Articles Posted in Product Liability

Published on:

St. Jude Medical Inc.’s Riata defibrillator leads, which the company stopped selling last year, were recalled by the U.S. Food and Drug Administration because of their potential to injure or kill patients.

st-judes-riata-lead-recall-attorney.jpg

The devices remain implanted in an estimated 79,000 U.S. patients. The company voluntarily sent a letter to doctors on November 28 informing them that the wires used to connect the devices to the heart have a higher failure rate than was previously known.

According to the company, the FDA issued the Class 1 recall, its most serious designation, because of its potential risk of serious injury or patient death.

The company acknowledged that the wires inside some leads can penetrate the insulation, compromising the device’s integrity. The devices may inappropriately shock some patients and fail to deliver necessary therapy to others.

This potential for device failure, particular for defibrillators or for folks dependent on pacemakers, is worrisome.

Patients who need frequent shocks from their defibrillator to restore a normal heart rhythm and those who are dependent on pacemakers may be at greater risk, the company said. Doctors may design individual treatment plans for those with the damaged wires based on their risk level and options should be discussed with patients, the company said.

FDA notified healthcare professionals of a Class I Recall of the St. Jude Medical Riata and Riata ST Silicone Endocardial Defibrillation Leads. The silicone insulation covering these defibrillation leads is at risk of premature abrasion. When abrasion occurs, the conductors inside the leads can come out (externalized) of the insulation. Leads with externalized conductors may develop electrical dysfunction and not work as intended. In the event the device does not work as intended, should a life-threatening heart rhythm occur, pacing or defibrillation therapy may not be delivered as intended. This may result in serious adverse events, including death.

The recall includes the following model numbers:

Riata (8F) Silicone Endocardial Defibrillation Leads
Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592
Riata ST (7Fr) Silicone Endocardial Defibrillation Leads
Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042
BACKGROUND: The leads connect an implantable cardioverter defibrillator (lCD) or cardiac resynchronization therapy defibrillator (CRT-D) to cardiac tissue in order to monitor and regulate a patient’s heart rate by providing pacing and delivery of high voltage therapy for ventricular arrhythmias.

Published on:

The FDA have added new safety warnings to the heart rhythm drug Multaq, (dronedarone) after Sanofi company study linked the medication to higher rates of heart attack, stroke and death in a subset of patients. The FDA completed a safety review of dronedarone, which showed that the heart drug increased the risk for serious CV events, including death, when used by patients with permanent atrial fibrillation.

multaq-wrongful-death-attorney.jpg

The review was based on data from the PALLAS and ATHENA trials. As a result of the review, the FDA has provided new information and recommendations for use of dronedarone to manage the potential serious CV events associated with the drug, according to a statement from the agency.

The boxed warning highlights the results of a study in which Multaq doubled the risk of heart-related complications in patients with permanent atrial fibrillation. The revised label indicates that Multaq is only approved for the short-term form of atrial fibrillation and atrial flutter. Doctors routinely prescribe drugs for conditions not listed on the labeling approved by the FDA, a process called “off label prescribing.”

The label, instructs doctors to check patients’ heart rhythm at least once every three months. If patients appear to have the permanent form of atrial fibrillation, Multaq should be discontinued.

When first approved in 2009, Multaq was the first new drug in 10 years for atrial flutter and atrial fibrillation. Both conditions can cause stroke and death. Multaq has been subject to a series of safety concerns, both before and after its approval in the U.S.

European Union health officials have already restricted Multaq’s use based on the same safety information. In September the European Medicines Agency said that the drug should only be used after other treatments for atrial fibrillation have been tried.

In the study that triggered the warning, Sanofi recorded 25 deaths in the Multaq group compared with 13 in the placebo group. All 3,200 the patients in the study were older than 65 and had permanent atrial fibrillation.

Atrial fibrillation is the most common heart rhythm disorder and a frequent contributor to stroke. About 278,000 people in the U.S. have received prescriptions for Multaq as of October, according to the FDA.

