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Defective Medical Products Lawyers: We have a national practice and have been interviewed by CNN, CBS News, Fox News, Associated Press and others. Contact a lawyer at our firm for a free consultation: 1-888-377-8900.

Defective Medical Products

Medtronic Sprint Fidelis Case Highlights Need for Legislation to Nullify Riegel v. Medtronic

Last month, Mark Turnidge, a 33-year-old husband and father, died after doctors removed a fractured Medtronic Sprint Fidelis lead from his body. Medtronic had recalled Sprint Fidelis leads due to the fracturing problem in 2007 after over 200,000 patients had Sprint Fidelis leads implanted in their bodies.

Wendy Turnidge, Mark Turnidge’s wife, told The New York Times that Medtronic offered her $800. She turned it down. According to the Times story, her attorney, Fred Pritzker, said he is considering suing the hospital and Medtronic. Pritzker and his law firm PritzkerOlsen have filed a number of claims for other Sprint Fidelis patients in Minnesota state court. Pritzker told the Times that recent U.S. Supreme Court ruling in Riegel v. Medtronic made it likely that a state judge would reject such cases.

In Riegel v. Medtronic, the Court held that the pre-emption clause in The Medical Device Amendments of 1976 “bars common-law claims challenging the safety or effectiveness of a medical device marketed in a form that received premarket approval from the FDA.”

Fairness, decency and justice would require Medtronic to compensate Mr. Turnidge’s family for his death. But U.S. District Courts are citing Riegel v. Medtronic and the MDA’s pre-emption clause to bar families like Mr. Turnidge’s from suing Medtronic.

Our law firm believes in justice and opposes this sweeping use of the MDA and Riegel v. Medtronic to deny people their day in court. Thankfully, some federal legislators are looking at this problem and taking steps to give patients back the right to sue when they are injured by a defective medical device. According to The New York Times:

But now, some members of Congress want to give potential plaintiffs like Ms. Turnidge a chance for legal recourse. Two House Democrats, Henry A. Waxman of California, the chairman of the House Energy and Commerce Committee, and Frank Pallone Jr. of New Jersey, the head of its health subcommittee, plan to reintroduce soon legislation that would effectively nullify the Supreme Court decision.

A similar Senate bill, sponsored last year by Edward M. Kennedy, Democrat of Massachusetts, and Patrick J. Leahy, Democrat of Vermont, is expected to be reintroduced in coming months.

The lawmakers, as well as patient advocates and others, say the Supreme Court’s medical device decision has left patients legally powerless against what they criticize as spotty oversight of products by the F.D.A.

Most people assume any product approved by the FDA is safe. Wendy Turnidge and many others know this is not true. We ask that you support any efforts to nullify Riegel v. Medtronic. Wendy Turnidge is going to be raising her sons alone. She deserves justice.

Posted February 2009.

Labels: Medtronic defibrillator lead recall, Medtronic lawsuit

Cephalon Lawsuit Involving Actiq and Off-Label Uses

Wrongful death cases allegedly involve Cephalon Inc., one of the nations largest pharmaceutical companies, and one of its products, Actiq.

In September of 2008, Cephalon Inc. plead guilty to a criminal misdemeanor and agreed to pay a $425 million settlement in a federal case filed in Philadelphia. The case centered around Cephalon’s alleged marketing of Actiq for “off-label” uses, which increased the sales of the drug dramatically. Actiq is approved by the FDA for use for pain management on cancer patients, who experience excruciating pain. The Actiq label reads as follows:

ACTIQ is indicated only for the management of breakthrough cancer pain in patients with malignancies who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least 60 mg morphine/day, at least 25 mcg transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

ACTIQ is intended to be used only in the care of cancer patients and only by oncologists and pain specialists who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.

Because life-threatening hypoventilation could occur at any dose in patients not taking chronic opiates, ACTIQ is contraindicated in the management of acute or postoperative pain. This product must not be used in opioid non-tolerant patients.¹

The active ingredient of Actiq is fentanyl. According to attorney Fred Pritzker, “Fentanyl is a strong and dangerous drug that requires the utmost caution by both doctors and patients. We see many cases in which people die as a result of not being properly screened, trained, and instructed regarding use and danger of this drug and the various systems used to deliver it to the human body.”

