Chicago Personal Injury Lawyer Blog

An Illinois prescription drug case that originally had been dismissed due to issues of federal preemption, has been reinstated by the 7th Circuit Court of Appeals in Chicago. This case, Mason v. SmithKline Beecham Corp. d/b/a Glaxo SmithKline, No. 08-2265,___F.3d___, 2010 WL 605922 (7th Cir. Feb. 23, 2010) may be the first decision that addresses preemption with respect to prescription drugs.

The original Illinois prescription drug lawsuit was brought by the parents of 23 year-old Tricia Mason after she committed suicide just two days after being started on the prescription drug Paxil. The Illinois prescription drug lawsuit alleged that Paxil increases the risk in suicide in children and young adult, which the manufacturer should have known and therefore had a duty to warn its users.

The lawsuit alleged that GSK violated Illinois law by choosing not to warn Tricia Mason on its label that Paxil increases the risk of suicide for children and young adults. Two years after the decedent's suicide, Paxil added a label warning of an increased risk of suicide among children taking the drug.

Continue reading "Wyeth v. Levine Used to Reverse Pre-Emption of Chicago Pharmaceutical Litigation Case Against Glaxo Smith Kline (GSK)" »

Posted by Robert Kreisman | Permalink | Email This Post

Posted In: Federal Preemption , Pharmaceutical Litigation , Product Defects , Product Liability

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The Moot Court Team of the John Marshall Law School of Chicago headed by Mary Nagel, their faculty sponsor, argued their moot court competition at Chicago's Kreisman Law Offices before Civil Justice Attorney Robert Kreisman.

Moot Court is an activity where law students participate in simulated appellate court proceedings. However, moot court is actually more challenging than real appellate proceedings because students have to argue both sides of the critical issues in the case. The John Marshall Law School law students will be arguing both the appellant's position and the appellee's position in the national competition to be held in Cincinnati.

The issues of the fictional case involved pharmaceutical preemption by federal law, similar to those at issue in Riegel v. Medtronic, Inc and Wyeth v. Levine. The federal preemption issue revolves around whether or not warning language as to medical devices or pharmaceuticals approved by the Food & Drug Administration (FDA) are open to medical device liability lawsuits or product liability lawsuits under state law if those medical devices or drugs had been approved by the FDA. The law students also argued issues of punitive damages and constitutional law. The underlying case was on appeal to the supreme court from appellate level after a jury verdict of $900,000 was entered against the defendant pharmaceutical company. The appellate court denied a reversal of the compensatory damages, but remittur was allowed on the punitive portion of the verdict.

Continue reading "Chicago's John Marshall Law School Moot Court Team Practices at Kreisman Law Offices" »

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Posted In: Federal Preemption , Firm News

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In its recent ruling the U.S. Supreme Court ruled that premarket approval from the Food & Drug Administration (FDA) does not preempt pharmaceutical companies from being held liable when their drug fails to meet state standards. In Wyeth v. Levine the court held that drug manufacturers can be sued in state courts even when they follow the rules and standards set out by the FDA.

Wyeth v. Levine involves a female, Vermont musician who lost part of her right arm after Wyeth's drug Phenergan was injected into one of her arteries. The drug's FDA-approved warning label warned against administering the drug this way, but did not prohibit it.

Wyeth argued that they were not required to change their labels to comply with Vermont regulations and that meeting the federal standards was enough. Levine argued that she was able to bring a liability claim under Vermont law even though Wyeth complied with federal standards.

The key issue of the case was whether or not Levine's claim was preempted since Wyeth met the federal standards. The Supreme Court ruled that the case was not preempted and that Levine is able to bring a claim under Vermont law.

Continue reading "Wyeth v. Levine: Supreme Court Overturns Pharmaceutical Litigation Preemption Claim" »

Posted by Robert Kreisman | Permalink | Email This Post

Posted In: Federal Preemption , Medical Malpractice , Pharmaceutical Litigation

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Federal scientists associated with the Federal Food and Drug Administration (FDA), have written to the Obama transition team of widespread managerial misconduct within the medical device review department. The letter alleged that "the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers."

The letter came from the FDA's Center for Devices and Radiological Health, which is responsible from reviewing medical devices ranging from stents and breast implants to MRIs and other imaging machinery. The letter alleges that the agency managers employed intimidation to thwart scientific debate, the result being that some medical devices were approved despite questions as to their effectiveness. Furthermore, the letter states that scientists were forced to "accept clinical and technical data that [was] not scientifically valid.”

The authors of the letter expressed concern with the lowered standards and the effects that an ineffective review process would have on consumers. Approval by the FDA carries a certain level of integrity and instills a certain level of trust in medical professionals and their patients. However, if that process has been corrupted or compromised then that trust is unwarranted.

Continue reading "Obama Transition Team Receives Complaints of "Corruption at the FDA"" »

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Posted In: Federal Preemption

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U.S. District Court Judge Virginia M. Kendell denied a Chicago woman's medical device liability claim that her left knee injuries were caused by her knee replacement device. The complaint was removed to the federal court from Chicago's Cook County Circuit Court and contained claims of negligence, strict liability and breach of warranty based on Illinois law.

Judge Kendall granted summary judgment in favor of the the manufacturers, Zimmer Holdings, Inc., Zimmer U.S., Inc., and Zimmer, Inc., in a lawsuit brought by the plaintiff, Joyce Link.

After reviewing the case facts, Judge Kendell held that Ms. Link's claim against Zimmer for their manufacturing of the Natural Knee II was preempted under the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act. Per Judge Kendall's ruling this act “imposed detailed federal oversight onto the introduction of new medical devices onto the introduction of new medical devices onto the market”. Judge Kendall credited her interpretation of Riegel v. Medtronic, 128 S.Ct. 999 (2008), as partial basis for her opinion.