The FDA originally rejected the French drugmaker’s request to approve Multaq in 2006. That was after a widely publicized study showed patients in the group taking Multaq were twice as likely to die as patients in the comparison group.

But Sanofi said the study involved patients with severe heart failure and many of them did not even have the irregular heart rhythm Multaq was designed to treat.

Multaq already carries another black box warning, the most serious type of warning. It says that the drug can cause severe complications, including death, in people with recent severe heart failure and should not be used by them.

The new label changes for the drug include the following:

Dronedarone should not be prescribed to patients with permanent atrial fibrillation (those who cannot or will not be converted into normal sinus rhythm) because of the twofold risk of cardiovascular death, stroke, and heart failure in such patients.

Patients on the drug should be monitored via ECG every three months and patients in atrial fibrillation should discontinue the drug or be cardioverted if that is clinically indicated.

Patients prescribed dronedarone should receive appropriate antithrombotic therapy.

In January, the FDA alerted healthcare professionals to the potential for liver damage from dronedarone based on two reported post-marketing case reports of acute liver failure that required transplantation. The agency recommended periodic liver enzyme tests, especially in the first six months of treatment.

Published on:

The U.S. Judicial Panel on Multidistrict Litigation (JPML) has rejected calls for all federal Plavix lawsuits to be consolidated in one court for coordinated handling during pre-trial litigation. This means that the litigation will proceed as individual cases in various district courts throughout the United States.

plavix_injury_lawyer-1.jpg

Last week, the JPML denied a motion by Bristol-Myers Squibb and Sanofi-Aventis to centralize the federal Plavix litigation in the U.S. District Court for the District of New Jersey. According to the panel, the centralization would not help move the cases through the system faster and would provide no benefit to the parties involved.

There are currently only 12 lawsuits filed against Plavix pending in the federal court system, with 10 of them pending in the U.S. District Court for the District of New Jersey.

All of the Plavix suits allege that the drug makers failed to adequately research their medication or warn about the risk of Plavix side effects, which could increase the risk of serious and potentially life-threatening bleeding, as well as a rare blood disorder known as thrombotic thrombocytopenic purpura (TTP). Lawsuits had been filed against the makers of Plavix over internal bleeding, ulcers, heart attacks, strokes and other health problems allegedly caused by the popular blood thinner.

There are 40 Plavix cases filed in New Jersey state court. Plavix (clopidogrel) is prescribed as an anti-platelet agent, to prevent blood platelets from sticking together to form clots. It is prescribed to reduce the risk of heart attacks, strokes and blood clotting when drug coated stents are used in patients with arteriosclerosis and in other at-risk patients.

In November 2009, the FDA issued a public health advisory warning that side effects of Prilosec may interfere with Plavix effectiveness, increasing the risk of heart attack, death or other injuries for patients.

In March 2010, a Plavix “black box” warning was added to alert patients and healthcare professionals that the anti-clotting drug may not work in some patients due to genetics. The FDA indicated that a genetic test is available to determine whether patients are able to metabolize Plavix efficiently and suggested that doctors should consider another medication for at-risk patients who are confirmed to have the gene variant.

Published on:

According to plaintiffs’ lawyers, Knauf Plasterboard Tianjin Co., (KPT) a Chinese drywall maker, agreed to pay at least $800 million to settle homeowner claims that defective building materials contaminated their homes with corrosive sulfur fumes.

chinese-drywall-attorney.jpg

Knauf agreed to settle claims involving about 4,500 properties that contain the defective drywall. Homeowners said the faulty wallboard emits noxious sulphur gases that corrodes copper coils and electrical and plumbing equipment.

The accord was announced before U.S. District Judge Eldon Fallon in New Orleans, who is overseeing about 12,000 suits filed over the contaminated drywall that have been consolidated for pretrial evidence gathering.

According to the plaintiff attorneys, “homeowners who can show they have KPT product in their homes will be covered and the costs of those repairs are covered by the agreement no matter how much the total cost may be to the company.”

