Trial lawyers' ability to second guess the FDA on medical devices "neutered"

The US Supreme Court (SCOTUS) has dramatically shifted the balance of power in product liability lawsuits for makers of medical devices. By an 8-1 margin last week, the Justices decided that the tort system should not be a system that second guesses the scientific evaluations of the FDA on medical device designs. In the "Riegel Case", the Supreme Court concluded that the premarket approval process (PMA) would bar patients from later filing lawsuits.

This week they're hearing similar arguments over pharmaceuticals in Warner-Lambert v. Kent , a case from Michigan, click here to read about. The case was brought by plaintiffs who claim they were injured as a result of taking the diabetes pill, Rezulin, which has since been withdrawn from the US market. The plaintiffs claim the company withheld evidence from the F.D.A. of potential dangers to the liver that might have led the agency to deny an approval. They fighting against existing precedent from a 2001 case where the Supreme Court held that plaintiffs cannot sue based upon claims that a manufacturer defrauded the F.D.A.

While no one would reward fraud by industry, this claim has exploded by trial lawyers in all these cases and frequently comes down to statistical hair-splitting of published data rather then some "smoking gun" company memo. Even liberal jurist Steven Breyer has expressed frustration and skepticism of using state or federal courts to "retry" the FDA approval process before people unqualified to understand or interpret most of the studies and data that will be argued over. He posed the rhetorical question of who should be the arbiter of product safety during oral arguments yesterday,

An expert agency (the FDA) on the one hand or 12 people pulled randomly for a jury role who see before them only the people whom the drug hurt and don’t see those who need the drug to cure them?

This whole debate relates a little to the whole breast implant controversy from two decades ago where trial lawyers pulled off a multi-billion dollar shakedown of Dow Corning and others based on innuendo. We now have compelling safety studies from all over the world and universal treatment of these products by every western government health agency. It would appear these recent SCOTUS decisions would put the final stake in product liability cases relating to approved breast implant designs or materials. It's a little moot anyway, as trial lawyers largely haven't taken implant cases for years anyway as they're aware of the consensus body of of literature and know there's no money in it.

Rob

The ghost of "Bond Girls" past - What you can learn from Britt Eklund's aging face

You know you're having a bad week when you end up as a featured celebrity on Awful Plastic Surgery. Britt Eklund, former James Bond uber-chick, agent Mary Goodnight from 1974's "The Man With the Golden Gun" (the definitive Roger Moore-era Bond picture for my money), was the guest of honor last week with Awful Plastic Surgery zeroing in on her "trout pout" from over augmented lips. Poor Britt is still stinging from being voted in Entertainment Weekly (here) as the "6th Worst Bond Girl" in 2006 (Denise Richards character, Dr. Christmas Jones, the hot pants wearing nuclear physicist takes top honors for "The World Is Not Enough" BTW)

In 2007 that is usually achieved with an off the shelf filler like Juvederm or Restylane, while in years past it would have been collagen, fat grafts, or the occasional Gore-Tex implant.

Yeah, I guess her lips are pretty noticeably enlarged, but it was probably the least of her features that I zoned in on. She's got a very instructive feature on facial aging. Take note of her upper eyelids from her 20's versus her late 50's.

In her youth, she has full eyelids with very little upper lid skin showing. Presently, she has fairly hollowed out lids and lots of eyelid skin visible. These changes can happen naturally, but they're also the byproduct of classic upper lid blepharoplasty surgery. Many patients come in with the idea that a youthful eye should show lots of lid skin, such that they can apply lots of eyeshadow in that area.

Survey fashion magazines and take note of the models eyes. You'll see the same phenomena in that a youthful lid is full, quite often low, and shows little skin. We've undergone dramatic reinterpretation of oculoplastic procedures in recent years to recognize the actual problems. Gone is the axiom of taking as much skin, muscle, and fat so as to make the lid completely flat, even when the patient requests it. Many eyelid super specialists like Dr. Steve Fagien from Boca Raton,FL (the most elegant and logical speaker on this for my money) have gone to minimalist approaches resecting tiny amounts of skin, while using fat redraping,fat grafts, or fillers to augment the area.

Rob

Bedsores and surgery - an exercise in futility?

A little blurb in today's New York Times "Fighting Bedsores With a Team Approach" got me thinking about pressure sores

In the Plastic Surgery and wound care literature there are literally thousands of papers published re. to the surgical treatment of pressure sores ulcers. Many very elegant operations where soft tissue and muscle flaps are rotated to cover these wounds have been described.

These ulcers add an estimated burden nearly $10 Billion USD of expenditures and an additional 2.2 million Medicare hospital days to the United States healthcare system. The cost of treatment of large ulcers can approach nearly $50,000, depending on the stage of development. For reconstructive surgery candidates, costs might be an additional $25,000+ per patient in surgical charges. The actual costs of preventing and treating pressure ulcers in hospitals are not easy to figure as costs are distributed across many providers and settings for nursing and clinical care, but the likely overall costs are stunning, with perhaps 5% or more of our total healthcare costs attributable in some way to patient care involved with these wounds.



