Thursday, December 16, 2010

9th Circuit and a recent Opinion Regarding "Injury in Fact" Requirements

Worth a read, a case involving Starbucks, a stolen laptop and ID Theft.   Hollow win for the Plaintiff.

The Ninth Circuit noted that under Washington law, "actual loss or damage is an essential element" of a negligence claim. The Court noted that  plaintiffs waived the argument that "anxiety constitutes actionable injury.

Find the decision here:

"Although we have not previously determined whether an increased risk of identity theft constitutes an injury-in-fact, we have addressed future harm in other contexts, holding that “the possibility of future injury may be sufficient to confer standing on plaintiffs; threatened injury constitutes ‘injury in fact.’ ” Cent. Delta Water Agency, 306 F.3d at 947. More specifically, [a] plaintiff may allege a future injury in order to comply with [the injury-in-fact] requirement, but only if he or she “is immediately in danger of sustaining some direct injury as the result of the challenged . . . conduct and the injury or threat of injury is both real and immediate, not conjectural or hypothetical."

FDA Says More Scrutiny Over Dietary Supplements

Logo of the United States Office of Dietary Su...Image via WikipediaThe FDA took new steps aimed at keeping consumers safe from harmful products that are marketed as dietary supplements and that contain undeclared or deceptively labeled ingredients. The FDA has found that these products are often promoted for weight loss, sexual enhancement, and bodybuilding.

 From the FDA site:

Among the substances found in products that are marketed as dietary supplements and that contain hidden or deceptively labeled ingredients are
  • the active ingredients in FDA-approved drugs or their analogs (closely-related drugs).
  • other compounds, such as novel synthetic steroids, that do not qualify as dietary ingredients. 
Where FDA investigations have discovered tainted products marketed as dietary supplements, the agency has issued warning letters and conducted seizures and criminal prosecutions.

FDA has also alerted consumers to hundreds of products with these often deceptively labeled and harmful ingredients, including more than 80 products marketed for sexual enhancement, more than 70 products marketed for weight loss, and more than 80 products marketed for bodybuilding.

Interesting: We've been working on cases involving unsafe supplements for several years, and to me the problem is getting worse, not better. Let's see how the FDA moves on this.

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Tuesday, December 14, 2010

Florida Law: Appellate Court Reverses Trial Court Over Discovery Limits

An interesting decision from the Florida 4th DCA. It goes to show what lengths a corporate defendant will go to keep information from being disclosed (in this case, four years of 'protracted' fights).  From the appellate opinion:

It is said in this case that a trial judge unreasonably curtailed one party's pretrial discovery of directly relevant, valid and reliable information reasonably calculated to lead to admissible evidence. The argument is that the critical information about the subject matter was lodged solely with the adverse party, but the court's errant discovery restrictions resulted in one-sided evidence before the jury. Hence, there was a verdict based on faulty, defective information. It is contended that the resulting judgment must be reversed and the case returned to the trial court to allow the full measure of discovery in accord with the principles and purposes of the rules governing that process.
The underlying action was based on a personal wreck involving a fatality. The Plaintiff claimed that a tire tread separation caused a wreck, and Cooper Tire was sued.   The principal issue for discovery centered on the issue of whether the tire was defective and unreasonably dangerous in ordinary operation. Equally critical to discovery's scope was Cooper Tire's "state-of-the-art" affirmative defense.

When certain documents were sought, the Defendant filed numerous motions to keep the discovery out of the hands of the Plaintiff. Typical, you say. In this case, there was at least one evidentiary hearing that last four days, and there were 'protracted hearing over the span of four years." This fight continued over the course of two judges assigned to the action.

I reversing the lower court, the 4th DCA wrote this critical explanation that discovery should have been permitted on the issue of tire tread separation:

It  is difficult to comprehend any valid basis for concluding that it could not possibly have affected the jury's consideration of the claims and defenses. This was evidence from Cooper Tire's own design and manufacturing processes of all its models of passenger-light truck tires. What might be thought by reasonable jurors as merely an anomaly if found in only a single model tire quite reasonably could be seen as strong evidence of design defects if found in tires across the spectrum of the kind of product at issue. Denying plaintiff the discovery of this evidence from Cooper Tire itself is the equivalent of denying Cooper Tire discovery from plaintiff as to the use of seatbelts and maintenance of the tires, as well as of the financial and emotional effects of the death of the decedent on the members of his family.

A good read not only for the rules regarding discovery, but for the lengths a party will to to thwart the very purpose of the rules.

