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Ethicon Media Monitoring 1/9/2018
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Woman appeals to Ottawa for temporary ban on female pelvic mesh
Jan 8, 2018 | CTV
By Avis Favaro
A woman harmed by transvaginal mesh has filed a petition to the House of Commons in Ottawa, demanding tougher regulations on plastic mesh used inside the human body. -
Why Physician Choice Matters In Medical Product Cases
Jan 8, 2018 | Law 360
By Luther Munford
...As argued by Defendants, non-mesh repair is not an alternative design and does not meet Plaintiff’s burden to support this particular claim. -
Boston Scientific Settles More than 370 Transvaginal Mesh Lawsuits
Jan 8, 2018 | RX Injury Help
By Sandy Liebhard
Boston Scientific has agreed to settle around 378 transvaginal mesh lawsuits, according to court papers released last month in the U.S. District Court, Southern District of West Virginia.
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Woman appeals to Ottawa for temporary ban on female pelvic mesh
Jan 8, 2018 | CTV
By Avis Favaro
A woman harmed by transvaginal mesh has filed a petition to the House of Commons in Ottawa, demanding tougher regulations on plastic mesh used inside the human body.
The e-petition was launched by Nonie Wideman, who suffered complications from mesh implanted in 2011 to treat stress urinary incontinence.
Wideman developed pain and severe fatigue, later discovering bits of blue plastic mesh were poking out of her vagina and urethra, with some ending up in her urine.
“I was so bloody sick and it was hard to get help," Wideman told CTV News from her home in Montney, B.C. "So I started investigating … what the hell had happened to me.”
In the process, she discovered thousands of other women in Canada and the U.S. and Europe who were also in chronic pain, suffering untreatable infections linked to mesh implants.
The recent death of an Ontario woman, Chrissy Brajcic, who had also suffered complications linked to mesh, spurred Wideman to launch the petition.
"It renewed my determination … that something has to be done more than has been done," she said.
The petition has over 350 signatures and needs 500 to be filed with the House of Commons. The goal is to change laws and regulations on implanted medical devices in Canada.
The e-petition, sponsored by MP Martin Shields from Bow River, Alta., highlights female pelvic mesh but includes all medical devices and materials. Shields was not available for comment for this story.
According to data from the Canadian Institute for Health Information, about 25,000 Canadians undergo surgical procedures each year for treatment of stress-urinary incontinence -- where the bladder accidentally leaks because the muscles are weakened by age or childbirth.
Another 5,000 procedures are done for pelvic-organ prolapse -- where internal muscles don't support pelvic organs to fall. In recent years, one of the most popular treatments involved mesh implants to support organs in the pelvis.
Yet a recent review for the British Medical Journal found that many of the products used in the U.S. were approved "on the basis of weak evidence over the last 20 years." They were green-lighted in Canada and Europe as well, with little if any new clinical testing.
The petition calls on Ottawa to:Restrict the use of surgical mesh to research trials -- where patients are followed for at least five years, to see the rates of problems and complications;Temporarily suspend the licensing use of plastic vaginal mesh implants until further studies are done on the risks versus the benefits;Design a stronger approval system for permanent medical implants; andMake available a registry of all implanted products and the patients who get them to watch for emerging complications, and to warn patients of potential problems.
"We felt that government needs to step up to the plate. Health Canada has not been forthcoming with information," said Wideman.
The petition is similar to measures introduced in the U.K., Australia and New Zealand. Women affected by mesh products have banded together in vocal advocacy groups calling for controls on mesh use, if not outright bans, until more studies are done.
Last year, Australia and New Zealand banned mesh products used to treat organ prolapse, calling them too risky. The mesh products are still widely in use in Canada, because surgeons say many women still benefit from the implants.
https://www.ctvnews.ca/health/woman-appeals-to-ottawa-for-temporary-ban-on-female-pelvic-mesh-1.3750700
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Why Physician Choice Matters In Medical Product Cases
Jan 8, 2018 | Law 360
By Luther Munford
When the law addresses medical judgment directly, it allows room for reasonable physician choice. It is ironic, then, that a product liability suit over a design defect may not allow any such room. In order to protect physician choice, courts need to resist the temptation to turn product liability disputes into a contest in which reasonable physician choice has no place.
In medical malpractice litigation, where the standard of care is directly in issue, there is room for diversity of opinion. The jury focuses on the doctor’s choices. And if, in the light of a diversity of medical opinion, the doctor’s conduct was reasonable, there is no liability. Steven. E. Pegalis, 1 Am. Law Med. Malp. § 3:3 (2017) (“reasonably applicable alternative methods of diagnosis or treatment” allowed).
