Chicago Medical Malpractice Lawyer Blog

“The Bush administration, responding to a wave of recent food and product recalls, is set to announce today its most aggressive regulatory proposals yet on policing imports. But much of their success depends on congressional action, and some lawmakers and outside experts already contend they are inadequate. The initiative aims to steer the nation toward a prevention-based regulatory system that targets the riskiest products. It calls for giving more authority to agencies that regulate food and consumer goods, improving data-gathering on imports, and increasing cooperation between agencies and with U.S. trading partners. The Food and Drug Administration, for example, would be granted power to require manufacturers and importers of ‘high risk’ products to take steps to prevent contamination and other problems. The FDA could require producers and importers of such goods to certify they comply with FDA standards. The FDA could bar imports if it is given no access or only limited access to production records. The agency would also be able to mandate recalls on tainted products, something it can't do now.”

Jane Zhang, John D McKinnon, and Christopher Conkey, Wall Street Journal, 11-6-07

“The defibrillator leads pulled off the market this week by Medtronic Inc. may pose a higher risk of fracture in younger adults and children, a population for whom the devices were particularly popular in part because of their small diameter. Children make up a relatively small share of patients who receive the implanted devices. But leads -- wires that attach defibrillators to patients' hearts -- tend to come under greater stress in more-active people, including kids, adolescents and younger adults.”

Anna Wilde Mathews and Thomas M. Burton, Wall Street Journal, 10-19-07

As a Chicago medical malpractice lawyer I have known for a long time that drugs and medical devices are not necessarily safe just because the FDA says so. The fact is that the FDA is full of people that either used to or want to work for the drug and medical device companies. There are time when the regulatory system is so incestuous that safety is compromised. Consider this story from Barry Meier of the New York Times:

“A Congressional committee notified the Food and Drug Administration yesterday that, as a result of a recall by Medtronic of a product linked to patient deaths, it was reviewing how rigorously the agency required heart device components to be tested. In a letter to the agency, Representative Henry A. Waxman, Democrat of California and chairman of the Committee on Oversight and Government Reform, asked agency officials a series of questions about its oversight of leads, the wires that carry electrical information between an implanted defibrillator and the heart. Among other issues, Mr. Waxman asked the agency to provide information about how it determines how much to test leads before marketing and why the agency does not give leads the same scrutiny that it has given in recent years to defibrillators.”

Barry Meier, New York Times, 10-23-07

NORTHRIDGE, Calif., May 18, 2004 – Medtronic, Inc. today announced that its Diabetes division began notifying diabetic patients, healthcare professionals and distributors that it is conducting a nationwide recall of Quick-set® Plus infusion sets because of problems that can interrupt insulin flow to diabetics who use them. These problems have resulted in a number of serious injuries, including some hospitalizations.

The company is asking patients to contact its 24-Hour Help Line at (800) MINIMED (1-800-646-4633) to exchange any unused Quick-set Plus infusion sets for replacement sets available currently from Medtronic. In the event that it is necessary to continue use of the Quick-set Plus while replacement sets are in transit, Medtronic is recommending that patients monitor their blood glucose levels frequently and be prepared to treat any elevated glucose levels that may occur with injections. Patients are also being instructed to contact their healthcare professional in the event of excessively high or low glucose levels or with any questions about their care. Information regarding the exchange of Quick-set Plus infusion sets is available at www.minimed.com/QSP .

This recall applies to all Paradigm Quick-Set Plus models (MMT-359S6, MMT-359S9, MMT-359L6 and MMT-359L9) and lot numbers. This action affects only the Quick-set Plus infusion set; no other Medtronic devices or infusion sets are involved in this recall.

This notification is a follow-up to a voluntary action undertaken by the company in March 2004 in response to an increased number of complaints related to the use of the Quick-set Plus infusion set, which delivers insulin from an infusion pump to a patient’s body. The complaints involved problems with bending of the infusion set’s cannula or unintentional disconnection of the set at the insertion site. At that time, customers were provided with a Quick-set Plus tips guide and offered replacement infusion sets upon request. The company also discontinued selling the Quick-set Plus infusion sets in conjunction with this initial notification.

The U.S. Food and Drug Administration (FDA) has classified this voluntary action as a Class I recall. The FDA defines a Class I recall as a situation in which there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.

On October 14, 2007, Medtronic, the nation's largest heart implant device manufacturer, announced a defect in the critical electrical "lead" component of its heart defibrillator. The New York Times reported on October 15, 2007, that the defect in this electrical wire, called the Sprint Fidelis, has resulted in hundreds of malfunctions and may have played a role in the death of five Medtronic defibrillator patients.