Find the case here:

A Work Break: 2008 Snowfall in New Orleans

FDA takes a Look at Mercury in Tooth Fillings

An amalgam used as a restorative material in a...Image via WikipediaFour consumer advocacy organizations have challenged the FDA's March 2009 ruling about mercury fillings or amalgams. From 2009 on the FDA site:

The U.S. Food and Drug Administration today issued a final regulation classifying dental amalgam and its component parts – elemental mercury and a powder alloy—used in dental fillings. While elemental mercury has been associated with adverse health effects at high exposures, the levels released by dental amalgam fillings are not high enough to cause harm in patients.

The regulation classifies dental amalgam into Class II (moderate risk). By classifying a device into Class II, the FDA can impose special controls (in addition to general controls such as good manufacturing practices that apply to all medical devices regardless of risk) to provide reasonable assurance of the safety and effectiveness of the device.

The special controls that the FDA is imposing on dental amalgam are contained in a guidance document that contains, among other things, recommendations on performance testing, device composition, and labeling statements.

Specifically, the FDA recommended that the product labeling include:
  • A warning against the use of dental amalgam in patients with mercury allergy;
  • A warning that dental professionals use adequate ventilation when handling dental amalgam;
  • A statement discussing the scientific evidence on the benefits and risk of dental amalgam, including the risks of inhaled mercury vapor. The statement will help dentists and patients make informed decisions about the use of dental amalgam.

 The advocacy groups cite new studies pointing to neurological conditions and even Alzheimer's disease as consequences of some people's dental work. The organizations are asking the FDA's dental-products panel to, at the very least, reclassify the amalgam to bar its use in pregnant women and children. According to the news reports, "groups are also accusing the FDA and the American Dental Association of maintaining too cozy a relationship with the dental products industry."

Interesting reading from newsday, where you can find the article:
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Friday, December 10, 2010

More Good News about Amazing Aspirin

"Baby" AspirinFrom NPR:

I'm one of those guys who takes an aspirin daily. So, I read this news with interest:

A British study claims evidence that aspirin can prevent death from a variety of cancers, if you take the medicine long enough in middle age. Even a baby aspirin might be enough.

 Published in The Lancet, the study suggests aspirin could provide protection against a wide variety of tumors. They range from pancreatic cancer to the type of lung cancer that strikes nonsmokers.

For some of these cancers, the reduction in death was noteworthy. Twenty years after people had started taking aspirin regularly (and kept it up for at least five years), their deaths from esophageal cancer were reduced by 60 percent compared to study subjects who got a placebo.
Read more: 
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Levaquine: Verdict for Plaintiff in first trial -Jury's Discussion Point? Responsibility

NOT FOR SALEImage by Ricky Romero via FlickrYesterday a jury in Minneapolis today awarded a verdict in the case of John Schedin, who sued J&J and its Ortho-McNeil-Janssen Pharmaceuticals unit in 2008. Schedin said he ruptured both Achilles tendons after taking Levaquin. He claimed the companies failed to warn doctors and patients of the drug’s association with tendon damage.

This is the first case of more than 2,600 claims in U.S. courts alleging that Levaquin caused tendon damage in patients and that J&J failed to disclose the risk adequately.

In a report, particularly telling is a juror's statement: “We talked a lot about the responsibility the company had to the general public, as far as safety goes,” Zach Rawson, a juror from Rochester, Minnesota, said after the trial. “ We felt that they didn’t warn adequately, that they didn’t use enough means of warning the public, especially the doctors.”

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Vanity Fair's Must Read: Deadly Medicine

flickr pills - you should check how many you n...Image by higlu via FlickrA gripping article in Vanity Fair this month take a look at the outsourcing of clinical trials for proposed prescription drugs.

It's an eye opener. "Many of today’s trials still take place in developed countries, such as Britain, Italy, and Japan. But thousands are taking place in countries with large concentrations of poor, often illiterate people, who in some cases sign consent forms with a thumbprint, or scratch an “X.” 

Since the first week of posts on this blog, I have been critical of the FDA and many of the rules, regulations, and efforts by this guardian of the citizens to keep big pharma companies working in a safer way. The FDA fails people like you and me. An excerpt:

One big factor in the shift of clinical trials to foreign countries is a loophole in F.D.A. regulations: if studies in the United States suggest that a drug has no benefit, trials from abroad can often be used in their stead to secure F.D.A. approval. There’s even a term for countries that have shown themselves to be especially amenable when drug companies need positive data fast: they’re called “rescue countries.”

