chum.

  5. here is one from Reason magazine. these are not my words, but they are legitimate concerns. http://reason.com/blog/2010/03/03/fearmongering-at-the-splc quote: "The Southern Poverty Law Center, which would paint a box of Wheaties as an extremist threat if it thought that would help it raise funds, has issued a new "intelligence report" announcing that "an astonishing 363 new Patriot groups appeared in 2009, with the totals going from 149 groups (including 42 militias) to 512 (127 of them militias) -- a 244% jump." To illustrate how dangerous these groups are, the Center cites some recent arrests of right-wing figures for planning or carrying out violent attacks. But it doesn't demonstrate that any of the arrestees were a part of the Patriot milieu, and indeed it includes some cases involving racist skinheads, who are another movement entirely. As far as the SPLC is concerned, though, skinheads and Birchers and Glenn Beck fans are all tied together in one big ball of scary. The group delights in finding tenuous ties between the tendencies it tracks, then describing its discoveries in as ominous a tone as possible." --- I wonder if all the republicans that belong to the ISBA would like to know who and why this outfit was called upon to receive such accolades. I remember when they were off calling Trent Lott a bigot too. Preposterous that this man was brought to an overwhelmingly republican state to speak. This is a nakedly partisan institution and it was a seriously bad choice.

ADVERTISEMENT