As it is phrased in Pennsylvania, if there are “two schools of thought, the doctor is free to pick one over the other." Jones v. Chidester, 610 A.2d 964, 969 (Pa. 1992) (“school of thought” means “a considerable number of recognized and respected professionals”). See also Velazquez ex rel. Velazquez v. Portadin, 751 A.2d 102, 107-108 (N.J. 2000) (allowing practice with “substantial support as proper practice by the medical profession”) (quoting Schueler v. Strelinger, 204 A.2d 577, 585 (N.J. 1964)).
But in a product liability case over defective design, there may be no room for reasonable choice. Design defect law may ask a jury whether there is any “safer alternative” to a defendant’s device, and, if the jury believes there is, the defendant’s device may be found defective and presumably unsuitable for sale to anyone.
In fact, this question can arise whether or not there is a specific “safer alternative design” requirement in state law, because the plaintiff may simply offer such a design as evidence of unreasonable risk. In answering the question, the jury will be asked to choose which expert witness is “most credible” without any allowance for reasonable differences of opinion.
If the law is going to protect a doctor’s ability to exercise reasonable medical judgment in choosing among available devices and surgeries, the question is what needs to be done to keep the unsuitable instrument of design defect litigation – where the doctor may not even be a witness and there is no pre-suit screening panel — from taking away those choices. Only if the doctor has a choice can the doctor have the ability to determine the best method of treating the patient.
There are at least five ways design defect law can be shaped to protect doctor choice.
First, there is the question of actual doctor choice. Where the surgeon has chosen not to employ an alternative, perhaps because of the surgeon’s education, training and experience, the jury should not be allowed to find the manufacturer liable because a choice the surgeon rejected might be deemed by the jury to be “safer.” See Anderson v. PA Radocy & Sons Inc., 865 F. Supp. 522, 531 (N.D. Ind. 1994) (manufacturer not liable for employer’s decision to purchase uninsulated fiberglass bucket rather than insulated one); James. A. Henderson & Aaron. D. Twerski, Optional Safety Devices: Delegating Product Design Responsibility to the Market, 45 Ariz. St. L.J. 1399, 1417 (2013) (delegation to learned intermediary defeats design liability).
Second, a court should apply established product liability law principles and exclude from any list of “safer alternatives” those alternatives that present different advantages and disadvantages that require doctor choice, such as a different treatment or different surgery.
This is consistent with the way product liability generally protects consumer choice. It is generally accepted that, to be a “safer alternative design,” the design must be for the same product, not a different one. A different product may be safer in one respect, but if it serves different distinct purposes, it cannot provide a basis for finding the less safe product defective. Informed consumers remain free to choose, and manufacturers are allowed to innovate. The issue comes up in a variety of product liability contexts.
For example, the Fourth Circuit held in an early negligence case that, given the “peculiar purposes of [the] design” of a Volkswagen bus to provide room for passengers and cargo by placing the driver in front of the engine, a plaintiff could not argue that the design was unsafe because it was not as crashworthy as that of a passenger sedan. The court granted judgment as a matter of law for the defendant. Dreisonstok v. Volkswagenwerk A.G., 489 F.2d 1066, 1074 (4th Cir. 1974), followed in Restatement (Third) of Torts: Product Liability § 2, cmt. f, illus. 9 (1998).
Similarly, a safer bulletproof vest does not make a bulletproof vest with less coverage unreasonably dangerous when the vest allows a greater range of motion. Linegar v. Armour of Am. Inc., 909 F.2d 1150, 1154 (8th Cir. 1990); see also Hosford v. BRK Brands Inc., 223 So.3d 199, 208 (Ala. 2016) (smoke alarm not defective just because a more expensive dual-sensor alarm was sold).
This principle is particularly apt in the field of medical devices where different products offer different sets of benefits and complications and whose “safety” depends on professional judgment and, in the case of devices, surgical skill. Like the learned intermediary doctrine, device defect law should recognize that the doctor relies not only on what the manufacturer has supplied, but also “other medical literature, and any other source available to him, and … the personal medical history of his patient.” Lebowitz v. Ortho Pharmaceutical Corp, 307 A.2d 449, 457 (Pa. Super. 1973).
The Texas Court of Appeals so held in a hormone therapy case:
[A] plaintiff cannot prove that a safer alternative design exists by pointing to a substantially different product, even when the other product has the same general purpose as the allegedly defective product. ... Thus, a safer alternative design must be one for the product at issue. ... [Plaintiff] does not explain how [the drug] could have been modified or improved. ... In essence, [plaintiff] argues that the [drug] should have been a different product. ... But, as the supreme court has explained, Texas law does not recognize this sort of categorical attack on a product.
