According to the research article, “Inhaled Anticholinergics and Risk of Major Adverse Cardiovascular Events in Patients With Chronic Obstructive Pulmonary Disease” written by Sonal Singh, MD; Yoon K. Loke, MD; and Curt D. Furberg, MD, and published in the Journal of the American Medical Association, people using the Spiriva inhaler possibly face the following risks: cardiac death, heart attacks or strokes. Alarmingly, the risks are greater for the Spiriva inhaler users than inhaler users using a placebo or other drugs. This study published in the September 24, 2008 issue of JAMA denotes that although the risks were small, the popular inhalers could lead to potentially life threatening side effects.

The German Manufacturer, Boehringer Ingelheim Pharmaceuticals Inc. makes Spiriva Handihaler (tiotropium) and the  generic drug for Atrovent, Ipratropium, approved  for treating COPD.  In the United States, they have a joint marketing partnership with Pfizer Pharmaceuticals. In 2004, the inhaler was approved for a daily long-term treatment of bronchospasm, which is linked with COPD, chronic obstructive pulmonary disease.

It is important to note that both drugs have been used by approximately 8 million people worldwide. They are both known for helping to open passages and preventing spasms that decrease airways in the lungs to increase effective breathing.

The JAMA article details how authors, Sonal Singh, MD; Yoon K. Loke, MD; and Curt D. Furberg, MD analyzed the data from 17 randomized studies, and compared it to primarily older people on either Spiriva or Ipratropium, to people using placebos or other drugs. Their research found that patients had an increased risk over 50% in developing both fatal and non fatal heart problems, including heart attacks when they used Ipratropium or Spiriva.

Researchers are quick to add that additional studies are required to further evaluate the safety of the drugs. However, they recommended individuals with COPD to take precautionary measure prior to starting drug therapy that includes stop smoking, control blood pressure and cholesterol and the use of oxygen.

There was a statement issued by Boehringer and Pfizer indicating that disagreed with the analysis of the new study. They cited an analysis of 30 clinical trials that confirmed the safety of the Spiriva Handihaler and that showed no increased risk of all-cause death or cardiovascular death to the inhaler users.

However, the Food and Drug Administration, FDA issued an early communication in March 2008, that indicated they are evaluating the potential connection between the side effects of the the Spiriva Handihaler and strokes. The March 2008 FDA communication was quick to point out that their investigation was precautionary and did not mean that Spiriva causes strokes. They encouraged people on the drugs to not stop taking their drug based on the FDA early communication, in March but to wait until they have confirmed conclusions and recommendations.

We can only hope that the FDA’s conclusions will not be too late for some individuals.

 

Unfortunately, this is a serious recall, since a Class I Recall is the most serious type of product recall issued by the FDA, Food and Drug Administration.  A Class I Recall involves situations where there is a reasonable probability that death or a serious injury will occur from using the product. 

How are the recalled Products used?
The intrathecal catheter revision kits or the intrathecal catheter use a sutureless connector for the final connection to the implanted Medtronic SyncroMed II, SynchroMed EL, and IsoMed infusion pumps. The catheter  is a part of an infusion system. The catheter delivers and stores drugs into a specific space. 

What promoted the Recall?
The recall of the Medtronic Infusion Pump was due to the potential misconnections of the Medtronic sutureless connector ("SC") catheters from the catheter port on the pump. Reports have shown these misconnections to have caused a blockage between, the catheter port on the pump, disconnection from the pump connector and the sutureless pump connector.

The following product models are included in the Recall:
Sutureless Pump; Connector Revision Kit, Model 8678; 
Intrathecal Catheter, Model 8731SC; 
Intrathecal Catheter Pump Segment Revision Kit, Model 8596SC
Intrathecal Catheter, Model 8709SC

It is important to note that this recent recall does not include the MiniMed infusion pumps made by Medtronic.

What should you do if you have a Pain Pump?
If you or a loved one have used a Pain Pump since January 22, 2007, contact your physician to ask questions. You can also contact Medtronic Patient Services at 1-800-510-6735, Monday – Friday, 8 a.m. to 5 p.m. Central Daylight Time. 