In a news release published by Medtronic, the company says that since the Sprint Fidelis lead was introduced in 2004, approximately 268,000 patients in the United States have been implanted with the lead as part of the Medtronic defibrillator. Affected models of the Sprint Fidelis defibrillation leads are 6930, 6931, 6948 and 6949. All patients who have received the Medtronic defibrillator since 2004 are urged to visit their doctor to check for potential fractures. A fracture in the lead can cause the device to misread heart rhythms, sending unnecessary, painful shocks to patients or worse, failing to provide a vital life-saving shock.

The New York Times reports:

Medtronic estimated that about 2.3 percent of patients with the Fidelis lead, or 4,000 to 5,000 people, would experience a lead fracture within 30 months of implantation. Those patients will require a delicate surgical procedure to replace the lead, experts said.

Medtronic said it would stop selling the lead and recall all leads not yet implanted.

Replacing leads on a heart device like a defibrillator is considered by experts to be far more dangerous than replacing the device itself. As a result, doctors said that patients were better off leaving the lead in place except in those instances where it has stopped functioning properly.

“In the first federal pain patch trial, a Florida jury awarded $5.5 million to the father of a 28-year-old man who died at his computer while wearing a Duragesic patch. It was the second victory in as many tries for the plaintiffs' bar, with a $772,000 win in Texas state court last summer. (See ‘Leaky pain patch yields $772,000 verdict,’ Lawyers USA, Aug. 14, 2006. Search terms for Lawyers USA Archives: White and Duragesic.) Although the jury declined to award punitive damages, the verdict bodes well for future patch cases, said Dallas attorney Jim Orr, who tried the federal case. More than 50 wrongful death suits have already been filed. Duragesic pain patches, manufactured by Alza Corp. and Janssen Pharmaceutica, subsidiaries of Johnson & Johnson, have faced regulatory scrutiny and litigation since February 2004, when a recall was issued because of patch leaks. The recall was expanded later that year to more than 2 million patches, and the FDA is continuing to investigate 120 deaths among patch users.”

Correy E. Stephenson, Lawyers USA 8/03/07

“U.S. Food and Drug Administration approval of a drug label doesn't clear the manufacturer of claims that its warnings were inadequate, a judge ruled in a decision potentially affecting thousands of federal suits against Merck & Co. for the painkiller Vioxx. ‘The FDA's current view on the question of immunity for prescription drug manufacturers is entirely unpersuasive,’ U.S. District Judge Eldon Fallon wrote in the opinion handed down Tuesday. Had Fallon sided with Merck, the drug company also could have challenged claims brought by thousands of other plaintiffs who say it is to blame for heart attacks and other cardiovascular problems. That ‘would have been like wiping the whole board clean and wiping out all possible victories’ against Merck, said David Logan, dean of the Roger Williams University School of Law in Bristol, R.I. But the judge rejected Whitehouse Station, N.J.-based Merck's attempt to throw out lawsuits brought by two people who began taking Vioxx after April 2002, when the FDA approved a label warning that the drug might increase the chance of such problems.”

Janet McConnaughey, Associated Press 7/05/07
http://www.phillyburbs.com/pb-dyn/news/94-07032007-1372754.html

“A judge says Guidant Corp. must face a trial over allegations it hid problems with its heart defibrillators and is responsible for injuries suffered by a California man who had one of the devices removed. U.S. District Judge Donovan Frank in Minneapolis on Tuesday allowed Leopoldo Duron to pursue his lawsuit and seek punitive damages over Guidant's failure to adequately warn doctors and consumers about problems with its defibrillators. The ruling clears the way for a July 27 trial. The lawsuit is the first of more than 1,400 over the implantable defibrillators to be set for trial. Indianapolis-based Guidant, which was acquired by Boston Scientific Corp. last year, has acknowledged that the defibrillators have been linked to at least seven deaths.”

Bloomberg, Indianapolis Star 6/13/07
http://www.indystar.com/apps/pbcs.dll/article?AID=/20070613/
BUSINESS/706130428/1003/BUSINESS

“In the wake of a new study linking the Type II diabetes drug Avandia to a 43 percent increase in the risk of a heart attack, the plaintiffs' bar is building its failure-to-warn case against GlaxoSmithKline, the drug's manufacturer. Although no personal injury suits had been filed at press time, a shareholder class action was filed on behalf of investors, claiming that GlaxoSmithKline issued multiple ‘false and misleading’ statements about the drug. Meanwhile, personal injury lawyers have been fielding a steady stream of calls since the study came out. Both Thomas Kline of Kline & Specter in Philadelphia and Karen Barth Menzies of Baum Hedlund in Los Angeles are currently evaluating cases. The potential for litigation is vast, because more than a million people have taken the drug in the U.S. alone - and 6 million worldwide. Like Vioxx, the major claims by Avandia plaintiffs will be failure-to-warn and aggressive marketing despite risks the drug maker knew or should have known existed.”

