many drugs are not safe and effectiveIn march 2009, it was discovered that the FDA has changed its position on state tort law, which may mean that pharmaceutical companies can now be sued without being able to hide behind federal law.
While the blame game continues, and nobody except dr. sober companion points finger at pharmaceutical companies, it has been discovered that the pharmaceutical companies can no longer hide behind FDA warning labels, which made them teflon coated until Wyeth v. Levine appeared in the supreme court of the united states.
Michael Jackson, Heath ledger, Anna Nicole Smith and millions of non famous people may now point a dead finger at pharmaceutical companies because we are not talking about street drugs like heroine and cocaine, but instead their pharmaceutical counterparts, which are as easily available as ordering a pizza and commonly available at your nearest pharmacy.
While Levine also went after the doctors for malpractice, it did not stop with them.
3Respondent sued her physician, physician’s assistant, and hospital for malpractice. After the parties settled that suit for an undisclosed sum, respondent’s physician sent her a letter in which he admitted “responsibility” for her injury and expressed his “profoun[d] regre[t]” and “remors[e]” for his actions. 1 Tr. 178–179 (Mar. 8, 2004) (testimonyof Dr. John Matthew); see also App. 102–103 (testimony of physician’sassistant Jessica Fisch) (noting that her “sense of grief” was so “great” that she “would have gladly cut off [her own] arm” and given it torespondent). Thereafter, both the physician and the physician’s assistant agreed to testify on respondent’s behalf in her suit against Wyeth.
The significance of the supreme court ruling is that the blame game can now include pharmaceutical companies and not just the doctors who administered the drugs. I think the only reason people never thought of this before was that pharmaceutical companies were largely untouchables.
Wyeth (a pharmaceutical company), filed a motion for summary judgment, arguing that Levine’s failure-to-warn claims were pre-empted by federal law.
Just because a drug is FDA approved, and has a federal law approved warning label, this does not mean the drug won't kill you.
If a drug kills enough people, it is taken off the market, however if it is because of overdose, it is blamed on the person taking it. If a drug causes distinct negative side effects, those are added to the micro sized small print. Is this adequate to save lives? Dr. sober companion says this is not adequate to save lives.
The following is exerted from Wyeth v. Levine
Petitioner Wyeth manufactures the antinausea drug Phenergan. After a clinician injected respondent Levine with Phenergan by the “IV-push” method, whereby a drug is injected directly into a patient’s vein, the drug entered Levine’s artery, she developed gangrene, and doctors amputated her forearm. Levine brought a state-law damages action, alleging, inter alia, that Wyeth had failed to provide an ade-quate warning about the significant risks of administering Phener-gan by the IV-push method. The Vermont jury determined that Le-vine’s injury would not have occurred if Phenergan’s label includedan adequate warning, and it awarded damages for her pain and suf-fering, substantial medical expenses, and loss of her livelihood as aprofessional musician. Declining to overturn the verdict, the trial court rejected Wyeth’s argument that Levine’s failure-to-warn claimswere pre-empted by federal law because Phenergan’s labeling hadbeen approved by the federal Food and Drug Administration (FDA). The Vermont Supreme Court affirmed.
Wyeth’s argument that requiring it to comply with a state-law duty to provide a stronger warning would interfere with Congress’ purpose of entrusting an expert agency with drug labeling decisions is meritless because it relies on an untenable interpretation of con-gressional intent and an overbroad view of an agency’s power to pre-empt state law. The history of the FDCA shows that Congress didnot intend to pre-empt state-law failure-to-warn actions. In advanc-ing the argument that the FDA must be presumed to have estab-lished a specific labeling standard that leaves no room for different state-law judgments, Wyeth relies not on any statement by Congress but on the preamble to a 2006 FDA regulation declaring that state-law failure-to-warn claims threaten the FDA’s statutorily prescribed role.
The warnings on Phenergan’s label had been deemed sufficient by the federal Food and Drug Administration (FDA) when it approved Wyeth’s new drug application in 1955 and when it later approved changes inthe drug’s labeling. The question we must decide is whether the FDA’s approvals provide Wyeth with a com-plete defense to Levine’s tort claims. We conclude that they do not.
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I don't know if you understand the significance of this supreme court ruling, so let me try to explain in more detail.
Wyeth lawyers made it clear the blame game has changed when it argued that recognition of Levine’s state tort action creates an unacceptable “obstacle to the accomplishment and execution of the full purposes and objectives of Congress,” Hines v. Davidowitz, 312 U. S. 52, 67 (1941), because it substitutes a lay jury’s decision about drug labeling for the expert judgment of the FDA.
Do you now begin to see the layers of government protection that was afforded the pharmaceutical companies? Do you begin to see lobbying efforts, and the billions of dollars that went into paying off congress for their votes. The government protection afforded them is now unravelling before our eyes.