In addition, Judge Kendall cited 21 U.S.C. § 360(c), which states that as part of the oversight states and their subdivisions are barred from implementing their own requirements concerning medical devices, such as the Natural Knee II. The federal act specifically preempts any state requirement regarding a medical device “which is different from, or in addition to” a requirement imposed by the MDA.

In Judge Kendall's opinion, the state requirement is not preempted unless it also “relates to the safety or effectiveness of the device or to any other matter” covered by the MDA. Kendall held that Ms. Link's claim was just the kind that Congress intended to preempt under the MDA.

Continue reading "Chicago Plaintiff's Medical Device Lawsuit Denied by Illinois U.S. District Court Judge" »

Posted by Robert Kreisman | Permalink | Email This Post

Posted In: Federal Preemption , Medical Device Liability , Product Liability

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Since early 2006, drug and medical device companies have been on an unprecedented roll as pre-emption clauses become more and more prevalent. Despite recent controversies over prescription drugs like Vioxx and Celebrex, drug companies continue to successfully utilize Federal Drug Administration (FDA) policies to shield drug companies from civil lawsuits in the form of pre-emption clauses. This has far-reaching effects on pharmaceutical liability lawsuits in Illinois and the rest of the country.

And not just the FDA are upholding and propagating these preemption clauses- the U.S. Supreme Court has also supported pre-emption laws that prevent claimants from filing civil law suits against deep-pocketed drug and medical device companies in state courts.

The beginning of the preemption era can be traced back to January 2006, when the FDA issued a statement of its new labeling policy under the “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products.” This policy not only set out labeling requirements, but also deemed that if the FDA approved the labeling then this alone "pre-empts conflicting or contrary state law”.

The federal pre-emption clauses have little or no bearing on FDA drug recalls, which can be initiated by the FDA, by FDA statutory authority, or by the drug company itself. The FDA maintains a list of recent drug recalls.

Yet the seemingly simple pre-emption declaration had far-reaching effects within the legal community and reversed decades of policies enforcing state's rights to civil enforcement of liability law. This was done without a public notice or hearing- instead it was quietly tacked on to the labeling policy.

Continue reading "Pharmaceutical Liability for Prescription Drugs Possibly Pre-empted by FDA Regulations and Policies" »

Posted by Robert Kreisman | Permalink | Email This Post

Posted In: Federal Preemption , Medical Device Liability , Pharmaceutical Litigation

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A suit was filed against Phillip Morris claiming its practice of labeling cigarettes as "Light" qualified as consumer fraud. The Appellate Court denied Phillip Morris's argument that it was immune from such lawsuits under federal law so the company is appealing to the U.S. Supreme Court.

The plaintiffs in Altria v, Good, 501 F. 3d 29 (1st Cir. 2007) alleged that Phillip Morris violated state laws prohibiting fraudulent misrepresentation in its false promotions and advertising for Marlboro and Cambridge Lights as "Light" with "Lowered Tar and Nicotine" when in fact the "Light" cigarettes would not deliver any less tar or nicotine to the smoker.

Phillip Morris responded to plaintiff by stating that the consumer fraud claims are preempted by the Federal Cigarette Labeling and Advertising Act, and preempted implicitly in the "efforts of Congress and Federal Trade Commission for 40 years to implement a national, uniform policy of informing the public about the health risks of smoking."

The majority of the defendant's argument rests on its assumption that the plaintiffs are bringing a claim for a failure to warn and not for fraud. Because a failure to warn would fall under the banner of warning label regulations, which is overseen by the federal government, any such claims would need to be brought under federal, and not state, law.

However, the US Court of Appeals for the First Circuit did not see plaintiffs' claim as dealing with a failure to warn, but rather with Phillip Morris fraudulently representing its product. And because the federal law does not deal directly with fraud there is nothing to preempt the state law from taking precedent. Therefore, Phillip Morris is not immune from litigation dealing with plaintiffs' claim because federal law does not negate consumer fraud claims related to the sale of light cigarettes.

To reach a final conclusion, the US Supreme Court has agreed to review Phillip Morris's argument that federal law totally immunizes it from suits regarding consumer fraud claims as to "light" cigarette labeling. The case is set for oral argument in the fall of 2008.

Continue reading "Consumer Fraud Claim Against Phillip Morris In "Light" Cigarette Case: U.S. Supreme Court to Review" »

Posted by Robert Kreisman | Permalink | Email This Post

Posted In: Federal Preemption

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Much has been said about the preemption of state actions for Illinois personal injury cases or Illinois wrongful death lawsuits. A recent federal district court decision ruled that a failure-to-warn lawsuit is not preempted by the federal statutes. The suit was brought by the parents of a teenager who committed suicide while taking the antidepressant Paxil.

The plaintiffs' son was prescribed Paxil by his dermatologist, not for his acne, but to treat a psychiatric disorder in which the individual is overly concerned about real or imagined defects in their physical appearance. Shortly after the second prescription of Paxil was refilled, the plaintiff's son committed suicide.

The parents alleged that the pharmaceutical company was liable for their son's death because it failed to warn the physician about the risk of suicide that the drug posed to children and adolescents. The court rejected the argument raised by pharmaceutical giant, Glaxo-SmithKline (GSK), that preemption applied to this case.

Continue reading "Paxil-Related Teen Suicide State Lawsuits Not Preempted By Federal Statutes According to Federal Court" »

Posted by Robert Kreisman | Permalink | Email This Post

Posted In: Federal Preemption , Pharmaceutical Litigation

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