 This article - a 21st century version, in shorter form, of The Jungle.  

Read it here:

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Tuesday, December 07, 2010

December 7, 2010 Darvocet Legal Recall News and Updates

Some folks are asking why did it take 30 years to pull Darvocet/Darvon off the market? As Dr. Sidney Wolfe, a drug expert at Public Citizen in Washington, D.C.,has said to many reporters: "Propoxyphene has been one of the top 50-selling drugs for at least 40 years," and its sales have generated huge profits for drug companies. Yet its dangers have been well known for most of that time.

Estimates are that several thousand people died as a result of taking the drug, countless others developed serious medical problems, and millions wasted money on an expensive painkiller that didn't work.
Over the years, many experts called for the removal of propoxyphene, but those calls were routinely ignored. Public Citizen petitioned the FDA to ban the drug in 1978 and again in 2006; finally, the group sued the FDA in 2008.

Six years ago, the drug was banned in the United Kingdom based on data that it didn't work and, at doses only slightly above those often prescribed, leads to accidental overdoses. 

In 2004, British health authorities ordered a phased withdrawal of the drug, known in the U.K. as co-proxamol. It was withdrawn gradually rather than immediately because the narcotic has addictive properties and patients require adequate time to switch to other painkillers.

From the BBC in 2004: A popular painkiller is being withdrawn from the UK market over concerns about links with suicide. Co-proxamol, used by thousands for conditions such as back pain, will be phased out over the next year or two. Data showed fatal overdoses due to co-proxamol are the second most frequent means of suicide with prescribed drugs in England and Wales, accounting for up to 400 deaths each year.The risk of death associated with co-proxamol overdose seems to be higher than for either tricyclic antidepressants or paracetamol.

According to British health authorities, the drug was banned because “each year there are 300- 400 fatalities following deliberate or accidental drug overdose involving propoxyphene/acetaminophen in England and Wales alone. Approximately one-fifth [60-80] of these deaths are considered to be accidental.” The British government further stated that the drug’s effectiveness “is poorly established and the risk of toxicity in overdose, both accidental and deliberate, is unacceptable.... It has not been possible to identify any patient group in whom the risk-benefit [ratio] may be positive.”

Finally in 2008 the UK banned it outright. Interestingly, the UK's role seemed to be to reduce suicides, as opposed to concerns about heart conditions. 

Read more here:

Read more:

Read more:

Monday, December 06, 2010

Prempro: Verdict for the Defendant

Wyeth  properly warned a Virginia woman’s doctors about the risks of its Prempro menopause drug, a jury ruled today in rejecting her claim for damages. The Plaintiff was Ms. Torkie -Tork.

The verdict was reached in USDCT in Alexandria, Virginia last week. It took just a few hours to reach the result. Wyeth has now successfully defended four lawsuits in a row.

Also last week the Nevada Supreme Court last week affirmed a $57.6 million award to three women who said  Prempro was the cause of the cancer each suffered. The verdict included $35 million in punitive damages the panel handed down in 2007 over Wyeth officials’ mishandling of the drug.


Sunday, December 05, 2010

Google Earth: Using it as Demonstrative Evidence

Google EarthFound this from another lawyer on the web:

State ex rel J.B., Case No. A-2228-08T4 (N.J. Ct. App.; Sept. 27, 2010)  

Some key language in the opinion:

The [c]ourt finds that other than very recently what would have happened is . . . that the State would have brought in an atlas map and ask[ed] somebody familiar with the area to point on the map where different locations are and how you would get there. And this is just an updated manner of getting the same information. If the [d]efense wants to show that the information is incorrect, they can certainly do it by either cross examination or they can do exactly what I just suggested and bring in an atlas map and show where the exhibit that the State is offering is incorrect.

Pretty sound reasoning in my view.

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Saturday, December 04, 2010

Keeping an Eye on Lupron News

Lupron As Hormone Therapy

Abbott Labs is the marker of Lupron, more commonly referred to as leuprolide. Lupron is supposed to help both men and women's sexual health, ailing in the treatment of prostate cancer for men and helping to combat endometriosis in women. The medication may also be used for early puberty.