Indeed, prior to 2007, the FDA lacked the authority toorder manufacturers to revise their labels. See 121 Stat. 924–926. When Congress granted the FDA this authority,it reaffirmed the manufacturer’s obligations and referred specifically to the CBE regulation, which both reflects the manufacturer’s ultimate responsibility for its label and provides a mechanism for adding safety information to the label prior to FDA approval. See id., at 925–926 (stating that a manufacturer retains the responsibility “to main-tain its label in accordance with existing requirements, including subpart B of part 201 and sections 314.70 and
601.12 of title 21, Code of Federal Regulations
We also learn from this case that the pharmaceutical companies try to blame the doctor as noted here: Nevertheless, the jury rejected Wyeth’s argument that the clinician’s conduct was an intervening cause that absolved it of liability. See App.234 (jury verdict), 252–254. In finding Wyeth negligent as well as strictly liable,
federal law and FDA labeling
In order to identify the “purpose of Congress,” it is ap-propriate to briefly review the history of federal regulation of drugs and drug labeling. In 1906, Congress enacted itsfirst significant public health law, the Federal Food andDrugs Act, ch. 3915, 34 Stat. 768. The Act, which prohib-ited the manufacture or interstate shipment of adulter-ated or misbranded drugs, supplemented the protection for consumers already provided by state regulation and common-law liability. In the 1930’s, Congress becameincreasingly concerned about unsafe drugs and fraudulent marketing, and it enacted the Federal Food, Drug, and Cosmetic Act (FDCA), ch. 675, 52 Stat. 1040, as amended,21 U. S. C. §301 et seq. The Act’s most substantial innova-tion was its provision for premarket approval of new drugs. It required every manufacturer to submit a newdrug application, including reports of investigations and specimens of proposed labeling, to the FDA for review.Until its application became effective, a manufacturer was prohibited from distributing a drug. The FDA could reject an application if it determined that the drug was not safe for use as labeled, though if the agency failed to act, anapplication became effective 60 days after the filing. FDCA, §505(c), 52 Stat. 1052.
In 1962, Congress amended the FDCA and shifted the burden of proof from the FDA to the manufacturer. Before 1962, the agency had to prove harm to keep a drug out of the market, but the amendments required the manufac-turer to demonstrate that its drug was “safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling” before it could distribute the drug. §§102(d), 104(b), 76 Stat. 781, 784. In addition, the amendments required the manufacturer to prove thedrug’s effectiveness by introducing “substantial evidencethat the drug will have the effect it purports or is repre-sented to have under the conditions of use prescribed,recommended, or suggested in the proposed labeling.” §102(d), id., at 781.
As it enlarged the FDA’s powers to “protect the public health” and “assure the safety, effectiveness, and reliabil-ity of drugs,” id., at 780, Congress took care to preserve state law. The 1962 amendments added a saving clause,indicating that a provision of state law would only be invalidated upon a “direct and positive conflict” with theFDCA. §202, id., at 793. Consistent with that provision,state common-law suits “continued unabated despite . . . FDA regulation.” Riegel v. Medtronic, Inc., 552 U. S. ___, ___ (2008) (slip op., at 8) (GINSBURG, J., dissenting); see ibid., n. 11 (collecting state cases). And when Congressenacted an express pre-emption provision for medicaldevices in 1976, see §521, 90 Stat. 574 (codified at 21
U. S. C. §360k(a)), it declined to enact such a provision for prescription drugs.
In 2007, after Levine’s injury and lawsuit, Congressagain amended the FDCA. 121 Stat. 823. For the first time, it granted the FDA statutory authority to require amanufacturer to change its drug label based on safety information that becomes available after a drug’s initial approval. §901(a), id., at 924–926. In doing so, however,Congress did not enact a provision in the Senate bill thatwould have required the FDA to preapprove all changes todrug labels. See S. 1082, 110th Cong., 1st Sess., §208, pp. 107–114 (2007) (as passed) (proposing new §506D).Instead, it adopted a rule of construction to make it clearthat manufacturers remain responsible for updating their labels. See 121 Stat. 925–926.
See De la Cuesta, 458 U. S., at
153. The FDA’s premarket approval of a new drug appli-cation includes the approval of the exact text in the pro-posed label. See 21 U. S. C. §355; 21 CFR §314.105(b) (2008). Generally speaking, a manufacturer may only change a drug label after the FDA approves a supplemen-tal application. There is, however, an FDA regulation that permits a manufacturer to make certain changes to its label before receiving the agency’s approval. Among otherthings, this “changes being effected” (CBE) regulation provides that if a manufacturer is changing a label to “add or strengthen a contraindication, warning, precaution, or adverse reaction” or to “add or strengthen an instructionabout dosage and administration that is intended to in-crease the safe use of the drug product,” it may make thelabeling change upon filing its supplemental application with the FDA; it need not wait for FDA approval. §§314.70(c)(6)(iii)(A), (C).