Actiq is considered a fentanyl “lollipop.”

Federal prosecutors alleged that Cephalon was marketing the use of Actiq for migraine headaches and other “off-label” purposes. Fentanyl is a drug that is 100 times more potent than morphine. People allegedly died using Actiq for these “off-label” purposes.

Wrongful death lawsuits against Dr. Stephen Schneider allegedly involve Actiq and fentanyl overdose:

In December 2008, the family of Robin Geist-Wick - a 45-year-old patient who died of fentanyl intoxication on May 15, 2007 - added Cephalon as a defendant in its wrongful-death lawsuit against Schneider and another doctor from his clinic, Lawrence Simons, who also had treated Geist-Wick.²

According to the complaint, Dr. Schneider had prescribed Actiq for Ms. Geist-Wick’s migraine headaches.

To contact our law firm about an Actiq wrongful death and a Cephalon lawsuit, please call 1-888-377-8900 (toll-free) or submit our free case consultation form.

Important related FDA information: In January, the FDA finalized new guidelines that allow pharmaceutical companies to market off-label uses for drugs. We are concerned that these new guidelines will endanger the lives of countless patients. If you would like federal legislation to prevent this type of marketing, please contact your federal legislators. It is vitally important for all of us to care about the safety of our health care system. Given the FDA's track record, we cannot rely on the FDA to protect the public.

References:
1. http://www.actiq.com/ 2. Roxana Hegeman, Drugmaker Cephalon linked to indicted Kan. Doctor, Forbes, February 3, 2009.

Pritzker Olsen attorneys have appeared on national television and have been quoted by national publications, including The New York Times, The Wall Street Journal, Associated Press and Lawyers USA. Attorneys Fred Pritzker, Elliot Olsen and Eric Hageman have been named "Super Lawyers" by Law and Politics magazine (2008 and previous years). Attorney Fred Pritzker is also listed in the current edition (2008) of The Best Lawyers in America. To contact Pritzker Olsen Attorneys, please call 1-888-377-8900 (toll free) or submit the firm's free consultation form.

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Firm News

AV Preeminent Rating by Martindale-Hubbell

Attorneys Fred Pritzker and Eric Hageman have been given the highest rating by Martindale-Hubbell for attorney, AV Preeminent. An AV® certification mark is a significant rating accomplishment - a testament to the fact that a lawyer's peers rank him or her at the highest level of professional excellence.

Adjunct Teaching Position At U of M Law School

Attorney Brendan Flaherty has accepted an adjunct teaching position at the University of Minnesota Law School. For the 2011 spring semester, Flaherty will teach a course entitled "Practice and Professionalism," which will introduce students to foundational lawyering skills and professional responsibility issues.

Attorney Elliot Olsen Speaks at Conference

Attorney Elliot Olsen recently spoke at the Seventh Annual LifeScience Alley Conference in Minneapolis on Preemption and the Future of Medical Device Litigation. He appeared with Randall Pattee of Lindquist and Vennum and Jean Lance, VP of corporate legal and general counsel for Boston Scientific.

Named Super Lawyer

In recognition of their achievements, Attorneys Fred Pritzker, Elliot Olsen and Eric Hageman were named "Super Lawyers" by Law & Politics magazine. According to Super Lawyers, "The objective is to create a credible, comprehensive and diverse listing of outstanding attorneys that can be used as a resource to assist attorneys and consumers in the search for legal counsel."

Brendan Flaherty Named a Rising Star

In recognition of his achievements, Attorney Brendan Flaherty was named a 2010 Rising Star by Minnesota Law & Politics. Only 2.5 percent of the state’s lawyers are included on the list, which highlights Minnesota’s best up-and-coming legal talent.

Fred Pritzker Listed in The Best Lawyers in America

Fred Pritzker has been notified that he will again be listed in The Best Lawyers in America for his work in personal injury litigation.

This is attorney advertising. Past results do not guarantee a similar outcome. The result of each case is determined by the specific facts and the applicable law.