There are five types of Lupron that can be injected under a patients skin to help with his or her hormone therapy. The kinds of Lupron are:
  • Lupron Depot 30
  • Lupron Depot 22.5
  • Lupron Depot 7.5
  • Lupron Depot 11.25
  • Lupron Depot 3.75 
There are side effects of this drug, including:

There is a long list of potential side effects linked to Lupron. Some apply only to men and others affect just women, but others, such as chronic muscle pain, have been reported in both sexes.
Lupron side effects that have been documented are:
  • Chronic muscle pain and weakness
  • Back pain
  • Joint pain
  • Limb pain
  • Urine with blood in it
  • Diarrhea
  • Severe headaches
  • Vomiting
  • Muscle atrophy
  • Depression
  • Decreasing of hemoglobin
  • Decreasing of hematocrit
  • Bone density changes
  • Loss of the sense of smell
  • Loss of the sense of taste
  • Enlargement and sensitivity to breasts (women)
  • Decrease in size of testicles (men)
  • Erectile dysfunction (men)
  • Decreased sexual desire (both men and women)
  • Thyroid problems 
In October, the FDA issued an update about Lupron:

The U.S. Food and Drug Administration (FDA) has notified the manufacturers of the Gonadotropin-Releasing Hormone (GnRH) agonists of the need to add new safety information to the Warnings and Precautions section of the drug labels. This new information warns about increased risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, stroke) in men receiving these medications for the treatment of prostate cancer. FDA’s notification to manufacturers of GnRH agonists to add this safety information is based on the Agency’s review of several published studies1-7, described in the Agency’s Ongoing Safety Review of GnRH Agonists and possible increased risk of diabetes and certain cardiovascular diseases, issued in May 2010.
GnRH agonists are approved to treat the symptoms (palliative treatment) of advanced prostate cancer. The benefits of GnRH agonist use for earlier stages of prostate cancer that have not spread (non-metastatic prostate cancer) have not been established.
Although the risk for diabetes and cardiovascular diseases appears to be low in men receiving GnRH agonists for prostate cancer, it is important for healthcare professionals to evaluate patients for risk factors for these diseases. Healthcare professionals should always carefully weigh the benefits and risks of using GnRH agonists before determining appropriate treatment for prostate cancer.
Patients who are receiving treatment with GnRH agonists should undergo periodic monitoring of blood glucose and/or glycosylated hemoglobin (HbA1c). Increased blood glucose levels may represent development of diabetes or worsening of blood glucose control in patients with diabetes. Healthcare professionals should also monitor patients for signs and symptoms suggestive of development of cardiovascular disease and manage according to current clinical practice.
Additional Information for Patients
  • GnRH agonists are sold as the brand names – Lupron, Zoladex, Trelstar, Viadur, and Eligard.
  • Before receiving GnRH agonists, tell your healthcare professional if you have diabetes, heart disease, a previous heart attack or stroke, or any cardiovascular risk factors like high blood pressure, high cholesterol, or cigarette smoking.
  • If you have any concerns about receiving these medicines, talk to your healthcare professional.
  • Report any side effects from the use of GnRH agonists to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of the page.

Thursday, December 02, 2010

Drug Induced Liver Injuries from Anti-microbial Medications

This month there will be a report released in Hepatology journal that suggest that anti-microbial medications are a common cause of drug-induced liver injury (DILI) leading to acute liver failure or ALF. Acute liver failure is the appearance of severe complications rapidly after the first signs of liver disease (such as jaundice), and indicates that the liver has sustained severe damage (loss of function of 80-90% of liver cells). The complications are hepatic encephalopathy and impaired protein synthesis (as measured by the levels of serum albumin and the prothrombin time in the blood). Source

What could be the cause? More than 1100 drugs, herbal remedies, natural products, vitamins, minerals, and dietary supplements are known to cause liver injury.
(You may find the abstract here:

Detailed case reports were collected from 1,198 subjects with ALF enrolled at 23 sites participating in the National Institutes of Health-funded Acute Liver Failure Study Group. The findings included evidence that showed high female predominance in DILI ALF, suggesting that women may be more susceptible to liver injury or use more prescription drugs than men.

What were the types of drugs and products? More than sixty, alone or in combination, could cause liver injury and failure in the study population. Anti-microbial agents were found to be the most common cause of DILI ALF cases and included anti-tuberculosis drugs (25), sulphur-containing drugs (12), nitrofurantoin (12), other antibiotics (7), antifungal agents (6), and anti-retroviral drugs (4).