According to state Attorney General James Caldwell, More than 1.1 million sheets of harmful Chinese drywall were used in Louisiana rebuilding projects after hurricanes Katrina and Rita struck in 2005.

About 55 percent of the property owners who may benefit from the settlement live in Florida while 35 percent are Louisiana residents, according to experts.

The remaining cases involve drywall made in China by units of Taishan Gypsum Co. and Beijing New Building Materials Public Limited Co., the judge said. Fallon said he will travel to Hong Kong to supervise depositions in the suits.

Other drywall suppliers, such as Miami-based Banner Supply Co., agreed in June to pay about $55 million to settle claims over the contaminated building materials made in China.

The consolidated case is In re Chinese-Manufactured Drywall Products Liability Litigation, 2:09-md-02047, U.S. District Court, Eastern District of Louisiana (New Orleans).

Published on:

As public awareness of problems with artificial hips and other medical implants increase, legislation was introduced in the Senate that would force manufacturers to track the performance of such products after they were approved for sale.

The bill would allow the Food and Drug Administration (FDA) to compel companies to track medical implants.

The bill is to address the controversial 510(k) process that the FDA uses to clear the sale of certain implants like artificial joints. To sell a new product under 510(k) process, a producer need only show that it is “substantially similar” to a product already on the market.

Thousands of the all-metal hips that are now failing prematurely in patients were approved through the 510(k) system. The new proposal would not require added premarket testing of such implants but would broaden the F.D.A’s postapproval oversight by giving it the authority to mandate that companies collect data on device performance.

Along with introducing the bill, the bill originators sent letters to five major producers of medical devices seeking documents about how they track product safety and recall devices.

The companies were Johnson & Johnson, an artificial joint maker; Zimmer Holdings, another producer of artificial joints; Medtronic, a heart and spinal implant producer; Boston Scientific, a heart device maker, and C. R. Bard, a surgical implant maker. All of these companies have had problems with defective medical products, leading to recalling them.

Specifically, in the case of Johnson & Johnson, Congressional investigators want to know when the company was warned that one of its all-metal hips — the ASR, or Articular Surface Replacement — was failing and how it tracked those problems. Last year the DePuy division of Johnson & Johnson recalled the device after it had been implanted in some 93,000 patients worldwide, including 40,000 in this country.

As of early October, about 3,500 lawsuits have been filed against Johnson & Johnson in connection with the ASR, and medical studies suggest that the ASR may have already failed a few years after implant. Artificial hips are supposed to last 15 years or more before requiring replacement.

Last month, a legislative panel in Australia issued a report that concluded that Johnson & Johnson was probably aware of serious problems with the ASR well before recalling it. The panel also characterized the company’s responses to its questions as “decidedly opaque.”
“Many people could have avoided considerable pain, suffering and diminished quality of life if the company had acted in a responsible manner to known problems with these devices,” the Australian report stated.

Published on:

A motion has been filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate and centralize all federal Wright Conserve hip replacement lawsuits. These lawsuits have been brought in courts throughout the United States by individuals who experienced injury problems after receiving the metal-on-metal artificial hip system.

dallas_hip_recall_attorney.jpg

Several lawsuits have been filed against Wright Medical in different federal district courts through the nation by individuals who complain that their metal-on-metal Wright Conserve Plus hip system failed within a few years of implant, often resulting in the need for revision surgery.

Since the FDA approved the Wright metal-on-metal hip replacement system under their controversial 510(k) approval system, more than 200 adverse event reports have been submitted by patients or physicians, which likely only represents a small percentage of the total number of problems with Wright Conserve hip replacements.

All of the lawsuits involve similar allegations of design defects involving the Conserve acetabular cup, which plaintiffs claim has a tendency to loosen and fail as metal particles are shed into the body from the metal parts rubbing against each other.

