Chicago Medical Malpractice Lawyer Blog

As a medical malpractice attorney in Chicago with experience in medial drug products liability, the recent ruling of the Australian court with regards to the drug Vioxx intrigues me.

An Australian court ruled Friday, “the once-popular painkiller Vioxx doubled the risk of heart attack and was unfit for consumption” (K. Gelineau, 3/5, AP). This ruling opens up claims for many other litigants in lawsuits against the U.S. company Merck & Co. Although the drug was removed from the global market in 2004 after research indicated the risk of stroke and heart attack, millions consumed the drug before it was taken off the market.

The Australian judge found “that Merck Sharpe & Dohme failed in its duty of care by not warning Peterson's doctor about the drug's potential cardiovascular risk, and by its sales representatives emphasizing the drug's safety.”

The Food and Drug Administration says, “an organ transplant drug from Bristol-Myers Squibb improves kidney function, but the agency has concerns about potentially fatal side effects.” (AP Washington, 2/25). Although Bristol has asked the FDA to approve its drug Belatacept for patients undergoing a kidney transplant, the FDA is concerned that the drug suppresses the body's immune system to avoid organ rejection.

In online documentation, the FDA noted that although more patients taking Belatacept had a higher two year survival rate than those taking other drugs, it also noticed higher rates of severe kidney rejection and neurological disease.

As the next step, the FDA wants its outside advisers to vote on the drug's safety and effectiveness, which is set to occur next week. As a medical malpractice lawyer in Chicago, I have seen many incidents of fatal side effects, and am hopeful the FDA will act quickly and decisively in determining the safety of Belatacept.

As a medial malpractice and products liability attorney, I am pleased with the FDA’s latest action targeting major drug companies. These companies may billions off patients, and all too often, fail to adequately disclose serious risks.

In a recent agreement with government regulators, “Amgen and Johnson & Johnson will do more to publicize the safety risks of their anemia drugs for cancer patients” (AP for FindLaw, 2/16). The plan developed in concert the Food and Drug Administration targets risk management and is the latest government action aimed at the drug makers. The plan applies to Amgen's Aranesp and Epogen and Johnson & Johnson's Procrit.

As part of the deal, “Amgen and J&J will be required to register each cancer doctor who prescribes their drugs and document that they have discussed the drugs' risks before prescribing them to patients. The three medicines within the plan are huge moneymakers for the respective companies because of their success and reputation regarding reducing the need for blood transfusions, however, recent studies have indicated the drugs can also cause tumor growth.

Matthew Perrone reports, “A consumer advocacy group is asking government regulators to recall a drug they approved last year for a little-understood pain ailment, saying the pill can lead to dangerously high blood pressure” (AP for FindLaw, 1/20). The drug in question is Savella, which has been on the market for nearly a year after it was cleared by the FDA.

As a products liability lawyer with experience regarding medical drugs gone wrong, I join the consumer advocacy group in urging a recall of potentially dangerous drugs. If nothing else, more testing or the drug is certainly necessary. Interestingly, European regulators rejected Savella last summer due to “lack of effectiveness and side effects.” Many are wondering if the FDA should have reached the same conclusion.

Fibromyalgia is a disease that is “characterized by a wide range of pain-related symptoms, including muscle soreness, headache, fatigue and depression.” Recent studies of the drug have shown approximately 20 percent of patients on Savella experienced hypertension or high blood pressure, compared to 7 percent of those patients taking the placebo. Moreover, only 9 percent of study patients taking Savella experienced reduced pain, compared to 7 percent of patients taking the placebo. Clearly, there are some unanswered questions regarding this drug, which should at least prompt the FDA to reevaluate.

At Hurley, McKenna & Mertz we seek to represent victims who have been devastated by medical negligence. Unfortunately, those who are victims of medical negligence often do not know where to turn. It is always a good idea to seek a consultation from a lawyer about your medical malpractice case. At Hurley, McKenna & Mertz, we are always willing and ready to review your case. The following story exemplifies the sadness and devastation that accompanies medical malpractice.

Walt Bogdanich reports for the New York Times, “As Scott Jerome-Parks lay dying, he clung to this wish: that his fatal radiation overdose — which left him deaf, struggling to see, unable to swallow, burned, with his teeth falling out, with ulcers in his mouth and throat, nauseated, in severe pain and finally unable to breathe — be studied and talked about publicly so that others might not have to live his nightmare” (1/24). At merely 43 years of age, he died only several weeks after he summoned his family for a final Christmas.