As the FDA ex-plained in its notice of the final rule, “‘newly acquired information’” is not limited to new data, but also encom-passes “new analyses of previously submitted data.” Id., at 49604. The rule accounts for the fact that risk informa-tion accumulates over time and that the same data maytake on a different meaning in light of subsequent devel-opments: “[I]f the sponsor submits adverse event informa-tion to FDA, and then later conducts a new analysis of data showing risks of a different type or of greater severityor frequency than did reports previously submitted toFDA, the sponsor meets the requirement for ‘newly ac-quired information.’” Id., at 49607; see also id., at 49606.
Wyeth suggests that the FDA, rather than the manufacturer, bears primary re-sponsibility for drug labeling. Yet through many amend-ments to the FDCA and to FDA regulations, it has re-mained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of itslabel at all times. It is charged both with crafting anadequate label and with ensuring that its warnings re-main adequate as long as the drug is on the market.
why can't FDA adopt the same warning labels as required by tobacco industry?
In 1962, Congress amended the FDCA and shifted the burden of proof from the FDA to the manufacturer. Before 1962, the agency had to prove harm to keep a drug out of the market, but the amendments required the manufac-turer to demonstrate that its drug was “safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling” before it could distribute the drug. §§102(d), 104(b), 76 Stat. 781, 784. In addition, the amendments required the manufacturer to prove thedrug’s effectiveness by introducing “substantial evidencethat the drug will have the effect it purports or is repre-sented to have under the conditions of use prescribed,recommended, or suggested in the proposed labeling.” §102(d), id., at 781.
As it enlarged the FDA’s powers to “protect the public health” and “assure the safety, effectiveness, and reliabil-ity of drugs,” id., at 780, Congress took care to preserve state law. The 1962 amendments added a saving clause,indicating that a provision of state law would only be invalidated upon a “direct and positive conflict” with theFDCA. §202, id., at 793. Consistent with that provision,state common-law suits “continued unabated despite . . . FDA regulation.” Riegel v. Medtronic, Inc., 552 U. S. ___, ___ (2008) (slip op., at 8) (GINSBURG, J., dissenting); see ibid., n. 11 (collecting state cases). And when Congressenacted an express pre-emption provision for medicaldevices in 1976, see §521, 90 Stat. 574 (codified at 21
U. S. C. §360k(a)), it declined to enact such a provision for prescription drugs.
In 2007, after Levine’s injury and lawsuit, Congressagain amended the FDCA. 121 Stat. 823. For the first time, it granted the FDA statutory authority to require amanufacturer to change its drug label based on safety information that becomes available after a drug’s initial approval. §901(a), id., at 924–926. In doing so, however,Congress did not enact a provision in the Senate bill thatwould have required the FDA to preapprove all changes todrug labels. See S. 1082, 110th Cong., 1st Sess., §208, pp. 107–114 (2007) (as passed) (proposing new §506D).Instead, it adopted a rule of construction to make it clearthat manufacturers remain responsible for updating their labels. See 121 Stat. 925–926.
See De la Cuesta, 458 U. S., at
153. The FDA’s premarket approval of a new drug appli-cation includes the approval of the exact text in the pro-posed label. See 21 U. S. C. §355; 21 CFR §314.105(b) (2008). Generally speaking, a manufacturer may only change a drug label after the FDA approves a supplemen-tal application. There is, however, an FDA regulation that permits a manufacturer to make certain changes to its label before receiving the agency’s approval. Among otherthings, this “changes being effected” (CBE) regulation provides that if a manufacturer is changing a label to “add or strengthen a contraindication, warning, precaution, or adverse reaction” or to “add or strengthen an instructionabout dosage and administration that is intended to in-crease the safe use of the drug product,” it may make thelabeling change upon filing its supplemental application with the FDA; it need not wait for FDA approval. §§314.70(c)(6)(iii)(A), (C).
As the FDA ex-plained in its notice of the final rule, “‘newly acquired information’” is not limited to new data, but also encom-passes “new analyses of previously submitted data.” Id., at 49604. The rule accounts for the fact that risk informa-tion accumulates over time and that the same data maytake on a different meaning in light of subsequent devel-opments: “[I]f the sponsor submits adverse event informa-tion to FDA, and then later conducts a new analysis of data showing risks of a different type or of greater severityor frequency than did reports previously submitted toFDA, the sponsor meets the requirement for ‘newly ac-quired information.’” Id., at 49607; see also id., at 49606.
Wyeth suggests that the FDA, rather than the manufacturer, bears primary re-sponsibility for drug labeling. Yet through many amend-ments to the FDCA and to FDA regulations, it has re-mained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of itslabel at all times. It is charged both with crafting anadequate label and with ensuring that its warnings re-main adequate as long as the drug is on the market.
why can't FDA adopt the same warning labels as required by tobacco industry?