So, what type of drugs/brand names might make this sub group of 60? Examples of drugs that can cause acute liver hepatitis include acetaminophen (Tylenol), phenytoin (Dilantin), aspirin, isoniazid (Nydrazid, Laniazid), diclofenac (Voltaren), and amoxicillin/clavulanic acid (Augmentin). Examples of drugs that can cause chronic hepatitis include minocycline (Minocin), nitrofurantoin (Furadantin, Macrodantin), phenytoin (Dilantin), propylthiouracil, and fenofibrate (Tricor). The Merck Manual has a comprehensive list as well:


Patients who develop ALF after taking these  typically did not experience a spontaneous recovery—the transplant-free survival rate in this study was 27%. 

Stay tuned for the full article. 

Wednesday, December 01, 2010

12/1/10 Darvocet Legal: FDA Drug Safety Podcast for Healthcare Professionals: FDA recommends against the continued use of propoxyphen

Good stuff in this transcript from the FDA's podcast:

Welcome, my name is Mary Kremzner, a pharmacist in the Division of Drug Information. On November 19, 2010, the Food and Drug Administration issued a Drug Safety Communication recommending against continued prescribing and use of the pain reliever propoxyphene because new data show that the drug can cause serious toxicity to the heart, even when used at therapeutic doses. FDA has requested that companies voluntarily withdraw propoxyphene from the United States market.
Propoxyphene is an opioid pain reliever used to treat mild to moderate pain. It is sold under various names as a single-ingredient product, for example Darvon, and as part of a combination product with acetaminophen, named Darvocet.

FDA's recommendation is based on all available data including data from a new study that evaluated the effects that increasing doses of propoxyphene have on the heart. The results of the new study showed that when propoxyphene was taken at therapeutic doses, there were significant changes to the electrical activity of the heart: prolonged PR interval, widened QRS complex and prolonged QT interval. These changes, which can be seen on an electrocardiogram, or EKG, can increase the risk for serious abnormal heart rhythms. FDA has concluded that the safety risks of propoxyphene outweigh its benefits for pain relief at recommended doses.

In July 2009, FDA announced an ongoing safety review of propoxyphene, which included evaluating its potential effects on the heart.

Following receipt of a Citizen Petition requesting the withdrawal of propoxyphene-containing products from the United States market, FDA convened an Advisory Committee meeting on January 30, 2009. After presentations by FDA, the petitioner, and the company reviewing the efficacy and safety data from the propoxyphene drug applications, the literature and postmarketing safety databases, the committee voted by a narrow margin of 14-to-12 against the continued marketing of propoxyphene products. Those who voted for propoxyphene to remain on the market advised requiring improved labeling, particularly with warnings about use in elderly patients and about use with concomitant opioids or alcohol. Finally, there was general agreement that additional information about the cardiac effects of propoxyphene would be relevant in further weighing the risk and benefit. As a result, under new authorities given to FDA by the Food and Drug Administration Amendments Act, the agency required the drug manufacturer to conduct a thorough QT study to formally evaluate the effects of propoxyphene on cardiac electrophysiology. In order to determine a safe supratherapeutic dose to incorporate into the Thorough QT study, FDA required the drug manufacturer to first conduct a multiple-ascending dose study or MAD.

The MAD study was a randomized, double-blind, placebo-controlled sequential multiple-ascending dose study of propoxyphene for 11 days. The study was conducted in healthy volunteers. The first cohort of study subjects was dosed with a total daily dose of 600 mg of propoxyphene (the maximum labeled dose) and the second cohort was dosed with a total daily dose of 900 mg. Additional doses were planned, however the study was placed on clinical hold due to safety concerns. Study subjects were monitored with telemetry and intermittent EKG recordings, comparable to the monitoring that would occur during a Thorough QT study.

The drug manufacturer has submitted to FDA the results from the 600 mg and 900 mg cohorts.
Significant QTc interval prolongations were observed with the propoxyphene 600 mg and 900 mg dose levels. With the 600 mg daily dose, at steady state on Treatment Day 11, the largest mean change of QTc was 29.8 milliseconds, which occurred 7 hours after the last dose; with the 900 mg dose the largest mean change was 38.2 milliseconds, which occurred 2 hours after the last dose. It is recognized in the International Conference on Harmonisation, or ICH, E14 Guideline1 that drugs that prolong the mean QT/QTc interval by >20 milliseconds have a substantially increased likelihood of being proarrhythmic. In addition, a dose-dependent prolongation of PR and QRS intervals was observed in the study.
Because the elderly and patients with renal insufficiency have a reduction in the clearance of propoxyphene and its cardioactive metabolite, norpropoxyphene, through the kidneys, these populations can be especially susceptible to proarrhythmic effects of the drug.
At this time, FDA recommends that Healthcare Professionals:
  1. Stop prescribing and dispensing propoxyphene-containing products to patients.
  2. Contact patients currently taking propoxyphene-containing products and ask them to discontinue the drug.
  3. Inform patients of the risks associated with propoxyphene.
  4. Discuss alternative pain management strategies other than propoxyphene with your patients.
  5. Be aware of the possible risk of cardiac conduction abnormalities, for example prolonged QT, PR, and QRS intervals, in patients taking propoxyphene and assess patients for these events if they present with any signs or symptoms of arrhythmia.
  6. Report any side effects with propoxyphene to FDA's MedWatch program at