Click here to read FDA Recall of Medtronic Pain Pump.

However, a recently published study called Seas, disputes these findings and  found an increased risk of cancer and deaths from cancer in patients taking Vytorin, compared with those given a placebo.

According to a WSJ article, the new Seas study, released in July, has surprised investors and the medical community.

Click here to read more on this Vytorin Study dispute from the Wallstreet Journal. (Note: Subscription required)

Health writer, KATE BARRETT, wrote a great article for ABCNews.com, entitled: "New Toy Safety Standards Become Law". The article discussed in detail, the new legislation on Consumer Product Safety and how it impacts children's toys.  The article highlighted the addition of tough  new  standards that address lead levels and chemicals in products for children under 12 years old.  According to the new Bill,  safety tests will be required with the efforts of keeping kids safe and preventing recalls. 

This Bill was a Bi-partisan effort on behalf of our legislators in the House and  the Senate. According to Senate Commerce, Science, and Transportation Committee chairman Daniel K. Inouye, D-Hawaii,  "The Consumer Product Safety Commission (CPSC) has been a neglected agency for too many years, but this legislation puts an end to that neglect. Texas Republican, Joe Barton, ranking member on the House Committee on Energy and Commerce panel, stated "One of the roles of government is to get between kids and the sorts of hazards that are well beyond parents who aren't engineers and chemists with laboratories at their disposal". It is nice to see members of the House and the Senate putting their differences aside and doing what is right to protect our children. The last thing that we need is a repeat of the horrors from the recalls from last year for toys such as the Thomas Tank Engine trains and Dora the Explorer/ Diego toys.

Click here to read the ABC.com article on Safety for Children's Toys.

 Click here to read Consumer Safety Protections Bill H.R. 4040

In a separate action, Medtronic is advising customers that selected lots of Trillium-coated products were also manufactured with heparin containing OSCS. Trillium is another biosurface used on CPB products. The ultimate goal is to remove all contaminated products from the market.

The Medtronic recall is a precautionary one. Let's all hope the company continues to take measures regarding their products that will help save lives and not threaten them.

In a blog post on the Pharmaceutical Blog Pharmalot, the author mentions that a lawyer for Zyprexa purchasers, is pushing for Judge Weinstein to certify classes of individual Zyprexa users and third-party payers, such as insurers. He believes that Zyprexa maker, Eli Lilly exaggerated the effectiveness of the drug; failed to adequately warn about side effects including weight gain, diabetes and other illnesses; and promoted Zyprexa for off-label use, including for treating elderly dementia patients and children.

Drug manufacturer, Eli Lilly has paid over $1billion to settle over 30,000 claims brought by patients stating they were not given adequate warning about the side effects of Zyprexa.

Judge Weinstein is supposed to issue a ruling sometime soon.. Everyone is waiting to see if justice will be served for the purchasers.  Stay tuned...

Bloggers for the Drug and Device Law Blog have some interesting comments on the subject. It is nice to see a healthy discussion between bloggers and readers...

One has to agree with the plaintiff's attorney Capretz that "This is a very disturbing decision with several major implications", especially for the plaintiffs.

Stay tuned for more information on this court decision.

Ashley Phelps' life was cut short last year when the all-terrain vehicle she was a passenger on struck some mailboxes and rolled over. The driver, Gregory Hebert, then allegedly drove away, leaving the injured 21-year-old behind. Head injuries sustained as a result of the ATV crash caused Ashley's death.

According to the most recent CPSC Annual Report of ATV deaths and injuries for 2006, that was released in February 2008, there have been over 8100 deaths related to ATV crashes or ATV fatalities.  The state of Pennsylvania leads the nation in ATV fatalities with 420 total deaths from 1982 - 2006. The State California  comes in second with 418 ATV fatalities from the same period. In the state of Florida, there were 349 deaths as of result of ATV accidents.