But the trial court and the Vermont SupremeCourt found that the 1988 warning did not differ in any materialrespect from the FDA-approved warning. See ___ Vt. ___, ___, 944
A. 2d 179, 189 (2006) (“Simply stated, the proposed warning was different, but not stronger. It was also no longer or more prominent than the original warning . . .”); App. 248–250. Indeed, the United States concedes that the FDA did not regard the proposed warning as substantively different: “[I]t appears the FDA viewed the change as non-substantive and rejected it for formatting reasons.” Brief for United States as Amicus Curiae 25; see also ___ Vt., at ___, 944 A. 2d, at 189.
A. 2d 179, 189 (2006) (“Simply stated, the proposed warning was different, but not stronger. It was also no longer or more prominent than the original warning . . .”); App. 248–250. Indeed, the United States concedes that the FDA did not regard the proposed warning as substantively different: “[I]t appears the FDA viewed the change as non-substantive and rejected it for formatting reasons.” Brief for United States as Amicus Curiae 25; see also ___ Vt., at ___, 944 A. 2d, at 189.
what does this mean as far as the blame game?
7Although the first version of the bill that became the FDCA would have provided a federal cause of action for damages for injured consum-ers, see H. R. 6110, 73d Cong., 1st Sess., §25 (1933) (as introduced), witnesses testified that such a right of action was unnecessary because common-law claims were already available under state law. See Hearings on S. 1944 before a Subcommittee of the Senate Committee on Commerce, 73d Cong., 2d Sess., 400 (1933) (statement of W. A. Hines); see id., at 403 (statement of J. A. Ladds) (“This act should not attempt to modify or restate the common law with respect to personalinjuries”). 8In 1997, Congress pre-empted certain state requirements concerningover-the-counter medications and cosmetics but expressly preservedproduct liability actions. See 21 U. S. C. §§379r(e), 379s(d) (“Nothing inthis section shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of anyState”).
additional notes:
during his closing argument, respondent’s attorney told the jury, “Thank God we don’t rely on the FDA to . . . make the safe[ty] decision.You will make the decision. . . . The FDA doesn’t make the decision, you do,” id., at 211–212.2
Alito commented: Federal law, however, does rely on the FDA to make safety determinations like the one it made here.
But turning a common-law tort suitinto a “frontal assault” on the FDA’s regulatory regime for drug labeling upsets the well-settled meaning of the Supremacy Clause and our conflict pre-emption jurisprudence. Brief for United States as Amicus Curiae 21.
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more notes:
They try to solve that problem with helpful politicians doing by executive fiat at an agency what they could not do in Congress; for example, by placing a corporate immunity clause in the preamble of an FDA rule that says if a drug is FDA approved, you can't sue. Thus, drug companies ask the courts to imply that preemption exists even though it was not expressly legislated.
Next up is from the Center for Justice and Democracy, a consumer rights group dedicated to preserving the civil justice system. They issued a report today: THE BITTEREST PILL -- How Drug Companies Fail To Protect Women and How Lawsuits Save Their Lives. The report, according to the authors, "tells the story of the hyped marketing to women of a disproportionate number of unsafe drugs and devices resulting in countless deaths and injuries." As you may guess, they aren't too keen on immunity being granted to a company that was negligent, and whose negligence injured people. It's part of that whole personal responsibility thing that conservatives usually talk about, except when it comes to big business.
In piecing together the emails from the FOIAs, AAJ uncovered the cozy relationship between federal officials and the industries they regulate. For example, the pharmaceutical industry intensified its efforts to influence the FDA in the months leading up to the physician labeling rule's release on January 24, 2006. Much of the lobbying efforts were aimed at Sheldon Bradshaw, who had succeeded Daniel Troy as FDA chief counsel in April 2005.
AAJ obtained emails that list attendees of a meeting between Bradshaw and the Pharmaceutical Research and Manufacturers of America (PhRMA) revealing the FDA chief counsel met with legal representatives from Pfizer, Wyeth, Eli Lilly, Berlex, Organon, Abbott Laboratories, Takeda, Sanofi-Aventis, Serono, AstraZeneca, Cephalon, Millenium, Eisai, Amgen, Astellas, GlaxoSmithKline, Bristol Myers Squibb, Johnson & Johnson, Novartis, Merck, and 3M.
Less than six months after this meeting, the agency would release its final physician labeling rule with complete immunity preemption language in the preamble, a complete about-face from the language in the proposed rule that specifically said the agency did not intend to preempt state law with the rule.
"Big business lobbyists have been on a crusade to destroy state consumer protection laws, and further stack the deck against American consumers," said Weisbrod.
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