What's the dirty secret about these wounds?

Almost all approaches besides letting these wounds heal by scarring (secondary intention) have abysmal track records. Data from medicare patients and from the VAMC have suggested that in excess of 90% of these reoccur within a year. When you consider the tremendous expense of these surgeries and post-operative convalescence, you have to wonder why we've treated these the way we have. Increasingly, you're seeing more plastic surgeons no longer attempt such aggressive closures which is evidence-based medicine at work.

If you are going to try to close these wounds, you've got to pick your spots. The only people I consider good candidates for closure are high functioning young paraplegics and older patients who have a reversible condition that led to the ulcer (ie. a hip fracture). A patient who can't relieve pressure themselves is an absolute contraindication in most instances to me.


As developing pressure sores are one of the indicators of quality that hospitals are being penalized for by the feds, we're seeing alot more of these documented. Many of these patients are nursing home medicare beneficiaries who bring with them multiple medical comorbidities, thin skin, immobility, incontinence, and nutritional problems. It is literally impossible to prevent breakdowns over bony areas and that shouldn't be the goal. We should try to prevent them from progressing to advanced stages for pragmatic care of these patients.

Lawsuits over pressure sores are a growth industry for the trial lawyers. Frequently when you talk to patients' families, they have poor understanding of the how's and why's of why these wounds develop which contributes to their anger sometimes and leads to them suing the nursing home or hospital. I try to explain it in simple terms with the concept that it is unrealistic in vulnerable patients to prevent pressure sores indefinitely as it is impossible to deliver perfect nursing care 24/7/365. Breakdowns are inevitable and should be expected, and the goal should be to minimize the damage.

Rob

2008 Plastic Surgery Board Certification data

The American Board of Plastic Surgery has released it's 2008 data on it's most recent board-certification testing applicants. Board certification takes passing both a written exam followed by an oral examination in the next 1-2 years.

The failure rate for each exam traditionally hovers around 20% (19.6% for the written and 21.4% for the orals in 2007), which is highest among all the surgical specialties certification processes, and continues to reaffirm the general opinion that the ABPS exam is the most difficult to pass. Another thing to keep in mind is that due to the intense competition for training spots, even those 20% who failed either exam were likely among the top-performing students in their medical school classes (for those who were in "integrated" programs where you start out of medical school) or in their prerequisite surgical residencies.

You can check your doctor's board-certification status for free at the American Board of Medical Specialties (ABMS)site (click here). The ABMS is the American gold-standard for physician accredidation and is what people are referring to when they talk about "board certification". Please note that organizations like the American Academy of Cosmetic Surgery, The American Board of Cosmetic Surgery, and the American board of Cosmetic Gynecology(?)are not (and likely will never) be recognized by the ABMS.

The celebrity blog, Knifestyles of the Rich and Famous (LOVE that name!) had a post in December, "Doing Due Dilligence", (click here to read), which gives a little overview for the laypeople on this topic that's worth reading.

Rob

No Mom, no one has died from me giving them BOTOX.

Talk about the "Law of Unintended Consequence", the Drudge Report , highlighting a newswire link about the FDA looking at BOTOX-related deaths, has stirred up a bit of anxiety about one of the world's most popular cosmetic medicines. I've gotten a few patient emails over the last week asking about this. It even generated a phone call from my mother asking "Did you hear the FDA banned Botox?"

The newswire blub (here) doesn't really make clear what is being talked about with the "BOTOX deaths". The fatalities associated with have NOT been associated with cosmetic uses for wrinkles. The handful of deaths has mostly been in people being treated with high doses (MUCH in excess of cosmetic doses) for esophageal motility disorders and for spastic contractures in children with cerebral palsy.

Your esophagus is essentially a muscular tube, and botox has been used to relax overactive or chronically contracted muscle. A consequence of this is that you can facilitate aspiration of secretions into the lungs and cause acute repiratory distress. Like I mentioned before re. Donde West's death (see here) after cosmetic surgery, this type of aspiration was what I think was the reason she died suddenly.

Rob

Smiley boobs

Clever text "smiley boobs" from the Every Man For Himself blog.

My favorite is the vampire bite :)

(o)(o) perfect breasts
( + )( + ) fake silicone breasts
(*)(*) high nipple breasts
(@)(@) big nipple breasts (you know who you are)
o o a cups
{ O }{ O } d cups
(oYo) wonder bra breasts
( ^)( ^) cold breasts
(o)(O) lopsided breasts
(Q)(Q) pierced breasts
(p)(p) breasts w/hanging tassels
(:o)(o) bitten by a vampire breasts
\o/\o/ Grandma's breasts
( - )( - ) flat against the shower door breasts
(o) _ Breast cancer survivor breast


Rob