His story is one that is, unfortunately, not unfamiliar; “A New York City hospital treating him for tongue cancer failed to detect a computer error that directed a linear accelerator to blast his brain stem and neck with errant beams of radiation. Not once, but on three consecutive days.” Mr. Jerome Parks and others experienced the “wonders and brutality: of radiation technology, giving them an advanced diagnosis and prognosis for treatment, but also a mistake that lead to unspeakable pain. Shortly after the incident, state health officials warned hospitals to use extreme caution with linear accelerators.

While Mr. Jerome-Parks hoped that his misfortune would allow medical providers and safety regulators to avoid similar accidents in the future. However, the intricacies of his case, and of other similar incidents, have been “shielded from the public view by the government, doctors, and the hospital.”

Although radiation technology has, without a doubt, saved countless lives, such powerful treatment must be executed with precision. The New York Times found that radiation does allow “doctors to more accurately attack tumors and reduce certain mistakes, its complexity has created new avenues for error.” Although Mr. Jermoe-Parks’s tale is devastating, it is a tale that must be told, and a tale that cannot be covered by for there are lessons that must be learned.

Recent news of a new medical device has doctors and researchers excited of a possible ground breaking discovery. Doctors say that a “new type of heart pump greatly improves survival of people with severe heart failure,” and could become the first one of these devices to be widely used as a permanent treatment (AP for FindLaw, 11/17). The HeartMate II device is implanted into a patient’s heart to help the heart pump adequately.

Although more research is certainly necessary, in one study, the new device increased the number of patients who survived at least two years four-fold compared to an older pump. The older pump is used now just to keep patients ticking while they await a transplant. However, as with many new medical technologies, there is a substantial cost issue as the device itself runs up an $80,000 bill with an additional $45,000 necessary for the implanting surgery and hospital stay.

Although the new device has potential to enhance many lives, as a Chicago lawyer with medical malpractice and products liability experience, I hope adequate safety testing is completed before the device is used consistently. One very promising study certainly is exciting, but other confirming studies are necessary before a new device is used widely.

Marilynn Marchione reports on surprising new research that suggest, “Giving babies Tylenol to prevent fever when they get childhood vaccinations may backfire and make the shots a little less effective” (AP for FinLaw, 10/16). The new research, which only studied the use of Tylenol to prevent fever, not its effect in reducing a fever, is the first substantial study about the potential link between the use of fever-reducing medicines and reduced immunity.

Although the research also suggests that the vast amount a children still received enough protection from the vaccines despite ingesting Tylenol, the “results make a ‘compelling case’ against routinely giving Tylenol right after vaccination… Tylenol or its generic twin, acetaminophen, is widely recommended as a painkiller for babies. Many parents give it right before or after a shot to prevent fever and fussiness, and some doctors recommend this.”

Developing a fever after a vaccination is not necessarily a bad thing, as it is natural part of the body’s response to the vaccination. Some other researchers suggest that although “there’s been speculation for a long time that the use of [fever reducers] might [have] an effect on antibody production after vaccination…this is far from proved [and] given that so few children develop high fevers after vaccinations, skipping the meds unless fever develops might be the way to go.”

As a products liability and medical negligence lawyer, I am intrigued be the results of this study. Since the results suggest that there is little to no risk of holding off on giving children a fever reducing medicine until after a fever develops, parents may want to consider waiting to give their children Tylenol or other fever reducers. Further research should clarify the actual risk of ingesting Tylenol after a vaccination.

The Food and Drug Administration is “alerting doctors that a widely-used blood thinner has been reformulated to improve its safety, though the change could open the door to dosing errors” (AP for FindLaw, 10/1). The FDA is alerting doctors about the change in potency so they will be aware that patients may need higher dosages to achieve the same effect.

The drug, Heparin, will be ten percent less potent than the original drug. The change was designed to make it easier to spot impurities in the drug, which was linked last year to hundreds of life-threatening allergic reactions and deaths. As a result of the problems with contamination, “the drug was recalled by Baxter International and the U.S. blocked imports from a Chinese company that supplied the key ingredient.”

As a Chicago lawyer who has seen too many disastrous drug cases, I am pleased to see the FDA’s actions in communicating to doctors the changes in a drug. Changes in drug composition can be especially dangerous after the drug has been on the market and doctors are accustomed to prescribing the drug. Under such circumstances, it is extremely important that doctors be made aware of changes so they can prescribe accordingly.