Brockert v. Wyeth Pharm. Inc., 287 S.W.3d 760, 770-71 (Tex. App. 2009). See also In re Propulsid Prod. Liab. Litig., No. MDL 1355, 2003 WL 367739, at *3-4 (E.D. La. Feb. 18, 2003) (alternative or different methods of treatment insufficient to prove alternative design).
In medical device cases, courts have held that different devices which perform in different ways cannot be treated as safer alternatives. The principal authorities come from the pedicle screw cases, where the courts refused to accept other fixation devices, such as those involving hooks and wires, as presenting safer alternative designs. The Fifth Circuit explicitly gave doctor choice as a primary reason for its holding. It said:
[Plaintiff] therefore argues that other products that do not use pedicle screws should be considered as alternative designs. ... Underlying this argument is the assumption that all pedicle screws are defective and there can be no system using pedicle screws that would be an acceptable product. The problem with this argument is that it really takes issue with the choice of treatment made by [plaintiff’s] physician, not with a specific fault of the pedicle screw sold by [defendant].
Theriot v. Danek Med. Inc., 168 F.3d 253, 255 (5th Cir. 1999).
Similarly, in other device cases it has been held that a treatment that uses no device at all cannot be considered as a safer alternative. As the United States District Court for the District of Nevada explained:
Neither is the Court swayed by Plaintiff’s argument that the testimony of [the expert] to the effect that Plaintiff’s [surgery] could have been accomplished without use of [the product]. The fact that an alternative method of [surgery] was potentially available does not support Plaintiff’s design defect claim. As argued by Defendants, non-mesh repair is not an alternative design and does not meet Plaintiff’s burden to support this particular claim.
Schmidt v. C.R. Bard Inc., No. 2:11-CV-00978-PMP, 2013 WL 3802804, at *2 (D. Nev. July 22, 2013).
While this rule would have its most direct application in states with a safer alternative design requirement, it would not be limited to those states. It should apply wherever alternative design is used as a basis for declaring a device unreasonably dangerous.
In Driesenstock, the Fourth Circuit’s Volkswagen bus case, the issue was whether the alternative could be used to prove the defendant’s negligence. And in Linegar, the Eighth Circuit’s bulletproof vest case, the question was whether the vest was unreasonably dangerous. In neither case was there a specific safer alternative design requirement. See James Beck, On Alternative Design, Take Two — Negligence, Drug and Device Law Blog (Feb. 27, 2017) (use of alternative design in negligence cases).
Third, even where the products might be very similar, the jury should not be asked to choose between two products where either one is supported by a “school of thought” or “substantial medical opinion.” From the “doctor’s choice” perspective, it is error for a court to intervene in the diagnosis and treatment of a patient in order to dictate the treatment of a patient when reasonable medical professionals could disagree.
For example, one court recognized the “same product” requirement but nevertheless said a jury could find that an alternative was safer if it did not alter “a fundamental and necessary characteristic of the product.” Hines v. Wyeth, No. CIV. A. 2:04-0690, 2011 WL 1990496, at *8 (S.D.W. Va. May 23, 2011) (citing Torkie-Tork v. Wyeth, 739 F. Supp. 2d 895, 900 (E.D. Va. 2010)). In that case the court said it was for the jury to decide whether natural progestin and synthetic progestin were different products. Id. at *9. But if either choice would be within the doctor’s standard of care, that difference should not matter.
Fourth, the principle of reasonable doctor choice could also be used to interpret comment k to the Restatement (Second) of Torts §402A. That comment rules out design defect liability for medical products if a proper warning is given and the device is “unavoidably unsafe.”
This has sometimes been incorrectly said to simply import a risk-utility test. Mullins v. Ethicon Inc., 117 F. Supp. 3d 810, 818-819 (S.D.W. Va. 2015). But a better reading would be to say that a medical product is “unavoidably unsafe” and so qualifies for comment k protection if its use, within the professional standard of care, presents a risk of injury to the patient. That would, for example, be true of nearly all implantable medical devices. See James Beck, Unavoidably Unsafe PMA Medical Devices, Drug and Device Law Blog (Nov. 30, 2017).
Finally, the principle of doctor choice might be a basis for excluding from evidence actions of the U.S. Food and Drug Administration based on a comparison of one treatment to another if both treatments were considered to be within the doctors’ standard of care. Congress has told the FDA that it is not to “limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient. …” 21 U.S.C. § 396 (2009).