The Wright Conserve hip system is a metal-on-metal design, which consists of cast cobalt chromium molybdenum that provides the cup (socket) for the cobalt chromium molybdenum femoral head (ball). The metal femoral head turns within the metal monoblock Conserve Cup, which does not have a protective liner. This may result in the release of metal particles, through the metal on metal grinding. The metal ions can cause metal toxicity in the blood, soft tissue and bone. This condition can result in metallosis, tissue necrosis and pseudotumors, according to the complaints.

In May 2011, the FDA asked Wright Medical and other metal-on-metal hip makers such as DePuy, Smith and Nephew, Stryker and Zimmer, to obtain more information about the level at which the metal particles released by hip replacements becomes dangerous, how much metal they actually release and to quantify the potential side effects of metallosis.

The Wright Conserve Cup features a similar design to the DePuy ASR Cup, which was recalled in August 2010 after medical data suggested that a higher-than-expected number of people had their artificial hip fail within a few years.

Due to the similarities between the designs, the MDL motion suggests that a Wright Conserve hip recall is likely to be issued as well.

The plaintiffs argue that centralizing the Wright Conserve metal-on-metal hip lawsuits as part of an MDL will serve the convenience of the parties, prevent duplicative discovery and avoid conflicting pretrial rulings from different judges.

Published on:

Transvaginal mesh plaintiffs are petitioning for the vaginal mesh litigation pending against 4 different companies to be centralized before one judge in the U.S. District Court for the Southern District of West Virginia.

Ethicon_Gynecare_Transvaginal_Mesh_Lawsuits.jpg

As described in previous blogs, thousands women throughout the United States are bringing product liability lawsuits against the 4 main medical device manufacturers as a result of injuries with transvaginal bladder mesh systems, which have been associated with reports of infection, vaginal erosion and pelvic pain.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) in November received motions for many Boston Scientific pelvic mesh lawsuits, American Medical Systems (AMS) mesh lawsuits and Ethicon/Gynecare mesh lawsuits to be centralized before Chief Judge Joseph R. Goodwin, who is already presiding over all federal Bard Avaulta mesh lawsuits that were consolidated for pretrial proceedings.

The plaintiffs are calling for the Panel to establish three new MDLs, or multidistrict litigations, in the Southern District of West Virginia, where Judge Goodwin can coordinate the litigation together with the Bard Avaulta cases.

The vaginal mesh lawsuits contain allegations involving defects with pelvic repair products used during transvaginal surgery to repair pelvic organ prolapse (POP) or stress urinary incontinence (SUI), which caused women to experience painful and debilitating complications.

Commonly, women are implanted with more than one product, which are often manufactured and sold by different companies. Thus, plaintiffs have requested that currently unconsolidated litigation for vaginal mesh products sold by Boston Scientific, AMS and Ethicon/Gynecare be transferred to the Southern District of West Virginia, for coordinated handling.

The plaintiffs argue that “the centralization of these actions in a single judicial district for coordinated and/or consolidated pretrial proceedings will promote the interests of justice.”
“The transfer of these cases will conserve judicial resources, reduce litigation costs, avoid potentially inconsistent pretrial scheduling orders and substantive rulings, and will eliminate unnecessary duplicative discovery.”
Plaintiffs further argue that the claims against all of these manufacturers are similar, and Judge Goodwin has already become familiar with the factual and legal issues presented throughout the cases and is uniquely positioned to handle the conflicts that may arise from cases involving individual women who received multiple devices from different manufacturers.

The general public has become increasingly about the risk of vaginal mesh problems, after the FDA issued warnings about an increasing number of adverse event reports associated with the products.

In July, the FDA issued transvaginal mesh warning, indicating that they have been unable to find any scientific evidence that transvaginal mesh kits provide any benefit over other available means of treatment.

In September, an FDA advisory panel was held to review the potential health risks with vaginal mesh products. At the hearing, a majority of surgical mesh manufacturers joined together to create a “Transvaginal Mesh Working Group”, making a joint presentation to the committee and presenting a unified voice and position at the hearing.

