UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW HAMPSHIRE

Sarah Lampron and Walter Lampron

v. Civil No. 20-cv-317-JD Opinion No.

Ethicon, Inc. and Johnson and Johnson

O R D E R

Sarah and Walter Lampron bring a product liability action,

arising from injuries Sarah Lampron alleges that she incurred

from surgically implanted mesh made by Ethicon, Inc. The case

was recently transferred to this court from multidistrict

litigation, In re: Ethicon, Inc. Pelvic Repair Sys. Prod. Liab.

Litig., MDL No. 2327, (S.D.W. Va. filed on March 4, 2015). The

Lamprons move to preclude the defendants’ expert witness, Dr.

Joseph Carbone, from providing certain opinions.1 The defendants

object to the motion.

Standard of Review

The admissibility of expert opinion evidence is governed by

Federal Rule of Evidence 702. Rule 702 provides that “[a]

witness who is qualified as an expert by knowledge, skill,

1 The Lamprons appear to have filed the motion twice. Docs. Nos. 59 and 60. The defendants responded to document no. 60. experience, training, or education may testify in the form of an

opinion or otherwise if” four requirements are satisfied. Those

requirements are:

(a) the expert’s scientific, technical, or other specialized knowledge will help the trier of fact to under the evidence or to determine a fact in issue; (b) the testimony is based on sufficient facts or data; (c) the testimony is the product of reliable principles and methods, and (d) the expert has reliably applied the principles and methods to the facts of the case.

Fed. R. Evid. 702. The proponent of the expert’s opinion bears

the burden of showing that it is admissible. Milward v. Rust-

Oleum Corp.,

(1st Cir. 2016); United States v.

Tetioukhine,

(1st Cir. 2013).

Discussion

The Lamprons challenge Dr. Carbone’s opinions about the

safety and efficacy of the defendants’ mesh products, the design

of the products, and the adequacy of the warnings in the

instructions for use of the products. They contend that Dr.

Carbone is not qualified to give those opinions and that the

opinions are not reliable due to a lack of research to support

them. In response, the defendants argue that Dr. Carbone’s

clinical experience supports his opinions, that he is qualified

to give his opinions, and that his design opinions are based on

reliable methodology.

2 Dr. Carbone produced two reports that address different

products. One report addresses TVT, TVT-O, and TVT-Secur and

the other addresses Prolift. The Lamprons represent that the

two reports contain the same opinions.

A. Safety and Efficacy of Defendants’ Mesh Products

The Lamprons seek to exclude Dr. Carbone’s testimony about

safety and efficacy rates based on his own experience with the

defendants’ products. More specifically, the Lamprons object to

Dr. Carbone’s statement that he had no complications in using

Prolift. They contend that his opinion is not reliable because

it is based on an undisclosed summary prepared by his office

manager, because he did not do an investigation or a survey to

determine how many Prolift complications had occurred, and

because he did not consider Prolift separately from other

prolapse product failures. Due to the lack of data to support

the opinion, the Lamprons contend that they have no way to test

the reliability of Dr. Carbone’s opinion.

In response, the defendants contend that Dr. Carbone’s

opinion on safety and efficacy is reliable because it is based

on his forty or fifty mesh removal procedures and on his review

of relevant medical literature. They explain that Dr. Carbone

had his office manager code his removal procedures, based on the

International Classification of Diseases coding, to show whether

3 the removal was required due to erosion of the product. Based

on his office manager’s coding, Dr. Carbone decided that his

complication rate was slightly less that the rates reported in

medical literature. The defendants contend that Dr. Carbone’s

method was reliable and that he was not required to conduct any

other survey or investigation.

The defendants also state that the Lamprons’ attorney

elicited the complication rate opinion from Dr. Carbone during

his deposition and that Dr. Carbone did not include an opinion

in his expert reports about his own complication rates with the

defendants’ products.2 An expert opinion must be disclosed in an

expert report. Fed. R. Civ. P. 26(a)(2)(B)(i). A failure to

comply with that rule may be grounds to exclude the opinion,

even when the opinion was offered during a deposition. Fed. R.

Civ. P. 37(c)(1); see also Arrieta v. Hosp. Del Maestro,

, at *2 (D.P.R. July 13, 2018) (citing cases).

In addition to the disclosure error, the defendants have

not persuasively shown that Dr. Carbone’s opinion about his own

complication rate is based on a reliable methodology. The

2 It is unclear what significance the defendants place on that circumstance. The defendants argue, however, that other disclosed opinions are sufficient to meet their disclosure obligations. The opinions in the reports cited by the defendants do not appear to include the complication rate opinion that is based on Dr. Carbone’s office manager’s coding system.

4 defendants provide no information about International

Classification of Diseases coding or Dr. Carbone’s office

manager’s qualification and training to perform the coding that

is the basis for his opinion. Although those deficiencies might

be addressed through cross examination, the combination of the

lack of disclosure and the questionable methodology precludes

Dr. Carbone’s complication rate opinion. Therefore, Dr.

Carbone’s opinion about the safety and efficacy of the

defendants’ products, based on his own experience, is excluded.

B. Opinions on Safety and Efficacy of Design

The Lamprons challenge Dr. Carbone’s opinions that the

defendants’ products were reasonably safe for their intended

use, that their benefits outweigh the risks, and that they are

safer and more effective than non-mesh alternative products.

They contend that he lacks the knowledge and experience

necessary to be a design expert for purposes of those opinions.

The defendants contend that Dr. Carbone is qualified to provide

opinions about safety and efficacy of the design of the

defendants’ products based on his own clinical experience using

and removing their products.