Click here to read more from the AP and the Insurance Journal and Click here to read more from the Consumer Product Safety Commission on ATV Accidents, death and injuries.

The court, in its first few paragraphs, related the story of the Dalkon Shield, an intrauterine device that harmed thousands of women. The court made a broad accusation that the Dalkon Shield created a barrage of tort lawsuits that proved the common law tort system (read: American System of Justice) is defective and unable to properly handle tort claims related to medical devices. The court gave no basis for this opinion, except for the fact that there were many tort claims filed because thousands of woman here harmed by the Dalkon Shield. For most of America the Dalkon Shield cases were proof, similar to Ford Pinto cases, that Corporate profit motives outweigh human safety all too often, even with Federal oversight.

Are medical devices so special that they get special handling or special rules compared to any other "device" produced today. If the court system cannot properly handle medical devices then why it is able to handle front-end loaders that have a "device defect" that kills people. Why can the court properly handle tire defect cases, roof crush, seat belt failures, or any other "non-medical" device that harms people? It is illogical. The only logical position is that medical devices interact with the human body in a more intimate and significant way so they need additional protection from lawsuits. I feel the exact opposite. The fact that a medical device is such an intimate thing leads me to believe that the law should garner the human participant in using the medical device MORE not LESS protection from device defects.

The language of 21. U.S.C. section 360 states as follows:
Except as provided in subsection (b) see below of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement (emphasis added) -
(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter." Section 360k(a).
(The exception noted in subsection (b) allows the FDA some latitude in giving local and State government oversight in some limited instances, which were not covered by the court in the opinion.)

Justice Ginsberg noted this exact point in her dissent but was preempted in the argument by Justice Scalia in his controlling opinion with the indictment that the entire tort system is not deserving of "preservation" and that "juries...see(s) only the cost of a more dangerous design, and is not concerned with its benefits..."

Juries are given both sides of a matter. Drug and medical device companies spend significant money on hiring the best and brightest lawyers money can buy. The typical medical device case has a small law office representing the Plaintiff. The Plaintiff’s attorney usually attended a local or state college and a local law school. He or she may have graduated in the middle of their class and may have a paralegal and a legal secretary helping out on the case. I am sure the attorney is bright and passionate. If that attorney is lucky, he or she may even have an associate with the same legal pedigree. By contrast, the Drug or Medical Device Company has a team of legal scholars at their disposal. Most of their team, a team of maybe 10 or 20 attorneys and a cadre of paralegal assistants, investigators and legal secretaries all graduated at the top of their class from the best law schools in the nation. They are a highly trained and well-paid group of white shoe legal assassins. There is no doubt in my mind the battle is David vs. Goliath and the Plaintiff’s attorney is the David in this story. It is only the fact that the jury often finds truth and passion in the Plaintiff’s story that permits plaintiff’s to ever win a case. Justice Scalia’s argument relies on the myth that Plaintiff attorneys are a secret society of Svengali’s who use Jedi mind control to blind the jurors into believing their side of the case. That is just ridiculous and I am sure every egocentric defense attorney looks at Justice Scalia’s opinion as a direct insult.

The court directly took up the challenge that the legislature did not intentionally, without any comment, struck down any reference to public redress or access to the court system. Justice Scalia says that is "exactly what pre-emption clause for medical devices does by its terms. The operation of law enacted by Congress need not be seconded by a committee report on pain of judicial nullification... It is not our job to speculate on congressional motives."

Then why go out of your way to force the issue and push for Federal pre-emption?
A casual reader may think that the opinion is only about Medical Devices. However, how long will that last? How simple will it  be for Congress to slip in Federal oversight preemption language into bill after bill until all torts are preempted by Federal oversight. It is against my Republican sensibilities to create Federal agencies to oversee private industry so that private industry can escape liability for harming the public with a faulty or defective product.