Published on:

A panel of federal drug experts has recommended that the FDA require newer warnings for side effects of the Ortho Evra birth control patch. These patches may increase the risk of venous thrombosis embolism (VTE) when compared to using some older oral contraceptives. The panel did not recommend that the FDA issue an Ortho Evra recall due to the potential dangers.

yamin-blood-clot-attorney.jpg

The FDA recently held the advisory committee to review the risk of VTE with the Ortho Evra patch, as well other newer forms of contraceptives, such as Yaz and Yasmin birth control pills and the NuvaRing birth control ring.

The panel voted 19-5 that the benefits of the Ortho Evra outweighed its health risks, and they voted 20 to 3, to recommend that the birth control patch’s blood clot warnings be rewritten.

Ortho Evra is a form of birth control that is delivered through a patch. Ortho Evra patch is promoted as an alternative to daily birth control pills, some studies have shown that the Ortho Evra patch delivers substantially more estrogen and significantly increases the risk of blood clots and VTEs in women.

The FDA committee’s recommendations would call for the language to be simplified and made clearly understandable by consumers. While the committee’s decisions are not binding for the FDA, they generally factor significantly into the agency’s final regulatory action.

A recent FDA study of all of the newer forms of birth control indicated that women who use the Ortho Evra patch or the NuvaRing are 55% more likely to suffer a VTE, which can lead to a pulmonary embolism, heart attack or stroke, than women who take levonorgestrel-based birth control pills.

Women who took Yaz, Yasmin or other generic pills that also use the drospirenone progestin, faced a 75% increased risk of VTE and twice the risk of heart attack or stroke.

The committee voted against recommending a recall for Yaz and Yasmin, but also found that the label warnings should be made more clear on those products as well.

Published on:

Another example of a corporation being caught with its hand in the cookie jar. Medtronic has agreed to pay the U.S. Justice Department $23.5 million to settle allegations that the company paid doctors to implant its pacemakers and defibrillators.

medtronic-infuse-lawsuits.jpg

The Justice Department investigation alleged that Medtronic paid doctors between $1,000 and $2,000 per patient implanted with a Medtronic pacemaker or defibrillator as part of four post-marking studies.

According to a press release from the Justice Department, the payments were to promote doctors to use a Medtronic device over other competing devices, and to persuade them to be loyal to Medtronic for future cardiac procedures.

The settlement ends a federal qui tam suit filed in Minnesota, as well as a similar qui tam suit filed in California. Both suits alleged Medtronic violated the U.S. False Claims Act by using post-market studies and device registries as vehicles to pay participating physicians kickbacks for implanting its pacemakers and ICDs in Medicare or Medicaid beneficiaries.

According to the attorneys bringing the whistle blower action, “Our society owes an enormous debt to individuals with the courage to blow the whistle when medical device makers try to influence physicians.” “When the use of procedures or devices is driven by corporate greed rather than medical need, it creates a potentially dangerous situation for patients and contributes to escalating medical costs.”

The qui tam or whistle blower provisions of the False Claims Act permit private citizens, called “relators,” to bring lawsuits on behalf of the United States and receive a portion of proceeds of any settlement or judgment.

According to Tony West, assistant attorney general for the department’s civil division, “patients who rely on their healthcare providers to implant vital medical devices expect that those decisions will be made with the patients’ best interests in mind.” “Kickbacks, like those alleged here, distort sound medical judgments with financial incentives paid for by the taxpayers.”

Medtronic said the payment is not an admission that any of the company’s studies were “improper or unlawful.”

“Medtronic is happy to have this investigation behind us, so we can continue designing and executing clinical trials that generate evidence to improve patient care, outcomes, and cost effectiveness,” Marshall Stanton, MD, vice president of clinical research and reimbursement for the Medtronic’s Cardiac and Vascular Group, said in a statement.

Medtronic also is being investigated by the Justice Department over allegations that doctors paid by the company failed to report serious side effects associated with Medtronic’s spine surgery device, Infuse.