The first challenged opinion is part of a section titled

“PROFESSIONAL ENDORSEMENTS.” It is not clear that Dr. Carbone

is providing his own opinions in that section. Instead, he

5 appears to be summarizing the opinions provided by medical

organizations and the FDA.

The second challenged opinion is a discussion about the

invention and use of Prolift products. Dr. Carbone’s discussion

concludes with the following:

In summary, Prolift has been demonstrated to be safe and effective. Longer term studies continue to show its efficacy and safety. While there have been claims of the mesh roping and curling by experts of the Plaintiff, when placed according to the IFU and the arms detensioned the mesh will lie flat. Claims have been made regarding alternative meshes being better however, the overall data show that the Type 1 macroporous Prolene mesh in Gynemesh PS is suitable for use in pelvic organ prolapse and the mesh has been studied more and for longer follow up than others. The theory that an even larger pore and lighter weight mesh would be better has not shown to be true. One such mesh, Vypro, was studied by the TVM Group and found to not be tolerable. Other meshes do not have a higher efficacy profile nor have the data shown them to be safer overall. There is still a risk of mesh exposure with the use of any mesh. As an example, the rates of exposure with Prolift+M which uses Ultrapro mesh are not lower than the rates in Prolift which uses Gynemesh PS. The data has demonstrated that both are suitable options to treat prolapse. Dyspareunia is always a risk with or without mesh and, as discussed earlier, the risk of dyspareunia, pelvic pain and sexual dysfunction with Prolift is no different than native tissue repairs. There have also been claims that the mesh degrades, is cytotoxic, leads to an adverse significant inflammatory response, and that it causes sarcoma formation or cancer. However, the clinical data is inconsistent with this theory as there are long-term studies of efficacy and safety. Additionally, the macroporous Prolene material has been studied in the body for up to 17 years showing its long-term biocompatibility. The data do not show a malignant risk.

Doc. 60-4, at *24-*25.

6 It is not entirely clear what specific opinions the

Lamprons seek to exclude as design opinions.3 To the extent Dr.

Carbone provides opinions about the safety and efficacy of the

defendants’ products based on his personal complication rate,

that opinion is excluded for the reasons stated above. To the

extent the challenged opinions are Dr. Carbone’s interpretations

of the medical literature, which seems to be the case, those

opinions may be challenged on cross examination based on the

infirmities raised by the Lamprons in their motion.

C. Opinions on Adequacy of Warnings

The Lamprons challenge Dr. Carbone’s opinions that the

warnings provided in the instructions for use of the defendants’

products are adequate. They contend that he lacks the necessary

expertise in warnings and has admitted that he is not an expert

on warnings, that he does not know the industry or regulatory

standards for warnings, does not know what standards Ethicon

used in composing its warnings, and does not rely on

instructions for use. In response, the defendants acknowledge

that Dr. Carbone’s opinions about the adequacy of the

3 The defendants state that Dr. Carbone does not provide any opinions on design of their products and cites a decision from the MDL that a challenge to Dr. Carbone’s design opinions was moot.

7 instructions for use are limited to whether the specific risks

of implanting mesh were included.

In the first challenged opinion, Dr. Carbone states:

Instructions for use (IFU) accompany all medical devices like the TVT. An IFU is not intended to serve as a comprehensive guide for a surgeon. Instead, it provides information about the device, the procedure, the indications, and warnings and precautions that the surgeon can use in conjunction with his or her training and experience. A reasonably prudent surgeon will be trained in pelvic floor surgery, with or without mesh, before he or she attempts to implant a TVT. An IFU only supplements that training and experience. The TVT IFU adequately warns of all risks and potential complications associated with the TVT. These risks are well known to the medical community. Even the FDA has acknowledged that that risks known to be common to pelvic floor surgery (even without mesh) include pain, infection, urinary problems, recurrent incontinence, pain during sexual intercourse (dyspareunia), bleeding, organ perforation, neuoro- muscular problems and vaginal scarring.1 The TVT IFU fairly and completely informs reasonably prudent surgeons about the TVT, including the procedure and the associated risks and potential complications.

1 FDA, Considerations About Surgical Mesh for SUI, April 2, 2013. U.S. Food and Drug Administration http://www.fda.gov/MedicalDevices/ProductsandMedicalPr ocedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm 345219.htm downloaded Feb 10, 2016.

Doc. 60-3, at *21. Given the acknowledged limitations, Dr.

Carbone’s opinion is limited to the highlighted paragraph and

the remainder is excluded.

In the second challenged opinion, Dr. Carbone states:

Instructions for use (IFU) accompany all medical devices like the Prolift. An IFU is not intended to

8 serve as a comprehensive guide for a surgeon. Instead, it provides information about the device, the procedure, the indications, and warnings and precautions that the surgeon can use in conjunction with his or her training and experience. A reasonably prudent surgeon will be trained in pelvic floor surgery, with or without mesh, before he or she attempts to implant a Prolift. An IFU only supplements that training and experience. The Prolift IFU adequately warned of all risks and potential complications associated with the Prolift. These risks were well known to the medical community.

Doc. 60-4, at *26. That statement does not include any opinion

about whether specific risks of implanting mesh were included in

the instructions for use. Therefore, that opinion is beyond the

allowable scope for Dr. Carbone and is excluded.

Conclusion

For the foregoing reasons, the plaintiffs’ motions to

preclude certain opinions by Dr. Carbone (documents 59 and 60)

are granted in part and denied in part as is provided above.

SO ORDERED.

______________________________ Joseph A. DiClerico, Jr. United States District Judge

June 8, 2020

cc: Counsel of record.

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