I am sure the burden on the court system will be greatly lightened when individuals can’t obtain  help for their injuries. Certainly if we do not permit people to bring lawsuits there will be less lawsuits. However, what is the effect of that? I wonder who pay the medical costs associated with the injury. Will the person's health carrier have to pay? What if they do not have health insurance? Will the local hospital and doctors care for the person? How much is the Federal Government willing to spend to take care of those harmed by the negligence of corporations whose products are sold to our people, our children without the worry that the company can be held accountable for injuring those people? With regard to many medical devices, we are going to find out real soon.

Brian

Click here to read the Supreme Court decision for Riegel v. Medtronic, Inc., 552 U. S. ___ (2008)

"Articles that discuss unapproved uses of FDA-approved drugs and devices can contribute to the practice of medicine and may even constitute a medically recognized standard of care," said Randall Lutter, FDA deputy commissioner for policy. "This guidance also safeguards against off-label promotion."

Previously, Section 401 of the Food and Drug Administration Modernization Act set out guidelines that allowed the dissemination of information on unapproved uses of FDA-approved products. As long as the guidelines were met by the manufacturers, the dissemination of such materials was not viewed by the FDA as evidence of an intent to promote the product for an "off-label" use. However, Section 401 expired on Sept. 30, 2006.

Comments via the Internet:  go to Docket Number FDA-2008-D-0053 on the Regulations.gov Web site.

Comments via mail:
Submit comments to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

All comments should be identified with the docket number, FDA-2008-D-0053. For single copies of the draft guidance, call 301-827-3360 or contact: Office of Policy, Food and Drug Administration, 5600 Fishers Lane, Room 14-101, HF-11, Rockville, MD 20857.

The drug's marketers, Biogen Idec and Elan,issued a letter to clinicians,  stating a warning about liver toxicity has been added to the natalizumab label.

The new warning informs the user that signs of liver injury "including markedly elevated serum hepatic enzymes and elevated total bilirubin" not only occurred within six days of initial doses, but also had "been reported for the first time after multiple doses."

One can only wonder how someone can feel safe taking this drug after reading such a warning.  I applaud the manufacturer for at least including the warning on the label now, so that the consumer can be fully aware of risks and side effects of this drug.

Click here to read more from Medpage Today on this new warning for natalizumab or click here to read more on Tysabri.

The Counsel for the Plaintiff argued the seat belt was called an "energy absorbent" belt and was designed with an extra 10 inches of overlapping fabric, that could break and cause the belt to extend. 

The Counsel for the Defense argued the loop of material installed on the front passenger seat was designed to help protect the passenger from head and chest injuries. The Defense attorneys are appealing the $11 million jury verdict.

Thankfully the driver's belt did not have any extra material, therefore he suffered only minor injures.

According to the National Highway Traffic Safety Administration's 2007 report of rollover crashes and outcomes, there were 10,553 fatalities involving rollovers in 2004. Florida came in third in the nation with 627 fatal Rollovers in Florida. Texas came in second in the nation with 876 fatal rollovers in Texas. California led the nation with 1068 fatal rollovers in California. Ironically, Montana led the nation percentage wise with 67% fatal rollovers in Montana.

Click here to read more of this case from the Daily Business Review and Click here to read more from NHTSA on Rollovers

Click here to read more on the RC2 settlement for Thomas the Tank Engine   

The FDA has announced an urgent nationwide recall of pre-filled Heparin and normal Saline Flushes that were manufactured by AM2 PAT, Inc. of Angier, a North Carolina based Company. The pre-filled syringes are contaminated with Serratia marcescens, which has resulted in patient infections. The products can be found under the brand names, Sierra Pre-Filled Inc. and B. Braun. They are sold in 3ml, 5ml sizes for Heparin and 3ml, 5ml and 10ml sizes for Normal Saline. Both products are sold as pre-filled syringes.

One lot under recall of this product 1003-02, Lot 070926H, Heparin IV flush syringes was found to be contaminated with Serratia marcescens, which has resulted in patient infections. The CDC  confirmed growth of Serratia marcescens from several unopened syringes of this product.

This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.

Consumers and user facilities who have any of these recalled pre-filled syringes, Heparin or Saline Lock Flush Solution USP, should stop using the product immediately. These products should be immediately quarantined in your inventory and returned to your distributor immediately.