As a medical malpractice lawyer, I am concerned by the following story. The FDA, as the chief regulatory agency for new medical devices, has a duty to make sure the devices are as safe as possible, and it is crucial, therefore, that the review process is untainted.

Matthew Perrone reports, “The Food and Drug Administration's top lawyer says the agency failed to follow its own rules when it approved a knee repair product last year against the recommendation of its own scientists” (9/24, AP for FindLaw).
An internal examination by the FDA’s Chief Counsel raised concern that “agency leadership caved to pressure from the company,” in approving the ReGen Biologics’ Menaflex device.

FDA scientists rejected the product in question in both 2006 and 2007. FDA’s device division chief, who retired last month, overruled those decisions in 2008 leading to the approval of the ReGen’s device.

The probe, which was requested by Obama administration officials detailed several problems where there was concern about “a clear deviation from the principles of integrity.”

The AP reports (8/28, FindLaw) “Federal regulators are questioning whether Genzyme’s leukemia drug should be approved for older patients based on limited studies conducted by the biotech drug maker.” Genzyme has asked the FDA to approve the drug Colar for use by adults who are over 60 years of age, but are not healthy enough to undergo chemotherapy.

However, the FDA reviews have complained about several problems with the company’s study. One such issue is “the 112-patient study did not compare patient’s taking the drug to those taking a sham treatment, a practice commonly used to gauge a drug’s effect.” As a part of the continuing review process, the FDA will ask a panel of cancer experts to evaluate the drug in the near future.

As a medical malpractice lawyer, I advocate for thorough reviews before approving a drug. One special, but necessary consideration should be how the drug might react differently in elderly patients, and drugs such as this one that will be use primarily by older patients should take that into account during the review process.

Mark Hirschbeck “had his dream job as a Major League Baseball umpire and reached a career high with the 2001 World Series, but he says what started as a routine hip replacement surgery cost him his career and has led to years of pain” (New Haven Register, Sullo 7/21). The pain began when his ceramic hip replacement shattered during recovery, even though his surgeon had told him he was getting the “Rolls Royce” of artificial hips.

Two additional ceramic hip replacements and a staph infection later left Mr. Hirschbeck unable to sit or stand for long periods of time. He obtained another physician who replaced the ceramic hip with a non-ceramic hip and he is now doing better.

Now, Mr. Hirschbeck has turned his attention towards Congress by advocating for the Medical Device Safety Act. In 2008, the U.S. Supreme Court ruled, “manufacturers of class III medical devices that have U.S. Food and Drug Administration approval, like Hirschbeck’s artificial hip, are immune from claims challenging these products’ safety or effectiveness.” The Medical Device Safety Act, if passed, “would allow injured consumers like Hirschbeck to bring product liability claims to a jury, and potentially hold medical device manufacturers accountable when their products cause injury or death.”

As a medical malpractice lawyer, I am disappointed that the same medical mistakes were made repeatedly. I support the Medical Device Safety Act because manufacturers of medical devices should be held liable for the injuries caused by their products. Furthermore, ceramic hip replacements should be subject to thorough evaluation if they both have a tendency to shatter and cause infection.

As a personal injury lawyer, I am pleased to see that the FDA has been proactive in considering health hazards from generic drugs. Consider two recent instances where the FDA has both seized drugs for violating manufacturing standards and called for a panel of experts to scrutinize the link between acetaminophen and liver injury.

David Olmos reports for the Bloomberg News (6/26) "Generic drugs made by Caraco Pharmaceutical Laboratories Ltd. were seized by US authorities, who cited violations of manufacturing standards." The company had received a warning letter in October 2008 after inspections in May and June found deficiencies. Deborah Autor, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research, said inspectors who saw the facilities in May 2009 "found 'serious violations' of manufacturing standards and 'serious deficiencies' in quality control."

The FDA said drugs "and raw ingredients for pain, heart ailment, and psychiatric medications were confiscated today at three Caraco facilities in Michigan to prevent the Detroit-based company from distributing its products until the manufacturing deficiencies are corrected."