So did the company learn anything? Or were they surprised to be caught with their hand in the cookie jar. The hits keep on coming…, are there any depths to which these corporations will not stoop to? Where will the companies draw the line, where is the lesson learnt?
Unfortunately we will have to wait until the corporate executives start being accountable for their actions and end up in jail. So far only civil fines and no admissions of guilt or liability. Just the cost of doing business in the US of A.

Published on:

This week the FDA held a 2 day meeting evaluating the newer oral, patch and ring contraceptives. This was a long overdue and highly anticipated hearing.

YAZ-Blood-Clot-ATTORNEY.jpg

The FDA advisory panel voted 19-5 that the benefits of the Ortho Evra norelgestromin/ethinyl estradiol transdermal patch outweigh the blood clot risks, but panel members think those risks should be more clearly stated on the label.

The FDA’s Advisory Committee for Reproductive Health Drugs and a drug safety committee voted Friday to recommend that the FDA should allow the patch to remain a contraceptive option.

The same panel had voted 15-11 that the benefits of drospirenone-containing oral contraceptives such as Yaz and Yasmin outweigh the risk of venous thromboembolism (VTE).

Reproductive and drug safety experts advised the FDA to add stronger label warnings of Yaz and Yasmin blood clot risks, but decided not to recommend a Yasmin and Yaz recall.

The panel voted 21-5 to add new blood clot label warnings to drospirenone-based birth control pills, saying that the current warnings are vague, too confusing, and need to be updated with the most recent drug safety information.

One of the most recent reports examined by the committee was from the FDA itself, which found that Yaz and Yasmin side effects increased the risk of blood clots 74% when compared to older birth control pills that use levonorgestrel as a progestin instead of drospirenone. The panel noted that the FDA study did not account for smoking, obesity and some other health factors which could have played a part in its findings.

Newly unsealed documents, revealed during discovery in thousands of Yaz and Yasmin lawsuits, indicate that Former FDA Commissioner David Kessler believes that the company kept important safety data from federal regulators. Kessler gave expert opinion testimony that Bayer purposefully mislead the FDA about Yaz and Yasmin’s safety by selectively presenting data on thromboembolic events to make the drugs appear to be safer than they really were. The testimony was barred from the committee hearing because it was not submitted in time.

The Ortho Evra patch, from Johnson & Johnson’s Janssen, does not contain drospirenone, but it contains higher levels of estrogen than found in many common second-generation birth control pills (which contain lower doses of estrogen than the first-generation pills introduced in the 1960s).

An FDA postmarking report in October stated that the patch, the norelgestromin/estradiol vaginal ring, and birth control pills containing drospirenone, were all associated with increased risk for VTE, compared with hormonal contraceptives with relatively low doses of estrogen.

The panel addressed labeling on the patch, voting 20-3, that it should more clearly state the patch’s risks and calling the current labeling confusing.

Janssen has changed its label three times since 2005 to update the risk of the patch, and earlier this year the FDA added a boxed warning saying that one study found the VTE risk was significantly greater with Ortho Evra than with lower-estrogen birth control pills.

The black box warning was meant to draw more attention to the risk of blood clots, according to Scott Monroe, MD, director of the FDA’s Division of Reproductive and Urologic Products.

So what does all add up to? It means we have to slog through the bellwether trials that are scheduled for next year for both the Nuvaring and Yaz and Yasmin contraceptives. After they are played out, perhaps then these companies will come to the settlement table and compensate the thousands of women who have been horribly injured by these drugs.

Unfortunately the general public does not understand the risk associated with these drugs. They are not benign and they have a significant side effect profile and risk. These women need to understand that and the risk needs to be emphasized by their doctors. But sadly it is not. And in fact most doctors do not have that discussion with their patients. A lot of refills are filled automatically and the game of Russian Roulette continues.

The FDA could have done the right thing but sadly it abrogated its regulatory role to the powerful business interests and lobbyists at the hearing. Business as usual at the FDA, with its revolving door and life goes on Washington, except it does not for the women who have died as a side effect of these drugs. I will light a candle for you and your families, and you are in my prayers this Holiday Season.