The following information for this recall includes:

MANUFACTURER: Sierra Pre-Filled, Inc., Angier, North Carolina

PRODUCT DESCRIPTION: Heparin Lock Flush Solution USP, All Strengths and Sizes

Saline Lock Flush Solution USP, All Strengths and Sizes

LOT # NDC # CATALOG # Product Brand Name
All 64054-1003-02 1003-02 Heparin Lock Flush 100units/ml 5ml
64054-1003-01 1003-01 Heparin Lock Flush 100units/ml 3ml
64054-3005-02 3005-02 Heparin Lock Flush 10units/ml 5ml
64054-3003-02 3003-02 Heparin Lock Flush 10units/ml 3ml
64054-3003-06 3003-06 Heparin Lock Flush 10units/mL 3ml (6ml syringe)
64054-3005-06 3005-06 Heparin Lock Flush 10units/mL 5ml (6ml syringe)
64054-0910-2 0910-12 Normal Saline Flush 10ml
64054-0905-2 0905-12 Normal Saline Flush 5ml
64054-0903-2 0903-12 Normal Saline Flush 3ml

The products were recalled after bacterial contamination in some end user samples of product code 1003-02, Lot 070926H was found.

It appears from an ongoing Food and Drug Administration (FDA) inspection of AM2 PAT, Inc.’s facility that the firm is not in compliance with the Quality System regulation and failed to have adequate controls to ensure necessary sterility of its pre-filled syringes.

Consumers with questions may contact Sierra Pre-Filled at 919-552-9689, Monday through Friday, 10am-5pm Eastern Standard Time.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Pointsoflaw.com, provided an excellent summation of the Vioxx litigation in their  vioxx roundup yesterday. They cited several cases pending trials and gave updates on Merck. All eyes are on Merck. Let's see if their proposed vioxx settlement of $4.85 billion will make the jury trials go away. In a newswire release, Merck indicated that there are 50,000 Vioxx claimants. 

Only time will tell how this saga will end. Stay tuned...

John Michael Spinelli, gives a brilliant outline of both sides of the arguments, in his post on Daily Kos entitled "Ohio Supreme’ Ruling Good for Bad Bills, Bad for Good Juries". One point that he drives home in the post is that the ruling came from an all-Republican Supreme Court. One could gather from his clever intro "the best Republican Supreme Court money can buy" that he has strong feelings on this subject.

Chief Justice Moyer, writing for the majority opinion, states "The decision in this case affirms the General Assembly’s efforts over the last several decades to enact meaningful tort reforms. It also places Ohio firmly with the growing number of states that have found such reforms to be constitutional. However, the issue remains a contentious one across the nation, with several states finding such statutes unconstitutional."

Justice Paul Pfeifer, writing for the dissenting opinion states "Instead of jealously safeguarding the right to trial by jury, the majority opinion in this case eviscerates it by holding constitutional a statute that enables courts to ‘enter judgments in disregard of the jury’s verdict.’ Instead of jealously safeguarding the right to trial by jury, the majority opinion employs shallow reasoning and shoddy logic in concluding that juries can meaningfully determine only facts that do not conflict with predetermined assessments of the General Assembly. Instead of jealously safeguarding the right to trial by jury, the majority opinion "cleans the scalpel for the legislature to cut away unrestrainedly at the whole field of tort redress."

This case sends a resounding message to the legal community that the issue of tort reform will continue to be hotly debated.  The Ohio Supreme Court ruling will no doubt add fuel to the tort reform discussion.  Those in favor of tort reform, just received a check mark in their column with this decision.  One can only hope that this does not give corporations a false sense of security in future product liability cases.

Johnson & Johnson stock is trading at $67.43, yesterday, the day of the Ohio Supreme Court ruling,  it closed at $67.33.

To read more on this story, check out the following articles: Daily KOS, The Toledo Blade, Ohio State Supreme Court Slip Opinion No2007 -Ohio 6948