Reni Gertner, Lawyers USA 6/19/07
http://www.lawyersusaonline.com/subscriber/archives.cfm?page=usa/07/618071.htm

"The Food and Drug Administration is investigating allegations by a former Medtronic Inc. engineer that the medical-device company didn't adequately test its new Concerto cardiac device for patients with congestive heart failure. The FDA's Minneapolis office is conducting an inquiry into the claims by Christopher Fuller, who worked as an engineer at Medtronic until late 2005. Mr. Fuller's concerns deal with one of the Minneapolis company's newest and most lucrative products. The Concerto device is one that can resynchronize the heartbeat of a patient and also provide backup "defibrillator" capability to save the patient's life if the heart goes into cardiac arrest."

Thomas M. Burton, Wall Street Journal

"A birth control patch has triggered a major legal migraine for Johnson & Johnson, which has been hit with a slew of lawsuits over its patented contraceptive device. As many as 500 suits have been filed over the Ortho Evra patch in the last two years, claiming it has caused clots, strokes and in several cases, death, according to court records and plaintiffs' lawyers."

Tresa Baldas, National Law Journal, 12/18/06
http://www.law.com/jsp/nlj/PubArticleNLJ.jsp?id=1166177119102

Federal health officials yesterday proposed sterner warning labels for acetaminophen, aspirin and ibuprofen, again cautioning millions of Americans who take the nonprescription pain relievers regularly of potentially serious side effects."

Andrew Bridges, Associated Press, Washington Post, 12/19/06
http://www.washingtonpost.com/wp-dyn/content/article/2006/12/19/AR2006121901327.html

As a medical malpractice lawyer I have unfortunately seen my share of cases where health care providers failed to adequately intervene on behalf of a suicidal patient. Now there is evidence that medications may be playing a role in the suicides of young adults on antidepressant medications. Benedict Carey of the New York Times reports:

"In a long-awaited analysis, health officials reported yesterday that antidepressant medications appeared to increase significantly the risk of suicide attempts and related behaviors in adults under 25, while reducing such risks in older people. The analysis, the most comprehensive and rigorous to date, found that suicidal behavior of any kind was rare, and that people taking the medications were no more likely to kill themselves than those taking placebo pills. But adults under 25 taking the drugs were more than twice as likely as those on placebos to report a suicide attempt, or to prepare for one by, say, writing a suicide note. The report, which included more than a dozen medications, was compiled by the Food and Drug Administration and posted on its Web site."

Benedict Carey, New York Times, 12/6/06
http://www.nytimes.com/2006/12/06/health/06drug.html?_r=1&oref=s

When larger numbers of people in a clinical trial died on a drug for high colesteral than people not in the trial Pfizer stopped the trial.

"The news came to Pfizer's chief scientist, Dr. John L. LaMattina, as he was showering at 7 a.m. Saturday: the company's most promising experimental drug, intended to treat heart disease, actually caused an increase in deaths and heart problems. Eighty-two people had died so far in a clinical trial, versus 51 people in the same trial who had not taken it. Within hours, Pfizer, the world's largest drug maker, told more than 100 trial investigators to stop giving patients the drug, called torcetrapib. Shortly after 9 p.m. Saturday, Pfizer announced that it had pulled the plug on the medicine entirely, turning the company's nearly $1 billion investment in it into a total loss. The abrupt decision to discontinue torcetrapib was a shocking disappointment for Pfizer and for people who suffer from heart disease. The drug, which has been in development since the early 1990s, raises so-called good cholesterol, and cardiologists had hoped it would reduce the buildup of plaques in blood vessels that can cause heart attacks. Just last Thursday, Pfizer's chief executive, Jeffrey B. Kindler, said publicly that the drug could be among the most important new developments for heart disease in decades and that the company hoped to get Food and Drug Administration approval for it in 2007."

Alex Berenson, New York Times, 12/4/06
http://www.nytimes.com/2006/12/04/health/04pfizer.html?_r=1&ref=todayspaper&oref=slogin

As a medical malpractice lawyer I have handled a large number of suits involving defective medications and medical devices. A recent jury verdict in Pennsylvania highlights the tragic consequences of poorly labeled drugs.

"When Dunson, 1, developed cold symptoms, his parents gave him Infants' Tylenol over a three-day period. During that time, he began vomiting and grew listless. When his parents took him to the family physician on the third day, he was lethargic, dehydrated, and in acute distress. He died shortly thereafter. An autopsy concluded the cause was liver damage due to acetaminophen toxicity. Dunson is survived by his parents and four minor siblings. Dunson's parents, on behalf of their son's estate, sued the manufacturer of the drug in strict liability, alleging the drug was defective in that its label failed to warn of the risks of liver damage and death from acetaminophen and failed to warn that the product is three times more concentrated than Children's Tylenol."

Dunson v. McNeil-PPC, Inc., Pa., Phila. Co. Com. Pleas, No. 040302907, July 24, 2006.
ATLA Products Liability Reporter, December 2006
http://www.atla.org/Publications/PLlawreporter/2006_12/0612dru_inad.aspx