Jared Favole reports on other recent FDA activity for the Dow Jones Newswires (6/26) stating "painkillers such as Tylenol will go under a microscope... as federal regulators and medical experts debate how to limit liver injury in patients who take the medicines." At issue is acetaminophen, which is the most widely used drug in America. Approximately "100 people die annually from accidentally overdosing on acetaminophen,” and over 50,000 are temporarily hospitalized. The Food and Drug Administration says the drug is safe if taken at recommended levels, but “the drug's prevalence in a variety of pain relievers, fever reducers, and cough medicines means patients don't realize they are taking several drugs that contain the same ingredient, often leading to an overdose of acetaminophen."

According to Dow Jones, the FDA has been struggling with how best to control the issues surrounding acetaminophen since at least 1977, when an agency committee suggested labels for pain relievers contain a warning that they can damage a patient's liver. In April, the FDA mandated that over the counter drugs containing acetaminophen must have a label warning of liver injury. On Tuesday, the panel of experts voted to lower the maximum over the counter dosage and to ban drugs that combine narcotics and acetaminophen, including Vicodin and Percocet. Perhaps warning labels and other possible safety measures - including reducing recommended dosage levels, limiting the number of pills or liquid in each drug containing acetaminophen, and eliminating medicines that combine acetaminophen with other ingredients - could save many lives per year.

The impact that drug and medical device companies may have on physician treatment decisions is a cause for concern. Creating incentives for physicians to use a certain company’s devices or drugs may jeopardize patient care. As a medical malpractice lawyer in Chicago, I support the University of Wisconsin policy that requires physicians to divulge outside income.

John Fauber reported for the Milwaukee Journal Sentinel (6/20), "At least 11 doctors with the University of Wisconsin School of Medicine and Public Health received more than $50,000 from drug or medical device companies last year, including seven who pulled in six-figure amounts." As a result, the university is requiring "doctors for the first time...to specify how much outside income they receive." According to "the disclosure forms...orthopedic surgeons, who command some of the highest salaries among university and state employees, also got some of the biggest outside income checks, mostly from companies that make medical devices."

Some of these surgeons "were among the most vocal opponents to the university's new disclosure requirements, referring to the more stringent disclosure requirements as voyeuristic." Meanwhile, "critics of these arrangements say they increase the cost of medicine, potentially compromise patient care, and damage the integrity of medical research." Physicians who work "for drug and device companies" have "come under scrutiny in recent years, including congressional investigations, medical journal articles and the media."

The New York Times (6/16) reports “a medical device maker, Synthes Inc., and four of its executives were indicted Tuesday on federal charges that they improperly promoted a bone filler for purposes not approved by the Food and Drug Administration including encouraging its use in what prosecutors called ‘unauthorized’ human trials.”

The Indictment was sought by the United States attorney in Philadelphia and is one of the strongest actions against medical drug and device makers in years. Michael L. Levy, the United States attorney said, “they put their profits ahead of responsible business practices and the truth.”

In 2002, the FDA approved the bone filler only for general bone repair but regulators “insisted that Synthes not promote its use for spinal procedures.” Charges in the indictment allege that Synthes company officials went behind the FDA’s back and approached selected operators to perform unapproved operations with the understandings that “the company would help them publish their clinical results.”

Cautionary findings, including possible severe blood clotting caused by the use of the bone filler were not taken seriously by executives. The company was further accused of running unauthorized human trials of the bone filler in spinal procedures, which may have lead to three deaths. These deaths were not reported to the FDA.

Improper business relationships between doctors and medical device makers are a cause for concern. If a doctor has the incentive to use one device over another, then patients cannot be certain that they are receiving the best quality care. Incentives drive human behaviors, and as a Chicago medical malpractice lawyer, I feel strongly that such incentives should not influence the doctor-patient relationship.

In 2006, the hip resurfacing procedure became available in the United States. Since that time, some physicians have aggressively promoted the procedure because it supposedly allows for better and quicker return to normal activities and should last longer than the 15-20 year life span of normal hip replacements. Thus, the procedure is best for patients who are younger and physically active, have strong bones, and are expected to live longer than the lifespan of a traditional hip replacement. (New York Times, 11/8/2008)

However, hip resurfacing is “typically more difficult to perform than replacing the total joint. In general, surgeons say, resurfacings can take longer and require bigger incisions than hip replacements.” (Wall Street Journal, 6/4) Moreover, women who receive the hip resurfacing procedure seem to be at a greater risk for failure. Researches found that “five years after surgery, 5.2% of women under 55 with a resurfacing had undergone a second, corrective operation.”