Nevertheless, the FDA does take regulatory actions based not on independent judgments about safety and effectiveness but rather upon comparisons among methods of treatment. A negative comparison that failed to recognize reasonable doctor choice should be just as inadmissible as expert testimony that failed to apply the correct liability standard. See, e.g., United States v. Wintermute, 443 F.3d 993, 1001 (8th Cir. 2006).
If the principle of doctor choice were applied in design defect law, it would be necessary to decide what theories of design defect liability would survive. Certainly a device not considered to be within the standard of care would face liability if it were so egregiously dangerous as not to have any justifiable therapeutic use. Or if scientific testing proved a way to design the same product so that it was both safer and equally effective, that might be considered in some jurisdictions.
And none of this would directly affect liability for failure to warn, because any rule that rests on doctor’s choice has to assume that doctors are aware of the complications that may arise out of use of the device.Luther T. Munford is a member of Butler Snow LLP, based in Jackson, Mississippi. He is part of the firm’s appellate and written advocacy group, and concentrates his practice on appellate matters, media law, constitutional law, professional liability and product liability defense.
The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients, or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.https://www.law360.com/articles/999364/why-physician-choice-matters-in-medical-product-cases
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Boston Scientific Settles More than 370 Transvaginal Mesh Lawsuits
Jan 8, 2018 | RX Injury Help
By Sandy Liebhard
Sandy Liebhard is an Senior Partner at Bernstein Liebhard LLP
Boston Scientific has agreed to settle around 378 transvaginal mesh lawsuits, according to court papers released last month in the U.S. District Court, Southern District of West Virginia.
Joint motions seeking dismissal of the claims – which had been in litigation for about 5 years — were filed by the company and plaintiffs on December 13, 2017. The motions were granted the following day.
Details of the transvaginal mesh settlements have not been disclosed.Boston Scientific Transvaginal Mesh Settlements
Boston Scientific is just one of several medical device manufacturers who have been accused of marketing defective vaginal mesh to treat women suffering from pelvic organ prolapse and stress urinary incontinence. A number of cases involving the company’s implants have gone to trial in state and federal courts around the country, with various juries rendering verdicts for plaintiffs and defendants.
Boston Scientific announced its first transvaginal mesh settlement in April 2015, when it agreed to resolve 2,970 cases for about $119 million. At the time, the company was facing more than 25,000 vaginal mesh lawsuits nationwide. In a recent filing with the U.S. Securities and Exchange Commission, Boston Scientific acknowledged that it had been named a defendant in approximately 48,500 product liability claims involving its transvaginal mesh devices.
“As of October 25, 2017, we have entered into master settlement agreements in principle or are in final stages of entering one with certain plaintiffs’ counsel to resolve an aggregate of approximately 44,000 cases and claims,” the filing stated. “These master settlement agreements provide that the settlement and distribution of settlement funds to participating claimants are conditional upon, among other things, achieving minimum required claimant participation thresholds. Of the approximately 44,000 cases and claims, approximately 15,500 have met the conditions of the settlement and are final. All settlement agreements were entered into solely by way of compromise and without any admission or concession by us of any liability or wrongdoing.”Transvaginal Mesh Litigation
The litigation surrounding transvaginal mesh began to gain momentum in 2008, after the U.S. Food & Drug Administration (FDA) began investigating an increasing number of reports linking the products to serious and life-changing complications. In July 2011, the agency warned that transvaginal mesh complications associated with prolapse repair were not rare, a change from its previous position on the issue.
In 2016, the FDA reclassified transvaginal mesh indicated for prolapse repair as Class III (high risk) medical devices, making the implants ineligible for the agency’s 510(k) clearance program. This program allows devices to come to market without the benefit of human clinical trials as long as a manufacturer can show that the new product is “substantially equivalent” to a device that was already subject to the agency’s more stringent premarket approval process.
Other medical device makers involved in the massive transvaginal mesh litigation include Johnson & Johnson’s Ethicon, Inc. subsidiary, American Medical Systems, Inc., C.R. Bard, Inc., Coloplast Corp. and Cook Medical, Inc. Of 31 cases that have gone to trial nationwide, 22 have produced plaintiffs’ verdicts in excess of $1 million. While a large percentage of claims have been settled, thousands of transvaginal mesh lawsuits remain to be litigated.
https://www.rxinjuryhelp.com/news/2018/01/08/boston-scientific-settles-more-than-370-transvaginal-mesh-lawsuits/
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