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Align Technologies and Invisalign get FDA Warning Letter


Align Technology, which markets its Invisalign system to reposition teeth, disclosed Tuesday that it received the warning letter from the Food and Drug Administration on Nov. 18 and that it has since provided the agency with information it hopes will resolve the matter.

After being inspected by the FDA this summer, Align sent the agency a response to its concerns Nov. 8, the company said. But that response, which spelled out "the actions Align has completed and plans to complete" to address the agency's concerns, "may have crossed the mail with the FDA's warning letter," General Counsel Roger George said in a statement.

FDA officials in San Francisco who sent the letter could not be reached for comment. But their warning accused the company of failing to comply with federal reporting requirements covering medical devices that contribute to serious injury or death.
 In March 2008, a patient complained of "injuries of swelling that could be life-threatening" after using the device, the FDA also said. In May of this year, it added, a patient reported "a burning tongue sensation, sore throat, ulcerations in the mouth and swollen lymph nodes."
Source here: 

Here is the letter:



November 17, 2010

Mr. Thomas M. Prescott
President and Chief Executive Officer
Align Technology, Inc.
2560 Orchard Parkway
San Jose, California 95131
Dear Mr. Prescott:
During an inspection of your firm located in San Jose, California on June 29, 2010, through August 9, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Invisalign System, including orthodontic devices and appliances. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.

Our inspection revealed that your Invisalign System, including orthodontic devices and appliances are misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.c. 360i, and 21 CFR Part 803 - Medical Device Reporting (MDR) regulation. We received a response from Mr. David Kolesar, Director, Regulatory Affairs and Quality Systems dated August 26, 2010, concerning our investigator's observations noted on the Form FDA 483, List of lnspectional Observations that was issued to you. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to submit reports of individual adverse events no later than 30 calendar days after the day that you receive or otherwise become aware of information, from any source, that reasonably suggests that a device that you market may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1). For example, Complaint Identification Number (b)(4) documents a patient received steroids for the treatment of adverse events which occurred subsequent to the use of your Invisalign System. You became aware on March 17, 2008, of this event in which the device caused or contributed to the injuries of swelling that could be life threatening.
We have reviewed your response and have concluded that we cannot determine the adequacy at this time because your firm has not provided adequate documented evidence of written implemented corrections and corrective actions taken on this deficiency observed during the inspection. Specifically, your firm did not provide documentation of your revised standard operating procedures (SOPs), and revised forms.
2. Failure to submit reports of individual adverse events no later than 30 calendar days after the day that you receive or otherwise become aware of information, from any source, that reasonably suggests that a device that you market has malfunctioned and this device or a similar device that you market would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2). For example:
a. Complaint Identification Number (b)(4), received on November 2, 2007, documents a patient experienced "swollen, irritated and sore lips and additionally her gingival is also swollen". You have evidence from complaints received and filed as MDRs prior to this event that similar incidents required hospitalization. You also have documentation that the patient discontinued the use of the device to avoid further risk of further adverse events.
b. Complaint Identification Number (b)(4), received on May 11, 2010, documents that a patient experienced a burning tongue sensation, sore throat, ulcerations in the mouth and swollen lymph nodes. Based on previous events documented by Align Technology, Inc., your firm has knowledge that this device would be likely to cause or contribute to a death or serious injury if the event were to recur.
We have reviewed your response and have concluded that we cannot determine the adequacy at this time because your firm has not provided adequate documented evidence of written implemented corrections and corrective actions taken on this deficiency observed during the inspection. Specifically, your firm did not provide documentation of your revised standard operating procedures (SOPs), and revised forms.

You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties.

Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be sent to: Mr. Russell A. Campbell, Compliance Officer, San Francisco District, U.S. Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, California 94502. If you have any questions about the content of this letter, please contact Mr. Campbell at (510) 337-6861 begin_of_the_skype_highlighting              (510) 337-6861      end_of_the_skype_highlighting.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
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