On the other hand, only “3.6% of women in that age group needed a second operation after getting a full hip replacement.” Corrective surgeries are necessary when resurfacing causes the “femoral neck – a piece of bone surgeons retain in resurfacing but replace in a full hip replacement” to fracture. Women can be at greater risk due to their generally smaller frames, and lower bone densities.

Many studies have been performed and others are currently underway. The most consistent results include the finding that the overall functional outcomes of hip resurfacings and hip replacements appear to be very similar. Only in the studies where participants get to choose the procedure do results show that those who receive hip resurfacings appear to be more active, which is likely reflective of the fact that they were more active originally.

In the United States last year, resurfacing accounted for no more than 3.5% of the 430,000 hip replacements that occurred, but the number of new resurfacing patients this year is expected to increase by 40 to 50 percent, according to the consulting firm Millennium Research Group (NYT).

When considering any surgical procedure it is important to discuss and consider all of the risks with your physician. If you have been injured because you were not informed of the risks associated with a surgical procedure, you should contact a medical malpractice lawyer to discuss your case.

CQ Today (6/2, Armstrong) reports that Senate legislation authorizing the FDA to regulate tobacco (HR 1256) "will come to the Senate floor Tuesday, after two committee chairmen persuaded Majority Leader Harry Reid (D-NV) to cancel a Tuesday cloture vote on a railroad antitrust bill (S 146) that was the only item on the calendar ahead of the tobacco bill."

The bill "would give the Food and Drug Administration (FDA) wide new powers to regulate tobacco products. It would levy user fees on tobacco products and create a new department within the FDA with the authority to regulate tobacco marketing and advertising, control the amount of nicotine in products, and bar such product claims as 'light' and 'low-tar.'" While "floor action on the bill could take up most of the week," the bill "is expected to eventually pass."

The AP (6/3, Abrams) reports that on Tuesday the Senate voted 84-11 to advance the regulatory legislation. Since only sixty votes were needed, "the success in reaching that threshold increases the likelihood that the Senate will move to a final vote by the end of the week. If the House concurs with the Senate measure, it would go to President Barack Obama, who is ready to sign it into law."

The Campaign for Tobacco Free Kids (5/21) reported “tobacco use is the number one cause of preventable death in America,” killing more than 400,000 Americans annually and costing the nation $96 billion in health care bills per annum. Every day, another “1,200 lives are lost due to tobacco consumption and over 1,000 kids become new regular smokers”.

Despite being the deadliest product sold in America, tobacco products are among the least regulated. They are “exempt from basic health regulations that apply to other consumer products,” which allows tobacco companies to employ deceptive marketing techniques to attract children to their “deadly and addictive” products, “deceive consumers about the harm their products cause, and resist changes that could make their products less harmful.” Therefore, Congress has the opportunity to protect thousands of lives by passing the regulatory legislation.

As a Chicago medical malpractice lawyer, that has represented too many lung cancer victims; I consider this legislation now working its way through the Senate welcome news.

The Food and Drug Administration (FDA) issued a warning last month to doctors who treat patients with electronic devices such as pacemakers, cardiac defibrillators and insulin pumps. Judith Graham of the Chicago Tribune reports that the FDA public health alert cautioned doctors that these types of medical devices can malfunction when patients get computerized tomography (CT) scans. The health alert can be found here.

There have been six confirmed reports of devices that malfunctioned after a CT scan and nine other reports of suspected problems. No deaths have occurred as a result of this complication.

In its alert, the FDA warned that devices that could be affected by CT scans include pacemakers, implantable defibrillators, neurostimulators, drug infusion and insulin pumps, cochlear implants and retinal implants. Millions of Americans are equipped with these devices-- which use electrical current to help various organs overcome functional deficiencies. Among other measures, the alert recommends that CT operators use the least amount of X-ray exposure possible and stand prepared to treat adverse reactions.

From legal perspective, medical malpractice occurs when a doctor, hospital, or other health care provider fails, or breaches, their duty to care for a patient. In the case where a CT scan is scheduled for a patient equipped with a defibrillator or pacemaker, the FDA alert warns doctors to take certain precautions to ensure the medical device does not malfunction-- since it is forseeable that complication and injury can occur if the condition is ignored. If you think a healthcare professional made a mistake treating your condition, the first thing you should do is seek legal advice. The lawfirm of Hurley McKenna & Mertz, P.C. has sucessfully fought for patients who have received negligent healthcare at the hands of doctors and hospitals. If you have questions or comments about this blog post call Chris Hurley at 312-553-4900.

“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